Order Code RL33750
The WTO, Intellectual Property Rights, and the
Access to Medicines Controversy
Updated December 12, 2006
Ian F. Fergusson
Specialist in International Trade and Finance
Foreign Affairs, Defense, and Trade Division

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The WTO, Intellectual Property Rights, and the Access
to Medicines Controversy
Summary
In August 2003, the World Trade Organization (WTO) reached an agreement
on the use of compulsory licenses by developing countries without manufacturing
capacity to access life-sustaining medicines. This agreement was incorporated as an
amendment to Trade-Related Aspects of Intellectual Property Rights (TRIPS)
Agreement on the eve of the Hong Kong Ministerial in December 2005. The issue
of access to affordable medicines is one of great concern to developing countries
whose health-care systems are often overwhelmed by HIV/AIDS and other infectious
diseases. Some developing countries have viewed the TRIPS agreement as an
impediment in their attempts to combat such public health emergencies by restricting
drug availability and by transferring scarce resources from developing countries to
developed country manufacturers. For the developing world, the issue of compulsory
licenses is an important test as to whether the WTO can meet the development needs
of its members, and conversely, whether the developing world can influence the
actions of the world trading system.
Developed country pharmaceutical industries view the TRIPS agreement as
essential to encourage innovation in the pharmaceutical sector by assuring
international compensation for their intellectual property. Without such protection,
industry claims it could not recoup the high costs of developing new medicines.
Producers have unilaterally undertaken to reduce prices for certain HIV/AIDS
medicines, but these efforts at differential pricing have not been systematic. The
United States has been forceful in defending the interest of the U.S. pharmaceutical
industry in the negotiations. In December 2002, the United States blocked a
compromise on the compulsory licensing issue to which all other nations had agreed;
however, it was also the first nation to ratify the December 2005 amendment.
In the 109th Congress, legislation was introduced (S. 3175, Leahy) to establish
procedures to grant compulsory licenses for exporting patented pharmaceutical
products to certain countries under the WTO Decision. This legislation was not acted
upon in the 109th Congress, but it may be reintroduced in the 110th Congress.
The system of compulsory licensing may have a relatively modest effect on the
availability of medicines in the developing world. Compulsory licenses have rarely
been used by developing countries because many patent regimes did not protect
pharmaceuticals before 2006. Countries providing patent protection to
pharmaceuticals have used the threat of compulsory licensing as a method to
negotiate lower drug prices. Although some countries have amended their national
laws to allow compulsory licensing for pharmaceutical exports, there may be little
economic incentive for a supplier to manufacture the product in the case of an LDC
issuing a compulsory license.

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Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
The Doha Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Compulsory Licenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
The Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Disease Coverage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Eligible Countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Safeguards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Notifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
U.S. Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Policy Implications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

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The WTO, Intellectual Property Rights, and
the Access to Medicines Controversy
Introduction
In August 2003, the World Trade Organization (WTO) reached an agreement
on the use of compulsory licenses by developing countries without manufacturing
capacity to access life-sustaining medicines. This agreement was incorporated as an
amendment to Trade-Related Aspects of Intellectual Property Rights (TRIPS)
Agreement on the eve of the Hong Kong Ministerial in December 2005. The issue
of access to affordable medicines is one of great concern to developing countries
whose health-care systems are often overwhelmed by HIV/AIDS and other infectious
diseases. Some developing countries have viewed the TRIPS agreement as an
impediment in their attempts to combat such public health emergencies by restricting
drug availability and by transferring scarce resources from developing countries to
developed country manufacturers. For the developing world, the issue of compulsory
licenses is an important test as to whether the WTO can meet the development needs
of its members, and conversely, whether the developing world can influence the
actions of the world trading system.
Developed country pharmaceutical industries view the TRIPS agreement as
essential to encourage innovation in the pharmaceutical sector by assuring
international compensation for their intellectual property. Without such protection,
industry claims it could not recoup the high costs of developing new medicines.1
Producers have unilaterally undertaken to reduce prices for certain HIV/AIDS
medicines, but these efforts at differential pricing have not been systematic.2 The
United States has been forceful in defending the interest of the U.S. pharmaceutical
industry in the negotiations. In December 2002, the United States blocked a
compromise on the compulsory licensing issue to which all other nations had agreed;
however, it was also the first nation to ratify the December 2005 amendment. In the
109th Congress, legislation was introduced (S. 3175) to establish procedures to grant
compulsory licenses for exporting patented pharmaceutical products under the WTO
Decision. This legislation was not acted upon in the 109th Congress, but it may be
reintroduced in the 110th.
1 Pharmaceutical Research and Manufacturers of America, Intellectual Property website,
[http://www.phrma.org/issues/intprop].
2 Integrating Intellectual Property and Development Policy, UK Commission on Intellectual
Property (CIPR), September 2002, p. 41.

