On December 22, 2023, the U.S. Health and Human Services Department Office for Global Affairs requested comments “on the Implications of Access and Benefit Sharing (ABS) Commitments/Regimes and Other Proposed Commitments Being Considered Under a WHO Convention, Agreement or Other International Instrument on Pandemic Prevention, Preparedness and Response.”
See comments submitted by Public Citizen and civil society below:
There is a global lack of preparedness and reactive responses when confronted with emerging epidemic threats, a concerning lack of investment in the R&D vaccine and therapeutics pipeline, and signs of waning focus on pandemic preparedness, according to a new report by the International Pandemic Preparedness Secretariat (IPPS).
Misinformation, waning interest and entrenched positions threaten the World Health Organization’s (WHO) two pandemic-related negotiations aimed at strengthening future pandemic responses, according to a briefing given to the WHO executive board meeting on Monday. Draft agreements from the two processes – to establish a pandemic accord and to update the International Health Regulations (IHR) – are due to be presented to the World Health Assembly in May. But agreement will only be reached if member states are prepared to compromise and push back against “fake news, lies and conspiracy theories”, said WHO Director General Dr Tedros Adhanom Ghebreyesus. A global misinformation campaign is pushing the notion that the pandemic agreement and changes to the IHR will “cede sovereignty to WHO and give the WHO Secretariat the power to impose lockdowns or vaccine mandates on countries”, said Tedros. “We cannot allow this milestone in global health to be sabotaged by those who spread lies, either deliberately or unknowingly.
… As an international medical humanitarian organisation that provides medical care to people during crises, Médecins Sans Frontières/Doctors Without Borders (MSF) has responded to many infectious disease outbreaks, epidemics and pandemics over the last 50 years. These experiences have shown that timely, equitable and affordable access to medical products such as medicines, vaccines and diagnostic tests is crucial for an effective response to health emergencies. Based on our experiences, we believe that governments must take the following steps to ensure that the global pandemic accord safeguards access to medical products. … [1. Prioritise global equitable access and medical humanitarian needs in international stockpiling and allocation efforts; 2. Address intellectual property challenges for the protection of the right to health and access to medicines; 3. Ensure medical products that benefit from public contributions are accessible to people who need them; 4. Safeguard transparency, accountability and the public’s right to information by restricting confidentiality and trade secrets; 5.
Lower Drug Costs Are Just a Federal License Away. But They Require Biden Administration Leadership
It’s a longstanding government failure to never use federal “march-in”
licensing rights to lower drug prices. It’s also a mistake to limit them to only a few cases
JANUARY 23, 2024
BY JAMES LOVE
In December the White House announced a new draft guidance that allows federal agencies to grant nonvoluntary licenses to patents on inventions funded with taxpayer dollars. These are called “march-in” rights, and they allow the government to force licensing, when necessary, to remedy an abuse or nonuse of such patented inventions.
The draft guidance fundamentally changes policy on federally funded inventions, including drugs and other products that rely on inventions that are sold at high prices by pharma and biotech companies. In doing so, it flexes a muscle that past administrations feared to brandish.
… The addition of SII to the CEPI manufacturing network will be a significant boost to vaccine production efforts in Global South regions and will mean the world is better prepared to achieve the 100 Days Mission to develop new vaccines against known or novel infectious diseases within three months of a pandemic threat being recognised. To prepare for such a scenario, CEPI is investing up to $30 million to build upon SII’s proven track record of rapid response to outbreaks of infectious disease, expanding the company’s existing ability to swiftly supply investigational vaccines in the face of epidemic and pandemic threats. This would then enable CEPI-backed vaccine developers to quickly transfer their technology to SII within days or weeks of an outbreak to begin rapid production and equitable distribution of affordable vaccines to affected populations. … Given SII’s already proven production capabilities, in the event of an outbreak the company may be called upon to promptly supply investigational vaccines for preclinical and clinical testing as well as large-scale supply.
Millions of lives around the world could be saved by increasing regional vaccine manufacturing capacity. The Regionalized Vaccine Manufacturing Collaborative (RVMC), incubated at the World Economic Forum in partnership with Deloitte and co-chaired by the U.S. National Academy of Medicine and the Coalition for Epidemic Preparedness Innovations (CEPI), will now be established as a Global Initiative hosted at CEPI. This new Global Initiative will begin with an initial CEPI commitment of $15 million and be led by partner organizations including the Africa CDC, CEPI, Pan-American Health Organization, U.S. National Academy of Medicine, and the World Economic Forum in collaboration with both public and private sector leaders across regions. Dr Frederik Kristensen, former Deputy CEO of CEPI will assume the newly created role of RVMC Director.
An analysis by Sangeeta Shashikant
As Geneva was winding down for the Christmas break last December, the European Union (EU) circulated a six-page proposal on access and benefit-sharing to World Health Organization (WHO) Members. The proposal comes at a very late stage of the negotiations on the pandemic instrument and is expected to spark significant concerns. The EU proposal, which deviates from international norms established by the Convention on Biological Diversity (CBD) and its Nagoya Protocol is expected to exacerbate inequity, discourage the timely sharing of specimens and sequences by WHO Members, undermine national sovereignty, and erode the intergovernmental character of the WHO. The multilateral benefit sharing proposed by the EU is wholly inadequate and terribly flawed. This critique examines in detail the critical aspects that underscore the deficiencies in the EU's proposal and its possible ramifications on international collaboration during public health emergencies.
The first malaria vaccination campaign for children backed by the World Health Organization begins in Africa on Monday, with the distribution of nearly 30mn jabs in the coming months marking a milestone in the fight against the tropical disease. Children in Cameroon will begin receiving malaria vaccines as part of a rollout of the medicine developed by UK pharmaceutical company GSK in up to 12 countries across sub-Saharan Africa. A second vaccination developed by scientists at Oxford university and produced by the Serum Institute of India is set to be delivered in seven countries in May or June. … More than 30 countries across the continent have expressed an interest in receiving malaria jabs. Up to 18mn doses of the RTS, S vaccine are being distributed by Gavi, followed by an estimated 10mn doses of the R21/Matrix-M jab across seven countries in mid-2024.
As we approach the final months of member-state negotiations over a World Health Organization Pandemic Accord, due to come before the World Health Assembly in May, the efforts to forge a consensus have witnessed modest progress. However, the original divide between developed and developing countries on key issues such as finance, access and benefit sharing, transfer of health technologies, and ‘One Health’ approaches to pandemic prevention, continue to cast a long shadow over the process. Some critics worry that an accord, if and when one is achieved by the 2024 deadline, may be less meaningful in terms of substance and impact, because of the compromises required to reach an agreement. This issue of the Governing Pandemics Snapshot, the latest in the Geneva Graduate Institute series, recaps highlights of the past six months of negotiations.
