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The Role of the Pharmaceutical Industry and the World Trade Organisation in Vaccine Research and Development

First published in Croatian on Radnička Prava, 25/8/2022. The article is translated as a part of the cooperation between the members of the Eastern European Left Media Outlet – ELMO. Translation: Borna Karanušić.

Only 16 percent of people in low-income countries have been vaccinated. While some of the poorer countries have asked the World Trade Organisation (WTO) for exemption from intellectual property rights regarding vaccines, it is clear that the WTO continues to put profit ahead of the health of the entire world population.

Vials of the COVID-19 vaccine. Photo credit: US Department of Defense (God curse them), Wikimedia.

Coronavirus is still with us and, while we are slowly getting used to living with it, many vaccination problems have not yet been resolved. More specifically, there are problems with the development, production, and distribution of the vaccine, in which the pharmaceutical industry and the World Trade Organisation (WTO) play a major role (along with the health sector). This is most evident when it comes to intellectual property protections.

In October 2020, India, Kenya, South Africa, and Eswatini submitted a request to the WTO for an exemption from the obligations related to the protection of intellectual property rights in the case of medical products developed to combat Covid-19, which are defined by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The TRIPS Agreement stipulates that patent rights are protected for a period of 20 years. This is a major problem when a pandemic like this one occurs as medical copyright prevents countries from producing a generic vaccine or drug or, better yet, sharing knowledge about developed formulas for new vaccines.

The request for exemption was opposed by the United States, the United Kingdom, Japan, Canada, Switzerland and the EU, all rich countries with large pharmaceutical companies that can produce their own vaccines. Their opposition was based on the pretext that many countries do not have the capacity to produce vaccines and that the benefits of granting the exemption would not be significant. Although the request was not successful, a small shift and amendments to intellectual property rights took place this year at the 12th WTO Ministerial Conference, which took place from the 12th to 17th of June in Geneva. On 17 June 2022, a Decision was adopted, addressing this request for exemption from the obligations of the TRIPS Agreement, specifically when it comes to medical products developed for combating Covid-19. This Decision allows for more flexibility regarding intellectual property when it comes to Covid-19 vaccines.

The Decision encourages the reduction of export restrictions, and provides for trade facilitation measures, greater transparency in trade, and cooperation with international organisations, and more. The Decision focuses exclusively on vaccines, not other drugs and medical products needed to treat Covid-19, only partially addressing the problem faced by many poor-income countries. Additionally, the right to export vaccines is limited to countries with low and medium-low income, which excludes countries like China, one of the largest vaccine producers. In six months, the right to export will supposedly be extended to other medical products related to Covid-19, but that timeline is unlikely given the WTO’s reputation for implementing decisions in the past.

Ministerial Conference in Geneva, 12-17 June 2022. Photo: WTO

This Decision, although written in a positive tone, nevertheless puts profit before health and protects the existing international system that protects intellectual property, as well as the pharmaceutical industry. Not only does the Decision not protect health, it also does not promote the transfer of new technologies in vaccine manufacturing, so these minor changes are practically meaningless for the countries of the Global South, which includes poor and less developed countries in Africa, Latin America and parts of Asia and the Middle East, which have the most affected and least vaccinated populations.

Recent data provided by Our World in Data indicates that this slight blow to intellectual rights protection is still insufficient. In underdeveloped countries, only 20.2 percent of the population is vaccinated, compared to 67.2 percent in developed countries. In South Africa, 32 percent of the population is vaccinated, while that number is 73 percent in the European Union, 75 percent in the UK, 67 percent in the United States, 84 percent in Australia, and 89 percent in China. In high-income countries 74 percent of the population is vaccinated; in upper-middle income countries 79 percent; in middle-income countries 56 percent; and in low-income countries only 16 percent.

It should be noted that the pharmaceutical industry sees the situation differently from those in need and, according to their view, the granting of an exemption from the TRIPS Agreement for Covid-19 vaccines sends the wrong message to those engaged in research, development and innovation in medicine. From the point of view of the pharmaceutical industry, intellectual property protection is not an obstacle to the pandemic response; rather, it is a means to deliver safe (and legally protected) health solutions. Even though these solutions are available only to the rich.

Prior to this WTO Decision, two more meetings were held to discuss vaccine shortages, but these also did not contribute to the solution. Namely, the 75th World Health Assembly, which took place in Geneva on 22 May 2022, whereas the Covid-19 crisis was discussed only marginally at the European Union-African Union summit in Brussels in February 2022.

After a two-day meeting between the EU and African leaders, a proposal for a solution on technology transfer emerged. As part of a project implemented by the World Health Organisation (WHO), the European Commission, Germany, France and Belgium will invest 40 million euros in a technology hub that will enable African countries (Egypt, Kenya, Nigeria, Senegal, South Africa, and Tunisia) to increase production capacity and start producing mRNA vaccines for commercial sale (mRNA is a new and complex technology based on teaching cells how to produce proteins that will create an immune response to health threats), all in order to bridge the gap between the wealthier West. In the long run, this hub should facilitate the massive production of vaccines against tuberculosis and malaria. African leaders stressed that their countries cannot rely on donations from the West because this is not a viable solution; rather, the solution is to develop their own capacity to produce vaccines and medicines.

On one hand, there is a shortage of vaccines, and on the other hand, Western countries have a completely different problem with vaccination, namely a vaccine surplus, be it surplus orders or the amount of unused vaccines. According to the Croatian Institute of Public Health (HZJZ), Croatia has so far ordered 12.2 million doses of Covid-19 vaccine, while a total of 5.2 million doses have been used. For the end of next year, another 7 million doses have been reserved whereas 1.3 million unused doses remain stored in the warehouses. 354,999 doses were destroyed due to the expiry date. According to the HZJZ, Croatia was allocated 40 million doses according to its population, but this number proved to be too large and the competent institutions requested that this be reduced to 19 million doses (12.2 million so far and 7 million doses for the forthcoming period) in order to reduce surpluses. In the EU, other Member States have asked for contract changes because they have also ordered too many vaccine doses that are about to expire and therefore cannot be used. Like Croatia, Poland is also planning to destroy a certain amount of its vaccine doses. In a letter sent to the European Commission, Polish Minister of Health Adam Niedzielski, along with the ministers of Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania and Romania, asked for a reduction of vaccines ordered and a revision of contracts between vaccine manufacturers and EU Member States to address potential surpluses in a timely manner.

This series of events shows how pharmaceutical companies from the rich and developed countries of the Global North continue to hold a monopoly on research when it comes to new vaccines and drugs for Covid-19 (and this can also apply to any other disease or pandemic), which has devastating consequences for the people of the Global South, as poorer countries do not have the economic power to provide their citizens with vaccines and medicines and are thus in a more unfavourable situation.

While declaratively offering to help, the EU has in reality resisted the demands of the Global South and has instead defended the commercial interests of domestic companies, all the while protecting the right to intellectual property, thereby favouring profit over personal and public health.

Snježana Ivčić (1981) holds a PhD in public policy from the Faculty of Political Science in Zagreb. She has a great interest in the history of public health, the privatization of the healthcare systems, the nurses’ history and the impact of the EU on the health policies of the member states. She is a member of the Organization for Workers’ Initiative and Democratization (OWID). From early 2013 until 2020, she was involved in the research project “The Continuity of Social Conflict in Croatia 1987-1991”, conducted in cooperation with the Centre for Peace Studies (CMS) and the OWID. She currently works in the Croatian Academy of Sciences and Arts.