The first United States (US) human trials of a coronavirus vaccine began in March. These trials are being conducted by a research organisation in Seattle.  Two other frontrunners in the vaccine race are also US-based pharmaceutical companies. These are not the only candidates, there are many research groups, scientists and pharmaceutical companies racing to develop a vaccine and who finds it will play a large role in determining the price tag.

Although Dr. Tedros Adhanom Ghebreyesus, director-general of the World Health Organisation has said the vaccine should be affordable to all, there are questions about how this will be achieved. In particular, coronavirus vaccines developed by private pharmaceutical companies are likely to be subject to strong intellectual property (IP) protections and may carry unaffordable price tags. Deficiencies in existing laws may hinder efforts to make a potential vaccine affordable for developing countries and have a devastating impact on the global spread of corona.

The challenges of making medicines, vaccines and other health technologies affordable, accessible and available in developing nations are not new. Over the last two decades, demands to address this issue have led to the recognition of affordable medicines as an integral component of the right to health. As a result, a number of legal instruments have been adopted internationally that are designed to make lifesaving technologies accessible to low- and middle-income countries. The current outbreak of COVID-19 exposes the limitations of these instruments and provides an opportunity to introduce new measures to ensure that access to prevention and treatment are realised, not just for coronavirus but for other diseases as well.

There are three gaps in existing legal frameworks which, if addressed, could ensure that we are able to make access to an affordable and effective coronavirus vaccine a reality for all. First, we need to create more expansive benefit-sharing arrangements as a core component of pandemic preparedness. Second, we need to make vaccines affordable in the same way that generic medicines are by creating mechanisms to reduce the price of new vaccines.  Finally, developing countries need to streamline and strengthen local capacity to regulate and approve new health technologies.

Lack of Benefit Sharing Arrangements

Responses to the outbreak of COVID-19 have been extraordinarily fast and this is, in significant part, thanks to how quickly the virus sequence was shared. The sequence was shared just two days after the WHO announced the discovery of COVID-19. This enabled the development of diagnostic tests and is the reason why we are able to diagnose coronavirus.  Now, due to developments in virus sequencing and modelling, many of the vaccine candidates could be developed quickly once the virus sequence had been shared by scientists in China. A few years ago, scientists relied on virus sharing instead of sequence sharing to achieve many of these things. For this reason, when Indonesia refused to share virus samples of the avian flu in 2006, this presented a significant barrier to the development of a vaccine. Indonesia’s decision was motivated by a desire to make any vaccine developed accessible to its population and a belief that the samples they shared would be used by pharmaceutical companies to create a vaccine that Indonesians would not be able to afford.

When Indonesia refused to share virus samples, this started a discussion about equity in virus sharing and led to the creation of a (kind of) solution. This solution, or at least the start of one, was the WHO Pandemic Influenza Preparedness framework, also known as the PIP framework.  The PIP Framework is not binding but provides a guide (and sample contracts) to ensure equitable benefit sharing – i.e. equitable access to vaccines and medicines – when influenza virus samples are shared.  The PIP Framework is limited – it only applies to influenza viruses with pandemic potential, not other viruses. It also applies only to virus sharing, not the sharing of other kinds of information like the virus sequence. This immediately makes the framework outdated to deal with benefits sharing relating to things like virus sequencing.

Consequently, populations in China and other developing countries have little guarantee that any vaccines or treatments developed will be shared equitably. As a result, the affordability and accessibility of these interventions remain unanswered.  Developing a more comprehensive framework related to information sharing and pandemic preparedness would allow developing countries to respond without leaving unanswered fears that they will be unable to make treatments and vaccines affordable to their populations.

Deficiencies in the Doha Declaration

IP protections on medicines, vaccines and other medical technologies can make life saving interventions completely inaccessible, allowing pharmaceutical companies to profit at the cost of public health.

In 2000, dozens of the world’s biggest pharmaceutical companies filed a law suit against the South African government for violating IP protections by introducing measures to make antiretroviral drugs to treat HIV more affordable. After extensive public outcry and activism, this case was dropped in 2001 and the government was able to roll out HIV treatment to everyone in the country.

