© EJIL 2004

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The Road to Doha and Beyond:
Some Reflections on the TRIPS
Agreement and Public Health
Haochen Sun*

Abstract
Designed to respond to concerns about the negative impact of the TRIPS Agreement on access
to medicines, the Declaration on the TRIPS Agreement and Public Health (Doha
Declaration), adopted at the Doha Ministerial Conference, explicitly clarified for the first time
what flexibilities inherent in the TRIPS Agreement can be used by WTO Members to combat
a public health crisis. Nevertheless, the Doha Declaration did not fully dismantle the obstacles
created by the TRIPS Agreement. Even after the most recent agreement on access to generic
medicines in poor countries, serious differences of interpretation and implementation
difficulties under the TRIPS Agreement are likely to persist. This article explores the global
debate on the TRIPS Agreement and public health, as it has evolved over the years.
Specifically, it focuses on the implications, and limitations, of the Doha Declaration. It is
argued that the TRIPS Agreement should be implemented and interpreted so as to allow WTO
Members the maximum flexibility in increasing access to essential medicines for all.

Introduction
As evidenced first by the failure of its third Ministerial Meeting in Seattle in December
1999 and, more recently, by a similar failure at Cancun in September 2003, the
World Trade Organization (WTO) faces a severe legitimacy crisis. 1 At stake is the
ability of the organization to meet the needs of all of its 148 members, in spite of wildly
disparate levels of development. Critics charge that trade rules are rigged in favour of
rich countries and point to huge human costs in poor countries as a result of unfair
trade rules. High on the critics’ list is the Agreement on Trade-Related Aspects of

* LLM Candidate, Faculty of Law, National University of Singapore.

1
See, e.g., Esty, ‘The World Trade Organization’s Legitimacy Crisis’, 1 World Trade Review (2002) 7;
Howse, ‘The Legitimacy of the World Trade Organization’, in J. Coicaud and V. Heiskanen (eds), The
Legitimacy of International Organizations (2001) 355.
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EJIL (2004), Vol. 15 No. 1, 123–150
124 EJIL 15 (2004), 123–150

Intellectual Property Rights (TRIPS Agreement),2 which has come to be viewed as

perhaps the most controversial WTO agreement of all. On a general level, it is widely
blamed for its failure to fully take into account the complex links between intellectual
property protection and development. An increasing number of experts question its
one-size-fits-all approach and take the view that different levels of development call for
different levels of intellectual property protection.3 In addition, the Agreement has
come under attack for severely curtailing the availability of inexpensive copies of
patented medicines, raising the price of new medicines in developing countries as a
result of patent monopolies, and diminishing public access to essential medicines as a
consequence. Most dramatically, the cost of patented drugs has been a significant
obstacle to increasing the availability of AIDS treatment in the developing world. In
Africa, in particular, millions of people have died due to lack of access to affordable
treatment.4 This has led to an unprecedented public outcry against the WTO, and has
done much to de-legitimize the organization in the eyes of the general public.5
While agricultural subsidies may recently have displaced drug patent rules as the
most talked-about issue in the WTO today, it is submitted that the debate on the TRIPS

2
Agreement on Trade-Related Aspects of Intellectual Property Rights, 33 ILM (1994) 81. The TRIPS
Agreement is part of the Uruguay Round of trade agreements establishing the World Trade Organization
(WTO), the successor to the General Agreement on Tariffs and Trade (GATT). It was signed in Marrakech
on 15 April 1994 and entered into force on 1 January 1995. Its stated objective is to reduce distortions
and impediments to international trade by outlining a framework for minimum intellectual property
standards, including remedies for enforcement, which binds all WTO Members. The Agreement covers all
aspects of intellectual property, including literary and artistic property (copyrights), and industrial
property (trademarks, patents, geographical indications, industrial designs and trade secrets), and
incorporates by reference some of the basic provisions of international agreements already in force, such
as the Paris Convention for the Protection of Intellectual Property, the Berne Convention for the
Protection of Literary and Artistic Works, the Rome Convention for the Protection of Performers,
Producers of Phonograms and Broadcasting Organizations, and the Treaty on Intellectual Property in
Respect of Integrated Circuits. All four agreements continue to coexist with the TRIPS Agreement and are
administered by the World Intellectual Property Organization (WIPO), founded in 1967. One of the main
features of the TRIPS Agreement is that it binds all WTO Members to grant minimum periods of
protection for the various IP rights it covers (20 years for patents; seven years, renewable, for trademarks;
life of the author plus 50 years for copyrights). In particular, it requires Member states to provide 20-year
patent protection in all fields of technology, which implicitly includes pharmaceuticals. Prior to the
launching of the negotiations for the TRIPS Agreement, countries had various approaches to drug
patents, suited to their domestic public health policies and needs. Over 40 countries, including
middle-income countries such as Brazil and Argentina, and seven developed countries, provided no
product patent protections for medicines, and some 20 WTO members still did not do so by the time of the
conclusion of the negotiations.
3
See e.g. Report of the UK Commission on Intellectual Property Rights (dated September 2002), available
at www.iprcommision.org.
4
See Table in Section 1.
5
See Lazzarini, ‘Making Access to Pharmaceuticals a Reality: Legal Options Under TRIPS and the Case of
Brazil’, 6 Yale Human Rights & Development Law Journal (2003) 103; Sun, ‘A Wider Access to Patented
Drugs Under the TRIPS Agreement’, 21 Boston University of International Law Journal (2003) 101;
Abbott, ‘The TRIPS Agreement, Access to Medicines, and the WTO Doha Ministerial Conference’, 5
Journal of World Intellectual Property (2002) 15.
 The Road to Doha and Beyond 125

Agreement and public health is far from closed. Even after the most recent agreement6
on access to generic medicines in poor countries, serious differences of interpretation
and implementation difficulties under the TRIPS Agreement are likely to persist.7 In
this author’s opinion, implementing and interpreting the TRIPS Agreement in a
manner conducive to public health remains key to re-establishing WTO’s legitimacy.
This article explores the global debate on the TRIPS Agreement and public health,
as it has evolved over the years. Specifically, it focuses on the implications, and
limitations, of the Doha Declaration. Designed to respond to concerns about the
negative impact of the TRIPS Agreement on access to medicines, the Declaration on
the TRIPS Agreement and Public Health (Doha Declaration),8 adopted at the Doha
Ministerial Conference, explicitly clarified for the first time what flexibilities inherent
in the TRIPS Agreement can be used by Members to combat a public health crisis. It
was rightly viewed as a step in the right direction for the WTO. Nevertheless, the Doha
Declaration did not fully dismantle the obstacles created by the TRIPS Agreement.
Instead, there are still significant legal and economic barriers to the implementation of
policies that will actually result in the availability of reasonably priced medicines. This
paper argues that the TRIPS Agreement should be implemented and interpreted so as
to allow WTO members the maximum flexibility in increasing access to essential
medicines for all. The first section analyses the context of the Doha Declaration and
outlines the important events leading to the Declaration. Section 2 offers a detailed
analysis of the main provisions of the Doha Declaration. Section 3 reviews the
post-Doha negotiations on the TRIPS Agreement and public health.

1 The Road to Doha

A Global Epidemic Crises
In many regions, the health situation has sharply deteriorated in recent years,
primarily because of the devastating impact of the HIV/AIDS pandemic. According to
the Joint United Nations Programme on HIV/AIDS (UNAIDS) statistics, the HIV/AIDS
pandemic, in only 20 years, has caused untold suffering and death worldwide,
destroying entire communities, reversing development gains, and posing a serious
threat to whole continents.9 Dozens of countries are already in the grip of serious
HIV/AIDS epidemics, and many more are on the brink.10 Worldwide, more than 65

6
Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health,
Decision of 30 August 2003, WT/L/540 (see discussion infra Section 3).
7
See Abbott, ‘Trade Diplomacy, the Rule of Law and the Problem of Asymmetric Risks in TRIPS’, Quaker
UN Office Occasional Paper no. 13 (September 2003), available at www.quno.org.
8
Declaration on the TRIPS Agreement and Public Health, WTO Ministerial Conference, Fourth Session,
Doha, Adopted on 14 November 2001, WT/MIN(01)/DEC/2.
9
See generally, UNAIDS, Twenty Years of HIV/AIDS, www.unaids.org/UNGASS/index.html. A new report
concludes that, in 2002 alone, the AIDS epidemic claimed more than 3 million lives, and an estimated 5
million people acquired HIV, bringing to 42 million the number of people globally living with the virus.
See UNAIDS, ADIS Epidemic Updates: December 2002, at 2–3.
10
See UNAIDS, Report on Global HIV/AIDS Epidemic 2002, at 22–41.
126 EJIL 15 (2004), 123–150

million persons have been infected with the immunodeficiency virus (HIV) since the
epidemic began. In all, AIDS has claimed more than 25 million lives and orphaned
more than 14 million children throughout the world. In addition, two other major
infectious diseases, tuberculosis and malaria, are on the rise. According to the World
Health Organization (WHO), two million people die from tuberculosis every year,
while malaria causes 3,000 deaths a day, primarily among children. 11 Taken
together, these three epidemics account for 500 million or more illnesses, and a
staggering 6 million deaths each year.12 By way of illustration, the following table
provides statistical evidence of the stunning burden, in terms of deaths and
disability-adjusted life years (DALYs)13, from these three diseases, from 1999 to 2001.

Table 1
Deaths and DALYs caused by three major diseases, estimates for 1999–2001
(000s)
World Africa The Americas South-East Asia
Disease Deaths DALYs Deaths DALYs Deaths DALYs Deaths DALYs
HIV/AIDS 8482 268240 6743 214560 241 7942 1176 33951
TB 4973 132569 1074 27450 162 2079 2260 45016
Malaria 3290 127491 2882 94845 5 295 215 8625
Sources:
WHO, The World Health Report 2000 Health Systems: Improving Performance, Annex 2 and 3.
WHO, The World Health Report 2001 Mental Health: New Understanding, New Hope, Annex 2 and 3.
WHO, The World Health Report 2002 Reducing Risks, Promoting Health Life, Annex 2 and 3.

