The following communication, dated 29 February 2024, is being circulated at the request of the delegation of South Africa on behalf of the 65 Co-Sponsors of the IP/C/W/669/Rev.1 proposal and Brazil; Colombia; Paraguay and Sri Lanka.

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1.1. The most solemn obligation of every government is to protect the life and health of its people.

1.2. The Director General of the World Health Organization (WHO) declared the COVID-19 situation a Public Health Emergency of International Concern (PHEIC) on 30 January 2020. The need for scaled-up access to diagnostics, treatments, vaccines and personal protective equipment (PPE) (“health products”) was manifest.

1.3. The co-sponsors approached Members of the World Trade Organization (WTO) with a proposal to temporarily waive certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to support the global COVID-19 pandemic response. This was in recognition that the intellectual property system is meant to provide a balance between providing incentives for bringing about innovation and rewarding creativity and promoting the broader public interest. In the area of public health, intellectual property objectives must also be balanced against realising the right to health, of which access to medicines and other health products is a central part. It was also in recognition that allowing legal monopolies may delay access to the requisite health products becoming available, as evidenced by disputes on infringement of intellectual property rights even at the height of the pandemic and that health products would be in global short supply drawing from the experience of previous pandemics and health emergencies. The co-sponsors believed that pooling financial and scientific resources is the only option for accelerating progress towards new vaccines, treatments and diagnostics.

1.4. Developing countries including the LDCs were gravely concerned. Much of the latest technology used to develop and manufacture necessary health products was owned and controlled by companies, governments and other institutions based in developed countries. Without access to this technology, the prospects for manufacturing and distributing health products would be restricted. Access to health products would be at the discretion of pharmaceutical companies from a handful of high-income countries.

1.5. The COVID-19 pandemic offered WTO Members an opportunity to act in solidarity by adopting a multilateral solution to help bolster the capability of developing countries to respond to a health crisis. Co-sponsors advocated for a multilateral solution so as to restore faith in multilateralism and avoid Members adopting self-help measures, thereby fragmenting the intellectual property system. An undesirable outcome that a time-bound and limited waiver could have helped prevent.

1.6. The WTO failed to deliver a comprehensive multilateral solution on the pandemic and even when it delivered on COVID-19 vaccines, this was too little too late. Rather than heed the call of the co-sponsors, non-proponents advocated for voluntary arrangements and donations as the only solution to equitable distribution. In reality, however, an inconsequentially small number of voluntary licenses were availed with strict conditionalities that did not assist to respond to the global crisis. And there were no voluntary licenses or any licensing arrangements when it came to the most-used vaccines in developed countries.

1.7. The COVID-19 virus is still with us, and the world needs therapeutics and diagnostics to ensure better management of its impact. If WTO Members were serious about providing an effective solution in the context of global solidarity, they needed to extend the TRIPS decision to diagnostics and therapeutics within six months as promised. However, over a year after the deadline, the non-proponents have stalled any possible outcome, ensuring that the world remains vulnerable not only to this pandemic but future pandemics. Resilience for future pandemics can be achieved through resolving challenges of equitable and affordable access to health products by addressing concentration of production, and building adequate manufacturing capacity, especially in regions with limited production.

1.8. Failure to deliver on a multilateral outcome to effectively address concerns on equitable and affordable access to health products including therapeutics and diagnostics, casts a dim light on the ability of the WTO to act in solidarity during an international emergency as recognized by the WHO. The IP barriers that challenge equitable and affordable access have prolonged this pandemic and remain unaddressed, threatening us in the next pandemic. The co-sponsors remain committed to addressing these concerns of developing countries including the LDCs in the context of health emergencies such as pandemics by advancing policy space for Members, along with full utilization of existing flexibilities in the TRIPS Agreement including Article 73.

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Click here to read the full document as it was circulated.

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The following communication, dated 28 February 2024, is being circulated at the request of the delegations of Bangladesh, Columbia, Egypt and India.

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1. We, keeping in mind the upcoming 30th anniversary of the TRIPS Agreement, instruct the Council for TRIPS to undertake and finalize its first review under Article 71 on the implementation of the TRIPS Agreement.

2. Pursuant to paragraph 19 of the Doha Ministerial Declaration, we instruct the Council for TRIPS to expedite ongoing work to examine the relationship between the TRIPS Agreement and the Convention on Biological Diversity, and the protection of traditional knowledge and folklore.

