The Debate of Patent Rights Amid Covid-19

The year 2020 changed the world forever and life as we knew it changed as the Covid-19 pandemic became a global impediment. With a global pandemic going on, its treatment and medication became the center of debate and become the hot topic and still continues to be one. When the first wave of Covid-19 hit the world, in the absence of any vaccination or proper procedure of medication, a lot of drugs such as hydroxychloroquine tablets took the world by storm because of the shortage of these drugs and the absence of proper manufacturing which was limited given the laws and regulation. India overnight became a major exporter of hydroxychloroquine tablets but eventually, restrictions were put in place in order to meet the needs of the domestic markets. While the absence of proper medication or treatment process was creating havoc in the medical industry, the possible treatment through drugs like hydroxychloroquine tablets, anti-viral paracetamol tablets, etc. were the straws that the health care workers were hanging by. The major issue and debate with Intellectual Property Rights laws and patent laws took speed after the arrival of the second wave of Covid-19 which saw the emergence of Covid vaccines and drugs such as Remdevisir which got FDAs approval for Covid treatment. This debate caught the world‟s attention when the issue of patenting came at crossroads with Covid vaccines and the exclusivity of their developers over them. The catastrophic hit of the second wave of COVID-19 led to better 1000 people all over the globe, the situation was more aggravated due to the lack of proper medication or vaccine and amidst this chaos, one of the most important decisions was taken up by India with regards to the patent of Covid-19 vaccines. In order to tackle the issue of shortage of medication, drugs, and diagnostic kits that were of dire need amid this pandemic, a few ways were adopted to deal with it and they were IP waiver proposal, compulsory licensing, and voluntary licensing. The next part of this chapter would be dealing with the IP waiver aspect which is still under consideration before the World Trade Organization Council.

Patent Rights and Covid-19

IP Waiver:

India along with South Africa were the first countries that appealed for patent waiver of the Covid-19 vaccines so that this vaccine is readily available to everyone facing this pandemic. Before going into the discussion as to how the patent laws were affected by this is important to understand what is a patent waiver or an open patent. While the patent allows its holder to manufacture sell and market his invention or innovation and also grants him a monopoly over the same so that the innovator can make revenue out of his work thereby monetizing his innovation, patient waiver works in exactly the opposite manner. A patent waiver but an open patent removes these exclusive rights and allows anyone to use the patented information to manufacture, use or market the patented product without the fear of being sued on the grounds of patent infringement. A patent waiver if granted is a huge opportunity for countries that do not hold a patent for the Covid-19 vaccine as it would allow them to manufacture the required amount of vaccine for their own country and help curb the shortage of vaccines that we are facing today. In October 2020, India and South Africa came together to put forward a proposal before the World Trade Organization’s Council for trade-related aspects of intellectual property rights requesting for the waiver of certain provisions of the trips agreement in order to tackle COVID-19. In this proposal, it was put forward that given the global pandemic that we are facing where every country in the world is facing some of the other impediments with regards to prevention or treatment of COVID-19, it is important that certain regulations that are provided for under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) must be waived so as to curb this problem of shortage of medication and pharma products. One of the major suggestions that India made in this proposal was with regard to the use of article 31 b which talked about authorizing the use of patent products or technology with the patent holder‟s permission. India contended that the scope of article 31 b should be expanded in order to include medical equipment like ventilators, dialysis machines, diagnostic kits, etc. That is very crucial in this battle against COVID-19, this limitation of allowing only pharmaceutical drugs for production without authorization of patent holder in case of emergency is falling short to tackle the present pandemic.

