With the COVID-19 pandemic ravaging the world, one of the key aspects in its management is the rapid and cost-effective availability of medical supplies, including medicines, equipment and the vaccines to the people who need them.
Sourcing of these medical supplies has been the single biggest challenge for the governments across the world. One of the barriers to this has been the dependency on patent holders who only can decide who gets what.
To address this, on October 2, 2020, India and South Africa made a proposal for Intellectual Property Rights (IPR) waiver of certain provisions of the TRIPS Agreements for the prevention, containment and treatment of Covid-19. An amended proposal supported by about 60 members of the WTO was submitted to the WTO on May 21, 2021.
Experts believe that even if the waivers as demanded by India are granted, they would not suffice, and India needs to expand its demands to meet the objectives of ensuring easy availability and local production of critical supplies.
The proposal that has been tabled essentially seeks a waiver for a period of 3 years from the date of the decision, the provisions related to Copyright, Industrial Designs, Patents and Undisclosed Information in relation to health products and technologies including diagnostics, therapeutics, vaccines, medical devices, personal protective equipment, their materials or components, and their methods and means of manufacture for the prevention, treatment or containment of COVID-19.
The proposal of 60 member countries led by India is due for a detailed discussion at the WTO on June 8-9, 2021. It is imperative that the final outcome of these WTO deliberations ought to be inclusive of nations, governmental and non-governmental agencies and sectoral industries in preparing the members of WTO to responsibly mitigate and manage the present and future pandemic shocks.
Explaining this, leading IPR Expert, Prabuddha Ganguli, CEO, Vision-IPR, explains, “India as a major global vaccine manufacturer and lead producer of generic drugs, and has rightfully taken a leadership role in initiating the discussion at the WTO with far reaching consequences, especially preparing the league of nations to responsibly mitigate and manage any future pandemic shocks. However, mere waiver of the Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement which is too myopic and of little or no significance, will be inadequate to meet the key objectives of the India-Africa Proposal. It is not surprising that the USA and several countries in the EU have consented to initiate discussion on the text-based negotiations”.
“The text-based negotiations at the WTO should be holistic and strategically be directed to a declaration committed to the optimal boosting of the production and distribution of Covid-19 pandemic related products and services, coupled with enhancement of the much-needed accessibility & affordability in developing and least developed countries”, he added.
Ganguli has outlined a 3-point agenda which the Indian negotiators at the WTO must include as part of their demands for the new guidelines to be inclusive of nations, governmental and non-governmental agencies and sectoral industries:
i. A “Trade-related IPR Package” going beyond a “mere IPR waiver”, to include transfer of technology knowhow, facile access to raw materials for production, diagnostic methods, equipment for testing/ diagnostics, and all items related to medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment associated with the present pandemic.
ii. Pragmatic pathways to execute measures that prevent the abuse of IPR by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology by invoking IPR and technology enabling options under the Articles 7 & 8 of the TRIPS Agreement.
iii. A mechanism for the creation of a Structured Publicly Accessible International Database of all the Essential IPRs of Covid-19 (ECOVIPRs) related to products and processes (including pending applications in copyright, industrial design registrations, patents) and the products that have been cleared by Regulatory Bodies in various countries. It should be the responsibility of each Member State to ensure quarterly updating of the ECOVIPRs database with the filings/grants in their respective countries.
Such a publicly accessible transparent Worldwide IPR database would facilitate and promote seamless, fair, reasonable and non-discriminatory utilisation of the global knowledge bank and equip Member States in real time, to design and gear up their respective national production and sourcing plans.
The concept of “Standard Essential Patent” (SEP) and “Fair, Reasonable and Non-Discriminatory” (FRAND) terms is by now well established in the field of electronics and communications technology. Standards organizations, therefore, often require members disclose and grant licenses to their patents and pending patent applications that cover a standard that the organization is developing. Some of the global lessons learnt in the operation of SEPs and FRAND may be appropriately adopted in the creation and operation of ECOVIPR.