April 7, 2022

Breaking the cycle of profits and patents in a pandemic

Jaume Vidal

COVID-19, intellectual property, and unequal access to health technologies: painful lessons and reasons for hope

The COVID-19 pandemic, which brought in its wake so much heartache and turmoil, did not happen in a vacuum, but within already established structures of social inequity and patterns of political imbalance. The development and subsequent procurement of vaccines followed—and continues to follow—a trend whereby the wealthy were the first to access medical technologies, while the rest were forced to wait and hope for the best. A profit-driven biomedical research and development model and the important role that intellectual property (IP) plays in the business strategies of large, transnational pharmaceutical companies were also strong winds for the perfect storm.

Solidarity is never as close and necessary to survival as when a threat, like a pandemic, makes no distinction between border or wealth, and no country would escape unscathed. The response from the international community veered from the hefty words in the early days of the pandemic proclaiming vaccines to be global public goods, to the ensuing confusing multiplication of initiatives with lofty ambitions of global distribution of vaccines. Finally, we settled on the realization that, for the European Union and other pharma-friendly governments, even in such unprecedented times, it would be business as usual when it comes to IP and access to health technologies.

The waiver as a solution and indictment

That is why the proposal for a temporary TRIPS waiver on COVID-19 health technologies, submitted by South Africa and India in October 2020 (and revised with additional co-sponsors in May 2021), was timely and remains relevant[1]. It highlighted the fact that IP rules backed by the World Trade Organization (WTO) TRIPS Agreement were allowing for monopolies life-saving health goods. In addition, the limited existing  manufacturing capabilities (located essentially in the United States, European Union, United Kingdom and a few other countries) were clearly insufficient to meet global demand; the conditions for the  scramble for vaccines, as had happened with Personal Protective Equipment were set.

Secondly, it showed that dichotomy between access to health technologies and the protection of IP, which had already flared during the AIDS pandemic in the 90s, is still very much alive. Back then, when, in South Africa, the Mandela government attempted to use legitimate (and in line with international legal requirements) means to acquire generic antiretrovirals in a fight against a disease that was ravaging its population, it was brought to court by dozens of transnational pharmaceutical companies. This happened with the political support of their host governments, chiefly in the US, Europe, and UK. The backlash of such a move united Global South activists with grassroots organisations all over the world and brought about the Doha Declaration (November 2001)[2], endorsed by all WTO members. This would confirm the right of governments to make use of flexibilities in the enforcement of the TRIPS agreement in connection to pharmaceutical products.

While a victory for activists and developing countries, the Doha Declaration has shown its limits, especially for countries that are without pharmaceutical manufacturing capabilities of their own. It took years for governments to agree to a provisional solution, and over a decade for it to become a permanent amendment to the TRIPS agreement. In the meantime, the use of flexibilities, such as compulsory licensing, was de facto denied to most developing countries, especially on the African continent.

With the Covid-19 pandemic raging and  the goal of universal equitable access to life-saving health goods thwarted by limited manufacturing capabilities rooted in patent-based monopolies, many realized that only an exceptional measure covering all COVID-19-related items (including vaccines, therapeutics and diagnostics) would cut it. Only in combination with other measures, for example, strengthening of national health systems, regulatory capacities, and supply chains, could constitute an effective response to the challenge of a highly infectious disease.

A proposal with many supporters but fiercely opposed by a (powerful) few

The proposal was, initially, met with skepticism by the European Union, the US and a few additional countries like the UK and Switzerland. As the number of co-sponsoring governments grew, as did the support from civil society and academics, the position of the EU hardened and turned into strong opposition, even to the notion of a waiver.

Positions on the waiver evolved in some cases and hardened in others. The US, followed by other countries like Australia, publicly announced that they would not oppose to a waiver as long as it was limited to vaccines (hence excluding all other health technologies). The EU meanwhile did not even consider the issues raised by South Afria and India when presenting their response (self-styled as counterproposal) which essentially identified streamlining the use of compulsory licenses and lifting export controls as the best measures to counter shortcomings in production and delivery of COVID-19 related health goods.

For more than a year, there was no effective discussion about the proposal submitted by South Africa and India with meetings of WTO bodies like the TRIPS Council and the General Trade Council witnessing repeated demands for additional information by parties opposing the temporary waiver without engaging in a meaningful dialogue. At the same time, the European Parliament approved up to three formal calls for the European Commission to start text-based negotiations, a call echoed by dozens of national MPs as well as former heads of government and academics. 

While it opposed the TRIPS waiver at WTO and other international forums, the EU multiplied the announcements of unilateral initiatives to improve access to COVID-19 vaccines: from the support to the COVAX facility to the scale up of (unused) vaccine donations[3] and proposal of a new Pandemic treaty[4]. Mentioned often by European Commission officials as evidence of their commitment to global health and to equitable universal access to health technologies, such gestures were for the most part lacking in transparency, accountability or consultation with the interested parties and other stakeholders.