At first, this proposal faced opposition from the USA, UK, and EU who were against the idea of suspension of patent protection but recently, the USA has changed its direction and is in support of the waiver of the patent. Currently, this waiver proposal is backed by more than 100 countries including Russian and China, along with international organizations including the World Health Organization and the United Nations AIDS charity, UNAIDS. After the unexpected support from the USA government with respect to IP waiver, in one of the recent deliberations between India and the USA representatives, the USA has come forward to showcase that it will also reach out to its allies to gather approval for this IP waiver. However, this waiver still is facing a lot of opposition especially from the pharmaceutical industry, and believe that this IP waiver will only serve as a shortcut for many competitors who will be able to acquire expensive technology without any hassle. Though there are several oppositions to this IP waiver it is important to keep in mind the major reason as to why this waiver is important given the current situation i.e., the majority of vaccine manufacturing companies are limited to high-income countries or middle-income countries and thereby making it difficult for low-income countries to get even their first dose of vaccination as these companies have sold their vaccination to their own governments or high- income governments facilitate their shortage of vaccination. According to an article published by International Monetary Fund (IMF), the total amount of vaccination that will be manufactured by the end of 2021 is six million doses but this will fall short for the global population and thereby creating distress. And given the fact that the maximum of vaccine IP holders and manufacturers are concentrated in the small group of high-income or middle-income countries, it will become very difficult for low-income countries to acquire vaccination and in order to curb this issue, it is important that the patent waiver proposed is taken up and adopted as it would allow these countries to set-up their own manufacturing units for vaccination production. It is important to this core principle that is driving the patent waiver proposal so that this race against covid-19 can be fought efficiently. However, one of the biggest concerns about the knowledge dissemination about vaccines and allowing patent waiver is the fact that the manufacturing of vaccination with perfection. Given the fact that the USA forms one of the major exporters of COVID-19 vaccines two various countries across the globe, their support in the IP waiver proposal was quite unexpected as well as a beam of hope as the concern that only providing the recipe for the vaccine to other companies for manufacturing will also provide the background knowledge, the technique, proper skill, and process for the manufacturing are still pretty prevalent. The fact that the manufacturing process of vaccine does not only require a proper composition and recipe but also requires a lot of quality raw materials, proper infrastructure, and skilled labor and all the above requirements are not always readily available and this might affect manufacturers decided to take up production of the vaccination. Given the fact that the number of raw materials that are available is limited, and if in such scenario these are materials are given to manufacturers without ensuring their expertise in the production of vaccination it will only lead to wastage of raw materials and a much lesser stock of vaccination will be available than that is currently required. So, even though the proposal of patent waiver is a very welcoming and innovative approach that is taken up by countries in order to ensure that the demand for vaccination is met with without any problem whatsoever but if we consider the reality of vaccination production and manufacturing and the expertise that is required to ensure such products we can see that it will take up a lot more than just sharing of the vaccine recipe and hence would not make much difference in the current supply of vaccines.

Compulsory Licensing:

Apart from the approach that has been discussed above i.e., the patent waiver proposal before the World Trade Organization (WTO), there are other ways to ensure that the COVID-19 vaccine demand is met with, and one such way is through compulsory licensing. Under article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) The member states to the agreement are allowed to grant compulsory licenses to third parties with respect to patents. this article allows the member states to enable third-party companies to manufacture patent-protected vaccines in cases of dire situations such as a national emergency. The contents and the objective of this article have been included under the Indian patent legislation which lists down certain situations where compulsory licenses can be granted at the behest of the government. As discussed in previous chapters the concept of compulsory licensing forms part of The Patent Act, 1970 under section 88 of the Act, and under section 92 (3) of the Act it is stated that a compulsory license can be granted by the Government under certain dire circumstances such as:

