As the novel coronavirus (SARS CoV-2) pandemic is raging across the world, a race has already ensued for the discovery of a vaccine. Normally, vaccine development takes a decade. But given the urgent need for a vaccine to fight the novel coronavirus, different national drug regulatory agencies are observed to have fast tracked their approval process. Additionally, various regulatory bottlenecks were also removed in order to facilitate the development of a vaccine in an earliest possible time. According to the World Health Organization (WHO), as of 17th May 2020, there are eight vaccine candidates already in different phases of clinical trials around the world.
As the Covid-19 vaccine race picked pace, questions are once again raised over the affordability of the vaccines to the population in the Low and Middle Income Countries (LMIC). The question appears timely, given the past behavior of developed countries to place bulk orders and hoard vaccines, at the expense of other countries. Additionally, exorbitant prices will lead to denial of vaccines to the population in the global south. At the heart of this affordability debate is the “patent monopoly” usually enjoyed by the firm that discovers the vaccine first. In this context, the Doha Declaration on TRIPS and Public Health has allowed for “compulsory licensing” of pharmaceuticals during national health emergencies. Opponents of this emergency provision have made a counter-argument that invoking TRIPS exemption to break patent monopoly would disincentivize innovation. Their argument seems valid given the fact that vaccine discovery involves billions of dollars in sunk costs. Therefore, by following their line of argument, it can be stated that any measure taken to forcefully license a future Covid-19 vaccine would be counterproductive.
In the quest to make vaccines affordable, it is important to keep in mind the interest of both the patent holder and the populations in the LMIC. In recognition of this factor, the 73rd session of the World Health Assembly (WHA) passed a resolution to establish a ‘voluntary’ global patent pool. Another solution is to introduce a government-funded prizing system that would keep the incentives for vaccine development, and prevent the emergence of patent monopolies at the same time. Few others have called the future patent holders for Covid-19 vaccine to ‘unlock’ their patent for a short period. Such small steps would enhance vaccine availability during times of pandemic, by allowing vaccine manufacturers in LMIC to mass produce vaccines and distribute them at affordable prices. However, these global efforts and other suggestions made towards preventing the emergence of patent monopoly, has invoked opposition from the US, the UK and Switzerland, as these countries are the home to many of the world’s major pharmaceutical companies. In contrast, in his speech to the WHA made on 18th May 2020, President Xi of China declared that Chinese Covid-19 vaccine when available will be made a ‘global public good’, which will ensure “vaccine accessibility and affordability in developing countries”.
At the beginning of the current pandemic, states were seen to be behaving in their own self-interest by hoarding medical supplies. For instance, both Italy and Spain accused Germany for denying ventilators to them during their times of shortage. Similarly, the US was accused by a handful of countries for diverting critical medical supplies meant to be delivered to them. Eventually, as the pandemic control measures failed, states’ interests are seen to have shifted towards vaccine development and ensuring its future availability to their populations. In this regard, the Trump administration in the US was supposed to have paid the German firm Curevac to shift its vaccine research to the US, drawing Germany’s ire. The French were infuriated when its pharmaceutical major Sanofi announced that the US will be the first country to get access to its future vaccine. Also, the US did not participate in the EU-organized global fund raising event to support Covid-19 vaccine development, signaling its intention to go alone. Instead, the Trump administration offered $1 billion to UK firm AstraZeneca to support its vaccine development efforts. Thus, in ensuring vaccine accessibility, few developed countries are behaving in a similar way as they have done in the past.
The present situation has given an opportunity for Indian vaccine manufacturers to step in to ensure ‘equitable’ access to Covid-19 vaccines. India is known for mass production of vaccines and selling them at affordable costs to multilateral organizations like GAVI. Indian manufacturers also account for 60% of vaccines supplied to UNICEF’s global immunization programmes. India has also ramped up its efforts to indigenously develop a vaccine for Covid-19. If a successful vaccine emerges elsewhere, India could still leverage its strong biotech industrial base to partner with foreign firms and institutions for mass production of vaccines. In this respect, the University of Oxford has already partnered with Serum Institute of India in anticipation of a huge global demand for Covid-19 vaccines. Similarly, Bharat Biotech has joined hands with the University of Wisconsin and US firm FluGen to make 300 million doses of vaccines for global distribution. Given the uncertainty associated with vaccine development efforts, Indian pharmaceutical companies should choose the right partners based on the efficacy of their technology, and their suitability for mass production.
Majority of these partnerships are being formed while the vaccine is in the development phase and may fail to fructify in the future. This is because a successful vaccine candidate requires to pass rigorous clinical trials before it could be approved for wider usage. However, the need to mass produce vaccines to end the pandemic will lead to a number of post-development partnerships between biotech firms. In this respect, Indian vaccine manufacturers are better positioned to clinch more deals as they have the necessary ‘skilled’ workforce and R&D infrastructure for mass production. Still, the questions over the ‘equitable’ distribution of vaccines will remain unresolved, unless a percentage of vaccines produced by the manufacturers in India and other LMIC are reserved for local distribution at affordable prices.