Table 1.

Key Requirements of CEPI’s Original Equitable Access Policy.

Relationship between equitable access and price

CEPI and awardees agree up front on a transparent and agreed-to methodology for determining the cost of goods for the developed vaccines. Prices for vaccines will be set as low as possible for territories that are or may be affected by an outbreak of a disease for which CEPI funding was used to develop a vaccine. The price will be set [by CEPI] at one affordable to the affected territories and sustainable to the manufacturer.

Ensuring vaccine development progresses as planned

In the circumstance in which a company is sold, is not financially sustainable, or if the original product developer cannot or is unwilling to continue development of the CEPI-supported product, CEPI sought to ensure that vaccine development could progress as originally planned through the use of “step-in rights.” This meant that information, know-how and materials related to vaccine development must be shared with (or transferred to) CEPI so that it can ‘take over’ all aspects of product development including transfer of responsibilities to another developer of CEPI’s choosing.

Management of intellectual property (IP)

Patents are the type of IP of most potential concern to product developers. The IP of interest to CEPI includes patents protecting inventions that are either (1) pre-existing (i.e., existed prior to the funding agreement with the product developer and CEPI) and needed to develop the product (called here “background IP”) or (2) generated by CEPI funding (called here “project IP”). The original policy stated that CEPI would not take an ownership interest in project IP but that CEPI would have the necessary access to background and project IP – particularly to ensure it could exercise its necessary step-in rights.

Shared risk/benefit

CEPI would receive a share of financial benefits that might accrue from CEPI-sponsored vaccine development, to re-invest in support of its mission to provide global public health benefit.

Data sharing and transparency

Data sharing and transparency requirements stated that a product developer would be required to make information and data about development publicly available.