The pandemic has tested the resilience of the global community on various fronts such as whether it can unite to ensure the availability of COVID-19 medical products for all. In this regard, India and South Africa took a clarion call at the World Trade Organization (WTO) in October 2020. Demanding that the key provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement be temporarily waived. The developed world, especially the European Union (EU) kept dragging its feet on this while the virus raged. Now, The European Union has accepted, An agreement has been reached between the European Union, the US, India and South Africa on the issue of TRIPS exemption. The deal will now be submitted to the entire WTO membership to be accepted at the upcoming ministerial meeting. The exemption, however, is an excellent case for being too little, too late, and represents a significant climb from India and South Africa’s original offer.
discount vulnerabilities
First, the draft exemption covers only COVID-19 vaccines and not other COVID-19 medical products. This is a big obstacle. Medicines also play an equally important role in tackling the pandemic. For example, the World Health Organization (WHO) recommends baricitinib for the treatment of severe or severe COVID-19. But according to Médecins Sans Frontires, the generic version of baricitinib is not available in many countries because it is patented. This defeats the purpose of the TRIPS exemption, which was to ensure cheaper and faster availability of drugs like baricitinib.
Second, the draft exemption proposes to waive only patents and not other IP rights. India’s original stand was that all IP rights, not just patents, be waived. Access to COVID-19 medical products may be blocked due to multiple IP rights such as trade secrets.
Third, even on the issue of patents, the draft waiver seems to be old wine in a new bottle. For example, the draft exemption allows countries to limit the exclusive rights granted to patent holders under Article 28.1 of the TRIPS Agreement through the use of Article 31, which allows the issuance of compulsory licenses. But this flexibility is already available under the TRIPS agreement. The only exemption is from Article 31(f) which requires countries to ensure that products produced under compulsory licenses are primarily intended for the domestic market. The draft exemption allows countries to export any proportion of vaccines to eligible countries. However, this exemption is subject to a number of notification requirements. Eligible members are obliged to stop the re-export of COVID-19 vaccines that they have imported. In addition, eligible countries that issue mandatory licenses for COVID-19 vaccines are required to notify the WTO about the entity that has been authorized to produce the product, quantity, duration and a list of countries where the vaccines are being exported. All these procedural requirements will increase transaction costs and may prevent countries from using the system. What’s more, the discount adds a new TRIPS-plus liability. Article 31(a) of the TRIPS agreement requires that the permitting of a compulsory license be considered on a product-by-product basis. With regard to Article 31(a), the draft exemption clarifies that a single authorization may be granted to use the subject of multiple patents required for the production and supply of COVID-19 drugs. However, it includes a new obligation to identify and list all covered patents.
Fourth, the draft exemption is not universal. Only those developing countries that exported less than 10% of world exports of COVID-19 vaccine doses in 2021 are covered for export and import. There is no mention of less developed countries. Fifth, while the draft waives a member’s obligation to protect undisclosed information presented before a drug regulator to claim marketing approval in the current context, it also waives the protection of other trade secrets covered under paragraphs 39.1 and 39.2. is silent on overcoming the challenges posed by it. trips.
history repeats itself
In the aftermath of the HIV/AIDS crisis in Africa, the WTO adopted a decision in 2003 to waive some TRIPS obligations to increase access to medicines in countries that lack manufacturing capacity. However, this exemption was subject to stringent requirements, due to which hardly any country made effective use of this exemption. Developed countries serving the interests of their pharmaceutical firms are ready to conquer humanity’s public health concerns once again. This will further damage the relevance and credibility of the WTO. India has surrendered and will be on the wrong side of history in the end. It is up to the government to explain why it has accepted a surprisingly withered version of the TRIPS exemption.
Prabhas Ranjan is with OP Jindal Global University. Praharsh Gaur provided input for this piece. thoughts are personal