South Africa bags first mRNA tech transfer hub; The EU’s push for a declaration at the WTO

Newsletter Edition #65 [The Weekly Primer]

Originally published June 22nd, 2021 on Geneva Health Files.

Hi,

Summer is here in Geneva, which has already been blazing with world-turning events. As a third wave rages in Africa, WHO is hitting the right cues but it is not clear whether on-going efforts will effectively address the challenge of vaccine equity — an objective that straddles many actors and power centers.

The WTO is in the thick of negotiations on the TRIPS Waiver even as other proposals and ways to address vaccine inequities, muscle their way in.

We hope you enjoy reading this curated edition, where a number of different pieces are coming together. From the WHO mRNA hub, to the local production forum, all ostensible efforts to address production capacities in the medium to long term. The big question is, what is being done to address current shortages, apart from inadequate dose sharing plans to quell the pandemic? (See below now increasingly frequent, blistering analyses from academics and others, on the COVAX Facility.)

Sharing our update on the TRIPS Waiver from last Friday: The importance of the scope of the TRIPS Waiver. Talks off to a tough start at WTO. Sign up to become a paying member to access the nuances in a fast-changing policy space in the coming weeks. Readers paying for content helps us cover a part of our reporting costs.

Our efforts at unblinkered, and “one-handed” reporting continues. Like most character-building exercises, this experience has been unnecessary but ultimately useful. My cast will be off this week, and I hope to be faster here on. I am pleased that despite challenging circumstances, we managed to bring you most editions (albeit truncated) over the last four weeks, barring the immediate week following the mishap. Thank you for patience and understanding.

Best,

Priti

Feel free to write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com; Follow us on Twitter: @filesgeneva

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I. POLICY UPDATES

• South Africa bags the first mRNA tech transfer hub, backed by France
• For a world clutching at the straws, there is palpable excitement about a first tech transfer hub to produce mRNA vaccines in Africa.
• The statement from WHO on the South African consortium that has bagged the first COVID mRNA vaccine technology transfer hub, is scant on the details particularly on licensing terms. It is not clear whether for instance, such a hub, would work with the COVID-19 Technology Access Pool. (See our earlier story on this). Neither the press release nor the statement of DG Tedros has any mention of C-TAP.
• In April, WHO issued a call for expressions of interest to establish technology transfer hubs for COVID-19 mRNA vaccines, and it received 50 proposals, WHO has said.

WHO has said:

“The consortium involves a company called Afrigen Biologics and Vaccines, which will act as the hub both by manufacturing mRNA vaccines itself and by providing training to a second manufacturer called Biovac. In time, Afrigen could provide training to other manufacturers in Africa and beyond. The Africa Centres for Disease Control and Prevention will provide guidance through the Partnership for African Vaccines Manufacturing.”

…“We are now in negotiations with several companies that have indicated interest in providing their mRNA technology to the hub. This selection will be based on how advanced the technology is, in terms of clinical efficacy data, and on the terms under which the company is willing to share its technology.”

• Top officials indicated that it would be faster to produce approved mRNA vaccines, while new vaccine candidates would need to go through clinical trials.
• (Unfortunately we did not get a chance to ask our question at the briefing announcing the new hub.)
• In a statement, Kate Stegeman, Advocacy Coordinator, MSF Access Campaign in South Africa said:

“What needs to happen next is Moderna and Pfizer/BioNTech must immediately share their mRNA technology with the hub so that many more mRNA vaccines can be produced independently by manufacturers in South Africa and more broadly on the African continent, as soon as possible.

“All pharmaceutical corporations that share their technology with the hub through technology transfer agreements must do so in a transparent and non-restrictive way to maximize the chance of success: any licenses must include all low- and middle-income countries, and technology recipients must be free to build on the platform technology to tackle other health threats.”

• The lack of sufficient transparency around the creation of hubs, under the aegis of the ACT Accelerator is problematic. Nevertheless, this development is welcome considering the potential it generates for manufacturing capacities in Africa even if in the medium term.
• It is not evident how such hubs will address current challenges. After all, in Africa, the number of cases and deaths increased by almost 40% in the past week, and in some countries the number of deaths tripled or quadrupled, WHO has said.
• What was interesting note was the strong assertion at the event from South Africa’s President Cyril Ramaphosa suggesting that while the mRNA tech hub was a welcome initiative, he believed that the TRIPS waiver would go further to facilitate the sharing of technology.
• See Health Policy Watch: South Africa to Become Africa’s First mRNA Vaccine Manufacturing Hub — WHO Asks Big Pharma to Support Scaleup

Image Credit: Photo by Pixabay from Pexels

• (This post was updated after publication to include the view from the South African President.)