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Background
TRIPS is one of the Uruguay Round Agreements, which also created the WTO
in 1995. It sets minimum standards of protection for patents, copyrights, trademarks
and other forms of intellectual property based on three core commitments of the
WTO: minimum standards, national treatment, and most-favored-nation treatment.
Adherence to TRIPS is a prerequisite for membership of the WTO, and provisions
of the agreement can be enforced through the WTO’s Dispute Settlement
Understanding mechanism.3
The Doha Declaration

In agreeing to launch a new round of trade negotiations, trade ministers adopted
a “Declaration on the TRIPS Agreement and Public Health” on November 14, 2001.4
The Declaration sought to alleviate developing country dissatisfaction with the
TRIPS regime. It delayed the implementation of patent system provisions for
pharmaceutical products for least developed countries (LDCs) until 2016. The
declaration committed member states to interpret and implement the agreement to
support public health and to promote access to medicines for all. It also affirmed the
right of WTO members to use the flexibilities in the TRIPS agreement to promote
these goals. The declaration reiterated that each member has the right to grant
compulsory licenses and to determine the terms and circumstances in which they are
issued. Each country also has the right to determine what constitutes a national
emergency or circumstances of extreme urgency, defining these terms to include
public health crises such as “HIV/AIDS, malaria, and tuberculosis and other
epidemics.”
Compulsory Licenses. Paragraph 6 of the Declaration directed the WTO’s
Council on TRIPS to formulate a solution to the use of compulsory licensing by
countries with insufficient or inadequate manufacturing capability by December
2002. Compulsory licenses are issued by governments to authorize the use or
production of a patented item by a domestic party other than a patent holder. They
are authorized by Article 31 of TRIPS, which generally limits their issuance to cases
in which the government has made efforts to obtain authorization on reasonable
commercial terms or in a circumstance of extreme urgency or national emergency.
In addition, Article 31 limits the scope and duration of a compulsory license to
address the circumstances for which the license is authorized, grants the rights-
holder adequate remuneration for use of the patent covered by compulsory license,
and restricts production authorized by compulsory license predominantly to the
domestic market. It is this last provision that was the focus of the Paragraph 6
negotiations because it, in effect, conveys the right of compulsory licensing only to
countries with the capability to manufacture a given product.
3 The text and a summary of the TRIPS Agreement are available at the WTO website,
[http://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm].
4 Declaration on the TRIPS Agreement and Public Health, (WT/MIN(01)/DEC/2),
November 14, 2001, available at [http://www.wto.org/english/thewto_e/minist_e/min01_e/
mindecl_trips_e.htm].