3. We also call upon the TRIPS Council to examine how the TRIPS Agreement could facilitate transfer and dissemination of technologies to developing countries including LDCs.

4. We further instruct the Council to examine the TRIPS Agreement, the Doha Declaration on the TRIPS Agreement and Public Health of 2001 and the Ministerial Decision on the TRIPS Agreement of 2022, to review and build on the lessons learned during COVID-19, with the aim to address the concerns of developing countries including LDCs in the context of health emergencies including pandemic.

5. In undertaking this work, the TRIPS Council shall be guided by the objectives and principles set out in Articles 7 and 8 of the TRIPS Agreement and shall take fully into account the development dimension and shall provide a report on the progress made, including any recommendations, to the Ministers at the 14th Ministerial Conference.

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Click here to read the full document as it was circulated.

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There are only two changes from the draft document reviewed in mid-March. The first is the most important and concerns the definition of “an eligible member.” Originally, footnote 1 consisted of the following – “For the purpose of this Decision, developing country Members who exported more than 10 percent of world exports of COVID-19 vaccine doses in 2022 are not eligible Members.” From public data, this language would have excluded China from being an eligible Member. In the footnote 1 forwarded to the Membership on May 3, there are two bracketed sentences, the second of which is what was in the earlier draft. The other bracketed option would make all developing countries “eligible Members” — “[For the purpose of this Decision, all developing country Members are eligible Members. Developing country Members with capacity to export vaccines are encouraged to opt out from this Decision.]” Should China opt out of the Decision, the resulting potentially eligible countries would be the same. The opt out language could also arguably get additional Members who have significant vaccine producing and exporting capacity to voluntarily opt out as well (e.g., India).

The second change is the bracketing of paragraph 3.(a) with an additional footnote indicating that “This paragraph is under further consideration as to whether to keep or delete.” The paragraph (which is unchanged from the earlier draft other than the addition of brackets) reads,

“(a) [With respect to Article 31(a), an eligible Member may issue a single authorization to use the subject matter of multiple patents necessary for the production or supply of a COVID-19 vaccine. The authorization shall list all patents covered. In the determination of the relevant patents, an eligible member may be assisted by WIPOʼs patent landscaping work, including on underlying technologies on COVID-19 vaccines, and by other relevant sources. An eligible Member may update the authorization to include other patents.]”

It was reported that China was pushing to be included in the small group discussions and took exception to the footnote 1 language which would exclude only it. Presumably the alternative bracketed language in footnote 1 is designed to address Chinaʼs concerns. However, it is less likely that the U.S. will accept a final package if China doesnʼt opt out of the decision.

Consistent with the earlier draft, the Decision, if adopted would remain in effect for either three or five years (numbers are bracketed alternatives).

Many NGOs have raised concerns about the lack of immediate coverage of therapeutics and diagnostics. Paragraph 8 continues to read, “No later than six months from the date of this Decision, Members will decide on its extension to cover the production and distribution of COVID-19 diagnostics and therapeutics.” Thus, a decision on coverage of therapeutics and diagnostics will occur, absent a change in language in the text, by the end of 2022, if the decision is adopted.

If the text is accepted by the WTO membership (or modified in ways acceptable to all), then there should be an agreed WTO response to the pandemic at the 12th Ministerial. For reasons noted in recent posts, the value of such a response will be more in the other aspects of the response (keeping markets open, limits on export restraints, transparency, etc.) than on the document dealing with access to vaccines via TRIPS actions. Nonetheless, an agreed response, including the vaccine TRIPS provisions, would be an important accomplishment in the current times.

Terence Stewart, former Managing Partner, Law Offices of Stewart and Stewart, and author of the blog, Current Thoughts on Trade.

To read the full commentary from Current Thoughts on Trade, please click here. 

The post Access to Vaccines – The Public Release of the Text from the U.S., EU, India and South Africa to the Full WTO Membership for Consideration by the Council for Trade Related Aspects of Intellectual Property Rights appeared first on WITA.

