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by Tara Leevy
Over the past decade, global health issues, and questions about the impact of international trade on global health have taken centre-stage.
The diverse nature of health-related conflicts that have arisen within the international trade context dramatically illustrate that it is no longer possible to view issues of global health and international trade as existing within separate silos.
Health issues of global significance that have emerged over the past decade, and cut across international trade law and policy, include access to drugs and vaccines; infectious disease control; food safety; food security and nutrition; and access to health services.
As regards access to drugs and vaccines, the World Health Organisation (WHO) estimates that about one third of the world’s population lacks access to essential drugs, and that over fifty (50) per cent of people in poor countries do not have access to the most basic essential drugs.
Novel challenges to global health in the area of infectious disease control have emerged. HIV/AIDS, the Ebola and Marbug viruses, avian influenza, and now, the COVID-19 pandemic, constitute major threats to global health.
This SRC Trading Thoughts will demonstrate that whilst to a large extent, the World Trade Organisation’s (WTO) Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) has not taken adequate account of the impact of international trade on global health and has infringed upon the enjoyment of the right to health, the COVID-19 pandemic has ushered in a new dawn as regards coherence in the area 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 a standard of living adequate for the health of himself and of his family, including food, clothing, housing and medical care and necessary social services’.
The International Covenant on Economic, Social and Cultural Rights (ICESCR) provides in Article 12.1 that States parties recognise ‘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 ‘steps to be taken by States parties…to achieve the full realisation of this right.
Additionally, the right to health is recognised, 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 in Article 24 of the Convention on the Rights of the Child of 1989.
Several regional organizations also recognise 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 Article 10 of the Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social and Cultural Rights of 1988.
The right to health is also enshrined in numerous national constitutions-over one hundred 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
TRIPS is the WTO Agreement which has attracted the harshest criticism in so far 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 for protecting and enforcing intellectual property rights.
TRIPS provides comprehensive coverage for several types of intellectual property including product and process patents, copyright and related rights, trade marks, geographical indications, industrial designs, layout designs (topographies) of integrated circuits, and the protection of undisclosed information. However, most of the debate with respect to TRIPS and public health focuses on TRIPS’ patent provisions.
The implementation of TRIPS imposed a heavy social and economic cost on developing countries and least developed countries (LDCs) that had traditionally excluded food and medicine from their intellectual property laws in order to ensure that these basic necessities were accessible and affordable.
When the TRIPS Agreement went into effect in 1995, although it exempted the LDCs from patent rules, most of them lacked production capacity and depended on cheap imports from other countries, such as India, where low-cost generics were available.
This shortage of pharmaceutical manufacturing capacity in LDCs meant that once the generic supplier countries (often other developing countries) became subject to TRIPS patent rules, both the developing and LDC countries were faced with unaffordable drug prices.
Although theoretically TRIPS provide for some flexibility, notably in the form of compulsory licensing, poor countries were often pressured by more powerful interests against using such mechanisms.
The impact of TRIPS on the ability of states to safeguard the health of its citizens was clearly illustrated in a dispute which arose between South Africa and several pharmaceutical companies. In South Africa, over three million of the country’s forty million citizens are infected with the Acquired Immune Deficiency (HIV) virus, and thousands of new HIV cases emerge each month.
In 1998, South Africa passed a law which gave its Ministry of Health discretion to authorize parallel importing (buying in a country where the needed drugs are cheaper) and compulsory licensing in critical situations. South Africa sought to authorize such parallel importing and compulsory licensing under Article 31 of TRIPS.
A consortium of forty drug companies filed suit against South Africa’s actions alleging that multinational drug companies were being ripped off by countries which attempted to obtained cheap drugs.
The matter was eventually settled out of court. Similarly, Thailand, has sought to produce some patented AIDS drugs locally, however this has also caused furor among pharmaceutical companies.
The Doha Declaration proposed what would eventually become Article 31bis of the TRIPS Agreement, the first, and to-date only, amendment of the WTO Agreement. Under Article 31bis, a country in need of a particular pharmaceutical product, and without the manufacturing capabilities to produce it, is able to import the drug under a compulsory license from a producing country without violating provisions found elsewhere in the Agreement.
Although the framework was expected to be widely used, it has been used only once as it is considered to be unwieldy. Article 31bis outlines several procedural conditions an exporting Member state must fulfill when issuing a compulsory license.
However, with the onset of the COVID-19 pandemic, we are witnessing the advent of a new era as regards 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, the African Group, the LDC Group, Maldives, Fiji and Namibia – submitted a proposal to the TRIPS Council to suspend intellectual property protections for products and technologies needed for the fight against COVID-19, including vaccines, for the duration of the pandemic.
The document calls for a waiver for all WTO members of certain provisions of the TRIPS Agreement in relation to the “prevention, containment or treatment” of COVID-19.
According to the proponents, the objective is to avoid barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing, and supply of essential medical products.
After initially rejecting it, the ground seems to have shifted with the United States’ recent announcement of its limited support for a TRIPS waiver.
There has been less support by other developed countries, however since the United States has indicated its support for the waiver, the European Union and New Zealand have been expressing more willingness to negotiate. The African Caribbean and Pacific (ACP) Group is a strong supporter of the waiver proposal.
The Way Forward
Despite this progress, much remains to be resolved before the waiver is translated into increased vaccine supply.
First, the problem is less about permission and more about how the waiver may work. WTO rules – through Article 31bis – already allow for the temporary suspension of intellectual property rights in situations of public health emergencies like the COVID-19 pandemic.
Second, the details of the COVID-19 vaccine waiver are still to be worked out and require consensus among the WTO membership. This could take months, years, or even prove to be impossible.
Third, the Biden administration has only indicated that it would be willing to waive patent protection for vaccines. This would not be sufficient. The waiver should apply to all medical products.
In sum, then, we see that whilst historically, TRIPS has taken a lashing, especially for its stringent patent protection and the detrimental effect it has had on the ability of developing countries to access cheap medicines, the COVID-19 pandemic appears to have heralded a new age – one in which we are witnessing a willingness of WTO members to negotiate a kinder, gentler and developing country-friendly TRIPS Agreement.
Tara Leevy is a Dominican attorney, who has practised regionally in Dominica, Barbados, Saint Lucia and Jamaica and is a guest contributor to the SRC’s Trading Thoughts column. Learn more about the SRC at www.shridathramphalcentre.com.
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