As the table shows, these three diseases affect different continents and different
countries unevenly, with the heaviest burden falling on poor regions. This is
particularly true of malaria, which was eliminated from Europe, North America and
much of the Middle East by 1970. It is also true of HIV/AIDS and TB. Although
HIV/AIDS represents a global health crisis, sub-Saharan Africa is by far the most
severely afflicted region.14 In parts of southern Africa, two in five adults are now
infected. Average life expectancy in the region is now 47 years, while it would have

11
See WHO, Fact Sheets: Tuberculosis, No. 104, available at http://www.who.int/mediacentre/factsheets/
who104/en/; Fact Sheets: Malaria, www.who.int/inf-fs/en/fact094.html.
12
WHO, Coordinates 2002, Charting Progress against AIDS, TB and Malaria (2002), at 1.
13
Disability-adjusted life years (DALY) along with healthy life expectancy (HALE) are summary measures
of population health. It is a measure that considers the burden of a disease to a population in terms of
years of lost life, adjusted for the effect on health to those living with the disease. One DALY can be
thought of as one lost year of ‘healthy’ life and the burden of disease as a measurement of the gap between
the current health of a population and an ideal situation where everyone in the population lives to old age
in full health. See WHO, The World Health Report 2002 Reducing Risks, Promoting Healthy Life (2003)
Annex Notes.
14
Nearly three-quarters of persons living with HIV/AIDS are in sub-Saharan Africa. Of 3 million people
who died of AIDS in 2000, 2.4 million were in sub-Saharan Africa. See WHO Commission on
Macroeconomics and Health, Macroeconomics Health: Investing in Health for Economic Development (2001),
at 48–49.
 The Road to Doha and Beyond 127

been 62 years without AIDS.15 After sub-Saharan Africa, the Caribbean is the next
hardest-hit region as measured by HIV/AIDS prevalence.16 The Eastern European
region continues to experience the fastest-growing HIV/AIDS epidemic in the world,
with a 1,300 per cent increase in prevalence over the last five years.17 In Asia and the
Pacific, despite well-documented and successful HIV prevention programmes, the
HIV/AIDS epidemic continues to spread quickly.18 In contrast, in most of the
industrialized world, and in some countries in Latin America, the number of AIDS
deaths is now declining, thanks to access to anti-retroviral treatment.19

B Access to Essential Medicines

Although much has been achieved during the last five decades and the number of
people with access to essential drugs20 has doubled in the last 20 years, many millions
of people still cannot get affordable access to essential medicines and vaccines. The
World Health Organization estimates that one-third of the world’s population still
lacks such access, with this figure surpassing 50 per cent in parts of Asia and Africa.21
With regard to the highly expensive treatments, such as anti-retroviral therapy for
HIV/AIDS, the statistics are much worse. It is estimated that fewer than 5 per cent of
people in the developing world in need of anti-retroviral treatment receive it. In
sub-Saharan Africa, the figure is only 1 per cent.22

C The Role of International Organizations and Non-governmental

Organizations
1 WIPO and OHCHR Panel Discussion on Intellectual Property and Human Rights
On 9 November 1998, the World Intellectual Property Organization (WIPO), in
collaboration with the Office of the United Nations High Commissioner for Human
Rights (OHCHR), held a Panel Discussion on ‘Intellectual Property and Human
Rights’ to mark the fiftieth anniversary of the Universal Declaration of Human Rights
(UDHR). The objective of the panel was to highlight the universality of intellectual

15
UNAIDS, supra note 10 at 44.
16
See UNAIDS, HIV/AIDS: Key Facts, www.globalfundatm.org/journalists/fsheets/hiv&aids.htm.
17
In 2001, there were an estimated 250,000 new infections, bringing to 1 million the number of people
living with HIV/AIDS in Eastern Europe. See UNAIDS, supra note 10, at 32–33.
18
See ibid., at 28–30. See also, UNAIDS, AIDS Epidemic Updates: December 2002, at 7–9. See also Eberstadt,
‘The Future of AIDS’, Foreign Affairs (Nov./Dec. 2002) 22.
19
See WHO, supra note 12, at 4.
20
Essential medicines, as defined by WHO, are drugs that satisfy the priority health care needs of the
population. They are selected with due regard to public health relevance, evidence of efficacy and safety,
and comparable cost-effectiveness. Essential medicines are intended to be available within the context of
functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with
assured quality and adequate information, and at a price the individual and the community can afford.
The implementation of the concept of essential medicine is intended to be flexible and adaptable to many
different situations: exactly which medicines are regarded as essential remains a national responsibility.
21
See WHO, WHO Medicines Strategy: 2000–2003 (December 2000).
22
See WHO, supra note 12, at 1.
128 EJIL 15 (2004), 123–150

property and its role in social, economic and cultural development. 23 During the
discussion, the participants expressed their respective views on the role of intellectual
property in development and related policy areas. Sharing the view that it is possible to
afford universal access to intellectual property rights, the specialists analysed ways of
building up the linkages between the protection of intellectual property and the
promotion of human rights.24 The panel paid special attention to the complex and
controversial relations between intellectual property and the right to health,
including the pros and cons of drug patenting.25
2 UN Sub-Commission on Human Rights
In August 2000, the UN Sub-Commission on Human Rights adopted Resolution
2000/7 on ‘Intellectual Property Rights and Human Rights’.26 The Sub-Commission
concluded that the implementation of the TRIPS Agreement could affect the
enjoyment of human rights, including the right of all to enjoy the benefits of scientific
progress and its applications, the right to health, the right to food and the right of
self-determination. As a follow-up to the resolution, two reports focusing on
approaches to the Agreement that ensure the promotion and protection of human
rights, in particular the right to health, were submitted to the Sub-Commission.27 In
August 2001, the Sub-Commission adopted another resolution on ‘Intellectual
Property Rights and Human Rights’, urging all governments to take fully into account
existing state obligations under international human rights instruments in the
formulation of proposals for the ongoing review of the TRIPS Agreement.28
3 WHO and WHO Workshop on Affordable Drugs
On 8–11 April 2001, WHO and WTO jointly held a workshop in Norway on affordable
drugs, bringing together for the first time all major interest groups concerned with the

23
See WIPO, ‘Intellectual Property and Human Rights: WIPO and the UN High Commissioner for Human
Rights Hold a Panel Discussion to Highlight Common Ground’, Press Release PR/98/143, Geneva, 20
October 1998.
24
The main Panel contributions include: Drahos, ‘The Universality of Intellectual Property: Origins and
Development’; Steiner, ‘Intellectual Property and the Right to Culture’; Salazar, ‘Intellectual Property
and the Right to Health’; Mugabe, ‘Intellectual Property Protection and Traditional Knowledge’;
Chapman, ‘A Human Rights Perspective on Intellectual Property, Scientific Progress, and Access to the
Benefits of Science’; von Lewinski, ‘Intellectual Property, Nationality and Non-Discrimination’. All these
papers may be found at http://www.wipo.org/globalissues/activities/1998/humanrights/program/
index.html.
25
See one of the discussion papers, Salazar, supra note 24.
26
UN Commission on Human Rights, Sub-Commission for the Promotion and Protection of Human Rights,
Intellectual Property and Human Rights, 2000, E/CN/.4/Sub.2/2000/7.
27
UN Commission on Human Rights, Sub-Commission for the Promotion and Protection of Human Rights,
The Impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights on Human Rights,
Report of the High Commissioner, 27 June 2001, E/CN.4/Sub.2/2001/13. UN Commission on Human
Rights, Globalization and Its Impact on the Full Enjoyment of Human Rights, Progress report submitted by J.
Oloka-Onyango and Deepika Udagama, in accordance with Sub-Commission Resolution 1999/8 and
Commission on Human Rights Decision 2000/102, 2 August 2001, E/CN.4/Sub.2/2001/10.
28
UN Commission on Human Rights, Sub-Commission for the Promotion and Protection of Human Rights,
Intellectual Property and Human Rights, 2000, E/CN/.4/Sub.2/2001/21.
 The Road to Doha and Beyond 129

financing and pricing of essential drugs.29 The experts explored the complex questions
involved in ensuring access to essential drugs at affordable prices, securing adequate
financing for this purpose, and also providing incentives for research and develop-
ment (R&D) into new drugs. Specifically, the workshop focused on two important
topics: the practice of differential pricing (whereby prices are adapted by the seller to
the different purchasing powers in different countries) and the role of financing
(through increased domestic resource mobilization as well as increased aid flows) in
ensuring access to essential drugs.30
4 The 54th World Health Assembly
On 14–22 May 2001, the World Health Assembly (WHA), which is the annual
meeting of the 191 Member states of the WHO, took place in Geneva. The Assembly
sought various ways to strengthen global health systems and strategies to combat
HIV/AIDS, including access to essential drugs. Recognizing the unprecedented scale
of the HIV/AIDS crisis, the Assembly adopted Resolution WHA 10, Scaling Up the
Response to HIV/AIDS, urging Member states to make every effort to provide the
highest standard of treatment for HIV/AIDS progressively and in a sustainable
manner.31 Additionally, in the following Resolution, WHO Medicines Strategy, states
were urged to cooperate constructively in strengthening pharmaceutical policies and
practices, including those applicable to generic drugs and intellectual property
regimes, in order further to promote innovation and the development of domestic
industries, consistent with applicable international law.32
5 United Nations Special Session on HIV/AIDS
On 25–27 June 2001, Heads of State and Representatives of Governments met at the
United Nations General Assembly Special Session (UNGASS)33 dedicated to HIV/AIDS
and issued a Declaration of Commitment on HIV/AIDS.34 The Declaration is not a
legally binding document. However, it is a clear statement by governments on what
they have agreed should be done to fight against the HIV/AIDS epidemic and the
commitments they have given, often with specific deadlines. Therefore, the Declar-
ation is a powerful instrument with which to guide and secure action, commitment,
support and resources for all those fighting the epidemic, both on the national and
global levels. The UNGASS provided people with ‘an occasion as never before to face
up to our responsibility to future generations, and take decisive action now to turn
29
For various aspects of this workshp, all the presentations, background papers and final reports are
available at http://www.wtp.org/english/tratop e/trips e/tn hosbjor e.htm.
30
See in general, Report of the Workshop on Differential Pricing and Financing of Essential Drugs, prepared by
the WHO and WTO Secretariats.
31
See The 54th World Health Assembly, Agenda item 13.6, Scaling Up the Response to HIV/AIDS,
WHA54.10, 21 May 2001.
32
See The 54th World Health Assembly, Agenda item 13.8, WHO Medicines Strategies, WHA54.11, 21 May
2001.
33
Relevant information about this session is available at http://www.un.org/ga/aids/coverage/
index.html.
34
United Nations General Assembly, Declaration of Commitment on HIV/AIDS, A/RES/S-26/2, 27 June
2001.
130 EJIL 15 (2004), 123–150

back the progress of this terrible disease’,35 while indicating that the HIV/AIDS
epidemic is a ‘“global crisis” requiring global action’. In addition, a Global Fund was
launched by UN Secretary-General Kofi Annan to raise $7–10 billion a year to fight
against the ravages of HIV/AIDS.

