Legal Issues in COVID-19 Vaccine Development and Deployment

Changes from June 8, 2020 to November 25, 2020

This page shows textual changes in the document between the two versions indicated in the dates above. Textual matter removed in the later version is indicated with ~~red strikethrough~~ and textual matter added in the later version is indicated with blue.

Legal Issues in COVID-19 Vaccine Development ~~June 8~~November 25, 2020 and Deployment Kevin J. Hickey ~~, 2020~~
Private companies, universities, and governmental entities are Private companies, universities, and governmental entities are ~~wo rking~~working to develop a vaccine for to develop a vaccine for
Legislative Attorney coronavirus disease 2019 (COVID-19).coronavirus disease 2019 (COVID-19). Vaccines are biological products regulated under the Vaccines are biological products regulated under the
~~Kevin J. Hickey~~
Public Health Service Act Public Health Service Act ~~(PHSA)~~ and the Federal Food, and the Federal Food, ~~Dru g~~Drug, and Cosmetic Act (FD&C Act). , and Cosmetic Act (FD&C Act).
~~Legislative Attorney~~
~~New~~ New Wen W. Shen vaccines must generally be licensed by the U.S. Food & Drug Administration (FDA) before vaccines must generally be licensed by the U.S. Food & Drug Administration (FDA) before

~~they~~ they Legislative Attorney can be marketed and used in the United States. To obtain licensure, the vaccine must be can be marketed and used in the United States. To obtain licensure, the vaccine must be
tested in tested in human subjects through clinical trials. The clinical trials inform the dosing schedule and human subjects through clinical trials. The clinical trials inform the dosing schedule and
~~Erin H. Ward~~
labeling that will be used for the approved vaccine. Sponsors use the data from clinical trials, labeling that will be used for the approved vaccine. Sponsors use the data from clinical trials,
~~Legislative Attorney~~

~~along with~~ along with Erin H. Ward other information, to prepare a biologics license application (BLA) to submit to FDA. other information, to prepare a biologics license application (BLA) to submit to FDA.
~~FDA~~ FDA Legislative Attorney approves the BLA if it determines that the vaccine is safe, potent, and pure. approves the BLA if it determines that the vaccine is safe, potent, and pure.

Because the development and review process can be lengthy, the FD&C Act provides several Because the development and review process can be lengthy, the FD&C Act provides several avenues to accelerate this avenues to accelerate this
process for pharmaceutical products intended to treat or prevent serious diseases or conditions. FDA may grant fast track process for pharmaceutical products intended to treat or prevent serious diseases or conditions. FDA may grant fast track
product and breakthrough-therapy designation at the sponsor’s request for products that are intended to fill an unmet need or product and breakthrough-therapy designation at the sponsor’s request for products that are intended to fill an unmet need or
~~improve on~~improve existing therapies. Both designations entitle the sponsor to increased communication with FDA existing therapies. Both designations entitle the sponsor to increased communication with FDA ~~regarding the~~
~~clinical trial design and data collected, as well as~~and rolling review of the BLA. Products may also qualify for accelerated rolling review of the BLA. Products may also qualify for accelerated
approval based on intermediate or surrogate endpoints likely to predict a clinical benefit. approval based on intermediate or surrogate endpoints likely to predict a clinical benefit. ~~In addition,~~ FDA may FDA may also designate designate
products for priority review. products for priority review.
InFinally, in certain emergency situations, FDA may temporarily authorize the use of unapproved products or approved products for certain emergency situations, FDA may temporarily authorize the use of unapproved products or approved products for
unapproved uses through an emergency use authorization (EUA). For FDA to issue an EUA, the Secretary of Health and unapproved uses through an emergency use authorization (EUA). For FDA to issue an EUA, the Secretary of Health and
Human Services (HHS) must determine Human Services (HHS) must determine ~~(1)~~ that a qualifying emergency exists that a qualifying emergency exists ~~caused by~~due to a biological, chemical, or nuclear agent that can cause a serious or life-threatening disease. The Secretary must also determine that it is reasonable to believe that the authorized ~~a biological, chemical, radiological,~~
~~or nuclear (BCRN) agent and (2) that the BCRN agent can cause a serious or life-threatening disease. The Secretary, through~~
~~FDA, must also determine for each product that (3) it is reasonable to believe, based on the totality of the evidence available,~~
~~that the~~ product may treat or prevent the disease caused by the product may treat or prevent the disease caused by the ~~BCRN agent and that~~agent; the known and potential benefits the known and potential benefits
outweigh the known and potential risksoutweigh the known and potential risks,; and and ~~(4)~~ there are no approved, adequate, and available alternatives. there are no approved, adequate, and available alternatives. ~~If FDA issues an~~
~~EUA, the product~~Products authorized by an EUA may be marketed and used for the authorized use while the emergency persists unless FDA revokes the may be marketed and used for the authorized use while the emergency persists unless FDA revokes the
EUA. FDA may also modify or waive good manufacturing practice and prescription requirements EUA. FDA may also modify or waive good manufacturing practice and prescription requirements ~~when issuing~~in an EUA. an EUA.
FDA approval of a vaccine allows for its marketing, but does not guarantee that the vaccine will be widely available or FDA approval of a vaccine allows for its marketing, but does not guarantee that the vaccine will be widely available or
affordable. Because patents grant inventors affordable. Because patents grant inventors ~~the exclusive rights in~~a temporary monopoly on a patented invention, patents may influence a patented invention, patents may influence ~~COVID-19~~
~~vaccine affordability and access~~access to and the affordability of a COVID-19 vaccine. Federal agencies and funding support many of . Federal agencies and funding support many of ~~th e~~the COVID-19 vaccine candidates in COVID-19 vaccine candidates in
development, which may affect the allocation and scope of patent rightsdevelopment, which may affect the allocation and scope of patent rights~~. The Bayh-Dole Act allows a federal contractor to~~
~~obtain the patent on a federally funded invention, but the government retains a free license to use the invention and may~~
~~“march in” to grant patent licenses to third-party manufacturers in limited circumstances. If federal support is provided~~
~~through an “other transaction” agreement, however, the allocation of patent rights will depend on the terms of that contract.~~
~~The federal government has several authorities that it could exercise should~~, depending on the form of federal support and the terms of a vaccine developer’s contracts with the federal government. Under certain circumstances, the federal government can also exercise several legal authorities if patent rights limit the affordability of or access to patent rights limit the affordability of or access to
a COVID-a COVID-19 19 vaccine. For vaccines developed with federal vaccine. For vaccines developed with federal ~~funding or~~ support, the government may secure support, the government may secure ~~up-front~~
upfront guarantees on pricing or distribution via funding or purchasing contracts with vaccine developers. For vaccines protected by guarantees on pricing or distribution via funding or purchasing contracts with vaccine developers. For vaccines protected by
patents subject to the Bayh-Dole Act, the funding agency could patents subject to the Bayh-Dole Act, the funding agency could ~~seek to~~ invoke invoke “march-in rightsmarch-in rights” to enable other producers to to enable other producers to
manufacture the vaccine. For any U.S. patent, the federal government could use its “eminent domain” powers under 28 manufacture the vaccine. For any U.S. patent, the federal government could use its “eminent domain” powers under 28
U.S.C. § 1498, which allows the government to make and use patented inventions without licenseU.S.C. § 1498, which allows the government to make and use patented inventions without license~~—so long as the use is by~~
~~or for the United States and compensation is provided to the patent holder. As U.S. patent rights are a creation of Congress,~~
~~targeted legislation is another option, subject to the constraints of the U.S. Constitution and international treaties.~~
~~A COVID-19 vaccine is likely to be subject to specialized rules limiting legal liability~~ , if reasonable compensation is provided to the patent holder. Even if widely available and affordable, a COVID-19 vaccine can only prevent outbreaks if enough members of a community are vaccinated to achieve herd immunity. One legal tool for increasing vaccination rates is for the government to require it. Courts have typically interpreted states’ general police power to promote public health and safety as encompassing the authority to mandate vaccination. Congress’s authority to mandate vaccination, on the other hand, must emanate from its enumerated powers in the Constitution. Two potential sources of such power, the Spending Clause and the Commerce Clause, are subject to certain constraints that can limit the scope of a federal vaccination mandate. Legal liability for injuries caused by a COVID-19 vaccine is likely to be subject to specialized rules under the Public Readiness and under the Public Readiness and
Emergency Preparedness (PREP) Act. To encourage the expeditious development and deployment of medical Emergency Preparedness (PREP) Act. To encourage the expeditious development and deployment of medical
countermeasures, the Secretary of HHS countermeasures, the Secretary of HHS ~~has~~ declared COVID-19 declared COVID-19 ~~to be~~ a public health emergency and invoked the PREP Act a public health emergency and invoked the PREP Act
~~to limit liability for losses relating to the use of covered medical countermeasures during the public health emergency~~for COVID-19 countermeasures. Under . Under
HHS’s declaration, covered persons—including COVID-19 vaccine developers, manufacturers, distributors, and health care HHS’s declaration, covered persons—including COVID-19 vaccine developers, manufacturers, distributors, and health care
professionals who administer a vaccine—are generally immune from legal liability for losses relating to administration or use professionals who administer a vaccine—are generally immune from legal liability for losses relating to administration or use
of an FDA-approved COVID-19 vaccine, except for willful misconduct resulting in death or serious physical injury.of an FDA-approved COVID-19 vaccine, except for willful misconduct resulting in death or serious physical injury.
However, individuals who are However, individuals who are ~~injured or die as a result of receiving~~harmed by a COVID-19 vaccine may seek compensation through the a COVID-19 vaccine may seek compensation through the
Countermeasures Injury Compensation Program, a regulatory process administered by HHS. Countermeasures Injury Compensation Program, a regulatory process administered by HHS.
Congressional Research Service Congressional Research Service

Legal Issues in COVID-19 Vaccine Development

round the world, private companies, universities, and governmental entities are rapidly round the world, private companies, universities, and governmental entities are rapidly
working to develop a vaccine for coronavirus disease 2019 (COVID-19).1 In the United working to develop a vaccine for coronavirus disease 2019 (COVID-19).1 In the United
A States A States ~~alone~~, private industry and universities are developing and testing dozens of , private industry and universities are developing and testing dozens of
COVID-19 COVID-19 vaccine candidates,2 often in collaboration with federal agencies and/or supported by vaccine candidates,2 often in collaboration with federal agencies and/or supported by
federal funding. For example, the Biomedical Advanced Research and Development Authority federal funding. For example, the Biomedical Advanced Research and Development Authority
(BARDA)(BARDA) ~~has~~ , an agency within the U.S. Department of Health and Human Services (HHS), has partnered with Janssen Pharmaceuticals (a Johnson & Johnson subsidiary)partnered with Janssen Pharmaceuticals (a Johnson & Johnson subsidiary), AstraZeneca, and ~~and~~
Sanofi to help develop and scale up manufacturing capacity for each company’s COVID-19 Sanofi to help develop and scale up manufacturing capacity for each company’s COVID-19
vaccine candidate.3 Together with the National Institute of vaccine candidate.3 Together with the National Institute of ~~Al ergy~~Allergy and Infectious Diseases and Infectious Diseases
(NIAID), BARDA(NIAID), BARDA is also collaborating with Moderna to support the development of its COVID-is also collaborating with Moderna to support the development of its COVID-
19 vaccine candidate.419 vaccine candidate.4 In May 2020
~~More general y~~, the Trump Administration , the Trump Administration ~~recently~~ announced the creation of a program announced the creation of a program ~~cal ed~~
~~Operation~~ called Operation Warp Speed, which seeks to use coordinated government support to accelerate the Warp Speed, which seeks to use coordinated government support to accelerate the
development, manufacturing, and distribution of COVID-19 vaccines and other medical development, manufacturing, and distribution of COVID-19 vaccines and other medical
countermeasures.5 With respect to vaccines, the program countermeasures.5 With respect to vaccines, the program ~~initial y~~initially selected fourteen promising selected fourteen promising
~~vaccine~~ candidates, which candidates, which ~~was subsequently narrowed to five candidates.~~are being narrowed down to “about seven.”6 Under Operation Warp 6 Under Operation Warp
~~Speed, the federal government is investing in scaling up manufacturing and distribution for~~
~~selected COVID-19 vaccine candidates “at risk” (that is, before safety and efficacy is~~
~~demonstrated).7 For example, under the program, BARDA has entered into agreements to~~
~~accelerate the development and manufacturing of a vaccine candidate being developed by the~~
~~University of Oxford and AstraZeneca.8~~

Speed, the federal government is 1 1 See Draft Landscape of COVID-19 Candidate Vaccines, WORLD HEALTH , WORLD HEALTH ~~ORGANIZATION (June 2~~ORG. (Aug. 25, 2020), , 2020),
https://www.who.int/https://www.who.int/~~who-documents-detail/draft~~ publications/m/item/draft-landscape-of-covid-19-candidate-vaccines (listing -landscape-of-covid-19-candidate-vaccines (listing ~~133~~173 COVID-19 COVID-19
vaccine candidates in various stages of development worldwide);vaccine candidates in various stages of development worldwide); Jonathan Corum, Coronavirus Vaccine Tracker, N.Y. TIMES (Aug. 28, 2020), https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html (tracking COVID-19 vaccines candidates in clinical trials); Jeff Craven, Jeff Craven, COVID-19 Vaccine Tracker, REG. AFF. , REG. AFF.
PROFS. SOC’Y (PROFS. SOC’Y (~~June 1,~~ Aug. 27, 2020), https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker 2020), https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker
~~(tracking COVID-19 vaccine candidates currently in clinical trials).~~
2 See ~~T ung T hanh~~(same); Aaron Steckelberg, These Are the Top Coronavirus Vaccines to Watch, WASH. POST (Aug. 27, 2020) (tracking progress of over 200 COVID-19 vaccine candidates in various stages of development). 2 See Tung Thanh Le et al., Le et al., The COVID-19 Vaccine Development Landscape, NATURE REV. DRUG DISCOVERY (Apr. 9, , NATURE REV. DRUG DISCOVERY (Apr. 9,
2020), https://www.nature.com/articles/d41573-020-00073-5 (breaking down COVID-192020), https://www.nature.com/articles/d41573-020-00073-5 (breaking down COVID-19 vaccine candidates by vaccine candidates by
geographical location of lead developer). geographical location of lead developer).
3 3 BARDA is part of HHS’s Office of the Assistant Secretary for Preparedness and Response and was established to support the development of medical countermeasures to deal with threats from chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases through public-private partnerships. Biomedical Advanced Research and Development Authority, U.S. DEP’T OF HEALTH & HUM. SERVS. (last updated July 22, 2020), https://www.phe.gov/about/BARDA/Pages/default.aspx. See Press Release, U.S. Dep’t of Health & Hum. Servs., Trump Administration’s Operation Warp Speed Accelerates AstraZeneca COVID-19 Vaccine to be Available Beginning in October (May 21, 2020), https://www.hhs.gov/about/news/2020/05/21/trump-administration-accelerates-astrazeneca-covid-19-vaccine-to-be-available-beginning-in-october.html; Press Release, U.S. Dep’t of Health & Hum. Servs., HHS Engages ~~See~~ ~~Press Release, U.S. Department of Health and Human Services, HHS, Janssen Join Forces On Coronavirus~~
~~Vaccine (Feb. 11, 2020), https://www.hhs.gov/about/news/2020/02/11/hhs-janssen-join-forces-on-coronavirus-~~
~~vaccine.html; Press Release, U.S. Department of Health and Human Services, HHS Engages Sanofi’s Recombinant~~
~~T echnology~~Sanofi’s Recombinant Technology for 2019 Novel Coronavirus Vaccine (Feb. 18, 2020), https://www.hhs.gov/about/news/2020/02/18/hhs- for 2019 Novel Coronavirus Vaccine (Feb. 18, 2020), https://www.hhs.gov/about/news/2020/02/18/hhs-
engages-sanofis-recombinantengages-sanofis-recombinant ~~-technology-for-2019-novel-~~-technology-for-2019-novel-coronavirus-vaccine.html; Press Release, U.S. Dep’t of Health & Hum. Servs., HHS, Janssen Join Forces On Coronavirus Vaccine (Feb. 11, 2020), https://www.hhs.gov/about/news/2020/02/11/hhs-janssen-join-forces-on-coronavirus-vaccine.html. coronavirus-vaccine.html.
4 4 See Press Release, U.S.Press Release, U.S. ~~Department of Health and Human Services, HHS Accelerates Clinical T rials~~ Dep’t of Health & Hum. Servs., HHS Accelerates Clinical Trials, Prepares for , Prepares for
Manufacturing of COVID-19 VaccinesManufacturing of COVID-19 Vaccines (Mar. 30, 2020)(Mar. 30, 2020).
5 See ~~Press Release, U.S. Department of Health and Human Services, T rump~~, https://www.hhs.gov/about/news/2020/03/30/hhs-accelerates-clinical-trials-prepares-manufacturing-covid-19-vaccines.html. 5 See Press Release, U.S. Dep’t of Health & Hum. Servs., Trump Administration Announces Framework Administration Announces Framework
and Leadership for “and Leadership for “ Operation Warp Speed” (May 15, 2020), https://www.hhs.gov/about/news/2020/05/15/trumpOperation Warp Speed” (May 15, 2020), https://www.hhs.gov/about/news/2020/05/15/trump --
administration-announces-framework-and-leadership-for-operation-warp-speed.html. administration-announces-framework-and-leadership-for-operation-warp-speed.html.
6 6 See Press Release, U.S. Dep’t of Health & Hum. Servs., Fact Sheet: Explaining Operation Warp Speed (June 16, 2020), https://www.hhs.gov/about/news/2020/06/16/fact-sheet-explaining-operation-warp-speed.html. Previously, it was reported that Operation Warp Speed selected five COVID-19 vaccine candidates as finalists. See Noah Weiland & David E. Sanger,Noah Weiland & David E. Sanger, Trump Administration Selects Five Coronavirus Vaccine Candidates as
Finalists, N.Y. , N.Y. ~~T IMES~~TIMES (June 3, 2020), https://www.nytimes.com/2020/06/03/us/politics/coronavirus-vaccine-trump- (June 3, 2020), https://www.nytimes.com/2020/06/03/us/politics/coronavirus-vaccine-trump-
moderna.htmlmoderna.html~~. T he five candidates are vaccines being developed by (1) Moderna/NIAID; (2) University of~~
Oxford/AstraZeneca; (3) Johnson & Johnson; (4) Merck; and (5) Pfizer/BioNT ech. See id.
~~7 See Jennifer Jacobs and Drew Armstrong, Trump’s ‘Operation Warp Speed’ Aims to Rush Coronavirus Vaccine,~~
~~BLOOMBERG (Apr. 29, 2020), https://www.bloomberg.com/news/articles/2020 -04-29/trump-s-operation-warp-speed-~~
~~aims-to-rush-coronavirus-vaccine.~~
~~8 Press Release, U.S. Department of Health and Human Services, T rump~~ (identifying the COVID-19 vaccines being developed by Moderna/NIAID, AstraZeneca/University of Oxford, Johnson & Johnson, Merck, and Pfizer/BioNTech as the five finalists). BARDA’s COVID-19 countermeasures portfolio currently lists Congressional Research Service 1 Legal Issues in COVID-19 Vaccine Development investing in scaling up manufacturing and distribution for selected COVID-19 vaccine candidates “at risk” (that is, before safety and efficacy is demonstrated).7 Under the program, BARDA has entered into agreements to accelerate the development and manufacturing—and to purchase hundreds of millions of doses—for vaccine candidates being developed by AstraZeneca and the University of Oxford,8 Sanofi and GlaxoSmithKline (GSK),9 Pfizer and BioNTech,10 Moderna and NIAID,11 Novavax,12 and Johnson & Johnson.13 By November 2020, three of the manufacturers participating in Operation Warp Speed—Pfizer/BioNTech, Moderna/NIAID, and AstraZeneca/University of Oxford—announced encouraging safety and efficacy results from the Phase 3 trials of their vaccines.14 This report overviews certain legal issues in COVID-19 vaccine development, testing, licensing, production, and administration, focusing on four areas: (1) vaccine testing, authorization, and licensure by the U.S. Food and Drug Administration (FDA); (2) patent and other intellectual property (IP) rights that may protect a COVID-19 vaccine; (3) state and federal authority to mandate vaccination; and (4) liability and compensation issues for individuals harmed by the testing or administration of a vaccine. First, this report explains the existing legal requirements for clinical trials and FDA authorization or licensure of new vaccines, including different options seven COVID-19 vaccines that the agency is supporting, which are being developed by (1) Pfizer/BioNTech; (2) Novavax; (3) AstraZeneca/University of Oxford; (4) Sanofi/GlaxoSmithKline; (5) Moderna/NIAID; (6) Merck/IAVI; and (7) Johnson & Johnson. See COVID-19 Medical Countermeasures Portfolio, BARDA, https://medicalcountermeasures.gov/app/barda/coronavirus/COVID19.aspx?filter=vaccine (last accessed Sept. 3, 2020). 7 See Jennifer Jacobs & Drew Armstrong, Trump’s ‘Operation Warp Speed’ Aims to Rush Coronavirus Vaccine, BLOOMBERG (Apr. 29, 2020), https://www.bloomberg.com/news/articles/2020-04-29/trump-s-operation-warp-speed-aims-to-rush-coronavirus-vaccine. 8 Press Release, U.S. Dep’t of Health & Hum. Servs., Trump Administration’s Operation Warp Speed Administration’s Operation Warp Speed
Accelerates AstraZeneca COVID-19 VaccineAccelerates AstraZeneca COVID-19 Vaccine to be Availableto be Available Beginning in October (May 21, 2020), Beginning in October (May 21, 2020),
https://www.hhs.gov/about/news/2020/05/21/trumphttps://www.hhs.gov/about/news/2020/05/21/trump -administration-accelerates-astrazeneca-covid-19-vaccine-to-be--administration-accelerates-astrazeneca-covid-19-vaccine-to-be-
available-beginning-in-october.html. available-beginning-in-october.html.
~~Congressional Research Service~~
1

~~Legal Issues in COVID-19 Vaccine Development~~

~~This report overviews certain legal issues in COVID-19 vaccine development, testing, licensing,~~
~~production, and administration, focusing on three areas: (1) vaccine testing, authorization, and~~
~~licensure by the U.S. Food and Drug Administration (FDA); (2) patent and other intel ectual~~
~~property (IP) rights that may protect a COVID-19 vaccine; and (3) liability and compensation~~
~~issues for individuals harmed by the testing or administration of a vaccine.~~
~~First, this report explains the existing legal requirements for clinical trials and FDA authorization~~
~~or licensure of new vaccines, including different options~~ 9 Press Release, U.S. Dep’t of Health & Hum. Servs., HHS, DOD Partner With Sanofi and GSK on Commercial-Scale Manufacturing Demonstration Project to Produce Millions of COVID-19 Investigational Vaccine Doses (July 31, 2020), https://www.hhs.gov/about/news/2020/07/31/hhs-dod-partner-sanofi-gsk-commercial-scale-manufacturing-demonstration-project-produce-millions-covid-19-investigational-vaccine-doses.html. 10 Press Release, U.S. Dep’t of Health & Hum. Servs., U.S. Government Engages Pfizer to Produce Millions of Doses of COVID-19 Vaccine (July 22, 2020), https://www.hhs.gov/about/news/2020/07/22/us-government-engages-pfizer-produce-millions-doses-covid-19-vaccine.html 11 Press Release, U.S. Dep’t of Health & Hum. Servs., Trump Administration Collaborates with Moderna to Produce 100 Million Doses of COVID-19 Investigational Vaccine (Aug. 11, 2020), https://www.hhs.gov/about/news/2020/08/11/trump-administration-collaborates-with-moderna-produce-100-million-doses-covid-19-investigational-vaccine.html. 12 Press Release, Biomedical Advanced Rrch. and Dev. Auth., HHS, DOD Collaborate with Novavax to Produce Millions of COVID-19 Investigational Vaccine Doses in Commercial-scale Manufacturing Demonstration Project (July 7, 2020), https://www.medicalcountermeasures.gov/newsroom/2020/novavaxhhsdod/. 13 Press Release, U.S. Dep’t of Health & Hum. Servs., HHS, DOD Collaborate With Johnson & Johnson to Produce Millions of COVID-19 Investigational Vaccine Doses (Aug. 5, 2020), https://www.hhs.gov/about/news/2020/08/05/hhs-dod-collaborate-with-johnson-and-johnson-to-produce-millions-of-covid-19-investigational-vaccine-doses.html. 14 Press Release, AstraZeneca, AZD1222 Vaccine Met Primary Efficacy Endpoint in Preventing COVID-19 (Nov. 23, 2020), https://www.astrazeneca.com/media-centre/press-releases/2020/azd1222hlr.html; Press Release, Moderna, Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study (Nov. 16, 2020), https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy; Press Release, Pfizer, Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study (Nov. 9, 2020), https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against. Congressional Research Service 2 Legal Issues in COVID-19 Vaccine Development to accelerate those processes. Second, it to accelerate those processes. Second, it
analyzes who might own the patent rights in a potentialanalyzes who might own the patent rights in a potential COVID-19 vaccine, and the federal COVID-19 vaccine, and the federal
government’s legal options should patent rights restrict the government’s legal options should patent rights restrict the vaccine’s affordability or availabilityaffordability or availability ~~of a~~
~~vaccine. Third~~. Third, it overviews the scope of the federal and state governments’ authority to mandate vaccination. Fourth, it reviews the protections from legal , it reviews the protections from legal ~~liability available~~ liability available to vaccine developers, to vaccine developers,
manufacturers, administrators, and manufacturers, administrators, and ~~healthcare~~ health care professionals under the Public Readiness and professionals under the Public Readiness and
Emergency Preparedness (PREP) Act. Emergency Preparedness (PREP) Act.
FDA Law Considerations: Bringing a New Vaccine
to Market
Vaccines are intended to prevent diseases and Vaccines are intended to prevent diseases and ~~general y~~generally work by introducing pathogens to the work by introducing pathogens to the
human body (human body (~~usual y~~usually by injection) to trigger an immune response to the disease (i.e., producing by injection) to trigger an immune response to the disease (i.e., producing
antibodies to the pathogen).antibodies to the pathogen).915 Vaccines are biological products approved and regulated by FDA’s Vaccines are biological products approved and regulated by FDA’s
Center for Biologics Evaluation and Research (CBER) under Section 351 of the Public Health Center for Biologics Evaluation and Research (CBER) under Section 351 of the Public Health
Service Act (PHSA).Service Act (PHSA).1016 A biologic such as a vaccine A biologic such as a vaccine ~~general y~~generally cannot be introduced into cannot be introduced into
commerce unless FDA approves it.commerce unless FDA approves it.1117 To be approved, FDA must determine that the vaccine is To be approved, FDA must determine that the vaccine is
safe, potent, and pure based on data from laboratory studies and clinical trials.safe, potent, and pure based on data from laboratory studies and clinical trials.1218 This section This section
discusses the legal framework for developing, testing, and licensing (i.e., approving) new discusses the legal framework for developing, testing, and licensing (i.e., approving) new
vaccines under the PHSA and the Federal Food, Drug, and Cosmetic Act (FD&C Act), as vaccines under the PHSA and the Federal Food, Drug, and Cosmetic Act (FD&C Act), as ~~wel~~ well as as
existing legal avenues that existing legal avenues that ~~would al ow that process to be expedited to bring~~could expedite the process of bringing a new vaccine to a new vaccine to
~~market sooner~~market. .
Clinical Trials of Investigational New Drugs
Sponsors use clinical trials to generate the data needed to obtain FDA approval to market their Sponsors use clinical trials to generate the data needed to obtain FDA approval to market their
products. Because clinical trials expose human subjects to unapproved pharmaceutical products, products. Because clinical trials expose human subjects to unapproved pharmaceutical products,
they risk causing unanticipated serious adverse side effects in the participants. To manage these they risk causing unanticipated serious adverse side effects in the participants. To manage these
risks, the FD&C Act and FDA regulations risks, the FD&C Act and FDA regulations ~~have imposed~~impose procedural requirements, such as procedural requirements, such as
advance and ongoing scientific and ethical review, on clinical trials to help protect the advance and ongoing scientific and ethical review, on clinical trials to help protect the
participants by participants by ~~minimizing~~ minimizing risks, requiring informed consent, and ensuring that the studies collect risks, requiring informed consent, and ensuring that the studies collect
~~the data needed~~the necessary data to determine whether to approve the product. to determine whether to approve the product.

