[CTC] TRIPS Waiver 2.0 at the WTO: Proponents back at the table to push for therapeutics and diagnostics

Sat Jul 9 08:59:46 PDT 2022

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TRIPS Waiver 2.0 at the WTO: Proponents back at the table to push for therapeutics and diagnostics <https://substack.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.8-o1SBSFjfMD25qt7Cs__fdDh6trXToCGq7HRzaTieg?>
Newsletter Edition #148
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Priti Patnaik <https://substack.com/redirect/35e8ef06-1e08-49a0-bd0c-ad5d821bbf6e?u=43108641>
Jul 8	 <https://substack.com/redirect/2/eyJlIjoiaHR0cHM6Ly9nZW5ldmFoZWFsdGhmaWxlcy5zdWJzdGFjay5jb20vYXBpL3YxL3Bvc3QvZW1haWwtcmVhY3Rpb24_dXRtX3NvdXJjZT1zdWJzdGFjayZ1dG1fbWVkaXVtPWVtYWlsJnRva2VuPWV5SjFjMlZ5WDJsa0lqbzBNekV3T0RZME1Td2ljRzl6ZEY5cFpDSTZOakkyTWpFek1qZ3NJbkpsWVdOMGFXOXVJam9pNHAya0lpd2lhV0YwSWpveE5qVTNNalkxTXpZd0xDSnBjM01pT2lKd2RXSXROemt6T1RZaUxDSnpkV0lpT2lKeVpXRmpkR2x2YmlKOS5ibFVFa2JVX2lManRlX0R6QUo1NUo3ZmN5dXVOYTlDejFicE5CeVZJa1F3IiwicCI6NjI2MjEzMjgsInMiOjc5Mzk2LCJmIjpmYWxzZSwidSI6NDMxMDg2NDEsImlhdCI6MTY1NzI2NTM2MCwiaXNzIjoicHViLTAiLCJzdWIiOiJsaW5rLXJlZGlyZWN0In0.AU1jy_M8wGk2WO5LR8qDs9zJGjWNs_Zys1PmWTJfe8M?>	 <https://substack.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.FpX9OJUM7NkqA0SssNQ1rEdb4rgaBy1-uahMp-l46pU?&utm_source=substack&utm_medium=email>	 <https://substack.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.pFreyZXPGV6OLEfTuuuAOAk0yhNPsPUag2s-xbG0xX8?>

...

The embers from the WTO’s 12th ministerial conference are still warm. 

While the supporters of the original TRIPS waiver are still coming to terms with the remains of the 20 month saga that yielded a ministerial decision <https://substack.com/redirect/7943de51-be71-4d57-8acf-596aa1acd27c?u=43108641>clarifying the rules of compulsory licensing for the production of vaccines, they are back at the WTO to stomach another fight. This time, to discuss the way forward to boost the production of therapeutics and diagnostics by seeking to extend the applicability of the June decision to these medical products.

This puts the co-sponsors, again, directly in opposition to industry interests where companies such as Pfizer alone are projected to make billions off a single drug to treat COVID-19.  

At this week’s TRIPS Council meeting, the first since the ministerial that ended on June 17th, WTO members gathered to discuss, among other policy matters, paragraph 8 of the decision that concerns therapeutics and diagnostics.

Recall that the text said:

“8. No later than six months from the date of this Decision, Members will decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics.”

In an “unofficial room” document that is classified as “restricted” (RD/IP/49), South Africa, India, Pakistan, Indonesia, Egypt and Tanzania, on behalf of the co-sponsors of the original TRIPS waiver proposal (IP/C/W/669/Rev.1 <https://substack.com/redirect/2b0d7029-9564-4ae4-af29-7d38ad7522a0?u=43108641>), have suggested the rationale and the plan to conduct the discussions on therapeutics and diagnostics.

(According to the WTO, “documents issued in the RD series are not official WTO documents. They usually appear in their language of submission and will not be translated systematically into the working languages of the WTO. They are intended for use in WTO meeting rooms and are attributed an unofficial symbol for archiving purposes only”.)

THE RATIONALE

The document cites WHO’s analysis on the “the supply-side problems for tests and therapeutics, with insufficient funds and insufficient access” noting that developing countries have been most affected. The co-sponsors also cite two specific measures taken by the US and the EU in securing treatment courses – the test and treat initiative <https://substack.com/redirect/04bdc947-0e8e-4250-86e4-6415cb778231?u=43108641> by the US for rapid access to COVID-19 testing and treatments; and the EU Strategy on COVID-19 therapeutics <https://substack.com/redirect/b28f0374-be60-4bc0-8ba8-69b8d443f8d8?u=43108641>. It notes that the US has already “secured the purchase of 20 million treatment courses of Paxlovid and also procuring Molnupiravir”.