1. National emergency, or
2. extreme urgency, or
3. Case of public non-commercial usage

Under this section, it is made clear that in cases of public emergency where there is a dire need of the medication and it is patented under the Act, then in such cases the Central government is free to grant compulsory licenses to other manufacturers so as to enable the production of the same and meet the needs of the public at large. Given the current situation, ie., the situation of a pandemic where the entire nation is under the grass of COVID-19 and is struggling to find proper treatment and medication for it compulsory licensing of COVID-19 vaccines is one of the major ways to meet the needs of the public and fill up the shortage of vaccines. However, the issue of compulsory licensing off COVID-19 vaccines has been dragged into the debate by pharmaceutical companies and other stakeholders according to whom neither compulsory licensing of the vaccines not waiving off of the patenting rights would be effective in such scenarios as the manufacturing and production of the vaccines need a certain level of technical know-how. According to these companies in order to enable the production of vaccines by other manufacturers there would a necessity to transfer invaluable information, sharing trade secrets as well as some data with regards to clinical trials which are indispensable, and in the absence of proper legislation that talks about the transfer of trade secrets as well as data of clinical trials the transfer of mere recipe of vaccine would not benefit anyone. But given the current situation of pandemics, the government can resort to alternate ways to ensure sharing of such data by providing a mandate to these manufacturers and enabling the production of vaccines through other manufacturers as well. even though the government has enough power to grant licenses to other manufacturers for the production of vaccines yet till today no such steps have been taken at behest of the government, rather the government was criticized when it was found out that the Indian Council of Medical Research (ICMR) would be receiving royalties against every sale of a dose of Covaxin. In the wake of the second wave of the COVID-19, which nearly broke the health industry due to the lack of drugs and equipment that was required for the treatment and led to a large number of deaths in the country, the Supreme Court of India took up suo-moto cognizance to look into the matter with regards to a better distribution of essential supplies and services during the pandemic. In the very first hearing of this matter the Apex Court took up a few of the matters for consideration and one such question upon which the Hon’ble court presided is the Compulsory licensing of Covid medication. While dealing with the aspect of compulsory licensing the affected court took into consideration the Doha declaration 2001, according to its objective member states had the right to promote access to medicine and protect public health, and Agreement on Trade-Related aspects of Intellectual Property Rights (TRIPs). While taking into account the above objective the Court outlined sections 92 and 100 of the Patents Act, 1970 and recommended the government to consider granting of licenses for manufacturing purposes so that the demand of covid medications can be met with, as being a member state to TRIPs agreement is India free to use the flexibilities under Agreement on Trade-Related aspects of Intellectual Property Rights (TRIPs) to the fullest to ensure the objective under Doha declaration is met with. The Court also took into consideration the aspect that both Delhi High Court as well as the Bombay High had similar views with regards to granting of licenses to third parties for generic manufacturing of covid medications. The Apex court took the case of Rakesh Malhotra v. Govt. (NCT of India)into consideration where the Delhi High Court while addressing the issue of insufficiency of drugs and equipment recommended that:

“There are a number of other drugs which are being used for treatment Covid-19 patients, such as Tocilizumab, Favipiravir, Ivermectin, Dexamethasone, Methylprednisolone, Dalteparin, Enoxaparin, HCQ, and Baricitinib. As per news reports, there are shortages of some, if not all, of the aforesaid drugs. Looking to the emergent situation, we direct the Government to immediately reach out to the manufacturers/ patent holders/ licensees so as to forthwith ramp up the production capacities of the above, and all such other medications, as are essential for the treatment of Covid positive patients. We may take note of the fact that the Patents Act provides for Compulsory Licenses under Section 84, and Special Provision for Compulsory Licenses or Notifications by the Central Government, under Section 92. Section 100 provides the power of the Central Government to use inventions for purposes of the Government. Looking to the present-day situation, there can be no doubt that a case is made out for exercise of its power by the Central Government/ Controller under the aforesaid provisions of law.”

The Apex Court presided over various issues that revolve around the covid medication and treatment process and one such issue that the court dealt with in the case of In Re: Distribution of Essential Supplies and Services During Pandemic was the “potentiality of compulsory licensing for vaccines and essential drugs” where the court referred to both national and international provisions that covered compulsorily licensing and government licenses. The Court took into note the contentions made by the Union, before the World Trade Organization„s (WTO‟s) Council while putting across the IP waiver proposal, that various countries have amended their patent laws in order to expedite the process of issuing compulsory licenses as well as government use licenses and the Court laid down the provisions of Patent Act, 1970 that deals with the same. The Court also outlined section 102 of the Act under which the Government can acquire patents in order to benefit the public at large and places reliance on Canada and Germany, who have relaxed their patent laws in the wake of the pandemic in order to make the process of obtaining compulsory license against patented medication easier. However, these were only recommendations, the Apex Court in the end states that the Central government is free to adopt any such method or approach to tackling the issue of vaccine requirements in an equitable and expedient manner which may involve negotiations with domestic and foreign producers of vaccines.

