Perspective on WTO IPR Waiver negotiations

The WTO document IP/C/W/669 dated 2 October 2020 published the Communication from India and South Africa on the waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19. The amended proposal of IP/C/W/669/Rev.1 dated May 21, 2021, titled “Waiver from certain provisions of the TRIPS Agreement for the Prevention Containment and Treatment of Covid-19”, “Revised Decision Text”, a communication with a few additional features was submitted on May 21 2021 from the African Group, the Plurinational State of Bolivia, Egypt, Eswatini, Fiji, India, Indonesia, Kenya, The IDC Group, Maldives, Mozambique, Mongolia, Namibia, Pakistan, South Africa, Vanuatu, The Bolivarian Republic of Venezuela and Zimbabwe.

India as a major global vaccine manufacturer and lead producer of generic drugs has rightfully taken a leadership role at the WTO with far-reaching consequences, especially in preparing the league of nations to responsibly mitigate and manage any future pandemic shocks.

The essential features of the amended proposal for discussion on June 8/9 2021 are:

1. The obligations of Members to implement or apply Sections 1 (Copyright), 4 (Industrial Designs), 5 (Patents) and 7 (Undisclosed Information) of Part II of the TRIPS Agreement or to enforce these Sections under Part III of the TRIPS Agreement, shall be waived 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.

2. This waiver shall be in force for at least 3 years from the date of this decision. The General Council shall, thereafter, review the existence of the exceptional circumstances justifying the waiver, and if such circumstances cease to exist, the General Council shall determine the date of termination of the waiver.

3. The waiver in paragraph 1 shall not apply to the protection of Performers, Producers of Phonograms (Sound Recordings) and Broadcasting Organizations under Article 14 of the TRIPS Agreement.

It is to be appreciated that a “Mere waiver of the listed IPR” is rather short-sighted with little or no significance, and is inadequate to meet the key objectives of the forthcoming “text-based negotiations” on 8/9 June 2021.

Negotiations at the WTO need to be holistic, being mindful of the strategic need for immediate boosting of the production and distribution of COVID-19 pandemic related products to service the much-needed accessibility and affordability of such products and services in developing and least developed countries.

It is imperative that the concluding declaration be committed to:

1. Designing a ‘Trade-related IPR Package’ going beyond a ‘Mere IPR Waiver’ to include the transfer of technology knowhow, unconstrained 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.
2. Effective utilisation of Article 7 of TRIPS with IPR as an enabler for the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligation
3. Pragmatic pathways to execute measures that prevent the abuse of IPR by right holders or the resort to practices that unreasonably restrain trade or adversely affect the international transfer of technology by invoking Article 8 of the TRIPS Agreement.
4. Establishing 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 the 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) are well-established processes in the field of electronics and communications technology, wherein Standards Setting Organisations require members to disclose and grant licenses to their patents and pending patent applications that cover a standard that the organization is developing. 

In the case of ECOVIPRs, the concept of operating “standard” may not be applicable, but “a set of essential IPRs” related to COVID-19 can easily be listed by the Member States while drawing upon some of the principles of SEPs/FRAND in the creation and operation of ECOVIPR.

Hopefully, the Member States of the WTO peep beyond their respective borders and rise to the occasion.