My post of November 2 had raised a number of question presented by the proposed waiver:

” The proposal raises a series of questions that should be addressed to understand whether the waiver is appropriate. These questions include whether such a broad waiver request is appropriate or envisioned by Article IX:3 and 4 of the Marrakesh Agreement? Shouldn’t those requesting a waiver be required to demonstrate that the existing flexibilities within the TRIPS Agreement are inadequate to address concerns they may have? Can two Members request a waiver of obligations for all WTO Members? Can a waiver request be considered where the product scope is lacking clarity, and the uses/needs of the waiver are very broad and potentially open to differing views? To what extent is there a need for those seeking a waiver to present a factual record of actions being taken by governments, companies and international organizations to provide access to medical goods during the pandemic including to developing and least developed countries? Shouldn’t those seeking a waiver identify the extent of existing licenses by major pharmaceutical companies with them or other WTO Members for the production of vaccines or therapeutics to address COVID-19?”

The supplemental information provided by South Africa identifies various patent pending matters and identifies what it describes as restrictive actions by some companies and some patent litigation by certain companies. As such the communication provides some information of possible relevance in examining the proposed waiver. However, there is little if any information provided on most questions that seem important to an informed discussion of the proposed waiver.

On November 27, Australia, Canada, Chile and Mexico filed a communication entitled “Questions on Intellectual-Property Challenges Experienced by Members in Relation to COVID-19”. IP/C/W/671. While the entire communication is embedded below, paragraphs 3 and 4 are copied below and present a framework for the consideration of the proposed waiver and seek factual answers to a series of questions which would help understand if there are in fact any significant barriers being confronted by WTO Members in addressing the pandemic.

“3. The co-sponsors of this communication remain of the view that these important, challenging, and complex issues merit further reflection and significant consideration, in order to identify any specific and concrete IP-related challenges faced by Members in addressing COVID-19. In addition, we take note that IP rights are one part of a broad discussion informing the availability and accessibility of treatments for COVID-19. Indeed, as the Doha Declaration on the TRIPS Agreement and Public Health emphasizes, the TRIPS Agreement itself is part of the wider national and international effort to address public health problems. With respect to COVID-19, this broader response includes significant investments through procurement mechanisms like the Access to COVID-19 Tools Accelerator and the COVAX Facility and Advance Market Commitment, as well as work within the WTO and elsewhere to safeguard and protect global supply chains.

“4. The co-sponsors of this communication are actively committed to a comprehensive, global
approach that leverages the entire multilateral trading system in place to supporting the research, development, manufacturing, and distribution of safe and effective COVID-19 diagnostics, equipment, therapeutics, and vaccines. The co-sponsors also reaffirm their support for the TRIPS Agreement, including the flexibilities it provides, and for the Doha Declaration on the TRIPS Agreement and Public Health. In this context, we invite consideration of how the existing legal framework under the TRIPS Agreement, including the flexibilities affirmed under the Doha Declaration on the TRIPS Agreement and Public Health, have operated thus far in the context of Members’ efforts to address the COVID-19 pandemic. We are also committed to fully understanding the nature and scope of any concrete IP barriers experienced by Members related to or arising from the TRIPS Agreement, and such that would constitute impediments to the fight against COVID-19. To that end, and with a view to facilitating a consensual, evidence-based approach, the co-sponsors of this communication therefore respectfully submit the following questions to Members for their consideration and response.”

The communication from Australia, Canada, Chile and Mexico then provides eight questions designed to develop a factual record of challenges faced on procurement of products, local production, compulsory licenses, as well as copyright-related challenges, industrial-designs-related challenges, and challenges from undisclosed information. The questions also include an inquiry as to “what specific legal amendments or actions would the proponents seek to enact for the prevention, containment, and treatment of COVID-19 that are not – or may not be – consistent with the TRIPS Agreement and its flexibilities?”

There is a meeting of the Council for Trade-Related Aspects of Intellectual Property Rights scheduled for December 11 at the WTO. It is assumed that the only item on the agenda will be the consideration of the proposed TRIPS waiver submitted by India and South Africa and joined by four other countries. A recommendation should be forwarded to the General Council by December 31. While the proposed waiver may receive support from many WTO Members, it will be opposed by many as well as not justified and undermining the existing WTO TRIPS Agreement and built-in flexibilities. The communication from Australia, Canada, Chile and Mexico provides a possible path forward by seeking to gather factual information that would permit Members to identify what challenges actually exist and what existing tools are available for addressing the existing challenges so that the need for any waiver is limited to what is actually needed instead of being the very broad waiver proposal for all countries regardless of actual problems faced.

Terence Stewart, former Managing Partner, Law Offices of Stewart and Stewart, and author of the blog, Current Thoughts on Trade.

To read the original blog post, please click here. 

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