India and South Africa, along with other low and middle-income countries, have submitted a proposal to the World Trade Organization to initiate a “temporary waiver” on certain regulations of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.
They are concerned that intellectual property rights to COVID-19 vaccines and treatments will hinder global distribution and production. The monopolisation of manufacturing rights by a few selected companies located in the Global North means a higher cost for middle and low-income countries to purchase, transport, and store the vaccines.
The United States, Canada, and the United Kingdom have refused to comply with this petition seeing as intellectual property rights incentivize new research and ensure that the same research is not repeated. They posit that creating a “multilateral IP [intellectual property] system” will solve the problem of accessibility.
A multilateral system of IP would entail shared patents, permissions to use patented technology, and selective licensing based on an approval policy. Pharmaceutical company Moderna is already working with such a system, despite having waived IP rights for their COVID-19 vaccine.
What is TRIPS?
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) came into effect in 1995. It provides member nations of the World Trade Organization with guidelines to protect different categories of intellectual property (IP), including geography, industrial design, and patented inventions. The agreement is not legally binding but is open for countries to implement within their own judicial systems as they deem fit.
Under Article 7, the agreement posits that the “protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology.” While it reinforces that intellectual property rights must be protected, the agreement also acknowledges that “social and economic welfare” is a central consideration of making technological innovation accessible across the world.
The petition started by Indian and South Africa targets four sections of TRIPS including copyright (Section 1), industrial design (Section 4), patents (Section 5), and the protection of secret or undisclosed information (Section 7).
Innovation in the field of science and medicine has hastened since the beginning of the COVID-19 vaccine race. Thus, if protecting scientific discoveries is essential to the development of solutions to the virus, why are India, South Africa, and low-income countries opposing the patenting of the science? The issue boils down to social responsibility and equitable healthcare accessibility.
The role of big pharma in determining access to healthcare for survival
As of January 20, 2021, Pfizer-BioNTech is the only vaccine granted approval for distribution and large-scale production by the World Health Organization. Other vaccines nearing approval from the WHO include those developed by Moderna and Oxford-AstraZeneca.
However, individual countries like the United States and the United Kingdom have already approved the use of the Moderna and Oxford-AstraZeneca vaccines. India has approved the use of Covishield, the local name given to the Oxford-AstraZeneca vaccine, and Bharat Biotech’s Covaxin.
Despite there being only one globally approved vaccine, there are currently 50 vaccines in development and 100 in the pipeline for development, said Dr. Pooja Sharma, Associate Director and Head at Medanta Institute of Education and Research in Gurgaon, India, in an interview with Spheres of Influence (SOI).
Having multiple vaccines under development and trial around the world means different regions of the world might have access to at least one type of vaccine, including South Africa which isn’t able to manufacture its own vaccines. Multiple vaccines also mean a reduced geographical distance between the originating and recipient nations of the vaccine, which could debase the argument behind the petition to waive IP rights.
Dr. Sharma has been at the forefront of clinical research surrounding COVID-19 vaccines and their accessibility in India and believes vaccine distribution is determined by diplomatic relations between nations.
“India is doing it [distributing the vaccine] free to be altruistic,” Dr. Sharma added, because “in India, it’s all about the poorest poor, we want to provide [healthcare] to the last man standing.”
India’s Bharat Biotech is now supplying Rotavac, a COVID-19 vaccine, to many countries in Africa and the United States as an alternative to Moderna and Pfizer-BioNTech’s vaccines, said Dr. Sharma.
The question of profitability
It is important to note that while Big Pharma has a vested interest in making a profit from the sale of vaccines to higher-income countries, a waiver on IP rights does not need to mean a loss of profit for them.
One way of making such profit fits the capitalist model of vaccination and the marketization of healthcare by selling vaccines in small numbers at inflated prices, resulting in greater profit per sale. Manufacturers like Pfizer and Johnson & Johnson are employing this method.
Yet profits can also be made while ensuring widespread accessibility. Selling vaccines in larger numbers at an affordable cost to nations like Chad and South Africa that do not have a robust manufacturing system for vaccines can also create profits for pharmaceutical companies while providing healthcare to people in low and middle-income countries. Moderna is one such company, which announced soon after its vaccine rollout that it would not be imposing intellectual property restrictions on its vaccine.
Allowing the licensing of patented Moderna technologies with manufacturers other than Moderna has implications beyond the immediate impact of messenger-RNA vaccines on the pharmaceutical industry. This new medical technology was introduced to the market by Moderna and by allowing the licensing of mRNA patents in different countries, Moderna’s goal is to engage “the potential to treat or prevent diseases that today are not addressable,” according to their website.
Compared to other Big Pharma like Pfizer and Johnson & Johnson, the majority of whose supplies are directed to wealthy nations, Moderna’s approach to vaccine accessibility not only ensures profitability for the company but also contributes to making healthcare more accessible outside the context of COVID-19.
India has the manufacturing capacity to produce Moderna vaccines, said Dr. Ram Vishwakarma, Director of the Indian Institute of Integrative Medicine at the Council of Scientific and Industrial Research. But for countries that do not have adequate manufacturing facilities to take on the responsibilities of the waiver, a successful petition might do more harm than good, he added in conversation with SOI.
This is because there is little incentive for companies like Pfizer and Johnson & Johnson to provide affordable healthcare and no legal obligation to do so under a global treatise. The only motivation, thus, would be to protect the human right of basic healthcare of people who are unable to afford it. The question then arises whether an altruistic motive is enough for Big Pharma to put a temporary waiver on their IP.
In the long term, the petition against intellectual property rights could create a “hostile environment for innovation” because Big Pharma has the scientific and technical resources to mass manufacture new biotechnology, but need funding and incentivization to be able to manufacture, Dr. Vishwakarma said.
For that reason, governments need to incentivize the private sector while also subsidizing vaccine accessibility. Dr. Vishwakarma expects this will create room for more research, funding, and sustainable scientific innovation processes.
It remains to be seen what the petition will yield. The World Trade Organization’s next hearing on the matter is scheduled for March 10-11, 2021.
Restricting IP rights may cause tensions between Big Pharma and low and middle-income countries trying to gain access to vaccines. However, the number of vaccines under development provides hope that nations who do not have adequate manufacturing facilities for vaccines will still have access to immunization against COVID-19. Unless Big Pharma pledges to work towards ensuring the human right of basic healthcare to all, universally affordable vaccination seems like a long-term goal beyond the scope of the current pandemic.