Rich countries' stance on local production of vaccines: Smoke and mirrors
Newsletter Edition #41 [The Weekly Primer]
After several weeks of speaking with sources on the phone and online, I had a rare in-person meeting last week. It was refreshing and affirmed how information gathering is very much a social process involving trust and understanding. It is not a transactional process, although reporters can often be perceived as merely chasing information.
Whilst discussing fast-paced, technical policy developments in global health, it occurred to me, we are not grieving enough. For all those who have died, and for our ways of life all over the world. One phrase from 2020, keeps coming back to mind: “lengthening lines of freezer trucks outside hospitals”. Even though we may be absorbed in simply keeping pace with the headlines, and ensuring our safety, it is important to take a moment and grieve with families whose lives have come undone during this pandemic.
This reality aside, it is business as usual. At the cusp of a third wave, the fatality numbers are not significantly changing some countries’ and the industry’s positions on taking bold measures to turn the tide of the pandemic. In his remarks at a briefing yesterday, WHO DG Tedros said, “The world’s poorest countries wonder whether rich countries really mean what they say when they talk about solidarity.”
Take, for example, the on-going discussions at WHO on local production of medicines and health technologies to improve access. If you want to understand the direction of the changes in global health, look at the reservations expressed by rich countries in these negotiations. In this edition, we take a quick look at the WHO resolution on local production, now gathering pace.
This follows neatly from our exclusive story last week which is now public: WHO donors seek a new tech transfer hub under ACT-A, C-TAP sidelined. You simply can not read it.
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I. POLICY UPDATES
The consultations on the WHO resolution on local production of medicines and technologies to improve access.
Here is a brief update on the WHO resolution on local production under consultations among member states.
We reviewed a recent draft (from early March 2021) of “Strengthening Local Production of Medicines and Other Health Technologies to Improve Access”. Some of the positions and language undoubtedly continue to evolve in on-going consultations. What is discussed below is not exhaustive and reflects only some of the key provisions in the resolution. (We are unable to share the version of the resolution in entirety in the interest of sensitive diplomatic positions.)
Voluntary approaches to production and “mutually agreed terms” are phrases creeping up in this resolution, spilling over from the wider debates on technology transfer at both WHO and WTO. There is also an overall emphasis on securing supply chains.
While at WTO, on the one hand, opposing countries to the TRIPS waiver proposal, including the US, the UK, the EU and others, are raising the banner highlighting the importance of the flexibilities in the TRIPS Agreement that safeguard public health; on the other, in their negotiations on this resolution, the reference to this language is being resisted. Some developed countries are hesitant to characterise TRIPS flexibilities as promoting local production and generic competition, according to discussions on the text of the resolution.
Some developing countries are pushing for the inclusion of “time limited waivers of some specified provisions related to COVID-19 products and technologies..” (PP5 of the draft resolution)
The mention of the COVID-19 Technology Access Pool (C-TAP), in a paragraph that spells out language on building capacity in LMICs for local production, has been resisted by Switzerland. (PP8 of the draft resolution.). Some rich countries wanted technology transfers on “voluntary and mutually agreed terms”.
Developing countries also questioned the characterisation of the “right” regulatory and policy environment for the integration of local production into overall health systems strengthening. (PP10 of the draft resolution)
Some developing countries (Zimbabwe and Ethiopia) also raised questions on how Unitaid and the Medicines Patent Pool would help in local production, in a paragraph with language on the inter-agency pharmaceutical cooperation group hosted by the WHO and the role of Unitaid and the Medicines Patent Pool. (PP12 in the draft resolution)
In a paragraph referring to the launch of the ACT Accelerator to meet the needs of the pandemic, Costa Rica suggested including a reference to C-TAP, Switzerland suggested deletion of such a reference. (Paragraph 13 of the draft resolution.)
In paragraph on local production as a strategy to improve access to medicines, developed countries (USA and UK) wanted to include language suggesting that in some countries, locally produced products may be more expensive than imported ones. This was resisted by developing countries including South Africa, Zimbabwe, Brazil, Ethiopia, Zambia and Argentina. (PP15 in the draft resolution)
On strengthening local production, countries disagreed on the inclusion of language on incentives for private sector investment. EU suggested including a reference on procurement decisions based on quality and not only lowest cost. (OP1.6 in the draft resolution)
Developing countries also want technical support in not only strengthening regulatory systems, but also implementing national policies and evidence-based comprehensive strategies and plans of action. They also pushed for a mechanism to collect and disseminate local production-related market intelligence. (OP2.3 in the draft resolution.)
