Covid-19 Vaccine: Profit should not trump public health needs

Indian Ocean, pirates and seizures

As the world races against time in search of a vaccine to attend to the Covid-19 (coronavirus) pandemic, one cannot help but feel that the more things change around access to medicines, the more they stay the same. The search for a vaccine has re-ignited debates on the role of big pharmaceutical companies (Big Pharma) in addressing the health needs of developing countries. So far the pathway to accessing a vaccine for developing countries is as clear as mud. The big question is whether it is possible to ensure that commercial gains do not trump public health needs.

In 2009, pirates operating in the Indian Ocean caused havoc, attacking over 200 vessels and hijacking more than forty. The situation was so bad that international warships were deployed to deal with the situation. What is less known about that same year are the adventures of custom officials from the European Community, who were confiscating shipments of medicines destined for developing countries.

There were also other seizures outside of the Indian Ocean with German authorities enraging public health activists when a shipment of the generic amoxicillin was seized in Germany on its way to Vanuatu, a little-developed country in the Pacific. The reason offered for the seizure was that the drugs violated trademark rules. Surprisingly, despite this “violation,” the drugs were eventually released. The generic drugs were from India. Developing countries protested at this seizure of 3, 047, 000 tablets in Frankfurt before they could be shipped to Vanuatu. Amoxicillin is an antibiotic used to treat a broad range of bacterial infections. There was therefore anger at the seizure, given the importance of the drug to public health.

In the Netherlands, health activists through the Health Action International took on the Dutch government through the Freedom of Information Act. The request filed under this Act revealed that there had been over 17 seizures by the Dutch authorities and that the medicine they had confiscated was for diseases ranging from cardiac ailments to dementia. Dutch authorities had seized medicines destined for Ecuador, Peru, and Nigeria, amongst others, getting their authority from the European Commission Council Regulation No 1383/2003 of 22 July 2003. This regulation gave custom officials the authority to take action against goods suspected of infringing certain intellectual property rights. It is important to note that “suspicion” is enough grounds to get medicines seized.

Vaccine nationalism

One would think that talk about access to medicines and public health issues should largely be within the ambit of the World Health Organisation (WHO). The reality, however, is that important aspects of access to medicine are handled within the domain of the World Trade Organisation (WTO). This is because in 1995, what we now know as the Trade-Related Aspects of Intellectual Property Rights (TRIPS) came into force.

TRIPS covers lots of things, including the relationship between intellectual property rights and public health. TRIPS rules obligate states to grant patent owners at least 20 years of exclusive commercial rights to make or sell their inventions, such as medicines. While this aims to protect research and development investments, it allows patent holders to keep patented drug prices artificially high, putting them out of reach to many. With mark-ups of patented drugs often a significant factor in high medicine costs, the manufacture and marketing of generic medicines can significantly reduce the cost of medicines.

In the last three months, the term “vaccine nationalism” has been in ascendancy, to describe how countries are sprinting to secure doses of the Covid-19 vaccine for their own citizens first. This has seen the richer countries signing pre-purchase agreements and entering advance market commitments with big pharmaceutical manufacturers. The United Kingdom (UK) government has struck a deal with Novax, and also with Johnson & Johnson for an extra 90 million vaccine doses for its citizens. This means that the UK now has at least six advance arrangements involving four different types of vaccines.

One would think that talk about access to medicines and public health issues should largely be within the ambit of the World Health Organisation (WHO). The reality, however, is that important aspects of access to medicine are handled within the domain of the World Trade Organisation (WTO). This is because in 1995, what we now know as the Trade-Related Aspects of Intellectual Property Rights (TRIPS) came into force.

In August, the United States of America (USA) government bought 100 million doses after ploughing $1.5 billion into the Moderna experimental vaccine. They also got the right to purchase an extra 400 million doses in future bringing their total commitment to the Moderna vaccine to just under $3 billion. This does not include the funding that USA has invested in a French company Sanofi. This funding invested through the United States Biomedical Advanced Research and Development Authority gives USA the priority for future pre-orders of the vaccine. Russia, through Gamaleya Research Institute, has also developed a Covid-19 vaccine for its domestic market, unsurprisingly named Sputnik V.

It is worrying that at a time when billions of dollars of public funds are being invested in future vaccines and treatment for Covid-19, not as much energy has been put in pushing for a relaxation of intellectual property to make access to vaccines easier. This means that Big Pharma and rich countries will determine who gets access. There is, therefore, merit in calls for Covid-19 vaccines to be designated global public goods to deal with this global pandemic, because in the final analysis, no one is safe, until all of us are safe. Hence, the Covid-19 vaccines should be free from the monopoly control of pharmaceutical companies.

Strengthening local productive capacity

Part of dealing with the monopolistic tendencies of big pharma requires the building of manufacturing capacity in developing countries. The debate on strengthening the local production of essential medicines has been raging on for some time. In this respect, WHO’s posture and positioning has not exactly been helpful. WHO has argued against local production not without reason, the chief being that that local production tends to be more expensive and commercially unviable. WHO has, therefore, argued that if the production capacity by companies from the developed countries can adequately supply the world demand, then it is not necessary to produce essential medicines in developing countries as these countries can just plug in to world supply. In contrast, the United Nations Conference on Trade and Development (UNCTAD) and the United Nations Industrial Development Organization (UNIDO) have been pushing for the strengthening and support of local pharmaceutical production in developing countries.

