Demand for Covid Vaccine Patent Waiver: Justified or Unreasonable?

GLA University - B.Com | LLB | B.A.
GLA University | B.Com | LLB | B.A.
On June 14, at an inaugural session at the G7 Summit, India stressed for Covid vaccine patent waiver for the umpteenth time. India requested a lift of patent for the Covid-19 vaccine after the United States had offered to support the same in May. While the Council of TRIPS recently decided to hold a series of meetings till July to mull over patent wavers for the Covid vaccine, the push for the same got initiated in October last year. Although reasonable, the demand for a patent waiver by South Africa and India caused quite a stir among pharmaceutical companies and wealthier nations.
Nishtha Mittal breaks down the meaning and significance of intellectual property rights with respect to the Covid vaccine and its equitable distribution. She argues that amid a raging emergency, a middle path could offer a tangible solution.

covid vaccine patent waver

By Nishtha Mittal, a fourth-year student of BA LLB  from Amity Law School, Delhi, Indraprastha University.

What’s IPR? Why Are We Talking about it Now?

Intellectual Property Right (IPR) is a legal tool meant to protect a creator’s right over their work. It does so in the form of patents, copyright, trademarks and industrial design. In addition, IPR seeks to balance the interests of the creator and the larger public by encouraging them with security and monetary benefit.

The investment, time, money, efforts and mind that a person puts through in an invention is the most fundamental ground to grant them such rights, which prevent third parties from stealing or claiming former’s work. And for the same reason, it is touted to increase a country’s GDP by promoting healthy competition, encouraging industrial development and fair globalisation.[1]

India is a signatory of several intellectual property rights related treaties and agreements, including the Paris Convention for the protection of industrial property (1883), the Berne Convention for protection of literary and artistic works (1886), Patent cooperation treaty and Agreement on Trade-Related Aspects of Intellectual Property Rights or TRIPS Agreement (1995), among others.

With newer developments in the pharmaceutical industry, the issue of patent protection keeps on arising. Amidst the Covid-19 pandemic, patent protection acquired much heat. The question posed was whether the Covid vaccine should be patent-protected? 

The answer involves many differing opinions. As developed countries have made swift progress with their vaccination programmes, many developing and underdeveloped countries have been left behind to struggle due to patent protection.[2] With the alarming rate at which the Covid-19 cases are rising, the world needs quick and easy access to the lifesaving drug.

This article begins by explaining the TRIPS Agreement and why the same garnered attention amid the Covid-19 pandemic. It will detail the demand for a patent waiver by developing countries ahead of the World Trade Organisation, analysing the reaction of developed countries and private companies. Eventually, it will stress a balanced approach, striking a middle path for all stakeholders.

All About TRIPS Agreement and Covid Vaccine Patent Waiver

TRIPS is one of the most comprehensive multilateral agreement on intellectual property.  It provides the basic framework for regulating intellectual property rights worldwide, but it’s not binding universally. Nevertheless, every WTO member shall include this Agreement in their domestic intellectual property legislations or laws.

TRIPS ensures minimum standards of protection, starting with substantive obligations in the main international agreements of the WIPO, including the Paris Convention for the Protection of Industrial Property and the Berne Convention for the Protection of Literary and Artistic Works. [3]

Since TRIPS adds to the existing ‘international standards’, it is sometimes referred to as a Berne and Paris-plus Agreement

PIMR Indore Admission

From the beginning of the pandemic, governments and stakeholders have deliberated on the development and distribution of the Covid vaccine. Several initiatives have addressed the voluntary sharing and pooling of IPRs.[4] Similarly, a range of policy options confirmed under the TRIPS Agreement will remain available to WTO members as tools to deal with public health issues wherever needed.[5] 

Patent Waiver Request By South Africa And India in WTO

In October 2020, South Africa and India,  ‘leaders’ of low-and middle-income countries, decided to address the inequitable access to the Covid vaccine at the WTO.

Placing the request to the WTO’s Council, both countries asked the WTO to allow member countries to waive patent rights related to Covid vaccines and other Covid-related technologies for a specific period. Even China had backed the measure.

The objective was to protect the interests of developing nations and ensure the supply of Covid vaccines smoothly.

This request sought that the waiver remains in place until most developed and developing nations have administered the Covid vaccine to their population.

