COVID Pandemic and Intellectual Property Rights
The second wave of this pandemic crisis has thrown light on both the globalist ideals but localist approach of developed nations but also of our own country’s inadequacy when it comes to handling this pandemic write Dr. Tamali Sen Gupta & Dhruv Shekhar.
Following the relatively low impact of the first wave of COVID 19 on India, the Government and the people were rudely shaken out of their inertia by the ferocity of the second wave. The emergence of the Indian variant B.1.617 came as a shock as the 14 day mutation cycle of the virus after the first wave was not tracked domestically and by the time it was identified had spread to 40 countries. The initial shortage of oxygen beds and medicines have largely been met due to the unstinting support of the private sector when Government institutions began faltering under the deluge of patients. As the second wave of the Covid-19 virus eases out in India, discussion about patent waivers of covid vaccines and other remedial tools have dominated multilateral channels. Closer to home, the Supreme Court too has questioned the Central Government whether it intends on using the compulsory licensing regime to address the vaccine shortages.
Between TRIPS and the embargo on the export of raw materials by the United States under the Trump administration, India could not make as many vaccines as needed to immunise a significant part of the population by mid-2021. India also did not place orders internationally by November 2020 as many other nations did. Our Government did place orders for a small amount of vaccines in early 2021 mostly for front line workers and senior citizens. They bet only on Covaxin which was unproven at that time and even today is not being produced on the scale required for our population. The decision to start vaccinating with Covaxin with limited data and before full clinical trials has created a deficit of trust among international agencies. By the time Covaxin completed its phase 3 trials, the second wave was on us. As of June 2021, the vast majority of vaccinations are still Covishield as Covaxin is simply not available. Further Covaxin may or may not be effective for the mutations that will happen in the next 3 months as the virus variants mutate every fortnight or so. As a nation, we need to go with the most effective vaccine which is capable of being produced in the numbers needed for our population.
This article attempts to address some of the questions surrounding the proposed patent waivers and the issuance of compulsory licenses and whether they will be able to help in increasing vaccine production. And to examine what should the policy and IPR initiatives be to expedite drug availability by September 2021 and fortifying India’s preparedness for the third phase
Patent Waivers & Compulsory Licensing
India and South Africa had in October of 2020 made a joint representation to the World Trade Organisation’s (WTO) TRIPS Council for providing waivers to certain provisions of the TRIPS Agreement. This was done with the objective that IPR’s should not restrict the access to affordable medicines or R&D, manufacturing and supply of medical products which are essential to combat COVID-19.
This representation gained wide support and crucially, the United States supported the waiver of patent rights in accordance with flexibilities provided in the TRIPS agreement and the Doha Declaration to the agreement, in May 2021. These flexibilities were included to ensure that a nation could restrict monopolies that are created upon the grant of patents in certain situations such as health emergencies like a pandemic.
A corollary to this step would be the issuance of compulsory licensing of vaccines. But first, what is a compulsory license? A compulsory license is a licence or an authorisation issued by the government to an applicant for making, using and selling a patented product or employing a patented process without taking the consent of the patent holder. A crucial aspect of this definition is that they can only be granted when an invention is patented in the first place.
Are there any patents on the vaccines yet?
At present there are no patents granted on the Covid-19 vaccines, however many of the vaccines being produced are protected owing to patents on their underlying technology. For instance, the Pfizer- BioNTech’s BNT 162 Vaccine uses patented lipid nanoparticle (NP) technology to deliver mRNA to cells. Even the underlying technology behind Moderna’s mRNA vaccine is patent protected. Similarly, the technology behind the vaccine being used in India i.e. the Astrazeneca vaccine (Covidshield) is also patent protected under Patent no. 318021 and Patent no. 263933.
Can compulsory licenses help ramp up vaccine production?
Compulsory licenses are deemed as a critical tool to ramp up vaccine productions as well as for other drugs, therapeutics, and related technologies. In the event the government intends to grant compulsory licenses, a notification may be issued Section 92 (1) under the Patents Act, 1970 and any interested party/ies may apply before the controller for the issuance of a license.
The Government can also invoke Section 100 of the Patents Act,1970 which would enable it to authorize any person to manufacture vaccines and other therapeutics even if there is no patent in place, but an application for a patent grant has to have been filed for it. Specifically, on the issue of the vaccines, it is unclear if any patent has been filed but as stated above, these measures can be used for the underlying patented technology.