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The Agreement
The Decision5 reached on August 30, 2003, adopted the text drafted by a
previous TRIPS Council Chairman Eduardo Perez Motta in 2002. That text
previously was approved by all WTO members save the United States, which
blocked its passage in December 2002 due to concerns of the U.S. pharmaceutical
industry about potential abuse of the system. The Decision did not amend the Motta
text, but added a chairman’s statement to clarify certain aspects of it. The Decision
provided for a waiver of Article 31(f) of the 1994 TRIPS agreement, the language
which stipulates that compulsory licenses are to be used predominantly for the supply
of the domestic market. The Decision waived 31(f) for exports of pharmaceutical
products to least developed countries (LDCs) and countries with insufficient
manufacturing capacity. The accompanying Chairman’s statement, which did not
have the status of a binding legal document, reflects what it terms “several key shared
understandings” of Members concerning the interpretation and implementation of
the agreement.
Disagreements persisted over how to permanently incorporate the Decision and
the Chairman’s statement into the TRIPS agreement until the eve of the Hong Kong
Ministerial in December 2005. On December 6, WTO members agreed to incorporate
the 2003 Decision as an amendment and an annex to TRIPS. The chairman’s
statement was reread, but it was not incorporated into the text of the agreement,
which was seen as a concession by the United States.6 The change would enter into
force after being ratified by two-thirds of the member states; the waiver will continue
in effect until the ratification period terminates in December 2007. As of November
2006, the protocol has been ratified by the United States, Switzerland, and El
Salvador.7
Disease Coverage. One key issue of the debate was disagreement on the
language defining a grave public health threat. The Decision allowed compulsory
licensing for medicines based on the scope of the language in the Doha ministerial
declaration: “HIV/AIDS, malaria, tuberculosis and other epidemics.” During the
December 2002 debate, developing countries accepted this wording as reflecting the
intent of the Doha Ministerial declaration, although they had sought even less
restrictive language. However, the U.S. considered this position too broad, and
countered with more restrictive language: “HIV/AIDS, malaria, tuberculosis or other
infectious epidemics of comparable gravity or scale, including those that may arise
5 Council for TRIPS, “Implementation of Paragraph 6 of the Doha Declaration on the
TRIPS Agreement and Public Health,” IP/C/W/405, August 30, 2003, and accompanying
Chairman’s statement available at [http://www.wto.org/english/news_e/pres03_e/
pr350_e.htm].
6 “Proposal for a Decision on an Amendment to the TRIPS Agreement,” IP/C/41, December
6, 2005. [http://www.wto.org/english/news_e/news05_e/trips_decision_e.doc]
7 Council for TRIPS, “Annual Review of the Decision on the Implementation of Paragraph
6 of the Doha Declaration on the TRIPS Agreement and Public Health,” IP/C/42, November
2, 2006. Available at [http://docsonline.wto.org].

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in the future.”8 This language was too restrictive for the developing countries, and
debate over this language subsequently caused the United States to reject the Motta
text. Developing countries were adamant that the language in the Ministerial
Declaration on the scope of diseases should form the basis for the agreement, and this
position eventually prevailed. During negotiations in the spring and summer of 2003,
the U.S. position seemingly shifted from limiting the scope of diseases to restricting
country eligibility.9
Eligible Countries. The scope of developing country eligibility to use the
compulsory license mechanism also proved controversial in the negotiations. The
term ‘developing country’ in the WTO runs the gamut from the poorest, least
developed countries to middle-income countries like South Korea and Brazil who
have their own manufacturing capacity. As stated above, TRIPS grants each nation
the ability to assign compulsory licenses to their domestic manufacturers. However,
there is a broad range of technical sophistication among the pharmaceutical industries
of the developing countries. A country that can make aspirin may not be able to
reengineer or reformulate sophisticated drugs in order to utilize the existing
compulsory license language of the agreement. The question became whether a
country that has some manufacturing capability, but not necessarily a specialized
expertise, would be able to use a Paragraph 6 mechanism to issue a compulsory
license to a more sophisticated industry in another country to produce a medicine.
The Decision set out certain criteria for determining whether a country lacks
domestic manufacturing capacity, but essentially countries would self-declare their
eligibility by notification to the TRIPS council. This position reflected the rejection
by developing countries of any restrictions on their ability to self-determine
eligibility. The Decision clarified that eligibility notification would include
information on the manner in which a country determined it had no manufacturing
capability. However, no formal reviewing mechanism to assess the self-
determination of eligibility by developing countries, as the United States proposed,
was incorporated into the statement.10 The Chairman’s statement also contained
language that the system not be used as an instrument to pursue industrial or
commercial policy objectives. This statement reflects industry concerns that the
system could serve to aid the expansion of generic pharmaceutical industries in
developing nations.
In addition, several groups also indicated they would not avail themselves of the
new compulsory license system. The Decision referred to 23 developed countries that
would refrain from using the system as an importer. The chairman’s statement
reported that the 10 nations joining the European Union in 2004 would also opt out
of using the mechanism as importers from the date of their accession. Until that time,
they pledged to use the mechanism only “in situations of national emergency or other
8 “U.S. Sticks to Hard Line on TRIPS, as Supachai Tries to Broker Deal,” Inside U.S. Trade,
December 20, 2002.
9 “U.S. Government, Industry Wrestle with New Approach to TRIPS and Health,” Inside
U.S. Trade, June 27, 2003.
10 “U.S. Pushes for System to Review TRIPS Compulsory License Requests,” Inside U.S.
Trade, August 8, 2003.

