US Congressional Committee advances legislation that fails to fix FDA PRV program for neglected diseases
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 (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.
Response by MSF to the invitation to comment on CEPI’s Policy Regarding Equitable Access, 2018
Watch, read, shareMSF's response to CEPI’s policy regarding equitable access > Paragraphs
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.
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
Read, watch, shareMSF Statement on the WHO Roadmap for access 2019 -2023: Comprehensive support for access to medicines and vaccines > Paragraphs
To improve the quality of life and the health of people suffering from neglected diseases by using an alternative model to develop drugs for these diseases and ensuring equitable access to new and field relevant health tools.
In this not-for-profit model, driven by the public sector, a variety of players will collaborate to raise awareness of the need to research and develop drugs for those neglected diseases that fall outside the scope of market-driven research and development (R&D). They will also build public responsibility and leadership in addressing the needs of these patients.
DNDi will develop new drugs or new formulations of existing drugs for patients suffering from the most neglected communicable diseases. Acting in the public interest, it will bridge the existing R&D gaps in essential drugs for these diseases by initiating and coordinating drug R&D projects in collaboration with the international research community, the public sector, the pharmaceutical industry, and other relevant partners.
DNDi will address unmet needs by taking on projects that others are unable or unwilling to pursue. Although DNDi’s primary focus will be the development of drugs for the most neglected diseases such as sleeping sickness, kala-azar, and Chagas disease, it will also consider engaging R&D projects on other neglected diseases. As means permit, it will consider the development of diagnostics and/or vaccines. In pursuing these goals, DNDi will manage R&D networks built on South-South and North-South collaborations and solidarity. It will use and support existing capacity in countries where the diseases are endemic, and contribute to building additional capacity in a sustainable manner through technology transfer in the field of drug research and development for neglected diseases.
Civil Society Reaction to the European Commission’s Proposal on Horizon Europe
MSF Access Campaign joined twenty other civil society organisations to raise strong concerns about the European Commission’s proposal on its next research framework programme, Horizon Europe, which fails to make a serious commitment to ensure public interest-driven biomedical research and innovation. Read the full statement below.