Jan Yves Remy and Mustaqeem De Gama
Through its Resolution WHA73.1 of 19 May 2020, the World Health Organization recognizes that the COVID-19 pandemic has a disproportionately heavy impact on the poor and the most vulnerable, with repercussions on health and development gains, in particular, in low-income countries. The global challenge is to produce an effective vaccine to meet the needs of world’s 7.8 billion people, in as short a time frame as possible. This will require the sharing of knowledge and technology of successful vaccines so that the widest distribution at lowest cost can be achieved.
The COVID-19 virus has had far-reaching economic impacts on the Caribbean region, exposing pre-existing vulnerabilities at a time when they were just emerging from the 2007 financial crisis, a point made by ECLAC in its Special Report on COVID-19. ECLAC further points out the social and health factors that increase the toll of the pandemic, including the large share of persons employed in the informal sector, and without social security; limited health care systems; food insecurity; disease prevalence; and the lack of access to medical equipment, medicines and protective equipment. These realities make clear that drastic and collective approaches will be needed to address priority areas exposed by COVID-19 such as infrastructure development, access to safe water, education for all, climate mitigation and other programmes that focus on sustainable outcomes and the wellbeing of the region’s citizens.
And yet, there seems to be some positive news on the horizon. Today marks the first day that the COVID-19 vaccine will be made available to persons in the United Kingdom (UK), following its approval by the medicines regulator. More approvals will surely follow in the developed world, leaving us in the Global South to wonder: will our citizens get the same access to the vaccine as our developed country counterparts?
In this SRC Trading Thoughts, we consider whether a proposed waiver from intellectual property rights protected under the “TRIPS Agreement” of the World Trade Organization provides a viable option for all WTO Members, including developing ones, to access life-saving treatments such as the COVID-19 vaccine.
CURRENT ACCESS UNDER THE WHO COVAX FACILITY
While richer countries have managed to secure vaccinations through bilateral arrangements with pharmaceutical companies, the rest of the world must rely on international efforts being coordinated under the so-called COVAX Facility. The COVAX Facility is an alliance led by the World Health Organization (WHO) in partnership with the Vaccine Alliance (GAVI), the Centre for Epidemics Preparedness Innovations (CEPI) and others.
The Facility works with pharmaceutical companies to put manufacturing in place so that vaccine doses can be procured and produced at scale as soon as they receive regulatory approval and are licensed. Higher income countries participating in the initiative’s procurement mechanism will partner with lower income countries to help evenly distribute doses. COVAX offers doses for at least 20% of each countries’ populations to be delivered when they are available, with an initial aim of having 2 billion doses available by the end of 2021, half of which will go to lower-income countries. GAVI has announced deals for 700 million vaccine doses, including through a collaboration with the Serum Institute of India and the Bill & Melinda Gates Foundation.
Approximately 184 countries – excluding the United States – have indicated willingness to participate in the COVAX Facility: 92 are “fully self-financing” and 92 are “funded participants” or “AMC-eligible countries”. Most CARICOM countries have signed on as self-financing countries, with the exception of Dominica, Grenada, Guyana, Haiti, St Lucia, St Vincent and the Grenadines which have been accepted as AMC-eligible countries (and are therefore funded). The classification system has not met with approval by CARICOM, which, at its 41st regular meeting of the Conference of Heads in November, expressed disappointment that the per capita income criterion was still being used to determine financing under COVAX. It lead to the issuance of a mandate for the Caribbean Public Health Agency (CARPHA) to explore, in collaboration with the CARICOM Secretariat and PAHO, other financing options to cover additional costs for vaccines.
ANOTHER PATH TO SALVATION THROUGH A WTO TRIPS WAIVER?
While COVAX provides one path to accessing the vaccine, it is neither a complete nor legally enforceable solution. CARICOM Member States would do well therefore to explore other options on the table for safeguarding the health of their citizens. One such option has emerged under the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), an agreement which sets minimum standards for the regulation of different forms of intellectual property (IP).
In October 2020, South Africa, India, Kenya and Eswatini presented a proposal to the WTO TRIPS Council which aims to provide easier access to medical and other IP-protected goods – including vaccines – necessary to fight COVID-19. The proposal calls on the WTO’s main deliberative body, the General Council, to do so by suspending the operation of TRIPS provisions concerning copyrights, industrial designs, patents and protection of undisclosed information in order to “prevent, contain and treat’ COVID-19, for a period of time, to be decided. If accepted, the proposal could be achieved through a so-called WTO “waiver” process – that is, an agreement by three-quarters of WTO Members to suspend TRIPS obligations.