6 Civil Society
Starting as early as 1998, a number of influential non-governmental organizations
(NGO), such as Médecins Sans Frontières (MSF), Oxfam, CpTech, Health Action
International and Third World Network (TWN), expressed concern that the
implementation of the TRIPS Agreement could be detrimental to the protection of
public health in poor countries. They soon joined forces and launched ambitious and
effective campaigns in which they voiced their objections to the TRIPS Agreement.36
Their principal arguments may be summarized as follows. First, strengthened drug
patent protection in developing countries will likely result in higher drug prices,
especially for new medicines.37 Even if one accepts the assumption that strengthened
patent protection under the TRIPS Agreement should induce greater scientific and
technological development, and lead to an increase in the number of new, innovative
drugs, the cost of these new, patented drugs will likely be too high for poor people in
developing countries. Secondly, pharmaceutical patent protection under the TRIPS
Agreement will not necessarily make a significant contribution to increasing R&D
expenditure by the private sector for the treatment of diseases, such as malaria, which
plague developing countries but have little incidence in rich countries.38 Given the low
purchasing power and uncertain profit prospects prevalent in poor countries, a strong
patent protection system, in and of itself, is unlikely to provide sufficient incentives for
the pharmaceutical industry to invest in R&D for drugs which have no lucrative
markets. Additional measures of support (such as increased international financing)
for such R&D would be needed.39
Finally, a major problem, well recognized and emphasized in NGO campaigns is that
developing countries are under pressure from both developed countries and the
pharmaceutical industry to implement patent protection that is stricter than the
obligations of the TRIPS Agreement40 under bilateral and regional agreements
commonly referred to as ‘TRIPS plus’ agreements. Examples of ‘TRIPS plus’

35
Remark by UN Secretary-General Kofi Annan, available at www.un.org/ga/aids/background.htm.
36
For a comprehensive description of the role of civil society in the debate on TRIPS and public health, see
S. K. Sell, Private Power, Public Law: The Globalization Of Intellectual Property Rights (2003).
37
See Oxfam Briefing Paper, ‘Patent Injustice: How World Trade Rules Threaten the Health of Poor People’
(February 2001); Oxfam GB Policy Paper, ‘Fatal Side Effects: Medicine Patents under the Microscope’
(February 2001).
38
See Médecins Sans Frontières (MSF), Fatal Imbalance: The Crisis in Research and Development for Drugs for
Neglected Diseases (2001).
39
See ibid.
40
See Drahos, ‘Bits and Bips — Bilateralism in Intellectual Property’, 4 Journal of World Intellectual Property
(2001) 791. This paper was commissioned by Oxfam GB as part of its Cut the Cost of Medicines
Campaign.
 The Road to Doha and Beyond 131

obligations include extending patent life beyond the 20-year TRIPS minimum,
limiting compulsory licensing in ways not required by TRIPS, or limiting exceptions
which facilitate the prompt import of generics in developing countries.

D Two Cases Regarding TRIPS and Public Health

1 The South African Medicines Act Litigation
In the midst of a catastrophic HIV/AIDS epidemic, in November 1997, the South
African Government introduced the Medicines and Related Substances Control
Amendment Act in order to promote the availability of affordable HIV/AIDS-related
drugs via parallel imports and compulsory licensing under the TRIPS Agreement.41
The goal of this amendment was to implement key elements of the South African
national drug policies, including generic substitution, greater competition in public
drug procurement, improved drug quality, and more rational use of medicines.
Shortly thereafter, a number of pharmaceutical companies lodged protests against the
Amendment Act. In February 1998, 39 drug companies submitted a formal
complaint to the Pretoria High Court in South Africa, challenging the consti-
tutionality of the Act, including its compatibility with the TRIPS Agreement. In
addition, at the request of the US pharmaceutical industry, the US Trade Representa-
tive placed South Africa on its ‘Section 301 Watch List’42 and the US administration
tentatively withheld preferential treatment for several South African exports. It is only
thanks to the activism of NGOs that the situation was reversed. Public outrage,
particularly at the Seattle WTO Ministerial, was such that the US had to change its
policies. In May 2000, President Clinton issued an executive order to promote access
to HIV/AIDS medicines,43 and the five largest pharmaceutical companies signed an
agreement with the United Nations to cut the price of HIV/AIDS drugs by up to 80 per
cent for poor countries (the ‘Accelerating Access’ Initiative)44. Thanks to a well-
organized grassroots campaign, the legal action turned into a public relations
disaster for the drug companies, and the suit was finally withdrawn in April 2001.45
The successful resolution of this case had a number of far-reaching implications.

41
The amendment provided for the: (1) generic substitution of off-patent medicines and medicines imported
and produced under compulsory licences, (2) parallel importation of patented medicines, and (3) a
transparent medicine pricing system through the establishment of a pricing committee.
42
Section 301 of the Trade Act of 1974 enables the Office of the US Trade Representative to impose trade
sanctions on other countries, including those countries that ‘deny fair and equitable market protection to
US persons that rely upon intellectual property protection’.
43
Exec. Order No. 13155, 3 C.F.R. 268–70 (2000). ‘This order prohibits the US Government from taking
action pursuant to Section 301(b) of the Trade Act of 1974 with respect to any law or policy in
beneficiary Sub-Saharan countries that promotes access to HIV/AIDS pharmaceuticals or medical
technologies and that provides adequate and effective intellectual property protection consistent with the
TRIPS Agreement.’
44
For a description of the Accelerating Access to HIV Care, Support and Treatment Initiative, see
www.unaids.org/acc access/ (last visited June 23, 2003); for a critique of the Initiative, see Act Up Paris,
‘“Accelerating Access” Serves Pharmaceutical Companies While Corrupting Health Organizations’,
available at http://www.actupparis.org/pdf/nord sud/02 05 15 Accele Acc ENG.pdf.
45
For the details of the lawsuit, see Kongolo, ‘Public Interest versus Pharmaceutical Industry’s Monopoly in
South Africa’, 4 Journal of World Intellectual Property (2001), 609–627.
132 EJIL 15 (2004), 123–150

First, the adjournment of the court case will allow South Africa to concentrate on the
concrete implementation of its existing legislation and policies and will help make
essential HIV/AIDS-related medicines more widely available.46 It will give South
Africa the ability to combat the HIV/AIDS epidemic more effectively with expanded
access to low-priced drugs. Another positive factor is that the case, thanks to a
well-organized grassroots campaign, brought international attention to the plight of
AIDS sufferers in the region. As a result, increased resources for prevention and care
are now forthcoming both domestically and internationally, and broad commitments
have finally been made to improve the health infrastructure throughout Africa.47
Thirdly, even though no decision was made, the case has given rise to a wealth of
expert opinions on the TRIPS Agreement. Encouragingly, the bulk of expert opinion is
that the Amendment Act is consistent with the TRIPS Agreement.48 The case has thus
strengthened the view that the TRIPS Agreement contains the necessary flexibility to
meet the health needs of developing countries and can be used as a basis for resolving
difficult issues concerning access to essential drugs.49 In particular, it has encouraged
the view that developing countries afflicted with grave public health crises should be
entitled to avail themselves of TRIPS-compatible policy options, such as parallel
importation and compulsory licensing, to implement the Agreement in a manner
conducive to public health. However, in early 2001, these conclusions and opinions
still needed authoritative interpretation to confirm their validity under the TRIPS
Agreement.

2 US v. Brazil
At around the same time (February 2001), the United States filed a complaint before
the WTO dispute settlement body challenging the compatibility of Article 68 of
Brazil’s Industrial Property Law with the TRIPS Agreement. 50 The United States
argued that this provision for the granting of compulsory licences in the event that a
patented invention was not in manufacture in Brazil within three years of the
issuance of the patent (‘local working’ requirement), was a protective industrial policy

46
This is the view of UNAIDS, see ‘UNAIDS Welcomes Outcome of the South Africa Court Case’,
www.unaids.org/whatsnew/press/eng/pressarc01/SAfrica 190401.htm.
47
See e.g. G8 Africa Action Plan adopted at the Kananaskis Summit in 2002 and G8 Action Plan on Health
adopted at the Evian Summit, both available at www.g8.fr. See also ‘United States Leadership against
HIV/AIDS, Tuberculosis and Malaria Act of 2003’, P.L. No. 108–25.
48
See e.g. B. Hoekman, A. Mattoo, and P. English (eds), Development, Trade and the WTO (2002), at 374, and
Abbott, supra note 7.
49
This view is expressed by the former WTO Director-General, Mike Moore. See WTO News, ‘Moore
Welcomes News of Settlement of South Africa Drug Lawsuit’, available at http://www.wto.org/
english/news e/spmm e/spmm58 e.htm. However, it does not necessarily mean that the TRIPS
Agreement does not exert any negative influences on more affordable access to some essential drugs.
50
See Brazil — Measures Affecting Patent Protection — Request for Consultation by the United States,
WT/DS199/1, Brazil — Measures Affecting Patent Protection — Request for the Establishment of a Panel by
the United States, WT/DS199/3, available at www.wto.org.
 The Road to Doha and Beyond 133

measure and inconsistent with the provisions of the TRIPS Agreement.51 In the 2001
‘Special 301’ Report, the United States Trade Representative (USTR), Robert Zoellick,
defined Article 68 as a protectionist measure intended to create jobs for Brazilian
nationals.52 The Brazilians took the view that this measure was a necessary part of
their programme to combat the HIV/AIDS epidemic and was entirely consistent with
the TRIPS Agreement. Following bilateral consultations, in June 2001, rather than
pursuing the dispute under the WTO Dispute Settlement Understanding procedures,
Brazil and the United States announced that they had reached a mutually agreed
solution.53
Although the dispute between the US and Brazil was successfully settled, the
question remained: To what extent could developing country Members avail
themselves of the flexibility afforded by the TRIPS Agreement to combat public health
crises? In this dispute, the US and Brazil had completely different views on the
compatibility of Brazil’s local working requirement with Article 27.1 of the TRIPS
Agreement. The settlement of the dispute left both the broad question of the flexibility
of the TRIPS Agreement and the narrower question of the legality of ‘local working’
requirements open.54

