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Waiver Of Patent Protection For Covid Vaccines: Need Of An Hour

The tussle between the developed and developing countries for covid 19 vaccines has just begun. Believed by many that it is not the beginning of the end of the pandemic but the beginning of endless wait for covid 19 vaccine. The vaccines are not enough even to go to the richest countries around the globe along with poor countries. 7.8 billion people are living in a world in the grips of a pandemic and vaccines for only 650 million of them, produced and distributed by only a handful of large pharmaceutical companies, and so far distributed mostly to rich countries of the world. If and when governments should intervene to ensure affordable supplies of medicines is a long-standing issue, but it may be a global pandemic that focuses minds on whether Big Pharma has the whole world exactly where it wants it.

To change this monopoly, countries like India and South Africa are aiding the World Trade Organization to introduce a temporary patent waiver for producing COVID-19 vaccines. In October 2020, the joint statement was given by India and South Africa to The World Trade Organization (WTO) to exempt manufacturer countries from enforcing some patents, trademarks, trade secrets, or pharmaceutical monopolies on the covid 19 vaccines under the organization’s agreement on Trade-Related Intellectual Property Rights (TRIPS).[i]

The joint statement was made in order to make covid 19 vaccines affordable and accessible to the least developed countries and developing countries. The waiver could be a first step towards distributing vaccines more uniformly. Also, in the joint statement, it was said that the exceptional circumstances created by the pandemic and argue that intellectual property protections are potentially hindering timely provisioning of affordable medical products. The idea is to allow other countries to make their versions of vaccines and increase production, it is essential to winning the race against time with a mutating virus, but so far without success. A patent waiver would help overcome certain legal barriers preventing developing countries from producing their vaccines.

Impact
If WTO accepts the proposal given by the joint statement, then the member countries could make the generic versions of any coronavirus vaccines and covid 19 treatment.

If WTO waives off the patent right on covid vaccines, then India can make Covid – 19 vaccines into generic medicines due to which a larger number of populations would get the much-needed relief from the vaccines at an extremely lower rate. India can emerge as the leader of the developing nations if India doesn’t budge from its stand and continues to consolidate the crisis-stricken poor countries.

This could set a precedent for making the IPR norms of WTO flexible and pliant for any such future exigency. The medicinal hegemony of the developed nations would also be challenged who have succeeded through the years the unjust share of similar innovations.

The vaccines developed by the companies which are based in developed countries have manufactured vaccines with the help of tax payer’s money. Those vaccines essentially belong to the people – and yet the people are supposed to pay for the vaccines again, and with little prospect of getting as many as they need fast. Around 90 billion pounds of public money has gone into developing COVID treatments and vaccines, and the public must have a stake.

The joint statement was opposed by the United States, the European Union, Britain, Norway, Switzerland, Australia, Brazil Japan, and Canada and major pharma companies are opposing it too because these countries don’t want to leave the monopoly. The longer-term plan of the manufacturer countries is to increase the price of the vaccines after the most urgent phase of the pandemic is over, due to which developing countries need to, gain the ability to produce these vaccines themselves.

There's another aspect that is if developed countries increase the knowledge of vaccine production in other parts, or all parts of the world, developing or poor countries can be much better prepared for the next pandemic.

European Union
The European Union argues that there was no indication that intellectual property rights issues have been a genuine barrier about covid-19 related medicines and technologies. The British mission also agrees to the waiver of the proposal because it is an extreme measure to address an unproven problem.

United States
The US trade representative said that protecting intellectual property rights and otherwise facilitating incentives for innovation and competition was the way to ensure the swift delivery of any vaccines and treatment.

One government that signaled it may rethink its opposition to the waiver is the Biden administration. Outside pressure on the US has been mounting over 170 former heads of state and Nobel laureates, as well as a series of US lawmakers and global organizations, have called on the government to reverse its veto.

In recent days, the EU and UK have been taking the wrong kinds of jabs at each other over frustrations around vaccine supply, but there is of course a bigger picture.

Coverage Issue
The global capacity for producing vaccines is around 3.5 billion, while 10 billion is needed. Additionally, these vaccines are produced and supplied in wealthy countries and are kept by those wealthy countries. Developing nations are saying, they need to have a share of the pie, not only the share of the vaccine but also the share of the right to produce these vaccines. To make a vaccine, they need to have the right to produce the original substance, which is protected by patents.

