WTO and the Right to Health: Pharmaceutical Patents During

COVID-19
Mansi Avashia and Rohin Goyal are fourth-year students at Gujarat National Law University.

Introduction
Due to the large-scale spread of the COVID-19 pandemic, there was a worldwide demand for the
development of a vaccine to combat the virus. However, there are concerns about how the
assignment of intellectual property rights to the owner of the vaccine can delay its production
and trade.

In this paper, the authors argue that the general notion that intellectual property rights and human
rights are at loggerheads with one another will not act as an impediment to the vaccine
distribution in the market. This argument is expanded by showing that the World Trade
Organization Agreement [“WTO Agreement”] and the Agreement on the Trade Related
Aspects of Intellectual Property Rights [“TRIPS Agreement”] grant some form of protection to
human rights. The flexibility of the TRIPS Agreement in unprecedented situations such as the
coronavirus will also be analyszed. Thus, we believe that a vaccine for the coronavirus will not
be restricted by the existing international trade and intellectual property principles.

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 Part I

WTO agreement protects Human Rights

At present, around 75% of the Preferential Trade Agreements [“PTAs”] contain human rights
protections and obligations. This reflects a progress in international law, which shows that States
believe they cannot fulfill their economic goals without complying with good governance
principles and human rights law. However, this is still not common in agreements drafted by
developing and middle-income countries.

The human rights promoted in these agreements include, inter alia, privacy rights, transparency,
due process, access to information provisions, access to affordable medicines. Most of the WTO
members have ratified the International Covenant on Civil and Political Rights [“ICCPR”] and
the International Covenant on Economic, Social, and Cultural Rights [“ICESCR”] and hence,
they are obliged to uphold and promote human rights in their policies.

Understanding the relationship between WTO and Human Rights

In the event of a conflict between a trade law principle and a well-recognized human right, the
latter will prevail over the former. The trade law must be interpreted in light of the particular
human right because the objectives of trade law are not more significant than the protection of
human rights. Strengthening the economy is important but all business and trade practices have
to be accountable for human rights protection.

The United Nations Committee on Economic, Social, and Cultural Rights has emphasized that
trade liberalization is ‘a means, not an end’. It has been specified that trade should seek to
achieve human well-being, as understood in international human rights agreements.

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 How Does WTO Promote Human Rights?

The following mechanisms have been used for the promotion of human rights in the WTO:

Negotiations

The General Agreement on Tariffs and Trade [“GATT”] negotiations have helped in the
development of the existing trade law regime. Since all countries are free to participate and give
their suggestions, human rights protection has often been a topic of discussion in these
negotiations.

Waivers

Waivers are a form of permission granted to a WTO member from other members to not comply
with regular commitments. With respect to human rights protection, the members came up with a
Kimberley Process Certification Scheme to ascertain that consumers and producers do not
engage in trading of diamonds to indirectly fund wars in the Democratic Republic of Congo or
Sierra Leone.

Trade Policy Reviews

The WTO has a Trade Policy Review Mechanism to review the national trade policies of its
members. In 1995, the restrictions of the reviews’ applicability to traded goods were removed
and it was extended to intellectual property rights and trade in services. It is a peer-reviewed
assessment undertaken by the WTO General Council. These policy reviews often lead to the
discussion of human rights in member States.

GATT provisions

Article XX of the GATT provides for general exceptions under which the members can be
exempted from applying the GATT rules to pursue specific interests. This extends to the
protection of public morals, animal, human, and plant life or health, measures related to prison
labour, and preservation of natural resources. These exceptions were carved out when

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international human rights were not as well developed as it is today. The text is wide enough to
include a large number of exceptions as a result of which a WTO Member can help in human
rights protection without violating GATT principles.

Understanding the consonance between the two

Although trade law and human rights law have developed in their separate ways after World War
II, international law as a whole today aims at promoting peace, security, social and economic
development. The world is largely integrated, and the challenge is to eliminate poverty,
suffering, and exclusion with the help of the globalization. Trade, a major driving force of the
globalization process, should not violate human rights.

The general rule is that human rights, due to their status of customary international law, will
prevail over any specific or conflicting provisions of any treaty, such as WTO law. The preamble
of the WTO does not make achieving free trade an indispensable goal. It also seeks to achieve a
better standard of life and sustainable development. It is widely accepted that such objectives
cannot be fulfilled without due regard for human rights.

Smooth functioning of markets has a strong connection with human rights promotion. This is
because markets contribute to economic and social development by producing resources.
Production of resources means adequate food, education, housing, and employment for more
people, which is often discussed in modern literature. This creates an environment for self-
fulfilment and free choice. Thus, there is a dual contribution by markets –- to human welfare and
development.

Due to increased globalization and dependency, there is a need to remove barriers for efficient
interaction between different stakeholders located in different countries. Removal of such trade
barriers is the WTO’s primary goal. Nations cannot unilaterally achieve such goals of
liberalization, thus the WTO, by promoting market efficacy, promotes the well-being and human
rights of people.