The current scramble for access to Covid-19 vaccines and the attendant vaccine nationalism which has come with it means that the WHO position is problematic. For example, the USA, the European Union (EU) and the UK have signed pre-purchase orders for the first 2.5 billion doses of the different vaccines being developed. If anything, the position pushed by WHO has encouraged dependency which has left developing countries exposed and at the mercy of donations. Even the argument on expensive costs of production by developing country companies now seems tenuous. Big Pharma in the EU and other developed countries, including the USA, have tended to entrust certain medicine productive capacities in Asian countries to take advantage of low labour costs. However, there are now calls to reconsider this approach. The most vocal calls have come from the Germany Federal Minister of Health, Jens Spahn, who has urged the EU to seriously consider relocating back to the EU countries the production of Active Pharmaceutical Ingredients (API).

This seems to suggest that the EU may opt to pay higher costs so that it exercises some level of control on productive capacities. The pre-purchase orders for billions of doses has also created a shortage of doses which will negatively impact on Africa and most of the world’s developing countries. In short, this means that even if these developing countries were able to raise enough money, there will not be any vaccines available for purchase because of existing prior deals.

The trouble with COVAX

In April 2020, what is known as the Access to Covid Tools (ACT) Accelerator was launched as part of a global collaboration to push for equitable access to Covid-19 vaccines. COVAX is the vaccine pillar at the heart of the ACT Accelerator. This collaboration brings together scientists, governments, philanthropists and civil society organisations amongst others. COVAX is jointly led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO. The idea behind COVAX is to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee equitable access for every country in the world. It is therefore not surprising that COVAX has been touted as some kind of solution for Africa and for developing countries elsewhere.

So far, a total of $5 billion seems to have been set aside to procure vaccines for Africa. However, there are some unanswered questions, including worries that COVAX seems to be a Western-driven arrangement that prioritises self-financing countries. It is also worrying that a small group took critical decisions without much consultation on how allocations for the vaccine will be made. There are also concerns that if the pre-purchase agreements are anything to by, it may take more than a year after vaccines are out for Africa to obtain access.

What is to be done?

Against this background, it may be important for Africa to seriously explore potential multiple sources for vaccine access. China seems to be the best bet for Africa given that the country has already committed to sharing its vaccines with developing countries that it has ties with. China’s president, Xi Jinping, promised the World Health Assembly in May that its vaccines would be “global public goods”. The China Centre for Disease Control and Prevention in Beijing revealed that two vaccines developed by the Chinese pharmaceutical company, Sinopharm, will be ready latest in December. Apart from the tests in China, these two vaccines are also being tested in other countries, including Argentina and the United Arab Emirates. Russia also is a good candidate for Africa to reach out to. It has so far covered significant ground as it seeks to register its second coronavirus vaccine before the end of October. The experimental vaccine has been developed by Vector State Research Center of Virology and Biotechnology and early clinical trials were conducted on volunteers in July.

The market dominance of Big Pharma will continue to be a problem and affect access to patented health products needed to address Covid-19. However, countries should take advantage of flexibilities built in the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Doha Declaration on TRIPs and Public Health. The Doha declaration allows WTO members to interpret TRIPS in a manner that supports and promotes access to medicines. The Doha declaration also gives countries the authority to use the flexibilities provided in the TRIPS Agreement the right to grant a license, without permission from the license holder, on various grounds including public health. The demand for access to the Covid-19 vaccine will far outstrip its supply and if the world is serious with dealing with the Covid-19 pandemic, then the enforcement of patents on Covid-19 products must be suspended. The world must also invest resources in building and strengthening production capacity in developing countries.

It is worth noting that India and South Africa have jointly asked the World Trade Organization (WTO) to allow all countries to neither grant nor enforce patents and other intellectual property rights related to Covid-19 health products until some kind of herd immunity has been established. The request is a reasonable one as it calls for a waiver only within the confines of what is needed for Covid-19 prevention and treatment. At any rate, Article IX 3 and 4 of what is known as the Marrakesh Agreement Establishing the WTO (WTO Agreement) are clear that a waiver can be granted under exceptional circumstances from some obligations required by WTO treaties such as TRIPS. The granting of waivers is not unprecedented at the WTO. A waiver, for example, has previously been granted to allow countries producing generic medicines through a compulsory license to supply the medicines to other countries that do not have the capacity to produce the medicines themselves. As aptly demanded by civil society organisations, WHO and the United Nations must push for “binding commitments from biopharmaceutical companies and other manufacturers for the rapid supply of existing and future medical products, especially diagnostics, therapeutics and vaccines to developing and least developed countries at an affordable price and also ensure that intellectual property rights do not affect or hinder efforts to curb the Covid-19 outbreak”.

*Makombe is the team leader for the Democracy and Governance cluster at the Open Society Initiative for Southern Africa.