After this, it was decided that, internationally, IP rights could no longer continue to limit access to life saving medicines in developing countries. This led to the adoption of the Doha Declaration in 2001, an agreement that allowed low- and middle-income countries to prioritise public health over IP rights. The Declaration introduced several measures that make medicines more affordable including allowing compulsory licenses and parallel imports—which allow for the production or import of cheaper drugs without the permission of the company which originally developed them.  Affordable medicines are now available in many developing nations. There are also pharmaceutical manufacturers based within these countries who are able to produce and supply large quantities of the required drugs.  This has not been the case for vaccines.

When the Declaration was negotiated, little attention was paid to vaccines and as a result, there are few measures which could be used to make vaccines affordable. In 2001, few vaccines were covered by patents so IP protections hadn’t been a significant barrier to accessing vaccines.   But with increasing outbreaks of novel viruses, this has changed, and the Doha Declaration offers limited solutions to this new problem of producing affordable vaccines in developing countries.

Though compulsory licenses without the involvement of IP holders are feasible for the production of generic medicines, this is not so for vaccines.  This is because highly technical information needed to produce a vaccine may not be publicly available thus requiring governments to work with an IP holder to access to this information, even in a public health emergency where negotiations would ordinarily not be compulsory.

Vaccines are also more difficult to create. Affordable vaccine production requires sufficient expertise, infrastructure and capacity to produce the vaccines at scale and at a lower cost in developing countries.  Few countries have this kind of capacity, making production of vaccines under compulsory license extremely unlikely.

With so many of the leading vaccine candidates being developed in high income countries like the US, COVID-19 highlights how the vaccine landscape has changed since 2005. At present, efforts to make vaccines affordable have relied on large international aid organisations such as Gavi, one of the biggest providers of vaccine aid to low-income countries or philanthropic foundations, such as Gates or USAID negotiating bulk purchases for eligible countries. These organisations are then in a position to determine which vaccines are provided and in what quantity with recipient countries having little say. This also leaves countries not covered by initiatives like Gavi without a route to making new vaccines affordable. There is a need to think seriously about how to create mechanisms to make vaccines subject to IP protections affordable in developing countries.  This could include investments to improve capacity and infrastructure for vaccine production or instituting global price regulation on critical vaccines.

Lack of Regulatory Capacity

An additional hurdle arises, even if an affordable vaccine can be produced.  Vaccines are often subject to very strict regulatory approvals before they can be made available in a particular country.  This is an important requirement which ensures that vaccines provided are effective and safe for us.

In countries like the US, well-established and resourced bodies like the Food and Drug Administration are able to make these decisions efficiently and a new vaccine can be made available quickly. However, many developing countries have limited capacity to evaluate new vaccines and have few measures in place for recognition of approvals in other countries. Measures such as the African Medicines Regulatory Harmonization Initiative attempt to streamline approval processes through the creation of a regional body whose approvals would be recognised by member countries.  Creating an equivalent for vaccine approvals would provide substantial safeguards against ineffective vaccines while avoiding the need for each country to invest substantially in the development of local regulatory agencies. In addition, approvals given for the original vaccines are often not transferable to “generic” versions of the vaccine and so additional testing along with entirely new approvals may be needed.

For these reasons, harmonisation of laws or the creation of regional mechanisms to recognise approvals from other countries and improving capacity in developing countries are critical to ensuring that vaccines can actually be made available to those who need it.

Conclusion

Although the COVID-19 outbreak has exposed the limitations in laws that seek to make vaccines affordable and accessible to those in developing countries, none of these limitations are insurmountable. From benefits sharing alongside information sharing to improving infrastructure to approve new medical technologies, changing the legal landscape around affordable vaccines can have benefits for broader pandemic preparedness and future outbreaks. As scientists race to develop an effective vaccine, countries – and perhaps lawyers – should be racing to fix this system and create a means to make vaccines affordable and accessible in developing countries.

Safura Abdool Karim is a senior researcher and public health lawyer at the South African Medical Research Council’s Centre for Health Economics and Decision Science – PRICELESS SA researching how to use the law to improve health.  She is a 2020 Aspen Institute New Voices Fellow.