We will continue to track these discussions and how they evolve in the coming months.
This commission, an independent and interdisciplinary group of leaders convened by the WHO Regional Office for Europe, was set up “to rethink policy priorities in the light of pandemics.”
The group of 19 Commissioners is chaired by Professor Mario Monti, President of Bocconi University and former Prime Minister of Italy. The commission will publish a report in September 2021 with recommendations “on investments and reforms to improve health and social care systems”.
Last week, the commission launched a call to action, that includes establishing an Intergovernmental Panel on Health Threats, greater interoperability of health data in Europe, promoting an International Pandemic Treaty, and proposing a Global Health Board at the G20 level to address questions of global public goods.
The Independent Panel for Pandemic Preparedness and Response Considers its Recommendations for May report: Press Release from The Independent Panel
The Independent Panel is scheduled to meet next on April 14-15, 2021, when it will finalize its recommendations.
“The Panel also considered an in-depth analysis of 28 countries, ranging across those which experienced low mortality to those experiencing high mortality from the pandemic. Common features identified for countries with high mortality included a tendency for leaders to devalue public health and/or deny social and economic supports, delay the response, and distrust science. By contrast, those with low mortality had whole-of-government approaches and effective leadership, coordination of health delivery services, applied learnings from previous outbreaks, and demonstrated trust in scientific advice.”
II. WHAT WE FOUND INTERESTING
The former director of US Biomedical Advanced Research and Development Authority (BARDA), Rick Bright has joined the Rockefeller Foundation to work on genomic surveillance of viruses. Read this interview, importantly, on the travails faced by government-affiliated scientists who faced political pressure.
“Q:Why build this system outside of the government? [Amy Maxmen]
We want to partner with the CDC and other national and international health entities. But there are advantages to having a neutral, non-political organization manage this type of information.
One is that a non-governmental platform would be less susceptible to politics, internationally and domestically. I’ve worked under four different presidents, and I’ve seen various levels of political influence, collaboration and cooperation with science. This last administration certainly had a way of suppressing and revising science-based messages, and that got us into this spot where we are today with the pandemic in the United States — and that really impacted the world. So, a non-governmental, non-political entity would have the ability to seal and protect those data, and to make sure that the world has access to all the same information at the same time.”
Nature Interview: Rick Bright
Rich Countries Signed Away a Chance to Vaccinate the World: New York Times
A story that pulls everything together - the science, the technology, the law and the politics.
… “Exactly who holds patents for which vaccines won’t be sorted out for months or years. But it is clear now that several of today’s vaccines — including those from Moderna, Johnson & Johnson, Novavax, CureVac and Pfizer-BioNTech — rely on the 2016 invention. Of those, only BioNTech has paid the U.S. government to license the technology. The patent is scheduled to be issued March 30.”
..“Large chunks of the contracts are redacted and some remain secret. But public records show that the government used unusual contracts that omitted its right to take over intellectual property or influence the price and availability of vaccines. They did not let the government compel companies to share their technology.
British and other European leaders made similar concessions as they ordered enough doses to vaccinate their populations multiple times over.”
New York Times
A detailed story based on quotes from CEO’s of pharma majors at investor calls. Should have all of us worried.
Wolk noted that the end of the pandemic is a “fluid” question. The announcement, Wolk said, would come down to a percentage of people vaccinated, though he did not give any specific figures. The “pandemic period will be in place for the majority of this year, if not the entire piece of this year,” he continued, before making it clear that the declaration would be left to Johnson & Johnson.
“I think when we look at it, it’s not going to be something that’s dictated to us,” said Wolk.
The Intercept citing Joseph Wolk, the executive vice president of Johnson & Johnson
Europe’s Vaccine Ethics Call: Do No Harm and Let More Die? New York Times
A timely story that weighs the ethical implications of pausing the administration of the AstraZeneca COVID-19 vaccine in parts of Europe.
.. “And while “first, do no harm” can feel like an iron law of medical ethics, it is in fact primarily a professional code of conduct. For centuries, it has reflected an inborn human bias that sees affirmatively causing harm as categorically different than passively allowing it.
