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Covid 19 was declared a pandemic on the 12th of March 2020, and at the time of writing this article has taken over 3 million lives.[1]  The advent of the virus has magnified healthcare inequality worldwide.  Some pharmaceutical companies, well known ones being BioNTech/Pfizer, Moderna and Astra Zeneca have innovated and created effective vaccines to curb the virus, but not everyone has access to these.  This has created a conversation around intellectual property rights and systems and the ethical considerations of patenting a vaccine during a global pandemic.

What are patents and how do they relate to vaccines?

A patent is a title which gives intellectual property rights granting the patent holder an exclusive right to make, use, sell, or import a product.  A patent can also be held over a process.  The rationale is to give the patent owner the opportunity and time to recover costs expended in developing the product or process, and eventually make a profit.  The term of a patent is usually 20 years.  As a result, the holder can either bar third parties completely from their technology or allow permission (license) with specific and restrictive conditions, and charge accordingly.   

The WTO’s agreement on Trade-Related Aspects of IP (TRIPS) seeks to implement a uniform set of standards of IP protection across member nations for greater stability in international economic relations.  The aforementioned rights are enshrined in article 28 of TRIPS.  The holder may charge highly to recoup on their investment; however, this has implications on who can access the technology.  As a result, voluntary licensing may not be a feasible option for many developing countries.

Of the vaccinations that have been administered worldwide thus far, the vast majority have been in a handful of rich and vaccine producing countries, while some poor countries are in the side-lines watching and waiting.  One may argue that the gravity of the situation that faces us demands the boosting of manufacturing and thus a waiver on IP rights held by pharmaceutical companies.  The virus has been mutating, with newer, more transmissible, and deadlier variants appearing.  The Director of WHO has stated that as long as the virus is allowed to continue spreading anywhere, it shall continue to mutate and this may ultimately affect the efficacy of the existing vaccines.[2]  As a result, sustainable vaccine manufacturing and production worldwide is required.     

Balancing between the right to the protection of intellectual property vs public health and the accessibility to new medicines

On one hand, the protection of IP is a crucial mechanism in encouraging innovation as well as research and development. On the other hand, in times of global emergencies such as the Covid-19 Pandemic, there is need for global access to research and development into new drugs in a manner conducive to social and economic welfare.[3] A careful balance between these two needs to be found. Articles 30 to 31 of TRIPS provide flexibilities to the patent rights enshrined in Article 28 by way of compulsory licensing.  This is a process by which a government licenses companies or individuals other than the patent owner to use the rights of the patent—to make, use, sell, or import a product under patent—without the permission of the patent owner.[4] 

As a result, governments can overcome access and pricing barriers.  Third parties are required to attempt negotiating a voluntary license with a patent holder before taking the step of requesting a compulsory license.  Voluntary licensing can be bypassed where there is extreme emergency, however the emergency compulsory licenses resulting from this are limited to authorization for mainly domestic use.  In practice, this is ineffectual as many developing countries do not have the capacity to produce pharmaceutical products domestically. However, some developed countries have opted out of importing foreign manufactured and patented medicines where “…compulsory license is issued to export for other countries.”[5] This may be detrimental as these countries’ unwillingness to make use of compulsory licenses limits the export market.  For example, where the United states opts out of compulsory licenses for vaccines produced in India, other countries with domestic manufacturing capabilities are deprived of issuing compulsory licenses for US manufactured and patented medicines as the US would no longer be an eligible importing member.  Article 31bis was adopted to remedy this- countries lacking manufacturing capability may import specific pharmaceutical products but this is costly and cumbersome.

This makes it necessary to consider the temporary waiving of IP rights by pharmaceutical companies.  South Africa and India were the first to call for the vaccine patents to be temporarily waived and have subsequently been joined by some 80 developing countries, along with rights groups.[6]  Rich and vaccine producing countries including Britain, The United States and some EU Nations have blocked this, arguing IP rights are necessary to incentivize research and innovation, and safeguard against low quality replications.  Discussions are still ongoing. 

What is the way forward?

The possible solution to swiftly curbing the virus may be a combination of dose sharing, tech transfer, voluntary licensing and the temporary waiving of intellectual property rights. Furthermore, individuals and multinational corporations with trade interests along with governments from developed countries can donate to COVAX to hasten efforts to end the pandemic. In this case, the altruistic efforts of pharmaceutical corporations may also assist in achieving global herd immunity.

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By Kudzai Mushangwe and Chido Gezimati

[1] https://covid19.who.int/

[2] https://www.who.int/news-room/commentaries/detail/waive-covid-vaccine-patents-to-put-world-on-war-footing

[3] Article 7 of the TRIPS Agreement.

[4] https://www.wto.org/english/thewto_e/glossary_e/compulsory_licensing_e.htm

[5] https://www.csis.org/analysis/compulsory-licensing-cure-distributing-cure

[6] https://www.france24.com/en/europe/20210416-could-waived-covid-19-patents-save-the-world