Voluntary Licensing:

Another approach that can be said to be used in order to deal with the issue of insufficient pharmaceutical products that are required to treat Covid, by the process of granting voluntary licenses to third parties that would allow them to manufacture covid medication that is protected under patent laws. A voluntary license is another form of granting licenses to third parties but in this case, the patentee is at the liberty to fix a rate of a reasonable amount of fee in exchange for the license. As discussed in the previous chapter, the concept of voluntary licensing refers to is the arrangement between the parties where the patent holder and the third party from any of the countries come to an agreement of making affordable medicines in their respective countries. Though after the amendments made to the Patents Act, 1970 in order to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) provisions were added for compulsory licensing, no such specific section is there for voluntary licensing yet this practice is encouraged especially in the current situation of a pandemic even by Courts. In the Rakesh Malhotra case where the court recommended the government to look into the possible granting of compulsory licenses, the court also went ahead to talk about the rights of the patent holder and its importance and stated that:

“..At the same time, the interests of the Patent holders/ licensees should be kept in mind, since it is on account of their investments, inventions, and hard work that such like medicines are made available to the public at large. The best course would be to encourage the existing manufacturers to ramp up their production on a war footing. They should also be encouraged to grant voluntary licenses to other entities to manufacture the requisite drugs..”

The Hon’ble Delhi High Court specifically recommends the importance of voluntary licensing given the situation we are in where both the rights of the patent holder and the public seeking medicine have to be addressed as both hold equal importance. This idea of voluntary licensing was suggested during the IP waiver deliberations, as a solution to the covid crisis, but according to the joint statement made by both the delegations from India as well as South Africa it has proven to be inadequate. They cited the case of Remedisivir where even after receiving a significant amount of funding from the public which amounted to at least 70.5 million U.S. dollars the parent company Gilead signed bilateral licenses with certain generic companies that excluded almost half of the world’s population from its license territories. The fact that Moderna issued a waiver of its IP rights from the covid vaccine formulas in October 2020 and yet till today we see no manufacturing company taking on that opportunity to enable vaccine production also showcases that there is bleak hope for voluntary licensing to actually work.

Given the situation that we are in a position where securing an adequate number of Covid vaccines and are there medications that are crucial for its treatment it is important to understand that each and every approach that has been discussed in this chapter has its own set of pros and cons attached with it. While suggestions like IP waiver could be a long-term solution in securing an ample number of vaccinations especially for low-income countries who do not have any vaccine manufacturing companies and are fully dependent on other countries yet the number of resources that would go into setting up of those manufacturing units and starting vaccine production is a long and tedious process and would require a lot more than just revealing of the vaccine recipe. Also, the fact that cutting off incentives, i.e., the monetary fee that vaccine companies get in return for their sale, might work as in detriment. In both situations, where a patent waiver is approved and where it is rejected and nations resort to compulsory licensing, it provides little incentive to manufacturing companies to engage in the transfer of know-how and that is very much essential for vaccine production as without it a simplest mistake can lead to complete wastage of both raw materials and other resources which are very limited.

According to the researcher, there is a different way to help solve this dilemma and work efficiently in curbing the issue of COVID-19 vaccine production i.e., voluntary licensing but with a better framework like vaccine companies entering into a license agreement with the Medicines Patent Pool (MPP), a World Health Organization (WHO) backed public health organization under which the big pharmaceutical companies can negotiate a license with the Medicines Patent Pool (MPP) and get an incentive in exchange of that, and because of the license the generic drug manufacturers are free to develop a new treatment based on that knowledge and also enables them to distribute patented medicines at an affordable cost in low- and middle-income countries.

