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 everyone. In this regard, India and South Africa, in October 2020, gave a clarion call at the World Trade Organization (WTO) demanding that 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 on. Now, the EU has conceded. A deal has been brokered between the EU, the U.S., India, and South Africa on the issue of the TRIPS waiver. This deal will now be presented to the entire WTO membership to be accepted at the forthcoming ministerial meeting. However, the waiver is a classic case of too little, too late, and represents a significant climb down from the original proposal of India and South Africa.
Waiver weaknesses
First, the draft waiver includes only COVID-19 vaccines and not other COVID-19 medical products. This is a major handicap. Medicines also play an equally important role in combating the pandemic. For instance, the World Health Organization (WHO) has recommended baricitinib for treating severe or critical COVID-19. But according to the Médecins Sans Frontières, the generic version of baricitinib is not available in many countries because it is patented. This defeats the purpose of the TRIPS waiver, which was to ensure cheaper and faster availability of drugs such as baricitinib.
Second, the draft waiver proposes to waive only patents and not other IP rights. India’s original stand was that all IP rights, not just patents, be waived. The accessibility of COVID-19 medical products can be held up due to many IP rights like trade secrets.
Third, even on the issue of patents, the draft waiver appears to be old wine in a new bottle. For instance, the draft waiver allows countries to limit the exclusive rights conferred on patent holders under Article 28.1 of the TRIPS agreement through the use of Article 31, which permits the issuance of compulsory licenses. But this flexibility is already available under the TRIPS agreement. The only waiver is from Article 31(f) which requires countries to ensure that products produced under a compulsory license are predominantly for the domestic market. The draft waiver allows countries to export any proportion of vaccines to eligible countries. However, this waiver is subject to several notification requirements. Eligible members are obligated to prevent re-exportation of COVID-19 vaccines that they have imported. Furthermore, the eligible countries which issue a compulsory license for COVID-19 vaccines have to notify the WTO about the entity that has been authorised to produce the product, the quantities, duration, and the list of countries to which the vaccines are being exported. All these procedural requirements will increase the transaction costs and may deter countries from using the system. Not just this, the waiver adds a new TRIPS-plus obligation. Article 31(a) of the TRIPS agreement requires that permission for compulsory licenses shall be considered on a product-by-product basis. Concerning Article 31(a), the draft waiver clarifies that a single authorisation may be given to use the subject matter of multiple patents necessary for the production and supply of COVID-19 medicines. However, this entails a new obligation to identify and list all covered patents.
Fourth, the draft waiver 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 exportation and importation. There is no mention of least developed countries. Fifth, while the draft waives the obligation of a member to protect undisclosed information submitted before a drug regulator to claim marketing approval in the present context, it is silent on overcoming the challenges posed by protection to other trade secrets covered under Article 39.1 and 39.2 of TRIPS.
History repeats itself
In the aftermath of the HIV/AIDS crisis in Africa , the WTO adopted a decision in 2003 waiving certain TRIPS obligations to increase the accessibility of medicines in countries that lacked manufacturing capability. However, this waiver was subject to stringent requirements because of which hardly any country made effective use of this waiver. The developed countries serving the interests of their pharmaceutical firms are all set to triumph, once again, over the public health concerns of humanity. This will further dent the WTO’s relevance and credibility. India has surrendered and will end up being on the wrong side of history. It is incumbent on the government to explain why it has accepted a strikingly withered-down version of the TRIPS waiver.
Prabhash Ranjan is with the O.P. Jindal Global University. Praharsh Gour gave inputs for this piece. Views are personal