9 Using Clinical Trials to Collect Substantial Evidence Sponsors must submit “substantial evidence” to FDA that their products are safe and effective (or safe, potent, and pure) to obtain FDA approval.19 Section 505(d) of the FD&C Act defines substantial evidence to mean adequately and well-controlled investigations on the basis of which qualified scientific experts could fairly and responsibly conclude that the product has the 15 Vaccines: The Basics, CTRS. FOR DISEASE CONTROL & PREVENTION, https://www.cdc.gov/vaccines/vpd/vpd-vac-, CTRS. FOR DISEASE CONTROL & PREVENTION, https://www.cdc.gov/vaccines/vpd/vpd-vac-
basics.html (last updated Mar. 14, 2012); basics.html (last updated Mar. 14, 2012); Understanding How Vaccines Work,, CTRS. FOR DISEASE CONTROL & CTRS. FOR DISEASE CONTROL &
PREVENTION, https://www.cdc.gov/vaccines/hcp/conversations/understanding-vacc-work.html (last updated Aug.PREVENTION, https://www.cdc.gov/vaccines/hcp/conversations/understanding-vacc-work.html (last updated Aug. 17, 17,
2018). 2018).
10 16 42 U.S.C. 42 U.S.C. § 262; § 262; Vaccine Product Approval Process, U.S. FOOD & DRUG ADMIN., https://www.fda.gov/vaccines- U.S. FOOD & DRUG ADMIN., https://www.fda.gov/vaccines-
blood-biologics/developmentblood-biologics/development -approval-process-cber/vaccine-product-approval-process-cber/vaccine-product -approval-process (last updated Jan. 30, 2018) -approval-process (last updated Jan. 30, 2018)
[hereinafter [hereinafter FDA Vaccine Approval Process]. ].
1117 42 U.S.C. 42 U.S.C. § 262(a)(1). § 262(a)(1).
1218 Id. § 262(a)(2); 21 C.F.R. §. § 262(a)(2); 21 C.F.R. § ~~601.2.~~
601.2. 19 21 U.S.C. § 355(d). Congressional Research Service Congressional Research Service
23

link to page link to page 67 link to page 7 Legal Issues in COVID-19 Vaccine Development purported effect.20 ~~Legal Issues in COVID-19 Vaccine Development~~

~~Using Clinical Trials to Collect Substantial Evidence~~
~~Sponsors must submit “substantial evidence” to FDA that their products are safe and effective (or~~
~~safe, potent, and pure) to obtain FDA approval.13 Section 505(d) of the FD&C Act defines~~
~~substantial evidence to mean adequately and wel -controlled investigations on the basis of which~~
~~qualified scientific experts could fairly and responsibly conclude that the product has the~~
~~purported effect.14~~ FDA assesses both the quality and quantity of the data provided when FDA assesses both the quality and quantity of the data provided when
determining whether a product meets this standard.determining whether a product meets this standard.1521
Quality refers to the strength of the evidence and the amount of certainty it provides as to the Quality refers to the strength of the evidence and the amount of certainty it provides as to the
product’s safety and effectiveness—that is, whether the investigation is “adequate” and “product’s safety and effectiveness—that is, whether the investigation is “adequate” and “~~wel~~ well--
controlled.”controlled.”1622 The quality of the evidence depends on how the clinical trial is designed and how The quality of the evidence depends on how the clinical trial is designed and how
the study is conducted.the study is conducted.1723 Under FDA regulations, the design must Under FDA regulations, the design must ~~al ow~~allow for a valid comparison of for a valid comparison of
the product to a control, such as a placebo, an existing therapy, or no treatment.the product to a control, such as a placebo, an existing therapy, or no treatment.1824 FDA also FDA also
evaluates whether the study’s method for selecting participants and assigning them to groups is evaluates whether the study’s method for selecting participants and assigning them to groups is
adequate to ensure that meaningful data are collected.adequate to ensure that meaningful data are collected.1925 The methodology must also include a The methodology must also include a
~~wel~~ well-defined and reliable-defined and reliable means of assessing the participants’ responses and explain the analytical means of assessing the participants’ responses and explain the analytical
and statistical methods used to assess the results.and statistical methods used to assess the results.~~20 Final y~~26 Finally, sponsors must provide a clear , sponsors must provide a clear
statement of the investigation’s objectives and take adequate measures to minimize bias in the statement of the investigation’s objectives and take adequate measures to minimize bias in the
study.study.2127 FDA may, however, waive any of these criteria for a specific investigation if the sponsor FDA may, however, waive any of these criteria for a specific investigation if the sponsor
can show can show ~~that~~ the criteria are not reasonably applicable to the study and an alternative approach the criteria are not reasonably applicable to the study and an alternative approach
yields substantial evidence of effectiveness.yields substantial evidence of effectiveness.2228 FDA guidance further clarifies how sponsors FDA guidance further clarifies how sponsors
should select their clinical trial design, endpoints, and statistical methods.should select their clinical trial design, endpoints, and statistical methods.2329
As for quantity, FDA As for quantity, FDA ~~general y~~generally requires that sponsors complete two “adequate and requires that sponsors complete two “adequate and ~~wel~~ well--
controlled clinical investigations” to meet the substantial evidence standard.controlled clinical investigations” to meet the substantial evidence standard.2430 FDA notes in its FDA notes in its
guidance that completing two studies, particularly if they are designed and conducted differently, guidance that completing two studies, particularly if they are designed and conducted differently,
reduces the likelihood of a design flaw, bias, or other issue or anomaly that could result in reduces the likelihood of a design flaw, bias, or other issue or anomaly that could result in
erroneous conclusions.erroneous conclusions.2531 However, under the Food and Drug Modernization Act of 1997, However, under the Food and Drug Modernization Act of 1997,2632 FDA FDA
may may ~~al ow~~allow sponsors to rely on one large sponsors to rely on one large, multicenter multicenter, adequate adequate, and and ~~wel~~ well-controlled clinical -controlled clinical
investigation supported by another form of additional data,investigation supported by another form of additional data,2733 such as data regarding the such as data regarding the

~~13 21 U.S.C. § 355(d).~~
14 Id.
15effectiveness of other drugs in the same pharmacological class.34 In deciding whether to allow a sponsor to rely on a single study, FDA states that it considers, among other factors, the seriousness of the disease, whether there is an unmet medical need, and whether additional trials would be ethical and practicable.35 20 Id. 21 U.S. FOOD & DRUG ADMIN., DEMONSTRATING SUBSTANTIAL EVIDENCE OF EFFECTIVENESS FOR HUMAN DRUG AND U.S. FOOD & DRUG ADMIN., DEMONSTRATING SUBSTANTIAL EVIDENCE OF EFFECTIVENESS FOR HUMAN DRUG AND
BIOLOGICAL PRODUCTS: DRAFT GUIDANCE FOR INDUSTRY 3BIOLOGICAL PRODUCTS: DRAFT GUIDANCE FOR INDUSTRY 3 (Dec. 2019), https://www.fda.gov/media/133660/download (Dec. 2019), https://www.fda.gov/media/133660/download
[hereinafter [hereinafter ~~16 Id. at 5.~~
16DEMONSTRATING SUBSTANTIAL EVIDENCE]. 22 Id. at 5. at 5.
1723 21 C.F.R. § 21 C.F.R. § 314.126. 314.126.
1824 Id. § 314.126(b)(2). § 314.126(b)(2).
1925 Id. § 314.126(b)(3) & (4). § 314.126(b)(3) & (4).
2026 Id. § 314.126(b)(6) & (7). § 314.126(b)(6) & (7).
2127 Id. § 314.126(b)(1) & (5). § 314.126(b)(1) & (5).
2228 Id. § 314.126(c). § 314.126(c).
2329 DEMONSTRATING SUBSTANTIAL EVIDENCE, DEMONSTRATING SUBSTANTIAL EVIDENCE, supra ~~note 15~~, note 21, at 5. at 5.
2430 Id. at 8. at 8.
2531 Id. at 9 at 9-–10. 10.
2632 Pub. L. No. 105-115 Pub. L. No. 105-115, § 115, 111 Stat. 2313 (1997). § 115, 111 Stat. 2313 (1997).
2733 21 U.S.C. 21 U.S.C. ~~§ 355(d).~~
§ 355(d). 34 DEMONSTRATING SUBSTANTIAL EVIDENCE, supra note 21, at 12. 35 Id. at 10. Congressional Research Service Congressional Research Service
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~~effectiveness of other drugs in the same pharmacological class.28 In deciding whether to al ow a~~
~~sponsor to rely on a single study, FDA states that it considers, among other factors, the~~
~~seriousness of the disease, whether there is an unmet medical need, and whether additional trials~~
~~would be ethical and practicable.29~~
~~Given the flexibility~~ Given the flexibility afforded sponsors in designing and conducting their clinical trials, FDA uses afforded sponsors in designing and conducting their clinical trials, FDA uses
written guidance and individualwritten guidance and individual meetings to help sponsors ensure that their investigations meetings to help sponsors ensure that their investigations ~~wil~~
will generate the substantial evidence needed for approval.generate the substantial evidence needed for approval.3036 Sponsors that obtain fast track product or Sponsors that obtain fast track product or
breakthrough therapy designation for their products are entitled to additional assistance from and breakthrough therapy designation for their products are entitled to additional assistance from and
communication with FDA staff to craft efficient and effective clinical trial designs.communication with FDA staff to craft efficient and effective clinical trial designs.3137
Submitting an Investigational New Drug Application to FDA
New drugs and biological products that are being tested in clinical trials are referred to as New drugs and biological products that are being tested in clinical trials are referred to as
investigational new drugs.investigational new drugs.3238 Section 505(i) of the FD&C Act, Section 351(a)(3) of the PHSA, and Section 505(i) of the FD&C Act, Section 351(a)(3) of the PHSA, and
their implementing regulations their implementing regulations ~~al ow~~allow investigational new drugs to be used for research before investigational new drugs to be used for research before
they are approved.they are approved.3339 To conduct clinical trials of investigational new drugs, the company To conduct clinical trials of investigational new drugs, the company
developing the product (i.e., sponsor) must developing the product (i.e., sponsor) must ~~general y~~generally receive FDA approval for the investigation receive FDA approval for the investigation
and comply with regulatory requirements for human subjects research.and comply with regulatory requirements for human subjects research.3440
Sponsors obtain FDA approval to test an investigational new drug on human subjects through an Sponsors obtain FDA approval to test an investigational new drug on human subjects through an
investigational new drug application (IND).investigational new drug application (IND).3541 The IND gives FDA an opportunity to ensure The IND gives FDA an opportunity to ensure ~~that~~
~~the study wil~~ the study will protect the safety and rights of its human subjects and gather scientific data that protect the safety and rights of its human subjects and gather scientific data that
adequately show the product’s safety and effectiveness.adequately show the product’s safety and effectiveness.3642 The sponsor may begin its clinical trials The sponsor may begin its clinical trials
30 days after submitting an IND unless FDA notifies the sponsor that it is either (1) authorizing 30 days after submitting an IND unless FDA notifies the sponsor that it is either (1) authorizing
the IND and the study can begin immediately or (2) imposing a clinical hold due to concerns the IND and the study can begin immediately or (2) imposing a clinical hold due to concerns
about the study.about the study.3743 If FDA imposes a clinical hold, the study cannot begin (or resume, for ongoing If FDA imposes a clinical hold, the study cannot begin (or resume, for ongoing
investigations) pending further notification.investigations) pending further notification.3844
FDA regulations prescribe the information FDA regulations prescribe the information ~~that~~ sponsors must include in an IND.sponsors must include in an IND.3945 The IND must The IND must
contain information about the product, such as the substance and formulation; existing data on contain information about the product, such as the substance and formulation; existing data on
use in animals or humans if available;use in animals or humans if available; and anticipated risks and side effects.and anticipated risks and side effects.4046 The IND must also The IND must also
contain a general investigationalcontain a general investigational plan, which explains why the sponsor is undertaking the study plan, which explains why the sponsor is undertaking the study
and includes, among other things, the indications being studied, the sponsor’s approach to and includes, among other things, the indications being studied, the sponsor’s approach to
evaluating the product, the kinds of clinical trials being conducted, the anticipated number of evaluating the product, the kinds of clinical trials being conducted, the anticipated number of

~~28 DEMONSTRATING SUBSTANTIAL EVIDENCE, supra note 15, at 12.~~
~~29 Id. at 10.~~
~~30 See, e.g., 21 C.F.R. § 312.47; DEMONSTRATING SUBSTANTIAL EVIDENCE, supra note 15.~~
31participants, and any anticipated risks.47 Along with the general investigational plan, the IND must include specific protocols for each clinical trial phase.48 The sponsor must also generally certify that an institutional review board (IRB) will provide initial and continuing review of each 36 See, e.g., 21 C.F.R. § 312.47; DEMONSTRATING SUBSTANTIAL EVIDENCE, supra note 21. 37 See “Shortening the Development and Review Processes.”
3238 21 C.F.R. § 21 C.F.R. § 312.3. 312.3.
3339 21 U.S.C. 21 U.S.C. § 355(i); 42 U.S.C.§ 355(i); 42 U.S.C. § § 262(a)(3); 21 C.F.R. § 312.2(a). 262(a)(3); 21 C.F.R. § 312.2(a).
3440 See generally 21 C.F.R. 21 C.F.R. ~~Parts~~pts. 50, 56, & 312. 50, 56, & 312.
3541 21 C.F.R. § 21 C.F.R. § 312.20; 312.20; Investigational New Drug (IND) Application, U.S. FOOD & DRUG ADMIN., , U.S. FOOD & DRUG ADMIN.,
https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application (last updated May 12, 2020). https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application (last updated May 12, 2020).
3642 21 C.F.R. § 21 C.F.R. § 312.22. 312.22.
3743 Id. §§ §§ 312.40 & 312.42. 312.40 & 312.42.
3844 Id. § 312.42(a) & (e). § 312.42(a) & (e).
3945 Id. § 312.23. § 312.23.
4046 Id. 47 Id. 48 Id.
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Legal Issues in COVID-19 Vaccine Development

~~participants, and any anticipated risks.41 Along with the general investigational plan, the IND~~
~~must include specific protocols for each clinical trial phase.42 The sponsor must also general y~~
~~certify that an institutional review board (IRB) wil provide initial and continuing review of each~~
study, including the proposed protocols and any subsequent changes to the study.study, including the proposed protocols and any subsequent changes to the study.4349 FDA may, FDA may,
however, waive any IRB requirements, including the requirement of IRB reviewhowever, waive any IRB requirements, including the requirement of IRB review itself.itself.4450
Institutional Review Board Review and Approval
An IRB is a group convened by an institution to review and approve biomedical research An IRB is a group convened by an institution to review and approve biomedical research
involving humans.involving humans.4551 IRBs evaluate the initial IRBs evaluate the initial clinical study design and protocols, along with any clinical study design and protocols, along with any
changes implemented during the investigation, in an effort to ensurechanges implemented during the investigation, in an effort to ensure ~~that~~ the rights and the rights and ~~wel~~ well-being -being
of the human subjects are protected.of the human subjects are protected.4652 To that end, IRBs assess whether risks to the participants To that end, IRBs assess whether risks to the participants
are minimized and reasonable in relation to the anticipated benefits, both to the participants are minimized and reasonable in relation to the anticipated benefits, both to the participants
directly and from the knowledge expected to be gained directly and from the knowledge expected to be gained ~~through~~from the study. the study.4753 IRBs also aim to IRBs also aim to
ensure that the researchers ensure that the researchers ~~wil~~ will obtain adequate informed consent from obtain adequate informed consent from al all participants (unless an participants (unless an
exemption applies) and that selection of the participants exemption applies) and that selection of the participants ~~wil~~ will be equitable.be equitable.4854 IRBs may also IRBs may also
require (as appropriate) that the research plan provide for monitoring of the collected data to require (as appropriate) that the research plan provide for monitoring of the collected data to
protect the participants’ safety and privacy.protect the participants’ safety and privacy.4955 To the extent the study may include participants To the extent the study may include participants
from populations that may be vulnerable to coercion or undue influence (e.g., children, prisoners), from populations that may be vulnerable to coercion or undue influence (e.g., children, prisoners),
IRBs must ensure that sufficient safeguards are in place to protect these populations in participant IRBs must ensure that sufficient safeguards are in place to protect these populations in participant
selection and during the clinical trials.selection and during the clinical trials.5056
IRBs review clinical trial plans and protocols from various standpoints, including ensuring IRBs review clinical trial plans and protocols from various standpoints, including ensuring ~~that~~
~~the~~ the study complies with legal, ethical, and professional standards; is study complies with legal, ethical, and professional standards; is ~~scientifical y~~scientifically sound; and is sound; and is
free from free from ~~il icit~~illicit discrimination. Accordingly, to ensure adequate and independent review, IRBs discrimination. Accordingly, to ensure adequate and independent review, IRBs
must have at least five members from multiple backgrounds, including at least one member with a must have at least five members from multiple backgrounds, including at least one member with a
scientific background and at least one with a nonscientific background.scientific background and at least one with a nonscientific background.5157 At least one member At least one member
must be independent from the institution running the clinical trials, and the IRB members cannot must be independent from the institution running the clinical trials, and the IRB members cannot
have any financial or other conflicting interests in the project.have any financial or other conflicting interests in the project.5258 IRB review must comply with IRB review must comply with
any other requirements relating to IRBs and human subject research found in Parts 50 and 56 of any other requirements relating to IRBs and human subject research found in Parts 50 and 56 of
Chapter 21 of the Code of Federal Regulation. Chapter 21 of the Code of Federal Regulation.
Clinical Trial Phases
Clinical Clinical trials for a new pharmaceutical product trials for a new pharmaceutical product ~~general y~~generally proceed in three phases, transitioning proceed in three phases, transitioning
from from ~~smal er~~smaller trials focused on initial safety early on to larger trials assessing safety and trials focused on initial safety early on to larger trials assessing safety and

41 Id.
42 Id.
43 Id.
~~44 21 C.F.R. § 56.105(c).~~
~~45 Id. § 56.102(g).~~
46 Id.
~~47 Id. § 56.111(a)(1)-(2).~~
~~48 Id. § 56.111(a)(3)-(5).~~
~~49 Id. § 56.111(a)(6)-(7).~~
~~50 Id. § 56.111(b) & (c).~~
~~51 Id. § 56.107(a)-(c).~~
~~52 Id. § 56.107(d)-(e).~~
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~~effectiveness to inform approval and labeling.53 The size, duration, and specific purpose of each~~
~~clinical trial phase varies from product to product depending on such factors as the type of~~
~~product (e.g., a vaccine, treatment, or preventative medication), how the product works, and the~~
effectiveness to inform approval and labeling.59 The size, duration, and specific purpose of each clinical trial phase varies from product to product depending on such factors as the type of product (e.g., a vaccine, treatment, or preventative medication), how the product works, and the 49 Id. 50 Id. § 56.105(c). 51 Id. § 56.102(g). 52 Id. 53 Id. § 56.111(a)(1)–(2). 54 Id. § 56.111(a)(3)–(5). 55 Id. § 56.111(a)(6)–(7). 56 Id. § 56.111(b) & (c). 57 Id. § 56.107(a)–(c). 58 Id. § 56.107(d)–(e). 59 Id. § 312.21. Congressional Research Service 6 link to page 6 link to page 6 Legal Issues in COVID-19 Vaccine Development relevant underlying patient population. However, as defined by FDA regulations, a clinical relevant underlying patient population. However, as defined by FDA regulations, a clinical
investigation investigation ~~general y~~generally proceeds as follows: proceeds as follows:
  Phase 1 Trials. Phase 1 trials are the first time the product is introduced in Phase 1 trials are the first time the product is introduced in
human subjects. human subjects.5460 These These ~~careful y~~carefully controlled trials controlled trials ~~typical y~~typically involve 20 to 80 involve 20 to 80
patients or volunteer subjects, though the exact numbers may vary depending on patients or volunteer subjects, though the exact numbers may vary depending on
the product.the product.5561 Phase 1 trials Phase 1 trials ~~general y~~generally assess how the product acts in the body and assess how the product acts in the body and
evaluate initialevaluate initial safety (i.e., side effects).safety (i.e., side effects).5662 They may also be used to determine the They may also be used to determine the
dosing levels to use in phase 2 (e.g., the maximum safe dose or what dose is dosing levels to use in phase 2 (e.g., the maximum safe dose or what dose is
required to have an effect).required to have an effect).5763 Depending on the product, phase 1 trials may also Depending on the product, phase 1 trials may also
provide some initialprovide some initial indication as to whether the product may be effective.indication as to whether the product may be effective.5864 In In
the case of vaccines the case of vaccines ~~specifical y~~specifically, phase 1 trials also assess their ability to provoke , phase 1 trials also assess their ability to provoke
an immune response in the body (i.e., immunogenicity).an immune response in the body (i.e., immunogenicity).5965
  Phase 2 Trials. Phase 2 trials continue to assess safety but also evaluate the Phase 2 trials continue to assess safety but also evaluate the
product’s effectiveness and common short-term side effects or other risks product’s effectiveness and common short-term side effects or other risks
associated with the product.associated with the product.6066 Phase 2 trials are also used to determine the Phase 2 trials are also used to determine the
optimal dose of the product.optimal dose of the product.6167 For vaccines, phase 2 assesses how much of the For vaccines, phase 2 assesses how much of the
vaccine to administer and on what dosing schedule (e.g., whether a boost is vaccine to administer and on what dosing schedule (e.g., whether a boost is
needed to maximize its effectiveness or whether the vaccine must be needed to maximize its effectiveness or whether the vaccine must be
administered on a regular schedule to maintain immunity).administered on a regular schedule to maintain immunity).6268 As with phase 1 As with phase 1
studies, phase 2 studies are carefully controlled.studies, phase 2 studies are carefully controlled.6369 However, phase 2 involves a However, phase 2 involves a
larger (though larger (though ~~stil~~ still relatively limited) number of volunteer subjects—relatively limited) number of volunteer subjects—~~general y~~generally no no
more than a few hundred participants.more than a few hundred participants.6470
  Phase 3 Trials. Phase 3 trials involve an expanded number of participants—from Phase 3 trials involve an expanded number of participants—from
several hundred to thousands—and are used to assess the product’s safety and several hundred to thousands—and are used to assess the product’s safety and
effectiveness across a wide range of patient categories through controlled and effectiveness across a wide range of patient categories through controlled and
uncontrolled studies.uncontrolled studies.6571 These trials are intended to present a clearer picture of These trials are intended to present a clearer picture of

~~53 Id. § 312.21.~~
~~54 Id. § 312.21(a).~~
55 Id.
56 Id.
57 Id.
58 Id.
~~59 FDA Vaccine Approval Process, supra note 10.~~
~~60 21 C.F.R. § 312.21(b).~~
61 See, e.g.~~, Kert Viele & Jason T~~ expected risks and benefits under real-world conditions.72 The information obtained from phase 3 trials also forms the basis for the product’s labeling.73 Sponsors must generally complete all three phases to obtain FDA approval unless they obtain accelerated approval,74 in which case FDA requires postapproval trials to confirm the expected 60 Id. § 312.21(a). 61 Id. 62 Id. 63 Id. 64 Id. 65 FDA Vaccine Approval Process, supra note 16. 66 21 C.F.R. § 312.21(b). 67 See, e.g., Kert Viele & Jason T. Connor, . Connor, Dose Finding Trials: Optimizing Phase 2 Data in the Drug Development
Process, 314 J. AM. MED. ASS’N 2294, 2294 (2015), https://jamanetwork.com/journals/jama/fullarticle/2473474, 314 J. AM. MED. ASS’N 2294, 2294 (2015), https://jamanetwork.com/journals/jama/fullarticle/2473474 . .
6268 FDA Vaccine Approval Process, , supra ~~note 10.~~
63note 16. 69 21 C.F.R. § 21 C.F.R. § 312.21(b). 312.21(b).
6470 Id.
6571 Id. § 312.21(c). 72 Id. 73 Id. 74 Accelerated Approval, U.S. FOOD & DRUG ADMIN., https://www.fda.gov/patients/fast-track-breakthrough-therapy- Congressional Research Service 7 link to page 7 link to page 6 Legal Issues in COVID-19 Vaccine Development clinical benefit.75 Id. § 312.21(c).
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~~expected risks and benefits under real-world conditions.66 The information~~
~~obtained from phase 3 trials also forms the basis for the product’s labeling.67~~
~~Sponsors must general y complete al three phases to obtain FDA approval unless they obtain~~
~~accelerated approval,68 in which case FDA requires postapproval trials to confirm the expec ted~~
~~clinical benefit.69~~ FDA may also require, at its discretion, additional clinical trials after approval FDA may also require, at its discretion, additional clinical trials after approval
(i.e., phase 4 trials) for any approved product to continue assessing the product’s safety and (i.e., phase 4 trials) for any approved product to continue assessing the product’s safety and
effectiveness once on the market.effectiveness once on the market.7076
Considerations for Congress
The current legal framework seeks to balance various competing interests, which may be The current legal framework seeks to balance various competing interests, which may be
amplified in the current crisis. The FD&C Act and implementing regulations provide standards amplified in the current crisis. The FD&C Act and implementing regulations provide standards
and factors to consider but otherwise give FDA and IRBs discretion to evaluate investigational and factors to consider but otherwise give FDA and IRBs discretion to evaluate investigational
plans and clinical trial protocols for investigational new drugs. FDA may also waive requirements plans and clinical trial protocols for investigational new drugs. FDA may also waive requirements
relating to IRB review and clinical trial design. To the extent Congress may seek to direct how relating to IRB review and clinical trial design. To the extent Congress may seek to direct how
FDA and IRBs exercise that discretion with respect to any potential COVID-19 vaccine, Congress FDA and IRBs exercise that discretion with respect to any potential COVID-19 vaccine, Congress
could consider implementing legislationcould consider implementing legislation that provides more specific direction on how to approach that provides more specific direction on how to approach
clinical trials either clinical trials either ~~specifical y~~specifically for the current COVID-19 pandemic or in epidemic, pandemic, or for the current COVID-19 pandemic or in epidemic, pandemic, or
other emergency situations more other emergency situations more ~~general y~~generally. For example, courts have determined that Congress . For example, courts have determined that Congress
can cabin FDA’s discretion by imposing mandatory (e.g., “can cabin FDA’s discretion by imposing mandatory (e.g., “~~shal~~ shall”) rather than permissive (e.g., ”) rather than permissive (e.g.,
“may”) language in a statute.“may”) language in a statute.7177
In light of the multiple companies involved in developing potential COVID-19 vaccines, In light of the multiple companies involved in developing potential COVID-19 vaccines,
Congress could also consider facilitating the coordination of any clinical trials or appointing a Congress could also consider facilitating the coordination of any clinical trials or appointing a
neutral scientific body to consider the ethical and scientific considerations and generate neutral scientific body to consider the ethical and scientific considerations and generate
guidelines or a master protocol. The World Health Organization (WHO) employed this approach guidelines or a master protocol. The World Health Organization (WHO) employed this approach
to facilitate development of an Ebola vaccine following the 2014 to 2016 Ebola epidemic.to facilitate development of an Ebola vaccine following the 2014 to 2016 Ebola epidemic.7278
Congress could also direct or fund increased global collaboration between regulators to promote Congress could also direct or fund increased global collaboration between regulators to promote
information sharing, which could information sharing, which could ~~potential y~~potentially result in more streamlined clinical investigations result in more streamlined clinical investigations
with fewer participants being exposed to investigational vaccines.with fewer participants being exposed to investigational vaccines.7379 Congress could also consider Congress could also consider
providing additional funding or other resources to facilitate the clinical trials themselves or any providing additional funding or other resources to facilitate the clinical trials themselves or any
research directed toward understanding the SARS-CoV-2 virus or COVID-19 disease to research directed toward understanding the SARS-CoV-2 virus or COVID-19 disease to ~~al ow~~allow for for
improved risk minimizationimproved risk minimization in future clinical trials. FDA Approval and Options for Bringing a New Vaccine to Market Faster If the clinical trials are successful, the sponsor may seek FDA approval to market its new vaccine. FDA approves new vaccines through biologics license applications (BLAs) reviewed by CBER.80 ~~in future clinical trials.~~

66 Id.
67 Id.
~~68 Accelerated Approval, U.S. FOOD & DRUG ADMIN., https://www.fda.gov/patients/fast -track-breakthrough-therapy-~~
accelerated-approval-priority-review/accelerated-approval (last updated Jan. 4, 2018). accelerated-approval-priority-review/accelerated-approval (last updated Jan. 4, 2018).
69 75 DEMONSTRATING SUBSTANTIAL EVIDENCE, DEMONSTRATING SUBSTANTIAL EVIDENCE, supra ~~note 15~~, note 21, at 2. at 2.
7076 21 C.F.R. § 21 C.F.R. § 312.85. 312.85.
7177 See, e.g., Cook v. FDA, 733 F.3d 1, 8 (D.C. Cir. 2013). , Cook v. FDA, 733 F.3d 1, 8 (D.C. Cir. 2013).
7278 WORLD HEALTH ORG., WHO R&D BLUEPRINT – AD-HOC WORKSHOP ON EBOLA VACCINES: DELIBERATIONS ON WORLD HEALTH ORG., WHO R&D BLUEPRINT – AD-HOC WORKSHOP ON EBOLA VACCINES: DELIBERATIONS ON
DESIGN DESIGN ~~OP TIONS~~OPTIONS FOR CLINICAL TRIALS TO ASSESS THE SAFETY AND EFFICACY OF INVESTIGATIONAL EBOLA VACCINES FOR CLINICAL TRIALS TO ASSESS THE SAFETY AND EFFICACY OF INVESTIGATIONAL EBOLA VACCINES
(Jan. 23, 2019), https://www.who.int/docs/default(Jan. 23, 2019), https://www.who.int/docs/default -source/blue-print/ebola-vaccine-meeting--source/blue-print/ebola-vaccine-meeting-
report.pdf?sfvrsn=9dd492f4_2. report.pdf?sfvrsn=9dd492f4_2.
7379 See, e.g., , Summary of FDA & EMA Global Regulators Meeting on Data Requirements Supporting First-in-Human
Clinical Trials with SARS-CoV-2 Vaccines, U.S. FOOD & DRUG ADMIN., https://www.fda.gov/news-events/fda-, U.S. FOOD & DRUG ADMIN., https://www.fda.gov/news-events/fda-
meetings-conferences-and-workshops/summary-fda-ema-global-regulators-meeting-data-requirements-supporting-first-meetings-conferences-and-workshops/summary-fda-ema-global-regulators-meeting-data-requirements-supporting-first-
human-clinical-trials (last updated Mar. 18, 2020). human-clinical-trials (last updated Mar. 18, 2020).
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~~FDA Approval and Options for Bringing a New Vaccine to Market~~
~~Faster~~
~~If the clinical trials are successful, the sponsor may seek FDA approval to market its new vaccine.~~
~~FDA approves new vaccines through biologics license applications (BLAs) reviewed by CBER.74~~
80 21 U.S.C. § 262(a); FDA Vaccine Approval Process, supra note 16. For additional information about the biologics licensing process, see CRS Report R45666, Drug Pricing and Intellectual Property Law: A Legal Overview for the Congressional Research Service 8 link to page 12 Legal Issues in COVID-19 Vaccine Development BLAs contain data from the laboratory and clinical studies and information about how and where BLAs contain data from the laboratory and clinical studies and information about how and where
the biologic the biologic ~~wil~~ will be manufactured.be manufactured.7581 As courts have recognized, FDA exercises its scientific As courts have recognized, FDA exercises its scientific
judgment when deciding whether to license vaccines based on such studies.judgment when deciding whether to license vaccines based on such studies.7682 Biologics that are Biologics that are
approved through a BLAapproved through a BLA receive 12 years of regulatory exclusivity, during which time FDA receive 12 years of regulatory exclusivity, during which time FDA
cannot approve any biosimilars (i.e., abbreviated applications for the same biologic that depend cannot approve any biosimilars (i.e., abbreviated applications for the same biologic that depend
on the clinical data in the BLAon the clinical data in the BLA to demonstrate safety, potency, and purity).to demonstrate safety, potency, and purity).7783
The process of developing and testing a new vaccine to the point where it meets the safety, purity, The process of developing and testing a new vaccine to the point where it meets the safety, purity,
and potency standard can be a lengthy process. The FD&C Act provides several options that may and potency standard can be a lengthy process. The FD&C Act provides several options that may
~~al ow~~allow a sponsor to bring a new vaccine to market faster. a sponsor to bring a new vaccine to market faster.~~78 General y~~84 Generally, these options use one of two , these options use one of two
approaches. First, FDA can direct more of its resources to the product to accelerate the approaches. First, FDA can direct more of its resources to the product to accelerate the
development and/or review processes (e.g., fast track product designation, breakthrough therapy development and/or review processes (e.g., fast track product designation, breakthrough therapy
designation, and priority review). Second, FDA can modify how it evaluates the risks and benefits designation, and priority review). Second, FDA can modify how it evaluates the risks and benefits
of the vaccine before of the vaccine before ~~al owing~~allowing its use, either by relying on different types of evidence (e.g., the its use, either by relying on different types of evidence (e.g., the
accelerated approval process) or lowering the evidentiary standard in emergency situations (e.g., accelerated approval process) or lowering the evidentiary standard in emergency situations (e.g.,
~~emergency use authorization~~an EUA). (For ease of reference, this section uses the general term “biologic” ). (For ease of reference, this section uses the general term “biologic”
because vaccines are biological products, but the pathways discussed below are also available for because vaccines are biological products, but the pathways discussed below are also available for
~~traditional smal~~ traditional small molecule drugs.) molecule drugs.)
Shortening the Development and Review Processes
Several avenues are available Several avenues are available for expediting the development and review processes for biologics for expediting the development and review processes for biologics
used to treat or prevent serious or life-threatening conditions and diseases. In its guidance, FDA used to treat or prevent serious or life-threatening conditions and diseases. In its guidance, FDA
~~general y~~generally considers a condition or disease considers a condition or disease serious if it if it ~~substantial y~~substantially affects day-to-day functioning affects day-to-day functioning
and is irreversible, persistent, or recurrent.and is irreversible, persistent, or recurrent.7985 A condition or disease may be found to be serious as A condition or disease may be found to be serious as
a matter of clinical judgment based on its effect on survival, day-to-day functioning, or the a matter of clinical judgment based on its effect on survival, day-to-day functioning, or the
likelihoodlikelihood that it that it ~~wil~~ will progress to a more serious condition if left untreated.progress to a more serious condition if left untreated.8086 As a matter of As a matter of
course, FDA considers any life-threatening condition or disease to be serious.course, FDA considers any life-threatening condition or disease to be serious.8187 The drug must The drug must
also be intended to also be intended to treat the serious condition or disease by having an effect on the disease itself the serious condition or disease by having an effect on the disease itself
or a serious aspect of the disease, such as a symptom or other manifestation.or a serious aspect of the disease, such as a symptom or other manifestation.~~82 Among the~~

