Waiver of IP Rights for COVID-19 Vaccine: A Path to Equitable Distribution or not?
Owolabi R., Anusionwu J. and Raji S.
Introduction
The sudden emergence of COVID-19 threw the whole world in disarray, causing disruption in all aspects of life. This has necessitated the scientific and technological processes that has gone into the production of vaccine by pharmaceutical companies. It is common knowledge that Intellectual Property seeks to protect creations of the mind, such as inventions, novel creations, literary and artistic work among others, which gives individuals a recognition or financial benefit from what they created or invented. [1]
The ongoing vaccine production process has sparked conversations on patent as they are the “lifeblood” of the pharmaceutical industry.[2] According to the World Intellectual Property Organization (WIPO), patent is the exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new way of doing something, or even offers a new technical solution to a problem.[3]
The conversation on the impact of patent and other forms of IP rights on COVID-19 vaccination have brought about two divides, those on the utilitarian side of the argument, who believe that IP Rights are a barrier to widespread vaccination and that human lives should be placed before profits. On the other hand, are those on the economic side of the argument; who believe that entities who have invested in the research and development (R&D) process which has brought about the production of a vaccine should be able to enjoy exclusive rights to their invention and profit from it.
In October 2020, India and South Africa, which seem to be on the utilitarian divide and have recognized some of the current inefficiencies of the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS), called for a waiver by the World Trade Organization (WTO) to promote an effective coordinated response to the spread of COVID-19 vaccine.[4] This waiver is to permit a temporary suspension of intellectual property rights such as patents, trade secrets, industrial designs and copyrights under the WTO’s Agreement on TRIPS Agreement of COVID-19-related medical products, including vaccines. While India and South Africa’s proposal is still under consideration, powerful states such as the United States and the European Union are opposed to it. A brief analysis of both sides of the argument, at this juncture, will be necessary.
Arguments for the waiver of IP Rights
The proposal for the waiver of Intellectual Property Rights was formally made before the WTO by South Africa and India.[5] The proposal has then been welcomed by over 100 low and middle income countries including Eswatini, Kenya, Mozambique, Bolivia and Pakistan. International human rights organizations like Amnesty International and the Human Rights Watch have also lent their voice to this.[6] Pro-waiver countries see IP rights as a barrier to the access to COVID-19 vaccines and that a waiver of such IP rights will facilitate the production and distribution of vaccines especially to developing nations.
It is important to state that there are emergency health safeguards provided under the TRIPS Agreement by virtue of the provisions on compulsory licensing which is the noncommercial use of a patent by the government through domestic production or importation without authorization from the patent holder, usually in cases of national emergency.[7] Compulsory licensing provides countries with flexibility for facilitating the access to public goods such as vaccines. The Doha Declaration on the TRIPS Agreement and Public Health also supported the flexibility agreement for compulsory licensing in the interest of public health. The Doha Declaration restated each WTO member’s right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.[8]
The proponents for the waiver of IPRs have argued that the provisions on compulsory licensing is not sufficient enough to address a global health emergency like the COVID-19 which has claimed millions of lives. Countries advocating for waiver also see the process of compulsory licensing as very complex and bureaucratic. The process of negotiation and judicial or independent review may be time consuming and can consequently delay the procurement of vaccines. To ameliorate the burdensome process involved, some countries have been reported to have created legislative framework for the ease of issuing compulsory licenses.[9]
Developing countries might also choose to restrain from adopting compulsory licensing due to certain bilateral agreements which places limitations on its use. While there may not be an express provision prohibiting compulsory licensing, developing countries may refrain from its use due to fear of payback in form of trade sanctions from developed countries.[10]
While the TRIPS Agreement provides for adequate remuneration to made on compulsory licensing based on the economic value of the authorization,[11] the TRIPS agreement do not provide a clear definition of what ‘adequate’ is. Also, no guideline was given as to the computation of the economic value.[12] There is also tendency for the patent holders to decide on a high remuneration based on the value of COVID-19 vaccine. This can consequently limit the access of low and middle income countries to the vaccines.