Author: Awisurya Sudhansubala – an LLM student of National Law University (Odisha), in case of any queries please contact/write back to us at IIPRD.

IPR Waiver and Covid-19 Vaccines

December of 2019, this is when the outbreak of novel coronavirus disease (COVID-19) was initially noticed in a seafood market of Wuhan city in Hubei Province of China. On March 11, 2020 World Health Organisation declared COVID-19 as a pandemic and that’s when the things changed. Every country was in the race of developing a vaccine for this disease and certain high-income nations came up with a vaccine too, but their ability to fight the disease or what we call their effectiveness was always questioned. Before it all became a mere business, in October of 2020, India and South Africa took the initiative and requested the World Trade Organisation (WTO) to suspend the intellectual property rights related to COVID-19 vaccine for a limited period of time. The countries had asked the TRIPS Council to recommend, a waiver on the implementation, application and enforcement of four sections in the second part of the agreement. These sections are “1, 4, 5, and 7”. They pertain to copyright and related rights, industrial designs, patents, and the protection of undisclosed information. 

According to India and South Africa, the intellectual property waiver might help middle income countries as this will open up space for production with “emergency use authorisations (EUA)” — such as those developed by Pfizer, Moderna, AstraZeneca, Novavax, Johnson & Johnson and Bharat Biotech – since most part of production was concentrated in the high-income countries, only. Middle income countries were only able to produce vaccines through “licensing or technology transfer agreements”. Basically, the main objective of making this request was to ensure rapid scaling-up of manufacturing of vaccines and ensuring accessibility and affordability of vaccines for all.

INTELLECTUAL PROPERTY RIGHTS AND ITS SIGNIFICANCE

“Intellectual property (IP) pertains to any original creation of the human intellect such as artistic, literary, technical, or scientific creation. Intellectual property rights (IPR) refer to the legal rights given to the inventor or creator to protect his invention or creation for a certain period of time. These legal rights confer an exclusive right to the inventor/creator or his assignee to fully utilize his invention/creation for a given period of time.” 

In modern economy, intellectual property plays a vital role. It has also been conclusively established that the intellectual labour associated with the innovation should be given due importance so that public good emanates from it. Since the market place has seen a jump in investments in new technologies, there has been a quantum jump in the costs of research and Development (R&D), as well. The stakes of the developers of technology have become very high, and hence, the need to protect the knowledge from unlawful use has become expedient, at least for a period, that would ensure recovery of the R&D and other associated costs and adequate profits for continuous investments in R&D. Drugs and Pharmaceuticals, more than any other technological area, match the description of globalization and a need to have a strong intellectual property system. Cost of introducing a new drug into the market can be anywhere around $300 million to $1000 million with which comes a tonne of associated risks at the development stage. There exists no doubt in it, that no company would appreciate its intellectual property becoming a public property without any financial benefit to it or having adequate returns. Pharmaceutical industry is basically driven by its scientific knowledge and a company’s success is largely dependent in Research and Development (R&D) efforts and not manufacturing know-how. Therefore, investments in R&D in the drug industry are very high as a percentage of total sales. There is high cost attached to the risk of failure in pharmaceutical R&D with the development of potential medicines that are unable to meet the stringent safety standards, being terminated, sometimes after several years of investment. It takes at least 8-10 years from the date of compound synthesis for the final medicine to be delivered to the market place.

DETERRENTS OF WAIVER

Pharmaceutical companies including Pfizer and AstraZeneca had opposed the proposed waiver — saying “eliminating IP protections would undermine the global response to the pandemic, including the ongoing efforts to tackle new variants. It could also create confusion that could potentially undermine public confidence in vaccine safety and create a barrier to information sharing. Most importantly, eliminating protections would not speed up production”.

Not only this, the founder of Microsoft – Mr. Bill Gates, had expressed his opinion against the proposal and sharing COVID-19 vaccine technologies. He also said in one of his interviews that, “The thing that’s holding things back, in this case, is not intellectual property. It’s not like there’s some idle vaccine factory, with regulatory approval, that makes magically safe vaccines”. He also mentioned that it would not be feasible for a company to move vaccines to a developing nation.