~~74 21 U.S.C. § 262(a); FDA Vaccine Approval Process, supra note 10. For additional information about the biologics~~
~~licensing process, see CRS Report R45666,~~ ~~Drug Pricing and Intellectual Property Law: A Legal Overview for the~~
~~116th Congress, coordinated by Kevin J. Hickey, at 17-27.~~
~~75 21 C.F.R. § 601.2.~~
~~76 Rempfer v. Sharfstein, 583 F.3d 860, 868 (D.C. Cir. 2009).~~
~~77 21 U.S.C. § 262(k)(7)(A).~~
~~78 See generally 21 U.S.C. § 356.~~
7988 Among the examples FDA provides in its guidance is a product intended to prevent the serious condition.89 Given that COVID-19 is life threatening, a vaccine intended to prevent COVID-19 seems likely to qualify as a drug used to treat or prevent a serious or life-threatening condition or disease—making it eligible for the following designations to accelerate the approval process. 116th Congress, coordinated by Kevin J. Hickey, at 17–27. 81 21 C.F.R. § 601.2. 82 Rempfer v. Sharfstein, 583 F.3d 860, 868 (D.C. Cir. 2009). 83 21 U.S.C. § 262(k)(7)(A). 84 See generally 21 U.S.C. § 356. 85 U.S. FOOD & DRUG ADMIN., GUIDANCE FOR INDUSTRY: EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS – DRUGS AND U.S. FOOD & DRUG ADMIN., GUIDANCE FOR INDUSTRY: EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS – DRUGS AND
BIOLOGICS 2BIOLOGICS 2-–3 (2014), https://www.fda.gov/media/86377/download3 (2014), https://www.fda.gov/media/86377/download [hereinafter EXPEDITED PROGRAMS FOR SERIOUS [hereinafter EXPEDITED PROGRAMS FOR SERIOUS
CONDITIONS: FDA GUIDANCE]. CONDITIONS: FDA GUIDANCE].
80 86 21 C.F.R. § 21 C.F.R. § 312.300(b)(1). 312.300(b)(1).
8187 EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, supra ~~note 79, at 3.~~
82note 85, at 3. 88 Id. 89 Id.
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~~examples FDA provides in its guidance is a product intended to prevent the serious condition.83~~
~~Given that COVID-19 is life threatening, a vaccine intended to prevent COVID-19 seems likely~~
~~to qualify as a drug used to treat or prevent a serious or life-threatening condition or disease—~~
~~making it eligible for the following designations to accelerate the approval process.~~
~~Fast Track Product Designation~~
~~Section 506 of the FD&C Act al ows~~ FDA to designate certain biologics as fast track products, FDA to designate certain biologics as fast track products,
which receive FDA assistance in expediting development and review.which receive FDA assistance in expediting development and review.8490 A biologic may be A biologic may be
designated as a fast track product if FDA determines that the biologic designated as a fast track product if FDA determines that the biologic ~~wil~~ will treat or prevent a treat or prevent a
serious or life-threatening disease or condition and serious or life-threatening disease or condition and ~~fil~~ fill an unmet medical need.an unmet medical need.8591 An unmet An unmet
medical need exists when available therapies do not adequately address treating or diagnosing a medical need exists when available therapies do not adequately address treating or diagnosing a
condition or disease.condition or disease.8692 FDA recognizes in its guidance that an unmet medical need necessarily FDA recognizes in its guidance that an unmet medical need necessarily
exists if there is no availableexists if there is no available therapy.therapy.8793 Sponsors may provide FDA with nonclinical or clinical Sponsors may provide FDA with nonclinical or clinical
data to demonstrate that the drug has the potential to data to demonstrate that the drug has the potential to ~~fil~~ fill that unmet medical need.that unmet medical need.8894 Given that Given that
there are no approved vaccines for COVID-19, any vaccine that showed potential to prevent there are no approved vaccines for COVID-19, any vaccine that showed potential to prevent
COVID-19 in laboratory or clinical trials would seem likely to qualify for fast track designation. COVID-19 in laboratory or clinical trials would seem likely to qualify for fast track designation.
On May 12, 2020, FDA designated Moderna’s COVID-19 vaccine as a fast track product after it On May 12, 2020, FDA designated Moderna’s COVID-19 vaccine as a fast track product after it
completed its Phase 1 trials.completed its Phase 1 trials.8995
At its discretion, the biologic’s sponsor requests fast track designation for its product. At its discretion, the biologic’s sponsor requests fast track designation for its product.9096 It may It may
request fast track designation when it submits an IND or any time thereafter.request fast track designation when it submits an IND or any time thereafter.9197 FDA has 60 days FDA has 60 days
to determine if the biologic qualifies for the designation.to determine if the biologic qualifies for the designation.9298 Once FDA designates a biologic as a Once FDA designates a biologic as a
fast track product, FDA must facilitate its development and expedite review of the biologic.fast track product, FDA must facilitate its development and expedite review of the biologic.9399 In In
practice, this process practice, this process ~~general y~~generally means that the biologic’s sponsor has greater access to FDA means that the biologic’s sponsor has greater access to FDA
through written and in-person communications during the development and testing process to through written and in-person communications during the development and testing process to
improve efficiency and ensure that appropriate data are collected.improve efficiency and ensure that appropriate data are collected.94100 FDA may also review the FDA may also review the
~~BLA~~ BLA for a fast track product on a rolling basis as sections are complete (rather than waiting for a for a fast track product on a rolling basis as sections are complete (rather than waiting for a
completed application) if initialcompleted application) if initial clinical testing shows the biologic may be effective.clinical testing shows the biologic may be effective.95

83 Id.
~~84 21 U.S.C. § 356(b).~~
85 Id.
86101 Breakthrough Therapy Designation Section 506 of the FD&C Act also allows FDA to designate certain biologics as breakthrough therapies, which similarly heightens FDA involvement in the development and review process.102 Breakthrough therapy designation is based on preliminary clinical evidence showing the biologic may be a substantial improvement over available therapies for one or more clinically significant 90 21 U.S.C. § 356(b). 91 Id. 92 EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, supra ~~note 79~~,note 85, at 4. at 4.
8793 Id. at 5. at 5.
8894 Id. at 9. at 9.
8995 Press Release, Press Release, Moderna, Moderna Receives FDA Fast Moderna, Moderna Receives FDA Fast ~~T rack~~Track Designation for mRNA Vaccine Designation for mRNA Vaccine (mRNA(mRNA -1273) Against -1273) Against
Novel Coronavirus (May 12, 2020), https://investors.modernatx.com/news-releases/news-release-details/moderna-Novel Coronavirus (May 12, 2020), https://investors.modernatx.com/news-releases/news-release-details/moderna-
receives-fda-fast-track-designation-mrna-vaccine-mrna. receives-fda-fast-track-designation-mrna-vaccine-mrna.
90 96 21 U.S.C. 21 U.S.C. § 356(b)(2). § 356(b)(2).
9197 Id.
92 98 Id. § 356(b)(3). § 356(b)(3).
9399 Id.
94100 EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, supra ~~note 79~~,note 85, at 9; at 9; Fast Track, U.S. FOOD & , U.S. FOOD &
DRUG ADMIN.DRUG ADMIN. (Jan. 4, 2018), https://www.fda.gov/patients/fast, https://www.fda.gov/patients/fast -track-breakthrough-therapy-accelerated-approval-priority-review/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast -
~~track (last updated Jan. 4, 2018).~~
95-track. 101 EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, supra ~~note 79, at 10;~~note 85, at 10; Fast Track, U.S. Food & U.S. Food & ~~Drug Admin.,~~
~~Fast T rack (Jan. 4, 2018), https://www.fda.gov/patients/fast -track-breakthrough-therapy-accelerated-approval-priority-~~
~~review/fast -track~~Drug Admin., supra note 100. 102 21 U.S.C. § 356(a). .
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link to page link to page 1112 link to page link to page 1112 link to page link to page 1112 Legal Issues in COVID-19 Vaccine Development endpoints.103 Endpoints measure the outcome of a clinical trial.104 Under FDA guidance, a clinically significant endpoint generally ~~Legal Issues in COVID-19 Vaccine Development~~

~~Breakthrough Therapy Designation~~
~~Section 506 of the FD&C Act also al ows FDA to designate certain biologics as breakthrough~~
~~therapies, which similarly heightens FDA involvement in the development and review process.96~~
~~Breakthrough therapy designation is based on preliminary clinical evidence showing the biologic~~
~~may be a substantial improvement over available therapies for one or more clinical y significant~~
~~endpoints.97 Endpoints measure the outcome of a clinical trial.98 Under FDA guidance, a clinical y~~
~~significant endpoint general y~~ measures an effect on irreversible morbidity or mortality or on measures an effect on irreversible morbidity or mortality or on
symptoms representing serious consequences of the disease or condition.symptoms representing serious consequences of the disease or condition.99105 Unlike fast track Unlike fast track
product designation, which can be based on laboratory data, breakthrough therapy designation product designation, which can be based on laboratory data, breakthrough therapy designation
requires evidence from clinical trials.requires evidence from clinical trials.~~100~~106 FDA exercises its judgment in determining whether the FDA exercises its judgment in determining whether the
data show a substantial improvement over existing therapies, taking into consideration both the data show a substantial improvement over existing therapies, taking into consideration both the
magnitude of the biologic’s effects on the endpoint and the importance of the effect measured by magnitude of the biologic’s effects on the endpoint and the importance of the effect measured by
that endpoint to treating the disease or condition.that endpoint to treating the disease or condition.~~101~~107 When there are no existing therapies, such as When there are no existing therapies, such as
with a COVID-19 vaccine, FDA compares the biologic to a placebo or with a COVID-19 vaccine, FDA compares the biologic to a placebo or ~~wel~~ well-documented -documented
historical control.historical control.~~102~~108 A COVID-19 vaccine may be eligible A COVID-19 vaccine may be eligible for breakthrough therapy designation for breakthrough therapy designation
if the sponsor can demonstrate potential effectiveness in early clinical trials. if the sponsor can demonstrate potential effectiveness in early clinical trials.
At its discretion, the sponsor requests breakthrough therapy designation and may do so with At its discretion, the sponsor requests breakthrough therapy designation and may do so with
submission of an IND or at any time thereafter.submission of an IND or at any time thereafter.~~103~~109 FDA must determine whether the biologic FDA must determine whether the biologic
qualifies as a breakthrough therapy within 60 days of receipt.qualifies as a breakthrough therapy within 60 days of receipt.~~104~~110 As with fast track product As with fast track product
designation, the FD&C Act directs FDA to expedite the development and review of applications designation, the FD&C Act directs FDA to expedite the development and review of applications
for breakthrough therapies.for breakthrough therapies.~~105~~111 Per FDA guidance, expedited development and review of Per FDA guidance, expedited development and review of
breakthrough therapies entails (1) intensive assistance from FDA on efficient development and breakthrough therapies entails (1) intensive assistance from FDA on efficient development and
clinical trial design; (2) organizational commitment from FDA, including senior management and clinical trial design; (2) organizational commitment from FDA, including senior management and
experienced staff; (3) rolling review of the BLA;experienced staff; (3) rolling review of the BLA; and (4) other actions to expedite review, such as and (4) other actions to expedite review, such as
priority review discussed below.priority review discussed below.~~106~~112 Extensive FDA assistance during the development process and Extensive FDA assistance during the development process and
the involvement of senior managers distinguishes breakthrough therapy designation from fast the involvement of senior managers distinguishes breakthrough therapy designation from fast
track product designation. track product designation.
Accelerated Approval
Section 506 of the FD&C Act also Section 506 of the FD&C Act also ~~al ows~~allows FDA to approve certain biologics based on surrogate or FDA to approve certain biologics based on surrogate or
intermediate endpoints, referred to as accelerated approval.intermediate endpoints, referred to as accelerated approval.~~107~~113 In general, sponsors select In general, sponsors select

~~96 21 U.S.C. § 356(a).~~
~~97 Id. § 356(a)(1).~~
98endpoints that directly measure the clinical outcome (i.e., the benefits expected from the biologic), such as whether the patient feels better or lives longer.114 Surrogate and intermediate endpoints do not measure the clinical benefit directly but instead measure an effect that is 103 Id. § 356(a)(1). 104 Surrogate Endpoint Resources for Drug and Biologic Development, U.S. FOOD & DRUG ADMIN., , U.S. FOOD & DRUG ADMIN.,
https://www.fda.gov/drugs/developmenthttps://www.fda.gov/drugs/development -resources/surrogate-endpoint-resources/surrogate-endpoint -resources-drug-and-biologic-development-resources-drug-and-biologic-development (la (la
updated Julyupdated July 24, 2018). 24, 2018).
99 105 EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, supra ~~note 79~~,note 85, at 12. at 12.
~~100~~106 Id. at 11 at 11-–12; 12; compare 21 U.S.C. § 21 U.S.C. § 356(a)(1), 356(a)(1), with id. § 356(b)(1). § 356(b)(1).
~~101~~107 EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, , supra ~~note 79~~,note 85, at 12. at 12.
~~102~~108 Id.
~~103~~109 21 U.S.C. 21 U.S.C. § 356(a)(2). § 356(a)(2).
~~104~~110 Id. § 356(a)(3)(A). § 356(a)(3)(A).
~~105~~111 Id. § 356(a)(3)(B). § 356(a)(3)(B).
~~106~~112 EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, supra ~~note 79~~,note 85, at 13 at 13-–15. 15.
~~107~~113 21 U.S.C. 21 U.S.C. § 356(c); § 356(c); see also Accelerated Approval, U.S. FOOD & DRUG ADMIN., https://www.fda.gov/patients/fast, U.S. FOOD & DRUG ADMIN., https://www.fda.gov/patients/fast --
track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval (updated Jan. 4, 2018). track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval (updated Jan. 4, 2018).
114 See Surrogate Endpoint Resources for Drug and Biologic Development, U.S. FOOD & DRUG ADMIN., https://www.fda.gov/drugs/development-resources/surrogate-endpoint-resources-drug-and-biologic-development (last updated July 24, 2018). Congressional Research Service 11~~Congressional Research Service~~
10

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~~endpoints that directly measure the clinical outcome (i.e., the benefits expected from the~~
~~biologic), such as whether the patient feels better or lives longer.108 Surrogate and intermediate~~
~~endpoints do not measure the clinical benefit directly but instead measure an effect that is~~
~~expected to predict a clinical benefit.109~~expected to predict a clinical benefit.115 For example, a drug to treat strokes would have an For example, a drug to treat strokes would have an
intended clinical outcome of reducing the incidence or severity of strokes.intended clinical outcome of reducing the incidence or severity of strokes.~~110~~116 But rather than But rather than
measuring the incidence of strokes directly, an investigator might measure the drug’s effect on measuring the incidence of strokes directly, an investigator might measure the drug’s effect on
blood pressure as a surrogate endpoint due to the strong correlation between strokes and blood blood pressure as a surrogate endpoint due to the strong correlation between strokes and blood
pressure.pressure.~~111~~117
To qualify for accelerated approval, (1) the biologic must treat a serious or life-threatening To qualify for accelerated approval, (1) the biologic must treat a serious or life-threatening
condition or disease and (2) FDA must determine that the biologic has an effect on a surrogate or condition or disease and (2) FDA must determine that the biologic has an effect on a surrogate or
intermediate endpoint that is reasonably likelyintermediate endpoint that is reasonably likely to predict a clinical benefit. When deciding to predict a clinical benefit. When deciding
whether to approve a biologic on this basis, FDA must consider how severe, rare, or prevalent the whether to approve a biologic on this basis, FDA must consider how severe, rare, or prevalent the
condition is and the availabilitycondition is and the availability of alternative treatments. A vaccine for COVID-19 could qualify of alternative treatments. A vaccine for COVID-19 could qualify
for accelerated approval if investigators identified a surrogate or intermediate endpoint that could for accelerated approval if investigators identified a surrogate or intermediate endpoint that could
reasonably predict the vaccine would be effective against the virus. reasonably predict the vaccine would be effective against the virus.
Priority Review
Once a BLAOnce a BLA is submitted, FDA can designate the BLAis submitted, FDA can designate the BLA for standard review or priority review.for standard review or priority review.~~112~~118
FDA aims to act on priority review applications within 6 months, compared to 10 months or more FDA aims to act on priority review applications within 6 months, compared to 10 months or more
for standard review applications.for standard review applications.~~113~~119 FDA makes this determination for every application, though a FDA makes this determination for every application, though a
sponsor can expressly request priority review.sponsor can expressly request priority review.~~114~~120 FDA may designate a BLA FDA may designate a BLA for priority review if for priority review if
it represents a “significant improvement” over existing treatments in terms of safety or it represents a “significant improvement” over existing treatments in terms of safety or
effectiveness in treating, diagnosing, or preventing the disease or condition.effectiveness in treating, diagnosing, or preventing the disease or condition.~~115~~121 In the absence of In the absence of
any approved vaccine for COVID-19, FDA would likely designate for priority review any BLA any approved vaccine for COVID-19, FDA would likely designate for priority review any BLA
for such a vaccine. for such a vaccine.
Emergency Use Authorizations Before Approval
In certain emergency situations, Section 564 of the FD&C Act In certain emergency situations, Section 564 of the FD&C Act ~~al ows~~allows FDA to authorize the use of FDA to authorize the use of
a drug or biologic (e.g., a vaccine) before it is approved (i.e., an Emergency Use Authorization or a drug or biologic (e.g., a vaccine) before it is approved (i.e., an Emergency Use Authorization or
EUA).EUA).~~116~~122 FDA may issue an EUA FDA may issue an EUA ~~only if the Secretary of Health and Human Services (HHS) has~~

~~108 See Surrogate Endpoint Resources for Drug and Biologic Development, U.S. FOOD & DRUG ADMIN.,~~
~~https://www.fda.gov/drugs/development -resources/surrogate-endpoint -resources-drug-and-biologic-development (last~~
~~updated July 24, 2018).~~
109 Id.
110 Id.
111 Id.
~~112 Prescription Drug User Fee Act of 1992, Pub. L. No. 102~~ only if the HHS Secretary has declared that circumstances exist justifying emergency authorized use of the medical product.123 Of relevance to the COVID-19 pandemic, on February 4, 2020, the Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent (BCRN agent)—namely, the virus that causes COVID-19.124 Based on this determination, the Secretary 115 Id. 116 Id. 117 Id. 118 Prescription Drug User Fee Act of 1992, Pub. L. No. 102-571, 106 Stat. 4491 (1992); -571, 106 Stat. 4491 (1992); Priority Review, U.S. FOOD & , U.S. FOOD &
DRUG ADMIN., https://www.fda.gov/patients/fastDRUG ADMIN., https://www.fda.gov/patients/fast -track-breakthrough-therapy-accelerated-approval-priority--track-breakthrough-therapy-accelerated-approval-priority-
review/priority-review. (last updated Jan. 4, 2018) [hereinafter review/priority-review. (last updated Jan. 4, 2018) [hereinafter Priority Review]. ].
~~113~~119 Priority Review, , supra ~~note 112~~;note 118; EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, supra ~~note 79~~,note 85, at at
2424-–25. 25.
~~114~~ 120 Priority Review, , supra ~~note 112.~~
~~115 Priority Review, supra note 112~~note 118. 121 Id.; EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, ; EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS: FDA GUIDANCE, supra ~~note 79,~~
~~at 24-25.~~
~~116~~note 85, at 24–25. 122 21 U.S.C. 21 U.S.C. § 360bbb-3;§ 360bbb-3; see also Emergency Use Authorization, U.S. FOOD & DRUG ADMIN., , U.S. FOOD & DRUG ADMIN.,
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-
use-authorization#2019-ncov (last updated May 22, 2020)use-authorization#2019-ncov (last updated May 22, 2020).
~~Congressional Research Service~~
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~~link to page 4~~ ~~Legal Issues in COVID-19 Vaccine Development~~

~~declared that circumstances exist justifying emergency authorized use of the medical product.117~~
~~Of relevance to the COVID-19 pandemic, on February 4, 2020, the Secretary determined that~~
~~there is a public health emergency that has a significant potential to affect national security or the~~
~~health and security of U.S. citizens living abroad, and that involves a biological, chemical,~~
~~radiological, or nuclear agent (BCRN agent)—namely, the virus that causes COVID-19.118 Based~~
~~on this determination, the Secretary~~ [hereinafter Emergency Use Authorization]. 123 See 21 U.S.C. § 360bbb-3(b). 124 Alex M. Azar II, Sec’y of the Dep’t of Health & Human Servs., Determination of a Public Health Emergency and Congressional Research Service 12 link to page 15 link to page 15 link to page 4 Legal Issues in COVID-19 Vaccine Development has authorized the emergency use of several diagnostic has authorized the emergency use of several diagnostic
tests.tests.~~119~~125 On March 2, 2020, the Secretary determined that circumstances exist to On March 2, 2020, the Secretary determined that circumstances exist to ~~al ow~~allow for the for the
emergency use of certain respirators not approved by the agency,emergency use of certain respirators not approved by the agency,~~120~~126 and FDA issued an EUA and FDA issued an EUA
~~al owing~~allowing for the emergency use of such respirators. for the emergency use of such respirators.~~121~~127
After the Secretary determines a public health emergency exists (one of four bases for declaring After the Secretary determines a public health emergency exists (one of four bases for declaring
an emergency or threat), FDA may issue an EUA for a specific product if the Secretary concludes an emergency or threat), FDA may issue an EUA for a specific product if the Secretary concludes
that that
1. the BCRN agent can cause a serious or life-threatening disease or condition; 1. the BCRN agent can cause a serious or life-threatening disease or condition;
2. it is reasonable to believe, based on the totality of the scientific evidence available, 2. it is reasonable to believe, based on the totality of the scientific evidence available, that that
a. the product may be effective in diagnosing, treating, or preventing the disease or a. the product may be effective in diagnosing, treating, or preventing the disease or
condition caused by the BCRN agent; and condition caused by the BCRN agent; and
b. the known and potential benefits of the product outweigh the known and potential b. the known and potential benefits of the product outweigh the known and potential
risks; and risks; and
3. there is no adequate, approved, and available 3. there is no adequate, approved, and available alternative to the product.alternative to the product.~~122~~128
In evaluating a product for an EUA, FDA uses a lower evidentiary standard, determining whether In evaluating a product for an EUA, FDA uses a lower evidentiary standard, determining whether
the product “may be effective” in diagnosing, treating, or preventing a disease rather than the product “may be effective” in diagnosing, treating, or preventing a disease rather than
evaluating its “effectiveness” in doing so.evaluating its “effectiveness” in doing so.~~123~~129 As discussed above, COVID-19 is a serious or life- As discussed above, COVID-19 is a serious or life-
threatening disease, confirmed by the fact that FDA has already issued EUAs in connection with threatening disease, confirmed by the fact that FDA has already issued EUAs in connection with
COVID-19 for diagnostic tests and certain personal protective equipment.COVID-19 for diagnostic tests and certain personal protective equipment.~~124~~130 There is also no There is also no
alternative to a COVID-19 vaccine at this time.alternative to a COVID-19 vaccine at this time.~~125~~131 Any decision by FDA to issue an EUA Any decision by FDA to issue an EUA ~~for a~~

