Compromised TRIPS waiver: One step forward, two steps back

Eighteen months and counting, the World Trade Organization (WTO) members have yet to reach a resolution on the proposal submitted by South Africa and India for a temporary waiver from certain provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement for the prevention, containment, and treatment of COVID-19 (TRIPS waiver). A positive and meaningful TRIPS waiver would allow many countries to mass-produce life-saving COVID-19 vaccines, essential medicines, and testing kits.

This most awaited resolution is a critical step toward saving millions of lives and ending the COVID-19 pandemic, which is still raging in many parts of the world. Shanghai is under an indefinite lockdown, and Philadelphia re-imposed the indoor mask mandate. The developed countries narrative that the pandemic is over is clearly a farce. These privileged few first hoarded the COVID-19 vaccines and are now profiteering from COVID-19 vaccines monopolies while they continue to impede the decision on the TRIPS waiver at WTO.

While reflecting on the Quad group‘s half-baked compromised resolution on the TRIPS waiver and South Africa and India’s TRIPS waiver original proposal, this article argues that a fair TRIPS waiver on COVID-19 vaccines is possible under the present international legal framework. A global remedy to save lives and end the pandemic should not be collateral damage to the changing attitudes in multilateral bodies, given the Russia–Ukraine crisis-induced polarisation.

Quad‘s leaky resolution

Last month, a WTO-led negotiation between the Quad group, comprising the European Union, India, South Africa and the United States of America, reportedly reached a compromise on the TRIPS waiver, which is yet to be placed before the WTO members to iron out the final details. However, the leaked draft of the said compromise is far from the remedies South Africa and India had requested in their October 2020 communication. The Quad’s draft resolution, from a legal perspective, is obscure and not a remedy that would remove intellectual property barriers to allow swift and affordable production of COVID-19 vaccines, essential medicines, and testing kits.

The draft resolution does not allow suspension of any intellectual property rights (IPR) as it largely reiterates available flexibilities. In the present form, the draft resolution text refers to Article 28.1, Article 31, and Article 39.3 of the TRIPS Agreement. While the text of the compromised resolution, clarifies certain provisions of the TRIPS Agreement, it adds new conditions to existing provisions, while maintaining silence on terms that are critical for any meaningful TRIPS waiver.

Here is an overview of the draft resolution:

• Para 1 provides for waiver of Article 28.1 (patent holders rights), and it shall be limited to vaccines (para 1), underlying technologies (para 3(a)) and ingredients and process (footnote 2). Any relaxation under Article 28.1 does not include concession on therapeutics, diagnostics and ingredients, and processes.

• Para 2 clarifies that any WTO Member can authorise the benefits of Article 31 (compulsory licenses) by approving the use through any format of instrument available to the members under their domestic law. However, any such relaxation is likely subject to time and eligibility criteria outlined in paras 1, 3, and 6.

• Para 3 (a) and (b) reiterate the general practice to issue a single authorisation to cover multiple patents and products and the provision to waive prior negotiations requirement to allow emergency authorisation, respectively.

• Para 3 (a) also provides “the authorisation shall list all patents covered”, technically a TRIPS-plus requirement, which will restrict the flexibility. Indian patent law does not require this condition during an emergency.

• Para 3 (c) marks the only explicit waiver in the document as it removes the constraints on the export of products manufactured under the compulsory license, which is currently restricted under Article 31 (f). This flexibility suspends the procedural requirements provided under Article 31bis, which was inserted in the TRIPS Agreement after the 2001 Doha Declaration.

• Para 3 (e) keeps the obligation to determine adequate remuneration intact as provided under Article 31 (h).

• Para 4 provides a flexible interpretation of Article 39.3, which includes the treatment of regulatory data and its exclusivity. This provision is more relevant in places like the United States and the European Union, where data exclusivity is strictly regulated.

• Footnote 4 creates additional requirements on reporting the implementation status under Article 31, which is otherwise already followed in general practice.

• Para 6 and 7 on the duration of the waiver and legal impediments on the use of the waiver are similar to the flexibilities requested by South Africa and India.