Arguments are also made on the existence on global vaccination initiatives like the COVAX which are to ensure global access to vaccines. While it is commendable that many countries have shown global solidarity through their contributions to COVAX, such global initiatives are frustrated by high income countries. Countries like the UK for instance with a population of approximately 66 million people has ordered about 367million doses of vaccines in sharp contrast with Africa having ordered a total of 270million doses for a population of 1.2billion people.[13]
While Intellectual property can be said to have promoted research and development leading to the invention of the COVID-19 vaccine, combating the pandemic has been largely a collective effort, the role of public funding both from governments through taxpayers’ money and donations from philanthropic individuals for R&D on COVID-19 cannot be overemphasized. The role of healthcare workers, clinical trial volunteers and other frontline workers were also pivotal in combating the global pandemic.
Arguments against the waiver of IP Rights
Patent is more relevant to the subject matter when compared to other forms of intellectual property. Patent aims to protect inventors who have made use of their time, effort, intellect, and various skills to produce or create a process or method which is new, unique, novel or a solution to a novel situation. It serves as a way of crediting and honoring these inventors for their works by granting these inventors an exclusive right through patent.
As a result of the utility of such a patent, many high income countries like US, UK and many pharmaceutical companies, stand firmly that the COVID-19 vaccines should enjoy intellectual property protection.
While pharmaceutical companies like Moderna has agreed to relax on their IP rights by making an announcement not to enforce patent rights to its COVID-19 vaccines,[14] other pharmaceutical companies such as Pfizer and BioNTech have not made such commitment. Proponents on this end believe that there are valid concerns and reasons as to why IP rights on COVID-19 vaccines should not be waived.
Patent and Copyright grants protection to inventors and creators to gain their financial stance back. This is an economical benefit for inventors, which gives inventors a chance to retrieve the investments they had used in creating the novel product. Pharmaceutical and biotech companies while trying to come up with vaccines devote a lot of resource and investment whether physical, financial or emotional; therefore, it is only proper they get rewarded for their efforts.[15] If the proposal to the World Trade Organization to suspend patents covering covid-19 vaccines is accepted, there will be a very low motivation for pharmaceutical companies to invent or create future useful vaccines, and therefore discourages inventive work. An industry representative warned that such efforts can jeopardize future medical innovation and making us vulnerable to future diseases.[16]
Currently, with the patent right still on, the pandemic has led to an increase in research and development of vaccines, and this is because there is a patent system for encouragement. With this, and according to the World Health Organization(WHO), there are more than two hundred Covid-19 vaccines ongoing projects around the world. Some have been approved while some are still at the clinical stage. This will subsequently lead to competition and indirectly fight against overcharging for the vaccines as pharmaceutical companies will keep prices low in order to earn contracts.[17]
In as much as the vaccines is concerned, suspending of patent right does not give certainty that the vaccines will be evenly or equitably distributed, it is believed to only discredit the powers of Intellectual Property and slowly make patent irrelevant, and cause more harm than good.[18] It has been argued, that intellectual property right does not create a barrier to access the vaccines especially by low income countries and that there is no evidence that intellectual property right will tamper with access to Covid-19 related medicines and technologies,[19] as equitable distribution can be accessed through licensing under Article 31 of the TRIPS Agreement.
Recommendations
In as much as there are prominently two sides to the IP conversation on COVID-19 vaccine, there are also those who seek a middle ground. Thus, those advocating for a middle ground are of the opinion that there should be a way to cater for the interests of humanity in this global pandemic while still ensuring that the future of medical innovation is not put at risk. In lieu for suspending Intellectual property rights, there should be a proper balance of both the interest of the pharmaceutical companies and other countries proposing for a waiver. In a quest to finding a middle ground, the writers recommend the following:
a) Compulsory licenses should be encouraged and granted to countries who do not have R&D capacities in order for them to access these medicines. If compulsory licenses are granted it would make it easier for developing countries, especially African countries to obtain COVID-19 vaccines faster and at affordable rates. In the words of the recently appointed Director General of the WTO, Dr. Ngozi-Okonjo-Iweala, “Vaccine nationalism does not pay”. The world is a global village and the practice of rich countries securing vaccine from pharmaceuticals in large quantities before other countries would only bring their efforts to ruin because worst case scenario, the virus would likely return by way of variance.
