#BTColumn – TRIPS and Health Review
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by Tara Leevy
Over the past decade, global health issues and questions relating to the impact of international trade on global health have taken center stage.
The diverse nature of health-related conflicts that have arisen in the context of international trade dramatically illustrates that it is no longer possible to view global health and international trade issues as existing in separate silos.
Global health issues that have emerged over the past decade that cut across international trade law and policy include access to medicines and vaccines; fight against infectious diseases; food safety; food security and nutrition; and access to health services.
Regarding access to medicines and vaccines, the World Health Organization (WHO) estimates that about a third of the world population does not have access to essential medicines and that more than fifty (50) for One hundred percent of people in poor countries do not have access to the most basic essential medicines.
New challenges for global health in the field of infectious disease control have emerged. HIV / AIDS, Ebola and Marbug viruses, bird flu and now the COVID-19 pandemic pose major threats to global health.
This SRC Trading Thoughts will demonstrate that, although to a large extent the Agreement on the Trade Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO) has not sufficiently taken into account the impact of international trade on global health and violated the enjoyment of the right to health, the COVID-19 pandemic ushered in a new dawn of coherence in the field of international trade and health.
The right to health
The right to health is affirmed in various international conventions. Article 25.1 of the Universal Declaration of Human Rights states: “Everyone has the right to an adequate standard of living for his health and that of his family, including food, clothing, housing, medical care. and the necessary social services ”.
The International Covenant on Economic, Social and Cultural Rights (ICESCR) provides in article 12.1 that States Parties recognize “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health”. Article 12.2 sets out a number of “measures to be taken by States parties… to achieve the full realization of this right”.
In addition, the right to health is recognized in Article 5 (e) (iv) of the International Convention on the Elimination of All Forms of Racial Discrimination of 1965, in Articles 11.1 (f) and 12 of the Convention. on the Elimination of All Forms of Discrimination against Women of 1979 and article 24 of the 1989 Convention on the Rights of the Child.
Several regional organizations also recognize the right to health, for example Article 11 of the European Social Charter of 1961 as revised, Article 16 of the African Charter on Human and Peoples’ Rights of 1981 and the Article 10 of the Additional Protocol to the American Convention Convention on Human Rights in the Field of Economic, Social and Cultural Rights of 1988.
The right to health is also enshrined in many national constitutions – over 100 constitutional provisions include the right to health, the right to health care or health-related rights such as the right to a healthy environment. .
The WTO TRIPS Agreement: A Historical Perspective
The TRIPS Agreement is the WTO Agreement that has drawn the most severe criticism as its perceived negative impact on the right of states to safeguard the right to health of their members. The TRIPS Agreement requires WTO members to establish minimum standards to protect and enforce intellectual property rights.
The TRIPS Agreement provides comprehensive coverage of several types of intellectual property, including product and process patents, copyright and related rights, trademarks, geographical indications, industrial designs, trade patterns. configuration (topographies) of integrated circuits and protection of undisclosed information. However, most of the TRIPS and public health debate centers on the TRIPS patent provisions.
The implementation of the TRIPS Agreement imposed a heavy social and economic cost on developing and least developed countries (LDCs) which had traditionally excluded food and drugs from their intellectual property laws in order to ensure that these basic necessities are accessible and affordable.
When the TRIPS Agreement entered into force in 1995, although it exempted LDCs from patent rules, most of them lacked production capacity and depended on cheap imports from others. countries, such as India, where low-cost generics were available.
This shortage of pharmaceutical manufacturing capacity in LDCs meant that once generic supplier countries (often other developing countries) became subject to TRIPS patent rules, developing countries and LDCs were faced with at unaffordable drug prices.
Although in theory TRIPS provides for some flexibility, especially in the form of compulsory licenses, poor countries have often been pressured by more powerful interests to oppose the use of such mechanisms.
The impact of TRIPS on the ability of states to protect the health of their citizens has been clearly illustrated in a dispute that has arisen between South Africa and several pharmaceutical companies. In South Africa, more than three million of the country’s 40 million citizens are infected with the acquired immunodeficiency virus (HIV), and thousands of new cases of HIV appear every month.
In 1998, South Africa passed a law that gave its Department of Health the discretion to allow parallel importation (purchase from a country where the drugs needed are cheaper) and licensing mandatory in critical situations. South Africa was seeking to allow such parallel imports and compulsory licenses under Article 31 of the TRIPS Agreement.
A consortium of forty drug companies filed a lawsuit against South Africa’s actions, alleging that multinational drug companies were being scammed by countries trying to obtain cheap drugs.
The case was finally settled out of court. Likewise, Thailand has sought to produce some patented AIDS drugs locally, but this has also caused furore among drug companies.
The Doha Declaration proposed what would become Article 31bis of the TRIPS Agreement, the first, and to date the only, amendment to the WTO Agreement. Under Article 31bis, a country in need of a particular pharmaceutical product, and without the manufacturing capacities to produce it, can import the medicine under compulsory license from a producing country without violating the provisions found elsewhere in the Agreement.
Although the frame was to be used extensively, it was only used once as it is considered heavy. Article 31a sets out several procedural conditions that an exporting Member State must fulfill when issuing a compulsory license.
However, with the onset of the COVID-19 pandemic, we are witnessing the dawn of a new era in relation to the TRIPS Agreement. To make COVID-19 products and vaccines more accessible, a group of developing countries – South Africa and India and has since been co-sponsored by Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt, African Group, LDC Group, Maldives, Fiji and Namibia – submitted proposal to TRIPS Council to suspend intellectual property protections for necessary products and technologies the fight against COVID-19, including vaccines, during the pandemic.
The document calls for a waiver for all WTO members from certain provisions of the TRIPS Agreement regarding the “prevention, containment or treatment” of COVID-19.
According to the promoters, the goal is to avoid barriers to timely access to affordable medical products, including vaccines and drugs, or to increased research, development, manufacturing and the provision of essential medical products.
After initially rejecting it, the ground seems to have changed with the recent announcement by the United States of its limited support for a TRIPS waiver.
There has been less support from other developed countries, but since the United States indicated its support for the waiver, the European Union and New Zealand have expressed greater willingness to negotiate. The Africa, Caribbean and Pacific (ACP) Group is a strong supporter of the waiver proposal.
The path to follow
Despite this progress, much remains to be resolved before the waiver translates into an increase in vaccine supply.
First, the issue is less about authorization and more about how waiver can work. WTO rules – through article 31bis – already allow the temporary suspension of intellectual property rights in public health emergencies such as the COVID-19 pandemic.
Second, the details of the COVID-19 vaccine waiver have yet to be worked out and require consensus among WTO members. It can take months, years, or even impossible.
Third, the Biden administration has only indicated that it would be willing to waive patent protection for vaccines. It would not be enough. The exemption should apply to all medical products.
In summary, then, we see that while historically TRIPS has taken a boost, particularly for its strict patent protection and the detrimental effect it has had on the ability of developing countries to access it. cheap medicines, the COVID-19 pandemic appears to have heralded a new era – an era in which we are witnessing a willingness by WTO members to negotiate a milder, milder and more country-friendly TRIPS agreement in development.
Tara Leevy is a Dominican lawyer who has practiced regionally in Dominica, Barbados, Saint Lucia and Jamaica and is a guest contributor to the Trading Thoughts section of the CBC. Learn more about SRC at www.shridathramphalcentre.com.