~~117 See 21 U.S.C. § 360bbb-3(b).~~
~~118 Alex M. Azar II, Sec’y of the Dep’t of Health & Human Servs., Determination of a Public Health Emergency and~~
for a COVID-19 vaccine would accordingly depend on whether the totality of the evidence available to FDA shows that it is reasonable to believe that (1) the vaccine may be effective in preventing COVID-19 and (2) those benefits outweigh any known or potential risks from the vaccine. FDA would have to conduct this evaluation for each vaccine that is developed and submitted for an EUA. The FD&C Act requires FDA to impose certain conditions on EUAs as necessary and appropriate to protect the public health.132 The conditions vary depending on whether the product is unapproved or approved but for a different use.133 In general, the conditions provide for Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug,
and Cosmetic Act, 21 U.S.C.and Cosmetic Act, 21 U.S.C. § § 360bbb-3 (Feb. 4, 2020), https://www.fda.gov/media/135010/download. 360bbb-3 (Feb. 4, 2020), https://www.fda.gov/media/135010/download.
~~119~~125 See Emergency Use Authorization, , ~~U.S. FOOD & DRUG ADMIN., https://www.fda.gov/emergency-preparedness-and-~~
~~response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov (last updated May 22,~~
~~2020).~~
~~120~~supra note 122. 126 Alex M. Azar II, Sec’y of the Dep’t of Health & Human Servs., Declaration that Circumstances Exist Justifying Alex M. Azar II, Sec’y of the Dep’t of Health & Human Servs., Declaration that Circumstances Exist Justifying
Authorizations Pursuant to Section 564(b) of the Federal Food, Drug,Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.and Cosmetic Act, 21 U.S.C. § 360bbb-3 (Mar. 2, § 360bbb-3 (Mar. 2,
2020), https://www.fda.gov/media/135787/download. 2020), https://www.fda.gov/media/135787/download.
~~121~~ 127 Letter from Denise M. Hinton, Chief Scientist, U.S. Letter from Denise M. Hinton, Chief Scientist, U.S. Food & DrugFood & Drug Admin., to Dr. Redfield,Admin., to Dr. Redfield, ~~Director~~ Dir., Ctrs. for , Ctrs. for
~~Disease~~ Disease Control & Prevention (Mar. 28, 2020), https://www.fda.gov/media/135763/download. Control & Prevention (Mar. 28, 2020), https://www.fda.gov/media/135763/download.
~~122~~128 21 U.S.C. 21 U.S.C. § 360bbb-3(c). § 360bbb-3(c).
~~123~~129 U.S. FOOD & DRUG ADMIN., EMERGENCY USE AUTHORIZATION OF MEDICAL PRODUCTS AND RELATED AUTHORITIES: U.S. FOOD & DRUG ADMIN., EMERGENCY USE AUTHORIZATION OF MEDICAL PRODUCTS AND RELATED AUTHORITIES:
GUIDANCE FOR INDUSTRY AND OTHER STAKEHOLDERS 12 (Jan. 2017), https://www.fda.gov/media/97321/download. GUIDANCE FOR INDUSTRY AND OTHER STAKEHOLDERS 12 (Jan. 2017), https://www.fda.gov/media/97321/download.
~~124~~ 130 Emergency Use Authorization, supra note 122. 131 Press Release, Nat’l Insts. of Health, NIH Clinical Trial Emergency Use Authorization, U.S. FOOD & DRUG ADMIN., https://www.fda.gov/emergency-preparedness-and-
~~response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov (last updated May 22,~~
~~2020).~~
~~125 Press Release, Nat’l Insts. of Health, NIH Clinical T rial~~ of Investigational Vaccine for COVID-19 Begins of Investigational Vaccine for COVID-19 Begins (Mar. 16, (Mar. 16,
2020), https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins; 2020), https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins;
WHO ~~Draft~~ Draft Landscape of COVID-19 Candidate Vaccines, , supra ~~not~~enote 1.
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~~COVID-19 vaccine would accordingly depend on whether the totality of the evidence available to~~
~~FDA shows that it is reasonable to believe that (1) the vaccine may be effective in preventing~~
~~COVID-19 and (2) those benefits outweigh any known or potential risks from the vaccine. FDA~~
~~would have to conduct this evaluation for each vaccine that is developed and submitted for an~~
~~EUA.~~
~~The FD&C Act requires FDA to impose certain conditions on EUAs as necessary and appropriate~~
~~to protect the public health.126 The conditions vary depending on whether the product is~~
~~unapproved or approved but for a different use.127 In general, the conditions provide for~~ 132 21 U.S.C. § 360bbb-3(e). 133 Id. § 360bbb-3(e)(1) & (2). Congressional Research Service 13 Legal Issues in COVID-19 Vaccine Development
monitoring, reporting, and recordkeeping as monitoring, reporting, and recordkeeping as ~~wel~~ well as ensuring that the health care professionals as ensuring that the health care professionals
administering the product and the individuals being treated with the product are informed about administering the product and the individuals being treated with the product are informed about
the benefits and risks of using the product.the benefits and risks of using the product.~~128~~134 FDA may also waive good manufacturing practices FDA may also waive good manufacturing practices
~~(GMP)~~ and certain prescription requirements when issuing an EUA and may impose conditions and certain prescription requirements when issuing an EUA and may impose conditions
related to advertising the product.related to advertising the product.~~129~~135
Considerations for Congress
The current legal regime for approving new pharmaceutical products such as vaccines The current legal regime for approving new pharmaceutical products such as vaccines ~~general y~~generally
aims to strike a balance between bringing products to market sooner and ensuring that products aims to strike a balance between bringing products to market sooner and ensuring that products
on the market are safe and effective. For serious or life-threatening diseases and conditions or in on the market are safe and effective. For serious or life-threatening diseases and conditions or in
emergency situations, the law gives FDA a certain amount of discretion to shift that balance. FDA emergency situations, the law gives FDA a certain amount of discretion to shift that balance. FDA
~~general y~~generally expedites the process one of two ways: shifting its resources or shifting its standard in expedites the process one of two ways: shifting its resources or shifting its standard in
evaluating the risks and benefits. evaluating the risks and benefits.
In considering avenues to facilitate the development of a COVID-19 vaccine, Congress has In considering avenues to facilitate the development of a COVID-19 vaccine, Congress has
similar options. Congress could consider providing additional resources to FDA to exercise its similar options. Congress could consider providing additional resources to FDA to exercise its
existing authorities. Congress is already employing this approach: The Coronavirus Preparedness existing authorities. Congress is already employing this approach: The Coronavirus Preparedness
and Response Supplemental Appropriations Act, 2020, enacted on March 6, appropriated $61 and Response Supplemental Appropriations Act, 2020, enacted on March 6, appropriated $61
~~mil ion~~ million to FDA “to prevent, prepare for, and respond to coronavirus, to FDA “to prevent, prepare for, and respond to coronavirus, ~~domestical y or~~
~~international y,~~ domestically or internationally, including the development of necessary medical countermeasures and vaccines, ,
advanced manufacturing for medical products, the monitoring of medical product supply chains, advanced manufacturing for medical products, the monitoring of medical product supply chains,
and related administrative activities.”and related administrative activities.”~~130~~136 Alternatively, Alternatively, Congress could direct FDA to strike a Congress could direct FDA to strike a
different balance when evaluating the risks versus the benefits different balance when evaluating the risks versus the benefits ~~specifical y~~specifically in the context of in the context of
potential COVID-19 vaccines. In assessing that balance, Congress and FDA would face weighing potential COVID-19 vaccines. In assessing that balance, Congress and FDA would face weighing
the benefits from disseminating a vaccine to the public sooner (e.g., limiting the spread of the the benefits from disseminating a vaccine to the public sooner (e.g., limiting the spread of the
virus or reducing the economic consequences) against the risk that the vaccine may have been virus or reducing the economic consequences) against the risk that the vaccine may have been
authorized prematurely and prove ineffective or unsafe, authorized prematurely and prove ineffective or unsafe, ~~potential y~~potentially leading to worse public health leading to worse public health
outcomes. Any alteration to this balance that requires FDA to exceed or contradict its existing outcomes. Any alteration to this balance that requires FDA to exceed or contradict its existing
authority would require an act of Congress to amend the agency’s statutory authority. authority would require an act of Congress to amend the agency’s statutory authority.
Should FDA authorize or approve a COVID-19 vaccine, other considerations may come to bear. Should FDA authorize or approve a COVID-19 vaccine, other considerations may come to bear.
For example, registered manufacturers may not be able to produce an adequate supply of the For example, registered manufacturers may not be able to produce an adequate supply of the
vaccine. FDA is currently addressing hand sanitizer shortages by exercising its enforcement vaccine. FDA is currently addressing hand sanitizer shortages by exercising its enforcement
discretion with respect to production by over-the-counter drug manufacturers and discretion with respect to production by over-the-counter drug manufacturers and

~~126 21 U.S.C. § 360bbb-3(e).~~
~~127 Id. § 360bbb-3(e)(1) & (2).~~
128 Id.
~~129 Id. § 360bbb-3(e)(3) & (4).~~
~~130~~compounders.137 Congress may consider other avenues for increasing supply of the vaccine. In 134 Id. 135 Id. § 360bbb-3(e)(3) & (4). 136 Pub. L. No. 116-123, 134 Stat. 146 (2020) (emphasis added). Pub. L. No. 116-123, 134 Stat. 146 (2020) (emphasis added).
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~~compounders.131 Congress may consider other avenues for increasing supply of the vaccine. In~~
~~addition, existence of a vaccine would raise questions of mandatory vaccination to address the~~
~~public health crisis, which is addressed in a CRS Legal Sidebar.132~~137 Press Release, U.S. Food & Drug Admin., Coronavirus (COVID-19) Update: FDA Provides Guidance on Production of Alcohol-Based Hand Sanitizer to Help Boost Supply, Protect Public Health (Mar. 20, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-guidance-production-alcohol-based-hand-sanitizer-help-boost; U.S. FOOD & DRUG ADMIN., TEMPORARY POLICY FOR PREPARATION OF CERTAIN ALCOHOL-BASED HAND SANITIZER PRODUCTS DURING THE PUBLIC HEALTH EMERGENCY (COVID-19): GUIDANCE FOR INDUSTRY, https://www.fda.gov/media/136289/download (updated June 1, 2020); U.S. FOOD & DRUG ADMIN., POLICY FOR TEMPORARY COMPOUNDING OF CERTAIN ALCOHOL-BASED HAND SANITIZER PRODUCTS DURING THE PUBLIC HEALTH EMERGENCY: IMMEDIATELY IN EFFECT GUIDANCE FOR INDUSTRY https://www.fda.gov/media/136118/download (updated June 1, 2020). Congressional Research Service 14 Legal Issues in COVID-19 Vaccine Development addition, existence of a vaccine would raise questions of mandatory vaccination to address the public health crisis, which is addressed in a CRS Legal Sidebar.138
Patent Rights in COVID-19 Vaccines: Incentives,
Access, and Affordability
FDA authorization or licensure of a COVID-19 vaccine would permit the manufacturer to market FDA authorization or licensure of a COVID-19 vaccine would permit the manufacturer to market
the vaccine, but does not guarantee that the vaccine the vaccine, but does not guarantee that the vaccine ~~wil~~ will be widely availablebe widely available or affordable. A or affordable. A
significant factor that may influence COVID-19 vaccine affordability and significant factor that may influence COVID-19 vaccine affordability and ~~access~~accessibility is the existence is the existence
~~and al ocation~~and allocation of IP rights in a vaccine, such as patent rights. of IP rights in a vaccine, such as patent rights.~~133~~ While IP rights, such as patent rights, may provide critical incentives for manufacturers to invest in the development of COVID-19 vaccines,139 they may also significantly affect the accessibility and affordability of a COVID-19 vaccine.140 If some element of a successful ~~If some element of a successful~~
COVID-19 vaccine was patented, for example, the patent holder would have the exclusive right COVID-19 vaccine was patented, for example, the patent holder would have the exclusive right
to make and use that COVID-19 vaccine within the United States.to make and use that COVID-19 vaccine within the United States.~~134~~141
Some Members of Congress have raised concerns about whether a COVID-19 vaccine and other Some Members of Congress have raised concerns about whether a COVID-19 vaccine and other
medical countermeasures, if shown to be safe and effective, medical countermeasures, if shown to be safe and effective, ~~wil~~ will be affordable and accessible to be affordable and accessible to
the public—the public—~~especial y~~especially if federal funds contribute to their development. if federal funds contribute to their development.~~135~~142 Several of the Several of the
congressional responses to the COVID-19 pandemic contain provisions that relate to this issue.congressional responses to the COVID-19 pandemic contain provisions that relate to this issue.
~~First, under~~ Under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, most private the Coronavirus Aid, Relief, and Economic Security (CARES) Act, most private
health insurance plans must cover a COVID-19 vaccine and other COVID-19 preventative health insurance plans must cover a COVID-19 vaccine and other COVID-19 preventative
services without cost sharing (e.g., deductibles or co-pays).services without cost sharing (e.g., deductibles or co-pays).~~136~~143 Although individuals without health 138 CRS Legal Sidebar LSB10300, An Overview of State and Federal Authority to Impose Vaccination Requirements, by Wen S. Shen. 139 See, e.g., Adam Mossoff, Gutting Patent Protections Won’t Cure COVID-19 , HUDSON INST. (May 23, 2020), https://www.hudson.org/research/16069-gutting-patent-protections-won-t-cure-covid-19 (“Without [IP] protections, there’d be little incentive for private companies and investors to dedicate hundreds of billions of dollars to the scientists at the cutting edge of biomedical research.”); see generally Henry G. Grabowski et al., The Roles of Patents and Research and Development Incentives in Biopharmaceutical Innovation, 34 HEALTH AFF. 302, 302 (2015) (“Patents and other forms of intellectual property protection are generally thought to play essential roles in encouraging innovation in biopharmaceuticals.”). 140 See, e.g., Médecins Sans Frontières/Doctors Without Borders, MSF Calls for No Patents or Profiteering on COVID-19 Drugs, Tests, and Vaccines in Pandemic ~~Although this provision aims to~~

~~131 Press Release, U.S. Food & Drug Admin., Coronavirus (COVID-19) Update: FDA Provides Guidance on~~
~~Production of Alcohol-Based Hand Sanitizer to Help Boost Supply, Protect Public Health (Mar. 20, 2020),~~
~~https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-guidance-~~
~~production-alcohol-based-hand-sanitizer-help-boost ; U.S. FOOD & DRUG ADMIN., TEMPORARY POLICY FOR~~
~~PREP ARATION OF CERTAIN ALCOHOL-BASED HAND SANITIZER PRODUCTS DURING THE PUBLIC HEALTH EMERGENCY~~
~~(COVID-19): GUIDANCE FOR INDUSTRY, https://www.fda.gov/media/136289/download (updated June 1, 2020); U.S.~~
~~FOOD & DRUG ADMIN., POLICY FOR TEMPORARY COMPOUNDING OF CERTAIN ALCOHOL-BASED HAND SANITIZER~~
~~PRODUCTS DURING THE PUBLIC HEALTH EMERGENCY: IMMEDIATELY IN EFFECT GUIDANCE FOR INDUSTRY~~
~~https://www.fda.gov/media/136118/download (updated June 1, 2020).~~
~~132 CRS Legal Sidebar LSB10300, An Overview of State and Federal Authority to Impose Vaccination Requirements,~~
~~by Wen S. Shen.~~
~~133 See, e.g., Médecins Sans Frontières/Doctors Without Borders,~~ ~~MSF Calls for No Patents or Profiteering on COVID-~~
~~19 Drugs, Tests, and Vaccines in Pandem ic~~, MSF ACCESS CAMPAIGN (Mar. 27, 2020),, MSF ACCESS CAMPAIGN (Mar. 27, 2020), https://msfaccess.org/msf-calls-https://msfaccess.org/msf-calls-
no-patents-or-profiteering-covid-19-drugs-tests-and-vaccines-pandemic (urging suspension of patent rights in COVID-no-patents-or-profiteering-covid-19-drugs-tests-and-vaccines-pandemic (urging suspension of patent rights in COVID-
19 countermeasures to ensure affordability and access);19 countermeasures to ensure affordability and access); Jennifer Hillman, Jennifer Hillman, Drugs and Vaccines Are ~~Com ing~~Coming—But to
Whom ?, FOREIGN AFF. (May 19, 2020), https://www.foreignaffairs.com/articles/world/2020, FOREIGN AFF. (May 19, 2020), https://www.foreignaffairs.com/articles/world/2020 -05-19/drugs-and-vaccines--05-19/drugs-and-vaccines-
are-coming-whom (expressing concern that “are-coming-whom (expressing concern that “ intellectual property rights could prevent vaccines or drugsintellectual property rights could prevent vaccines or drugs from reaching from reaching
the poor and vulnerable”); the poor and vulnerable”); but see Daniel Hemel & Lisa Larrimore Ouellette, Daniel Hemel & Lisa Larrimore Ouellette, Pharmaceutical Profits and Public
Health Are Not ~~Incom patible~~ Incompatible, N.Y. TIMES (Apr. 8, 2020) (arguing that encouraging COVID-19 countermeasure , N.Y. TIMES (Apr. 8, 2020) (arguing that encouraging COVID-19 countermeasure
development need not come at the cost of reducing patient access).development need not come at the cost of reducing patient access).
~~134~~ 141 See 35 U.S.C. 35 U.S.C. § § 271(a). 271(a).
~~135~~142 See Ariel Cohen, Ariel Cohen, Senators Worry About COVID-19 Vaccine Affordability, Distribution, INSIDE HEALTH POLICY , INSIDE HEALTH POLICY
(May 14, 2020), https://insidehealthpolicy.com/daily-news/senators-worry-about-covid-19-vaccine-affordability-(May 14, 2020), https://insidehealthpolicy.com/daily-news/senators-worry-about-covid-19-vaccine-affordability-
distribution;distribution; Letter from Reps. James E. ClyburnLetter from Reps. James E. Clyburn & Carolyn Maloney to Sec.& Carolyn Maloney to Sec. Alex M. Azar II (June 2, 2020), Alex M. Azar II (June 2, 2020),
https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2020https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2020 -06--06-
02.Clyburn%20CBM%20to%20HHS%20re%20Vaccine%20and%02.Clyburn%20CBM%20to%20HHS%20re%20Vaccine%20and%~~20T reatment~~20Treatment%20Contracts.pdf%20Contracts.pdf ; Letter from Rep. ; Letter from Rep.
Jan Schakowsky et al. to President Donald J. Jan Schakowsky et al. to President Donald J. ~~T rump~~Trump (Feb. 20, 2020), https://freepdfhosting.com/20bf1d75af.pdf. (Feb. 20, 2020), https://freepdfhosting.com/20bf1d75af.pdf.
~~136~~143 Pub. L. No. 116-136, § 3203 (2020). Most specifically, this requirement applies to COVID-19 vaccines Pub. L. No. 116-136, § 3203 (2020). Most specifically, this requirement applies to COVID-19 vaccines
recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and
Prevention and to group health plans and health insurance issuersPrevention and to group health plans and health insurance issuers offering group or individualoffering group or individual ~~healt h~~ health insurance as ~~insurance as~~
~~defined by PHSA Section 2791. See id.~~ ~~§ 3203(b)(1), (3). For an analysis of the current federal insurance coverage~~
Congressional Research Service Congressional Research Service
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~~ensure that consumers with private health insurance wil not pay co-payments for accessing a~~
~~COVID-19 vaccine, it does~~insurance generally fall outside of this mandate, the Trump Administration has promised that the federal government will provide a COVID-19 vaccine for free to “any American who is vulnerable, who cannot afford the vaccine[],”144 which would presumably include many such individuals. Although these provisions may lessen concerns about the cost of a COVID-19 vaccine for patients, they do not directly address other pricing issues, such as the potential cost to not directly address other pricing issues, such as the potential cost to
health care providers, health insurance companieshealth care providers, health insurance companies~~, persons without health insurance, or the~~
, or the federal government.federal government.~~137~~
145 The Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSA) The Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSA)
contains two general provisions related to the affordability of COVID-19 countermeasures. First, contains two general provisions related to the affordability of COVID-19 countermeasures. First,
products purchased by the federal government using funds appropriated by CPRSA, including products purchased by the federal government using funds appropriated by CPRSA, including
vaccines, therapeutics, and diagnostics for COVID-19, “vaccines, therapeutics, and diagnostics for COVID-19, “~~shal~~ shall be purchased in accordance with be purchased in accordance with
Federal Acquisition Regulation guidance on fair and reasonable pricing.”Federal Acquisition Regulation guidance on fair and reasonable pricing.”~~138~~146 Second, CPRSA Second, CPRSA
states that the Secretary of HHS “may take such measures authorized under current law to ensure states that the Secretary of HHS “may take such measures authorized under current law to ensure
that vaccines, therapeutics, and diagnostics developed from funds provided in [CPRSA] that vaccines, therapeutics, and diagnostics developed from funds provided in [CPRSA] ~~wil~~ will be be
affordable in the commercial market.”affordable in the commercial market.”~~139 These general statements~~147 These provisions were repeated in the were repeated in the
appropriations for COVID-19 vaccines and other medical countermeasures in the CARES Act.appropriations for COVID-19 vaccines and other medical countermeasures in the CARES Act.~~140~~148
This section reviews IP rights provisions under current law that the federal government could use This section reviews IP rights provisions under current law that the federal government could use
to try to ensure that COVID-19 countermeasures such as a vaccine are accessible and affordable. to try to ensure that COVID-19 countermeasures such as a vaccine are accessible and affordable.
~~Other actions that the federal government might hypothetical y take—such as additional~~
~~spending, direct production by federal agencies, contractual guarantees from vaccine~~
~~manufacturers, governmental negotiation, or price controls—are not discussed, in that such~~
~~measures do not implicate IP rights and may require additional legislative action beyond the~~
~~“current law” referenced in CPRSA and the CARES Act.~~
~~Patent Rights in Inventions Made with Federal Assistance~~
~~Patent Basics~~
~~Under the Patent Act,141 any person who “invents or discovers any new and useful process,~~
~~machine, manufacture, or composition of matter” may apply for a patent on the invention with the~~
~~U.S. Patent and Trademark Office (PTO).142 PTO patent examiners evaluate the application to~~

requirements for COVID-19 testing, treatments, and vaccinations, see ~~CRS~~ After explaining the basics of the U.S. patent system as applied to a potential COVID-19 vaccine, it analyzes the scope of two existing legal authorities—Bayh-Dole “march-in rights” and governmental use under 28 U.S.C. § 1498—that the federal government could invoke should U.S. patent rights inhibit the development, distribution, access, or affordability of a COVID-19 vaccine. Finally, it discusses potential legislative options should Congress conclude that these existing authorities are insufficient. defined by PHSA Section 2791. See id. § 3203(b)(1), (3). For an analysis of the current federal insurance coverage requirements for COVID-19 testing, treatments, and vaccinations, see CRS Report R46359, Report R46359, COVID-19 and Private
Health Insurance Coverage: Frequently Asked Questions, by Vanessa, by Vanessa C. ForsbergC. Forsberg.
~~137~~144 See Lev Facher, Trump Administration Pledges Future COVID-19 Vaccines Will Be Free for ‘Vulnerable’ Americans, STAT (June 16, 2020), https://www.statnews.com/2020/06/16/free-covid-19-vaccines-vulnerable-americans/. 145 It is likely that the federal government will be It is likely that the federal government will be a primary purchaser and distributor of a COVID-19a primary purchaser and distributor of a COVID-19 vaccine. vaccine. ~~T he~~The
federal government currently purchases over half of the pediatric vaccines administered in the United States (primarily federal government currently purchases over half of the pediatric vaccines administered in the United States (primarily
for children who are uninsuredfor children who are uninsured or eligibleor eligible for Medicaid).for Medicaid). See Christoph Diasio, Christoph Diasio, Pediatric Vaccination: Who Bears The
Burden?, HEALTH AFF. (Feb. 6, 2016), https://www.healthaffairs.org/do/10.1377/hblog20160209.053058/full/; , HEALTH AFF. (Feb. 6, 2016), https://www.healthaffairs.org/do/10.1377/hblog20160209.053058/full/; see
generally Vaccines for Children Program (VFC), CTRS. FOR DISEASE CONTROL & PREVENTION (Feb. 18, 2016), , CTRS. FOR DISEASE CONTROL & PREVENTION (Feb. 18, 2016),
https://www.cdc.gov/vaccines/programs/vfc/index.html; https://www.cdc.gov/vaccines/programs/vfc/index.html; ~~COMMITTEE~~COMM. ON THE EVALUATION OF VACCINE PURCHASE ON THE EVALUATION OF VACCINE PURCHASE
~~FINANCING~~FIN. IN THE IN THE ~~UNITED STATES~~U.S., FINANCING VACCINES IN THE 21ST CENTURY: ASSURING ACCESS AND AVAILABILITY 4 , FINANCING VACCINES IN THE 21ST CENTURY: ASSURING ACCESS AND AVAILABILITY 4
(2003), https://www.ncbi.nlm.nih.gov/books/NBK221813/pdf/Bookshelf_NBK221813.pdf(2003), https://www.ncbi.nlm.nih.gov/books/NBK221813/pdf/Bookshelf_NBK221813.pdf. .
During During the 2009 to 2010 H1N1 influenza pandemic, the H1N1 vaccine and ancillary the 2009 to 2010 H1N1 influenza pandemic, the H1N1 vaccine and ancillary ~~suppli es (~~supplies (e.g., needles, syringes, etc.) needles, syringes, etc.)
~~were~~ were purchased by the federal government and distributed to health care providers, who couldpurchased by the federal government and distributed to health care providers, who could charge only for the charge only for the
administration of the vaccine. administration of the vaccine. See Questions and Answers on 2009 H1N1 Vaccine Financing , CTRS. FOR DISEASE , CTRS. FOR DISEASE
CONTROL & PREVENTION (Nov. 30, 2009), https://www.cdc.gov/H1N1flu/vaccination/statelocal/vaccine_financing.htm. CONTROL & PREVENTION (Nov. 30, 2009), https://www.cdc.gov/H1N1flu/vaccination/statelocal/vaccine_financing.htm.
~~138~~146 Pub. L. No. 116-123, tit. III, 134 Stat. 146, 149 (2020). Pub. L. No. 116-123, tit. III, 134 Stat. 146, 149 (2020).
~~139~~147 Id.
~~140~~148 See Pub. L. No. 116-136, tit. VIII (2020).Pub. L. No. 116-136, tit. VIII (2020).
~~141 See Patent Act of 1952, Pub. L. No. 82-593, 66 Stat. 792 (1952) (codified as amended at 35 U.S.C. §§ 1-390).~~
~~142 35 U.S.C. §§ 101, 111.~~
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15

~~link to page 11~~ ~~Legal Issues in COVID-19 Vaccine Development~~

~~ensure it meets al~~ Congressional Research Service 16 link to page 11 link to page 11 Legal Issues in COVID-19 Vaccine Development Patent Basics Under the Patent Act,149 any person who “invents or discovers any new and useful process, machine, manufacture, or composition of matter” may apply for a patent on the invention with the U.S. Patent and Trademark Office (PTO).150 PTO patent examiners evaluate the application to ensure it meets all the applicable legal requirements to merit the grant of a patent.the applicable legal requirements to merit the grant of a patent.~~143~~151 If the patent If the patent
examiner concludes that the claimed invention is new, nonobvious, useful, directed at patentable examiner concludes that the claimed invention is new, nonobvious, useful, directed at patentable
subject matter, and adequately disclosed and claimed,subject matter, and adequately disclosed and claimed,~~144~~152 PTO PTO ~~wil~~ will issue the patent.issue the patent.~~145~~153 If granted, If granted,
patents patents ~~typical y~~typically expire 20 years after the initial expire 20 years after the initial patent application is filed.patent application is filed.~~146~~154
Patents are available for almost every field of technology, including biotechnology, chemistry, Patents are available for almost every field of technology, including biotechnology, chemistry,
computer hardware, electrical engineering, mechanical engineering, and manufacturing computer hardware, electrical engineering, mechanical engineering, and manufacturing
processes.processes.~~147~~155 In the pharmaceutical context, if an inventor is the first to synthesize a particular In the pharmaceutical context, if an inventor is the first to synthesize a particular
chemical that is useful in treating disease, she may seek a patent claiming the chemical itself.chemical that is useful in treating disease, she may seek a patent claiming the chemical itself.~~148~~
156 That said, patents on a pharmaceutical’s active ingredient are only a subset of patents relating to That said, patents on a pharmaceutical’s active ingredient are only a subset of patents relating to
pharmaceuticals and other medical treatments.pharmaceuticals and other medical treatments.~~149~~157 Particular drug formulations, methods of using Particular drug formulations, methods of using
the pharmaceutical to treat a particular disease, methods and technologies to administer a the pharmaceutical to treat a particular disease, methods and technologies to administer a
pharmaceutical, pharmaceutical, and methods and technologies to manufacture a pharmaceuticalmethods and technologies to manufacture a pharmaceutical~~, as wel as methods~~
~~and technologies for testing for and diagnosing disease, are al patentable~~ are all patentable if they meet the Patent if they meet the Patent
Act’s requirements.Act’s requirements.~~150~~
~~To encourage innovation, a valid patent holder has the exclusive right to make, use, sel , and~~
~~import (collectively, “practice”) the patented invention in the United States.151 Patents are thus~~
~~said to confer a “temporary monopoly” on the patent holder: anyone else who wishes to practice~~
~~the invention needs to obtain permission from the patent holder to do so (and, typical y, pays for~~
~~that permission).152 In some situations, patent rights can confer substantial market power on~~
~~patent holders, enabling them to charge higher-than-competitive prices for the patented product,~~
~~as a monopolist would.153 Some empirical studies have found patent rights are among the most~~
~~important factors driving high prices for pharmaceutical products.154 At least to some extent,~~

~~143 Id. § 131.~~
~~144 Id. §§ 101, 102-103, 112. For a summary of the requirements for patentability, see generally CRS Report R44962,~~
Patent Law: A Prim er and Overview of Em erging Issues, by Kevin J. Hickey, at 2-4.
~~145 35 U.S.C. § 151, 153.~~
~~146 Id. § 154(a)(2).~~
~~147 See id. § 101; Patent Technology Centers Management, U.S. PATENT & T RADEMARK OFFICE,~~
158 Under the Supreme Court’s long-standing interpretation of the Patent Act, “products of nature” (such as isolated human DNA sequences) are not patentable.159 However, genetically engineered organisms are patentable because they are not naturally occurring.160 Thus, while the antigen of a vaccine may sometimes be patentable—as in the case of genetically modified viral vector—the antigen of a vaccine using a naturally occurring form of a virus may not be patentable as such. However, a vaccine developer would still be able to seek patents on methods of manufacturing the vaccine, other vaccine components (such as adjuvants), and particular vaccine formulations, among other things.161 149 See Patent Act of 1952, Pub. L. No. 82-593, 66 Stat. 792 (1952) (codified as amended at 35 U.S.C. §§ 1–390). 150 35 U.S.C. §§ 101, 111. 151 Id. § 131. 152 Id. §§ 101, 102–103, 112. For a summary of the requirements for patentability, see generally CRS Report R46525, Patent Law: A Handbook for Congress, by Kevin T. Richards, at 8–16. 153 35 U.S.C. § 151, 153. 154 Id. § 154(a)(2). 155 See id. § 101; Patent Technology Centers Management, U.S. PATENT & TRADEMARK OFF., https://www.uspto.gov/patent/contact-patents/patent-technology-centers-managementhttps://www.uspto.gov/patent/contact-patents/patent-technology-centers-management (last visited May 29, 2020) (last visited May 29, 2020)
(listing technological divisions for (listing technological divisions for ~~PT O~~PTO examiners). For a full discussion examiners). For a full discussion of the scope of patentable subject matter, of the scope of patentable subject matter, see
generally CRSCRS Report R45918, Report R45918, Patent-Eligible Subject Matter Reform in the 116th Congress, by Kevin J. Hickey. , by Kevin J. Hickey.
~~148~~156 See 35 U.S.C. 35 U.S.C. § § 101 (allowing patents on “101 (allowing patents on “ any new and usefulany new and useful . . . composition of matter”). . . . composition of matter”).
~~149~~157 See Amy Kapczynski et al., Amy Kapczynski et al., Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of “Secondary”
~~Pharm aceutical~~Pharmaceutical Patents, 7 PLOS ONE 1, 4, 7 PLOS ONE 1, 4-–6 (2012). 6 (2012).
~~150~~ 158 See Hickey et al., Hickey et al., supra ~~note 74~~,note 80, at 12 at 12~~-13.~~
~~151 35 U.S.C. § 271(a). T hese actions are the core of direct patent infringement. There are also a variety of ways to~~
indirectly infringe a patent, such as actively inducing another person to infringe a patent or selling a component
~~especially made or especially adapted for an infringing use. See id. § 271(b)-(c), (f)-(g).~~
~~152 See, e.g., Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 730 (2002) (characterizing pat ents~~
~~as a “temporary monopoly”). It should be noted that this usage of “monopoly” is somewhat imprecise, because the~~
~~exclusive rights provided by IP law do not necessarily confer monopolistic market power in the economic sense —for~~
~~example, there may be noninfringing substitutes for a patented good in the relevant market. See WILLIAM M. LANDES &~~
~~RICHARD A. POSNER, THE ECONOMIC STRUCTURE OF INTELLECTUAL PROPERTY LAW 22 (2003) (“ [IP] protection creates a~~
~~monopoly, in the literal sense in which a person has a monopoly in the house he owns but [only] occasionally in a~~
~~meaningful economic sense as well because there may be no good substitutes for a particular intellectual work.”).~~
~~153 See FT C v. Actavis, Inc., 570 U.S. 136, 147 (2013) (“ [Patent rights] may permit the patent owner to charge a higher-~~
~~than-competitive price for the patented product .”).~~
~~154 See, e.g., Aaron S. Kesselheim et al.,~~ ~~The High Cost of Prescription Drugs in the United States: Origins and~~
~~Prospects for Reform~~ ~~, 316 JAMA: J. AM. MED. ASS’N 858, 861 (2016) (“ The most important factor that allows~~
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–13. 159 See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589–90 (2013). For a full discussion of the judicially developed law of patent-eligible subject matter, including the product-of-nature exception, see generally CRS Report R45918, Patent-Eligible Subject Matter Reform in the 116th Congress, by Kevin J. Hickey. 160 Diamond v. Chakrabarty, 447 U.S. 303, 309–10 (1980). 161 See Hickey et al., supra note 80, at 12–13. Congressional Research Service 17 Legal Issues in COVID-19 Vaccine Development To encourage innovation, a valid patent holder has the exclusive right to make, use, sell, and import (collectively, “practice”) the patented invention in the United States.162 Patents are thus said to confer a “temporary monopoly” on the patent holder: anyone else who wishes to practice the invention needs to obtain permission from the patent holder to do so (and, typically, pays for that permission).163 In some situations, patent rights can confer substantial market power on patent holders, enabling them to charge higher-than-competitive prices for the patented product, as a monopolist would.164 Some empirical studies have found patent rights are among the most important factors driving high prices for pharmaceutical products.165 At least to some extent, higher prices are part of the patent system’s design, in that they enable inventors to recoup the higher prices are part of the patent system’s design, in that they enable inventors to recoup the
costs of research and development necessary to produce the invention in the first place.costs of research and development necessary to produce the invention in the first place.~~155~~166 IP law IP law
thus seeks to balance the importance of providing incentives to innovate against the costs that IP thus seeks to balance the importance of providing incentives to innovate against the costs that IP
rights impose on the public in the form of higher prices and reduced competition.rights impose on the public in the form of higher prices and reduced competition.~~156~~
167 Patent Rights in Inventions Made with Federal Assistance
Patent rights Patent rights ~~initial y~~ initially vest in the individualvest in the individual inventor or inventors, as a general rule.inventor or inventors, as a general rule.~~157~~168 Commonly, Commonly,
however, employees agree by contract to assign their patent rights to inventions made however, employees agree by contract to assign their patent rights to inventions made induring the the
course of their employment to their employer, who may seek a patent on an employee’s behalf.course of their employment to their employer, who may seek a patent on an employee’s behalf.~~158~~
~~When private parties rely on federal assistance to develop an invention, any resulting patent rights~~
~~wil typical y be owned by either the U.S. government or the federal contractor, depending on the~~
~~nature of federal involvement. For inventions made by federal employees during their official~~
~~duties, the federal government wil typical y obtain title to the patent.159 The federal government’s~~
~~general policy for federal y owned inventions, under the Stevenson-Wydler Technology~~
~~Innovation Act160 and the Federal Technology Transfer Act of 1986,161 is to encourage their~~
~~commercialization by licensing the federal y owned patent rights to private parties—a process~~
~~cal ed “technology transfer.”162 Under technology transfer agreements, federal agencies grant~~
~~private parties the exclusive or nonexclusive right to practice the invention,163 while the U.S.~~
~~government retains (1) a “nontransferable, irrevocable, paid-up license . . . to practice the~~
~~invention . . . by or on behalf of” the United States (the “government-use license”);164 and (2) the~~