Several reports about IPRs hindering or potentially hindering timely access to affordable medical products to the patients have surfaced.[7]  Beyond patents, other intellectual property rights may also pose similar problems.

The main concern for low-and middle-income countries has been not having a manufacturing capacity or an effective one needed for Article 31b and the lengthy complex mechanism for trading pharmaceutical products. Internationally, there is a need for unity among the member countries for global equitable sharing of Covid vaccines to respond urgently to the Covid-19 pandemic.

The delegates of both the countries laid down grounds to support their proposal of waiver. They had contended that the United States, United Kingdom and European Union held approximately 30 per cent of over 200 million Covid vaccine doses. And only ten countries administered 75 per cent of the Covid vaccine, whereas 100 countries have not yet been able to give the first dose of the Covid vaccine.[8]

They had argued that the same indicated the concentration of the Covid vaccine in a few countries resulting in an inequitable distribution.

The Indian delegate had also pointed out that despite purchasing Covid vaccines in advance, India faced an acute shortage of supplies. Therefore, a mutual agreement between countries to share Covid vaccines couldn’t replace the need to waiver IPRs.[9]

Doctors Without Borders (also called Médecins Sans Frontières or MSF) supported the contention raised by India and South Africa. MSF stated:

“the waiver proposal offered in WTO allows several governments to show solidarity in dealing with the pandemic by developing and equitably distributing the Covid vaccine without private monopolisation by industries acting as a barrier in the same.”[10]

If patent protection is provided, the private corporations may continue to pursue secretive and limited Covid vaccine supplies, which exclude many low-and middle-income countries.

The Covid vaccine patent waiver proposal could aid in removing legal uncertainties and risks for potential producers and governments to produce and supply Covid vaccines and other essential medical tools.[11]

Around 90 members of WTO supported the proposal of waiver, including 57 co-sponsors, supported by various delegations like Jamaica on behalf of the African, Caribbean and Pacific Group, Afghanistan, Argentina, Bangladesh, Cambodia, Sri Lanka, Honduras, Nigeria, Cuba, Nepal, Nicaragua, Indonesia, Tunisia, Mali and Mauritius.[12]

Against Covid Vaccine Patent Waiver: Opposition from Developed Countries and Pharmaceutical Industry

Initially, when India and South Africa had proposed the Covid vaccine patent waiver, the US, Russia, UK and European Union had vocalised their concern and hostility towards the proposal propounded in WTO.[13]

The pharmaceutical companies contented that the world saw a stimulus in COVID-19 solutions and the partnerships to co-operate in research and development, including scaling up Covid vaccines manufacture and treatments. Thus, diluting national and international IP frameworks may prove to be a bane.

It was argued that the same could be counterproductive to research and development or access and may also sabotage the well-functioning IP[14] system that allows the industry to partner with the academic and research institutes, foundations and other private companies. And since IP develops confidence in new innovators, thus the proposal went against ensuring that the future generation of inventors and investors remain secured.[15]

A European Union spokesperson explained that there was no evidence or conclusive proof that IPRs are a genuine barrier to the access and distribution of Covid vaccines and technologies. Therefore, a patent waiver was not the only solution to this issue.[16]

Although the US has recently changed its stance and came forward to support the Covid vaccine patent waiver, at the time, the US had opposed the same. The US Chamber of Commerce’s Global Innovation Policy Center (GIPC) had reasoned that the demand to waive off IPRs was nothing but a distraction from the real work of reinforcing supply chains. Such as procurement, distribution and immunisation of Covid vaccines to the citizens of the country. Thus, restricting IPRs, according to them, would hinder its effective development and timely administration for proper treatments presently and in future morbid times.

The UK  at the time had reasoned that a waiver to the IPRs was an extreme measure to address the inequitable distribution of the Covid vaccine. They had opined that a patent waiver was counterproductive and discouraged a regime that offered solutions to the problem, and it was ineffective in curbing it. Instead, the UK had proposed that countries considered issues related to prevention, containment and treatment of the pandemic. Thus, the IP mechanism isn’t only about protecting the rights of the inventors and enhancing equitable sharing and dissemination of equipment and valuable information on innovation. The waiver thus could hinder the path of progress laid down by the IP regime.[17]

Can There Be a Middle Ground?

