By Johny Solomon Raj and Swaraj Raghuwanshi
At the 12th Ministerial Conference of the World Trade Organization (WTO) held in Geneva, Switzerland on June 17th, 2022, a politically significant deal to partially waive off the intellectual property restrictions on the manufacture and production of COVID-19 vaccines for the next five years has been approved by the participating countries. A series of agreements have been approved by the WTO that includes a patent waiver for COVID-19 vaccines. This decision has been reached after nearly two years of deliberations and efforts, involving dozens of ministerial meetings and many political negotiations. The move will prove helpful for manufacturers in developing and under-developed nations by giving them access to trade secrets from local regulatory authorities on how to produce a viable COVID-19 vaccine. However, the agreement has excluded diagnostics and therapeutics from the scope of the waiver, due to which several health advocacy groups and countries have been left dissatisfied. Mr. Ngozi Okonjo Iweala, the Director-General of WTO had earlier commented that the patent waiver was necessary to combat the “morally unacceptable” inequity with regard to access to coronavirus vaccines.
Practical Significance of the Waiver
An intellectual property rights waiver waters down the restrictions on patents, trademarks, copyrights and industrial designs. Under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, a vaccine manufacturer is not allowed export its vaccines in bulk to another country, and the majority of the vaccine production is to be retained for the home country. Vaccines are manufactured only in a few countries, which makes it quite difficult for the vaccine manufacturer to export the vaccine in bulk to other countries during periods of crisis. The IPR waiver will enable vaccine manufacturers to share their trade secrets with regulatory authorities in other countries to enable local manufacture there that will further bolster vaccine equity, accessibility, and affordability across nations.
In 2020, South Africa and India were the first nations to propose a TRIPS waiver on tools required for the treatment of COVID-19, and this move was supported by over 100 countries. The draft proposing the TRIPS waiver underwent prolonged deliberations and modifications over the past 20 months. The waiver was resisted by USA, UK, Switzerland and several countries in the European Union at the ministerial meeting held between June 12 and June 16, 2022. USA had manifested its concerns over dispensing its modern vaccine technology to China.
Finally, the draft was modified, and the modified draft excluded diagnostics and therapeutics from its ambit. It was stated in the meeting that the final decision to apply a waiver on the production and supply of diagnostics and therapeutics will be taken after another six months. The absence of a waiver on diagnostics and therapeutics implies that the cost and availability of treatment drugs and testing kits may still remain inaccessible for many low and middle income countries.
Global Glut of Vaccines
As per the data collected from the European Federation of Pharmaceutical Industries and Associations, there were around 2.1 billion excess doses of COVID-19 vaccines as of May 2022, and their production has consistently outnumbered the number of doses administered. Mr. Chad Bown, a senior fellow at the Peterson Institute for International Economics has remarked that “there is no longer a supply-side constraint on the availability of vaccines.”
The deliberations over the IP waiver has taken so long that the WTO’s final deal may not have a significant impact on the production of COVID-19 vaccines, as there is a global glut of them. One of the world’s largest vaccine manufacturers, Serum Institute of India (SII) commented that “while patent waivers for Covid-19 vaccines are encouraging, their demand is declining.”
India rebuked powerful nations for stretching the negotiations for so long that it has lost its relevance as pharmaceutical manufacturers have eventually been able to produce surplus amount of vaccines.
Dr. Christos Christou, International President of Médecins Sans Frontières (MSF) (Doctors Without Borders), has criticized the move by stating that “the agreement has failed to offer an effective and meaningful solution to help increase people’s access to medical tools during the pandemic, since it does not apply to all countries. Governments should consider using all available legal and policy options, including suspending intellectual property on Covid-19 medical tools, issuing compulsory licenses on key medical technologies to overcome patent barriers, and adopting new laws and policies to ensure the disclosure of essential technical information needed to support generic production and supply.”
Ms. Candice Sehoma, South Africa Advocacy Officer at Médecins Sans Frontières (MSF) has also said that “the proposed waiver was too narrow as it only focused on vaccines.”
Indian Trade Minister, Mr. Piyush Goyal has remarked that “What we are getting is completely half-baked and it will not allow us to make any vaccines. Vaccines have already lost its relevance. It’s just too late; there is no demand for vaccines anymore.”
Even if the technology is readily available, it will take no less than a year to develop the manufacturing processes and commercialize them. Since vaccines are potentially hazardous biological products involving viruses, the manufacturing involves extremely complex and lengthy processes and hazard protocols. Any modification in that process can result in failure to formulate the right vaccine and risk the safety of the general populace. Moreover, vaccine manufacturers feel that unless the vaccine innovator company comes forward to support another manufacturer, the process of making a vaccine will not be easy, even if the IP restrictions are to be waived off. Therefore, it can be said that in absence of an entire TRIPS waiver, the WTO’s waiver of IP rights for COVID-19 vaccines may unfortunately turn out to be of little use.
Richa Pushpam, Intern at SSRANA has assisted in the research of this article.