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 TRIPS Agreement Protects Human Rights

Protection of intellectual property has serious implications on developing countries when it

comes to the protection of human rights as well as access to basic medicines. Currently, most of
the developed countries in the world have started vaccinating their population while other lesser
developed nations are still trying to reduce the impact of the virus on its people. At such a time,
if countries seek to profit off their vaccine by imposing high licensing costs, it could spell
disaster for a sizeable percentage of the world’s population.

Diseases that amount to pandemics like COVID-19, H1N1, or HIV-AIDS are a global threat,
whose impacts are significantly reduced with access to affordable medications. The right to
health has long been recognized as a basic human right, both by national governments and
international organizations. It is incomplete without the right to essential drugs and vaccines.
Therefore, it becomes necessary to examine whether the TRIPS Agreement is inclusive of the
right to health.

To examine this, this component has been divided into 3 parts

1. Should the TRIPS Aagreement protect the right to health?

2. Does the TRIPS Aagreement protect the right to health?
3. How does the TRIPS Aagreement protect the right to health?

Should the TRIPS Agreement Protect the Right to Health Over IPR Rights?

Article 27.1 of the TRIPS Agreement prima facie allows pharmaceutical inventions to be eligible
for patent protection. Pharmaceutical patents, however, are vulnerable when it comes to
generating monopolies in the quest for preventing the introduction of competitive generic
products during the term of a patent. This, in turn, leads to an oligarchic or monopolistic control
of the price of drugs, vaccines, and technologies. The combination of globalization and TRIPS
patent rights would give drug companies the ability to create monopolies and oligarchies and

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artificially inflate prices which would thereby result in a reduction in the ability of poor countries
to access essential drugs and vaccines.

Pursuant to these considerations, the Doha Ministerial Conference in 2001 passed a declaration
stressing the need for the TRIPS Aagreement to be integrated within a wider international action
and not work independently to address these problems. It acknowledged that the protection of
intellectual property is necessary for the invention of novel medicines, but also highlighted the
major concerns about its effect on prices. Additionally, it was agreed in the Doha Conference
that the TRIPS Aagreement should be implemented in a way that is supportive of a Member
Nation’s right to protect public health and that it should not work against the human right to the
health of individuals across the globe. It further went on to hold that the right to health includes
the right to access to essential drugs and medicines. Despite this, however, there is nothing
substantive preventing pharmaceutical lobbies from compelling governments to provide strong
patent protection.

In the book ‘The Right to Health’, Brigit Toebes analyses that under international human rights
law, the right to health covers the right to medicines, vaccines, disease prevention, and also
highlights the preconditions a state should guarantee for the protection of people’s health. It
includes the enjoyment of the highest attainable standards of both physical and mental health.
This interpretation has been recogniszed in international human rights instruments, national
legislation, domestic and international courts of law.

Does the TRIPS Agreement Protect the Right to Health?

Preamble

The Preamble of the TRIPS Aagreement contains:

1. A desire to reduce distortions and impediments to international trade and

considering the need to promote effective and adequate protection of intellectual
property rights.
2. A recognition of the underlying public policy objectives of national systems for
the protection of intellectual property, including developmental and technological
objectives and.

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 3. A recognition of the special needs of the least-developed country members in
respect of maximum flexibility in the domestic implementation of laws and
regulations to enable them to create a sound and viable technological base.

This can be interpreted in a manner that suggest that the TRIPS Aagreement focuses on a need to
protect Intellectual Property R rights in the sphere of international trade without compromising
on the duty WTO owes to the lesser developed countries.

The right to health is implied in the aim and object of TRIPS. The Preamble, Articles 7 and 8,
consists of expressions like ‘public policy’, ‘conducive to social and economic welfare’, and
‘public health’. These lack internal explanation and thus, one needs to rely on the interpretation
of panels, appellate bodies and external sources such as human right norms. While Article 7
focuses on generic terms such as public policy and social and economic welfare, Article 8 dwells
deeps into broader principles such as necessary measures for the protection of public health,
technological development and specific measures that would prevent abuse of the intellectual
property by the patent owners responsible.

Analysis of Article 8

Article 8 embodies the broad principles under which the TRIPS Aagreement has been framed.
Article 8.1 permits the Mmembers States to undertake necessary measures for the protection of
public health and nutrition and promotion of public interest in important sectors for socio-
economic and technological development. Article 8.2 refers to the possible need to make
provisions that prevent owners from abusing intellectual property in such a way that might
adversely affect trade or the international transfer of technology. It also elucidates the need for
technology transfer which is generally regarded as advantageous in economic and social
development. Such expression suggests that Article 8(1) is not subordinate to other provisions of
TRIPS and Article 8 has constituted a policy statement to explain the rationale for measures
taken under Articles 30, 31, and 40.

The WTO Panel relied on this interpretation of the Preamble in the case of Canada-Patent
Protection of Pharmaceutical Products. In this dispute, the Panel held, there is an element of
public policy within the TRIPS Agreement and that patent disclosure obligations will necessarily
lead to the advancement of science, technology, and society. The Panel further held that the

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Object and Purpose of the TRIPS Aagreement can be found by a conjoined reading of Article 7,
8, and the Preamble.

