18/10/2023
on (at the request of on Dec. 16, 2022) published on October 17, 2023 while it DOES NOT recommend TRIPS waiver to be extended to -19 and provides information on whether IP acts as a barrier to access, particularly in developing countries, on supply and demand of COVID-19 diagnostics and therapeutics, and identify where significant data and information gaps exist. In October 2020, and sought a temporary patent for COVID-19 , therapeutics and related equipment and technologies in four categories of intellectual property under the TRIPS agreement. On June 17, 2022, ’s 12th (MC12) decided on a 5 year patent-related waiver for COVID-19 vaccines. It also stated that no later than six months, WTO members are to decide whether to extend the waiver to cover the production and supply of COVID-19 diagnostics and therapeutics. The date has been extended several times. The next TRIPS Council Meeting is scheduled on October 30, 2023. Here are 5 Highlights of the Report:
1. No consensus on whether MC12 decision expanded flexibilities re. Covid vaccines and whether the decision should be extended to COVID-19 diagnostics and therapeutics.
2. Determining what products are included by the terms “diagnostics” and “therapeutics” as they pertain to COVID-19, whether they are covered by patents and whether the products have obtained MA is complicated, challenging and subject to interpretation.
3. The development and commercialization of COVID-19 diagnostics and therapeutics occurred on an extremely compressed timeline. R&D primarily occurred in High Income Countries (HIC), and manufacturing occurred in HIC and LMIC. As of July 2023, China had the highest number of manufacturers of COVID-19 diagnostics (247), and India (LMIC) had the largest number of therapeutics manufacturers (56).
4. (VLs) were not used to access IP associated with COVID-19 diagnostics. However, VLs have been an important mechanism to offer COVID-19 therapeutics for sale at reduced prices in LICs, LMICs, and some UMICs. VL was also used for technology transfer and knowledge sharing to support the manufacture and regulatory approval of less expensive licensed products.
5. (CLs) were generally not used to access associated with COVID-19 diagnostics. CLs have been used by a small number of countries to access IP associated with certain COVID-19 therapeutics. The primary, commonly cited benefits for countries utilizing CLs are reduced costs and improved access. Another primary benefit of CLs reportedly is that they provide leverage to negotiate VLs. One of the main disadvantages is that they do not provide a basis for sharing knowledge.
Krishna Sarma
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