The global pandemic, COVID-19, took the world by surprise and human civilization presently has no cure to the infectious virus that has affected over 10 million people. On 1 May 2020, the U.S. Food & Drug Administration (“FDA”) authorised the antiviral drug, Remdesivir manufactured by Gilead Sciences as the only treatment to help patients of the disease so far. Such approval came after a successful lab test of the drug against SARS and MERS cause by coronavirus. Since then, Gilead Sciences has been in close watch by Wall Street investors to find out whether it will choose any different path than what its history suggests while pricing Remdesivir. This article assesses the access to medicine under the existing International Intellectual Property (“IIP”) Law regime for Least Developing Countries (“LDCs”) in the wake of COVID-19.
Joseph Stiglitz in his groundbreaking book ‘Making Globalisation Work’ regarded the WTO Agreement on Trade-related aspects of Intellectual Property (“TRIPS”) as “a death warrant for thousands of people in the poorest countries of the world”. Notably, as consolation, some flexibilities were also provided to the developing countries and LDCs — including the grant of a transition period till 2005. Later two successive extensions were granted to LDCs, taking into consideration the formidable restructuring and reorganizing required for comprehensive implementation of TRIPS by the LDCs. Bangladeshi Prime Minister Sheikh Hasina played a crucial role in propounding the latest grant of waiver with her bold stance in the 64th World Health Assembly, followed by a successful formal request to the TRIPS Council on behalf of the LDC group. Currently, LDCs are exploiting the waiver of compliance to TRIPS till 1 January 2033 or till the graduation to developing country status, whichever is earlier.
During the COVID-19 crisis, LDCs with higher disease burden are susceptible to avail medicines patented by pharmaceutical giants of the developed countries. Stiglitz probed for public intervention to make the monopoly-driven pharmaceutical industry more humane for a large portion of the population in developing countries and LDCs. While amending TRIPS currently seems quite implausible, according to Dr. Henning Grosse Ruse-Khan, the key hurdle in ensuring access to medicine in the midst of this pandemic would not be patent rights, but rather involves finding countries that have the pharmaceutical manufacturing ability to produce medicines for both, their citizens and poor countries with no or lesser manufacturing capacity. Thus, when Remdesivir was being approved around the globe, the only hope for the global south was to avail a generic version of the drug produced by Compulsory Licensing (“CL”) or Reverse Engineering of the drug.
Along with the pandemic, there emerged a plethora of CL rules and policies around the globe from March 2020. Israel led the permit-sprint issuing compulsory license for Kaletra with Canada, Germany and France moving in the same direction. Among developing nations, India has been using this tool since 2012 for lowering the price of medicines. However, amidst a call for the Government to revoke Gilead’s patent by public health groups, India, and later Pakistan preferred signing a Non-Exclusive Licensing Agreement (“NLA”) with Gilead. The NLA allowed five generic manufacturers from these countries to manufacture and distribute Remdesivir.
As opposed to a generic production of medicine, such an agreement brings forth twofold repercussions. Firstly, the license creates two facets of the global market of which Gilead will supply to the profit generating developed countries at $390 per vial, and the licensed companies will supply to the rest. Secondly, the licenses are royalty-free till the WHO declares the end of public health emergency or until an alternative cure is approved. As such, the cheaper version of the drug may not be available in countries which are considered as non-profitable to Gilead. At the same time, the current pricing of each vial at $65-$71 will vary drastically with payment of royalty once an alternative cure springs in the play, affecting the fair distribution of the drug.
In contrast, Bangladesh, the only LDC with pharmaceutical manufacturing capacity meeting 97% of its domestic demand itself, inchoately preferred taking a preemptive action to escape the legal monopoly of the pharmaceutical industry by approving 8 pharmaceutical companies to produce generic versions of Remdesivir. Bangladesh has the industrial capacity to espouse reverse engineering to produce and export generic version of drugs to the LDCs. Bangladesh also has a comparative advantage in producing generic Remdesivir since Gilead has not filed any application for its patent protection in Bangladesh, evading consequences of compulsory licensing or mailbox problem. Thereafter, on 21 May 2020, Bangladesh’s pharmaceutical giant Beximco Pharma introduced the world’s first generic version of the Remdesivir at $71 per vial to private clinics and free for state-run hospitals. Earlier in June, the Nigerian government had flown chartered aircrafts to Bangladesh for collecting Remdesivir produced by Beximco. A delayed production under the NLA and a favorable pricing has pinned hope for many Asian and African countries on Bangladeshi generic Remdesivir for ensuring fair distribution and quick access to COVID-19 cure for all.
At least 50 former world leaders till date have urged the eventual COVID-19 vaccine to become “the people’s vaccine”. Generic production under the TRIPS mechanism will enable governments to supply to its citizens, cheap and available versions of patented treatments either through domestic production or foreign imports. The effectiveness of limiting patent protection for better access to antiretroviral drugs has already been successfully examined in the face of the AIDS epidemic. While rich countries will lead the queue for producing, as well as procuring COVID-19 drug and vaccine, Bangladesh not shying away from utilizing the flexibility in international law has illustrated exemplary vision and pragmatic leadership of the current Government. This may well ensure the access to necessary medication to combat the COVID-19 pandemic, specifically for the underprivileged population of the world. As Shamnad Basheer once said, “the issue of access is dependent, to some extent, on the ability to create affordable generic versions of patented drugs.”
Shahrima Tanjin Arni is a LL.M student at the Department of Law, University of Dhaka and the International Affairs Secretary, Dhaka University Central Students’ Union (DUCSU).
Md Azhar Uddin Bhuiyan is a LL.M Candidate at the Department of Law, University of Dhaka and the Editor-in-Chief, DUCSU Law and Politics Review.
Image: Pierre Albouy. [Copyright: WHO].