This proposal is strengthened by the fact that, in paragraph 4, the Doha Health Declaration
explicitly integrates the word "access to medicines". The particular terms used to encourage
"access to medicines" represent the aims of TRIPS participants to recognize the right to health,
since access to medicines is a very critical part of the fundamental right to health. The WHO
Action Programme on Essential Drugs has also taken a step in this direction by interpreting the
people’s right to health as a duty of the state to provide essential and life-saving drugs.

Therefore, it is seen that the TRIPS Aagreement protects the right to health and access to
essential medicines.

How does the TRIPStrips Aagreement protect the right to health, in cases like pandemics?

Human rights bodies have observed that Article 31 of the TRIPS Agreement is significant for the
promotion of the right to health by facilitating access to affordable essential drugs. The Article
creates a provision for ‘compulsory licensing’ whereby a member state may make use of a patent
without the authoriszation of the right holder when certain conditions are fulfilled. Other parties
can develop and provide safe life-saving drugs with reasonable compulsory licencing
arrangements. Compulsory licensing is extremely important in health-sensitive patent law and is
necessary to promote competition and increase the affordability of drugs. It allows member states
to use, provide, and manufacture a specific patented drug, if the situation is that of national or
extreme emergency and would result in the saving of lives. The state would be subject to no
consequences for an action under this article.

There are 2 requirements for a member state to compulsorily license a patented product –-
national emergency and other circumstances of extreme urgency. However, the TRIPS
Agreement does not define these terms and the only requirement within the text is that the
invoking party should notify the patent holder as soon as possible.

Paragraph 5(b) of the Doha declaration affirms the freedom of each party to decide the grounds
for compulsory licensing and paragraph 5(c) makes it clear that the member has the inherent
right to determine what constitutes a “national emergency” or “other circumstances of extreme
urgency” and that a compulsory license can and should be issued based on good faith. Further,

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the paragraph goes on to elaborate on the fact that HIV/AIDS, Malaria, and Tuberculosis are
examples of epidemics and states are justified in declaring these public health crises as national
emergencies. Looking at the present COVID -19 scenario, it is quite clear that any nation may
choose to declare it as an emergency to bypass any patenting of a vaccine or cure.

Even if the branded version continues to be covered by a patent, a government may grant a
compulsory licence, essentially allowing a generic version of a drug to be licenced. Compulsory
licenses are one of the flexibilities in the WTO’s agreement on intellectual property — the
TRIPS Agreement. The Doha Declaration on TRIPS and Public Health further indicates that
countries are entitled to decide what constitutes a national emergency or other serious emergency
situation.

Findings:

Thus, if any country attempts to patent a vaccine or cure for COVID-19, it may not actually stop
any other countries from manufacturing and using it under the TRIPS agreement as:

1) The grant of compulsory licensing is in the perspective for respecting, protecting, and
fulfilling the right to health.
2) Article 31 of the TRIPS Aagreement prevents a member nation from patenting a life-
saving drug for purely economic reasons.
3) Member states are free to determine the constituents of national emergency, extreme
urgency, and public non-commercial use. The public non-commercial use
justification can not only be used for compulsory licensing to deal with epidemic
disease, but it can be used to handle other diseases which impact upon the public
interest domain - iIn this case -, the COVID-19 Pandemic.

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 STATE SOVEREIGNTY AND HUMAN RIGHTS

Given that the international law system is founded upon the consent of states and respecting state
sovereignty/practice it is highly possible that States would want a coronavirus vaccine should
have maximum accessibility and Intellectual Property Rights restrictions should be removed.

At the WTO’s TRIPS Council, the governments of India and South Africa have requested the
WTO to waive certain provisions of the WTO and TRIPS Agreements, related to patents,
copyrights, industrial designs and protection of undisclosed information. This request was made
in October 2020 as they believe that if this is not done, developing and lesser developed
countries will not get equal access to the vaccine.

Canada has circumvented the process under Article 31 that mandates consultation and
negotiation with the patent owner before manufacturing and licensing a drug. The European
Union has suggested a ‘patent pooling’ system for speeding up the manufacturing process. Thus,
it may be possible that States will consent to create an exception and allow for the supply of the
vaccine to combat the pandemic.

CONCLUSION

Often, critics of the organization argue that the WTO has not managed to protect human rights
and other policy objectives. Through this paper, the authors try to argue that members attempt to
reconcile their human rights obligation with the help of the WTO as well as TRIPS regime. Since
the WTO members have emphasiszed the right to health and access to medicine, the agreements
will not obstruct the distribution of a coronavirus vaccine.

The coronavirus vaccine developers can be given a transferable or roaming patent, with the help
of which the company can be granted an additional patent on a product of their choice, and the
coronavirus vaccine can be freely distributed. This can solve the availability problem and the
developer would still be entitled to royalties. Other incentives such as government commitment
and rapid regulatory reviews can also be given. Important articles in both the TRIPS Aagreement
that allow for compulsory licensing and the WTO preamble which enshrine the inherent
importance of human rights in the arena of international trade law highlight the progressive

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mindset of the drafters of these agreements and are today ensuring that in the pursuit of
liberalized international trade, basic necessities that protect people are not forgotten.

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