The global order has taken a disruptive hit. COVID-19 has resulted in travel bans, accusations among governments, and a massive spread of xenophobia concomitant with the spread of the virus. In all likelihood, until we put a stop to viral transmission, we will go through many waves of infection and its accompanying social and economic harms. Experts predict that the only way out is to develop an effective vaccine that can defeat the virus. However, while the search for a cure is underway, the next set of theatrics will most likely feature this controversial headline: Who Gets the Vaccine First?
The World Health Organization (WHO) reports that there are ten vaccine candidates in the clinical evaluation stage and 114 in the pre-clinical evaluation stage. The Coalition for Epidemic Preparedness Innovations (CEPI), an organisation whose mission is to accelerate the development of vaccines against emerging infectious diseases and enable equitable access to these vaccines for people during outbreaks, is an active ally in the vaccine discovery project. CEPI hopes to mobilise 2 billion USD to manufacture and distribute vaccines around the world. Gavi, the Vaccine Alliance, has already pledged that it will assist low-income countries in preparing for the dissemination of COVID-19 vaccines by executing vaccine bonds through its International Finance Facility for Immunisation.
Many pharmaceutical companies have teamed up with one another and with governments to develop a COVID-19 vaccine. Bio-technology companies concern themselves with the research and development of vaccines, while large pharmaceutical companies play the predominant role in commercialisation, marketing, and distribution of vaccines. It is with these companies that countries and the WHO execute pre-purchase agreements to procure vaccines. A pre-purchase agreement is a contract between (usually) two parties (here, a pharmaceutical company and the government of a state) which does not come into effect and is unenforceable until a predetermined event triggers its operation (i.e. a pandemic, actual vaccine production, or both), after which it becomes legally binding. Since private actors are engaged in the production of vaccines, they naturally seek a return in investment, thus affecting pricing.
However, immunisation (the herd immunity a vaccine provides) is a public good and a public health priority. Its collective benefit is unparalleled, ranging from control of mortality and morbidity of diseases, to disease eradication, enhancing life expectancy, and promoting peace and equity, to name a few. It is therefore no surprise that when the Chief Executive of the pharmaceutical company Sanofi recently stated that "the U.S. Government has the right to the largest pre-order because it is invested in taking the risk," it immediately prompted strong comments from the French Government that the company’s reasoning was mere monetary pretext. After a flummoxed international community’s furore over such a statement, Sanofi released another statement that global access of COVID-19 vaccine is its priority. Clearly, “nationalising” the vaccine could derail the progress made in the hard-fought COVID-19 battle.
THE GLOBAL HEALTH FRAMEWORK FOR VACCINE DEVELOPMENT
The existing international legal framework promoting global health includes, broadly, the WHO Constitution and the internationally-codified right to health, set out in the Universal Declaration of Human Rights (UDHR), the International Covenant on Economic, Social and Cultural Rights (ICESCR), and the International Health Regulations (IHR).
The WHO Constitution defines health as, “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”. It also states that “the highest standard of health” is a fundamental right of every person. Article 25 of the UDHR and Article 12 of the ICESR additionally recognise health as a part of the right to an adequate standard of living.
The IHR forms the overarching, binding international legal framework regulating the international spread of disease. It boasts 196 state parties, including WHO’s member states. The IHR’s main purpose is “to prevent, protect against, control and provide a public health response to the international spread of disease”. IHR is hardly a passive instrument; it stipulates that state parties are under an obligation to cooperate in good faith with the WHO and one another. They must assess health events occurring on their territories, notify the WHO about health events attaining a certain gravity threshold, and take many requisite measures in response to such events. The IHR also mandates that state parties maintain core capacity in their national health systems and promptly detect, notify, and respond to public health emergencies. This particular clause has posed a challenge in implementation, though, since the IHR does not have an oversight mechanism regulating compliance.
PRACTICAL ISSUES AND POTENTIAL SOLUTIONS
It is perhaps singularly infelicitous that none of these instruments contains any binding obligation relating to equitable access to vaccines for developing countries. CEPI has stated that there is no agreement on the rules for the fair allocation of vaccines. The pandemic could be more effectively stifled, if, before a vaccine for COVID-19 is produced and distributed, states, pharmaceutical manufacturers, and perhaps the WHO, executed an agreement on fair and equitable allocation of the vaccine.
Organisations like Gavi and the Bill and Melinda Gates Foundation could aid in providing limited financing to countries that cannot afford the pre-purchase costs for the vaccine. However, one must remember that pre-purchase agreements among the WHO, pharmaceutical manufacturing companies, and recipient countries are time-consuming to draft and establish. Also, developed countries may feel threatened by any binding instrument, since this would, in effect, prevent them from placing advanced orders for vaccines and also involve strict intellectual property mandates. Regrettably, this is exactly what happened during the 2009 swine flu pandemic, where developed countries like Australia, the United States, and Canada placed hordes of advanced orders for the vaccine and developing countries could not vaccinate their populations. With respect to COVID-19, the United States has already executed partnerships with big pharmaceutical companies by directly investing in their vaccine manufacturing efforts.
Additionally, the relevant legal instruments fail to address the dissemination of vaccines under the international human rights framework. A report on the intersection of health and human rights, published by the United Kingdom's Commonwealth Medical Trust and the American Association for the Advancement of Science, stipulates that “when vaccines are characterised as a human right…governments are more likely to provide” citizens (including vulnerable populations, like children) with immunisations.
APPLYING THE INTELLECTUAL PROPERTY REGIME
Per the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS), patents that protect drugs and other related technology are increasingly common. Patents enable manufacturers to exercise complete control over how their drugs are distributed. As private market participants, these manufacturers then have little incentive to make a vaccine widely available at affordable rates. Article 7 of TRIPS states that:
The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation into the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.
Therefore, keeping with the spirit of the text, protection of intellectual property of COVID-19 related research must take a backseat, since these times must be marked by generous knowledge-sharing. To that end, an international coalition of scientists and lawyers is calling upon organisations around the world to ensure that their intellectual property is freely available to one and all in order to battle COVID-19 with efficiency. If such a laudable effort is successful, it would ease out the legal wrinkles of the intellectual property regime, endorsing the open sourcing of COVID-19 solutions.
Vaccine development during pandemics has typically been viewed as a vaccine problem that should be addressed with better science, however, at the root of it, it is a global health problem with a pressing need for better management. As global crises have time and again shown, health systems are only as strong as their weakest link—poor and fragile economies. There has never been a more compelling time for global collaboration to establish an equitable vaccine distribution system. In the global health framework, the whole must always be greater than the sum of its parts.
Aparajitha has a Bachelor of Laws (LL.B.) degree from I.L.S. Law College, India (2015) and an LL.M. in Public International Law from Leiden University. She currently works as a Lecturer at Jindal Global Law School and handles the subject, ‘Global South and International Law’, taught by Prof. (Dr.) B.S. Chimni. Her areas of interest include International Criminal Law, Public International Law and International Humanitarian Law.