WHO Intergovernmental Negotiating Body (INB) intersessional briefing on “Access and benefit sharing”
On 22 March, IFPMA delivered a shortened version of the below statement at the WHO INB intersessional briefing on “Article 10: WHO Pathogen Access and Benefit Sharing System, with the Pandemic Influenza Preparedness Framework as an example” of the WHO convention, agreement, or other international instrument on pandemic prevention, preparedness, and response (“WHO CA+”).
Via the Berlin Declaration, industry has expressed its commitment to early access to reserve an allocation of real-time production of vaccines, treatments, and diagnostics for priority populations in lower-income countries, and to take measures to make them available and affordable.
Industry disagrees with the proposed transactional approach to benefit-sharing outlined in Article 10 of the Zero Draft of the CA+ (the “PABS System”) and which mimics that of the PIP Framework. Such approaches are more than likely to delay access to pathogens and the timely development of medical countermeasures in the event of a pandemic. Industry’s experience with the Nagoya Protocol has shown that a transactional approach is not compatible with rapidly accessing pathogens, particularly when rapid response is needed for epidemics and pandemics. Access to pathogens and their associated information must be fast, easy, and legally certain, and not built on a transactional principle.
Beyond the shortcomings of transactional approaches, due to the specificities of seasonal and pandemic influenza the PIP Framework system cannot be successfully expanded to other pathogens or be applied to the CA+.
The Zero Draft should recognize and accommodate for differences between vaccines, therapeutics and diagnostics on dimensions that drive demand and supply such as manufacturing, regulation, financing, procurement, delivery, and clinical use.
Benefit-sharing should be understood as a more holistic concept, including benefits to Parties such as information sharing, capacity building, local manufacturing initiatives, and investments, among others.
The Zero Draft should also enable processes to be undertaken in partnership with relevant international procurement agencies with a strong track record in supplying low-income countries and the appropriate capacity and resources to manage it.
About IFPMA
IFPMA represents the innovative pharmaceutical industry at the international level, engaging in official relations with the United Nations and multilateral organizations. Our vision is to ensure that scientific progress translates into the next generation of medicines and vaccines that deliver a healthier future for people everywhere.
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To achieve this, we act as a trusted partner, bringing our members' expertise to champion pharmaceutical innovation, drive policy that supports the research, development, and delivery of health technologies, and create sustainable solutions that advance global health.