E September 11 Terrorist Attack and Subsequent Biological Attack

The terrorist attack of September 11, involving four hijacked planes, demolished the
World Trade Center and struck the Pentagon, killing more than 5,000 US citizens and
other nationals.55 Shortly after the September 11 attack, there followed a series of
anthrax attacks in the US, with several grave illnesses and deaths. To prepare for the
possibility of a massive bio-terrorist attack, the US and Canadian Governments both
decided to stockpile an adequate supply of Cipro, an antibiotic to treat anthrax.
Canada promptly overrode the German pharmaceutical company Bayer’s patent for

51
The US considered that such a requirement is inconsistent with Brazil’s obligations under Articles 27 and
28 of the TRIPS Agreement, and Article III of the GATT 1994. Essentially, the US asserted Brazil’s breach
of Article 27.1 of the TRIPS Agreement. Article 27.1 of the TRIPS Agreement provides: ‘Subject to
paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be
available and patent rights enjoyable without discrimination as to the place of invention, the field of
technology and whether products are imported or locally produced’ (emphasis added).
52
See USTR, 2001 ‘Special 301’ Report, at 10, available at www.ustr.gov/enforcement/index.shtml.
53
See Brazil — Measures Affecting Patent Protection — Notification of Mutually Agreed Solution, WT/DS199/4,
available at www.wto.org.
54
The US and Brazil reached a mutually-agreed solution on the basis of the establishment of a US–Brazil
bilateral Consultative Mechanism. Under this Mechanism, Brazil will provide advance notice to the US
Government before utilizing this provision. Therefore, if Brazil seeks to activate this provision there will be
an adequate opportunity for consultations in the bilateral Consultative Mechanism. This will provide an
early warning system to protect US interests. The United States reserves all its rights in the WTO with
respect to this matter.
55
U.S. Department of State, Office of the Historian, Significant Terrorist Incidents, 1961–2001: A Brief
Chronology, www.state.gov/r/pa/ho/pubs/fs/5902.htm.
134 EJIL 15 (2004), 123–150

Cipro, and ordered a million tablets of a generic version from a Canadian company.56
For its part, the US Government won a major price concession from Bayer A.G. for its
antibiotic Cipro, after the Bush administration threatened to override the drug’s
patent and allow generic production.57 The anthrax scare drew a new focus on the
relationship between patent protection and access to essential drugs. Some legal
experts pointed out that the Canadian Government had not completed the procedures
required under its own intellectual property legislation for overriding Bayer’s patent,
and further remarked that it would be difficult for the Government to justify its
decision by claiming a national emergency, given that there had been no cases of
anthrax in Canada at that time.58 The international community was particularly
critical of the US Government, which was accused of following double standards. 59
Developing countries were quick to ask how developed countries could insist on poor
countries respecting patent rights, even in the face of genuine public health crises,
while the US Government itself threatened to override patents on the antibiotic Cipro
during the outbreak in October 2001 of anthrax infections.
The anthrax scare revealed that every nation in the world, even the most powerful,
could be faced with a national public health emergency. The subsequent debate
focused on a number of questions. First, what constitutes a national public health
emergency? If confronted with a public health emergency, can a government grant
compulsory licences on the ground of protecting national public health? If so, is this
action legitimate under the TRIPS Agreement? Apart from the granting of such
compulsory licences, what other TRIPS-compatible flexibilities can Member govern-
ments use to combat national public health crises? In addition, will the use of such
flexibilities discourage new research and development into new drugs? All these
questions required prompt answers at the Doha Ministerial Conference, which took
place just weeks after the anthrax scare.

2 The Doha Declaration

On 20 June 2001, the TRIPS Council held a special discussion on intellectual property
and access to medicines at the request of the African Group. The goal was to initiate
discussions on the interpretation and application of the relevant provisions of the
TRIPS Agreement with a view to clarifying the flexibilities that Members are entitled
to and, in particular, to establish the relationship between intellectual property rights
and access to medicines. During the session, a wide range of relevant issues were

56
See Harmon and Pear, ‘Canada Overrides Patent for Cipro to Treat Anthrax’, New York Times, 19 October
2001. The Canadian Government subsequently withdrew its decision after agreeing on the Monday to
buy the tablets from Bayer.
57
See Bradsher and Andrews, ‘U.S. Says Bayer Will Cut Cost of Its Anthrax Drug’, New York Times, 24
October 2001.
58
See Dyer and Michaels, ‘Anthrax Scare Raises Awkward Patent Questions’, Financial Times, 22 October
2001.
59
See ibid.
 The Road to Doha and Beyond 135

discussed, some for the first time ever in the TRIPS Council. 60 The former WTO
Director-General Mike Moore described the discussion as an opportunity for Member
governments to feel secure that they can use the flexibility that is written into the
TRIPS Agreement.61
On 19 and 21 September, the TRIPS Council held its second special discussion on
TRIPS and public health, which primarily focused on objectives and principles (TRIPS
Articles 7 and 8), parallel imports (Article 6) and compulsory licensing (Article 31).
The discussion broadened to cover other related issues because of three draft texts that
members submitted for a ministerial declaration at the Doha Conference. The
developing country draft emphasized the importance of TRIPS’s role in the protection
and promotion of fundamental human rights. The core of this 14-point draft lies in the
proposition that ‘nothing in the TRIPS Agreement shall prevent Members from taking
measures to protect public health’.62 Therefore, various flexibilities available in the
TRIPS Agreement, including parallel imports and compulsory licensing, should be
made more user-friendly to the developing country Members. The alliance of
developing country Members, and their insistence on the need for a strong ministerial
declaration on the protection of public health, sent a clear signal that they were
determined to reverse the unbalanced outcome of the Uruguay Round in the future
new round of multilateral trade negotiations.63 In contrast, the draft proposed by a
group of developed country Members (including Australia, Canada, Japan, Swit-
zerland and the US, but not the European Union) held the opposite position by
stressing the merits of strong patent protection. The developed countries’ draft
proposed that ministers recognize that ‘strong, effective and balanced protection for
intellectual property is a necessary incentive for research and development of life-
saving drugs’ and, therefore, ‘recognize that intellectual property contributes to
public health objectives globally’. Additionally, the developed country draft omitted

60
There are two papers respectively submitted to the TRIPS Council from the African Group and EU. See
Communication From the European Communities and Their Member States, ‘The Relationship between
the Provisions of the TRIPS Agreement and Access to Medicines’, 12 June 2001, IP/C/W/280; ‘TRIPS
Public Health’, Submission by the Africa Group, Barbados, Bolivia, Brazil, Dominican Republic, Ecuador,
Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka, Thailand and
Venezuela, 29 June 2001, IP/C/W/296.
61
See WTO NEWS, ‘Moore: Countries Must Feel Secure That They Can Use TRIPS’ Flexibility’, 20
June 2001.
62
This is the developing countries’ negotiating target in the Doha Conference. See C. M. Correa, Implication
of the Doha Declaration on the TRIPS Agreement and Public Health (2002).
63
See Proposal by the African Group, Bangladesh, Barbados, Bolivia, Brazil, Cuba, Dominican Republic,
Ecuador, Haiti, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka,
Thailand and Venezuela, ‘Ministerial Declaration on the TRIPS Agreement and Public Health’, 4 October
2001, IP/C/W/312.
136 EJIL 15 (2004), 123–150

any mention of the role of compulsory licensing in expanding access to affordable

medicines.64
In the course of negotiating the prospective ministerial declaration at the Doha
Conference, the developed country Members came to understand that no broad
negotiating mandates such as investment and competition would emerge from the
conference in the absence of a meaningful result on medicines. In the end, the United
States accepted the essentials of the developing country group’s recommendations,
which were strongly supportive of public health.65 On 14 November 2001, the
Ministers at the Doha Conference adopted the final Declaration by consensus.

A Content of the Doha Declaration

1 The Relationship between the TRIPS Agreement and Public Health
First, the Declaration explicitly recognizes ‘the gravity of the public health problems
afflicting many developing and least-developed countries, especially those resulting
from HIV/AIDS, tuberculosis, malaria and other epidemics’.66 Next, in paragraph 2,
the Declaration stresses that the TRIPS Agreement should be viewed as part of the
wider national and international action to address public health problems. 67 In
paragraph 3, the ministers recognize the complexities of drug patent protection, by
stating that ‘intellectual property protection is important for the development of new
medicines’, but also recognizes ‘concerns about its effect on prices’. In paragraph 4,
the core of the Declaration, ministers ‘agree that the TRIPS Agreement does not and
should not prevent members from taking measures to protect public health’.
Therefore, they ‘affirm that the Agreement can and should be interpreted and
implemented in a manner supportive of WTO members’ right to protect public health
and, in particular, to promote access to medicines for all’. 68 In this connection, they
‘reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS
Agreement which provide flexibility for this purpose’.69
2 Principles Applied to Interpreting the TRIPS Agreement
The Doha Declaration requires that ‘in applying the customary rules of interpretation
of public international law, each provision of the TRIPS Agreement shall be read in the
light of the object and purpose of the Agreement as expressed, in particular, in its

