Drawn-out discussions about a covid-related TRIPs suspension will not help the huge numbers of people in India and elsewhere waiting for vaccines, argue Deepa Tiku and Jyoti Sagar of K&S Partners
As the world wades through the second year of the deadliest pandemic in living memory, we are all fighting a common invisible enemy: the novel coronavirus SARS-CoV-2.
Coming to humanity’s rescue, scientists from around the world have worked round the clock to develop, within an unprecedented timeline, several vaccines to battle the virus. According to data published by the WHO, a total of 102 novel coronavirus vaccine candidates are under clinical development and another 185 are in pre-clinical development. Many vaccines have already been deployed around the world and the latest statistics available from ourworldindata.org indicate that more than 2 billion people have already been vaccinated. This is no mean feat in such a short time.
Yet, there is a glaring gap in the vaccinated populations between the developed world and the rest. While the United States has inoculated more than 65% of its citizens, some of the least developed countries (LDCs) have yet to begin their vaccination programmes.
This brings to fore the raging debate on vaccine inequity, and rightly so. After all, how can anyone be safe until everyone is safe?
The IP Waiver proposal
Back in October 2020, India and South Africa made a joint proposal to the World Trade Organization (WTO), requesting all 164 member countries temporarily waive IP rights on inventions relating to the treatment and management of covid-19. The proposal also stated that an unhindered global sharing of technology and know-how was needed for rapid handling of covid-19 on a real time basis. On 21 May 2021, a revised proposal was submitted focusing the text on "health products and technologies" for prevention, treatment or containment of covid-19. All in all, IP has been identified as an obstacle in ramping up production and distribution of covid-19 related products
As an obvious consequence, there have been polarised responses to this proposal. In May 2021, in a substantial shift from previous policy, the United States offered in principle, a conditional text-based support for a waiver limited to IP around covid-19 vaccines. Negotiations are already in progress but given the complexity of the issue, these may take up to a year to get to conclusion, while for anything to happen all 164 countries need to find a consensus. Any resolution on that front could be too little and certainly too late.
While the proposal is well-intentioned and rings the right morality bells, one wonders whether this is really the silver bullet that can address the urgency of the situation, particularly, in the wake of the recent heart wrenching devastation in India wrought by the second wave of the pandemic. While India has announced an ambitious target of vaccinating all Indians by end of 2021, vaccine shortages in most states have led to considerable doubt and anxiety.
Indian laws in the context of TRIPS flexibilities
Pursuant to the Doha Declaration of 2001, several statutory provisions were incorporated within the Indian Patents Act 1970 to address use of inventions for public emergency and export to countries with no manufacturing capacity. The provisions of compulsory licensing (CL) under sections 99 and 100 of the act allow the government of India (GOI) to take over patents in cases of public emergency.
However, as regards the possibility of exploring CLs as a means for ramping up production of covid-19 vaccines and drugs, the GOI, in a recent affidavit submitted to the Supreme Court of India, has emphasised that the real barrier to scaling up production is availability of raw materials and capacity and not IP. This somewhat contradicts GOI’s assertion in the TRIPS waiver proposal of October 2020 that IP is indeed a barrier for ramping up production of covid-19 medical supplies.
The Prime Minister, in his latest address to the nation, promised vaccination for every Indian by the end of 2021. Government projections indicate that India will be able to procure more than two billion doses of vaccines by the conclusion of the year. This should be enough to vaccinate the entire eligible population and perhaps even enable sharing with the rest of the world. This leaves one to ponder over the whole issue of pressing for IP waivers, more so as it is likely that the discussions on any such waivers will be limited to vaccines.
The danger is real and present – action needed today
While negotiations are on at the WTO, the devil is at large and a solution is needed urgently. The process of negotiation is expected to be complex, especially as the revised proposal is broad and aims for suspension of IP rights for all “health products and technologies” for the prevention, treatment or containment of covid-19, while the United States is offering conditional support only for “vaccines” and Germany has opposed such a waiver.
The word “complex” could not be defined better than what the landscape of licensing and patenting around covid-19 vaccines looks like. While most patent applications may still be pending and have not even been published, it is a dense maze to work around as some of the underlying technologies may have patents on them. Needless to say, even if patent rights were to be waived, technology transfer and know-how for bringing these vaccines to life will remain unaddressed.
Making IP the whipping boy
IP, and in particular the patent system, is often regarded as the real obstacle for access to medicine and healthcare. The present pandemic seems to be proving otherwise. Nobody is suing anyone as of now! While Moderna has announced that it will not enforce its patents on its vaccine, most of the innovators have extended multiple voluntary licences for manufacturing drugs and vaccines for covid-19.
