AN EVALUATION OF THE TRIPS AGREEMENT

AND ACCESS TO HEALTH CARE DEBATE

BY:
Manikanta Mahima
20BAL7015
BA.LLB

SUBMITTED TO:
Mr. Ananthu S Hari

Amaravathi
Andhra Pradesh, INDIA

MARCH,2023
 CONTENTS

Table of Contents

INTRODUCTION…………………………………………………………………………..…………2

THE DOHA DECLARATION AND ITS LEGAL STATUS:…….………………………………….3

TRIPS FLEXIBILITIES IN THE POST DOHA CONTEXT:…………………………..……………3

COMPULSORY LICENSE:………………………………………………………………..………...4

PARAGRAPH 6 DECISION AND THE PROTOCOL AMENDING THE TRIPS

AGREEMENT…………………………………………………………………..…………………5

TRIPS AND COVID-19:…………………………………………………….………………..7

CONCLUSION:………………………………………………………………………………………8
INTRODUCTION:

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an

international agreement that was established by the World Trade Organization (WTO) in 1995.
Its aim is to harmonize intellectual property rights (IPR) laws and regulations across countries,
thus promoting innovation and technological development. However, the implementation of
TRIPS has been controversial, particularly in relation to access to healthcare. One of the main
issues with TRIPS is that it can lead to higher prices for essential medicines, as it allows for
patent protection of pharmaceutical products. This can result in limited access to life-saving
drugs, particularly in low-income countries where people cannot afford the high prices. Critics
argue that TRIPS prioritizes pharmaceutical companies' profits over people's health needs,
particularly those living in developing countries.

The Doha Declaration on the TRIPS Agreement and Public Health was adopted to address this
issue in 2001. The Declaration affirmed the right of governments to take measures to protect
public health and ensure access to essential medicines for all. It also recognized the need for
flexibility in the implementation of TRIPS, particularly in relation to pharmaceutical patents.
Since the adoption of the Doha Declaration, there have been efforts to improve access to
healthcare while also maintaining the benefits of intellectual property rights. For instance,
countries such as Brazil, India, and South Africa have used the flexibility in TRIPS to issue
compulsory licenses for the production of essential medicines, thereby reducing their cost and
increasing access to them.

The TRIPS agreement and access to healthcare debate has been brought into sharp focus by the
COVID-19 pandemic. The pandemic has highlighted the tension between protecting intellectual
property rights and ensuring global access to life-saving medicines and vaccines. The pandemic
has underscored the importance of global cooperation and solidarity in addressing public health
crises, and efforts must be made to strike a balance between protecting intellectual property rights
and ensuring access to healthcare for all. The TRIPS agreement and access to healthcare debate
will continue to be a key issue in the post- pandemic world, as countries grapple with the long-
term impacts of the pandemic and work towards building more resilient and equitable healthcare
systems.

THE DOHA DECLARATION AND ITS LEGAL STATUS:

The Doha Declaration on TRIPS Agreement and Public Health has clarified that public health has
predominance over private commercial interests, and the victory of public health over trade
interests is momentary. Using trade sanctions, the big pharmaceutical industries and the
developed countries effectively prevented developing countries from entirely using the
flexibilities in the TRIPS Agreement procured by the Doha Declaration. Ultimately, developed
countries use free trade agreements to impose TRIPS-plus obligations on developing countries.
These developments once again ascertain that the trade forum has its limits in protecting public
health interests against trade interests.

The major achievement of the Doha Declaration is that it stressed the need for the TRIPS
Agreement to be part of the wider national and international action to address the public health
problems afflicting the developing and least developed countries 1. In pursuing that objective, it
came to the agreement that the TRIPS Agreement ‘does not and should not prevent members
from taking measures to protect public health’ and it ‘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’ 2. It also reaffirmed the right of WTO Members
to use the TRIPS flexibilities to the fullest extent possible to protect public health and promote
access to medicines.

TRIPS FLEXIBILITIES IN THE POST-DOHA CONTEXT:

Paradoxically, developing countries continued to experience setbacks with reference to all types
1
The Doha Declaration on TRIPS Agreement and Public Health, WT/MIN(01)/DEC/2
2
Paragraph 4 of the Doha Declaration on TRIPS Agreement and Public Health
of TRIPS flexibilities. Every attempt by the developing countries to pursue the Doha principles
met with severe resistance in the form of trade sanctions from the developed countries and Big
Pharma. It could also be seen that the developed countries simultaneously resorted to forum
shifting once again, this time from the TRIPS Agreement to bilateral or regional Trade
Agreements, to serve their trade interests. These bilateral or regional trade agreements quite often
reveal a tendency to go TRIPS-plus. A brief overview of how the developed countries, prompted
by Big Pharma, continued to resist the developing countries when they attempted to make use of
different TRIPS flexibilities is given below:

COMPULSORY LICENSE:
Compulsory licensing is a provision under the TRIPS agreement that allows governments to
override patent rights and allow for the production and distribution of generic versions of
patented medicines, in certain circumstances. This provision is intended to strike a balance
between protecting intellectual property rights and ensuring access to essential medicines,
particularly in low-income countries. Under the TRIPS agreement, compulsory licensing can be
used in cases of national emergency or other circumstances of extreme urgency, or for public
non-commercial use. In order to issue a compulsory license, the government must follow certain
procedures, including notifying the patent holder, negotiating with the patent holder, and
providing adequate compensation for the use of the patent. In several cases, compulsory licensing
has been used to increase access to essential medicines, particularly for HIV/AIDS and cancer
treatments. For example, in 2001, the government of South Africa issued a compulsory license
for generic versions of HIV/AIDS medicines to make treatment more affordable and accessible
for its citizens.

Interesting information revealed by the database is the higher level of compulsory licensing
activity in Upper Middle-Income Countries (UMICs) than in Low-Income Countries (LICs) and
the Least Developed Countries (LDCs). The reason for LDCs and LICs not resorting to
compulsory licensing could be traced to many factors: alternative sources for generic drugs
available to those countries from countries like India which enjoyed the benefits of the transition
period up to 2005; lack of manufacturing ability of those countries even after the lapse of more
than ten years of the commencement of TRIPS Agreement as result of non-fulfillment of the
TRIPS obligation under Article 66.2; and fear of political and trade sanctions from developed
countries. Since the chances for getting generic drugs from India have reduced after 2005, the real
reasons must be the poor manufacturing ability due to lack of transfer of technology or fear of
trade sanctions. The study confirms this view when it attributes the high UMIC activity to the
comparatively high production and distribution capacity of UMICs over LICs and LDCs and their
ability to withstand political pressure and threats of retaliatory action.

A significant impediment for the developing countries in utilizing TRIPS flexibilities is the
concern that it could provoke retaliatory actions, including market withdrawal by the patent-
owning pharmaceutical companies and trade sanctions from the governments of developed
countries representing those companies3. A policy brief prepared by the South Centre to
commemorate the 10th anniversary of the WTO Ministerial Doha Declarations on TRIPS and
Public Health has expressed concern over the fact that ten years since the Doha Declaration,
multinational pharmaceutical companies and developed countries continue to exert commercial
and political pressure on developing countries not to make use of TRIPS flexibilities for public
health.4

In spite of the Doha Declaration, developing countries are reticent in making use of compulsory
licensing. Only countries that have the ability to resist the pressures from Big Pharma and the
developed countries, that vigorously uphold the interests of Big Pharma, can be expected to come
up with further experiments of this nature. This has to be read in contrast with the use of
compulsory or other forms of non-voluntary licensing by developed countries, especially the US5.
This shows the weakness of the trade forum to safeguard the public health interests of developing
countries, in spite of the high public opinion in their favor

PARAGRAPH 6 DECISION AND THE PROTOCOL AMENDING THE TRIPS AGREEMENT:

Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, adopted in

3
Ho Cynthia M, Patent breaking or balancing? Separating strands of fact from fiction under TRIPS (Loyola University Chicago
School of Law, Public Law & Legal Theory - Research Paper No 2009-003), North Carolina Journal of International Law and
Commercial Regulation, 34 (2) (2008) 373.
4
Abbott Frederick M & Reichman Jerome H, The Doha Round’s Public Health Legacy: Strategies for the production and
diffusion of patented medicines under the amended TRIPS provisions, Journal of International Economic Law, 10(4) (2007)
921, 937
5
Supra note 7
2001, recognized the importance of protecting public health and ensuring access to essential
medicines for all. It affirmed that the TRIPS agreement should be interpreted and implemented in
a manner that is supportive of public health and that countries have the right to use the
flexibilities provided for in the agreement to protect public health. The Paragraph 6 Decision,
adopted in 2003, provides a temporary solution to address the issue of access to medicines in
countries with insufficient manufacturing capacity. The decision allows countries with
insufficient or no manufacturing capacity for patented medicines to issue compulsory licenses and
import generic versions of those medicines from countries with the manufacturing capacity to
produce them. The decision also provides for the waiver of the obligation to seek the agreement
of the patent holder before issuing a compulsory license, in cases where efforts to obtain a
voluntary license on reasonable commercial terms have failed. It also requires that the importing
country notify the patent holder of the decision to issue a compulsory license and information on
the quantity and destination of the medicines being imported.

The Protocol Amending the TRIPS Agreement, adopted in 2005, provides a permanent solution
to the issue of access to medicines by allowing for the export of generic medicines to countries
with insufficient manufacturing capacity, even in the absence of a national emergency or other
circumstances of extreme urgency. The protocol also includes provisions related to the prevention
of the diversion of medicines and the notification and consultation requirements between
importing and exporting countries.