In justifying their proposal and responding to criticisms by the US, EU, Japan, Canada and Brazil that the proposed waiver is unduly broad and granting it would curtail innovation, especially during an epidemic, the proponents have made a number of counter-arguments. First, they argue that an effective COVID-19 response requires rapid access to medical products, new diagnostics, therapeutics and vaccines in sufficient quantities and at affordable prices to meet global demand; second, that the proposal would prevent the recurrence of situations, already seen where IP-rights have hindered testing and access to medicines; and third, that the so-called “existing flexibilities” and procedures under the TRIPS Agreement are ill-equipped and too cumbersome for dealing with the COVID-19 pandemic.
By referring to existing flexibilities, the proponents mean those identified in the 2001 Declaration on TRIPS Agreements and Public Health (the Declaration) which, against the backdrop of the HIV-AIDS spread, stressed the need for national and international action to address public health problems afflicting developing countries and least-developed countries. The Declaration highlighted in particular the fact that the TRIPS Agreement allows the grant of compulsory licenses (where governments allow patented inventions to be used without the consent of the patent holder) but also that the TRIPS Agreement did not address the needs of countries with insufficient or no manufacturing capacity. The Declaration led to an amendment– under a new Article 31bis – which now allows low-cost generic medicines to be produced and exported under a compulsory licence exclusively for the purpose of serving the needs of countries that cannot manufacture those products themselves.
While most WTO Members have accepted Article 31bis, it hasonly been used once, since coming into effect in 2017. Accessing the license requires detailed notification and amendment to patent laws which makes it an unattractive option for many.
SHOULD CARICOM MEMBER STATES SUPPORT THE PROPOSED WTO TRIPS WAIVER?
The current proposal for suspension of TRIPS obligations during COVID will come up for consideration at the next TRIPS Council meetings on 10 December. At that point, CARICOM Members will have an opportunity to share their views. In considering the proposed waiver, we highlight the following six considerations to guide the position they take on the matter:
- First, that unlike the COVAX Facility which limits funding support to certain qualifying countries, access to the proposed waiver would be available to all WTO Members.
- Second, that the waiver would provide WTO Members with broader policy space than that provided under “existing flexibilities” of the TRIPS Agreement and COVAX to fully meet the needs of their constituents, putting the power, in exceptional times, back in the hands of governments.
- Third, that the waiver can facilitate knowledge-transfer and the development of home-grown medical inventions that might be constrained existing IP protections. Without the Damocles’ sword of IP enforcement hovering, we may yet see some new patentable inventions by our Caribbean scientific and engineering experts and academic institutions, including those that emerged during COVID-19 from students and faculty at the University of the West Indies.
- Fourth, that allegations that a waiver would lead to widespread abuse and halt innovation are likely overblown. Pharmaceutical companies already have received billions in government support to produce the vaccines and, just by filling first world orders, they will likely recoup (and exceed) their expenses. It is very unlikely that sales to the Third World factored into their profit and loss calculations.
- Fifth, CARICOM Member States yet to pass the Article 31bis amendment – including Suriname, Jamaica and Antigua and Barbuda – should take the opportunity to do so given that, in the absence of local or regional manufacturing capacity, the amendment would allow legal cover to access generic COVID-19 medicines or vaccines.
- Sixth, CARICOM Member States should enter into discussions with those sponsoring the waiver to address concerns that have been raised in the TRIPS Council so far, and ensure that it provides adequate flexibility, while taking account of legitimate concerns raised.
On balance, CARICOM countries should support the waiver, and thereby move closer to ensuring access to life-saving medicines and equipment for all of their citizens. Of course, there still is the matter of convincing a skeptical Caribbean population that the vaccine is actually safe to use … we will leave that for another day!
Jan Yves Remy is an international trade lawyer and Deputy Director at the Shridath Ramphal Centre for International Trade Law, Policy & Services (SRC) at The University of the West Indies, Cave Hill, Barbados; Mustaqeem De Gama is counsellor at South Africa’s Permanent Mission in Geneva, and one of the co-sponsors of the waiver proposal.
The SRC One-on-One interview between Dr. Remy and Mr. De Gama on this topic will be made available on the SRC website from December 10.