EU push for a declaration at WTO:

• Draft General Council Declaration On The Trips Agreement And Public Health In The Circumstances Of A Pandemic Communication From The European Union To The Council For TRIPS
• Follows up from EU’s earlier submission. The crux is the focus on compulsory licensing:

“We agree that:

a. A pandemic is ‘a national emergency or other circumstances of extreme urgency’ within the meaning of Article 31(b) of the TRIPS Agreement. For the purposes of issuing a compulsory licence pursuant to Articles 31 and 31bis of the TRIPS Agreement, a Member may waive the requirement of making efforts to obtain authorization from the right holder, provided for in Article 31(b).

b. In the circumstances of a pandemic and to support manufacturers ready to produce vaccines or medicines addressing the pandemic at affordable prices for low- and middle-income countries, a Member may provide, for the purposes of determining the remuneration to be paid to the right holder pursuant to Article 31(h) and paragraph 2 of Article 31bis of the TRIPS Agreement, that the remuneration reflects the price charged by the manufacturer of the vaccine or medicine produced under the compulsory licence.

c. In the circumstances of a pandemic, for the purposes of Article 31bis and paragraph 2.c) of the Annex to the TRIPS Agreement, the exporting Member may provide in one single notification a list of all countries to which vaccines and medicines are to be supplied by the exporting Member directly or through indirect means, including international joint initiatives that aim to ensure equitable access to the vaccines or medicines1 covered by the compulsory licence. It shall be presumed that such joint initiatives supply those vaccines and medicines to eligible importing Members within the meaning of paragraph 1.b) of the Annex to the TRIPS Agreement.”

(It is understood that, in the circumstances of the COVID-19 pandemic, COVAX is an international joint initiative within the meaning of this paragraph.)

EU Submission on WTO General Council, June 21, 2021

• See also our earlier story which talks about how the goals of a declaration is different from the objectives of the on-going TRIPS Waiver negotiations.
• WHO: The meeting of the 23rd WHO Expert Committee on the Selection and Use of Essential Medicines is being held virtually on 21 June to 2 July 2021 to revise and update the WHO Model List of Essential Medicines (EML) and the WHO Model List of Essential Medicines for Children (EMLc).
• See the quick update from Health Policy Watch on this: Forty New Medicines & 16 New Indications Under Consideration For WHO Essential Medicines List
• Unitaid’s Executive Board meets to discuss strategic direction in an evolving global health landscape at 38th meeting
• Ahead of Gavi’s board meeting, MSF urges critical look at COVAX shortcomings: MSF

II. WHAT WE FOUND INTERESTING

NEWS:

My colleague Rithika has pulled this together for you:

• Global south politicians to lead vaccine summit after G-7 ‘fiasco’: Devex
• WHO official urges faster supply of Covid vaccines to Africa as cases surge: The Guardian
• Cuba’s homegrown Covid vaccine shows promise: Financial Times
• How the COVID pandemic is changing global science collaborations: Nature
  Public-health power couple takes on Brussels: Politico
• The World Health Organization broke its own rules to spend millions on BCG consultants: Vox
• ‘I’m still feeling that we’re failing’: Exasperated WHO leader speaks out about vaccine inequity: Science Magazine
• In the Wake of India’s Covid Crisis, a ‘Black Fungus’ Epidemic Follows: New York Times
• A Pill to Treat Covid-19? The U.S. Is Betting on It. New York Times
• A BLUEPRINT FOR PREVENTING ANOTHER PANDEMIC: TIME
• Breakthrough deal to help solve Covid oxygen crisis: The Bureau of Investigative Journalism
• Why Are Indians So Angry at Bill Gates?: The Diplomat

FROM THE JOURNALS/REPORTS

• A beautiful idea: how COVAX has fallen short: The Lancet
• To end COVID-19 we need vaccine justice for developing countries not outdated charity — viewpoint: The Conversation

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III. WHAT WE ARE WATCHING:

• WHO: WORLD LOCAL PRODUCTION FORUM — Enhancing access to medicines and other health technologies 21–25 June
• WHO: 23rd Expert Committee on Selection and Use of Essential Medicines: 21 June — 1 July
• Gavi board meeting: 23–24 June
• WTO: The EU proposal on Compulsory Licensing will be considered by WTO members in the context of the discussions at the TRIPS Council: 24 June
• WHO: Working Group on Sustainable Financing: 23–25 June 2021

IV. TWEET OF THE WEEK

Antoine de Bengy at the University of Oslo citing Sophie Harman’s recent piece.