However, in spite of the presence of these provisions, the Government has so far seemed reticent on using them. When asked by the Supreme Court about the proposed issuance of compulsory licenses they responded in the negative and instead preferred for voluntary cooperation with pharmaceutical companies.
One must also consider that producing the mRNA vaccines is complicated and Pfizer and Moderna are unlikely to let India or any other country produce them. The technology is considered the latest and billions of dollars have been spent on perfecting it for many years (much before Covid). The mRNA technology is unlikely to be transferred to India. J&J may agree to manufacture in India in addition to exporting the millions of vaccines that are stockpiled and on the verge of expiring.
In addition, Adar Poonawala (India’s largest producer of drugs) has left India under duress to set up manufacturing facilities in the UK to service global contracts for Covishield.
China is now looking to come out with its own mRNA vaccine as its own Sinopharm shot does not have great efficacy. However given the relationship with our neighbour, it's not likely that India can license their vaccine.
India was slow to lock down production agreements with manufacturers worldwide like the US and Europe did. Even recently, Europe signed an agreement with Pfizer to provide 2 billion doses and this includes new variants and booster shots. While Covaxin has proven to be effective, India cannot produce it fast enough and only focusing on an India made vaccine would be considered a mistake in hindsight by the families of those who have succumbed to the disease and many others.
A worthwhile question to ask would be, why is there a divergence in the government’s position, when it's globally advocating for patent waivers yet domestically it seems hesitant in using a statutory provision created specifically for such situations? We are in the middle of the most devastating breakdown of the health system in the world in recent times and clearly, India’s preparedness for epidemics is lacking in proportion to the population. While all the Government and private hospitals were working to capacity in April and May 2021, there were still a number of deaths from lack of oxygen in parking lots as people could not get Oxygen beds. The situation was finally addressed between the Government, private companies and international agencies. What is clear is that the Government needs to make universal health care available to all in such a situation and more attention needs to be paid to ensuring the dignity of the deceased. Oxygen beds have been made available and hospital facilities ramped up in a remarkable fashion.
Reasons for divergence in the Government’s positions
The answer to the above question is actually unclear. However, the Government in its response to the Supreme Court’s query about using compulsory licenses filed an affidavit stating that paucity of raw materials is the real issue when it comes to increasing production.
While the debate over the divergence in the government’s actions ensues, there is a fair bit of truth in their statement. As Chris Garrison points out, vaccine formulations are like an information stack with patents forming only a part of the equation – other aspects such as knowhow and trade secrets being shared by the inventor are crucial in reverse engineering vaccines.
In the unlikely event that generic manufacturers are able to reverse engineer these vaccines, it will take time before they secure the requisite regulatory approvals. Coupled with this is the issue of scaling up the capacity of production, a factor that is reliant on access to raw materials, technology transfer, human capital and expertise.
Additionally, some commentators have also pointed out there are few other issues with the compulsory licensing framework. One being that a compulsory licensing system requires the payment of adequate compensation to the patent holders. However, the TRIPS Agreement does not specify what constitutes adequate compensation. Thus an issue could arise where time could be squandered due to lengthy negotiations between the patent holder and the government. A secondary issue that arises is that the manufacturer can produce only predefined quantities, as a result, the objective of mass production of vaccines and other therapeutic items is halted. The last concern and perhaps very crucial for the government is that large pharmaceutical corporations take retaliatory steps against countries that push for compulsory licensing. On occasion, the developed nations backing these corporations have also imposed retaliatory tariffs, though in the event of a WTO waiver that seems to be unlikely.
The last stated reason is likely to have played on the Indian government’s mind, in addition to their stated reasons for not issuing compulsory licenses.
What needs to be done?
The first thing that is required is that the government needs to realistically assess as to how it will operationalise the TRIPS waivers. The TRIPS waivers seem to be an uncertain tool to build an entire vaccination strategy around. Even if the IP waivers are granted, the question of technology transfer still looms large and one which is controlled by the pharmaceutical corporations.
The suggestion from certain quarters of using punitive measures such as revoking patents (Section 102 of Patents Act) in the event companies of not voluntarily complying as has been done by Brazil, might turn out to be a mistake. Doing this would not only affect relations with companies and their host nations, but in reality, it would also provide no solution to resolve the issue of access to technology.
