Independent External Review of CEPI’s COVID-19 Vaccine Development Agreements Published
05 May 2022
…Despite the efforts of CEPI, our COVAX partners, and many other governments and agencies, the global inequity in vaccine distribution remains stark. Seventeen months after the first doses of vaccine were deployed, only about 16% of people living in low-income countries have received at least one dose, compared to 65% of the world’s population as a whole. Even though supplies of vaccines for LMICs have ramped up in recent months, this situation remains wholly unacceptable in human, epidemiological, and economic terms. It is therefore incumbent upon all of those involved in responding to COVID-19 to reflect upon the roles we have played so far so we can identify areas of improvement that can help hasten the end of this pandemic and leave the world better prepared for the emergence of the next ‘Disease X’ – an emerging pathogen with epidemic or pandemic potential.
Following advice from the CEPI Board’s Equitable Access Committee (EAC), which provides the Secretariat with strategic guidance on access, CEPI commissioned an independent external review of how equitable access has been achieved through our COVID-19 vaccine development agreements.
The review was carried out by the University of Georgetown’s O’Neill Institute for National & Global Health Law and aimed to generate learnings about how CEPI performed against its mission on equitable access; and how these learnings can contribute to enhancing CEPI’s agreements in future. We are publishing the review’s final report today so that our stakeholders, investors and partners can review the findings and recommendations.
REPORT – EQUITABLE ACCESS REVIEW OF CEPI’S COVID-19 VACCINE DEVELOPMENT AGREEMENTS
O’Neill Institute for National & Global Health Law, University of Georgetown
May 2022 :: 28 pages
University of Georgetown’s O’Neill Institute for National & Global Health Law
CEPI’S STRONG COMMITMENT TO EQUITABLE ACCESS
CEPI maintains a nuanced, robust commitment to equitable access, a commitment that manifested over the course of the COVID-19 pandemic, although necessarily adapted to a context in which it worked with, and alongside, international partners and commercial partners of varying size, capital, and governance structure; did so on accelerated schedules; and, faced significant competition from government funders seeking or requiring bilateral arrangements.
THE CRITICAL RELATIONSHIP BETWEEN CEPI’S EQUITABLE ACCESS COMMITTEE AND SECRETARIAT STAFF
This commitment is explained by multiple factors, including a focused and efficient governance relationship between the CEO, the Secretariat Staff, and the CEPI Board’s Equitable Access Committee.
CEPI’S LEADERSHIP IN COVAX AND ACCESS TO THE OXFORD/ASTRAZENECA VACCINE
CEPI’s most visible and measurable success, other than its leadership in establishing COVAX, is its role in facilitating global access to ChAdOx1 nCoV-19 (the “Oxford/AstraZeneca” vaccine, “Vaxzevria”, “Covishield”, AZD1222, among other trade and regulatory classifications). That vaccine has reached more people, and saved more lives, than any other.
CEPI’S MOST SUCCESSFUL AGREEMENTS WERE WITH SMALLER AND NEWER COMPANIES AND UNIVERSITIES
With respect to its COVID-19 vaccine development, scale-up of manufacturing, and vaccine supply agreements, CEPI enjoyed the most favorable equitable access terms with newer and smaller biotechnology companies, including manufacturers, and universities.
COMPETITION FOR DISEASE X PLATFORMS, A FOCUS OF CEPI 2.0, WILL BE FIERCE AND CEPI WILL NEED TO PARTICIPATE IN THE WIDER BIOMEDICAL INNOVATION ECOSYSTEM TO ENABLE EQUITABLE ACCESS TO THOSE PLATFORMS
Disease X platforms that represent a priority for CEPI 2.0 planning, also represent complex and competitive assets where CEPI’s appeal as an investor will depend on multiple factors in the biomedical innovation ecosystem
CEPI SHOULD REVIEW COMMERCIAL BENEFITS
Related to competitiveness for Disease X technologies, CEPI’s approach to sharing commercial benefits should be comprehensively reviewed.
BASED ON REVIEWS OF 28 AGREEMENTS COVERING 17 PARTNERS AND INTERVIEWS WITH CEPI STAFF AND EQUITABLE ACCESS COMMITTEE MEMBERS, THE FOLLOWING SPECIFIC AGREEMENT PROVISIONS ARE RECOMMENDED:
more frequent and robust monitoring of equitable access commitments at the JMAG level including a JMAG member specifically charged with addressing equitable access in JMAG meetings;
consideration of the appointment of a civil society representative and/or another LMIC representative to the Equitable Access Committee;
the designation of a CEPI “open access officer” or enhanced auditing and monitoring of partners’ open access obligations;
consistent dispute resolution clauses;
appropriate conditions or rights to information as to partners’ dealings with third parties;
the development and recommended/required use of template third-party or subawardee equitable access clauses;
adaptation of force majeure clauses; and,
adaptation of the CEPI Equitable Access Dashboard into a checklist for both the CEPI Equitable Access Committee and CEPI Secretariat staff
CEPI SHOULD REFLECT AND CONSTRUCT ITS ROLE IN THE GLOBAL HEALTH GOVERNANCE COMMUNITY
CEPI’s 2.0 role will unfold in the context of multiple private- , public- and international organizational- partners and CEPI should undertake a comprehensive review of how that context will affect its planning.
comprehensive review of how that context will affect its planning.