~~manufacturers to set high drug prices for brand-name drugs is~~ 169 162 35 U.S.C. § 271(a). These actions are the core of direct patent infringement. There are also a variety of ways to indirectly infringe a patent, such as actively inducing another person to infringe a patent or selling a component especially made or especially adapted for an infringing use. See id. § 271(b)-(c), (f)-(g). 163 See, e.g., Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 730 (2002) (characterizing patents as a “temporary monopoly”). It should be noted that this usage of “monopoly” is somewhat imprecise, because the exclusive rights provided by IP law do not necessarily confer monopolistic market power in the economic sense; for example, there may be noninfringing substitutes for a patented good in the relevant market. See WILLIAM M. LANDES & RICHARD A. POSNER, THE ECONOMIC STRUCTURE OF INTELLECTUAL PROPERTY LAW 22 (2003) (“[IP] protection creates a monopoly, in the literal sense in which a person has a monopoly in the house he owns but [only] occasionally in a meaningful economic sense as well because there may be no good substitutes for a particular intellectual work.”). 164 See FTC v. Actavis, Inc., 570 U.S. 136, 147 (2013) (“[Patent rights] may permit the patent owner to charge a higher-than-competitive price for the patented product.”). 165 See, e.g., Aaron S. Kesselheim et al., The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform, 316 JAMA: J. AM. MED. ASS’N 858, 861 (2016) (“The most important factor that allows manufacturers to set high drug prices for brand-name drugs is market exclusivity, which arises from 2 forms of legal market exclusivity, which arises from 2 forms of legal
protection against competition [i.e., patent rights and FDA regulatory exclusivities.]”); protection against competition [i.e., patent rights and FDA regulatory exclusivities.]”); Generic ~~Com petition~~Competition and Drug
Prices, FOOD & DRUG ADMIN. (Nov. 28, 2017), , FOOD & DRUG ADMIN. (Nov. 28, 2017),
https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm129385.htmhttps://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm129385.htm (finding (finding
association between generic competition and lower association between generic competition and lower ~~drug~~ drug prices). prices).
~~155~~ 166 See, e.g., Kewanee, Kewanee Oil Co. v. Bicron Corp., 416 U.S.Oil Co. v. Bicron Corp., 416 U.S. 470, 480 (1974) (“The patent laws promote [the progress of 470, 480 (1974) (“The patent laws promote [the progress of
the usefulthe useful arts] by offering a right of exclusion for a limited period as an incentive to inventors to risk the often arts] by offering a right of exclusion for a limited period as an incentive to inventors to risk the often
enormous costs in terms of enormous costs in terms of ~~t ime~~time, research, and development.”); Emily Michiko Morris, , research, and development.”); Emily Michiko Morris, ~~T he~~ The Myth of Generic
~~Pharm aceutical Com petition~~Pharmaceutical Competition under the Hatch ~~-Waxm an~~-Waxman Act, 22 FORDHAM INTELL. PROP. MEDIA & ENT. L.J. 245, 252 , 22 FORDHAM INTELL. PROP. MEDIA & ENT. L.J. 245, 252
(2012) (“(2012) (“ [P]harmaceuticals are also widely[P]harmaceuticals are also widely ~~recognized~~ recognized as one of the industries most dependent on patent protection to as one of the industries most dependent on patent protection to
recoup its enormous research, development, regulatory, and postrecoup its enormous research, development, regulatory, and post -marketing costs . . . .”). -marketing costs . . . .”).
~~156~~167 See Sony Corp. of Am. v. Universal City Studios,Sony Corp. of Am. v. Universal City Studios, Inc., 464 U.S.Inc., 464 U.S. 417, 429 (1984) (“[D]efining the scope of [patents 417, 429 (1984) (“[D]efining the scope of [patents
and copyrights] involves a difficult balance between the interests of authors and inventors in the control and and copyrights] involves a difficult balance between the interests of authors and inventors in the control and
exploitation of their writings and discoveries on the one hand, andexploitation of their writings and discoveries on the one hand, and ~~society~~ society’s competing interest in the free flow of ideas, ’s competing interest in the free flow of ideas,
information, and commerce on the other hand . . . .”); Mark A. Lemley, information, and commerce on the other hand . . . .”); Mark A. Lemley, Property, Intellectual Property, and Free
Riding, 83 , 83 ~~T EX~~TEX. L. REV. 1031, 1031 (2005) (“. L. REV. 1031, 1031 (2005) (“ [Traditionally,] the proper goal of intellectual property law is to give as [Traditionally,] the proper goal of intellectual property law is to give as
little protection as possible consistent with encouraging innovation.”). little protection as possible consistent with encouraging innovation.”).
~~157~~168 Bd. Bd. ~~of T rustees~~ of Trustees of Leland Stanford Junior Univ. v. Roche Molecular Sys., of Leland Stanford Junior Univ. v. Roche Molecular Sys., Inc., 563 U.S. 776, 785 (2011) (“Our Inc., 563 U.S. 776, 785 (2011) (“Our
precedents confirm the general rule that rights in an invention belong to the inventor.”); precedents confirm the general rule that rights in an invention belong to the inventor.”); see 35 U.S.C. §§35 U.S.C. §§ 100(f), 101. 100(f), 101.
~~158~~169 See Roche, 563 U.S. at 793 (noting “common practice” of assignment of patent rights in inventions from employees , 563 U.S. at 793 (noting “common practice” of assignment of patent rights in inventions from employees
~~to their employer); 35 U.S.C. §§ 118, 152, 261.~~
~~159 See 37 C.F.R. § 501.6(a).~~
~~160 Pub. L. No. 96-480, 94 Stat. 2311 (1980).~~
~~161 Pub. L. No. 99-502, 100 Stat. 1785 (1986).~~
162 See ~~15 U.S.C. § 3710(a) (“The Federal Government shall strive where appropriate to transfer~~ Congressional Research Service 18 link to page 24 link to page 24 link to page 11 Legal Issues in COVID-19 Vaccine Development A number of the COVID-19 vaccine candidates currently in development are supported by federal funding or other assistance, which can affect the allocation and scope of any resulting patent rights. When private parties rely on federal assistance to develop an invention, any resulting patent rights will typically be owned by either the U.S. government or the federal contractor, depending on the nature of federal involvement. For inventions made by federal employees during their official duties, the federal government will typically obtain title to the patent.170 The federal government’s general policy for federally federally owned inventions, under the Stevenson-Wydler Technology Innovation Act171 and the Federal Technology Transfer Act of 1986,172 is to encourage their commercialization by licensing the federally owned patent rights to private parties—a process called “technology transfer.”173 Under technology transfer agreements, federal agencies grant private parties the exclusive or nonexclusive right to practice the invention,174 while the U.S. government retains (1) a “nontransferable, irrevocable, paid-up license . . . to practice the invention . . . by or on behalf of” the United States (the “government-use license”);175 and (2) the ~~owned or~~
~~originated technology to State and local governments an d to the private sector.”); 35 U.S.C. § 209 (conditions for~~
~~licensing of federally owned inventions).~~
~~163 35 U.S.C. § 209(a).~~
~~164 Id. § 209(d)(1).~~
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power “to terminate the license in whole or in part” based on grounds similar to the conditions for power “to terminate the license in whole or in part” based on grounds similar to the conditions for
Bayh-Dole “march-in rights“march-in rights.” As discussed in greater detail below,176 the~~” (discussed below).165~~
~~The~~ Bayh-Dole Act of 1980 (Bayh-Dole), Bayh-Dole Act of 1980 (Bayh-Dole),~~166~~177 as amended, applies to inventions that a federal as amended, applies to inventions that a federal
contractor conceives or first reduces to practice during the performance of a funding agreement contractor conceives or first reduces to practice during the performance of a funding agreement
with a federal agency.with a federal agency.~~167~~178 Under Bayh-Dole, the federal contractor may elect to retain the patent Under Bayh-Dole, the federal contractor may elect to retain the patent
rights for a rights for a ~~federal y~~federally funded invention. funded invention.~~168~~179 In exchange, however, the contractor provides the In exchange, however, the contractor provides the
federal agency with a government-use license,federal agency with a government-use license,~~169~~180 and the United States retains the authority to and the United States retains the authority to
grant compulsory licenses to third parties in certain circumstances (“march-in rights”).grant compulsory licenses to third parties in certain circumstances (“march-in rights”).~~170~~
181 Although Bayh-Dole, by its terms, only applies to federal contractors that are nonprofit Although Bayh-Dole, by its terms, only applies to federal contractors that are nonprofit
organizations or organizations or ~~smal~~ small businesses, long-standing executive practice (codified by regulation) has businesses, long-standing executive practice (codified by regulation) has
applied Bayh-Dole to applied Bayh-Dole to al all federal contractors, regardless of size.federal contractors, regardless of size.~~171~~
~~Final y~~182 Finally, federal laboratories and private parties may enter into cooperative research and , federal laboratories and private parties may enter into cooperative research and
development agreements (CRADAs) in which both parties agree to provide services, facilities, development agreements (CRADAs) in which both parties agree to provide services, facilities,
~~equipment, IP, or other resources, but the federal government does not provide federal funding to~~
~~the nonfederal party.172 In this situation, ownership of IP rights may depend on the terms of the~~
~~agreement. That said, the federal laboratory general y has the authority to license existing~~
~~federal y owned IP to a private party as part of a CRADA, as wel as to license or assign~~
~~inventions made in whole or part by a federal employee working under a CRADA.173 In return,~~
~~the federal government retains a government-use license174 and compulsory-licensing authority~~
~~similar to Bayh-Dole march-in rights.175~~
~~These general rules for patent ownership are subject to various exceptions and waivers,~~
~~depending on the agency and circumstances. For example, some agencies (including BARDA and~~
National Institutes of Health [NIH]) have the authority to enter into transactions that are not
~~contracts, grants, or cooperative agreements, known as “other transaction” authority.176 Other~~

165 Compare id. § 209(d)(3)(A)-(D) with 35 U.S.C. § 203(a)(1)-(4); see infra to their employer); 35 U.S.C. §§ 118, 152, 261. 170 See 37 C.F.R. § 501.6(a). 171 Pub. L. No. 96-480, 94 Stat. 2311 (1980). 172 Pub. L. No. 99-502, 100 Stat. 1785 (1986). 173 See 15 U.S.C. § 3710(a) (“The Federal Government shall strive where appropriate to transfer federally owned or originated technology to State and local governments and to the private sector.”); 35 U.S.C. § 209 (conditions for licensing of federally owned inventions). 174 35 U.S.C. § 209(a). 175 Id. § 209(d)(1). 176 Compare id. § 209(d)(3)(A)-(D) with 35 U.S.C. § 203(a)(1)-(4); see discussion infra in “March-In Rights Under the Bayh-Dole
Act (35 U.S.C. § 203).”
~~166~~ 177 Act of Dec. 12, 1980 to Amend the Patent and Act of Dec. 12, 1980 to Amend the Patent and ~~T rademark~~Trademark Laws (Bayh Laws (Bayh -Dole Act), Pub. L. No, 96-517, § 6, 94 Stat. -Dole Act), Pub. L. No, 96-517, § 6, 94 Stat.
3015, 30183015, 3018-–27 (1980) (codified as amended at 35 U.S.C.27 (1980) (codified as amended at 35 U.S.C. ch. 18).ch. 18).
~~167~~178 See 35 U.S.C.35 U.S.C. §§ §§ 201(b), (e).201(b), (e).
~~168~~179 Id. § 202(a). § 202(a).
~~169~~180 Id. § 202(c)(4). § 202(c)(4).
~~170~~181 Id. § 203; § 203; see generally Hickey et al., Hickey et al., supra ~~note 74~~,note 80, at 17. at 17.
~~171~~182 37 C.F.R. § 37 C.F.R. § 401.1(b) (Bayh-Dole regulations apply “401.1(b) (Bayh-Dole regulations apply “ to all funding agreements with businessto all funding agreements with business firms regardlessfirms regardless of of
size”); Exec. Order No. 12591, Facilitating Access to Sciencesize”); Exec. Order No. 12591, Facilitating Access to Science ~~& T echnology~~ & Technology, 52 Fed. Reg., 52 Fed. Reg. 13,414, 13,414 (Apr. 10, 13,414, 13,414 (Apr. 10,
1987) (granting “1987) (granting “ to all contractors, regardless of size, the title to patents made in whole or in part with Federalto all contractors, regardless of size, the title to patents made in whole or in part with Federal funds, in funds, in
exchange for royalty-free use by or on behalf of the exchange for royalty-free use by or on behalf of the ~~governmen t”).~~
~~172 15 U.S.C. § 3710a(a)(1) (CRADA authority); id. § 3710a(d)(1) (CRADA definition).~~
~~173 See id. § 3710a(a)(2), (b)(1)-(2); 35 U.S.C. §§ 207, 209.~~
~~174 15 U.S.C. § 3710a(b)(1)(A), (2).~~
~~175 See id. § 3710a(b)(1)(C)(i)-(iii) (grounds for compulsory licensing of inventions “made in whole or in part by a~~
~~[federal] laboratory employee” under a CRADA). In the case of inventions “made solely by [the private collaborating~~
~~party’s] employee” in the course of a CRADA, the federal agency retains a government -use license, but need not~~
~~impose march-in rights. Com pare id. § 3710a(b)(1) with 3710a(b)(2).~~
~~176 42 U.S.C. § 247d-7e(c)(5) (granting Secretary of HHS authority to enter into other transactions for BARDA~~
~~projects); id. § 282(n) (granting director of NIH other transaction authority in certain contexts). Because NIAID is one~~
~~of NIH’s research institutes, see id. § 281(b)(6), this authority could apply to NIAID projects approved by the Director~~
~~of NIH. In the case of COVID-19 projects, NIH authority for use of other transactions when “ urgently required to~~
~~respond to a public health threat” appears applicable. See id. § 282(n)(1)(C). For a general overview of other~~
~~Congressional Research Service~~
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~~transactions are exempt from many statutory provisions and procurement regulations, including~~
~~Bayh-Dole’s requirements.177~~
~~Thus, for other transactions, the al ocation of IP rights between the government and private~~
~~contracting entities wil depend on the agreement. For example, BARDA’s template for other~~
~~transactions includes contractual patent provisions much like those of Bayh-Dole, including~~
~~march-in rights provisions.178 These patent provisions are “fluid and negotiable,” however, and~~
~~may be different for particular transactions.179 In addition, both Stevenson-Wydler’s and Bayh-~~
~~Dole’s requirements contain specific exceptions. For example, Bayh-Dole’s patent provisions do~~
~~not apply to contractors located outside the United States, nor in “exceptional circumstances,”~~
~~including if necessary “to meet the needs of the Government and protect the public against~~
~~nonuse or unreasonable use of inventions.”180~~
~~Governmental Compulsory Patent Licenses~~
~~As explained above, a patent holder general y has the exclusive right to make, use, sel , and~~
~~import an invention.181 Thus, any other person who wishes to practice that invention wil~~
~~ordinarily need a license (i.e., permission) from the patent holder, or else be exposed to legal~~
~~liability. In certain cases, however, patents may be subject to a “compulsory license,” which~~
~~al ows another person to practice the invention without the consent of the patent holder.182~~
~~Compulsory licenses require the sanction of a governmental entity and the payment of~~
~~compensation to the patent holder.183 Compulsory licenses differ from ordinary licenses in two~~
~~important respects. First, the person seeking to use the invention need not obtain permission from~~
~~the patent holder.184 Second, the compensation paid to the patent holder is determined by~~
~~operation of law, not by private contractual negotiations between the licensee and the patent~~
~~holder.185~~
~~March-In Rights Under the Bayh-Dole Act (35 U.S.C. § 203)~~
~~Although Bayh-Dole general y al ows federal contractors to take title to patents on inventions~~
~~created with federal funding,186 the federal government retains the authority to “march in” and~~

~~transactions, see U.S. GOVERNMENT ACCOUNTABILITY OFFICE, USE OF ‘OTHER TRANSACTION’ AGREEMENTS LIMITED~~
~~AND MOSTLY FOR RESEARCH AND DEVELOPMENT ACTIVITIES 3-12 (2016), https://www.gao.gov/asset s/680/674534.pdf~~
~~[hereinafter GAO OT A REPORT].~~
~~177 See GAO OT A REPORT, supra note 176, at 4-5; 35 U.S.C. § 201(b) (defining “funding agreements” subject to Bayh -~~
~~Dole to include “any contract, grant, or cooperative agreement”).~~
~~178 See Other T ransaction for Advanced Research (OT AR) T emplate, BIOMEDICAL ADVANCED RESEARCH AND~~
~~DEVELOP MENT AUTHORITY, https://www.phe.gov/about/amcg/otar/Documents/otar-consortium.pdf (last visited May~~
~~31, 2020), at pp. 16-21 [hereinafter BARDA OT A T emplate]; see generally Other T ransaction Agreements,~~
~~BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY,~~
~~https://www.phe.gov/about/amcg/otar/Pages/default.aspx (last visited May 31, 2020).~~
~~179 BARDA OT AR T emplate, supra note 178, at 16.~~
~~180 See 35 U.S.C. §§ 200, 202(a)(ii),~~
~~181 Id. § 271(a).~~
~~182 See generally Hickey et al., supra note 74, at 16-17.~~
~~183 Id. at 1.~~
~~184 See Hickey et al., supra note 74, at 16.~~
~~185~~ ~~Id.~~
~~186 35 U.S.C. § 202(a)-(b).~~
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~~grant compulsory licenses to third parties in some circumstances.187 Specifical y, the federal~~
~~agency that provided the funding may require the federal contractor to grant a patent license to a~~
~~third party if the agency determines that either~~
~~(1) action is necessary because the contractor or assignee has not taken, or is not expected~~
~~to take within a reasonable time, effective steps to achieve practical application of~~ government”). Congressional Research Service 19 link to page 23 link to page 23 Legal Issues in COVID-19 Vaccine Development equipment, IP, or other resources, but the federal government does not provide federal funding to the nonfederal party.183 In this situation, ownership of IP rights may depend on the terms of the agreement. That said, the federal laboratory generally has the authority to license existing federally owned IP to a private party as part of a CRADA, as well as to license or assign inventions made in whole or part by a federal employee working under a CRADA.184 In return, the federal government retains a government-use license185 and compulsory-licensing authority similar to Bayh-Dole march-in rights.186 These general rules for patent ownership are subject to various exceptions and waivers, depending on the agency and circumstances. For example, some agencies (including BARDA and National Institutes of Health [NIH]) have the authority to enter into transactions that are not contracts, grants, or cooperative agreements, known as “other transaction” authority.187 Other transactions are exempt from many statutory provisions and procurement regulations, including Bayh-Dole’s requirements.188 Thus, for other transactions, the allocation of IP rights between the government and private contracting entities will depend on the agreement. For example, BARDA’s template for other transactions includes contractual patent provisions much like those of Bayh-Dole, including march-in rights provisions.189 These patent provisions are “fluid and negotiable,” however, and may be different for particular transactions.190 Based on the limited number of publicly available federal contracts for COVID-19 vaccines (most of which are other transactions), some contracts retain federal march-in rights under Bayh-Dole, while others eliminate or restrict the grounds for march-in rights.191 183 15 U.S.C. § 3710a(a)(1) (CRADA authority); id. § 3710a(d)(1) (CRADA definition). 184 See id. § 3710a(a)(2), (b)(1)–(2); 35 U.S.C. §§ 207, 209. 185 15 U.S.C. § 3710a(b)(1)(A), (2). 186 See id. § 3710a(b)(1)(C)(i)–(iii) (grounds for compulsory licensing of inventions “made in whole or in part by a [federal] laboratory employee” under a CRADA). In the case of inventions “made solely by [the private collaborating party’s] employee” in the course of a CRADA, the federal agency retains a government-use license, but need not impose march-in rights. Compare id. § 3710a(b)(1), with id. § 3710a(b)(2). 187 42 U.S.C. § 247d-7e(c)(5) (granting Secretary of HHS authority to enter into other transactions for BARDA projects); id. § 282(n) (granting director of NIH other transaction authority in certain contexts). Because NIAID is one of NIH’s research institutes, see id. § 281(b)(6), this authority could apply to NIAID projects approved by the Director of NIH. In the case of COVID-19 projects, NIH authority for use of other transactions when “urgently required to respond to a public health threat” appears applicable. See id. § 282(n)(1)(C). For a general overview of other transactions, see U.S. GOVERNMENT ACCOUNTABILITY OFF., USE OF ‘OTHER TRANSACTION’ AGREEMENTS LIMITED AND MOSTLY FOR RESEARCH AND DEVELOPMENT ACTIVITIES 3–12 (2016), https://www.gao.gov/assets/680/674534.pdf [hereinafter GAO OTA REPORT]. 188 See GAO OTA REPORT, supra note 187, at 4–5; 35 U.S.C. § 201(b) (defining “funding agreements” subject to Bayh-Dole to include “any contract, grant, or cooperative agreement”). 189 See Other Transaction for Advanced Research (OTAR) Template, BIOMEDICAL ADVANCED RSCH. & DEV. AUTH., https://www.phe.gov/about/amcg/otar/Documents/otar-consortium.pdf (last visited May 31, 2020), at 16–21 [hereinafter BARDA OTA Template]; see generally Other Transaction Agreements, BIOMEDICAL ADVANCED RSCH. & DEV. AUTH., https://www.phe.gov/about/amcg/otar/Pages/default.aspx (last visited May 31, 2020). 190 BARDA OTAR Template, supra note 189, at 16. 191 See Kathryn Ardizzone & James Love, Other Transaction Agreements: Government Contracts that Eliminate Protections for the Public on Pricing, Access and Competition, Including in Connection with COVID-19 Vaccines and Treatments, KNOWLEDGE ECOLOGY INT’L 3–5, 36–42 (June 29, 2020), https://www.keionline.org/wp-content/uploads/KEI-Briefing-OTA-29june2020.pdf. Congressional Research Service 20 link to page 11 link to page 11 Legal Issues in COVID-19 Vaccine Development Governmental Compulsory Patent Licenses As explained above, a patent holder generally has the exclusive right to make, use, sell, and import an invention.192 Thus, any other person who wishes to practice that invention will ordinarily need a license (i.e., permission) from the patent holder, or else be exposed to legal liability. In certain cases, however, patents may be subject to a “compulsory license,” which allows another person to practice the invention without the consent of the patent holder.193 Compulsory licenses require the sanction of a governmental entity and the payment of compensation to the patent holder.194 Compulsory licenses differ from ordinary licenses in two important respects. First, the person seeking to use the invention need not obtain permission from the patent holder.195 Second, the compensation paid to the patent holder is determined by operation of law, not by private contractual negotiations between the licensee and the patent holder.196 March-In Rights Under the Bayh-Dole Act (35 U.S.C. § 203) Although Bayh-Dole generally allows federal contractors to take title to patents on inventions created with federal funding,197 the federal government retains the authority to “march in” and grant compulsory licenses to third parties in some circumstances.198 Specifically, the federal agency that provided the funding may require the federal contractor to grant a patent license to a third party if the agency determines that either: (1) action is necessary because the contractor or assignee has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the the
subject invention in such field of use; subject invention in such field of use;
(2) action is necessary to alleviate health or safety needs which are not reasonably satisfied (2) action is necessary to alleviate health or safety needs which are not reasonably satisfied
by the contractor, assignee, or their licensees; by the contractor, assignee, or their licensees;
(3) action is necessary to meet requirements for public use specified by federal regulations (3) action is necessary to meet requirements for public use specified by federal regulations
and such requirements are not reasonably satisfied by the contractor, assignee, or licensees; and such requirements are not reasonably satisfied by the contractor, assignee, or licensees;
or or
(4) action (4) action is necessary becauseis necessary because ~~the agreement~~ the agreement [to prefer U.S. manufacturing[to prefer U.S. manufacturing of the of the
~~invention by the~~ invention by the contractor’s exclusivecontractor’s exclusive ~~licensees] has not been obtained or waived~~ licensees] has not been obtained or waived or or
because a licensee of the exclusive right to use or sell any subject invention in the United because a licensee of the exclusive right to use or sell any subject invention in the United
States is in breach of its agreement [to prefer U.S. manufacturing].States is in breach of its agreement [to prefer U.S. manufacturing].~~188~~199
A license granted under Bayh-Dole’s march-in provisions must be “upon terms that are A license granted under Bayh-Dole’s march-in provisions must be “upon terms that are
reasonable under the circumstances,”reasonable under the circumstances,”~~189~~200 which may require that the licensee pay compensation to which may require that the licensee pay compensation to
the patent holder (i.e., the federal contractor or its assignee).the patent holder (i.e., the federal contractor or its assignee).~~190~~201 192 35 U.S.C. § 271(a). 193 See generally Hickey et al., supra note 80, at 16–17. 194 Id. at 1. 195 See Hickey et al., supra note 80, at 16. 196 Id. 197 35 U.S.C. § 202(a)–(b). 198 Id. § 203. 199 Id. § 203(a)(1)–(4). 200 Id. § 202(a). 201 See id § 203(a); Jennifer Penman & Fran Quigley, Better Late than Never: How the U.S. Government Can and Congressional Research Service 21 Legal Issues in COVID-19 Vaccine Development
The federal government has never exercised march-in rights under Bayh-Dole. The federal government has never exercised march-in rights under Bayh-Dole.~~191~~202 Advocacy Advocacy
groups have petitioned NIH several times to exercise march-in rights based on the high prices of groups have petitioned NIH several times to exercise march-in rights based on the high prices of
certain drugs developed with federal funding, such as treatments for HIV/AIDS.certain drugs developed with federal funding, such as treatments for HIV/AIDS.~~192~~203 NIH has NIH has
rejected these petitions, contending that pricing concerns alone are insufficient to exercise march-rejected these petitions, contending that pricing concerns alone are insufficient to exercise march-
in rights—so long as the invention is on the market and availablein rights—so long as the invention is on the market and available to patients.to patients.~~193~~204 In the context of a In the context of a
pandemic like COVID-19, the “health or safety needs” language would appear to provide a pandemic like COVID-19, the “health or safety needs” language would appear to provide a
possible basis for the exercise of march-in rights, should the funding agency determine that possible basis for the exercise of march-in rights, should the funding agency determine that
compulsory licensing is necessary to address public health needs unmet by a federal contractor.compulsory licensing is necessary to address public health needs unmet by a federal contractor.~~194~~205
Governmental Use Rights (28 U.S.C. § 1498)
A broader statutory authority than march-in rights, 28 U.S.C. § 1498 (Section 1498), applies to A broader statutory authority than march-in rights, 28 U.S.C. § 1498 (Section 1498), applies to
any patented invention—not just inventions made with federal funding.any patented invention—not just inventions made with federal funding.~~195~~206 Under Section 1498, sometimes described as an “eminent domain” provision for patents,207 the U.S. government has the authority to use or manufacture any patented invention “without license.”208 In practice, this means that if the U.S. government determines that it needs to practice an invention, it need not ask permission from the patent holder to do so, and—despite the existence of the patent—courts will not order the government to cease infringing activity.209 The patent holder, however, has the right to sue in the U.S. Court of Federal Claims for “reasonable and entire compensation” for the government’s use of the patented invention.210 In effect, then, Section 1498 allows the United States to issue itself a compulsory license to make and use any patented invention without obtaining permission from the patent holder, in exchange for consenting to liability in a suit seeking reasonable compensation for the government’s use.211 In the context of COVID-19 vaccines, the U.S. government could rely on Section 1498 to make and use any patented invention without the patent holder’s consent. Because Section 1498 extends to infringement “by a contractor, a subcontractor, or any person, firm, or corporation for the [U.S.] Government and with the authorization or consent of the [U.S.] Government,”212 the ~~Under Section 1498,~~

