Intervention of Dr Bernard Pécoul, MD, MPH, Executive Director, Drugs for Neglected Diseases initiative

Chair, distinguished colleagues,

DNDi welcomes the development of a roadmap to tackle access to and shortages of medicines. Today the consequences of lack of access to existing and new health tools are felt in all countries, at all levels of income, and across diseases areas, from insufficient R&D for neglected and emerging infectious diseases, AMR, and high prices of medicines, such as for Hepatitis C or oncology.

If this access crisis is to be resolved, the roadmap must include concrete deliverables in the short-, medium-, and long-term, that provide practical guidance and support to all the stakeholders involved.

Our experience over the last 15 years has shown that it is possible to work openly and collaboratively with a variety of partners to develop affordable and easy-to-use drugs provided there is a shared vision, clear definition of needs, target product profiles, careful coordination of partners, and policies to ensure sustainable, equitable access.

We would like to make the following proposals for some tangible deliverables:

1. Prioritization of R&D: priority setting based on public health needs, not commercial gain is crucial, The WHO has a key role in providing guidance through:
   • The reconvening of the Expert Committee on Health Research and Development to identify health R&D priorities. The WHO could then produce a list of missing essential medicines.
   • The formulation of a methodology for the prioritization of R%&D needs, including through the use of TPPs.
2. Open and collaborative approaches to innovation can significantly speed up drug discovery, increase efficiency and reduce costs. The roadmap should include:
   • A review and evaluation of existing models, and of best practices.
   • The development of a Code of Principles for Biomedical R&D, based on the practical implementation of the CEWG principles of affordability, effectiveness, efficiency and equity to provide guidance to all R&D actors.
   • The development of a pro-access legal terms repository, that promotes access to knowledge throughout the R&D process, and reflects the flexibilities provided for in the TRIPS Agreement.
   • Support to Member States to implement existing schemes which delink R&D costs from product prices and volume.
   • A specific commitment to help mobilize financial resources to ensure that plans can be turned into action.
3. Regulatory infrastructure
   • A review and identification of continued gaps in regulatory capacity, and harmonization of regional regulatory authorities, to continue to build capacity where needed.
4. Finally, there are two gaps in the implementation plan:
   • first, no mention is made of the importance of diagnostics, which are critical in facilitating access, and rational use, which is key to sustainable access;
   • second, the roadmap should include recognition of the specific needs of children, who are among the most neglected.

For our part, we will continue to contribute to the WHO efforts to achieve access for all people, everywhere.

Read about the development of the roadmap on access to medicines and vaccines 2019-2023