“That doing/allowing asymmetry is of course not just in the medical codes but in the law,” Dr. McMahan said. Especially liability law…”
New York Times
WHO Scientist Who Spoke Out Against Controversial Italy Report Resigns: Health Policy Watch (HPW)
Last year HPW, extensively reported on the suppression of a damning report exposing key flaws in Italy’s COVID-19 response. It now reports that the whistle-blower has resigned.
“Franscesco Zambon, a senior figure at WHO’s Venice Office who led the preparation of the controversial report, told Health Policy Watch that he resigned over the WHO’s censorship of an “independent” report that was intended to “critically examine” both the strengths and weaknesses of Italy’s COVID-19 pandemic response. That report, said critics, contained valuable evidence that could have helped other countries in their COVID-19 response when it first hit.”
Health Policy Watch
The inside story of how Cormann got his magic number: Sydney Morning Herald
On the recent OECD election, with lessons for diplomacy in Geneva. Fascinating.
“The Paris-based club of rich nations has 37 members and a majority — 22 — belong to the European Union which desperately wanted the influential job for one of its own. Had European solidarity held, Australia’s longest-serving finance minister would have been denied the post. But it didn’t: the 50-year-old broke the bloc apart to turn the arithmetic in his favour.
For Cormann, victory meant bagging the magic number of at least 19 votes during last Friday’s final round of voting. How he did it is a case study in the dark arts of diplomacy and power of personal relationships.”
Sydney Morning Herald
Buying Know-How to Scale Vaccine Manufacturing: James Love, KEI on Medium
“If governments could collaborate to create a buyout fund, they can offer to pay for full technology transfer. This can be done with or without royalties from generic suppliers, although, to truly open source the know-how, and make it a global public good, royalties, if desired, can be replaced with payments from a fund to reward vaccines that become the most important in terms of their use and efficacy, such as was proposed by Barbados and Bolivia to the WHO in 2008.”
James Love, Knowledge Ecology International
How access to Covid-19 vaccines has highlighted the need for the WTO to rebalance its IP rules: South China Morning Post
See this important piece from James Bacchus, former chairman of the Appellate Body of the World Trade Organization.
“Modernisation of the Trips Agreement must also include protecting IP rights related to new technologies of digital trade. This updating could begin with making multilateral the basic provisions on transparency, customs duties, online consumer protection, online personal information and more, in Chapter 12 of the RCEP, Chapter 19 of the United States Mexico Canada Agreement and Chapter 14 of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership.
There is need, too, for compromise on an appropriate balance between exclusivity and access for new pharmaceutical products, including biological drugs that are made from living organisms or that contain components of living organisms. The lines drawn between exclusivity and access in such new protections must foster innovation, and not simply create undue global rents for the IP right holders.”
James Bacchus in South China Morning Post
FROM THE JOURNALS / REPORTS:
Promoting diagnostics as a global good: Nature Medicine
(Note that one of the authors is the current Chef de Cabinet at WHO.)
“There is also growing concern that diagnostics companies might focus exclusively on COVID-19 diagnostics due to the huge demand and greater profits, at the cost of essential tests for tuberculosis, human immunodeficiency virus (HIV), malaria and other critical health needs. Until vaccination is widespread, effective ‘test, trace and isolate’ interventions, coupled with non-pharmaceutical public-health interventions (e.g., mask wearing and physical distancing), remain the most effective strategy for containing this pandemic.”
III. WHAT WE ARE WATCHING:
Virtual consultation among some member states at the TRIPS Council: 24th March
Member States Virtual Informal Consultation on Strengthening WHO Preparedness for and Response to Health Emergencies (organized by the European Union): 25th March
Member States Virtual Informal Consultation on a proposed draft resolution on local production (organized by Ethiopia): 26th March
Working Group on Sustainable Financing: 29th-31st March
Webinar Watch: Non-commercial pharmaceutical R&D: What do PDPs suggest about costs and efficiency?
IV. THE WEEK IN TWEETS
EU Commissioner’s tweet on WTO engagement
This tweet from an IP academic, captures the denial one notices, every once in a while these days in global health: “I’m happy to look the other way, no matter what my country does” or worse, “my country can do no wrong”.
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