b) International collaborations between states should be encouraged. Upon observation, one would observe that the reason behind the promotion of intellectual property rights is majorly economical. In a situation where there is a collaboration to buy out these rights in order to ensure cost recovery in the R&D process, the production of vaccines can now be made possible in many countries.
c) If the WTO can review the TRIPS Agreement and provide sufficient flexibility under its rules to facilitate the export of vaccines, therapeutics and diagnostics to other countries. This connotes coming up with a more flexible licensing arrangement which takes into account public health emergencies while not undermining medical innovation.
Conclusion
The Coronavirus has claimed millions of lives with many still counting. governments must collectively combat this global pandemic by ensuring that IP Rights do not constitute a barrier to the access to vaccines while sustaining the right balance for medical innovation
[1] WIPO: https://www.wipo.int/about-ip/en/
[2] Mark Grayson, ‘5 Reasons why biopharmaceutical patents are different’ (September 10, 2015) <https://www.google.com/amp/s/catalyst.phrma.org/5-reasons-why-biopharmaceutical-patents-are-different%3Fhs_amp%3Dtrue>.
[3] WIPO, ‘Patents’ <https://www.wipo.int/patents/en/>.
[4] Faith Tigere and Kholofelo Kugler, ‘Compulsory Licensing: The Key to Accessing the Future COVID-19 Vaccine for Africa?’ <https://www.tradeexperettes.org/corona/compulsory-licensing-the-key-to-accessing-the-future-covid-19-vaccine-for-africa>.
[5] Proposal Available at <https://wto.org/dol2fe/pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True>
[6] Urgently Waive Intellectual Property Rules for Vaccine: <https://www.hrw.org/news/2020/12/10/urgently-waive-intellectual-property-rules-vaccine>Accessed 19th February 19, 2021
[7] Provided under Article 31 of the TRIPS Agreement
[8] Clause 5 of the Doha Declaration
[9] COVID-19: Countries Race to Strengthen Compulsory Licensing Legislation <http://www.devex.com/news/covid-19-countries-race-to-strengthen-compulsory-licensing-legislation-97595/amp> Accessed 19th February 19, 2021
[10] Example is the retaliatory responses of the U.S. Government on Thailand over the compulsory licensing of Efavirenz, an antiretroviral drug.
[11] Article 31h of the TRIPS Agreement
[12] India and South Africa’s COVID Vaccine Proposal to the WTO: Why Patent Waiver Must Be
Considered Over Compulsory < https://www.ipwatchdog.com/2021/01/02/india-south-africas-covid-vaccine-proposal-wto-patent-waiver-must-be-considered over compulsory-licensing/id=128652/ > Accessed 19th February 19, 2021
[13] Canada And UK Among Countries With Most Vaccine Doses Ordered Per Person <http://www.theguardian.com/world/2021.jan/28/canada-and-uk-among-countries-with-most-vaccine-doses-ordered-per-person> Accessed 19th February 2021.
[14] Statement on Moderna on Intellectual Property Matters during the COVID-19 Pandemic
[15] Lisa M.Mandrusiak, ‘ United States: Should Companies Suspend Patent Rights On Covid-19 Vaccines (2020) Mondaq < https://www.mondaq.com/unitedstates/operational-impacts-and-strategy/1019362/should-companies-suspend-patent-rights-on-covid-19-vaccines >
[16] Andrew Green, ‘ At WTO, a battle for access to COVID-19 Vaccines’ (2020) Devex < https://www.devex.com/news/at-wto-a-battle-for-access-to-covid-19-vaccines-98787/ >
[17] Ibid.
[18] Ibid.
[19] Thomas Cueni, ‘The Risk in Suspending Vaccine Patent Rules’ (2020) , The New York Times < https://www.google.com/amp/s/.www.nytimes.com/2020/12/10/.coronavirus-vaccine-patents.amp.html >