The co-sponsors point out that there are four times as many patent filings related to therapeutics compared to vaccines. Already, more than 5,200 patent applications related to COVID-19 were published across 49 patent offices between 2020-21 according to the World Intellectual Property Organization (WIPO) Patent Landscape Report (PLR), the co-sponsors cite.

“Many of these patent applications are for repurposed drugs rather than innovative products developed to treat COVID-19. Government funding has supported a significant part of the research and clinical trial efforts,” they say.

They argue that granting of patents could delay the entry of generic drugs, and in turn lead to price increases affecting access.

Although voluntary licensing approaches have been championed by the industry and other stakeholders, they point out that such terms are limited in scope. The example of voluntary licenses for Paxlovid and Molnupiravir, negotiated by Medicines Patent Pool has been cited.

“Under the high-profile agreement between the originator and the MPP, only 95 countries can benefit from the potential supply of generics. Even within those countries, only a limited number of companies have the capacities to access MPP under the strict requirements of the WHO Prequalification of Medicines Programme (PQWHO). Although the license will ultimately allow for generic production by companies that signed the license, it has been estimated that new generic companies may only be able to start supplying the treatment in 2023,” the co-sponsors say.

On the importance of addressing the access to diagnostics, co-sponsors say that that by the end of 2021, of the more than 3 billion tests reported across the world, only 0,4% had been performed in low-income countries.

Because diagnostics has been mostly produced in high-income countries, over-reliance on imported diagnostics resulted in scarcity and high prices which restricted access in low- and middle-income countries (LIMCs), they say in their proposal.

THE PROCESS

They seek an extension of the policy tools provided in the June ministerial decision to therapeutics and diagnostics. This, they say, “will help developing countries to address IP barriers to the expansion and diversification of production”.

The co-sponsors are pushing for a resolution on this matter within the 6-month period as worded in the ministerial decision. While some countries seek consultations on this over the coming weeks and months, they also want an update to be sent to the WTO General Council meeting that will convene at the end of this month. Another formal TRIPS council meeting is scheduled in October this year. They hope that the discussions are concluded by December 2022 as set out in the decision.

Sources familiar with the proceedings of the meeting this week said that a number of members made interventions supporting the engagement in these discussions including South Africa, Cambodia, Indonesia, Egypt, Zimbabwe, the EU, among others.

A few other members reportedly sought more time for consultations. (In the run up to the ministerial in June 2022, the US, for example, was keen on limiting the waiver to vaccines only. Top US officials have also indicated consultations with domestic stakeholders on this.)

In a statement <https://substack.com/redirect/9dd25ec2-69ec-4ba3-91c0-accdb104f4f6?u=43108641> made at the meeting, the UK said:

“…The UK will engage constructively and in good faith, being guided by evidence and noting the distinction between vaccines, therapeutics, and diagnostics. We welcome all Members’ views and the opportunity to engage bilaterally on the matter. We are pleased to see the IP framework has been put in use by licensing partnerships for COVID-19 treatments underway, including via the Medicines Patent Pool….,” the statement said.

“…Given the complexities of therapeutics and diagnostics, we will use the time available, and we call on others to do the same, to gather and analyse evidence and engage bilaterally during the summer months, so that we are able to deliver on the mandate via multilateral evidence-based discussions after the summer. We see the TRIPS Council, with you, Chair, at the helm, as the right forum to hold these discussions….”

For developing countries getting the text on therapeutics and diagnostics in the June decision was seen as a minor win, in a decision that effectively codified EU’s initial proposal on clarifying rules on the compulsory licensing system. Whether developing countries will be able to extract commitments on this, is another matter entirely.

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Photo by Harrison  Candlin: Pexels <https://substack.com/redirect/fdcce9d3-0048-4f09-8df4-0c440d5a048d?u=43108641>
THE LINK BETWEEN THERAPEUTICS AND DIAGNOSTICS

While some global health experts believe that intellectual property is not a barrier for diagnostics, others say that both therapeutics and diagnostics are collectively important in fighting the pandemic.

WHO officials have decried the lack of adequate testing over the last many months. “We are flying blind,” officials remarked at several instances on the decrease in testing systems even as variants of SARS-CoV-2 emerge. Diagnostics are vital not only for surveillance but to simply manage the pandemic, they say.

At an event earlier this week, the South Centre discussed <https://substack.com/redirect/b966f450-6d1a-4c31-be82-59856b38a824?u=43108641> the implications of the WTO ministerial decision on the TRIPS Agreement. Experts cited prevailing laws at the national level to demonstrate the link between these two categories of medical products.

Nirmalya Syam, a senior programme officer at the South Centre explained at the event that there is an intrinsic linkage between these categories. As an example, he pointed to provisions in the Indian patent law to demonstrate precedence on these issues.

