Table 2.

Key themes from stakeholder comments.

Overarching concerns

The policy was deemed ‘inflexible’, requiring provisions worded in a particular way, to be included in all agreements, and that would not allow for different approaches to be taken unless the policy itself was modified. Comment:CEPI concluded that, as a learning organization, it needed to be flexible enough to adjust to circumstances consistent with a set of principles. Hence, the term ‘policy’ is now used to identify the principles to be followed to achieve equitable access, and that set of principles allows flexibility for CEPI and potential partners to find mutually agreeable terms to achieve the fundamental principles of equitable access.

Relationship between equitable access and price

•The definition of equitable access, and hence the policy, should not include references to price of pre-licensed vaccines (as unlicensed vaccines cannot be sold); it should only refer to cost. Further, price considerations vary depending on the situation and therefore cannot be reduced to a set formula or predicted in advance of commercial scale manufacturing. •The policy should include a description of an agreed-upon, transparent methodology on how vaccines will be priced and include affordability commitments or standards. •Prices should be set as low as possible and as close as possible to the marginal cost while ensuring the price is sustainable for the awardee to maintain manufacturing, supply, and availability. •It is virtually impossible to truly calculate the cost of goods in advance of when market requirements are understood, and unsustainable for a company to price a product as close as possible to the marginal cost. •It is not CEPI’s role to set price. CEPI deals with investigational vaccines, which cannot be sold. Vaccine manufacturers set a price, and negotiate that price with other global procurement organizations, such as Gavi and UNICEF. Comment:As is evident, the feedback received is mutually inconsistent, reflecting the range of views of different stakeholders. CEPI-supported vaccines are still in early development, and while CEPI does not sell or set the price of vaccines, CEPI has committed to examine opportunities to reduce cost of goods as its projects evolve. Moreover, CEPI understands that markets in affected territories are sensitive and includes provisions in its agreements requiring awardees to agree to prices affordable to those markets and sustainable to them.

Ensuring vaccine development progresses as planned

•Mandating step-in rights, i.e., allowing CEPI to take over, without any pre-defined criteria for doing so, is too prescriptive and unpredictable for developers. This is especially concerning for vaccine platforms which may have complex IP portfolios and broad uses beyond the CEPI-funded program. •The requirement to allow step-in rights should be balanced by the amount of investment the awardee has made, the relevant contribution of CEPI and the technical progress in the program, and only used when absolutely necessary. •The policy should mandate that step-in rights are only used as a last resort, and under pre-agreed terms. •The policy should explicitly describe a pre-agreed commitment to what step-in rights entail for IP, sharing of materials and know-how, e.g., what licenses the awardee will grant to CEPI covering relevant IP in the event that CEPI needs to step-in and/or when and how another developer or manufacturer can replace the awardee. •The policy should explicitly allow a developer to identify a trusted partner that will continue the work if the original developer is unwilling or unable. Comment:CEPI found through its first round of negotiations that it was able to navigate the issue of step-in rights by setting expectations as to when they would be used and what rights would be granted to enable CEPI to continue the work if the step-in rights are triggered. In some agreements CEPI worked up front with the developer to identify a preferred partner to whom the rights would be transferred were CEPI to exercise its step-in rights. This enabled step-in to be much more likely to succeed if needed, and specified conditions under which it would be used, and hence, more acceptable to developers.

Management of intellectual property (IP)

•CEPI should not seek ownership of any IP (background or generated by CEPI funding). CEPI’s potential ownership of IP is especially problematic for vaccine platforms because the patents protecting them can cover broad uses beyond the CEPI-funded program. •The policy should describe a flexible system that recognizes each manufacturer will have unique issues regarding the management of their assets and resources; these must be specifically addressed within the funding agreement. •The policy should contain a bright-line requirement that CEPI owns all IP generated with CEPI funding and seek licenses to all background IP, and that IP should not be used in a way that impedes equitable access to CEPI-funded vaccines or blocks additional research on vaccines to treat epidemic diseases. Also, any downstream use of CEPI’s IP by any licensee should meet equitable access policy requirements. •The policy should include a clear statement that CEPI will not pursue additional, secondary patents to “evergreen” the relevant technology (that is, to keep patent protection in force indefinitely), and CEPI should consider a strategy of “publication” of such IP to make it available immediately in the public domain for widespread use. •The policy should include a requirement that the equitable access policy obligations travel with ownership of all IP generated with CEPI funding. Comment:Both the original policy and the revised one recommended that CEPI not take ownership in IP, particularly with regard to patents. The work involved in drafting, filing and prosecuting patent applications around the world is complicated, specialized and expensive. Rather, CEPI relies on its step-in rights that include licenses to IP (including project and background patents) as well as written information, biological materials, software code and other materials as necessary. Moreover, the step-in rights attach to the particular vaccine being developed and survive even if the original CEPI funding agreement is legally terminated. Hence, CEPI would be able to transfer its rights to other entities in the future and as necessary. CEPI does pursue a policy of open access to publications and data. While this would not place all inventions arising with CEPI funding in the public domain, it does go a long way to ensuring the broadest possible use of publications and data arising out of CEPI funded projects.

Shared risk/benefit

•The policy should avoid including broad statements about shared benefit. Instead, CEPI should work with manufacturers to determine how any revenue or commercial benefits should be addressed on a case-by-case basis for a given funding agreement. •There should be no requirement for further benefit sharing other than to ensure that any vaccine developed is made available. •For platforms, benefit sharing can be especially problematic given broad uses of the platform in manufacturing numerous products. Comment:Based on feedback, and in the face of differences between developers, CEPI successfully worked with developers on a case-by-case basis on benefit sharing. This was particularly critical for vaccines that may have a commercial market, such as a traveler’s market, and in cases where CEPI funds the development of project IP that may have applications in fields that have more commercial significance, such as cancer vaccines. Any such commercial benefits shared with CEPI will go into the pool of resources to further CEPI’s mission. And if CEPI’s receipt of such benefits were to increase prices and thus interfere with access to vaccines, CEPI may decline to receive such benefits in favor of lower prices.

Data sharing and transparency

•The policy should not mandate overbroad disclosure (e.g., of all underlying data). •The policy should mandate data sharing and transparency in line with WHO’s Statement on Public Disclosure of Clinical Trial Results, as well as requirements for publication of results in open-access journals. Comment:CEPI has agreed to act in accord with WHO policies and has chosen to remain firm about data sharing. Moreover, CEPI requires that publications arising from its funding (and the underlying data) be published under open access terms and conditions.

Other

•CEPI should establish a transparent approach of external review to ensure that negotiated funding agreements are consistent with CEPI policies and intents. Comment:CEPI has established a Board-led process, that will include external advisors, to review all funding agreements.