Divyashree S. & Ashwin V.
Immune from Patents: TRIPS Waiver
Updated: Jun 22, 2022
The 12th Ministerial Conference (“MC12”) of the World Trade Organisation (“WTO”) released two Ministerial Declarations, which have a direct bearing on how the world will choose to emerge out of the problems posed by the ongoing COVID-19 pandemic and other future pandemics.
Question: What was the proposal made by a group of countries in 2020?
Answer: On October 2, 2020, a few months before the first vaccines were rolled out for civilian inoculations, India and South Africa requested a waiver of the applicability and enforcement of copyrights, industrial design rights, patent rights and right to protection of undisclosed information on products related to the containment, treatment and prevention of COVID-19. This proposal was endorsed by several countries and was revised over the course of two years.
Question: What is the waiver finally agreed upon by the WTO Members during MC12?
Answer: WTO Members agreed that it would be sufficient to ‘relax’ norms under Articles 28 and 31 of the TRIPS agreement. The consequence of this is as follows:
The use of patented products required for the production and supply of COVID-19 vaccines without the consent of the right holder is permitted.
The mandatory application process for use of products without the authorization of the patent-rights holder is waived.
Members have been barred from triggering the dispute settlement mechanism under Article XXIII of the General Agreement on Tariffs and Trade, 1994 in respect of any measures undertaken pursuant to the waiver.
Question: Does there exist a waiver on other intellectual property rights for the product concerned?
Answer: No. The waiver only extends to patent rights.
Question: What are the goods which are covered by this waiver?
Answer: Only those goods relating to the production and supply of COVID-19 vaccines are included in the ambit of this waiver. The Members have agreed upon deciding on whether other products are covered within a period of six months.
Question: Who can benefit from this waiver?
Answer: The waiver is only available to developing countries lacking the production and development capacity to manufacture COVID-19 vaccines.
Question: How is this waiver different from the initial proposal made by India and South Africa?
Answer: A brief comparison between the initial proposal and the accepted position is as follows:
Basis of Comparison
Proposal before the TRIPS Council
The Ministerial Declaration
Scope of Waiver Sought
The proposal sought the temporary the application of Sections 1, 4, 5, and 7 of Part II, and the applicable portions of Part III, of the TRIPS Agreement.
Norms under Articles 28 and 31 of the TRIPS Agreement were relaxed.
Intellectual Property Rights Involved
The applicability and enforcement of copyrights, industrial design rights, patent rights and right to protection of undisclosed information on products concerned would have been waived.
Only norms relating to patents were relaxed.
Medical Goods Involved
Proposals covered all 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.
Only goods relating to the production and supply of COVID-19 vaccines involved, whereas diagnostics and therapeutics may be brought into the scope of the Ministerial Decision six months from its release.
Scope of Applicability
Applicable to all Members.
Only covers ‘eligible Members’, which are developing countries lacking the production and development capacity to manufacture COVID-19 vaccines.
Limitations on re-exportation
No limits prescribed.
Countries which receive the benefits under this Ministerial Decision are prohibited from engaging in re-exportation of COVID-19 vaccines, or products imported on the basis of this Decision, except in extraordinary circumstances.
In the revised proposal dated May 25, 2021 [IP/C/W/669/Rev.1], the period prescribed for the waiver was 3 years.
Period of relaxation applicable for a period of 5 years.
WTO-Boutery: Talk Global Trade Comments:
What these decisions indicate that this waiver is simply partial, and not as radical as
expected in the proposals made before the TRIPS Council. The patent waiver is restricted to COVID-19 vaccinations and not diagnostics and therapeutics, for now. Additionally, the decision ignores the availability of drugs essential for persons recovering from COVID-19 in developing countries and LDCs. In stark contrast, the proposals before the TRIPS Council sought the termination of the relevant portions in Part II of the TRIPS Agreement for the equitable distribution of “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.”
Declaration on the WTO Response to the COVID-19 Pandemic and Preparedness for Future Pandemics
Question: What have the WTO Members agreed upon in in the said document?
Answer: In a comprehensive declaration noting several aspects of the economic challenges around the world, MC12 encouraged WTO Members to understand and build upon the experience of the COVID-19 pandemic, and build on several aspects relating to the disruptions caused by it.
Some of these aspects noted by the declaration include:
The availability of medical resources and vaccines for people around the world
Balance of payments challenges
Limitations in the fiscal means available to some developing country Members
Timely and accurate information to enable the quick identification by Members of potential disruptions in supply chains
Temporary trade barriers imposed in haste to control emergency supplies
Streamlining customs procedures
Decreasing and simplifying documentation requirements
Temporarily reducing or adjusting tariff rates and other charges on essential goods and services
Furthermore, MC12, through this declaration, also urged WTO bodies (such as councils and committees) to “analyse lessons that have been learned and challenges experienced during the COVID-19 pandemic,” and urged them to work in tandem and collaboration with other international organisations.