The need for accessible and affordable health care has never been more critical. Millions are infected and thousands die from the coronavirus every day. The health care system is on the brink. The pandemic-stricken world faces an inevitable shortage of medical supplies. This situation may not be brought under control until the majority of the population is vaccinated against the novel coronavirus to develop herd immunity. Encouragingly, advances in science have made it possible to develop vaccines in a record time of just a few months. Less than a year after the Covid-19 pandemic epidemic, around eight vaccine candidates from around the world have entered the market.
But vaccine development doesn’t mean the battle is won. There are several challenges in making these vaccines accessible to the world’s population, one of them being intellectual property rights (IPRs). India and South Africa’s proposal to the World Trade Organization (WTO) to waive patent rights to Covid-19 vaccines, as outlined in the Agreement on Intellectual Property Rights Aspects that affect trade (TRIPS), is still under discussion since October 2020. Today, World Intellectual Property Day, we must resolve to provide full and unhindered access to Covid-19 vaccines. IPR regimes around the world would have a major role to play.
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Inestimable patents for R&D but the world needs a vaccine
The well-established economic theory of patent protection suggests that patents promote innovation by granting a temporary monopoly to the innovator over his innovation, which allows him to recoup his investment and protect his innovation from imitation. For life-saving drugs and vaccines, billions of dollars are spent on research and development (R&D) and clinical trials. If pharmaceutical companies are not in a position to appropriate the returns on investment, they will not have the incentive to invest in the development of new drugs in the future.
In most countries, patent protection is granted for about 20 years, after which generic manufacturers can enter the market to produce cheaper biosimilars of these drugs. While granting monopoly rights to innovation is essential for advancing science, it is also often misused by large pharmaceutical companies to charge exorbitant prices. This limits access to these drugs at affordable prices for low- and middle-income countries.
In the current scenario, there is a global health emergency. About 70% of the world’s population must be vaccinated to overcome the pandemic. This means that more than 5 billion people need vaccines. With two doses each, that’s 10 billion doses of vaccine. Ngozi Okonjo-Iweala, Director General of the WTO, mentionned the world has the capacity to produce 3.5 billion doses of vaccine in one year, although capacity building plans are currently underway. Developed countries have already achieved all of this. Most low- and middle-income countries have not had access to vaccines so far, and given current capacity, it doesn’t look like that anytime soon.
Anticipating the situation, India and South Africa had proposed to the WTO in October last year to suspend the IPR of the Covid-19 vaccine from four provisions of the TRIPS Agreement in order to facilitate prevention , Containment and Treatment of Covid-19 – Section 1 on Copyright and Rights, Section 4 on Industrial Designs, Section 5 on Patents and Section 7 on Protection of Undisclosed Information. The waiver is requested until the majority of the world’s population is immunized after vaccination. The waiver of IPRs can allow for faster technology transfer and vaccine production in countries that have the production capacity. This can help immunize the masses in a shorter time frame.
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Developed countries must also participate
Major developed countries like United States, European Union, Canada, etc. oppose the proposal, arguing that the move will discourage pharmaceutical companies from investing in drug and vaccine development during future pandemics. This is a credible argument in ordinary times. However, the current situation is radically different. Much of the funding from government agencies has also been spent on the development of some Covid-19 vaccines, and with governments fully guaranteeing sales, the incentive argument may not materialize. In addition, these companies can sell the vaccine at a higher price in developed countries that can afford it. The vaccine from Pfizer and BioNTech costs $ 19.50 per dose and Moderna $ 15 per injection. Sales to low- and middle-income countries at lower rates may not pose a major threat to future R&D.
Unless the world’s population is vaccinated, developed countries will remain at risk of viral mutation and render the current series of vaccines ineffective. Given the limited production capacity of vaccine developers and their licensees, it will take several years to respond to the entire world population. Given the state of healthcare facilities and the devastating impact of Covid-19 on the global economy, we cannot afford to extend vaccination for several years. The world should learn the lessons of the past when millions of people died of HIV / AIDS due to lack of access to antiretrovirals in low- and middle-income countries. Ultimately, several countries had to resort to compulsory licenses under the provisions of the TRIPS Agreement to save lives.
The proposed IPR waiver for the Covid-19 vaccine has also won the support of the majority of countries and several leaders of developed countries. We hope that the WTO talks will now break the deadlock to reach consensus on the waiver. Although PGD is not the only challenge for access to vaccines, it is certainly a major challenge. May the force be with us.
Arvind Mayaram is the former Union Finance Secretary and President of the CUTS Institute for Regulation & Competition. Garima Sodhi is Senior Fellow, CUTS Institute for Regulation & Competition. Opinions are personal.
(Edited by Prashant Dixit)
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