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has pointed out the “real challenges” in scaling up production of COVID-19 vaccines. These include – trade barriers, limited supply chains, scarcity of raw, and the unwillingness of high-income countries to share doses with low-income nations.

VACCINE DIPLOMACY

As the COVID -19 pandemic continuous to rage dynamically, the world is still suffering from inadequate vaccine production and its shortages. Even after 170 million cases (approx.), over 3 million deaths and 22 months of pandemic Nations worldwide struggles to create a mechanism for equitable supply of vaccine. Current situation of vaccine production and supply is very flawed because the gap between vaccine supply of developed and developing companies are widening day-by-day. According to a magazine named Science, almost 85% of the vaccine administered worldwide are injected to rich and middle-income countries.

International diplomacy and relations have Overtaken the vaccination drives and administration and because of this international effort for equitable distribution of vaccine has compromised. The COVAX initiative, even though it was a great multilateral approach to provide vaccines globally has faced a lot of problems. Vaccine manufacturing and supple are uneven as per density. West countries produce most of the vaccines while countries like India and Russia find it very difficult to scale up their production. These problems get more worse because of numerous components such as non-availability of Raw material, Profit motive of big pharma companies and Pharma Lobbies which tend to control the rate of vaccine and its supply with using Intellectual Property Rights as weapon at the cost of human life and well-being. Adding to these points Vaccine Diplomacy has become a method for dominant countries to increase their influence and control in Diplomatic world.

While the west countries make administering the vaccine to their citizen as their priority, countries like Russia and China supply their stock in developing market to create a soft power for themselves. The mission which is to save humanity have converted into Diplomatic faceoff between prominent countries.

Vaccines are now considered as important weapon in International Politics and it is a part of what some groups refer to as Global Nationalism, to gain more dominance in this geopolitical struggle of powers. The difference between administering vaccines can be identified by the fact that in Developed and more Income countries, citizens are vaccinated every second while in underdeveloped countries large number of people await their first dose.

Many higher-income countries which have immense technology and IPR monopoly use this power to fuel their economies and develop it to become stable after the Lockdown. Because of the trade war with China going on, USA must put their economy first before human development. While USA and other west countries are occupied in this Russia and China have aggressive policies to fulfil the vacuum of vaccine by bilateral accords and negotiations. They are keen on taking their influence over the international arena.

WILL THE WAVIER OF IPR PROMOTE TECHNOLOGY TRANSFER ?

With respect to COVID vaccines whole body of knowledge that is used for developing the vaccine is not necessarily patented. But some of that knowledge is kept disclosed as trade secret. Patenting only ensures that companies can earn profit with their technological innovations. Even though patent information may make it feasible for outsiders to obtain development results that are equivalent to those accomplished by the patented technology through a similar process without breaching the patent right, maintaining the technology undisclosed as a trade secret or implementing critical procedures into it may be an efficacious method of preserving the technology’s appropriability. Through the technique of “reverse engineering,” which refers to the process by which the active ingredients of a medicine are determined because of DE formulation, pharmaceuticals may be easily pirated and trafficked onto the black market. Over this, it is usually seen to be important to avoid the occurrence of counterfeiting using patents.

While it is unknown how much of the relevant technological information is still to be patentably secured, it seems like there are various technical reasons for not acquiring comprehensive patent protection at this point. The Pfizer and Moderna vaccines make use of advanced technology built on messenger RNA (mRNA), and it’s the first time such technique is used in a realistic context. It is quite possible that such vaccines will be difficult to fake since their production entails use of complicated manufacturing techniques and proprietary technology.

When you patent anything, you are making specialist knowledge available to the public and providing guidelines on how to replicate patented inventions. Since it clarifies the rights of ownership to advanced technologies, it serves the function of reducing cost of technology transfer. The technical knowledge necessary for producing a certain product may not be preserved in any written or other tangible form if the trade secret is not disclosed, and it may be appropriate to transfer the technical data as progressive knowledge acquisition. As a result, it is possible that transfer of technology will become more difficult.