To speed up the vaccination rates worldwide, we need more global manufacturing capacity and pharmaceutical and therapeutically enhanced platforms.[18]

The same can be done by employing risk-tolerant capital and an effective partnership platform to share new technical knowledge, which requires cooperation with confidence in the platform.[19]

WTO Members are responsible for banning Covid vaccine nationalism and monopolisation. They are supposed to intensify cooperation on new Covid vaccines, therapeutics, and diagnostic techniques.[20] WTO could adopt a middle path by facilitating technology transfer as per multilateral treaties to make Covid vaccines accessible for developing countries. Also, allowing compulsory licensing[21] of medicinal products could be helpful.

AstraZeneca has been ahead in this proposal by licensing production in several countries, and Johnson & Johnson also seems willing to follow suit.

The private sector, civil society, and parliamentarians are coordinators of the WTO. The collaboration will be further nurtured by transferring technology and applying the framework of multilateral rules to encourage research and development without hindering the licensing agreements that help scale up the manufacturing of pharmaceuticals.

It’s also crucial that countries do not impose export barriers on Covid vaccines so that additional duties do not hinder the supply to least developed nations.[23]

Countering additional cost will enable countries to afford the Covid vaccines without having to suspend patent rights. If the world becomes ready to share the burden of the Covid vaccine, no nation shall be left out.

Stephen Ezell and Nigel Cory of the Information Technology and Innovation Foundation also stressed the need for a reasonable balance between exclusivity and access.[24]

Balancing The IP Rights And Equitable Access Before The Pandemic: Compulsory Licensing

The complicated task of balancing the two sides together is not new to the WTO. There was a long controversy regarding the access to HIV-AIDS drugs among the multilateral trading corporations approximately two decades ago.

The HIV-AIDS drugs were too expensive for the developing or under-developed countries, specifically the Sub-Saharan African countries that lacked infrastructure and the money to import the supply of drugs. Therefore, it would have been challenging for the WTO to give precedence to patent protection over the affordable medicines for HIV-AIDS to low-income nations.

The TRIPS Agreement has the scope and provisions to include extraordinary health emergencies in which the members of WTO may take reasonable measures to ensure safety.[25]

Article-7, for instance, lays down that social and economic welfare must be kept in mind while exercising patent rights. Article 8 gives members the power to amend or alter the provisions in case of any health emergency to protect public health within the provisions of the TRIPS Agreement.

In case of public health emergencies, one can use the compulsory license to use the patented product without the authorisation of the holder, as it may be challenging to obtain a voluntary license during such a time.[26] However, the use of such patent-protected technology is partially supervised and controlled by the patent holder.

Thus, compulsory licensing of medicines is not favoured by private drug manufacturing companies. However, these actions by the WTO members in previous years demonstrate that compulsory licensing helps strike a balance between protecting IPRs and ensuring access to essential medicines in public health emergencies.

Conclusion

Neither of the opinions entirely presented a proper solution to the impediment of Covid vaccine patent waiver. Although the recent developments and the upcoming meeting of the TRIPS Council could have positive repercussions, except for the US, there’s still a lot of hesitation on the end of the wealthier nations.

Developing countries couldn’t justify their demand for IP waiver in the debate despite having the right of compulsory licensing, which is usually effective against monopolisation.

Similarly, developed countries and pharmaceutical industries seem to misuse a public health emergency by contending that compulsory licensing would hinder the innovation of new Covid vaccines. The argument of private pharmaceutical players seems to be completely baseless, motivated by the capitalist and monopolistic intent.

The only way forward is to act in solidarity and mutually build trust among themselves and on various inter-regional treaties that ensure equitable distribution of the Covid vaccine.

If supply increases with the growing demand, inflation in Covid vaccine prices won’t hinder its distribution. Therefore, the world also needs greater manufacturing capacity with significant funding, necessary to curb the problem of patent price hike for developing countries.

Also, an authority to check monopolistic practices of pharmaceuticals and private manufacturers would prevent the unauthorised holding of Covid vaccine doses.

The WTO must consider the middle way of compulsory licensing.  As proven above, it would allow both ends to compromise and benefit.