• Para 8 proposed a decision on waiver on COVID-19 diagnostics and therapeutics shall be taken after six months from the date the TRIPS waiver shall be granted.

The draft text does not include ‘trade secrets’ being shared—which protect the complex manufacturing processes of vaccine production. Trade secrets relate to manufacturing methods, any unpatented technology or formulae, cell lines, genomic information, and other biological materials. A TRIPS waiver for COVID-19 vaccines without trade secrets would be meaningless. Therefore, the compromised waiver in its current form does not provide any mechanism to address vaccines production and supplies challenges; on the contrary, it reflects how the developed countries use the WTO rules to constrain the developing and least developing countries.

Compulsory licences to make COVID-19 vaccine？

A close reading of the draft resolution reflects similarities to the European Unions 2021 Trade Policy Responses to the COVID-19 Crisis, which emphasises the use of compulsory licenses to facilitate the production of COVID-19 medical tools. The European Union has maintained that TRIPS flexibilities, including voluntary and compulsory licenses, are sufficient to override the IPR barriers in an emergency, and therefore, no new flexibilities are required. However, while the patent waiver is possible through compulsory licenses, a new arrangement is needed to include trade secrets since the TRIPS and TRIPS-plus framework does not provide for it. The complicated procedure of compulsory licenses and its adverse political and economic constraints are well documented. Not surprisingly, in the last two years, no compulsory license has been granted by any pharmaceutical company to produce the COVID-19 vaccine.

South Africa and Indias proposal

The temporary waiver on TRIPS Agreement, as requested by South Africa and India to the TRIPS Council, is as follows:

“The obligation of Members to implement or apply Sections 1, 4, 5 and 7 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 prevention, containment or treatment of COVID-19, for [X] years from the decision of the General Council”.

And also, required that any such waiver shall not apply to:

“the protection of Performers, Producers of Phonograms (Sound Recordings) and Broadcasting Organizations under Article 14 of the TRIPS Agreement”.

Part II (Standards Concerning the Availability, Scope and Use of IPRs) of the TRIPS Agreement concerns the Copyright and Relations Rights (Section 1), Industrial Designs (Section 4), Patents (Section 5) and Protection of Undisclosed Information (Section 7).

Part III (Enforcement of IPRs) deals with the General Obligations (Section 1), Civil and Administrative Procedures and Remedies (Section 2), Provision Measures (Section 3), Special Requirements Related to Border Measures (Section 4), and Criminal Procedures (Section 5).

The joint proposal falls within the international legal framework both on trade and human rights. Article IX of the Marrakesh Agreement establishing the WTO provides that a waiver on IPRs is possible in emergencies like the COVID-19 pandemic. Furthermore, the WTO members are signatories to the International Covenant on Economic, Social, and Cultural Rights, which recognised peoples right to the highest attainable standard of physical and mental health (Article 12) and the right to enjoy the benefits of scientific progress (Article 6). The members are also signatories to the Vienna Convention on the Law of Treaties, which obliged the signatory states not to defeat the object and purpose of the treaty in force (Article 18) and to interpret a treaty in good faith (Article 31).

What is the relevance of these international instruments when they cant be enforced even in times of health emergency？ The developed countries should constructively interpret international laws relating to human right to health vis-à-vis access to COVID-19 vaccines and IPRs. The selective interpretation of rules breaches the sanctity of international law, undermines humanity, and perpetuates historical injustices.

Not to be collateral damage

Over two years into the pandemic, about 16 percent of people in low-income countries have at least one dose of a COVID-19 vaccine, while people in high-income countries can choose to take a booster shot. Unfortunately, vaccine inequity persists.

While time is running out on the TRIPS waiver, the negotiation procedure is strained with the changing landscape of the world. Russias special military operation in Ukraine has hampered the functioning of multilateral institutions, thus constricting negotiations. However, the TRIPS waiver for COVID-19 vaccines should not be collateral damage to the Ukraine crisis. A remedy that will save millions of lives and could end the pandemic should not be allowed to fail to achieve its objectives. South Africa and India should fight for a just and effective TRIPS waiver for global health equity.