64
See Contribution from Australia, Canada, Japan, Switzerland and the United States, ‘Preambular
Language for Ministerial Declaration’, 4 October 2001, IP/C/W/313. The third draft was submitted by
Hong Kong China. Hong Kong China took the view that TRIPS does not allow a government to
compulsorily license foreign companies and that therefore governments of the two countries might have
to cooperate. See WTO NEWS, ‘Members Discuss Drafts for Ministerial Declaration’, 19 and 21 September
2001. For its part, the EU tried to present itself as an ‘honest broker’ in the negotiations.
65
See Abbott, ‘The Doha Declaration on The TRIPS Agreement and Public Health: Lighting a Dark Corner
in WTO’, 5 JIEL (2002) 486.
66
Supra note 8, at para. 1.
67
Ibid., at para. 2.
68
Ibid., at para. 4. See also, Doha WTO Ministerial Declaration, 20 November 2001, WT/MIN(01)/ DEC/1,
para. 17.
69
Ibid., at para. 4.
 The Road to Doha and Beyond 137

objectives and principles’.70 The fundamental rule of treaty interpretation as set out in
Articles 31 and 32 of the Vienna Convention on the Law of Treaties (Vienna
Convention),71 which are firmly grounded in the antecedent state practice and
international cases,72 had attained the status of a rule of customary or general
international law.73 These two articles not only prescribe basic rules for the
interpretation of treaties, but also enumerate several sources of law by defining the
scope of the treaty and its context.74 Guided by the key elements of treaty
interpretation defined in these two rules, the would-be interpreters75 should examine
the provisions in the context of objectives and principles highlighted by the TRIPS
Agreement, rather than merely confine themselves to a restrictive textual approach.
3 Flexibilities Available in the TRIPS Agreement
a. Compulsory Licensing
The Doha Declaration clarifies Article 31 of the TRIPS Agreement by restating
propositions that big pharmaceutical companies, in particular, had put in doubt.76
Paragraph 5(b) clearly states that ‘each Member has the right to grant compulsory
licences and the freedom to determine the grounds upon which such licences are
granted’.77 The Declaration makes it clear that Article 31, while including a number
of procedural conditions for granting compulsory licences, does not limit the grounds
on which compulsory licences can be granted, leaving Members the right to stipulate
such grounds in their domestic legislations. Therefore, Members can grant such
licences on the grounds of protecting public health beyond the three illustrations
explicitly included in Article 31, which are national emergency, 78 public non-
commercial use79 and anti-competitive practices.80
b. Determination of National Emergency
The Doha Declaration explicitly gives each Member ‘the right to determine what
constitutes a national emergency or other circumstances of extreme urgency’. It
70
Ibid., at para. 5(a).
71
Vienna Convention on the Law of Treaties, done at Vienna, 23 May 1969, entered into force on 27
January 1980. For the detailed explanations of these two articles, see at 114–158.
72
See ibid, at 153.
73
See J. H. Jackson, The WTO Constitution and Jurisprudence (1998), at 95; Cameron and Gray, ‘Principles of
International Law in the WTO Dispute Settlement Body’, 50 ICLQ (2001) 248, at 254–256; see also
Lennard, ‘Navigating by the Stars: Interpreting the WTO Agreements’, 5 JIEL (2002) 17.
74
See Palmeter and Mavroidis, ‘The WTO Legal System: Source of Law’, 92 AJIL (1998) 400. See also
Cattaneo, ‘The Interpretation of the TRIPS Agreement — Considerations for the WTO Panels and
Appellate Body’, 3 Journal of World Intellectual Property (2000) 670.
75
The Ministerial Conference/General Council has the exclusive authority to adopt interpretations of the
WTO Agreement and of the Multilateral Trade Agreements, including the TRIPS Agreement. See Article
IV:2 of the WTO Agreement. Although the legal effect of the interpretations rendered by the Panels and
Appellate Body still remain controversial, it should be noted that these interpretations are only binding
on the disputed parties concerned.
76
See Abbott, supra note 65, at 493.
77
Supra note 8, at para. 5(b).
78
See Article 31(b) of the TRIPS Agreement.
79
Ibid.
80
See Article 31(k) of the TRIPS Agreement.
138 EJIL 15 (2004), 123–150

specifies that ‘public health crises, including those relating to HIV/AIDS, tuberculosis,
malaria and other epidemics, can represent a national emergency or other
circumstances of extreme urgency’.81 Hence, ministers reiterate the freedom to grant
compulsory licences in order to combat public health crises. The combination of
paragraphs 5(b) and 5(c) of the Declaration should enable developing country and
least-developed country Members to use TRIPS-compatible compulsory licensing as a
tool to protect public health without fear of challenge from the pharmaceutical
industry.
c. Parallel Imports
Subject to the most favoured nation (MFN) and national treatment provisions of
Articles 3 and 4, Members are free to adopt their own policies concerning the
exhaustion of intellectual property rights, and to establish their own parallel
importation system within the chosen policy. 82 This had been a disputed point of
interpretation under the TRIPS Agreement. By making it clear that Member states
may adopt legislation to allow parallel imports without the consent of the patent
holder, the Declaration greatly advances the interests of developing Members in
obtaining low-cost access to pharmaceutical supplies.83
d. Pharmaceutical Patent Protection in Least-developed Countries
The Doha Declaration exempts least-developed country Members from providing
patent protection to pharmaceutical products and enforcing such rights until
1 January 2016.84 Prior to this deadline, the least-developed country Members will be
free to increase their own capacity to manufacture generic drugs or obtain low-priced
drugs imported from other Members.
4 Technology Transfer
Though some developed country Members provide different forms of technical
assistance on IPR-related issues, least-developed country Members have repeatedly
noted that no or little action has been taken by developed countries to specifically
implement their obligations under Article 66.2.85 Importantly, the Doha Declaration
reaffirms the commitment of technology transfer made by developed country
Members,86 and urges such Members to provide incentives to their enterprises and
institutions to promote and encourage technology transfer to least-developed country
members.87 In addition, the ministers agreed to establish a Working Group under the
auspices of the General Council to examine the relationship between trade and
transfer of technology, and to make possible recommendations on steps that might be

81
Supra note 8, at para. 5(c).
82
Ibid, at para. 5(d).
83
See Abbott, supra note 65, at 497.
84
Supra note 8, at para. 7.
85
Correa, ‘Implications of the Doha Declaration on the TRIPS Agreement and Public Health’, WHO Health
and Economics Policy Paper, EDM Series No. 12 (2002), at 36.
86
See Article 66.2 of the TRIPS Agreement.
87
Ibid, at para. 7.
 The Road to Doha and Beyond 139

taken within the mandate of the WTO to increase technology flows to developing
countries.88

B Issues Remaining Unresolved

1 Effectiveness of Extension Accorded to Least-Developed Countries
Although the Doha Declaration extends the deadline for the least-developed country
Members to provide patent protection to pharmaceutical products, it does not
explicitly address the restrictions placed by Articles 70.889 and 70.990 of the TRIPS
Agreement. In the Indian patent protection case, both the Panel and the Appellate
Body made it clear that all WTO Members were required to implement the so-called
mailbox rule and the exclusive marketing rights (EMR) provision embodied in the
above two articles starting as of the date of entry into force of the TRIPS Agreement (1
January 1995).91 This means establishing systems for receiving and filing pharma-
ceutical and agricultural chemical product patent applications for later review
(mail-box rule) as well as providing exclusive marketing rights for those products that
are the subject of the mailbox rule. EMRs appear to be very similar to patent rights
under the obligation of the TRIPS Agreement92 and are possibly even stronger than
patent rights.93 Combined with the mailbox rule, the obligation to grant EMRs
severely curtails the discretion of the national patent office to grant or reject patent
rights and has been found by countries such as India to diminish significantly the
benefits from the transitional arrangements provided for in Articles 65.4 and 66.1.94
Similarly, were it applicable to LDCs, the obligation to grant EMRs could jeopardize the
benefits of the additional extension accorded by the Doha Declaration to the

88
See Doha WTO Ministerial Declaration, 20 November 2001, WT/MIN(01)/ DEC/1, para. 37.
89
Article 70.8 of the TRIPS Agreement deals with the requirement that each WTO Member shall establish
‘a means’ that adequately preserves novelty and priority in respect of applications for product patents in
respect of pharmaceutical and agricultural chemical inventions during the transitional periods provided
for in Article 65 of the TRIPS Agreement.
90
Article 70.8 of the TRIPS Agreement provides that each WTO Member shall establish, from 1 January
1995, a mechanism to provide for the grant of exclusive marketing rights to parties who file mailbox
applications.
91
See India — Patent Protection for Pharmaceutical and Agricultural Chemical Products, WT/DS50/R, adopted
on 5 May 1997, at paras 7.24–7.66.
92
The Panel in the India Patent Protection case described the economic function of the grant of EMRs as
follows: ‘Depending on the situation of a particular market, an exclusive marketing right for a period of
five years followed by a gap of a few years until full patent protection is granted some time subsequent to
1 January 2005 might be essential for manufacturers of pharmaceutical and agricultural chemical
products in order to set up their position in the market. Competitors, knowing that the grant of
subsequent patent protection is imminent, are likely to be discouraged from entering into the market
during this brief window of opportunity.’
Ibid., at para. 7.59.
93
See J. Watal, Intellectual Property Rights in the WTO and Developing Countries (2001), at 118–119.
94
Article 65.4 provides that some developing country Members may delay providing patent protection on
pharmaceutical products from 1 January 1995 until 1 January 2005. Article 66.1 gives the least-
developed country Members a period of 11 years (from 1 January 1995 until 1 January 2006) to
delay application of the Agreement, other than Articles 3, 4 and 5.
140 EJIL 15 (2004), 123–150

least-developed country Members with respect to drug patent protection. Paragraph 7

of the Declaration, instead of resolving this issue, merely instructs the TRIPS Council
to take the necessary action to give effect to this extension.

