On Monday morning, 10 September 2018, Knowledge Ecology International (KEI) delivered the following oral statement at the World Health Organization’s (WHO) Informal Discussion of the Roadmap Report on Access to Medicines and Vaccines 2019–2023. The morning session provided UN agencies, the WTO, OECD, South Centre, and non-governmental organizations the opportunity to provide oral interventions (the WHO imposed a 3 minute time limit on our statement). A more detailed letter addressed to WHO Director-General, Dr Tedros Adhanom Ghebreyesus (as part of a joint initiative with 15 other non-governmental organizations) can be found here: https://www.keionline.org/28644.
The letter requested the Director-General to strengthen activities on the following workstreams: A) Transparency, B) Excessive Pricing C) Biologics drug competition, D) Intellectual Property rights and E) Delinkage. More information about WHO’s roadmap can be found here: http://www.who.int/medicines/access_use/road-map-medicines-vaccines/en/
The signatories of the open letter include:
Alianza LAC – Global por el Acceso a Medicamentos
Asociación por un Acceso Justo al Medicamento
Canadian HIV/AIDS Legal Network
Health Action International
Knowledge Ecology International
Salud por Derecho
Union for Affordable Cancer Treatment
KEI’s Oral Intervention to the Informal Discussion of the WHO Roadmap Report on Access to Medicines and Vaccines 2019–2023
Thank you Dr. Simão.
Universal health coverage should serve as the overarching theme that underpins the vision for the WHO’s roadmap on access to medicines and vaccines.
The WHO’s draft roadmap on access to medicines and vaccines acknowledges that “some of the greatest challenges to achieving UHC stem from persistent barriers to accessing health services and to accessing affordable and quality-assured health products.” With a view to bridging these barriers, in early August 2018, 16 groups including KEI, HAI, and Oxfam wrote to the Director-General framing our vision for the WHO roadmap. I will present some key points from our joint letter (/https://www.keionline.org/wp-content/uploads/2018/08/Letter-to-Dr.-Tedros-on-the-WHO-Roadmap-on-Access-to-Medicines-and-Vaccines-2019-2023.pdf)
A roadmap with robust language on transparency would reinforce the WHO’s authority to explore norms and mechanisms to enhance the transparency of R&D costs, prices and revenues.
The lack of transparency currently impedes or delays many of the policies that would otherwise be available as policy measures to reduce the price of medicines and vaccines. In particular, without reliable information regarding the cost of R&D, the cost and results of clinical trials, private sector expenditure on the development of products, expenditures on marketing and revenues, it is hard to design alternative policy measures to reduce the current prices
On excessive pricing, we request the WHO secretariat to develop a best practices manual on the subject of the control of and remedies for excessive pricing by December 2020. The manual should compile expertise on various legal and technical aspects of excessive pricing, including the context specific methodologies employed by Member States for determining if prices are excessive, and the mechanisms to remedy and control pricing abuses.
With respect to the overarching theme of achieving universal health coverage (UHC), access will always be constrained and unequal without the delinkage of R&D costs from the prices of drugs, vaccines and other health technologies.
As countries wrestle with affordability and financial sustainability issues, they can seek technical assistance from the WHO or other entities in order to use lawful pathways to ensure treatments are affordable and widely available — including through the granting of compulsory licenses and/or through the use of competition law or other means to remedy excessive prices.
Finally, in multilateral settings such as the high-level meetings of the United General Assembly on non-communicable diseases and tuberculosis, WHO should be more vocal in pushing a public health agenda where UHC depends on timely and affordable access to health technologies by, among other means, making use of TRIPS flexibilities and other public health safeguards.