Developing or poor countries also need to know how to make them, because the technology can be complex. The World Health Organization does not have the authority to save that patent, but it's trying to bring countries together to find a way to bolster vaccine supplies.

Based on Pfizer's and Moderna's stated vaccine–production capacity and their supply deal with the United States and the European Union, as well as Japan and Canada, that these countries can expect to have 50% of their populations covered by the end of 2021. Considering that 82% of the vaccines Pfizer says it can produce through next year and 78% of Moderna's vaccine, have already been sold to rich countries. This shows the shortage and delay of the vaccine for poor and developing countries.

AstraZeneca has struck deals with manufacturers of poor or developing countries like India and Latin America as well as Gavi to help poor countries get access to its vaccine. It has also committed not to make a profit from its vaccine during the pandemic – though according to a Financial Times report based on company documents that AstraZeneca has retained the right to declare the end of the pandemic as early as July 2021, and the company estimates that it will be able to make three billion doses by the end of 2021 which will cover only 20% of the world’s population.

What Is IPR
Meaning of IP: intellectual property is an intellectual work that is produced by the intellect of the human brain. For example, literary work, musical work, inventions, etc.
Intellectual property is intangible property. It is described as property because it can be sold, purchased, mortgaged, etc. The person who creates an intellectual piece of work owns it like any other tangible property just like land or movable goods.

The owner of intellectual property has absolute rights over his intangible property. No one can use intellectual property without the consent of the owner. The exclusive rights which the person enjoys for his intellectual property are his/her ‘intellectual property rights.' Intellectual property is the outcome of intellectual activity in the industrial, scientific, and artistic fields. Intellectual law aims at protecting the creators and other producers of intellectual goods and services. Intellectual property rights (IPR) give the originator an exclusive right over the use of his/her creation for a limited period.

In the Paris Convention for the protection of industrial property[ii] and the Berne Convention for the protection of Literary and Artistic Work[iii], the importance of intellectual property was first recognized, which are administered by the World Intellectual Property Organization (WIPO). WIPO is one of the oldest agencies created in the year 1967 to keep encouraging creativity and promotion and protection of intellectual property.

Every 26th of April is celebrated as World Intellectual Property Day.

The law that protects the intellectual property rights is known as intellectual property law, for example, copyright law protects the copyright of authors, musicians, etc., patent law protects the invention of the inventor, trademark law protects the trademark.

Intellectual property law is divided into two heads
  1. Copyright:
    Intellectual property law relating to copyright includes original works of literary works, musical works, dramatic works, artistic works.
     
  2. Industrial property:
    Intellectual property law relating to industrial property includes patents, trademarks, and industrial design. Protection of distinctive signs, in particular trademarks and geographical indication. Trademark is a symbol to differentiate between the services and goods which are given by a certain company, for example, logos of Nike, Mc Donald’s, BMW, etc. A geographical indication is a mark to show the particular product is originating from that particular geographical area and the characters can be attributed to that geographical area. Patents protect innovation, design, and the creation

TRIPS Agreement
WTO’s agreement on TRIPS negotiated during the 1986-94 Uruguay Round, introduced intellectual property rules into the multilateral trading system for the first time, it aimed to order, predictability, and settle disputes more systematically. Before the TRIPS agreement, there was no other convention that took into consideration IPR and more than 40 countries of the world did not grant patent protection for pharmaceutical products.

TRIPS agreement requires all WTO members, with few exceptions, to adapt their laws to the minimum standards of IPR protection.

India And IPR
India is a member of the world trade organization and is committed to the agreement on trade-related aspects of intellectual property (TRIPS agreement). India is also a member of the world intellectual property organization. The national intellectual property rights (IPR) policy 2016 was adopted in May 2016 by India.

India has a clarion call, Creative India, Innovative India. This policy brings to a single platform all IPRs, considering all inter-linkages, and thus aims to create and exploit synergies between all forms of intellectual property, and concerned statutes and agencies. The nodal agency for this is the Department for Promotion of Industry and Internal Trade (DPIIT) which oversees the policies and makes sure that India is obligated by the TRIPS agreement. Under DPIIT, Cell for Intellectual Property Right and Management (CIPRM) was created which is an executing body.