2 Members with Limited Manufacturing Capacities in the Pharmaceutical Sector

Paragraph 6 of the Declaration recognizes that developing Members with insufficient
or no manufacturing capacities in the pharmaceutical sector could face difficulties in
making effective use of compulsory licensing under the TRIPS Agreement. This is
because Article 31(f) of the TRIPS Agreement provides that the manufacture of on-
patent pharmaceuticals under a compulsory licence must be predominantly for the
supply of the domestic market of the Member authorizing such compulsory
licence.95 The term ‘predominantly’ is not defined in the TRIPS Agreement but ‘it
would generally suggest that more than 50% of the production by a compulsory
licensee should be intended for supply of the domestic market’. 96 Difficulties could
arise, therefore, when a country with insufficient domestic manufacturing capacity
and experiencing grave health problems seeks to import a needed pharmaceutical
from a manufacturer in a WTO Member country where a patent exists on that
pharmaceutical. The Doha Declaration did not resolve the issue but instead instructed
the TRIPS Council to find an expeditious way to facilitate the effective use of
compulsory licensing by countries with insufficient manufacturing capacity and to
report to the General Council before the end of 2002.97

3 Beyond Doha
A Results of the Post-Doha Negotiations
1 Exclusive Marketing Rights
As the Doha Declaration instructed, the TRIPS Council promptly undertook the
necessary action to give effect to the extension accorded to LDCs. Considering that
obligations of granting exclusive marketing rights, where applicable, should not
prevent attainment of the objectives of extension accorded by the Declaration, the
General Council, on the basis of the report submitted by the TRIPS Council, formally
adopted a waiver decision in July 2002. Pursuant to this decision, the obligations of
least-developed country Members under paragraph 9 of Article 70 of the TRIPS
Agreement are waived with respect to pharmaceutical products until

95
Article 31(f) of the TRIPS Agreement provides: ‘(f) any such use shall be authorized predominantly for the
supply of the domestic market of the Member authorizing such use’ (emphasis added).
96
Abbott, supra note 65, at 499.
97
See supra note 8, at para. 6.
 The Road to Doha and Beyond 141

1 January 2016.98 In the meantime, this waiver shall be reviewed by the Ministerial
Conference not later than one year after it is granted, and thereafter annually until the
waiver terminates.99 The decision is part of the WTO Members’ ongoing efforts to
ensure that intellectual property protection supports, rather than hampers, poorer
countries’ efforts to tackle serious public health problems. By granting this waiver,
Members saw fit to go beyond the strict reading of the Declaration.100
2 Technology Transfer
Recently, particular attention has been paid to the effects of the TRIPS Agreement on
the transfer of technology to developing countries. The North–South technological
gap has continued to grow since the adoption of the Agreement. 101 Against this
background, the Doha Decision of 14 November 2001 on Implementation-related
Issues and Concerns both reaffirmed that developed country Members’ obligations to
provide incentives to their enterprises and institutions to transfer technology to the
least-developed Members under Article 66.2 of the TRIPS Agreement are mandatory,
and instructed the TRIPS Council to put in place a mechanism for ensuring the
monitoring and full implementation of the obligations in question. 102 In February
2003, the TRIPS Council adopted a decision pursuant to this mandate. Developed
country Members are required to submit annual reports on actions taken or planned
in pursuance of their commitments under Article 66.2 of the TRIPS Agreement. The
decision also provides that such submissions shall be reviewed annually by the TRIPS
Council.103
3 Article 31(f) of the TRIPS Agreement
Under paragraph 6 of the Doha Declaration, the TRIPS Council was instructed to find
an expeditious solution to the problem confronting WTO Members with insufficient or
no manufacturing capacities in the pharmaceutical sector when they attempt to
effectively use compulsory licensing. Pursuant to this mandate, the TRIPS Council
held several meetings in the year 2002 to discuss what came to be known as the
‘paragraph 6 problem’ or the ‘export problem’. A number of possible solutions were

98
See the General Council Decision, ‘Least-developed Country Members — Obligations under Article 70.9
of the TRIPS Agreement with Respect to Pharmaceutical Products,’ 12 July 2002, WT/L/478.
99
Ibid.
100
See Press Release, WTO, ‘Council Approves LDC Decision with Additional Waiver’, Press/301 at 1 (28
June 2002), available at www.wto.org/english/news e/pres02 e/pr301 e.htm.
101
Correa, ‘Review of the TRIPS Agreement: Fostering the Transfer of Technology to Developing Countries’,
Third World Network (TWN), Trade and Development Series No. 13.
102
See ‘Implementation-Related Issues and Concerns’, Decision of 14 November 2001, WT/MIN(01)/17,
para. 11.2. In addition, the Doha Ministerial Declaration instructs the General Council to examine the
relationship between trade and transfer of technology. See Doha WTO Ministerial Declaration, 20
November 2001, WT/MIN(01)/ DEC/1, para. 37.
103
See ‘Implementation of Article 66.2 of the TRIPS Agreement’, Decision of the Council for TRIPS of 19
February 2003, 20 February 2003, IP/C/28.
142 EJIL 15 (2004), 123–150

explored in the TRIPS Council: (i) an amendment to Article 31(f);104 (ii) a waiver with
regard to Article 31(f);105 (iii) a moratorium on dispute settlement; 106 and (iv) an
authoritative interpretation of Article 30.107 A compromise deal was nearly reached in
late December 2002, but failed because of US objections on the scope of diseases.108 In
the end, a belated compromise, analysed in Section 3 below, was finally reached on 30
August 2003, just days before the opening of the fifth WTO Ministerial in Cancun.109
4 Non-violation Complaints
Ordinarily, disputes in the WTO involve claims that a country has violated the
provisions of a WTO agreement. Non-violation complaints refer to a government’s
ability to bring a dispute to the dispute settlement body, based on loss of an expected
benefit under a WTO agreement (or impairment of an objective of such agreement)
caused by another Member’s measures — even if such measures do not actually
conflict with the provisions of the Agreement in question. 110 The TRIPS Agreement
(Article 64.2) set a temporary moratorium on non-violation complaints until 1
January 2000. In the meantime, the TRIPS Council started looking at the extent and
way (scope and modalities) in which non-violation complaints could be applied.111 ‘At
least two countries (the US and Switzerland) take the position that non-violation
complaints should be allowed in intellectual property protection in order to
discourage Members from engaging in “creative legislative activity” that would

104
Some developing country Members advocate the deletion or revision of Article 31(f). See Joint
Communication from the African Group in the WTO, ‘Proposals on Paragraph 6 of the Doha Declaration
on the TRIPS Agreement and Public Health’, IP/C/W/351, at para. 3(e) (24 June 2002); the EU favours
the specific amendment to Article 31(f). See communication from the European Communities and their
member states, ‘Concept Paper Relating to Paragraph 6 of the Doha Declaration of the TRIPS Agreement
and Public Health’, IP/C/W/339, Sec. III.1 at 4 (4 March 2002); Communication from the European
Communities and Their Member States, Paragraph 6 of the Doha Declaration of the TRIPS Agreement and
Public Health, IP/C/W/352 (20 June 2002).
105
See Second Communication from the United States, Paragraph 6 of the Doha Declaration of the TRIPs
Agreement and Public Health, IP/C/W/358 (9 July 2002).
106
See Communication from the United States, ‘Moratorium to Address Needs of Developing and Least
Developed Members with No or Insufficient Manufacturing Capacities in the Pharmaceutical Sector’,
IP/C/W/396 (14 January 2003).
107
See Communication from the United Arab Emirates, ‘Paragraph 6 of the Doha Declaration of the TRIPs
Agreement and Public Health’, IP/C/W/354 (24 June 2002); Communication from Bolivia, Brazil, Cuba,
China, Dominican Republic, Ecuador, India, Indonesia, Pakistan, Peru, Sri Lanka, Thailand and
Venezuela, ‘Paragraph 6 of the Doha Declaration of the TRIPs Agreement and Public Health’,
IP/C/W/355 (24 June 2002).
108
See WTO News 2002, ‘Supachai Disappointed over Governments’ Failure to Agree on Health and
Development Issues’, Press/329 (20 December 2002) available at www.wto.org/english/news e/
pres02 e/pr329 e.htm.
109
General Council Decision of 30 August 2003, IP/C/W/405.
110
See Article XXIII: 1(b) of the GATT 1994. For more information about non-violation complaints, see
TRIPS Council, ‘Non-violation Complaints; Background and the Current Situation’, available at
www.wto.org/english/tratop e/trips e/nonviolation background e.htm.
111
See ibid.
 The Road to Doha and Beyond 143

enable them to get around their TRIPS commitments.’112 The non-violation complaint
mechanism, however, could potentially function as a tool to circumscribe the
developing countries from effectively using flexibilities concerning public health in the
TRIPS Agreement. Non-violation complaints could force Members to raise intellectual
property protection beyond minimum requirements in the TRIPS Agreement. They
could also be used to constrain the adoption of national measures consistent with
Article 8 of the TRIPS Agreement to protect public health and nutrition. This issue is
largely neglected in the discussion of the TRIPS Agreement and public health.
Although the developing group, in its draft ministerial declaration, contended that
non-violation complaints should, at least, not apply to measures adopted by them for
the protection of public health,113 the final text of the Doha Declaration was still silent
on this issue. Instead, the Implementation Decision adopted at the Doha Conference
directed the TRIPS Council to continue to discuss this and to make recommendations
to the 2003 Fifth Ministerial Conference. Until then, Members have agreed not to file
non-violation complaints under TRIPS.114 Most developing countries would like to see
the ban continued or made permanent.115 As of the date of conclusion of this article,
the TRIPS Council had been unable to reach an agreement on this subject.

112
WTO, ‘TRIPS: “Non-violation” Complaints (Article 64.2). Background and the Current Situation’, at
http://www.wto.org/english/tratop e/trips e/nonviolation background e.htm. Other Members, like
the EU and Canada, oppose the instant application of the non-violation remedy to the TRIPS-related
disputes without careful deliberations on its potential impact on the international protection of
intellectual property rights. See Communication from Canada, ‘Non-violation Nullification or Impair-
ment under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)’,
IP/C/W/127(10 February 1999); Proposal from Cuba, the Dominican Republic, Egypt, Indonesia,
Malaysia and Pakistan, ‘Non-violation Nullification or Impairment under the Agreement on Trade
Related Aspects of Intellectual Property Rights (TRIPS)’, IP/C/W/141 (29 April 1999); Communication
from Canada, the Czech Republic, the European Communities and their member States, Hungary and
Turkey, ‘Non-violation Complaints under the TRIPS Agreement — Suggested Issues for Examination of
Scope and Modalities under Article 64.3 of the TRIPS Agreement’, IP/C/W/191(22 June 2000);
Communication from Australia, ‘Non-violation Complaints under the Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS)’, IP/C/W/212 (27 September 2000); Communication
from Canada, ‘Further Consideration of Non-violation Nullification or Impairment under the Agreement
on Trade-Related Aspects of Intellectual Property Rights’, IP/C/W/249 (29 March 2001); Communi-
cation from Argentina, Bolivia, Brazil, Colombia, Cuba, Ecuador, Egypt, India, Kenya, Malaysia,
Pakistan, Peru, Sri Lanka and Venezuela, ‘Non-Violation and Situation Nullification or Impairment
under the Trips Agreement’, IP/C/W/385 (30 October 2002).
113
Proposal by the African Group, Bangladesh, Barbados, Bolivia, Brazil, Cuba, Dominican Republic,
Ecuador, Haiti, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka,
Thailand and Venezuela, IP/C/W/312 (4 October 2001).
114
See ‘Implementation-Related Issues and Concerns’, Decision of 14 November 2001, WT/MIN(01)/17,
para. 11.1.
115
See Cancun WTO Ministerial Briefing Notes, TRIPS, Negotiations, implementation and TRIPS Council
Work, available at www.wto.org/english/thewto e/minist e/min03 e/brief e/brief06 e.htm.
144 EJIL 15 (2004), 123–150

