India: 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.

IPR Waiver And Covid-19 Vaccines

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