INTRODUCTION “I only feel angry when I see waste. When I see people throwing away…
The second wave of the Covid-19 pandemic in India has caused a catastrophic impact, leading to the deaths of thousands of people. The devastating consequences of the pandemic were aggravated due to the lack of medical facilities and health care resources. Despite India being one of the largest manufacturers of vaccines in the world, it still failed to vaccinate its population before the second wave descended on the country. In the midst of this calamity, India along with South Africa and a few other countries have been demanding a worldwide waiver on the covid-19 vaccine patent so as to ramp up the current vaccination drive and mitigate the impact of the second wave in the country. However, a controversial question has come to the surface with respect to the Indian government’s stance on the grant of compulsory licenses within its own country. While the government is asking for a waiver on the patent of international vaccines, it has not implemented a compulsory license(“cl”) for the vaccines in its own country. Cl as defined in the case of Bayer Corporation v Union of India is an authorization given to third parties to make, use or sell a product that has been patented without the express permission of the patent owner. The patent holder in return will be given royalties by the controller general.
This post will provide a brief on how intellectual property rights might prove as an obstacle in the production of important drugs and vaccines both within the country and internationally. To that end, this paper will look at analyzing what the statutory provisions for compulsory licensing in India are, what its pros and cons are, and finally what needs to be done in order to improve access and increase the production of life-saving resources.
What is compulsory licensing?
The provision for clean India has been invoked only once before to Natco pharmaceutical company for the production of an anti-cancer vaccine. This points out the fact that this provision cannot be invoked under ordinary circumstances and would have to comply with the criteria laid down in the Indian Patents Act of 1970. Under Section 92(3), a compulsory license can be granted under the following circumstances:
- Public emergency
- Extreme emergency
- In cases of public non-commercial usage
The Covid-19 pandemic and the consequent death of thousands of Indians would in all probability fulfill the criteria as laid down under this section. The crumbling health care system in India is in dire need of vital drugs and vaccination and a possible way out is to issue cl for its production.
Additionally, section 100 of the Patents Act grants power to the government to authorize certain companies to use any patents for the benefit of the government. This would help the country tap into its pharmaceutical resources and manufacturing units which currently cannot carry out the manufacturing of the vaccinations. Despite the previous apprehensions surrounding the issue of compulsory licenses, several countries across the world are now resorting to the use of CL to combat the pandemic. For instance, the United States of America (“USA”), despite being against the use of CL, has in its annual Special 301 Report, recognized the importance of the same.
Further, in a suo moto decision of the Indian Supreme Court in May 2021, the court urged the central government to consider issuing a compulsory license for the vital drugs and vaccines required to combat the pandemic. While invoking the 2001 Doha Declaration, the court said that the Trade-Related Aspect of Intellectual Property Rights Agreement, (“TRIPS”) should be interpreted in a manner most conducive to public health and social welfare.
The debate surrounding compulsory licensing in the current context
There is strong opposition from pharmaceutical companies and other stakeholders for the issue of compulsory license on the covid-19 vaccines. Among other things, they contend that neither waiving off nor compulsory licensing would be effective. The production of vaccines would require the transfer of invaluable information, including data sharing, technical know-how as well as trade-secrets. Clinical trial data is indispensable in the production of vaccines in order to determine their safety, quality, and efficiency. While the TRIPS Agreement provides for disclosure of clinical trial data in cases of emergencies, there are no equivalent provisions in the Indian statutes. In addition to this, the Indian statutes do not have any laws relating to trade secrets. It has been contended that if the government does issue cl or mandate the sharing of data, manufacturers of vaccines might resort to alternate ways of protecting information making it even more cumbersome to engage in its production.
Granting cl is undoubtedly a step towards improving the availability of crucial medication and vaccines, however, it is not the end-all solution. One needs to keep in mind several other resources needed for the manufacture of vaccinations. The government and the international community should step forward and reduce the existing obstacles in the IPR regime as far as possible to tackle the dire situation that the world is currently facing.