The major drawback of the paragraph 6 decision is the rule complexity. Generic drug
manufacturers need transparency and certainty, to have a clear understanding of their market
potential and a minimum assurance of the safety of their investment, when they apply for a
compulsory license. The high degree of rule complexity disincentivizes pharmaceutical
companies from using this provision to export generic medicines to countries having limited/no
manufacturing capabilities. It is no wonder that since the adoption of the paragraph 6 decision it
was invoked only once, and the amendment to TRIPS is not yet ratified by the required majority.

TRIPS AND COVID-19

The COVID-19 pandemic has brought the TRIPS agreement and access to healthcare debate
into sharp focus, particularly in relation to the global distribution of vaccines. The World Health
Organisation (WHO) launched the Access to COVID-19 Tools Accelerator(ACT-A) to ensure
equitable access to COVID-19 vaccines in response to the pandemic. Treatments, and
diagnostics. However, the TRIPS agreement has been a stumbling block in this effort as it
protects intellectual property rights, including vaccine patents.

Several countries, particularly those in the global south, have called for a waiver of TRIPS
provision related to COVID-19. The waiver would enable countries to produce and distribute
vaccines without fear of infringing on patent rights, thereby increasing access to vaccines for
their populations. The United States has recently expressed support for the waiver, which has
been welcomed by many global health organizations and activists. However, some
pharmaceutical companies and developed countries have opposed the waiver, citing concerns
about the impact on innovation and intellectual property rights.

In October 2020, India and South Africa submitted a proposal to the World Trade Organization
(WTO) for a temporary waiver of certain provisions of the TRIPS agreement related to
COVID-19 medical products, including vaccines, treatments, and diagnostics. The proposal
calls for a waiver of obligations related to patents, trade secrets, industrial designs, and
copyright protection for medical products and technologies related to COVID-19. The waiver
would be in place for the duration of the pandemic and would apply to all countries, not just
low-income countries.

India and South Africa argue that the TRIPS agreement, as currently interpreted, hinders access
to affordable COVID-19 medical products, particularly for developing countries. They argue
that the waiver would allow countries to overcome barriers to access and accelerate the
production and distribution of martial art to control the pandemic. The proposal has been
supported by several low-income and developing countries and several international
organizations, including the World Health Organization (WHO) and UNAIDS. Supporters of
the proposal argue that it is necessary to ensure global access to life-saving COVID-19 medical
products, particularly for low-income countries that may not have the resources to procure
them. However, the proposal has been opposed by some high-income countries, including the
United States, the European Union, and Japan. These countries argue that the TRIPS agreement
already includes provisions for flexibility in times of public health crises and that the proposed
waiver could disincentivize investment in research and development, which could have long-
term negative consequences for public health.

In conclusion, the India and South Africa proposal for a TRIPS waiver in the context of
COVID-19 has sparked a contentious global debate about the balance between protecting
intellectual property rights and ensuring global access to life-saving medical products. The
proposal highlights the need for global solidarity and cooperation in addressing public health
crises, and efforts must be made to strike a balance between protecting intellectual property
rights and ensuring access to healthcare for all

CONCLUSION:
Pressure tactics practiced by the developed countries at the instance of pharmaceutical industries
inside and outside the TRIPS forum promote trade interests rather than public health interests.
Even the hard-earned small gains of developing countries are continuously being thwarted by
these methods. This reaffirms the inability of trade fora to handle public health, a basic human
right which is to be protected by all members of the United Nations Organizations.6

BIBLIOGRAPHY

1. Abbott Frederick M, The Doha Declaration on the TRIPS Agreement and

Public Health: Lighting a dark corner at the WTO, Journal of International
Economic Law, 5 (2) (2002) 469–505.
2. The Doha Declaration on TRIPS Agreement and Public Health,
3. Thuo Gathii James, The legal status of the Doha Declaration on TRIPS and
Public Health under the Vienna Convention on The Law of Treaties’,
Harvard Journal of Law & Technology, 15 (2) (Spring 2002) 291.

6
Data exclusivity in international trade agreements: What consequences for access to medicines? MSF Technical Brief 2004
4. Smith Richard D, Correa Carlos and Oh Cecilia, Trade, TRIPS, and
pharmaceuticals, Lancet, 373 (9664) (2009) 684–691.
5. Ho Cynthia M, Patent breaking or balancing? Separating strands of fact
from fiction under TRIPS (Loyola University Chicago School of Law,
Public Law & Legal Theory - Research Paper No 2009-003), North
Carolina Journal of International Law and Commercial Regulation, 34 (2)
(2008) 373.
6. Muzaka Valbona, The Politics of Intellectual Property Rights and Access to
Medicines (Palgrave Macmillan), 2011, p. 91.