For example, in India, AstraZeneca and Novavax have entered into licence agreements with the Serum Institute of India. Sputnik V has been licensed to no fewer than six manufacturers: Dr Reddy’s, Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech. Johnson & Johnson has entered into a licensing agreement with Biological E, while Gilead has entered into non-exclusive voluntary licensing agreements with Cipla Ltd, Dr Reddy's Laboratories Ltd, Hetero Labs Ltd, Jubilant Lifesciences, Syngene, a Biocon company, and Zydus Cadila Healthcare Ltd for the manufacture of Remdesivir.
It cannot be disputed that the patent system has played an indispensable role in enabling the development of the vaccines in the shortest time ever. It is because of the incentives of the patent system that investments were made in cutting-edge technologies, underlying today’s vaccines, more than a decade earlier, when the covid-19 pandemic was merely the stuff of nightmares and not the terrible reality it is today.
The next pandemic may be around the corner. By making IP the whipping boy, we may already be jeopardising some of the new research being carried out by innovators and, thus, killing the goose that lays the golden egg.
The question is what will it take to get the shot in the arm (literally!). Hiding behind the smokescreen of patents being the obstacle are a plethora of other issues, some of which are listed below:
- Scarcity of raw materials and other inputs (eg, vials).
- Limited capacity and barriers to augmentation (eg, scarcity of bioreactor bags, filtration devices, pumps, etc).
- Problems in effective transfer of technology and know-how (especially because of travel restrictions).
- Scarcity of trained and skilled personnel.
- Supply chain bottlenecks.
- Geography and vaccine distribution logistics (especially for mRNA vaccines which require capital intensive and sophisticated distribution chains).
- Vaccine hesitancy.
- Lack of an approved vaccine in India for children below 18 years.
A blanket IP waiver can problematic in many ways
The International Federation of Pharmaceutical Manufacturers and Associations argues that waiving patents is likely to lead to disruption, while distracting from addressing trade barriers, supply chain bottlenecks and scarcity of raw materials and other inputs that are the real challenges in scaling up production and distribution of covid-19 vaccines globally.
In the absence of the right infrastructure, skills and technical know-how, no vaccine developer will be able to bring on board partner manufacturing organisations. In fact, a patent waiver risks diverting raw materials and supplies away from well established, effective supply chains to less efficient manufacturing sites where productivity and quality may be an issue. This could also open the door to counterfeit vaccines entering the supply chain around the world.
Thus, an IP waiver does not replace the additional measures the world should put in place to increase the global vaccine supply, including incentivising and funding the transfer of technology and know-how to LDC manufacturers, facilitating the supply of equipment and raw materials and donating excess covid-19 vaccine doses to Covax – the global collaboration initiative to accelerate the development, production and equitable access to covid-19 tests, treatments and vaccines. In a joint press release by various global pharma associations - PhRMA, ABPI, BIO, EFPIA, ICBA, IFPMA and Vaccines Europe - the following five-point approach was proposed:
- Step up dose sharing.
- Continue to optimise production.
- Elininate trade barriers.
- Support country readiness.
- Drive further innovation.
Way forward for India
India must maintain a balance between championing its position on access to medicine as well as the spirit of its National IPR Policy which promotes innovation and its protection. India, however, can play an important role in manufacturing and supplying covid-19 vaccines to the countries in emergent need. Some of the key steps that India must take to achieve this, without compromising any IP, are as follows:
- Continuous impetus to the Indian vaccine manufacturers for capacity building and augmentation.
- Diplomatic engagements for stepping up dose sharing, importation of raw materials and other inputs.
- Encouraging voluntary licensing and know-how sharing.
- Addressing trade barriers and carving out win-win solutions for long term sustainability.
- Encouraging indigenous and collaborative research on newer vaccines.
This is a golden opportunity for India to reinvent her policies around cutting-edge research and development. Unless we embrace science and technology, and make it a focal point of our healthcare policies, we can never be truly ‘Atma Nirbhar’ (self-reliant). A patent waiver is neither the silver-bullet for solving the immediate problems nor for tackling newer emerging diseases, and the sub-optimal healthcare system that we presently have.
Dr Deepa K Tiku is partner & patent attorney and Jyoti Sagar is founder & managing partner at K&S Partners, India. The authors would like to thank Shatadal Ghosh for his valuable assistance with research on statistics