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circumstances of extreme urgency.” In addition, several other nations announced that
they would only use the system as importers under this same formulation including
Hong Kong, Israel, Korea, Kuwait, Macao China, Mexico, Qatar, Singapore, Taiwan,
Turkey, and the United Arab Emirates. This list reflected U.S. efforts in the
negotiations to seek to persuade more advanced developing countries to refrain from
using the waiver.11
Safeguards. Another concern was the issue of the use of safeguards to
prevent diversion of these generically manufactured drugs from poor developed
countries to developed country markets. The Decision called for the drugs to be
specially marketed or packaged with identifiable characteristics, such as
distinguishable colors or shapes “provided that such distinction is feasible and does
not have a significant impact on price.”12 It also declared that importing countries
should take measures “within their means” to prevent trade diversion.13
The Chairman’s statement reaffirmed the importance of protecting the system
from diversion of pharmaceuticals to rich country markets. It clarified that
specialized marking and characteristics should apply to active ingredients and final
products, not just to formulated pharmaceuticals. It also adopted a U.S. suggestion
explicitly to state that using special packaging or distinguishing characteristics is
feasible and would not affect drug prices.14 The statement listed several best
practices for protecting against diversion in an annex. However, the statement did not
incorporate a U.S. proposal to limit distribution of these generic drugs to
humanitarian public health programs, either run by the government or by charitable
organizations.15
Notifications. The Decision also set forth certain notification requirements.
An eligible importing member, other than a least developed member, must notify the
WTO that it intends to use the system to import medicines under compulsory license.
For each instance, the importing country must disclose the name and expected
quantities of the medicine sought, affirm that it has insufficient manufacturing
capability to produce the medicine itself, and provide confirmation that it has granted
a compulsory license to obtain the medicine from a third-country manufacturer.
Conversely, an exporting country must provide information on the conditions
attached to the compulsory license it approves, the name and address of the licensee,
the products involved, the quantities produced, the designated import countries, and
the duration of the license. The WTO has set up a website in order to track
11 “WTO Chair Menon Pushes to Finalize Agreement on TRIPS- Essential Drugs,”
International Trade Reporter, August 21, 2003.
12 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and
Public Health, Note from the Chairman, Paragraph 2(b)(ii), December 16, 2002.
13 Ibid., Paragraph 4.
14 Inside U.S. Trade, August 22, 2003.
15 Inside U.S. Trade, August 1, 2003; “U.S. Sets New Condition for TRIPS Deal While
Showing Flexibility,” Inside U.S. Trade, August 22, 2003.

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notifications of the system’s use. To date, no country has notified the WTO of its
intention to use the system either as an importer or an exporter.16
U.S. Legislation
In the 109th Congress, the Life-Savings Medicines Export Act of 2006 (Leahy,
S. 3175) was introduced to establish procedures to grant compulsory licenses for
exporting patented pharmaceutical products to certain countries under the WTO
Decision. This legislation was not acted upon in the 109th Congress, but it may be
reintroduced in the 110th Congress.
The legislation would have authorized the Director of the U.S. Patent and
Trademark Office (PTO) to issue compulsory licenses for the export of generic
pharmaceuticals to least developed countries and other developing countries without
sufficient manufacturing capability. The legislation explicitly would have permitted
using non-governmental organizations to assist in distributing the medicines to the
eligible country. It stipulated the content for license applications, established an
office within PTO to assist applicants in filing applications, and placed certain
conditions on the granted license. Among the latter, the legislation specified that the
licensed product be distinguishable from product manufactured by the patent holder
in terms of size, shape, color, packaging or other distinguishing characteristics to
prevent reexportation of the product.
The normal term for the compulsory license under the bill was set at seven
years, and the bill provided for renewal under certain conditions. The Director would
have determined the royalty payment by using a formula provided by the bill and by
taking into account certain enumerated considerations. The legislation provided for
expedited approval of license applications for emergency situations. It also would
have established a national advisory board to provide advice and guidance on the
implementation of the compulsory licensing program and authorized appropriations
for this entity.
Policy Implications
The issuance of compulsory licenses has been advanced as a way for developing
countries without domestic manufacturing capability to obtain affordable medicines
to treat their populations afflicted with HIV/AIDS and other epidemics. However,
a system of compulsory licensing may have a relatively modest effect on the
availability of medicines in the developing world. According to then-EU trade
negotiator Pascal Lamy, “we have solved about 10% of the problem of access to
medicines by developing countries” by the WTO’s action. He cited other issues such
as inadequate distribution systems for medicines in poor countries and the lack of
16 “TRIPS and Public Health: Dedicated Webpage for Notifications,” [http://www.wto.org/
english/tratop_e/trips_e/public_health_e.htm]