~~187 Id. § 203.~~
~~188 Id. § 203(a)(1)-(4).~~
~~189 Id. § 202(a).~~
~~190 See id § 203(a); Jennifer Penman & Fran Quigley,~~ ~~Better Late than Never: How the U.S. Government Can and~~
Should Use Bayh-Dole March-in Rights to Respond to the Medicines Access Crisis,, 54 WILLAMETTE L. REV. 171, 178 54 WILLAMETTE L. REV. 171, 178
(2017). (2017).
~~191~~ ~~Id.~~
192 See id. ~~at 8-~~ 202 CRS Report R44597, March-In Rights Under the Bayh-Dole Act, at 8. 203 See id. at 8–10 (reviewing petitions to exercise march-in rights). 10 (reviewing petitions to exercise march-in rights).
~~193~~204 See, e.g., National Institutes of Health, Office of the Director, , National Institutes of Health, Office of the Director, In the Case of Norvir Manufactured by Abbott
Laboratories, Inc. (July (July 29, 2004), https://www.ott.nih.gov/sites/default/files/documents/policy/March29, 2004), https://www.ott.nih.gov/sites/default/files/documents/policy/March -In-Norvir.pdf, at -In-Norvir.pdf, at
~~pp. 5-~~5–6. 6.
~~194~~205 35 U.S.C. 35 U.S.C. § 203(a)(2). A federal contractor adversely affected by the exercise of march§ 203(a)(2). A federal contractor adversely affected by the exercise of march -in rights may challenge an -in rights may challenge an
agency’s determination through an agency’s determination through an ~~administrat ive~~administrative process, process, see 37 C.F.R.37 C.F.R. § 401.6, and may appeal an adverse § 401.6, and may appeal an adverse
determination through a petition in the U.S. Court of Federal Claims,determination through a petition in the U.S. Court of Federal Claims, see 35 U.S.C.35 U.S.C. § § 203(b). 203(b).
~~195~~206 28 U.S.C. 28 U.S.C. § 1498(a) (reaching “any invention described in and covered by a patent of the United § 1498(a) (reaching “any invention described in and covered by a patent of the United ~~St ates~~States”). Section 1498 does not apply to patent rights granted by other nations. 207 See, e.g., Motorola, Inc. v. United States, 729 F.2d 765, 768 (Fed. Cir. 1984) (“The theoretical basis for [Section 1498] recovery is the doctrine of eminent domain.”). 208 28 U.S.C. § 1498(a). 209 Advanced Software Design Corp. v. Fed. Reserve Bank of St. Louis, 583 F.3d 1371, 1375 (Fed. Cir. 2009); Motorola, 729 F.2d at 768 n.3. 210 28 U.S.C. § 1498(a); see generally Leesona Corp. v. United States, 599 F.2d 958, 966–69 (Ct. Cl. 1979). 211 See Amanda Mitchell, Tamiflu, the Takings Clause, and Compulsory Licenses: An Exploration of the Government’s Options for Accessing Medical Patents, 95 CAL. L. REV. 535, 541–42 (2007) (analogizing Section 1498 to a compulsory license). 212 28 U.S.C. § 1498(a). Congressional Research Service 22 link to page 27 Legal Issues in COVID-19 Vaccine Development ~~”). Section~~
~~1498 does not apply to patent rights granted by other nations.~~
~~Congressional Research Service~~
20

~~link to page 25~~ ~~Legal Issues in COVID-19 Vaccine Development~~

~~sometimes described as an “eminent domain” provision for patents,196 the U.S. government has~~
~~the authority to use or manufacture any patented invention “without license.”197 In practice, this~~
~~means that if the U.S. government determines that it needs to practice an invention, it need not~~
~~ask permission from the patent holder to do so, and—despite the existence of the patent—courts~~
~~wil not order the government to cease infringing activity.198 The patent holder, however, has the~~
~~right to sue in the U.S. Court of Federal Claims for “reasonable and entire compensation” for the~~
~~government’s use of the patented invention.199 In effect, then, Section 1498 al ows the United~~
~~States to issue itself a compulsory license to make and use any patented invention without~~
~~obtaining the permission of the patent holder, in exchange for consenting to liability in a suit~~
~~seeking reasonable compensation for the government’s use.200~~
~~In the context of COVID-19 medical countermeasures, the U.S. government could rely on Section~~
~~1498 to make and use any patented invention without the consent of the patent holder. Because~~
~~Section 1498 extends to infringement “by a contractor, a subcontractor, or any person, firm, or~~
~~corporation for the [U.S.] Government and with the authorization or consent of the [U.S.]~~
~~Government,”201 the~~ federal government could also extend its Section 1498 authority to the federal government could also extend its Section 1498 authority to the
actions of private entities by authorizing them to practice a patented invention on behalf of the actions of private entities by authorizing them to practice a patented invention on behalf of the
government. government.
Targeted Legislation and the Takings Clause
U.S. patent rights were created by an act of Congress. Thus, should patent rights inhibit access to U.S. patent rights were created by an act of Congress. Thus, should patent rights inhibit access to
or affordability of COVID-19 countermeasures such as a vaccine, and should Congress conclude or affordability of COVID-19 countermeasures such as a vaccine, and should Congress conclude
that existing legal authorities are insufficient, targeted legislation is a possible option. Although that existing legal authorities are insufficient, targeted legislation is a possible option. Although
~~the U.S.~~ the Constitution grants Congress the authority to create a patent system,Constitution grants Congress the authority to create a patent system,~~202~~213 it does not require it does not require
Congress to do so. Congress therefore has wide discretion in designing the patent system’s scope Congress to do so. Congress therefore has wide discretion in designing the patent system’s scope
and operation.and operation.~~203 So long as it operates prospectively (and consistent with its international treaty~~
~~obligations),204 Congress may exclude certain technologies from patent protection. For example, a~~
~~provision in the 2011 Leahy-Smith America Invents Act prohibits the PTO from issuing a patent~~
~~on inventions “directed to or encompassing a human organism.”205~~

~~196 See, e.g., Motorola, Inc. v. United States, 729 F.2d 765, 768 (Fed. Cir. 1984 ) (“T he theoretical basis for [Section~~
~~1498] recovery is the doctrine of eminent domain.”).~~
~~197 28 U.S.C. § 1498(a).~~
~~198 Advanced Software Design Corp. v. Fed. Reserve Bank of St. Louis, 583 F.3d 1371, 1375 (Fed. Cir. 2009);~~
Motorola, 729 F.2d at 768 n.3.
~~199 28 U.S.C. § 1498(a); see generally Leesona Corp. v. United States, 599 F.2d 958, 966-69 (Ct. Cl. 1979).~~
~~200 See Amanda Mitchell,~~ ~~Tamiflu, the Takings Clause, and Compulsory Licenses: An Exploration of the Government’s~~
~~Options for Accessing Medical Patents, 95 CAL. L. REV. 535, 541-42 (2007) (analogizing Section 1498 to a compulsory~~
~~license).~~
~~201 28 U.S.C. § 1498(a).~~
~~202 U.S. CONST. art. I, § 8, cl. 8.~~
203 See, e.g.~~, McClurg~~ 214 Thus, Congress could consider, for example, excluding certain technologies from patent protection, or creating broader systems for compulsory licensing. As discussed below, there are both constitutional and treaty-based constraints on these possibilities. Moreover, a critical policy consideration for Congress to evaluate is whether limitations on patent rights would reduce incentives for industry to create and develop vaccines to prevent COVID-19.215 Indeed, some argue that Congress should consider strengthening patent protections in order to protect greater incentives to invest in COVID-19 countermeasure development.216 In general, Congress may exclude certain technologies from patent protection, so long as the legislation operates prospectively and consistent with U.S. international treaty obligations.217 For example, a provision in the 2011 Leahy-Smith America Invents Act prohibits the PTO from issuing a patent on inventions “directed to or encompassing a human organism.”218 When legislation operates retroactively to invalidate a patent or diminish patent rights, however, it raises issues under the Takings Clause of the Fifth Amendment to the Constitution. The Takings Clause states that if “private property [is] taken for public use” by the U.S. government, it must provide “just compensation.”219 The Supreme Court has suggested several times that patents are private property under the Takings Clause,220 although it has never held so explicitly. Presuming 213 U.S. CONST. art. I, § 8, cl. 8. 214 See, e.g., McClurg v. Kingsland, 42 U.S. 202, 206 (1843) (“[T]he powers of Congress to legislate upon the subject v. Kingsland, 42 U.S. 202, 206 (1843) (“[T]he powers of Congress to legislate upon the subject
of patents is plenary by the terms of the Constitution, and as there are no restraints on its of patents is plenary by the terms of the Constitution, and as there are no restraints on its ~~exe rcise~~exercise, there can be no , there can be no
limitation of their right to modify them at their pleasure, so that they do not take away the rights of property in existing limitation of their right to modify them at their pleasure, so that they do not take away the rights of property in existing
patents.”). patents.”). ~~T here~~There are, of course, some limits on the power granted Congress in the IP Clause. are, of course, some limits on the power granted Congress in the IP Clause. See generally, e.g., Eldred , Eldred
v. Ashcroft, 537 U.S. 186, 199v. Ashcroft, 537 U.S. 186, 199-–208 (2003); Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 5208 (2003); Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 5 -–10 (1966).10 (1966).
~~204 See infra note 211 and accompanying text.~~
~~205 Pub. L. No, 112-29, § 33, 125 Stat. 284, 340 (2011).~~
~~Congressional Research Service~~
21

~~Legal Issues in COVID-19 Vaccine Development~~

~~When legislation operates retroactively to invalidate a patent or diminish patent rights, however,~~
~~it raises issues under the Takings Clause of the Fifth Amendment to the U.S. Constitution. The~~
~~Takings Clause states that if “private property [is] taken for public use” by the U.S. government,~~
~~it must provide “just compensation.”206 The Supreme Court has suggested several times that~~
~~patents are private property under the Takings Clause,207 but it has never held so explicitly.~~
~~Presuming that patents are private property under the Fifth Amendment,208~~215 See, e.g., Fred Reinhart, Exercising Bayh-Dole March-in Rights Would Handicap Covid-19 Innovation, STAT (May 4, 2020), https://www.statnews.com/2020/05/04/bayh-dole-march-in-rights-handicap-covid-19-innovation/; James Edwards, We Won’t Stop Coronavirus Without IP, IPWATCHDOG (Mar. 10, 2020), https://www.ipwatchdog.com/2020/03/10/wont-stop-coronavirus-without-ip/id=119735/. 216 See, e.g., Adam Mossoff, Patent Term Extensions Will Help Speed up Development of Coronavirus Drugs, WASH. TIMES (Mar. 12, 2020). 217 See infra note 224 and accompanying text. 218 Pub. L. No, 112-29, § 33, 125 Stat. 284, 340 (2011). 219 U.S. CONST. amend. V. 220 Compare James v. Campbell, 104 U.S. 356, 357–58 (1881) (“[By issuing a patent, the United States] confers on the patentee an exclusive property in the patented invention which cannot be appropriated or used by the government itself, without just compensation . . . .”), with Oil States Energy Servs. v. Greene’s Energy Grp., 138 S. Ct. 1365, 1379 (2018) (holding that the grant of a patent is matter of public rights, but stating that “our decision should not be misconstrued as suggesting that patents are not property for purposes of the Due Process Clause or the Takings Clause”). Congressional Research Service 23 Legal Issues in COVID-19 Vaccine Development that patents are private property under the Fifth Amendment,221 legislation that ~~legislation that~~
retroactively impairs patent rights could give rise to a constitutional claim for just retroactively impairs patent rights could give rise to a constitutional claim for just
compensation.compensation.~~209~~ 222 Recognizing this, Congress has often provided for compensation in past Recognizing this, Congress has often provided for compensation in past
~~legislation~~ legislation that has retroactively invalidated patents. For example, the Atomic Energy Act of 1954 that has retroactively invalidated patents. For example, the Atomic Energy Act of 1954
“revoked” existing patents on “any invention or discovery which is useful solely in the utilization “revoked” existing patents on “any invention or discovery which is useful solely in the utilization
of special nuclear material or atomic energy in an atomic weapon,” while providing a process to of special nuclear material or atomic energy in an atomic weapon,” while providing a process to
provide just compensation to any such patent holder.provide just compensation to any such patent holder.~~210~~223
If Congress seeks to preclude the exercise of exclusive patent rights over COVID-19 If Congress seeks to preclude the exercise of exclusive patent rights over COVID-19 ~~medical~~
~~countermeasures~~vaccines, it could pass legislation preventing the PTO from issuing such patents, or , it could pass legislation preventing the PTO from issuing such patents, or
~~invalidating~~ invalidating already issued patents relating to countermeasures. In the latter case, some already issued patents relating to countermeasures. In the latter case, some
mechanism for compensation to the patent holder might be required under the Takings Clause. In mechanism for compensation to the patent holder might be required under the Takings Clause. In
either case, such legislation could raise issues under the United States’ treaty obligations, either case, such legislation could raise issues under the United States’ treaty obligations,
including the treaty on Trade-Related Aspects of including the treaty on Trade-Related Aspects of ~~Intel ectual~~Intellectual Property Rights Property Rights (TRIPS) of the Marrakesh of the Marrakesh
Agreement establishing the World Trade Organization (WTO), in which WTO members agree to Agreement establishing the World Trade Organization (WTO), in which WTO members agree to
make patents availablemake patents available ~~in “al~~ in “all fields of technology,” with some exceptions.224 State and Federal Authority to Mandate Vaccination Even if widely available, a COVID-19 vaccine can only prevent outbreaks if a sufficient percentage of a population is vaccinated to achieve herd immunity.225 Herd immunity occurs when a high percentage of a community becomes immune to a disease (either through exposure to the disease or a vaccine) to provide indirect protection to those who are not immune, thereby protecting the whole community.226 The more contagious a disease, the higher the percentage of the population must have immunity to achieve herd immunity.227 Based on early estimates of 221 Legal academics have debated ~~fields of technology,” with some exceptions.211 In addition,~~
~~limitations on patent rights could reduce incentives to create and develop medical~~
~~countermeasures against COVID-19.212~~

~~206 U.S. CONST. amend. V.~~
~~207 Compare James v. Campbell, 104 U.S. 356, 357-58 (1881) (“[By issuing a patent, the United States] confers on the~~
~~patentee an exclusive property in the patented invention which cannot be appropriated or used by the government itself,~~
~~without just compensation . . . .”), with Oil Stat es Energy Servs. v. Greene’s Energy Grp., 138 S. Ct. 1365, 1379 (2018)~~
~~(holding that the grant of a patent is matter of public rights but stating t hat “ our decision should not be misconstrued as~~
~~suggesting that patents are not property for purposes of the Due Process Clause or the T akings Clause.”).~~
~~208 Legal academics have debated~~ this point. this point. Compare Adam Mossoff, Adam Mossoff, Patents as Constitutional Private Property: The
Historical Protection of Patents Under the Takings Clause, 87 B.U. L. REV. 689 (2007), , 87 B.U. L. REV. 689 (2007), with Davida H. Isaacs, Davida H. Isaacs, Not All
Property Is Created Equal: Why Modern Courts ~~Resist~~ Resist Applying the Takings Clause to Patents, and Why They Are
Right to Do So, 15 GEO. MASON L. REV. 1 (2007). Notably, in a recent Federal Circuit case, the , 15 GEO. MASON L. REV. 1 (2007). Notably, in a recent Federal Circuit case, the ~~PT O~~PTO conceded that conceded that
patents were “private property” under the patents were “private property” under the ~~T akings~~Takings Clause. Clause. See CelgeneCelgene Corp. v. Peter, 931 F.3d 1342, 1358 (Fed. Cir. Corp. v. Peter, 931 F.3d 1342, 1358 (Fed. Cir.
2019), 2019), petition for cert. filed, No. 19-1074 (U.S. Feb. 26, 2020).No. 19-1074 (U.S. Feb. 26, 2020).
~~209~~222 See, e.g., , Celgene, 931 F.3d at 1358 (rejecting claim that retroactive application of inter partes review procedures is , 931 F.3d at 1358 (rejecting claim that retroactive application of inter partes review procedures is
an unconstitutional taking of patent rights).an unconstitutional taking of patent rights). For analyses of potential For analyses of potential ~~T akings~~Takings Clause claims Clause claims as applied to patents, see as applied to patents, see
generally, e.g., Gregorygenerally, e.g., Gregory Dolin & Irina D. Manta, Dolin & Irina D. Manta, Taking Patents, 73 WASH. & LEE L. REV. 719 (2016); Joshua I. Miller, , 73 WASH. & LEE L. REV. 719 (2016); Joshua I. Miller,
28 U.S.C. § 1498(a) and the Unconstitutional Taking of Patents, 13 YALE J.L. & TECH. 1 (2010); Christopher S. Storm, , 13 YALE J.L. & TECH. 1 (2010); Christopher S. Storm,
Federal Patent Takings, 2 J. BUS. ENTREPRENEURSHIP & L. 1 (2008); Justin , 2 J. BUS. ENTREPRENEURSHIP & L. 1 (2008); Justin ~~T orres,~~ ~~The Governm ent~~Torres, The Government Giveth, and the
~~Governm ent~~Government Taketh Away: Patents, Takings, and 28 U.S.C. § 1498 , 63 N.Y.U. ANN. SUR. AM. L. 315 (2007); Jesse S. , 63 N.Y.U. ANN. SUR. AM. L. 315 (2007); Jesse S.
Chui,Chui, To What Extent Can Congress Change the Patent Right Without Effecting a Taking? , 34 HASTINGS CONST. L.Q. , 34 HASTINGS CONST. L.Q.
447 (2007); Shubha Ghosh, 447 (2007); Shubha Ghosh, Toward A Theory of Regulatory Takings for Intellectual Property: The Path ~~Left~~ Left Open
After College College ~~Savings~~ Savings v. Florida Prepaid, 37 SAN DIEGO L. REV. 637 (2000). v. Florida Prepaid, 37 SAN DIEGO L. REV. 637 (2000).
~~210~~ 223 42 U.S.C. 42 U.S.C. §§ §§ 2181(a), 2187.2181(a), 2187.
~~211 T RIPS~~224 TRIPS: Agreement on : Agreement on ~~T rade~~Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement -Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement
Establishing the World Establishing the World ~~T rade~~Trade Organization, Annex 1C, 1869 U.N.T Organization, Annex 1C, 1869 U.N.T .S. 299 (1994), .S. 299 (1994),
https://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm, at arthttps://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm, at art . 27. For analysis of how the limits of . 27. For analysis of how the limits of ~~T RIPS~~
TRIPS might apply to exclusions from patent protection or compulsory licensing in the COVIDmight apply to exclusions from patent protection or compulsory licensing in the COVID -19 pandemic, see-19 pandemic, see CRSCRS Legal Legal
~~Sidebar~~ Sidebar LSB10436, LSB10436, COVID-19: International Trade and Access to ~~Pharm aceutical~~Pharmaceutical Products, by Nina M. Hart. 225 Michelle M. Mello et al., Ensuring Uptake of Vaccines Against SARS-CoV-2, NEW ENGLAND J. MED. (June 26, 2020), https://www.nejm.org/doi/full/10.1056/NEJMp2020926. 226 See Herd Immunity and COVID-19 (Coronavirus): What You Need to Know, MAYO CLINIC (June 6, 2020), https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/herd-immunity-and-coronavirus/art-20486808. 227 Id. Congressional Research Service 24 link to page 5 Legal Issues in COVID-19 Vaccine Development COVID-19’s infectiousness, some experts have estimated that about 60% to 70% of the population needs to be immune to prevent outbreaks.228 One early poll indicated that the voluntary vaccination rate for a potential COVID-19 vaccine may be lower than necessary to achieve herd immunity.229 While a discussion of the potential public health and policy tools to increase vaccine uptake is beyond the scope of this report, one legal tool for increasing vaccination rates is for the government to require it. Under the United States’ federalist system, states and the federal government share regulatory authority over public health matters, with states traditionally exercising the bulk of the authority in this area pursuant to their general police power.230 This power authorizes states, within constitutional limits, to enact laws “to provide for the public health, safety, and morals” of the states’ inhabitants.231 In contrast to this general power, Congress’s power to legislate is confined to those powers enumerated in the Constitution.232 This section provides an overview of state and federal authority to mandate vaccination. State and Local Authority to Mandate Vaccination The states’ general police power to promote public health and safety encompasses authority to mandate vaccination.233 In the early part of the 20th century, the Supreme Court twice considered constitutional challenges to such mandates.234 Each time, the Court rejected the challenges and 228 See, e.g., What is Herd Immunity and How Can We Achieve It with COVID-19?, JOHNS HOPKINS BLOOMBERG SCH. OF PUB. HEALTH (Apr. 10, 2020), https://www.jhsph.edu/covid-19/articles/achieving-herd-immunity-with-covid19.html; COVID-19 Herd Immunity: 7 Questions, Answered, M.D. ANDERSON CTR. (July 17, 2020), https://www.mdanderson.org/cancerwise/what-is-covid-19-coronavirus-herd-immunity-when-will-we-achieve-herd-immunity.h00-159383523.html. At least one study found that herd immunity could be as low as 43% when considering differences in age and social activity level. COVID-19 Herd Immunity Threshold Could Be Lower, Study Finds, SCIENCE DAILY (June 23, 2020), https://www.sciencedaily.com/releases/2020/06/200623111329.htm. 229 Expectations for a COVID-19 Vaccine, ASSOCIATED PRESS-NORC CTR. FOR PUBLIC AFF. RSCH., https://apnorc.org/projects/expectations-for-a-covid-19-vaccine/ (last accessed Sept. 2, 2020) (summarizing polling results in which 49% of those surveyed stated that they plan to get vaccinated if a COVID-19 vaccine becomes available to the public, and another 31% stated that they were not sure whether they would get vaccinated). Moreover, under current FDA guidance, FDA would authorize or license a COVID-19 vaccine if it concludes from the clinical trial results that the vaccine “would prevent disease or decrease its severity in at least 50% of people who are vaccinated.” See Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines, U.S. FOOD & DRUG ADMIN. (June 30, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-help-facilitate-timely-development-safe-effective-covid; see also U.S. FOOD & DRUG ADMIN., DEVELOPMENT AND LICENSURE OF VACCINES TO PREVENT COVID-19: GUIDANCE FOR INDUSTRY 14 (June 2020); U.S. FOOD & DRUG ADMIN., EMERGENCY USE AUTHORIZATION FOR VACCINES TO PREVENT COVID-19: GUIDANCE FOR INDUSTRY 9 (Oct. 2020). This means that, potentially, an authorized or licensed vaccine may not be effective for many of its recipients, which may increase the number of people who must be vaccinated to achieve herd immunity. As of November 2020, however, several manufacturers participating in Operation Warp Speed have announced interim results from the Phase 3 trials of their vaccines. See supra note 14 and accompanying text. According to the manufacturers, these preliminary results show that some vaccine candidates may be over 90% effective at preventing COVID-19. See id. 230 See Elizabeth Y. McCuskey, Body of Preemption: Health Law Traditions and the Presumption Against Preemption, 89 TEMPLE L. REV. 95, 113–20 (2016). 231 Barnes v. Glen Theatre, Inc., 501 U.S. 560, 569 (1991). 232 See CRS Report R45323, Federalism-Based Limitations on Congressional Power: An Overview, coordinated by Andrew Nolan and Kevin M. Lewis, at 1. 233 See Jacobson v. Massachusetts, 197 U.S. 11, 39 (1905). 234 Id. at 39; Zucht v. King, 260 U.S. 174 (1922). Congressional Research Service 25 link to page 29 link to page 29 link to page 29 link to page 29 Legal Issues in COVID-19 Vaccine Development recognized such laws as falling squarely within the states’ police power.235 In 1905, the Supreme Court in Jacobson v. Massachusetts upheld a state law that gave municipal boards of health authority to require the vaccination of persons over the age of 21 against smallpox, determining that the vaccination program had a “real [and] substantial relation to the protection of the public health and safety.”236 In doing so, the Court rejected an argument that such a program violated a liberty interest that, under more modern jurisprudence, the plaintiff might have asserted as a substantive due process right.237 Less than two decades later, in Zucht v. King, parents of a child who was excluded from school due to her unvaccinated status challenged the local ordinance requiring vaccination for schoolchildren, arguing that the ordinance violated the Fourteenth Amendment’s Equal Protection and Due Process Clauses.238 Relying on Jacobson, the Supreme Court rejected the constitutional challenges, concluding that “it is within the police power of a State to provide for compulsory vaccination” and that the ordinance did not bestow “arbitrary power, but only that broad discretion required for the protection of the public health.”239 Based on this authority recognized by the Court, states and localities have enacted various compulsory vaccination laws for certain populations and circumstances. All fifty states and the District of Columbia, for instance, currently have laws requiring specified vaccines for students.240 With respect to adults, states have primarily limited vaccination mandates to health care workers, with wide variations in the mandates’ scope.241 These vaccination requirements are generally subject to certain exemptions, which vary from state to state.242 While all vaccination mandates provide for at least some degree of medical exemption (e.g., if one is allergic to vaccines or immunocompromised), some mandates also include religious exemptions for those whose beliefs counsel against immunization.243 In the case of student vaccination mandates, several states also provide a broader philosophical exemption for those who object to immunizations because of personal, moral, or other beliefs.244 These vaccination mandates—including ones that do not provide a religious exemption—have withstood more recent legal challenges.245 While the Supreme Court’s constitutional 235 Jacobson, 197 U.S. at 39; Zucht, 260 U.S. at 175–77. 236 Jacobson, 197 U.S. at 31. 237 See Dorit Rubinstein Reiss & Lois A. Weithorn, Responding to the Childhood Vaccination Crisis: Legal Frameworks and Tools in the Context of Parental Vaccine Refusal, 63 BUFF. L. REV. 881, 897–98 (2015). Since Jacobson, for instance, the Supreme Court has recognized that “a competent person has a constitutionally protected liberty interest in refusing unwanted medical treatment” under the Fourteenth Amendment. Cruzan v. Dir., Mo. Dep’t of Health, 497 U.S. 261, 278 (1990). 238 Zucht, 260 U.S. at 175–77. 239 Id. at 176–77. 240 States with Religious and Philosophical Exemptions From School Immunization Requirements, NAT’L CONF. OF STATE LEGISLATURES (NCSL) (June 26, 2020), https://www.ncsl.org/research/health/school-immunization-exemption-state-laws.aspx. 241 See Brian Dean Abramson, Vaccine Law in the Health Care Workplace, 12 J. HEALTH & LIFE SCI. L. 22, 24–27 (2019) (describing how three states require health care workers to receive annual flu vaccines; several others require hospitals or other health care facilities to ensure that their employees have been vaccinated against certain vaccine-preventable diseases, including hepatitis B, rubella, and mumps; and other states require hospital employees to provide proof of immunization against certain vaccine-preventable diseases). 242 See id. at 28–31 (describing scope of medical and religious exemptions for vaccination mandates for health care workers); NCSL, supra note 240 (describing exemptions for student vaccination mandates). 243 Abramson, supra note 241, at 28–31; NCSL, supra note 240. 244 NCSL, supra note 240. 245 See, e.g., Phillips v. City of New York, 775 F.3d 538, 542–44 (2d Cir. 2015); Workman v. Mingo Cty. Bd. of Edu. 419 F. App’x 348 (4th Cir. 2011); Whitlow v. California, 203 F. Supp. 3d 1079, 1085–89 (S.D. Cal. 2016); Boone v. Congressional Research Service 26 link to page 29 Legal Issues in COVID-19 Vaccine Development jurisprudence has evolved substantially since Jacobson and Zucht,246 modern courts have continued to rely on these cases to reject due process and equal protection claims against the mandates, giving considerable deference to the states’ use of their police power to require immunizations to protect public health.247 In cases that also challenge a mandate’s lack of religious exemption, plaintiffs have typically asserted a claim under the Free Exercise Clause of the First Amendment.248 Courts have generally rejected this claim—which was not available to the plaintiffs in Jacobson or Zucht because the Supreme Court had not yet held that the First Amendment applied to the states249—and concluded that a state is not constitutionally required to provide a religious exemption.250 The courts reasoned that under Employment Division, Department of Human Resources of Oregon v. Smith and its progeny, a vaccination mandate is a neutral, generally applicable law (i.e., one that does not target specific religious groups) that is not subject to heightened scrutiny.251 Under the lenient rational basis review, courts have held that “the right to free exercise of religion . . . [is] subordinated to society’s interest in protecting against the spread of disease.”252 Boozman, 217 F. Supp. 2d 938, 952–57 (E.D. Ark. 2002). Challenges against state vaccination mandates have primarily occurred in the context of student vaccination requirements. However, in 2009, following the emergence of a new strain of type A influenza (H1N1), New York State issued a regulation that made vaccination against seasonal and H1N1 influenza a condition of employment for health care workers who have direct contact with patients or who may expose patients to disease. This directive drew several legal challenges from local health care workers, who argued that the regulation violated the Fourteenth Amendment’s Due Process Clause, the First Amendment’s Free Exercise Clause, and the right to “freedom of contract” guaranteed by the Fifth and Fourteenth Amendments. See Alexander M. Stewart, Mandatory Vaccination of Health Care Workers, NEW ENG. J. OF MED. (Nov. 19, 2009), https://www.nejm.org/doi/full/10.1056/nejmp0910151. The litigation, however, was mooted in its early stages after the governor suspended the regulation due to a vaccine shortage. See Joe Nocera, When New York Mandated Vaccinations, Nurses Sued, BLOOMBERG BUSINESSWEEK (Mar. 23, 2020), https://www.bloomberg.com/news/articles/2020-03-23/can-states-mandate-vaccinations-for-health-care-workers. 246 Commentators, for instance, have observed that the Supreme Court decided Jacobson and Zucht before the advent of tiered scrutiny, which subjects regulations that infringe upon certain fundamental liberty interests to heightened scrutiny. Rubinstein Reiss & Weithorn, supra note 237, at 896–97. A regulation survives this heightened scrutiny only if it is narrowly tailored to serve a compelling government interest. See Reno v. Flores, 507 U.S. 292, 301–02 (1993). 247 See, e.g., Phillips v. City of New York, 775 F.3d 538 (2d Cir. 2015); Workman v. Mingo Cty. Bd. of Edu. 419 F. App’x 348 (4th Cir. 2011); Whitlow v. California, 203 F. Supp. 3d 1079 (S.D. Cal. 2016). 248 See, e.g., Phillips, 775 F.3d at 543; Workman, 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87; Boone, 217 F. Supp. 2d at 952–55. 249 See Phillips, 775 F.3d at 543. 250 See, e.g., id. at 543; Workman, 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87; Boone, 217 F. Supp. 2d at 952–55. 251 See, e.g., Phillips, 775 F.3d at 543; Workman, 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87; Boone, 217 F. Supp. 2d at 952–55. The Supreme Court heard oral argument on November 4, 2020 in Fulton v. City of Philadelphia, a case in which the petitioners have asked the Court to, among other issues, revisit Smith. See Pet. for a Writ of Cert. 31, Fulton v. City of Philadelphia, No. 19-123 (2020). 252 Boone, 217 F. Supp. 2d at 954; see also Phillips, 775 F.3d at 543; Workman, 419 F. App’x at 352–54; Whitlow, 203 F. Supp. 3d at 1085–87. In cases in which a vaccination mandate includes a religious exemption, plaintiffs have also filed suit to challenge their unsuccessful invocation of the exemption. In these cases, courts, applying the relevant state law, typically considered whether the plaintiffs’ objections to vaccination are based on a sincere religious belief. See, e.g., N.M. v. Hebrew Acad. Long Beach, 155 F. Supp. 3d 247, 257–58 (E.D.N.Y. 2016) (finding that plaintiff failed to establish her objections to vaccination were religious in nature); In re Matter of Christine M., 157 Misc.2d 4, 21 (N.Y. 1992) (finding that plaintiff’s objections to vaccination were based on plaintiff’s personal and medical, rather than religious, beliefs); Lewis v. Sobol, 710 F. Supp. 506, 516 (S.D.N.Y. 1989) (finding that plaintiffs’ objections to vaccination stemmed from their religious beliefs, which entailed “views of spiritual perfection” that they apply in their dietary and medical practices). Congressional Research Service 27 Legal Issues in COVID-19 Vaccine Development Federal Authority to Mandate Vaccination Executive Branch Authority to Mandate Vaccination Except in certain limited circumstances, including in the immigration253 and military254 contexts, no existing federal law expressly imposes vaccination requirements on the general populace. Certain existing authorities, however, could potentially form the basis of such executive action in the context of COVID-19. One such law could be Section 361 of the PHSA.255 This provision, which has been characterized as “broad [and] flexible,”256 grants the Secretary of HHS the authority—delegated in part to the Centers for Disease Control and Prevention (CDC)257—to make and enforce regulations necessary “to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.”258 A broad construction of this authority may permit the CDC to issue regulations requiring vaccination in circumstances that would prevent the foreign or interstate transmission of COVID-19.259 CDC’s exercise of this authority would nevertheless be restricted by the Constitution and other generally applicable statutory requirements, such as the Administrative Procedure Act260 or the Religious Freedom Restoration Act of 1993.261 The latter statute requires courts to grant certain religious exemptions from a generally applicable rule that imposes a substantial burden on a regulated person’s religious exercise.262 On the other hand, Section 361’s structure and language may subject it to a narrower construction. Following the broad statement of authority identified above, Section 361 provides that “[f]or purposes of carrying and enforcing such regulations,” the agency “may provide for such inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings, and other measures, as in [its] judgment may be necessary.”263 Section 361’s remaining subsections further contemplate the issuance of regulations related to the apprehension, detention, examination, and conditional release of individuals for purposes of preventing the spread of 253 Under 8 U.S.C. § 1182(a)(1)(A), for instance, immigrants seeking permanent residence in the United States must present documentation showing they have been vaccinated against certain specified vaccine-preventable diseases. 254 The Department of Defense’s Immunization Program, for instance, requires all health care personnel working in the Department’s medical treatment facilities, as well as all active duty and selected reserve personnel, to receive annual seasonal influenza vaccines or to obtain a medical or administrative exemption. DEP’T OF DEFENSE INSTRUCTION 6205.02 § 1.2b (July 23, 2019), https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/620502p.pdf?ver=2019-07-23-085404-617. 255 42 U.S.C. § 264. 256 Louisiana v. Matthews, 427 F. Supp. 174, 176 (E.D. La. 1977). 257 See Legal Authorities for Isolation and Quarantine, CTRS. FOR DISEASE CONTROL & PREVENTION (Feb. 24, 2020), https://www.cdc.gov/quarantine/aboutlawsregulationsquarantineisolation.html. 258 42 U.S.C. § 264(a). 259 See Christopher T. Robertson, Vaccines and Airline Travel: A Federal Role to Protect the Public Health, 42 AM. J.L. & MED. 543, 566 (2016) (suggesting the CDC has authority under Section 361 “to require vaccinations as a condition of airline travel”). 260 See, e.g., CRS Legal Sidebar LSB10523, Administrative Law Reform Legislation in the 116th Congress, by Daniel J. Sheffner. 261 See, e.g., CRS In Focus IF11490, The Religious Freedom Restoration Act: A Primer, by Whitney K. Novak. 262 42 U.S.C. § 2000bb-1. 263 Id. § 264(a). Congressional Research Service 28 link to page 29 link to page 28 link to page 28 link to page 28 Legal Issues in COVID-19 Vaccine Development communicable diseases.264 Given this structure and language, regulations issued pursuant to this authority have primarily been confined to two general types of control measures: (1) quarantine and isolation measures of people and goods (administered by the CDC); 265 and (2) measures that control or treat areas, animals, or articles that are susceptible of or subject to contamination or infection (administered by the FDA).266 This limited construction may be consistent with a canon of statutory interpretation—ejusdem generis—that confines the meaning of a general term (e.g., “other measures” deemed necessary by the agency) to matters comparable to the more specific terms enumerated in the statute.267 Further complicating the analysis is the potentially significant economic and political considerations at issue for a federal vaccination mandate.268 In assessing an agency’s statutory authority, the Supreme Court has cautioned that courts must “be guided to a degree by common sense as to the manner in which Congress is likely to delegate a policy decision of [significant] economic and political magnitude to an administrative agency.”269 In light of these considerations, it is difficult to predict whether courts would conclude that the CDC’s authority under Section 361 would extend to a federal vaccination mandate. Congress’s Authority to Mandate Vaccination Although states have traditionally exercised the bulk of authority over public health matters, including vaccination, Congress shares certain concurrent authority in this area emanating from its enumerated powers in the U.S. Constitution.270 This authority derives from, among other sources, the Constitution’s Spending Clause and the Commerce Clause.271 The Spending Clause empowers Congress to tax and spend for the general welfare.272 Under this authority, which is subject to several limitations, Congress may offer federal funds to nonfederal entities and prescribe the terms and conditions under which the funds are accepted and used by recipients.273 Over the past century, Congress has frequently invoked this authority in the public health context, including for purposes of controlling specified diseases, establishing neighborhood or community health centers, and creating federal health insurance programs, including Medicare and Medicaid.274 264 See id. § 264(b)–(d). 265 See 42 C.F.R. §§ 70.1–70.18 (regulations on interstate quarantine); §§ 71.1–71.63 (regulations on foreign quarantine). 266 See 21 C.F.R. §§ 1240.3–1240.95. 267 See, e.g., CRS Report R45153, Statutory Interpretation: Theories, Tools, and Trends, by Valerie C. Brannon, at 54. 268 Vaccine mandates and campaigns can implicate, for instance, complex issues of supply and distribution, as well as issues of vaccine hesitance stemming in part from prior governmental vaccine campaigns. See discussion supra note 245; Wendy E. Parmet, Pandemics, Populism and the Role of Law in the H1N1 Vaccine Campaign, 4 ST. LOUIS UNIV. L. J. 113, 115–24 (2010) (describing the history of pandemic influenza responses in the United States and issues related to the 2009 H1N1 vaccine campaign); Kat Eschner, The Long Shadow of the 1976 Swine Flu Vaccine ‘Fiasco’, SMITHSONIAN MAG. (Feb. 6, 2017), https://www.smithsonianmag.com/smart-news/long-shadow-1976-swine-flu-vaccine-fiasco-180961994/. 269 FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133 (2000). 270 McCuskey, supra note 230, at 113–20. 271 See id. at 116–19. 272 U.S. CONST. art. I, § 8, cl. 1. 273 See CRS Report R45323, supra note 232, at 29–31 (discussing South Dakota v. Dole, 483 U.S. 203, 207–08 (1987)). 274 See James G. Hodge, Jr., The Role of New Federalism and Public Health Law, 12 J.L. & HEALTH 309, 335–37 (1998); McCuskey, supra note 230, at 118–19. Congressional Research Service 29 link to page 28 link to page 32 link to page 28 Legal Issues in COVID-19 Vaccine Development Applying its authority in the context of a vaccination mandate, Congress could incentivize states to enact a vaccination mandate meeting certain federal requirements by imposing it as a condition of receiving certain federal funds.275 This use of the Spending Clause authority, assuming it falls within the broad parameters of being for the “general welfare,” would be permissible so long as (1) Congress provides clear notice of the vaccination mandate that states must enact; (2) the mandate is related to the purpose of the federal funds; (3) this conditional grant of funds is not otherwise barred by the Constitution; and (4) the amount of federal funds offered is not “so coercive as to pass the point at which pressure turns into compulsion.”276 The Commerce Clause grants Congress the power “[t]o regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes.”277 This authority empowers Congress to regulate “three broad categories of activities”: (1) “channels of interstate commerce,” like roads and canals; (2) instrumentalities of, or persons or things in, interstate commerce; and (3) activities that substantially affect interstate commerce.278 Congress relied on the Commerce Clause to enact some of the earliest federal health laws aimed at protecting the public from contagion and products posing health concerns.279 As the federal government increased its role in public health, Congress relied on the Commerce Clause to pass more comprehensive national health regulations, beginning with the Food and Drug Act of 1906.280 While Congress’s authority under the Commerce Clause is expansive, a majority of the Supreme Court in National Federation of Independent Business (NFIB) v. Sebelius agreed that there is a discrete limit to this authority—that it cannot compel individuals to engage in commercial activity.281 According to Chief Justice Roberts, in a portion of the opinion not joined by other Justices, but largely echoed in the view of the four dissenting Justices, the Commerce Clause did not empower Congress “to regulate individuals precisely because they are doing nothing.”282 While it is uncertain whether this conclusion constitutes binding precedent,283 it suggests that a direct federal mandate on individuals to receive a vaccine may be susceptible to challenge because such mandates could be construed as compelling individuals who are “doing nothing” to engage in the commercial activity of receiving a specified health care service.284 On the other hand, a federal mandate that requires vaccination as a condition to engage in existing economic activities, such as employment, may raise fewer constitutional concerns.285 275 See Dole, 483 U.S. at 211–12 (holding that 23 U.S.C. § 158, which conditioned the provision of certain federal highway funds upon a state’s enactment of a minimum drinking age of twenty-one, was a valid exercise of Congress’s spending clause authority). 276 See id. at 207–08, 211 (internal quotations omitted). 277 U.S. CONST. art. I, § 8, cl. 3. 278 United States v. Lopez, 514 U.S. 549, 558–59 (1995). 279 McCuskey, supra note 230, at 116–19 (noting that the Commerce Clause enabled several early federal health laws, including a law that authorized the quarantine of diseased livestock and people, and a law that regulated certain drugs and food products posing health concerns). 280 See id.; see also Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996); Hodge, supra note 274, 335–36 (noting that “[f]ederal regulation now reaches broad aspects of public health such as air and water quality, food and drug safety, tobacco advertising, pesticide production and sales, consumer product safety, occupational health and safety, and medical care”). 281 See CRS Report R45323, supra note 232, at 10. 282 See id. at 10–11 (quoting NFIB v. Sebelius, 567 U.S. 519, 551 (2012) (opinion of Roberts, C.J.)). 283 See id. at 11. 284 See NFIB, 567 U.S. at 551. 285 See Liberty Univ., Inc. v. Lew, 773 F.3d 72, 93 (4th Cir. 2013) (rejecting a Commerce Clause challenge to an Affordable Care Act requirement that certain employers offer a minimum level of health insurance coverage to their Congressional Research Service 30 link to page 28 link to page 28 link to page 30 link to page 19 link to page 6 link to page 31 Legal Issues in COVID-19 Vaccine Development Even if within Congress’s enumerated powers, other constitutional provisions may constrain governmental action.286 In the context of public health regulations, the key constraints are those grounded in federalism and the protection of individual rights.287 For example, the Supreme Court has interpreted the Tenth Amendment to prevent the federal government from commandeering or requiring states or localities to adopt or enforce federal policies.288 In the context of vaccination, this principle prevents Congress from directly requiring states or localities to pass mandatory vaccination laws or implement federal vaccination laws.289 It does not, however, impede Congress from using its Spending Clause authority to incentivize states to do so, as long as the amount offered is not so significant as to effectively coerce, or functionally commandeer, states into enacting the mandate.290 As to protection of individual rights, courts have recognized few rights-based constraints on the ability to impose mandatory vaccination requirements.291 As noted above, courts have largely rejected due process and equal protection challenges to compulsory vaccination under Jacobson and Zucht, and potential free exercise concerns are limited under Smith and its progeny.292 To date, the federal government has generally limited its role with respect to vaccination to promoting, facilitating, or monitoring the use and manufacture of vaccines. For instance, federal laws and agencies require insurance coverage for recommended vaccinations293 and the purchase of certain vaccines,294 provide clinical guidance on vaccinations,295 and ensure vaccine safety.296 As discussed above, there may be an open question as to whether the federal government has existing authority to mandate vaccination in the context of COVID-19.297 Thus, inasmuch as Congress determines that a federal vaccination mandate may be necessary to address the COVID-19 pandemic, legislative action—grounded in Congress’s enumerated authorities described above—may be required to implement such a mandate. employees and dependents on the grounds that the requirement merely regulates an existing commercial activity). 286 See CRS Report R45323, supra note 232, at 24–25. 287 See id. at 19, 24–25. 288 Id. at 25. 289 See id. 290 See id. 291 See text accompanying supra notes 234–252. 292 See id. 293 See 42 U.S.C. § 300gg-13(a) (requiring private health insurance plans to cover certain recommended immunizations); id. § 1396s(a) (requiring coverage of certain recommended pediatric vaccines under a state Medicaid plan). 294 See discussion supra note 145. 295 See Advisory Committee on Immunization Practices (ACIP) Charter, CTRS. FOR DISEASE CONTROL & PREVENTION, , https://www.cdc.gov/vaccines/acip/committee/charter.html. 296 See discussion supra in “FDA Law Considerations: Bringing a New Vaccine to Market.” 297 See discussion supra in “Executive Branch Authority to Mandate Vaccination.” Congressional Research Service 31 Legal Issues in COVID-19 Vaccine Development ~~Products, by Nina M. Hart .~~
~~212 See, e.g., Fred Reinhart, Exercising Bayh-Dole March-in Rights Would Handicap Covid-19 Innovation, STAT (May~~
~~4, 2020), https://www.statnews.com/2020/05/04/bayh -dole-march-in-rights-handicap-covid-19-innovation/; James~~
~~Congressional Research Service~~
22

