exchange of letters between MSF and CEPI around the critical issue of equitable access to vaccines

Milestones :: Perspectives

Editor’s Note:

We provide the full text of an exchange of letters between MSF and CEPI around the critical issue of equitable access to vaccines and how this is achieved and assured in the development context.

 

Open letter to CEPI Board Members: Revise CEPI’s access policy
MSF Letter  05 March 2019
Ahead of CEPI’s Board Meeting in Tokyo on 7–8 March 2019, MSF sent a letter to the organisation’s Board Members to express our concern and disappointment in CEPI’s revised Equitable Access Policy.

The Coalition for Epidemic Preparedness Innovations (CEPI) was launched in 2017 to finance and coordinate the development of new vaccines to prevent and contain infectious disease epidemics.

MSF engaged with CEPI as they developed and revised their Equitable Access Policy. CEPI’s original access policy contained clear commitments on pricing and the treatment of intellectual property, reflecting CEPI’s promise of public-interest R&D. The revised policy, adopted in December 2018, is a startling reversal. It does not ensure CEPI-funded vaccines will be affordable for people who need them most and does not protect the collective public and philanthropic investment that underpin the initiative.

Ahead of their meeting in Japan on 7–8 March 2019, we wrote a letter to CEPI’s Board to express our concern and disappointment in the revised Equitable Access Policy and to urge them to take swift action to develop and approve a new policy with bold commitments to affordable access and transparency for all CEPI-funded vaccines.

Letter

5 March 2019
CEPI
Oslo, Norway
Re: CEPI Equitable Access Policy
CC:
Cherry Gagandeep Kang, David Reddy, Ichiro Kurane, Jane Halton, Joachim Klein, John Nkengasong, Peter Piot, Rajeev Venkayya, Trevor Mundel, Richard Hatchett, Helen Rees, Peggy Hamburg, Peter Salama, Tim Evans

Dear Members of the CEPI Board,

Having cooperated extensively in the establishment of CEPI as a novel R&D initiative for public health-driven vaccine development, including as a Board member during its two formative years, we are writing to express our concern and disappointment in CEPI’s revised Equitable Access Policy, which was adopted during your December 2018 Board Meeting. Médecins Sans Frontières (MSF) was heartened by the creation of CEPI to break new ground in public-interest R&D because we believe it is a shared responsibility to ensure scientific and technological progress benefits all people – including the most vulnerable – and because we did not want to ever again be confronted with a terrible and deadly epidemic like the 2014-2016 Ebola outbreak without any tools to effectively respond.

For Reference: CEPI Equitable Access Policy Documents

CEPI’s original ‘Equitable Access’ Policy, 2017.
CEPI’s revised ‘Equitable Access’ Policy for consultation, 2018.

As a medical humanitarian organisation, MSF witnesses the deadly impact of inequitable access to lifesaving drugs and vaccines on a daily basis. For the past 20 years, we have advocated for governments, companies and civil society to assume collective responsibility for ensuring that medical innovation addresses the neglected health needs of people who are most in need. This cannot be achieved through business-as-usual approaches; it requires an innovative approach with a strong public commitment to adopt and enforce transparent, public health-focused rules of engagement with research partners – including the private sector.

CEPI’s revised Equitable Access Policy constitutes an alarming step backwards for the organisation because it no longer guarantees that the vaccines CEPI funds will be made available at an affordable price. It also provides no basis for CEPI to be held accountable to its public and philanthropic investors in its agreements with development partners on the ownership and treatment of intellectual property or the pricing of CEPI-funded vaccines. By replacing the previously detailed equitable access policy with only a broad statement of principle, the revised policy marks a concerning pivot away from CEPI’s early commitments to access, transparency and openness, and to breaking new ground in terms of public responsibility. It betrays the interests of everyone who invested in CEPI because they wanted to change the deadly status quo.

When CEPI was established, its interim Board committed to a strong and visionary access policy to guarantee equitable access to CEPI-funded vaccines, developed with the support of legal experts from WHO, Wellcome Trust and MSF. It contained important safeguards including enforceable commitments on pricing and intellectual property, grounded in transparency and disclosure of information and knowledge. Regrettably, the Board failed to ensure the policy was implemented and used to shape access provisions in the contractual agreements CEPI signed with developers. Instead, supposedly in response to industry actors’ dissatisfaction with the policy, it immediately gave in on its founding principles and decided to revise the access policy.

Over the summer, MSF provided repeated detailed and constructive feedback on the proposed revisions, including a proposal that an Access Advisory Committee of relevant experts be established to provide independent review of the legal agreements concluded with commercial developers from an access perspective. We also suggested ways to integrate access considerations at critical steps along the pathway of vaccines R&D. At the October 2018 Board meeting, we again raised our concerns about the weakening of CEPI’s initial access commitments.

Ultimately, the Board lacked the courage to maintain the critical safeguards built in to the original access policy. We were disappointed to learn that it was replaced by a vague, toothless and weak new policy in December 2018, disregarding our concerns and proposals, while delegating the development of more detailed, but secret, implementation guidance to the Secretariat.

As you meet as a Board later this week in Tokyo, we urge you to reconsider this change in direction, which stands in stark contrast to the original intent of CEPI. We ask that you agree to work quickly to revise your current policy and come to your next Board meeting in June ready to adopt these revisions. The unique thing about CEPI is not the science, but the unprecedented levels of public and philanthropic money provided to make the science possible, in the interest of global public health. CEPI must live up to its promises to break new ground in vaccine R&D and do things differently. At a minimum, this requires the Board to step up now and reintroduce an unapologetic commitment to affordable access and transparency.

Sincerely,

Dr Joanne Liu
MSF International President           

Dr Els Torreele
Executive Director, MSF Access Campaign

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CEPI’s statement in response to MSF’s open letter on equitable access.
Updated March 8
We share MSF’s view on the importance of access to needed vaccines.

The world now has 21 vaccines under development with CEPI funding. We are already engaging with affected countries to ensure that people who need them get them. Our commitment to access is unwavering and our ability to deliver is enhanced by experience.

We’re currently working with affected countries such as Nigeria, DRC, Bangladesh, and India as well as collaborating with public, private, and academic partners to get life-saving vaccines out of the lab and into the clinic so affected populations can benefit.

Achieving our aim requires working with multiple partners and taking multiple approaches to achieve the desired equitable access objectives. As a result of consultation, CEPI’s Equitable Access Policy has evolved from a “rules-based approach” that previously mandated specific access requirements that proved to be a barrier to many potential partners, to a “principles-based approach” that provides a robust foundation for advancing equitable access.

In practice, this means creating legally binding agreements with our partners that embed the principle of equitable access from the outset and which deploy a range of mechanisms for its realisation—whether that be through establishing requirements on access to vaccines (including price) for affected populations or ensuring that data, information, and materials arising from CEPI-funded R&D are rapidly and openly available for further study and research.

Over the past year, we’ve committed to investing up to $350 million in the development of potentially life-saving vaccines. We can now say with assurance that access will be delivered in all circumstances not just those specified in the previous policy.

We appreciate that it’s important this commitment is visible and understood by our partners. So, with the agreements relating to initial calls for proposals now complete, we will publish how access is being achieved for our developing vaccine portfolio by the end of March, 2019.

CEPI’s Equitable Access Policy is available here.