It is the common goal to get through the pandemic, which endangers the health of all of humanity, and for that, all have been watching for a vaccine and treatment to overcome the pandemic as soon as possible. Scientists have managed to go beyond the known in a considerably short time, and multiple COVID-19 vaccines were developed.
At this point, the equal distribution of vaccines emerged as a vital problem that hindered global salvation from this pandemic. While some developed countries had the chance to store vaccines to meet multiple dosages, hundreds of less developed or developing countries have not been able to access vaccines at all. According to Our World in Data, 23.4% of the world population received at least one dose of the COVID-19 vaccine. However, only 0.9% of people in low-income countries received at least one dose as of June 30, 2021.
While the reasons for this undesired situation were being discussed, IP rights, especially on vaccines, and whether these rights were the cause of the injustice in access to the vaccine became a very important topic of discussion. On the other hand, patent rights have been made a “scapegoat” for the vaccine inequity experienced so far.
The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) is the most comprehensive multilateral agreement on intellectual property.
If a TRIPS signatory country does not protect IP rights in its own country and, for example, uses or benefits from patented technologies without the consent of the right owner, it may face an accusation of breaching its obligations arising from TRIPS. In case it is accepted to remove IP protection temporarily, then the members will not be able to subsequently claim violations of the TRIPS obligations by other countries that temporarily waived intellectual protection rights.
Considering solution proposals of the member states and in order to eliminate the vaccine inequity problem, the European Parliament suggested that the European Commission start negotiations in the WTO on a temporary waiver on IP rights on COVID-19 vaccines and other medical products. As can be seen, the IP right waiver on COVID-19 is considered a milestone to enhance global access to affordable COVID-19 vaccines. However, it is highly controversial whether this alleged solution of suspending the patent rights addresses the vaccine inequity problem.
First and foremost, the COVID-19 virus continues to mutate rapidly, and it is a mystery how much protection these vaccines provide or will provide against which mutations in the long run.
Promoting science and innovation in this period, where the virus continues to mutate or at least not breaking the existing incentives disproportionately, is very important for a successful policy in the long run.
It should be borne in mind to address the issue correctly that one of the major problems regarding vaccine shortage and inequity in access to vaccines allegedly stems from the shortage of raw materials, production capacity constraints, and the extremely complex nature of the production of drugs. According to figures from the International Federation of Pharmaceutical Manufacturers and Associations, even a typical vaccine manufacturing plant uses approximately 9,000 materials sourced from 300 suppliers across 30 different countries. In this respect, it is argued that suspension of the patent rights will not yield more COVID-19 vaccine supply in 2021, considering that constraints are physical rather than legal.
As for patent rights, the scope of the suspension is also highly controversial. Indeed, although COVID-19 related patent applications have been filed, they are not published yet since the publication of the application only takes place after 18 months. As for the current patents, the scope of a potential suspension still seems to be problematic. Indeed, the suspension will not be limited to the rights related to COVID-19. The mRNA technology used in the BioNTech/Pfizer vaccine is protected by patents that have already been granted, and these technologies also have useful applications, in cancer treatment as well. When patents on vaccines are suspended, such patents will go into the pot.
While TRIPS Article 30 regulates the general exemption provision to the patent right, the exemption foreseeing the invention’s use by a third party or government without the patent owner’s consent is regulated under Article 31 of TRIPS. TRIPS Article 31bis, on the other hand, paves the way for the compulsory license application foreseen for the internal market need to be issued to send to the countries in need.
Patent protection is not the main obstacle to access the vaccine considering all. If all patents were abolished, would the injustice in access to the vaccine be eliminated? The answer seems not affirmative. It will be much more effective for the patent owners to cooperate and provide each other with the necessary licenses within the framework of contractual relations. In particular, international alliances such as COVAX should be supported, the rapid transfer of existing vaccine stocks should be facilitated, and new international agreements should be concluded if necessary.
First published by ManagingIP in Dec 10, 2021.