Challenges Before Wto And Trips
  1. The most insurmountable challenge now is to bring both developed and developing countries under one roof and on the same page to negotiate
     
  2. Countries in which drugs are relatively cheap, such as India, face another kind of challenge: attempts to overturn the laws that make those drugs accessible there for example there was a company Novartis, a Swiss pharmaceutical giant, fought a decade-long battle to secure monopoly control in India over its treatment for leukemia, and in this process, it tried to have Indian patent law[iv] struck down the and unconstitutional, although it did not succeed.
     
  3. The crises of access to affordable medicines also affect countries whose governments defend extensive intellectual property protection for companies, for example, insulin in the US can be punishingly expensive.
     
  4. Delay of the entire process of the distribution of vaccines for covid – 19 is a massive hindrance.

Way Forward
  1. Under the TRIPS regime, there are various tools such as compulsory licensing that are available to assure access to medicines. Compulsory licensing is when the government allows other people to produce a patented product without the consent of the manufacturer or patent owner.
     
  2. Society needs to respect innovations and therefore amend laws. For example, India generated its covid – 19 vaccines ‘COVAXIN’, which is approved by WHO for use in India but not granted EUL status.
     
  3. One more method by which accumulation and circulation of innovative products can be ensured is by creating a pandemic patent pool. It would be a fruitful endeavour to create a global pool of covid-19-related innovations or innovations related to a rare pandemic, in respect of vaccines and medicines. In the pandemic patent pool, aggregation, administration, and dissemination of the license will take place. The creation of a pool and immediate licensing will ensure that there are hundreds of manufacturers in the world. with the help of this pool, vaccines and medicines will be quickly available.

Conclusion
Several effective COVID-19 vaccines have become available. At the same time, new variants have emerged recently and there's fear that existing vaccines may be less effective against them. Against this background, international trade rules for vaccines have become a contentious issue. Recently the European Union imposes some export restrictions, although they were forced to backtrack in the case of Northern Ireland.

The UK is said to be considering restrictions as well. At the other extreme, India, which is a major vaccine manufacturer has been engaging in vaccine diplomacy giving millions of doses of the vaccine to neighbouring countries, even though it has barely gotten the domestic vaccination program off the ground itself. One important issue has been intellectual property protections or patent rules for COVID-19 vaccines and drugs.

The WTO agreement on intellectual property protection is the trade-related aspects of intellectual property or TRIPS Agreement. India and South Africa floated the idea in October of a waiver that would override patent rules allowing generic or other manufacturers to make vaccines and drugs. The proposed waiver, would last until the world has had immunity and the pandemic is declared over, and many developing countries have come out in favour of this.

The proposal was opposed by the United States UK Switzerland, basically countries with significant pharmaceutical industries. The WTO has delayed the discussion of this proposal and it appears to be at an impasse. So is the waiver a good idea, pharmaceutical companies that develop the vaccines have argued for the enforcement of intellectual property protection, it's a familiar argument that not allowing companies to profit from the fruits of their invention would blunt the incentive to invest? For instance, the CEO of Pfizer claimed that IPS were brought a solution to the pandemic in the first place.

And we may well need the ingenuity of these companies, even in this pandemic, if new vaccines are needed to control the variants. It's also worth noting that some companies proposed to sell the vaccine at cost, while the pandemic lasts and adds cost to poor countries even after that. Moreover, those opposed to waivers argue that the TRIPS Agreement already has mechanisms within it, to enable countries to compulsorily licensed patented products, but the process is both cumbersome and there's some ambiguity when it comes to cell lines needed for vaccines.

They also point to voluntary measures donations to the WHO COVAX facility as an alternative. The main issue is the need to get the vaccine to people everywhere, quickly. The new variants have changed the calculation. So long as the virus keeps raging through the world's population, new variants will continue to arise, and they will then inevitably spread everywhere so it's important to use all the world's production capacity as speedily as we can.

Spreading up the production also protects against the dangers of vaccine nationalism, of which we have already seen worrying signs, whether it's the TRIPS’ waiver or some other emergency mechanism that protects the profits and property of the vaccine developers, such as governments, collectively purchasing patterns and licensing them to producers, the need to expand and globally diversify vaccine production could not be more urgent.

End-Notes:
  1. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994
  2. Paris Convention for the Protection of Industrial Property (March 20, 1883; effective July 7, 1884, and amended June 2, 1934 and July 14, 1967) (the Paris Convention)
  3. The Berne Convention for the Protection of Literary and Artistic Works 1886
  4. Indian patent act, 1970

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