Research and development

Open letter to CEPI Board Members: Revise CEPI's 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.
 



5 March 2019

CEPI
Marcus Thranes gate 2
0473 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. 

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.

We urge you to reconsider this change in direction, which stands in stark contrast to the original intent of CEPI... CEPI must live up to its promises to break new ground in vaccine R&D and do things differently.

Dr Joanne Liu and Dr Els Torreele
MSF

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

vaccines Research and development Letter
Luis Encinas, Ebola expert and nurse, prepares a vaccine. Photograph by Louise Annaud

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.

Off

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.

0
center

MSF's response to CEPI’s policy regarding equitable access

Will equitable access to these new vaccines be secured?

In the wake of the large Ebola outbreak in West-Africa in 2014 – 2015, the Coalition for Epidemic Preparedness Innovations (CEPI) was launched at Davos in January 2017 to finance and coordinate the development of new vaccines to prevent and contain infectious disease epidemics. As one of the first responders to emergencies and outbreaks, MSF is following the development of this important initiative closely.

Based on our experience as a medical humanitarian organization and our experience of working for over fifteen years on access and innovation through the MSF Access Campaign we engaged with CEPI as they developed and revised their ‘Equitable Access’ policy.

This unprecedented public investment in vaccine research is a historic opportunity to establish a model for medical R&D that responds to public health emergencies and ensures access to vaccines for all in need.  It is essential that CEPI keep its initial commitments on pricing and intellectual property grounded in transparency and disclosure of information and knowledge. We remain engaged in discussions with CEPI, and trust that others will join us in ensuring that this important public investment will result is affordable access.

vaccines Research and development Technical brief innovationintellectual property & tradeoutbreak responseresearch and development (R&D)immunisation
Nurse prepares the Ebola vaccine in the site of Bikoro, DRC 2018. Photograph by Louise Annaud

Response by MSF to the invitation to comment on CEPI’s Policy Regarding Equitable Access, 2018

Off
0
center

MSF Statement on the WHO Roadmap for access 2019 -2023: Comprehensive support for access to medicines and vaccines

Speaker: Katy Athersuch

Médecins Sans Frontières welcomes the decision of the Seventy-first World Health Assembly to elaborate a road map outlining the programming of WHO’s work on access to medicines and vaccines. As an international medical humanitarian organisation, our teams see the devastating impact that widespread lack of access to essential health technologies has on people’s lives. Inadequate access to affordable health technologies and the failures of the global research and development (R&D) system are crises of international concern that touch on our operations every day.


For more information, please see MSF's comments on the WHO Roadmap for access 2019 - 2023: Comprehensive support for access to medicines and vaccines


With this experience in mind and having reviewed the zero draft, we would like to highlight the following points:

  • In line with commitments in the Global Strategy and Plan Of Action on Public Health and Intellectual Property (GSPOA) and previous resolutions, we urge WHO to include a deliverable on the provision of technical assistance and capacity building to countries to implement health needs-driven R&D that is evidence based and guided by the core principles of affordability, effectiveness, efficiency, equity and the principle of delinkage.
     
  • We urge WHO to fix the Roadmap’s definition of fair pricing. It is not about finding an algorithm that will mechanically give a fair price for each medicine. It is about the conditions of the price negotiations between public health and commercial interests in order to achieve a balance. It requires management of exclusive rights to avoid undue or abusive monopolies, and far more transparency and disclosure on public and private investments in a product’s development from basic research through to the delivery to people. This also requires disclosure on the real clinical benefits of the products for people in comparison to existing therapeutic options, and of course about the price agreed on itself. We urge WHO to include specific deliverables on transparency and disclosure within the work on fair pricing and under the ‘good governance’ pillar.
     
  • Regarding the application and management of intellectual property from a public health perspective, we are particularly concerned that the Roadmap weakens existing mandates given to WHO through the GSPOA. The Roadmap’s deliverables should reflect the GSPOA, and the qualifications that have been introduced to weaken this mandate should be removed.
     
  • In the area of supply chain, we urge WHO to provide technical assistance to donor-transitioning countries for the procurement of quality-assured medicines in national programmes. In its work on ‘supporting collaborative approaches’, WHO should reject the vertical supply chain model driven by pharmaceutical corporations.
     
  • We welcome the emphasis the Roadmap places on quality and safety of medicines, support to global procurement through the WHO Prequalification Programme (PQP), and strengthening national medicines regulatory systems to ensure and monitor the quality and safety of medicines in their countries. We urge WHO to provide the additional, sustained resources required to support and strengthen the quality assurance of medicines, vaccines and diagnostics that meet public health needs – specifically through additional investment in the WHO PQP.
     
  • Finally, accountability is key. The Roadmap must include more specific deliverables and timelines so that success can be measured.

We look forward to seeing a bold roadmap that ensures patient-centred innovation – and access to medicines, vaccines and diagnostics for all people.

World Health Organization Research and development Statement Doha Declarationintellectual property & tradeUN High Level Panel on Access to Medicines

MSF’s statement on the WHO Roadmap for access 2019- 2023: Comprehensive support for access to medicines and vaccines

MSF’s comments on the WHO Roadmap for access 2019- 2023: Comprehensive support for access to medicines and vaccines

Off
0
center
Subscribe to Research and development