Endnotes

[1] Intellectual property rights: An overview and implications in the pharmaceutical industry

Chandra Nath Saha and Sanjib Bhattacharya

[2] Exploring the Covid-19 Covid vaccine IP waiver proposal at WTO available at https://www.pharmaceutical-technology.com/features/wto-ip-waiver-proposal-Covid19-Covid vaccine. ( last modified March 12, 2021, at 16:21)

[3] Overview: the TRIPS agreement available at https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm (last visited on 8th April 2021)

[4] Priyanka Rastogi, ‘India: Patent Pool’ (07 July 2014) available at https://www.mondaq.com/india/patent/325602/patent-pool.

[5] TRIPS report e-pdf: The TRIPS Agreement and Covid-19

[6] Ibid

[7] Decker, Susan, and Christopher Yasiejko. “World War II-Style Mobilization Order May Carry Risks.” Bloomberg.com, Bloomberg, www.bloomberg.com/news/articles/2020-03-20/world-war-ii-style-production-may-carry-legal-risks-for-patriots.

[8] Editorial, “ South Africa IP waiver proposal gets the support of about 90 WTO members” The Hindu (February 24, 2021)

[9] Editorial, “ South Africa IP waiver proposal gets the support of about 90 WTO members” The Hindu (February 24, 2021)

[10] Countries must stop blocking and move towards formal negotiation on the pandemic monopoly waiver at WTO available at https://msfaccess.org/countries-must-stop-blocking-and-move-toward-formal-negotiations-pandemic-monopoly-waiver-wto (press release 19th March 2021)

[11] WTO Weighs South Africa, India Proposal To Waive Intellectual Property Rights On COVID-19 Products available at https://www.kff.org/news-summary/wto-weighs-south-africa-india-proposal-to-waive-intellectual-property-rights-on-Covid-19-products/ (December 17, 2020)

[12] Supra note [22]

[13] World Trade organisation

[14] Intellectual property rights

[15] Pharma delivers COVID-19 solutions, but calls for the dilution of intellectual property rights are counterproductively available at https://www.ifpma.org/resource-centre/pharma-innovation-delivers-Covid-19-solutions-beyond-expectations-but-calls-for-the-dilution-of-intellectual-property-rights-are-counteproductive/ (published on 8th December 2020)

[16] Collis, “WTO Members Reject IP Rules Waiver.”

[17] UK Mission to the WTO, UN, and Other International Organizations (Geneva), “UK Statement to the TRIPS Council: Item 15 Waiver Proposal for COVID-19,” UK Government, October 16, 2020.

[18] Would Exempting COVID-19 Covid vaccines from Intellectual Property Rights Improve Global Access and Equity? (Moderated by CGD PRESIDENT MASOOD AHMED).

[19] Supra note [33].

[20] Statement of Director-General Elect Dr Ngozi Okonjo-Iweala to the Special Session of the WTO General Council (February 13, 2021).

[21] Article 31 of TRIPS Agreement.

[22] ‘AstraZeneca takes next steps towards broad and equitable access to Oxford University’s potential COVID-19 Covid vaccine’ (4 June 2020) (Available at)- https://www.astrazeneca.com/media-centre/articles/2020/astrazeneca-takes-next-steps-towards-broad-and-equitable-access-to-oxford-universitys-potential-covid-19-Covid vaccine.html

[23] Allie Nawrat, “ Exploring the Covid-19 Covid vaccine IP waiver proposal at the WTO” (15th March, 2021) available at https://www.pharmaceutical-technology.com/features/wto-ip-waiver-proposal-Covid19-Covid vaccine/#:~:text=Their%20representatives%20asked%20the%20WTO,the%20duration%20of%20the%20pandemic.

[24] Ezell and Cory, “Intellectual Property Internationally,” p. 18.

[25] Supra note [43]

[26] Jennifer Hillman, “Drugs and Covid vaccines Are Coming—But to Whom?,” Foreign Affairs, May 19, 2020.

1 thought on “Demand for Covid Vaccine Patent Waiver: Justified or Unreasonable?”

  1. Looks like more of a news report than a legal article, no talk about the Indian patents act and various patent laws of other countries, no details about article 31 of the trips which should have been explained in detail for a proper understanding of the issue, writer has given us statements of various delegates and pharmaceutical giants, which though may be relevant but are of Jo use in a legal article I believe.
    Author talks about compulsory licensing but a layman has to Google it as to what it actually is as the author hasn’t explained it in detail in the light of trips and various laws(again maybe the Indian patents act).

    Reply

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