The government has to make a realistic assessment of the kind of tradeoffs it can make in the present scenario and communicate them accordingly to the public. They need to look at the technology licensing deals as well as creating financial incentives to increase manufacturing capacity.
The Government also needs to relax its process for granting indemnity to global vaccine makers for side effects. India needs to hedge its bets by using all vaccines available till December 2021.
The latest change to the vaccination policy from a highly fragmented, market-oriented model to a more centralised vaccination model appears to show that there is some course correction afoot. A similar approach has to be undertaken for the next stage of our national vaccination policy.
With respect to the TRIPS waivers, India needs to assert its stance as echoed in the representation made by it and South Africa last year to the WTO. This is integral because the United States’s response to the patent waivers request was limited only to vaccines and not other therapeutic equipment and raw materials for vaccines, hospital equipment and drugs to treat Covid-19. With the text-based negotiations of the WTO due to take place soon, it's crucial that we hold on to this stance and advocate for it, while accepting none of the dilutions stated by the pharmaceutical lobby.
The patent waiver request should not just be seen to meet the interim needs of India today but be seen as a critical step (albeit one of many) to combat the covid-19 pandemic in the next few years. Furthermore, if the patent waivers on all medicinal formulations coupled with access to relevant raw materials can be achieved, there would be ample vaccines over a period of time to not only meet India’s requirements but in due course also contribute to global networks such as COVAX so as to ensure that the excess vaccines can reach to developing nations as well.
The second wave of this pandemic crisis has thrown light on both the globalist ideals but localist approach of developed nations but also of our own country’s inadequacy when it comes to handling this pandemic. This is particularly baffling given our more than half a century’s worth of experience of carrying out vaccination programs across the nation. Polio eradication was a major success for India and the facilities used for Pulse polio were used for distributing COVID 19 vaccines.
Between November 2020 to March 2021 instead of focussing on a universal vaccination plan, the window was spent in organising mass gatherings and multi-state elections after which the second wave hit us, causing devastation all round.
India now has between June till August to step up production of vaccines and outreach to the 18-45 age group. If the third wave hits between end of August to September, a large proportion of the population will still not be vaccinated. The time frame of December 2021 to complete vaccination may be too late to help Indians during the third phase. The Medical infrastructure is collapsing from the sustained efforts they have put in over the last year and many medical professionals have been affected.
The Supreme Court of India has called out the Government for the vaccine policy for 18-45 which it says is "prima facie arbitrary and irrational” J. Dhananjay Chandrachud. State High Courts have asked why officials in charge of the process of approvals should not be charged with ‘manslaughter’ for their failure to make global vaccines available. Achieving vaccination of a critical mass of people by September is imperative and for this it's coming down to reducing bureaucratic delays and shaking ourselves out of the political inertia towards vaccination which has led to the current situation.
Legitimate questions can be asked of why the Indian Government did not hedge their bets by reaching out to different vaccine manufacturers instead of relying on only two, namely Serum Institute of India and Bharat Biotech. The Government needs, on an urgent basis to fast track the approval process for new vaccines. Whichever vaccine is found to be most effective should be deployed. India currently needs a lot of vaccines to cover the two doses needed for 60-70% of our approximately 1.38 billion population. There are currently plans for about a third of this. The Central Government opened up the procurement to the State Governments initially. This initiative did not take off as the Central Government controls all the clearances, and global vendors were unwilling to contract with State Governments and risk consignments getting stuck in cargo facilities. The Prime Minister announced earlier this week that the Centre will procure 75% of vaccines and distribute them and states can procure 25%. Prices will be controlled for both categories. For the first time, the Central Government has announced that they have paid for 300 Million Biological e-jabs experimental vaccine. The vaccine will be made available from August to December 2021 according to the government release.
These are welcome moves but the Government also needs to set up a central monitoring agency for overseeing the process. ICMR and the Health Ministry have failed in advising the Government on the seriousness of this matter. While GST collections continue to buoy the finances of the Government, this is not being deployed adequately as a war chest to tackle the pandemic.
While these questions need to be answered, the nation is waiting with bated breath to hear how the Government intends on ramping up vaccine production before the third wave and any subsequent waves of the Covid-19 virus and its mutations. Achieving 70% vaccination from the present level of 5-6% is a daunting task and it remains to be seen if the road map the Government submits to the Supreme Court is up to the task.
Disclaimer: The views expressed in the article above are those of the authors' and do not necessarily represent or reflect the views of this publishing house
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