During the last two days, two interesting articles addressing accessibility of medical products and methods were published. While one article in ‘The Hindu‘ spoke about capitalism and its inherent hurdles to access, another article written by Professor Arul Scaria in ‘The Wire‘ argued against Niti Aayog’s approach towards access to COVID vaccines and medicines. In his article, Professor Scaria specifically pointed out that Government’s reluctance to use the compulsory licensing mechanism as a part of the COVID vaccine/medicine access scheme reflects a very poor policy choice, and is not in line with India’s legal framework and access philosophy. At different levels, both the articles point out the systemic issues in the policy, attitude and approach of the Government. They provide qualitative and quantitative data and make a well-constructed argument on the access issues springing from macro and micro level Government choices.
In this article, I would like to supplement their views and arguments, especially the arguments put forth by Prof. Scaria. To start with, the compulsory licensing mechanism to address national problems was used as an option since the 17th century, and is not of recent advent. Compulsory licenses were granted even before the statute of monopolies, and compulsory licensing provisions existed in the Indian patent law since 1889. These were adopted from English patent law, and subsisted until independence and thereafter. They continue to find a place under the current Patents Act even after several amendments. Since compulsory licensing came into statutes, several compulsory licenses were granted before independence, and they were not just for medicines and treatments. They covered different inventions that had the potential to enhance human life and promote industrial progress. Compulsory Licensing is therefore a well tried and tested legal tool with specific, well defined objectives.
Over the years, India had always argued against stringent IP protection and enforcement at international forums, and played an important role in the DOHA Declaration and related flexibilities and interpretations in the interests of public health. Though sparingly used, the compulsory licensing provisions under the Indian patent law were considered by many nations as examples of a well-balanced approach to promote both innovation and access. The first general compulsory license was hailed as a victory of patient access to critical cancer treatment, and related social and public interest. It is noteworthy that just one compulsory license grant in India was enough to set off a series of strategic changes in the licensing approach of innovator pharma companies, many of which modified their licensing programs and adjusted prices to suit the Indian market. Along with legislative and executive action, the judiciary also played its role in furthering the interests of public health and access to medicines, and even the Supreme Court could not hold back its views on the value and importance to be given to health care and human rights while constructing the patent law though those questions were not directly relevant in the Novartis case. The narrowing of patent protection on one hand, and the compulsory licensing scheme on the other were argued in Government, scholarly and professional circles as ideal measures to promote access to medicines, and to remove patent hurdles to health care in India.
Alongside the general compulsory licensing regime, the compulsory licensing provision in the law pertaining to national emergency and extreme urgency was understood to be a fall back provision to cut short the process when time is of essence to promote access to patented inventions. It was understood to be a valuable tool in the hands of the Government, to be used when public health, public interest and public welfare demanded quick action. While incorporating these kinds of provisions in international regimes and national laws, countries, including India, were fully aware of the fact that most patented inventions relating to medical treatment and health care cannot be worked without access to clinical trial data, technical knowhow, and other information. While vouching for, and adopting these provisions through different amendments, India did not believe that technology transfer issues made compulsory licensing less valuable. India’s policy makers in fact felt that compulsory licensing would facilitate technology transfer, dissemination, and access.
Today, the much discussed and predicted time to use the compulsory licensing regime effectively has now arrived, but the Indian Government seems circumspect, unsure and unable to rise to the occasion. This is despite the fact that it is party to a waiver proposal to facilitate access to COVID vaccines, treatments and technologies. Is this India’s enlightenment that the much hailed compulsory licensing is worthless during an emergency, or is it something else? No one seems to understand why the Indian Government is unable to act.
There is a health crisis and emergency in India, and patent covered vaccines are required on a large scale. Those need to come from countries and companies, who believe in strong patent protection, and are pushing for patent driven measures. India has two options: it can take patent driven measures and steps proposed by them or adopt a strategy/approach that uses compulsory licensing, waivers, and other tools.
The questions before India are actually quite simple:
Should India change course, set aside compulsory licensing, and focus on voluntary patent licenses, technology transfer and supply to facilitate access to vaccines and medicines?
Should India grant compulsory licenses, and use those grants to promote and enable technology transfer, supply and access to vaccines and medicines from such measures?
As Prof. Scaria stated in his article, India is better off sticking to its access ideology driven by compulsory licensing and must not yield to the seemingly unsurmountable obstacles to access being presented by countries and companies, who strongly lobby for patents and profits therefrom. The interests of the public would be best served if India stops equivocating and stands by what has helped it facilitate access to medicines so far. Changing course might mean giving up all access battles won so far.
Authored by Dr. Kalyan C. Kankanala
- Chapter XI, The Law Of Patents In India : Ormond, E. Charles, portant Publications (1936), available at: https://archive.org/details/in.ernet.dli.2015.41799, visited on 30th May, 2021.
- Sections 84, 91, 92 and 92A of the Patents Act, 1970, available at: https://www.bananaip.com/the-patents-act/chapter-16-working-of-patents-compulsory-licences-and-revocation/, visited on 3oth May, 2021.
- Bayer Corporation Vs. UOI and Others, available at: https://indiankanoon.org/doc/28519340/, visited on 30 May, 2021.
- Novartis AG Vs. UOI and Others, available at: https://indiankanoon.org/doc/165776436/, visited on 30 May, 2021.
- The Doha Declaration, available at: https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm, visited on 30 May, 2021.
- IP Waiver proposal to the WTO TRIPs Council, available at: https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669R1.pdf&Open=True, visited on 30th May, 2021