Fotos: Marcelo Leal / Unsplash

Hope amidst the rage

Pace of events picked up in early 2022, after the cancellation of the 12th WTO Ministerial Conference in November of last year, with numerous informal meetings between the US, the EU, India and South Africa[5] (known as the Quad group). It was difficult to ascertain what was being discussed due to the lack of transparency and confidential nature of the conversations. The fate of trade, global health and multilateralism decided behind closed doors.

After increasing rumors about the general direction of the talks, a leaked document from the European Commission[6], purported to reflect a tentative agreement within the Quad group, was shared by several media outlets which labelled it a compromise (welcomed by the WTO DG).. Only applicable to vaccines, limited to the duration of the pandemic and dealing only with patents, the document seemed to add another bureaucratic layer to the use of TRIPS flexibilities  and it did not address most of main points of the original TRIPS waiver proposal. The discord was such that numerous voices indicated that it could not be considered a waiver.

However, as it was clearly stated by TRIPS waiver proponents, supporters, and allies: it was never a goal per se but part of a wider effort, framed in the long term. In gaining support from fellow governments and organized civil society, the mobilization and outreach efforts of the last 17 months have cemented, in public opinion, political parties and other stakeholders, the notion that there is a deep felt need for a major overhaul of how access to health technologies is managed and shaped. A conversation and discussion that will go on long after the pandemic is declared over.

This exchange must include, on one hand, only long-standing demands from the Global South regarding effective technology transfer, sharing of know-how and health-oriented IP management and, on the other  hand, the promises and commitments made by wealthy nations on such initiatives (WHO Covid-19 Technologies Access Pool, the mRNA tech transfer hub or the ongoing negotiations around pandemic preparedness[7]). The support professed by EU member states to greater equity in access to health technologies will then be put to a test. As will the ability and capacity of Global South governments to participate fully in discussions that affect them the most.

Finally, even though the TRIPS waiver discussions may have shown the limits of diplomacy and the declining appeal of multilateralism it also offers a valuable example how a coalition of governments, civil society and individual citizens worked together for a response to crisis guided by a moral compass and not short-term economic profits or political gains. It was not the first time and it will certainly not be the last.

Jaume Vidal is a Political Science graduate, specialising in International Relations, with a 20-year strong career on public health issues. His particular area of interest is the intersection between intellectual property rights, innovation, access to health technologies and human rights. His professional experience includes roles in various international organisations, think tanks and non-government organisations.

[1] DESIERTO, D Overcoming the Global Vaccine and Therapeutics Lag and ‘Vaccine Apartheid’: Abuse of Rights in the EU’s Continued Blocking of the TRIPS Waiver for COVID Vaccines and Related Medicines  Blog of the European Journal of International Law   25th January 2022 Accesible at https://www.ejiltalk.org/overcoming-the-global-vaccine-and-therapeutics-lag-abuse-of-rights-in-vaccine-apartheid-and-the-eus-continued-blocking-of-the-trips-waiver-for-covid-vaccines-and-related-medicines/ Consulted 18 March 2022

[2] See WORLD TRADE ORGANIZATION (WTO) Declaration on the TRIPS agreement and public health DOHA WTO MINISTERIAL 2001: TRIPS WT/MIN(01)/DEC/2 20 November 2001 Accessible at https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm Consulted 18 March 2022 Of special interest was paragraph 6 “ We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002” which was the object of protracted negotiations which would culminate, in 2017, with the adoption of Art. 31 bis as an amendment to the TRIPS agreement.

[3] information on European Union’ s support for Covax, ACT-A as well as “vaccine sharing” and other initiatives at EUROPEAN COMMISSION Global response to Coronavirus Accessible at  https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/safe-covid-19-vaccines-europeans/global-response-coronavirus_en Consulted on 18 March 2021

[4] European Council. An international treaty on pandemic prevention and preparedness Accessible at https://www.consilium.europa.eu/en/policies/coronavirus/pandemic-treaty/ Consulted on 18 March 2021

[5] Such quadrilateral dialogue with the support of the WTO DG, also know as Quad group, was deemed as exclusionary by other WTO members like the UK and Switzerland

[6] FURLONG, A Compromise reached on COVID-19 vaccine intellectual property rights waiver Politico Accessible at https://www.politico.eu/article/compromise-reached-on-covid-19-vaccine-intellectual-property-rights-waiver/ Consulted on 18 Mach 2022

[7] See WHO Director-General’s opening remarks at first meeting of the Intergovernmental Negotiating Body to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response – 24 February 2022 Accessible at https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-first-meeting-of-the-intergovernmental-negotiating-body-to-draft-and-negotiate-a-who-convention-agreement-or-other-international-instrument-on-pandemic-prevention-preparedness-and-response-24-february-2022 Consulted on 18 March 2022