Specifically, Section 92A in The Patents Act, 1970, on compulsory licence for export of patented pharmaceutical products in certain exceptional circumstances:

“…(3) <https://substack.com/redirect/72bb653d-9fc2-4a71-9c43-9e6ea579fde0?u=43108641> The provisions of sub-sections (1) and (2) shall be without prejudice to the extent to which pharmaceutical products produced under a compulsory license can be exported under any other provision of this Act. Explanation. -For the purposes of this section, 'pharmaceutical products' means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems and shall be inclusive of ingredients necessary for their manufacture and diagnostic kits required for their use.”

THE COVID-19 DRUGS MONEY SPINNER

Given the evolution of the disease, having access to drugs to treat COVID-19 are critical. Treatment activists have long pushed for the inclusion of these medical products in any measures on waiving IP rights.

But if the last 20 months are anything to go by, this will be even more contentious than what we have already witnessed, observers predict.

Privately, some diplomats in Geneva express concerns on whether WTO members will be able to arrive at a decision on this. After all, it took 20 months to agree on a narrow waiver, and that too only for vaccines. 

Much is at stake. In May 2022, it was forecasted that Pfizer’s Paxlovid could be among the fastest-selling treatments of all time, with revenue of almost $24 billion expected in 2022, Bloomberg said in a report <https://substack.com/redirect/b6501e75-de3e-421a-97b0-c7d67848d7c3?u=43108641> citing estimates from Airfinity.

In addition, drugs and diagnostics used for COVID-19 can also be adapted for use in fighting other diseases. There are efforts to optimise diagnostics to detect a range of infections.  

The industry fears that waiving IP rights in the production of these medicines and tests would undermine innovation. Some industry leaders have varyingly referred to the waiver proposal as dangerous and toxic.

Thomas Cueni, of IFPMA reportedly said <https://substack.com/redirect/3311798f-b1ff-424c-8427-adb8d6bb5c23?u=43108641> “It's a Pandora's box and sends completely the wrong signal for future pandemic preparedness", according to a Reuters story.

It is unclear whether the June decision will be applicable to therapeutics and diagnostics as it now stands. Neither the industry, nor civil society organizations want that. 

Activists believe that a stronger framework should be applicable to this second category of medical products, because they see the many caveats and conditions in the current decision as affecting access. 

This week WHO DG, Tedros Adhanom Ghebreyesus called <https://substack.com/redirect/8dbb8cc0-06ba-4ced-9e3e-1b3b15eb0a97?u=43108641> on Pfizer to work closely with health agencies and countries to ensure its new oral antiviral is available quickly and effectively. To fight the pandemic, he said that it was important to make new oral antivirals and other treatments available to all.

“Working with Global Fund and UNICEF, WHO has developed an allocation mechanism to support countries as antivirals become available. So far, 20 countries have accepted allocations of Molnupiravir, which has moved into distribution. For Nirmatrelvir-Ritonavir, – or Paxlovid - 43 countries have expressed interest. However, our organizations are still trying to finalize with Pfizer the appropriate terms and conditions for low- and middle-income countries. This is delaying access and some countries may choose to wait for a generic version of the antiviral, probably available only early 2023 and this will cost lives. I call on Pfizer to work closely with health agencies and countries to ensure its new oral antiviral is available quickly and effectively.”

TAILPIECE

Even as moves are being made to begin negotiation to waive or clarify certain provisions of the TRIPS agreement to enable access to therapeutics and tests, there are also efforts to increase the scope of IP protection.

In a proposal tabled by the US, the EU, Canada, Australia, Switzerland, China, the UK and others, (IP/C/W/691 <https://substack.com/redirect/2176394a-3f2d-4baa-865f-d0e7227410f0?u=43108641>), member seeks to identify IP licensing opportunities to further intellectual property and innovation.

Proponents of this new proposal discuss the various kinds of licensing of IP in categories such as technology, publishing and entertainment, and trademark and merchandising. This can involve all types of IP assets, including patents, copyright, trademarks, as well as know-how, they explain in their proposal.

On licensing know-how, the proponents say “Know-how can include a range of IP-protected and non-IP protected assets, such as unpatented, technical information, trade secrets, data, specifications, procedures, studies, processes, or methods in the manufacture, sale or use of licensed products. For instance, the technology. Know-how can also be licensed separately from patents, as a distinct form of IP with different terms. For example, a license for know-how can be for an indefinite term, whereas a license for a patent may expire with the patent expiration date.”

Access to technology has been central to the discussions not only at the WTO’s TRIPS waiver discussions, but also at WHO.

Watch this space.

In case you missed it, see: Why It's Time to Terminate the TRIPS Agreement is now up <https://substack.com/redirect/3faba9dc-058f-4d94-b167-afd732202741?u=43108641>: a lecture by Anne Orford, Melbourne Laureate Professor and Michael D Kirby Chair of International Law at Melbourne Law School.

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