ANNEX
PREFERRED SUPPLIER MODEL PRINCIPLES
CEPI-INITIAL
CEPI-REVISITED
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Negotiation of manufacturing commitments and volumes with awardee or with a third party if awardee does not have capability/capacity.
● Estimates of number of doses of each of the Project Vaccines that may be produced and dates by when such volume will be achieved. An estimate of the cost of doses of each of the project vaccines for both the investigational stockpile and any additional doses.
● A progress report on the scale-up of the platform for manufacturing and a good-faith estimate of the cost of the scale-up where such scale-up is necessary.
● Partners have also agreed to measures that will ensure that the vaccine price is at a level the publicsector agency agrees is affordable for use in the Affected Territories.
● Collaborating with other actors in the global health community to ensure the procurement, allocation, deployment and administration of licensed vaccines to protect global health at a price that does not limit equitable access and is sustainable for the manufacturer.
● Coordinating with other actors in the global health community to enable licensure of vaccines funded by CEPI, including by securing resources for pivotal clinical trials.
● Funding the development of vaccines and maintaining investigational stockpiles to be used free of charge when an outbreak occurs.
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The individual contract between CEPI and the awardee will set out (i) the processes by which the boundaries for the price of a licensed vaccine will be determined, and (ii) the awardee’s obligations in terms of registration and launch of the licensed vaccine in countries, manufacturing and availability, volume of doses and regulatory steps to best facilitate timely and sustainable access for populations in need.
● Equitable access to the final product.
Follow WHO recommendations with respect to access to and release of investigational vaccine stockpiles for emergency use and its use for conducting phase 3 clinical trials.
● Equitable access during an epidemic or a public health emergency of international concern.
Comparison of the Four Pillars of ISGlobal’s Preferred Supplier Model and CEPI’s Policies
ACCESS
Sharing needs: to ensure that the biomedical research agenda prioritises the public health needs of society, the preferred supplier will have to invest a tangible share of its R&D efforts in neglected, chronic and other high priority diseases (to be defined) for which new treatments and diagnostics are urgently needed. The model will also take into consideration the regulatory and market access situation of the new drugs. Equitable access to the final product, prioritising those most in need for whom the product represents a greater health impact, with collection of the necessary data.
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Prices, while set as low as possible and as close to optimal marginal cost as possible, must be sustainable for the awardee to maintain manufacturing, supply, and availability.
COVID-19 and the Reform of the Biomedical R&D System: A Proposal for a Preferred Supplier Model. An ISGlobal discussion paper.
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