B Some Reflections on the Post-Doha Negotiations

The terrorist attack of 11 September has been called a crime against humanity. 116
Terrorism is a global threat with global effects.117 The attack against the US threatens
more than the tragic loss of individual lives and the collapse of the World Trade
Center. It has had profound effects not only at the psychological, economic and
political level, but also at the international legal level. With respect to the multilateral
trading system, many developed country Members became more aware that the
launching of a new round of multilateral trade negotiations could not be separated
from the overall need to alleviate poverty, promote equity and foster economic growth
in most of the developing and least developed country Members. In a globalized world,
countries are interlocked both economically and politically. Most of the developed
country Members realized that there exists a truly global interest in effectively
combating regionally or globally transmitted diseases. As some commentators have
noted, the events in the months preceding the Doha Ministerial Conference were likely
more influential than international public pressure.118 The terrorist attack and the
subsequent anthrax scare taught the US a good lesson that, in the process of deeper
globalization, it should play a more positive rather than self-centred role in the new
round of multilateral trade negotiations. The positive attitude of the US was a key
factor in the success of the Doha Conference. As one economist observed:
The 11 September 2001 attacks on the World Trade Center left the United States more
determined than ever to launch the new round. The United States wanted to send a clear
message that such attacks could not undermine its resolve to achieve progressively open
markets. The US determination translated into a greater willingness to grant concessions than
at Seattle. Other WTO members shared the US goal and reciprocated by being more flexible
than they were at Seattle.119

Compared with the frustrating failure of the Seattle Conference in 1999, the Doha
Conference was regarded by many commentators as a turning-point in the history of
the WTO and in relations between developed and developing countries.120 The success
applauded at the Doha Conference was based on the joint efforts and shared interest
between developed and developing countries. Unfortunately, it would now appear
that the ‘spirit of Doha’ was short-lived. No sooner had the Declaration on TRIPS and

116
See Cassese, ‘Terrorism is Also Disrupting Some Crucial Legal Categories of International Law’ 12 EJIL
(2001) 1003.
117
UN Press Release, ‘Addressing Security Council, Secretary-General Endorses Three-pronged Counter-
terrorism Strategy’, SG/SM/8417, SC/7523.
118
See, e.g., Gold and Lam, ‘Balancing Trade in Patents — Public Non-Commercial Use and Compulsory
Licensing’, 6 Journal of World Intellectual Property (2003) 6.
119
Panagariya, ‘Developing Countries at Doha: A Political Economy Analysis’, 25 World Economy (2002)
1205.
120
See WTO, The Road to Doha and Beyond — A Road Map for Successfully Concluding the Doha Development
Agenda (2002), at 8.
 The Road to Doha and Beyond 145

public health been adopted than it was clear that differences of opinion on TRIPS and
public health had not been truly bridged.
As we saw above, the drafting process of the Doha Declaration revealed huge gaps
in opinions on the relationship between TRIPS and public health. While the
developing country group emphasized that patent protection should not impede
public access to affordable drugs,121 the US and other developed countries insisted that
patent protection contributes to public health objectives and took the position that
globally the TRIPS Agreement contributes to the availability of medicines.122 After the
adoption of the Doha Declaration, there were still substantially different viewpoints on
the relationship between the TRIPS Agreement and public health, as if no compromise
had ever been reached, or promises made. In particular, the pharmaceutical industry,
which had traditionally lobbied hard for high levels of intellectual property protection
in developing countries, took the position that the main theme of the Declaration was
to reaffirm the value of intellectual property protection and to recognize that the
TRIPS Agreement is part of the solution to better public health rather than a barrier to
access.123 On the contrary, most academics and NGOs point out that the final text
more closely resembles the developing countries’ draft than the developed countries’
positions. Outside the pharmaceutical industry, most commentators emphasize that
the Declaration gives broad discretion to Member states in deciding how to counter
the negative effects of the TRIPS Agreement, especially its impact on prices. They
stress that, for the first time, the Doha Declaration explicitly underscores that public
health concerns outweigh full protection of intellectual property.124
The difficulty of the post-Doha negotiations was not a total surprise. There had long
been signals that the pharmaceutical industry did not universally share ‘the spirit of
Doha’, and would lobby hard for tight restrictions on the interpretation of the
Declaration. Nonetheless, many observers were surprised by the intensity of the fight
that the US pharmaceutical industry put up. For instance, many observers were taken
aback when, as early as February 2002, the US pharmaceutical industry lobbied to
urge the Office of the United States Trade Representative (USTR) to make four new
countries listed as ‘Priority Foreign Countries’ for monitoring and potential trade
sanctions under the ‘Special 301’ provisions of the US trade law, for ‘their failure to
protect patented pharmaceutical products’.125
Under pressure from powerful pharmaceutical industry lobbies, the US voiced
firmly the significance of safeguarding the minimum patent protection standards

121
See Proposal by the African Group, Bangladesh, Barbados, Bolivia, Brazil, Cuba, Dominican Republic,
Ecuador, Haiti, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka,
Thailand and Venezuela, ‘Ministerial Declaration on the TRIPS Agreement and Public Health’, 4 October
2001, IP/C/W/312.
122
See Contribution from Australia, Canada, Japan, Switzerland and the United States, ‘Preambular
Language for Ministerial Declaration’, 4 October 2001, IP/C/W/313.
123
PhMRA, WTO Doha Declaration Reaffirms Value of Intellectual Property Protection, 14 November
2001, available at www.phrma.org/mediaroom/press/releases/14.11.2001.310.cfm.
124
Hoen, ‘TRIPS, Pharmaceutical Patents, and Access to Essential Medicines: A Long Way From Seattle to
Doha’, 3 Chicago Journal of International Law (2002) 27, at 47–48.
125
See Oxfam Brief Paper, TRIPS and Public Health: The Next Battle (2002), at 2.
146 EJIL 15 (2004), 123–150

provided for in the TRIPS Agreement, and stuck to its position that the obligation
under the TRIPS Agreement should be strictly interpreted and implemented, as if the
Doha Declaration had never been adopted. During the post-Doha negotiations, the US,
which has the strongest bargaining power in the WTO, played the most negative role.
Throughout 2002 and most of 2003, as the negotiations dragged on, the limitations
of the Doha Declaration were apparent. While the Declaration corrects, to some
degree, the unbalanced nature of the TRIPS Agreement, it was not followed by a
sufficient shift in the relative bargaining powers of developing and developed
Members, nor by any softening of the negotiating stance on the part of the US.126 For
instance, The USTR 2002 ‘Special 301’ report reaffirmed the US pharmaceutical
patent policy in the following terms:
The U.S. Government also remains committed to a policy of promoting intellectual property
protection, including for pharmaceutical patents, because of intellectual property rights’
critical role in the rapid innovation, development, and commercialization of effective and safe
drug therapies. Financial incentives are needed to develop new medications. No one benefits if
research on such products is discouraged.127

In December 2002, the US rejected a near deal on paragraph 6 because of ‘concerns

that it would undermine the WTO rules on patents that provide incentives for
development of new pharmaceutical products, including those of a non-epidemic
nature’.128 By the time it finally lifted its veto in late August 2003, two million more
Africans had died from AIDS, for want of treatment.129 As of the time of writing this
paper, the US is still aggressively pursuing TRIPS-plus agreements. The recently
signed US-Singapore Free Trade Agreement (FTA)130 and the US-Chile FTA131 set out
the highest standards of protection and enforcement for intellectual property yet
achieved in the bilateral and multilateral instruments. TRIPS-plus measures are still
being inserted into future FTAs132 and in the proposed Free Trade Agreement of the
Americas (FTAA).133 Last but not least, the US still wants to end the temporary ban on
non-violation complaints. This issue should not be overlooked, as it could significantly
constrain Members’ abilities to introduce new and perhaps vital social, economic,

126
See Panagariya, supra note 119, at 1218–1232.
127
USTR, 2002 ‘Special 301’ Report, at 5, available at www.ustr.gov/reports/2002/special301.htm.
128
See USTR Press Release of 20 December 2002, available at www.ustr.gov.
129
According to Morocco’s Ambassador to the WTO, 2.1 million Africans have died from diseases such as
AIDS since 16 December 2002 when the near-deal collapsed. See http://www.gulf-times.com/
2003/08/31/finance.htm.
130
US–Singapore Free Trade Agreement, available at http://www.ustr.gov/new/fta/singapore.htm. For
discussions about the US-Singapore FTA, see Kang and Stone, ‘IP, Trade, and U.S./Singapore Relations
— Significant Intellectual Property Provisions of the 2003 U.S.–Singapore Free Trade Agreement’, 6
Journal of World Intellectual Property (2003) 721.
131
US-Chile Free Trade Agreement, available at http://www.ustr.gov/new/fta/chile.htm.
132
These future FTAs include: US-Australia FTA, US-CA FTA, US-Morocco FTA, US-SACU FTA. See
http://www.ustr.gov/new/fta/index.htm.
133
See Médecins sans Frontières, ‘Don’t Trade Away Health in the FTAA’, available at www.accessmed-
msf.org. See also, Vivas-Eugui, ‘Regional and Bilateral Agreements in a TRIPS-plus World: The Free
Trade Area of the Americans (FTAA)’, TRIPS Issues Paper No.1, Quaker United Nations Office, available at
www.quno.org. For FTAA, see www.ustr.gov/regions/whemisphere/ftaa.shtml.
 The Road to Doha and Beyond 147

development, health, environmental and cultural measures that might be construed

as denying ill-defined benefits under the TRIPS Agreement.134

C The Decision on Implementation of Paragraph 6

1 A Complex, Controversial Decision
The Decision on Implementation of Paragraph 6 135 is meant to enable developing
countries to import generic medicines made under compulsory licensing if those
countries are unable to produce the medicines themselves. Commentators sharply
disagree on its assessment. For Director-General Supachai Panitchpakdi, it was ‘a
historic agreement for the WTO’, which ‘proves once and for all that the organization
can handle humanitarian as well as trade concerns.’136 Others call the deal ‘largely
symbolic.’137 Prominent NGOs such as Oxfam and Médecins sans Frontières, which had
campaigned hard for a broad agreement, have charged that it is so complex, riddled
with restrictions, safeguards and red tape as to be ‘unworkable’. 138 For their part,
African countries seem to welcome the deal. South Africa’s Ambassador to the WTO,
for instance, immediately announced that he believed ‘the mechanism will work, it
can work and we intend to use it’.139 Professor Abbott, a leading TRIPS expert who
was involved in advising a group of developing countries, has an interesting
viewpoint. First of all, he confirms that the negotiating process was ‘ugly’, and that he
is concerned about the implementation of the Decision.140 He makes it very clear,
however, that the rules are not the problem. Unlike Oxfam or Médecins sans Frontières,
he does not see the paragraph 6 procedures as particularly burdensome. The problem,
in his view, is the risk that poor countries may be pressured into not making use of the
mechanism. As a possible solution, he calls for leadership from the stronger of the
developing countries, as well as active support from multilateral institutions such as
WHO, the World Bank, UNCTAD and the UN human rights bodies in order to
encourage developing countries to use the paragraph 6 mechanism.

