India and South Africa’s joint proposal for the World Trade Organisation (WTO) to waive patents and other intellectual property rights for COVID-19 related vaccine supplies is seeing a renewed push following the United States’ (US) decision to support the motion. While several countries strongly oppose the proposal, the US’ about-turn from its initial opposition resulted in several international actors—including France, New Zealand, and the European Union—softening up to the proposal and expressing their willingness to discuss it. Consequently, on May 5, the WTO said that it would continue discussions on the issue, for which India and South Africa are devising a revised proposal. With the US’ support, India and South Africa, along with 120 other countries, are likely to see the proposal being accepted in the WTO. Yet, despite these promising signs, India’s struggle has only just begun. Even with a favourable decision on patent waivers, India has a long way to go before it can use this prospective change to strengthen its vaccine manufacturing capabilities to more effectively meet domestic and global demand.
The initial proposal, which was communicated to the WTO on October 2, called for a waiver on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for all COVID-19 related medical equipment, including vaccines, ventilators, N-95 masks, and medicines. However, the US has only offered its support for the waiver of these provisions for vaccines. If the proposal is explicitly passed for the waiver of restrictions on vaccine production, this would mean that any vaccine manufacturers with the recipe for the jab can produce them without the threat of fines and sanctions. This is particularly significant for India, which already produces 60% of the world’s vaccines. Nevertheless, even with the international community warming up to the proposal, there are a wide range of issues that Indian authorities need to prepare for to fully extract the benefits of the TRIPS waiver.
To begin with, the removal of intellectual property rights protections on the vaccines requires the untangling of a complex web of legal issues. Although patents protect the exact recipe of the vaccine, the manufacturing procedure can be kept confidential as a trade secret. Furthermore, the data from clinical trials and other relevant studies can be protected by copyright as well. Moreover, since the waiver merely disallows sanctions and fines in case of an intellectual property law violation, it only satiates the global demand for COVID-19 vaccines in the long run. Since pharmaceutical companies are not required to disclose the production process, it could take manufacturing and research facilities in India over a year to reverse engineer the vaccines and begin large-scale production.
Alternatively, if Indian authorities want to reap the benefits of the waiver earlier, they would need to enter into individual agreements with pharmaceutical companies to allow domestic production of their vaccines, such as the existing deal between the Serum Institute of India and AstraZeneca. Similar contracts could be signed with Johnson & Johnson, Pfizer, Moderna, and other pharmaceutical companies that have developed COVID-19 vaccines.
While the waiver will make it easier for India to negotiate access to the vaccine’s recipes, as the manufacturing facilities will automatically be permitted to reverse engineer the jabs, similar contracts with other pharmaceuticals will be difficult to achieve. Pfizer has already opposed the US government’s decision to support the waiver, reiterating that it was “not at all” in support of the decision. Furthermore, several pharmaceutical companies have come out criticising the decision and highlighting its long-term impact on innovation and research in the pharmaceutical industry.
In fact, Indian authorities have already been at odds with Pfizer, with the pharmaceutical giant seeking complete control over the pricing and export of the doses manufactured in India. Therefore, in order to seek access to the recipes of the vaccines, Indian authorities must prepare for challenging negotiations with pharmaceutical companies. These negotiations must centre around building a mutually beneficial agreement that leverages India’s unique manufacturing prowess while still ensuring the pharmaceutical companies are adequately compensated for the risks they have taken in investing in vaccine development. Hence, the revised proposal, which is set to be presented before the WTO in the coming weeks, needs to address the complexities that come with the TRIPS waiver to enable a more comprehensive, uniform, and transparent manufacturing process across the globe.
Nevertheless, even if India can gain access to these recipes and enter into agreements with other pharmaceutical companies, there is still the larger concern of technical expertise and infrastructural capacity. For instance, the Moderna and Pfizer vaccines use mRNA technology, which requires specially equipped engineers and manufacturing facilities. In addition, the transport and storage of these jabs are also complicated, as the Moderna and Pfizer vaccines respectively need to be stored at -20 and -70 degrees Celsius, the capacity for which is extremely limited in India. Hence, not only will Indian authorities have to prepare facilities for domestic storage and transport, but also for exporting the jabs.
Furthermore, as suggested by German chancellor Angela Merkel, vaccine shortages are also a result of the high quality standards for the production of the jabs. For instance, a massive vaccine manufacturing plant in Baltimore, which was considered to be one of the major facilities for both Johnson & Johnson and AstraZeneca, remains unused due to its inability to meet safety standards. Hence, the 24 vaccine production facilities in India, of which merely three are being used for COVID-19 jabs, need to be inspected to ensure that the safety protocols and standards are being followed.
The need to lift the restrictions imposed by the TRIPS agreement on vaccine production and the prospective benefits such a decision would enable are undeniable. However, this alone will not facilitate equitable and widespread access to vaccines for populations across the globe. India will have to engage with all stakeholders in the market, including governments, pharmaceutical companies, and producers of other necessary raw material for the jabs. All these players need to be consulted and brought together to combat this global crisis expeditiously. In the absence of this, with India being a key player in meeting global demand for the vaccine, the COVID-19 pandemic will continue to ravage the globe and cause irreparable damage to societies and their economies.
How Should India Prepare for the Waiver of Intellectual Property Protections by the WTO?
Despite the likelihood of a waiver of Intellectual Property Rights protections by the WTO, India has a long, long way to go to address its vaccine woes.
May 13, 2021
SOURCE: BUSINESS STANDARD