If technical data about patented vaccines is publicly disclosed, and it becomes feasible to manufacture the vaccines in third-party nations, as is generally the case, an increase in supply would benefit people since the elimination of a monopolies reduces cost for vaccines. Among past instances, we should consider the application of the WTO TRIPS agreement waiver to HIV/AIDS medications in 2001, which was the first time this had been done. Médecins Sans Frontiers believes that the costs of patented pharmaceuticals have plummeted to less than a 10th of their previous levels in only one year, hence expanding access to the treatments around the globe. Given the fact that the principle of competition is effective, it is expected that access to COVID-19 vaccinations would enhance.

In contrast, the positive example of the waiver applied to HIV/AIDS drugs may be hard to emulate if, as the pharmaceutical industry asserts, developing nations total absence the technology necessary to create and maintain vaccines, if the swift rise for vaccine raw materials induces production to be interrupted all around globe, or if limitations are levied on the export of vaccine raw materials.

Even if the patent is deferred, an unregulated distribution of production areas would be inefficient, provided that concept of scale economies appears to apply when fixed costs (such as those associated with factories, storage facilities, and other infrastructure) associated with vaccine development are extremely high. The most efficient way would almost likely be to concentrate vaccine manufacturing in a smaller number of specific nations with significant manufacturing capacity and then export the vaccines from those countries to other countries.

INDIA’S ROLE IN VACCINE DIPLOMACY

Ever since inception of the coronavirus outbreak, India has served as a model of success. Despite being one of the first nations to implement full lockdown and masking laws, the country has shown a dramatic increase in the number of coronavirus infections in latest days. Although the rate of infection increased, it fell just about as rapidly as it rose, with experts claiming a range of possible justifications, including outstanding mask adherence by the public, a nationally united quarantine approach, and the possibility of natural immunity in the public. Even though it launched considerably later than many western nations, India has been able to vaccinate over than 10 million citizens in a very short period.

The Government of India was among the first governments to indulge in “vaccine diplomacy,” that is a strategy for assisting countries who otherwise be incapable of getting access to promising vaccine candidates in the pipeline. According to the Ministry of External Affairs of the Indian government, “the Government of India has received multiple requests for the delivery of Indian made vaccines from surrounding and important regional allies.” By these requests and in compliance with India’s stated commitment for using India’s vaccine manufacturing and shipping capacity to assist all of humanity in the struggle against the Covid pandemic.

This is consistent with India’s traditionally recognized position in the development of vaccines for the whole world. For many years, India was hailed as having a thriving pharmaceutical sector, particularly because it is the world’s largest manufacturer of vaccinations. According to a previous Forbes article, the country’s expanding rapidly $19 billion-dollar pharmaceutical industry is due to the fact that “Many frequently utilised and very well medicines are broadly shipped overseas from India, such as Paracetamol (also known as Acetaminophen or Tylenol), anti-viral such as acyclovir, essential vitamins, progestin, and antimicrobials, among others.

In terms of production capacity, there are several industry-leading pharmaceutical companies in India that are stepping up their efforts to combat Covid-19, including the renowned Serum Institute of India and Bharat Biotech, among others.

ARGUMENTS IN FAVOUR OF WAIVER	ARGUMENTS AGAINST THE WAIVER
The pandemic is a global public health problem.	Reduced or no returns on R&D investments of pharmaceutical companies.
Patent holders cannot produce enough vaccines to meet demand.	Companies incur huge expenses as vaccine production requires specialised technology and best of brains.
Public funding is used for the development of some COVID-19 vaccines.	Pharma companies would hesitate to take the initiative, next time when there prevails a situation like COVID-19.

Author: Vishwas Nagori and Vaishnavi Deshpande –a students of NMIMS (Indore), in case of any queries please contact/write back to us at Khurana & Khurana, Advocates and IP Attorneys.