~~Legal Issues in COVID-19 Vaccine Development~~

~~The PREP Act:~~ Liability and Compensation for
COVID-19 Vaccine Injuries
To encourage the expeditious development and deployment of medical countermeasures during a To encourage the expeditious development and deployment of medical countermeasures during a
public health emergency, the PREP public health emergency, the PREP ~~Act213~~Act298 authorizes the Secretary of HHS authorizes the Secretary of HHS ~~to limit legal liability~~
(the Secretary) to limit legal liability for losses relating to the administration of medical countermeasures, including diagnostics, for losses relating to the administration of medical countermeasures, including diagnostics,
treatments, and vaccines.treatments, and vaccines.~~214~~299 In a declaration effective February 4, 2020 (the COVID-19 PREP Act In a declaration effective February 4, 2020 (the COVID-19 PREP Act
Declaration), the Secretary Declaration), the Secretary ~~of HHS~~ invoked the PREP Act and declared COVID-19 to be a public invoked the PREP Act and declared COVID-19 to be a public
health emergency warranting liability protections for covered countermeasures.health emergency warranting liability protections for covered countermeasures.~~215~~300 Under the Under the
COVID-19 PREP Act Declaration, covered persons are COVID-19 PREP Act Declaration, covered persons are ~~general y~~generally immune from legal liability immune from legal liability ~~for~~
for losses relating to the administration or use of covered countermeasures against COVID-19.losses relating to the administration or use of covered countermeasures against COVID-19.~~216~~ 301 The The
sole exception to PREP Act immunity is for death or serious physical injury caused by sole exception to PREP Act immunity is for death or serious physical injury caused by ~~“wil ful~~
“willful misconduct.”misconduct.”~~217~~302 However, individuals who die or suffer serious injuries directly caused by the However, individuals who die or suffer serious injuries directly caused by the
administration of covered countermeasures may be eligible to receive compensation through an administration of covered countermeasures may be eligible to receive compensation through an
HHS administrative process HHS administrative process ~~cal ed~~called the Countermeasures Injury Compensation Program the Countermeasures Injury Compensation Program
(CICP).(CICP).~~218~~303
Courts have characterized PREP Act immunity as “sweeping.” Courts have characterized PREP Act immunity as “sweeping.”~~219~~304 It applies to It applies to al all types of legal types of legal
claims under state and federal law.claims under state and federal law.~~220~~305 For example, under state tort law, individuals who suffer For example, under state tort law, individuals who suffer
injuries caused by injuries caused by ~~the~~another person’s intentional or negligent acts or omissions intentional or negligent acts or omissions ~~of another person may general y~~
may generally sue that person to recover monetary compensation.sue that person to recover monetary compensation.~~221~~306 Thus, in the health care context, if a health Thus, in the health care context, if a health
care provider negligently administers a drug or device that causes a foreseeable injury to a care provider negligently administers a drug or device that causes a foreseeable injury to a
patient, the injured person may be able to sue the provider for compensation.patient, the injured person may be able to sue the provider for compensation.~~222~~307
Federal laws such as the PREP Act may preempt state tort laws—as Federal laws such as the PREP Act may preempt state tort laws—as ~~wel~~ well as other state and federal as other state and federal
laws—in certain contexts.laws—in certain contexts.~~223~~308 Preemptive federal legislation displaces state law to alter the usual Preemptive federal legislation displaces state law to alter the usual
liabilityliability rules or immunize certain individuals from liability.rules or immunize certain individuals from liability.~~224~~ 309 In the PREP Act, Congress made In the PREP Act, Congress made
the judgment that, in the context of a public health emergency, immunizing certain persons and the judgment that, in the context of a public health emergency, immunizing certain persons and

~~Edwards, We Won’t Stop Coronavirus Without IP, IPWATCHDOG (Mar. 10, 2020),~~
~~https://www.ipwatchdog.com/2020/03/10/wont -stop-coronavirus-without -ip/id=119735/.~~
~~213 Pub. L. 109-148, div. C, 119 Stat . 2680, 2818-32 (2005) (codified as amended at 42 U.S.C. §§ 247d-6d, 247d-6e).~~
~~214 42 U.S.C. § 247d-6d(b)(1).~~
~~215 Declaration Under the Public Readiness~~ entities from liability was necessary to ensure that potentially life-saving countermeasures will be efficiently developed, deployed, and administered.310 298 Pub. L. 109-148, div. C, 119 Stat. 2680, 2818–32 (2005) (codified as amended at 42 U.S.C. §§ 247d-6d, 247d-6e). 299 42 U.S.C. § 247d-6d(b)(1). 300 Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against and Emergency Preparedness Act for Medical Countermeasures Against
COVID-19, 85 Fed.COVID-19, 85 Fed. Reg.Reg. 15,198 (Mar. 17, 2020) (effective Feb. 4, 2020) [hereinafter COVID-19 PREP Act 15,198 (Mar. 17, 2020) (effective Feb. 4, 2020) [hereinafter COVID-19 PREP Act
Declaration]. Declaration].
~~216~~ 301 Id. at 15,201 at 15,201-–02; 42 U.S.C. § 247d-6d(a)(1). 02; 42 U.S.C. § 247d-6d(a)(1).
~~217~~302 42 U.S.C. 42 U.S.C. § 247d-6d(d)(1). § 247d-6d(d)(1).
~~218~~303 Id. § 247d-6e; 42 C.F.R. pt. 110. . § 247d-6e; 42 C.F.R. pt. 110.
~~219~~304 See Parker v. St. Lawrence Cty. Pub. Health Dep’t, 102 A.D.3d 140, 143 (N.Y. App. Div. 2012). Parker v. St. Lawrence Cty. Pub. Health Dep’t, 102 A.D.3d 140, 143 (N.Y. App. Div. 2012).
~~220~~305 42 U.S.C. 42 U.S.C. § 247d-6d(a)(1). § 247d-6d(a)(1).
~~221~~306 See generally CRS CRS In Focus IF11291, In Focus IF11291, Introduction to Tort Law, by Kevin M. Lewis. , by Kevin M. Lewis.
~~222~~307 Id. at 1. at 1.
~~223~~308 See generally CRS CRS Report R45825, Report R45825, Federal Preemption: A Legal Primer, by Jay B. Sykes, by Jay B. Sykes and Nicole Vanatko. and Nicole Vanatko.
~~224~~309 See, e.g., CRS, CRS Legal SidebarLegal Sidebar LSB10461, LSB10461, Federal Legislation Shielding Businesses and Individuals from Tort
Liability: A Legal and Historical Overview,, by Kevin M. Lewisby Kevin M. Lewis (summarizing federal statutes that either insulate (summarizing federal statutes that either insulate
particular entities from tort liability or otherwise displaceparticular entities from tort liability or otherwise displace state tortstate tort ~~law).~~
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~~entities from liability was necessary to ensure that potential y life-saving countermeasures wil be~~
~~efficiently developed, deployed, and administered.225~~ law). 310 See, e.g., 151 CONG. REC. H12264 (daily ed. Dec. 18, 2005) (statement of Rep. Deal) (“Unfortunately, there is no business model that would have vaccine manufacturers take on the tremendous liability risks to produce [a pandemic Congressional Research Service 32 Legal Issues in COVID-19 Vaccine Development
So long as the COVID-19 PREP Act Declaration remains in effect, COVID-19 vaccine So long as the COVID-19 PREP Act Declaration remains in effect, COVID-19 vaccine
manufacturers, distributors, and qualified health care providers are manufacturers, distributors, and qualified health care providers are ~~general y~~generally immune from legal immune from legal
liabilityliability for losses relating to the use or administration of that vaccine. Instead, for losses relating to the use or administration of that vaccine. Instead, compensation through CICP may be available for individuals who individuals who
are injured or die as a result of receiving a COVID-19 vaccineare injured or die as a result of receiving a COVID-19 vaccine ~~may seek compensation through~~
~~CICP~~. This section explains the scope of this PREP Act immunity as it applies to COVID-19 . This section explains the scope of this PREP Act immunity as it applies to COVID-19
countermeasures, including vaccines, as countermeasures, including vaccines, as ~~wel~~ well as the contours and availability of CICP as the contours and availability of CICP
compensation. compensation.
The Public Readiness and Emergency Preparedness Act
Scope of Immunity from Liability
For the PREP Act to apply, the Secretary For the PREP Act to apply, the Secretary ~~of HHS~~ must determine that a disease or other threat to must determine that a disease or other threat to
health constitutes a public health emergency, or that there is a credible risk of such an health constitutes a public health emergency, or that there is a credible risk of such an
emergency.emergency.~~226~~311 The Secretary The Secretary ~~shal~~ shall consider the desirability of encouraging the design, consider the desirability of encouraging the design,
development, testing, manufacture, and use of countermeasures in determining whether to issue a development, testing, manufacture, and use of countermeasures in determining whether to issue a
PREP Act declaration.PREP Act declaration.~~227~~312 The Secretary must publish the PREP Act declaration in the The Secretary must publish the PREP Act declaration in the Federal
Register and identify, for each countermeasure, the particular disease, time period, population, and identify, for each countermeasure, the particular disease, time period, population,
and geographical area that the declaration covers.and geographical area that the declaration covers.~~228~~313
If within the scope of the declaration, the PREP Act immunizes a covered person from legal If within the scope of the declaration, the PREP Act immunizes a covered person from legal
liabilityliability for for al all claims for loss relating to the administration or use of a covered claims for loss relating to the administration or use of a covered
countermeasure.countermeasure.~~229~~314 The requirements for PREP Act immunity thus break down into four elements: The requirements for PREP Act immunity thus break down into four elements:
(1) the individual(1) the individual or entity must be a “covered person”; (2) the legal claim must be for a “loss”; or entity must be a “covered person”; (2) the legal claim must be for a “loss”;
(3) the loss must have a “causal relationship” (3) the loss must have a “causal relationship” ~~with~~to the administration or use of a covered the administration or use of a covered
countermeasure; and (4) the medical product that caused the loss must be a “covered countermeasure; and (4) the medical product that caused the loss must be a “covered
countermeasure.” countermeasure.”
“Covered Persons”
The PREP Act defines covered persons to include (i) the United States; (The PREP Act defines covered persons to include (i) the United States; (i ii) manufacturers and ) manufacturers and
distributors of covered countermeasures; (distributors of covered countermeasures; (~~i i~~iii) “program planners”; and (iv) “qualified persons” ) “program planners”; and (iv) “qualified persons”

~~225 See, e.g., 151 CONG. REC. H12264 (daily ed. Dec. 18, 2005) (statement of Rep. Deal) (“Unfortunately, there is no~~
~~business model that would have vaccine manufacturers take on the tremendous liability risks to produce [a pandemic~~
~~flu] vaccine. We must address this concern or we will have non e~~who prescribe, administer, or dispense covered countermeasures.315 Program planners include Indian Tribes, state governments, and local governments who supervise programs that dispense, distribute, or administer covered countermeasures, or provide policy guidance, facilities, and flu] vaccine. We must address this concern or we will have none. It’s really that simple. . . . What the [PREP Act] does . It’s really that simple. . . . What the [PREP Act] does
is provide authority to the Secretary[:] the ability to declare limited liability protection. is provide authority to the Secretary[:] the ability to declare limited liability protection. ~~T he~~The Secretary can use these Secretary can use these
declarations to make sure the vaccine gets developed and to make sure declarations to make sure the vaccine gets developed and to make sure ~~docto rs~~doctors are willing are willing to give it whento give it when the time the time
comes.”). comes.”).
~~226~~311 42 U.S.C. 42 U.S.C. § 247d-6d(b)(1).§ 247d-6d(b)(1).
~~227~~312 Id. § 247d-6d(b)(6). § 247d-6d(b)(6). A PREP Act declaration is distinct from the Secretary’s power to declare a publicA PREP Act declaration is distinct from the Secretary’s power to declare a public health health
emergency underemergency under Section 319 of the PHSA, which has a separate setSection 319 of the PHSA, which has a separate set of legalof legal implications. implications. Id. § 247d; § 247d; see generally
U.S.U.S. Dep’t of Health Dep’t of Health ~~and~~& Human Servs., Human Servs., ~~Office~~ Off. of the Assistant Sec. of the Assistant Sec. for Preparedness for Preparedness ~~and~~& Response, Public Health Response, Public Health
Emergency Declaration (Nov. 26, 2019) (describing powersEmergency Declaration (Nov. 26, 2019) (describing powers ~~of Secretary of HHS under Section 31 9). T he Secretary of~~
~~HHS~~ of Secretary under Section 319). The Secretary made the Section 319 declaration for COVID-19 on January 31, 2020. Alex M. Azar II, Sec’ymade the Section 319 declaration for COVID-19 on January 31, 2020. Alex M. Azar II, Sec’y of the Dep’t of of the Dep’t of
Health Health ~~and~~& Human Servs., Determination that a Public Health Emergency Exists, Human Servs., Determination that a Public Health Emergency Exists,
https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019 -nCoV.aspx (Jan. 31, 2020).-nCoV.aspx (Jan. 31, 2020).
~~228~~313 42 U.S.C. 42 U.S.C. § 247d-6d(b)(1)§ 247d-6d(b)(1)-–(3). (3).
~~229~~314 Id. § 247d-6d(a)(1).§ 247d-6d(a)(1).
315 Id. § 247d-6d(i)(2). Congressional Research Service Congressional Research Service
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~~who prescribe, administer, or dispense covered countermeasures.230 Program planners include~~
~~Indian Tribes, state governments, and local governments who supervise programs that dispense,~~
~~distribute, or administer covered countermeasures, or provide policy guidance, facilities, and~~
scientific advice on the administration or use of such countermeasures.scientific advice on the administration or use of such countermeasures.~~231~~316 Qualified persons Qualified persons
include licensed health professionals and other individuals authorized to prescribe, administer, or include licensed health professionals and other individuals authorized to prescribe, administer, or
dispense covered countermeasures under state law, as dispense covered countermeasures under state law, as ~~wel~~ well as other categories of persons as other categories of persons
identified by the Secretary in a PREP Act declaration.identified by the Secretary in a PREP Act declaration.~~232~~317 Employees and agents of Employees and agents of al all these these
persons and entities are also covered persons.persons and entities are also covered persons.~~233~~318
Covered “Claims for Loss”
PREP Act immunity reaches “PREP Act immunity reaches “al all claims for loss” under federal and state law.claims for loss” under federal and state law.~~234~~319 Loss is broadly Loss is broadly
defined to mean “any type of loss,” including (i) death; (defined to mean “any type of loss,” including (i) death; (i ii) physical, mental, or emotional injury, ) physical, mental, or emotional injury,
~~il ness~~illness, disability, or condition; (, disability, or condition; (~~i i~~iii) fear of such injury, including medical monitoring costs; and ) fear of such injury, including medical monitoring costs; and
(iv) loss of or damage to property, including business interruption loss.(iv) loss of or damage to property, including business interruption loss.~~235~~320 This language would This language would
seem to include, at a minimum, most state law tort, medical malpractice, and wrongful death seem to include, at a minimum, most state law tort, medical malpractice, and wrongful death
claims resulting from the administration of covered countermeasures. claims resulting from the administration of covered countermeasures.
Causal ~~Relationship~~ Relationship Between the Loss and the Countermeasure
To be preempted by the PREP Act, the claims for loss must have a causal relationship to the To be preempted by the PREP Act, the claims for loss must have a causal relationship to the
administration and use of a covered countermeasure.administration and use of a covered countermeasure.~~236~~321 As with the other elements, the PREP As with the other elements, the PREP
Act’s causation language sweeps broadly. PREP Act immunity applies to any claim for loss that Act’s causation language sweeps broadly. PREP Act immunity applies to any claim for loss that
has “a causal relationship with the design, development, clinical testing or investigation, has “a causal relationship with the design, development, clinical testing or investigation,
manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase,
donation, dispensing, prescribing, administration, licensing, or use” of a covered donation, dispensing, prescribing, administration, licensing, or use” of a covered
countermeasure.countermeasure.~~237~~322
“Covered Countermeasures”
~~Final y~~Finally, the medical product at issue must be a covered countermeasure. The PREP Act specifies , the medical product at issue must be a covered countermeasure. The PREP Act specifies
three three ~~general~~ types of covered countermeasures: (i) a qualified “pandemic or epidemic product”; types of covered countermeasures: (i) a qualified “pandemic or epidemic product”;
(i (ii) a “security countermeasure”; ) a “security countermeasure”; ~~and (i i~~(iii) a drug, biological product, or device that FDA has ) a drug, biological product, or device that FDA has
authorized for authorized for emergency use; and (iv) a “respiratory protective device” that is approved by the National Institute for Occupational Safety and Health (NIOSH) that the Secretary determines to be a priority for use during a public health emergency.323~~emergency use.238 As discussed below, Congress recently added a fourth covered~~
~~countermeasure category specifical y for respiratory protective devices.239~~
A A pandemic or epidemic product includes any drug, biological product, or device developed “to includes any drug, biological product, or device developed “to
diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic.”diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic.”~~240~~324 In addition, drugs, In addition, drugs,