D Promoting Public Health in the Post-Doha Era

The TRIPS Agreement establishes universal minimum standards of legal protection
and enforcement for a number of different forms of intellectual property rights.141 Due

134
See Abbott, ‘Non-Violation Nullification or Impairment Causes of Action under the TRIPS Agreement
and the Fifth Ministerial Conference’, Occasional Paper No. 11, July 2003, Quaker United Nations Office,
available at http://www.quno.org.
135
See supra note 6.
136
See Press Release 350, 30 August 2003, available at www.wto.org.
137
Comment, ‘Drug Resistance’, F.T, 29 August 2003.
138
See Joint Oxfam-MSF Press Release, 30 August 2003, available at www.oxfam.org and CPTech
Statement, available at www.cptech.org.
139
See ‘WTO Clinches Deal on Cheap Medicines’, 31 August 2003, at www.gulf-times.com.
140
See Abbott, supra note 5.
141
See e.g., Reichman, ‘Universal Minimum Standards of Intellectual Property Protection under the TRIPS
Component of the WTO Agreement’, in C. M. Correa and A. A. Yusaf (eds), Intellectual Property and
International Trade: The Trips Agreement (1998) 21; M. Blakeney, Trade Related Aspects of Intellectual
Property Rights: A Concise Guide to the Trips Agreement (1996); J. Watal, Intellectual Property Rights in the
WTO and Developing Countries (2001).
148 EJIL 15 (2004), 123–150

to different social and economic structures and scientific and technological capacities
in various Members, this one-size-fits-all approach to intellectual property protection
simply does not work. The optimal intellectual property regime is bound to vary
widely from one country to another, taking full account of each Member’s own
development levels. Patent law itself owes its very birth not to harmony but to
diversity of national law.142 Recognizing the Doha Declaration as a guideline for the
protection of public health, developing and least-developed country Members should
make every effort to incorporate their respective sustainable development policies into
their patent laws on the basis of effective use of the flexibility inherent in the TRIPS
Agreement.
1 Use of the Flexibility in the TRIPS Agreement
Using safeguards in intellectual property law to protect public health necessitates the
following national legislative provisions and policies:
● compulsory licensing is essential to many developing country Members so that
sources of generic or low-cost drugs can be made available.143 Developing
countries can limit the costs of the patent system for their population by
facilitating generic entry and generic competition by using compulsory licensing.
Therefore, developing countries should establish workable laws and related
procedures to give effect to compulsory licensing and then make cautious use of
this tool.
● limited exceptions provided for in Article 30 of the TRIPS Agreement are crucial
to developing country Members. Although the wording of Article 30 is
ambiguous and what ‘limited exceptions’ could be used is therefore not yet clear,
it is widely accepted that the ‘early working exception’144 falls under the category
of ‘limited exceptions’. Generally, developing countries should include this
exception in their patent laws to facilitate early entry of generic competition in
the pharmaceutical sector on patent expiry. Meanwhile, developing countries
should also seek Article 30-compatible exceptions to patent rights.
● under the TRIPS Agreement, Members are free to shape the legal system
regarding the exhaustion of intellectual property rights and the control of
anti-competitive practice.145 Therefore, developing country Members may estab-
lish the parallel importation and control of anti-competitive practices systems
conducive to the protection and promotion of public health.

142
See Duffy, ‘Harmony and Diversity in Global Patent Law’, 17 Berkeley Technology Law Journal (2002) 685.
143
See Abbott, ‘Compulsory Licensing for Public Health Needs: The TRIPS Agenda at the WTO after the
Doha Declaration on Public Health’, Occasional Paper No. 9 (2002), at 17. See also, Scherer and Watal,
‘Post-TRIPS Options for Access to Patented Medicines in Developing Nations’, 5 JIEL (2002) 914.
144
The early working exception makes it legal for a generic producer to import, manufacture and test a
patented product prior to the expiry of the patent in order that it may fulfil the regulatory requirements
imposed by particular countries as necessary for marketing as a generic.
145
See Articles 6 and 40.2 of the TRIPS Agreement.
 The Road to Doha and Beyond 149

2 Beyond TRIPS
According to the WHO, a number of socio-economic factors other than the patent
system have contributed to the diminishing availability of affordable drugs in poor
nations. WHO recognizes four key factors that influence access to drugs: rational
selection and use, affordable prices, sustainable financing, and reliable health and
supply systems.146 Many different actors have roles to play in making these factors into
enabling forces, rather than obstacles. These actors include governments of
developing countries, governments in industrialized countries, manufacturers,
consumer groups and non-governmental organizations, and international agencies
and private foundations. Therefore, TRIPS-related reforms will not suffice. The
following five recommendations should be given top priority.
First, given the lack of commercial interest in researching infectious diseases
prevalent in developing countries,147 public funding for research on health problems
in developing countries should be increased. This additional funding should seek to
exploit and develop existing capacities in developing countries for this kind of
research, and promote new capacity, both in the public and private sectors. The
increased funds should aim at assisting developing countries to gradually build a
sound technological base to address the public health and public policy concerns, and
to provide a sufficient economic incentive to spur the development of low-cost generic
drugs by companies located in developing countries.
Second, governments in both developing and developed countries should play a
stronger role in formulating risk prevention policies, including more support for
scientific research, improved surveillance systems and better access to global
information. Meanwhile, they should give top priority to developing effective,
committed policies for the prevention of globally increasing high risks to health. 148
Third, global efforts to find a workable, cost-effective and transparent way to
expand access to affordable drugs should be continued. Recently, a number of ways
have been sought to improve public access to essential drugs for people in poor
countries, for instance, differential pricing and financing,149 the initiative of a global
fund to fight against diseases of poverty150 and the establishment of a public-private
partnership model.151 Think tanks, independent researchers and policy makers should
146
See WHO, ‘More Equitable Pricing for Essential Drugs: What Do We Mean and What Are the Issues?,
Background paper for the WHO-WTO Secretariat Workshop on Differential Pricing and Financing of
Essential Drugs, Høsbjør, Norway, 8–11 April 2001.
147
See Médecins Sans Frontières (MSF), supra note 38.
148
See WHO, supra note 13.
149
See WHO, supra note 146; WTO, Background Note Prepared by Jayashree Watal for the WHO-WTO
Secretariat Workshop on Differential Pricing and Financing of Essential Drugs, Høsbjør, Norway, 8–11
April 2001. See also, Hammer, ‘Differential Pricing of Essential AIDS Drugs: Markets, Politics and Public
Health’, 5 JIEL (2002) 883.
150
‘The Global Fund to Fight AIDS, Tuberculosis & Malaria’ is one of most influential programmes. It may be
visited at www.globalfundatm.org/.
151
See Kettler, ‘Using Intellectual Property Regimes to Meet Global Health R&D Needs’, 5 Journal of World
Intellectual Property (2002) 655, at 674–677; see also, Reichman and Lange, ‘Bargaining around the
TRIPS Agreement: The Case for Ongoing Public-Private Initiatives to Facilitate Worldwide Intellectual
Property Transactions’, 9 Duke Journal of Comparative International Law (1998) 11.
150 EJIL 15 (2004), 123–150

continue to research the issues concerned and provide intellectual input to

governmental negotiating agencies. There needs to be a concerted and united fight
against global public health crises.
Fourth, international collaboration should be strengthened to combat disease
crises. Based on the principle of transparency, WTO should cooperate with other
relevant international organizations and non-governmental organizations. The
cooperation should encourage states to make constructive dialogues on how to have
successfully married implementations of the TRIPS Agreement with their obligations
under international human rights law. Additionally, it should inspire the engagement
and participation of civil society for the sake of fostering public scrutiny of
governmental policies on intellectual property protection.
Fifth, the pharmaceutical industry should perform its corporate social responsibility
and respond to the growing public concern about the accountability and the social,
and economic, impact of its comparatively high-priced drugs and corporate policies.
The pharmaceutical industry can and should play an important role in addressing the
deeply unequal or asymmetrical access to essential drugs between rich and poor
countries. Therefore, pharmaceutical companies should scrutinize how they can
undertake their core business in a way that ensures that benefits are shared more
evenly between rich and poor countries, and re-evaluate the impact of their business
policies on the universal enjoyment of fundamental human rights.

Conclusions
We live in a dangerous world, a world which is becoming increasingly vulnerable to
potential public health crises. The recent alarming outbreak of Severe Acute
Respiratory Syndrome (SARS) in South-east Asia makes it clear once again that
international cooperation is essential in combating global public health crises. Only
through global action can we solve global health problems. We are in the midst of a
global expansion in the extent to which pharmaceutical innovations are protected by
the intellectual property system. Finding a balanced intellectual property system that
can provide appropriate incentives to motivate private participation in R&D solutions
and which also ensures that patients and governments can have access to the results
of scientific and technological progress is a global challenge confronting international
health policy-makers and WTO negotiators.
The Doha Declaration clarifies the right of WTO Members to incorporate flexibilities
built into the TRIPS Agreement into their domestic intellectual property laws to
protect and promote public health. With the Declaration, Members are now more
confident of their right to shape their intellectual property laws in a manner conducive
to public health. It is crucial, however, that the ‘spirit of Doha’ be preserved, and that
both the Declaration and the implementation decisions thereunder be applied in good
faith. Not only is the legitimacy of the WTO at stake but, even more importantly, so are
the lives and health of millions of poor people throughout the world.