A key lesson learned from COVID-19 was the importance of immediate and unconditional access to pathogens and their genetic information. This will be essential to allow scientists to respond rapidly to future pandemics and meet the ambition of the 100 Days Mission.
On 21 March 2024, Thomas Cueni, Director General, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), delivered a statement at the 9th Meeting of the Intergovernmental Negotiating Body (INB) in an open session with relevant stakeholders focusing on critical elements for a pandemic agreement.
The full statement follows.
IFPMA strongly supports the efforts to find agreement on a Pandemic Accord and we reaffirm our full commitment to constructively contribute.
First, building on the Berlin Declaration, biopharmaceutical companies from both developed and developing countries released a new statement last week to make it clear that we do want a Pandemic Accord. Companies are willing to accept mandatory commitments to delivering equitable access to essential medical countermeasures, provided that the system is workable.
These commitments include allocation of a percentage of real time production of a relevant therapeutic or vaccine after a pandemic is declared on the basis of public health risks, needs, and demand. This could include a portion expected as a donation to low-income countries (LICs) and/or a portion negotiated under equity-based tiered pricing. But it could also include other important contributions such as improving surveillance; research on pathogens of pandemic potential; or voluntary licensing based on mutually agreed terms to improve geographic diversification of manufacturing.
We urge Member States to build on this statement signed by representative industry bodies from the Global North and the Global South to develop a flexible and agile approach to equitable access, which induce a critical mass of companies to voluntarily sign up to the system. Time does not permit to go into the details of all the commitments listed, but I encourage you to read the Joint Statement on Delivering Equitable Access in Pandemics released on 11 March with support from industry across the world, including from developing countries.
Second, we support a feasible and workable Access-Benefit-Sharing scheme, with the creation of a partnership that would attract broad, universal participation. The system must be open and unmonopolized, integrating rather than replacing existing systems and networks. Governance of the PABS system needs to be inclusive, with WHO having a central role as part of a broader partnership of Member States and stakeholders, including industry. In order to foster legal certainty, the Accord must be established and legally recognized as a Specialized International Instrument in accordance with Article 4, Paragraph 4 of the Nagoya Protocol.
Third, time is running short, so we call for realism and pragmatism to find an agreement. We believe that the recently submitted proposal by the European Union contains several practical and realistic elements we can work with.
As we have said multiple times in the past, the Accord needs to preserve what worked well in the COVID-19 pandemic – the rapid access to pathogens and genetic sequence information and the innovation system delivering fast and on record scale – but it must also fix what did not work well: the equitable rollout of medical countermeasures. I can assure you that we and our companies are willing to commit to this!
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9th Meeting of the Intergovernmental Negotiating Body (INB)
We see the revised negotiating text as a step backward in finding solutions to improve pandemic preparedness and response (PPR). It includes a large number of disincentives for the industry to enter into a PABS system and makes industry’s broad engagement in PPR even more risky and uncertain. If adopted as is, this text will deter researchers and manufacturers from working on pathogens with pandemic potential and stifle current and future innovation. A weakened innovation ecosystem will significantly impact global health preparedness and security. We support a feasible and workable access-benefit-sharing scheme, and a multi-stakeholder partnership that attracts broad, universal participation. The system must be open and unmonopolized, integrating rather than replacing existing systems and networks. (IFPMA)
Delivering Equitable Access in Pandemics: Biopharmaceutical Industry Commitments
Achieving equitable access to medical countermeasures requires a comprehensive solution and should not be based on linking access to pathogen samples and sequence data to benefit-sharing obligations. It is critical to preserve the innovation ecosystem and research incentives that were effective in the fight against COVID-19. Strong regulatory systems and the use of regulatory strategies ensure the accelerated availability of pandemic vaccines and treatments, in line with the G7 100 Days Mission. Internationally harmonized and streamlined approvals will be instrumental in improving equitable access. Member states need to facilitate distribution of donations by ensuring that such products are approved for use in that Member State, including through WHO Emergency Use Listing, prequalification, or based on reliance on approval by a stringent regulatory authority. (IFPMA)