Potential compromise on Covid-19 IPR waiver: deadlock resolved?
03 May 2022
In short, the TRIPS Waiver proposal as submitted by South Africa and India called for better access to Covid-19 vaccines and treatments worldwide by waiving certain intellectual property rights. For more details on the proposal, please read our first blog on this subject here. The contents of the leaked compromise between the four parties have not yet been confirmed, but since the Director-General of the WTO has confirmed the breakthrough, there are strong indications that the leaked document is reliable. In this blog, we will address the contents of the leaked compromise.
According to the document, the scope of the TRIPS Waiver will be more limited than the original proposal and will only cover patents on Covid-19 vaccines. If approved by all member states of the WTO, the TRIPS Waiver would allow ‘any developing country Member that exported less than 10 percent of world exports of Covid-19 vaccine doses in 2021’ (the Eligible Member States) to authorise the production of a patented Covid-19 vaccine without the consent of the patent owner.
The highlights of the compromise are as follows:
- Compulsory licensing provisions or other measures, such as executive orders, emergency decrees, and judicial or administrative orders could be used to effectuate the patent waiver. This means that the said compromise is much broader than the counter proposal as submitted by the European Commission in June 2021;
- The use of patents without consent of the patentee shall be authorised by governments of Eligible Member States on a product-by-product basis, where the member state has no obligation to undertake efforts to obtain an authorisation from the patentee first;
- Eligible Member States may export products subject to the waiver to other Eligible Member States to help ensure equitable access to Covid-19 vaccines. However, those member states must undertake all reasonable efforts to prevent the re-exportations of such Covid-19 vaccines to other member states that are not eligible for the application of the TRIPS Waiver. In turn, those other member states must prevent the importation of vaccines produced under the TRIPS Waiver, as well;
- Adequate remuneration for the patent holder in accordance with clause 31 (h) of the TRIPS Agreement shall be determined by taking account of the humanitarian and not-for-profit purpose of the vaccine distributions;
- Producers that are authorised by the Eligible Member State to produce Covid-19 vaccines under the TRIPS Waiver, may use the regulatory data produced through earlier trials by the patent holder in order to produce a vaccine under the TRIPS Waiver; and
- In principle, the TRIPS Waiver shall be applied by Eligible Member States for three or five years, but it seems that the exact period is still a point of discussion since both terms are marked tentative in the leaked document. According to the compromise, the Trips Council may extend the waiver period, taking into account the circumstances of the Covid-19 pandemic. After six months from the date of the final implementation of the TRIPS Waiver, member states shall decide on whether to extend the TRIPS Waiver to also cover the production and distribution of Covid-19 diagnostics and therapeutics.
- How should the assessment of whether a member state is ‘eligible’ be interpreted?
- How will Eligible Member States determine which companies may produce the Covid-19 vaccines?
- What are the financial implications of the TRIPS Waiver, i.e. should Eligible Member States pay for the development of the Covid-19 vaccines themselves?
- Do Eligible Member States have the adequate resources to produce their own Covid-19 vaccines?
- What will happen if member states fail to prevent re-exportation of Covid-19 vaccines that are produced under the TRIPS Waiver?
- How will be determined if the TRIPS Waiver should cover a broader range of measures?
The Director General of the WTO cautioned that ‘not all the details of the compromise have been ironed out’, but also emphasized that the compromise is a major step forward. Furthermore, the final text of the TRIPS Waiver will need to be approved by all 164 WTO member states. Since some member states have been strong opponents of the TRIPS Waiver, the discussions can still go either way. We will closely monitor any developments and will update this blog accordingly.