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trained personnel to administer the drugs as factors that could hinder the
effectiveness of the new policy.17
Compulsory licenses have rarely been used by developing countries. This
situation can be attributed to lack of patent protection in many countries. Developing
countries were not required to enforce a TRIPS compliant patent system before 2005,
and the compliance date for LDCs was extended until 2016 by the Doha Ministerial
Declaration. However, some developing countries do have patent regimes that cover
some pharmaceuticals. In these countries, the threat of compulsory licensing can be
used to negotiate better prices from developed-world pharmaceutical manufacturers.
Brazil, a country with a relatively sophisticated pharmaceutical industry with the
ability to reverse engineer and innovate new drugs, has threatened to use compulsory
licensing to manufacture generic HIV/AIDS drugs domestically to extract price
concessions from patent-holders, which it did most recently in 2005.18
Subsequent to the Decision, several nations announced that they will use this
mechanism. In Brazil, a presidential decree issued September 5, 2003, granted the
government the authority to import generic medicines without the consent of the
patent holder in cases of national emergency or public interest. Mozambique,
Zambia, Indonesia, and Malaysia announced the granting of compulsory licenses for
AIDS drugs; however, they did not do so under the aegis of the WTO system.19
In addition, several countries are considering legislation to provide patent
waivers to allow their generic pharmaceutical companies to manufacture drugs for
compulsory license under the WTO system. Canada, Norway, and India have passed
legislation amending their patent laws and the European Union has adopted
regulations to this effect in June 2006. Switzerland, France, and Korea have also
proposed regulations or legislation to comply with the agreement.
There may be little economic incentive for a supplier to manufacture the product
in the case of an LDC issuing a compulsory license. Under the Decision, a
developing country with no manufacturing capability may use a compulsory license
to obtain a product for a generic manufacturer in another country. However, the
generic manufacturer in the second country may have no incentive to do so,
especially in limited quantities to poor countries. In addition, under many of the
proposals the product would have to use special packaging or distinctive shapes to
avoid diversion. Under such restrictions, it is not certain that a generic producer
would undertake the development and formulation costs for such a limited market.20
Thus, even though a compulsory license may be issued, the drugs may never be
manufactured.
17 “WTO Drug Pact Lifts Trade Talks,” Wall Street Journal, September 2, 2003.
18 “Brazil Steps Up Pressure on U.S. Companies Over AIDS Drug Prices,” FDA Week,
September 2, 2005.
19 “Brazil to Issue Compulsory License on U.S. AIDS Drugs,” Inside U.S. Trade, July 1,
2005.
20 CIPR, pp. 45-46.

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According to some non-governmental organizations and AIDS activists, this is
precisely the result being sought by patent-holders. One activist claimed that
restrictions, such as special packaging and notification requirements, create “a
watertight system so that no generic drugs ever get through to the patients in
developing countries who desperately need them.”21 However, U.S. officials have
contended that these restrictions preventing diversion serve the interest of recipient
nations by providing additional safeguards that the medicines will be used by the
intended recipients.22
21 Medecins Sans Frontieres News Release, August 25, 2003. available at
[http://www.msf.org/content/page.cfm?articleid=E05CFA2B-B49D-4CED-8EA32C8A0
588D147].
22 Press Conference by Ambassador Peter Allgeier, Geneva, June 20, 2003.

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