~~230 Id. § 247d-6d(i)(2).~~
~~231 Id. § 247d-6d(i)(6).~~
~~232 Id. § 247d-6d(i)(8).~~
~~233 Id. § 247d-6d(i)(2)(B)(v).~~
~~234 Id. § 247d-6d(a)(1).~~
~~235 Id. § 247d-6d(a)(2)(A)(i)-(iv).~~
~~236 Id. § 247d-6d(a)(1).~~
~~237 Id. § 247d-6d(a)(2)(B).~~
~~238 Id. § 247d-6d(i)(1)(A)-(C).~~
~~239 Id. § 247d-6d(i)(1)(D); see infra “Recent Congressional Actions on COVID-19 Countermeasures Liability.”~~
~~240 42 U.S.C. § 247d-6d(i)(7)(A)(i). T he PREP Act incorporates the general definitions of “drug,” “biological product,”~~
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~~link to page 14~~ ~~Legal Issues in COVID-19 Vaccine Development~~

~~biological products, or devices uses to treat the side effects of a pandemic or epidemic product, or~~
~~to enhance their effects, may themselves be covered countermeasures.241 In either case, to be a~~
~~covered countermeasure, the pandemic or epidemic product must be approved, licensed, or~~
~~authorized for emergency use by FDA.242~~biological products, or devices used to treat the side effects of a pandemic or epidemic product, or to enhance their effects, may themselves be covered countermeasures.325 In either case, to be a 316 Id. § 247d-6d(i)(6). 317 Id. § 247d-6d(i)(8). 318 Id. § 247d-6d(i)(2)(B)(v). 319 Id. § 247d-6d(a)(1). 320 Id. § 247d-6d(a)(2)(A)(i)–(iv). 321 Id. § 247d-6d(a)(1). 322 Id. § 247d-6d(a)(2)(B). 323 Id. § 247d-6d(i)(1)(A)–(C). 324 Id. § 247d-6d(i)(7)(A)(i). The PREP Act incorporates the general definitions of “drug,” “biological product,” and “device” from the FD&C Act and PHSA. See 21 U.S.C. § 321(g)(1), (h); 42 U.S.C. § 262(i). 325 42 U.S.C. § 247d-6d(i)(7)(A)(ii)–(iii). Congressional Research Service 34 link to page 15 Legal Issues in COVID-19 Vaccine Development covered countermeasure, the pandemic or epidemic product must be approved, licensed, or authorized for emergency use by FDA.326
A A security countermeasure refers to a drug, biological product, or device used “to diagnose, refers to a drug, biological product, or device used “to diagnose,
mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent” mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent”
identified by the Secretary of Homeland Security as a material threat to national security.identified by the Secretary of Homeland Security as a material threat to national security.~~243~~327
The The emergency use category of covered countermeasure includes drugs, biological products, and category of covered countermeasure includes drugs, biological products, and
devices that FDA has authorized for use outside its ordinary regulatory process through an devices that FDA has authorized for use outside its ordinary regulatory process through an
EUA.EUA.~~244~~328 FDA has made wide use of its emergency authorities in response to the COVID-19 FDA has made wide use of its emergency authorities in response to the COVID-19
pandemic, issuing EUAs for certain in vitro diagnostic products (i.e., tests for COVID-19), pandemic, issuing EUAs for certain in vitro diagnostic products (i.e., tests for COVID-19),
antibody tests, personal protective equipment (e.g., respirators and face shields), devices modified antibody tests, personal protective equipment (e.g., respirators and face shields), devices modified
for use as ventilators, and therapeutic drugs.for use as ventilators, and therapeutic drugs.~~245~~
~~Thus~~329 Section 6005 of the Families First Coronavirus Response Act330 and Section 3103 of the CARES Act331 amend the PREP Act to clarify that certain “personal respiratory protective devices” (such as N95 respirators) are covered countermeasures. To be covered by the PREP Act, the respiratory protective device must be (i) approved by the NIOSH under 42 C.F.R. part 84; and (ii) determined by the Secretary of HHS to be a priority for use during a public health emergency.332 In sum, so long as FDA licensed or authorized a COVID-19 vaccine, it would be a covered , so long as FDA licensed or authorized a COVID-19 vaccine, it would be a covered
countermeasure within the countermeasure within the ~~scope of the PREP Act~~PREP Act’s scope, either as a “pandemic or epidemic product” or , either as a “pandemic or epidemic product” or
through the emergency use categorythrough the emergency use category, in the case of authorization through an EUA. Prior to in the case of authorization through an EUA. Prior to
licensure or authorization of a COVID-19 vaccine, the PREP Act would also afford liability licensure or authorization of a COVID-19 vaccine, the PREP Act would also afford liability
protections for injuries that may occur in the clinical testing process, if the vaccine is “the object protections for injuries that may occur in the clinical testing process, if the vaccine is “the object
of research for possible use” as a pandemic or epidemic product and subject to an investigational of research for possible use” as a pandemic or epidemic product and subject to an investigational
use exemption.use exemption.~~246~~333
The Willful Misconduct Exception
If a claim for loss is within the PREP Act’s scope, a covered person is If a claim for loss is within the PREP Act’s scope, a covered person is ~~general y~~generally immune from immune from
legal liability.legal liability.~~247~~ 334 The “sole exception” to immunity is when a covered person proximately causes The “sole exception” to immunity is when a covered person proximately causes
death or serious physical injury to another person through death or serious physical injury to another person through ~~wil ful~~willful misconduct. misconduct.~~248 A serious~~
~~physical injury must be life threatening, permanently impair a body function, permanently~~
~~damage a body structure, or require medical intervention to avoid such permanent impairment or~~
~~damage.249 Wil ful misconduct requires that the covered person acted (i) intentional y to achieve a~~
~~wrongful purpose; (i ) knowingly without legal or factual justification; and (i i) in disregard of a~~

~~and “device” under the FD&C Act and PHSA. See 21 U.S.C. § 321(g)(1), (h); 42 U.S.C. § 262(i).~~
~~241 42 U.S.C. § 247d-6d(i)(7)(A)(ii)-(iii).~~
~~242~~335 A serious 326 Id. § 247d-6d(i)(7)(B)(i), (iii). § 247d-6d(i)(7)(B)(i), (iii).
~~243~~327 Id. §§§§ 247d-6b(c)(1)(B), 247d-6d(i)(1)(B). 247d-6b(c)(1)(B), 247d-6d(i)(1)(B).
~~244~~328 Id. § 247d-6d(i)(1)(C); . § 247d-6d(i)(1)(C); see discussion supra in ~~supra~~ “Emergency Use Authorizations Before Approval.”.”
~~245~~329 Emergency Use Authorization: Coronavirus Disease 2019 (COVID-19) EUA Information, U.S. FOOD & DRUG , U.S. FOOD & DRUG
ADMIN., https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-ADMIN., https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
framework/emergency-use-authorization#covid19euas (last updated June 1, 2020) (listing FDA’s current EUAs for framework/emergency-use-authorization#covid19euas (last updated June 1, 2020) (listing FDA’s current EUAs for
COVID-19 diagnostics,COVID-19 diagnostics, antibody tests, personal protective equipment, therapeutics, and ventilators).antibody tests, personal protective equipment, therapeutics, and ventilators).
~~246 42 U.S.C. § 247d-6d(i)(7)(B)(ii).~~
~~247 Id. § 247d-6d(a)(1).~~
~~248~~ 330 Pub. L. No. 116-127, § 6005, 134 Stat. 178, 207 (2020). 331 Pub. L. No. 116-136, § 3103 (2020). 332 42 U.S.C. § 247-6d(i)(1)(D). Prior to these amendments, FDA issued an EUA on March 2, 2020 for the use of NIOSH-approved filtering respirators intended for general use in health care settings, and expressed its view that the PREP Act covered these respirators prior to the amendment because of their medical use. See Letter from Denise M. Hinton, Chief Scientist, FDA, to Robert R. Redfield, Dir. Ctrs. for Disease Control & Prevention (Mar. 28, 2020), https://www.fda.gov/media/135763/download. 333 42 U.S.C. § 247d-6d(i)(7)(B)(ii). 334 Id. § 247d-6d(a)(1). 335 Id. § 247d-6d(d)(1). In the case of actions by or against the United States, the PREP Act shall not “be construed to § 247d-6d(d)(1). In the case of actions by or against the United States, the PREP Act shall not “be construed to
abrogate or limit any right, remedy, or authority that the United States or any agency thereof may possess underabrogate or limit any right, remedy, or authority that the United States or any agency thereof may possess under any any
other provision of law or to waive sovereign immunity or to abrogate or limit any defense or protection available to the other provision of law or to waive sovereign immunity or to abrogate or limit any defense or protection available to the
~~United States or its agencies, instrumentalities, officers, or employees under any other law . . . .” Id. § 247d-6d(f).~~
~~249 Id. § 247d-6d(i)(10).~~
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Congressional Research Service 35 Legal Issues in COVID-19 Vaccine Development physical injury must be life threatening, permanently impair a body function, permanently damage a body structure, or require medical intervention to avoid such permanent impairment or damage.336 Willful misconduct requires that the covered person acted (i) intentionally to achieve a wrongful purpose; (ii) knowingly without legal or factual justification; and (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm known or obvious risk that is so great as to make it highly probable that the harm ~~wil~~ will outweigh outweigh
the benefit.the benefit.~~250~~337
The process by which an injured person (or their representative) may prove The process by which an injured person (or their representative) may prove ~~wil ful~~willful misconduct misconduct
under the PREP Act is limited in several ways. Before filing a suit claiming under the PREP Act is limited in several ways. Before filing a suit claiming ~~wil ful~~ willful misconduct, misconduct,
the injured person must first seek compensation through CICP, and they cannot sue if they elect to the injured person must first seek compensation through CICP, and they cannot sue if they elect to
receive that compensation.receive that compensation.~~251~~338 If they choose to file a lawsuit, injured persons may sue only in the If they choose to file a lawsuit, injured persons may sue only in the
U.S. District Court for the District of Columbia.U.S. District Court for the District of Columbia.~~252~~339 Such lawsuits are assigned to a three-judge Such lawsuits are assigned to a three-judge
panel, must meet heightened standards for pleading and discovery, and are subject to procedural panel, must meet heightened standards for pleading and discovery, and are subject to procedural
provisions provisions ~~general y~~generally favorable to defendants. favorable to defendants.~~253~~340 Injured persons must prove Injured persons must prove ~~wil ful~~willful misconduct by misconduct by
clear and convincing evidence,clear and convincing evidence,~~254~~341 a higher standard of proof than a typical civil case. Recovery a higher standard of proof than a typical civil case. Recovery
for noneconomic damages such as pain and suffering is limited.for noneconomic damages such as pain and suffering is limited.~~255~~342
In addition to these procedural and substantive limitations, the PREP Act contains two statutory In addition to these procedural and substantive limitations, the PREP Act contains two statutory
defenses to claims of defenses to claims of ~~wil ful~~willful misconduct. First, program planners and qualified persons cannot be misconduct. First, program planners and qualified persons cannot be
found to have engaged in found to have engaged in ~~wil ful~~ willful misconduct if they “acted consistent with applicable directions, misconduct if they “acted consistent with applicable directions,
guidelines, or recommendations by the Secretary regarding the administration or use of a covered guidelines, or recommendations by the Secretary regarding the administration or use of a covered
countermeasure,” and notify either the Secretary or a state or local health authority of the injury countermeasure,” and notify either the Secretary or a state or local health authority of the injury
or death or death ~~al egedly~~ allegedly caused by the countermeasure within seven days.caused by the countermeasure within seven days.~~256~~343 Second, countermeasure Second, countermeasure
manufacturers and distributors may rely on regulatory compliance as a complete defense to a manufacturers and distributors may rely on regulatory compliance as a complete defense to a
““~~wil ful~~willful misconduct” misconduct” ~~al egation.257~~allegation.344 When the act or omission When the act or omission ~~al eged~~alleged to be to be ~~wil ful~~willful misconduct is misconduct is
“subject to regulation” under the PHSA or the FD&C Act, an injured person cannot succeed on a “subject to regulation” under the PHSA or the FD&C Act, an injured person cannot succeed on a
~~wil ful~~willful misconduct claim unless the Secretary misconduct claim unless the Secretary ~~of HHS~~ or the Attorney General has brought certain or the Attorney General has brought certain
“enforcement actions” against the manufacturer or distributor that result in the imposition of “enforcement actions” against the manufacturer or distributor that result in the imposition of
particular penalties.particular penalties.~~258~~
~~The Countermeasures Injury Compensation Program~~
~~An individual seriously injured or kil ed by the administration of a covered countermeasure,~~
~~whether or not as a result of wil ful misconduct, may seek compensation through CICP.259 CICP~~
~~is a regulatory process administered by HHS’s Health Resources and Services Administration.260~~

~~250 Id. § 247d-6d(c)(1)(A).~~
~~251 Id. § 247d-6e(d)(1), (5).~~
~~252 Id. § 247d-6d(e)(1).~~
~~253 See id. § 247d-6d(e)(3)-(6), (10).~~
~~254 Id. § 247d-6d(c)(3).~~
~~255 Id. § 247d-6d(e)(7)-(8).~~
~~256 Id. § 247d-6d(c)(4).~~
~~257 Id. § 247d-6d(c)(5).~~
258 Id. ~~§ 247d-6d(c)(5)(A)(i)-(ii). T he~~345 United States or its agencies, instrumentalities, officers, or employees under any other law.” Id. § 247d-6d(f). 336 Id. § 247d-6d(i)(10). 337 Id. § 247d-6d(c)(1)(A). 338 Id. § 247d-6e(d)(1), (5). 339 Id. § 247d-6d(e)(1). 340 See id. § 247d-6d(e)(3)–(6), (10). 341 Id. § 247d-6d(c)(3). 342 Id. § 247d-6d(e)(7)–(8). 343 Id. § 247d-6d(c)(4). 344 Id. § 247d-6d(c)(5). 345 Id. § 247d-6d(c)(5)(A)(i)–(ii). The necessary “enforcement actions” include criminal prosecutions, civil monetary necessary “enforcement actions” include criminal prosecutions, civil monetary
proceedings basedproceedings based on willfulon willful misconduct, mandatory product recalls, or revocations, suspensionsmisconduct, mandatory product recalls, or revocations, suspensions, or withdrawals, or withdrawals, ~~based~~
based on willfulon willful misconduct, of FDA approval, licensure, or authorization. misconduct, of FDA approval, licensure, or authorization. Id. § 247d-6d(c)(5)(B)(i). Before a willful § 247d-6d(c)(5)(B)(i). Before a willful
misconduct claim can proceed, the enforcement action must conclude with the imposition of a “covered remedymisconduct claim can proceed, the enforcement action must conclude with the imposition of a “covered remedy,” such ” such
as a criminal conviction, an injunction, a civil monetaryas a criminal conviction, an injunction, a civil monetary payment, a product recall, or a suspension or withdrawalpayment, a product recall, or a suspension or withdrawal of of
FDA approval or licensure. FDA approval or licensure. Id. § 247d-6d(c)(5)(B)(ii). § 247d-6d(c)(5)(B)(ii).
~~259 Id. § 247d-6e(a)-(b).~~
~~260 See generally Countermeasure Injury Compensation Program , HEALTH RESOURCES & SERVS. ADMIN.,~~
~~https://www.hrsa.gov/cicp/index.html (last visited May 28, 2020).~~
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~~Legal Issues in COVID-19 Vaccine Development~~

~~HHS regulations govern CICP’s procedures and eligibility determinations.261 In general, eligible~~
~~individuals~~ Congressional Research Service 36 link to page 35 Legal Issues in COVID-19 Vaccine Development The Countermeasures Injury Compensation Program An individual seriously injured or killed by the administration of a covered countermeasure, whether or not as a result of willful misconduct, may seek compensation through CICP.346 CICP is a regulatory process administered by HHS’s Health Resources and Services Administration.347 HHS regulations govern CICP’s procedures and eligibility determinations.348 In general, eligible individuals (or their survivors) who suffer death or serious physical injury directly caused by the (or their survivors) who suffer death or serious physical injury directly caused by the
administration of a covered countermeasure may receive reimbursement through CICP for administration of a covered countermeasure may receive reimbursement through CICP for
reasonable medical expenses, loss of employment income, and survivor benefits in the case of reasonable medical expenses, loss of employment income, and survivor benefits in the case of
death.death.~~262~~349 Serious physical injuries under CICP are Serious physical injuries under CICP are ~~general y~~generally limited limited to those that warrant to those that warrant
hospitalization or lead to a significant loss of function or disability.hospitalization or lead to a significant loss of function or disability.~~263~~350 Congress funds CICP Congress funds CICP
compensation through emergency appropriations to the Covered Countermeasure Process compensation through emergency appropriations to the Covered Countermeasure Process
~~Fund.264~~Fund.351 Both the CARES Act and CPRSA appropriate funding that HHS may use for the Covered Countermeasure Process Fund, upon which CICP relies. CPRSA appropriates $3.1 billion to the Secretary to respond to COVID-19, including the development and purchase of countermeasures and vaccines, while allowing these funds to “be transferred to, and merged with” the Covered Countermeasure Process Fund.352 The CARES Act appropriates $27 billion to the Secretary for similar purposes, again providing that the Secretary may transfer these funds to the Covered Countermeasure Process Fund.353
CICP is distinct from the National Vaccine Injury Compensation Program, CICP is distinct from the National Vaccine Injury Compensation Program,~~265~~354 which provides which provides
compensation for injuries caused by most vaccines routinely administered in the United States, compensation for injuries caused by most vaccines routinely administered in the United States,
such as childhood vaccines (e.g., MMR, polio, hepatitis A) and nonpandemic seasonal influenza such as childhood vaccines (e.g., MMR, polio, hepatitis A) and nonpandemic seasonal influenza
vaccines.vaccines.~~266~~355 By contrast, CICP only applies to countermeasures covered by a PREP Act By contrast, CICP only applies to countermeasures covered by a PREP Act
declaration of a public health emergency, such as those issued for COVID-19, pandemic influenza declaration of a public health emergency, such as those issued for COVID-19, pandemic influenza
(e.g., the 2009 H1N1 “swine flu”), and the Ebola virus.(e.g., the 2009 H1N1 “swine flu”), and the Ebola virus.~~267~~356
The COVID-19 PREP Act Declaration
On March 10, 2020, the Secretary On March 10, 2020, the Secretary ~~of HHS~~ invoked the PREP Act and determined that COVID-19 invoked the PREP Act and determined that COVID-19
constitutes a public health emergency.constitutes a public health emergency.~~268~~357 The COVID-19 PREP Act Declaration therefore The COVID-19 PREP Act Declaration therefore
authorizes PREP Act immunity for the “manufacture, testing, development, distribution, authorizes PREP Act immunity for the “manufacture, testing, development, distribution,
~~administration, and use” of covered countermeasures.269 This immunity applies to al covered~~
~~persons as defined in the PREP Act, including any person authorized by state and local public~~
~~health agencies (or an EUA) to “prescribe, administer, deliver, distribute or dispense” covered~~
~~countermeasures.270 Covered countermeasures include “any antiviral, any other drug, any~~
~~biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent,~~
~~or mitigate COVID-19.”271 The “administration” of a covered countermeasure includes “physical~~
~~provision of the countermeasures” to patients, as wel as “activities and decisions directly relating~~
~~to . . . delivery, distribution and dispensing of” the countermeasures.272 The declaration provides~~
~~PREP Act immunity “without geographic limitation,” beginning on February 4, 2020, and ending~~
~~as late as October 1, 2025.273~~

~~261 See 42 C.F.R. pt. 110.~~
~~262 42 U.S.C.~~ 346 Id. § 247d-6e(a)–(b). 347 See generally Countermeasure Injury Compensation Program, HEALTH RESOURCES & SERVS. ADMIN., https://www.hrsa.gov/cicp/index.html (last visited May 28, 2020). 348 See 42 C.F.R. pt. 110. 349 42 U.S.C. § 247d-6e(a), (b), (e)(3), (e)(5); 42 C.F.R. § 110.2(a). § 247d-6e(a), (b), (e)(3), (e)(5); 42 C.F.R. § 110.2(a).
~~263~~350 42 C.F.R. § 42 C.F.R. § 110.3(z). 110.3(z).
~~264~~351 42 U.S.C. 42 U.S.C. § 247d-6e(a). § 247d-6e(a).
265 See ~~42 U.S.C. §§~~ 352 Pub. L. No. 116-123, tit. III, 134 Stat. 146, 149 (2020). 353 Pub. L. No. 116-136, tit. VIII. 354 See 42 U.S.C. §§ 300aa-10 to 300aa-34; 42 C.F.R. pt. 100. 300aa-10 to 300aa-34; 42 C.F.R. pt. 100.
~~266~~355 See National Vaccine Injury Compensation Program: Covered Vaccines, HEALTH , HEALTH ~~RESOURCES~~RES. & SERVS. ADMIN, & SERVS. ADMIN,
https://www.hrsa.gov/vaccine-compensation/covered-vaccines/index.html (last updated Mar. 2020). https://www.hrsa.gov/vaccine-compensation/covered-vaccines/index.html (last updated Mar. 2020).
~~267~~356 See HEALTH HEALTH ~~RESOURCES~~RES. & SERVS. ADMIN, COUNTERMEASURES INJURY COMPENSATION PROGRAM: FACT SHEET (Oct. & SERVS. ADMIN, COUNTERMEASURES INJURY COMPENSATION PROGRAM: FACT SHEET (Oct.
2017), https://www.hrsa.gov/sites/default/files/hrsa/cicp/cicpfactsheet.pdf2017), https://www.hrsa.gov/sites/default/files/hrsa/cicp/cicpfactsheet.pdf . .
~~268~~ 357 COVID-19 PREP Act Declaration, COVID-19 PREP Act Declaration, ~~85 Fed. Reg. at 15,201.~~
~~269~~ ~~Id.~~
~~270 Id. at 15,201-02.~~
~~271 Id. at 15,202.~~
~~272~~ ~~Id.~~
273 See id.supra note 300, at 15,201.
Congressional Research Service Congressional Research Service
2837 Legal Issues in COVID-19 Vaccine Development administration, and use” of covered countermeasures.358 This immunity applies to all covered persons as defined in the PREP Act, including any person authorized by state and local public health agencies (or an EUA) to “prescribe, administer, deliver, distribute or dispense” covered countermeasures.359 Covered countermeasures include “any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19.”360 The “administration” of a covered countermeasure includes “physical provision of the countermeasures” to patients, as well as “activities and decisions directly relating to . . . delivery, distribution and dispensing of” the countermeasures.361 The declaration provides PREP Act immunity “without geographic limitation” beginning on February 4, 2020, and ending as late as October 1, 2025.362 The HHS Declaration has been amended three times, each time broadening the scope of PREP Act immunity. First, on April 10, 2020, the Secretary amended the declaration to explicitly include NIOSH-approved respiratory protective devices as covered countermeasures pursuant to the CARES Act’s amendments to the PREP Act.363 Second, on June 4, 2020, the Secretary amended the declaration to clarify that drugs, biological products, and devices that “limit the harm COVID-19 . . . might otherwise cause” are covered countermeasures, and that the HHS Declaration reaches “all qualified pandemic and epidemic products defined under the PREP Act.”364 Third, on August 19, 2020, the Secretary expanded the definitions of covered diseases to reach not only COVID-19, but also “other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom,” including “the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.”365 The amendment thus declares that pediatric vaccines (if licensed by FDA and recommended by the Advisory Committee on Immunization Practices (ACIP)) are “covered countermeasures” and relies on the PREP Act’s preemption provisions to authorize state-licensed pharmacists to administer ACIP-recommended vaccines to children aged three to eighteen, notwithstanding state laws to the contrary.366 358 Id. 359 Id. at 15,201–02. 360 Id. at 15,202. 361 Id. 362 See id. 363 Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 21,012, 21,013–14 (Apr. 10, 2020). 364 Second Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 35,100, 35,101–02 (June 2, 2020). 365 Third Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 52,136, 52,141 (Aug. 19, 2020), 366 Id. at 52,139–40. Congressional Research Service 38

~~Legal Issues in COVID-19 Vaccine Development~~

~~Recent Congressional Actions on COVID-19 Countermeasures~~
~~Liability~~
~~Three recent congressional enactments in response to the COVID-19 pandemic, al now signed~~
~~into law, relate to the scope of immunity for individuals engaged in the COVID-19 response.~~
~~Section 6005 of the Families First Coronavirus Response Act274 and Section 3103 of the CARES~~
~~Act275 amend the PREP Act to clarify that certain “personal respiratory protective devices” (such~~
~~as N95 respirators) are covered countermeasures. To be covered by the PREP Act, the respiratory~~
~~protective device must be (i) approved by the National Institute for Occupational Safety and~~
~~Health (NIOSH) under 42 C.F.R. Part 84; and (ii) determined by the Secretary of HHS to be a~~
~~priority for use during a public health emergency.276~~
~~Section 3215 of the CARES Act contains an independent immunization from liability for~~
~~volunteer health care professionals responding to the COVID-19 pandemic. Under Section 3215,~~
~~licensed health care professionals are general y immune from state or federal liability for harm~~
~~they cause while providing health care services in response to the COVID-19 public health~~
~~emergency as a volunteer, if they act within the scope of their license and in good faith.277 There~~
~~are two exceptions to this immunity: (1) if the volunteer health care professional’s acts~~
~~constituted wil ful or criminal misconduct, gross negligence, reckless misconduct, or a conscious~~
~~flagrant indifference to the rights or safety of the individual harmed;278 or (2) if the volunteer~~
~~health care professional rendered health care services under the influence of drugs or alcohol.279~~
~~Section 3215 immunity may overlap with PREP Act immunity, or extend beyond it in some cases~~
~~(e.g., situations not involving a covered countermeasure).~~
~~Final y, both the CARES Act and CPRSA appropriate funding that HHS may use for the Covered~~
~~Countermeasure Process Fund, upon which CICP relies. CPRSA appropriates $3.1 bil ion to the~~
~~Secretary of HHS to respond to COVID-19, including the development and purchase of~~
~~countermeasures and vaccines, while al owing these funds to “be transferred to, and merged~~
~~with” the Covered Countermeasure Process Fund.280 The CARES Act appropriates $27 bil ion to~~
~~the Secretary of HHS for similar purposes, again providing that the Secretary may transfer these~~
~~funds to the Covered Countermeasure Process Fund.281~~

~~274 Pub. L. No. 116-127, § 6005, 134 Stat. 178, 207 (2020).~~
~~275 Pub. L. No. 116-136, § 3103 (2020).~~
~~276 42 U.S.C. § 247-6d(i)(1)(D). Prior to these amendments, FDA issued an EUA on March 2, 2020 for the use of~~
~~NIOSH-approved filtering respirators intended for general use in healthcare settings, and expressed its view that the~~
~~PREP Act covered these respirators prior to the amendment because of their medical use. See Letter from Denise M.~~
~~Hinton, Chief Scientist, FDA, to Robert R. Redfield, Director Centers for Disease Control and Prevention (March 28,~~
~~2020), https://www.fda.gov/media/135763/download.~~
~~277 Pub. L. No. 116-136, § 3215(a).~~
~~278 Id. § 3215(b)(1).~~
~~279 Id. § 3215(b)(2).~~
~~280 Pub. L. No. 116-123, tit. III, 134 Stat. 146, 149 (2020).~~
~~281 Pub. L. No. 116-136, tit. VIII.~~
~~Congressional Research Service~~
29

~~Legal Issues in COVID-19 Vaccine Development~~

~~Author Information~~

~~Kevin J. Hickey~~
~~Erin H. Ward~~
~~Legislative Attorney~~
~~Legislative Attorney~~

Legal Issues in COVID-19 Vaccine Development Author Information Kevin J. Hickey Erin H. Ward Legislative Attorney Legislative Attorney Wen W. Shen Legislative Attorney

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