Brussels, 21 December 2021

Members of the Alliance have published a note today outlining key recommendations of civil society organisations for the new EU pharmaceutical strategy. A key pillar for this new strategy is the balance between providing innovation incentives for new medicines and ensuring their accessibility, availability, and affordability.

The note identifies flaws and proposes recommendations for EU pharmaceutical incentives (e.g., orphan drug legislation, Supplementary Certificates of Protection, market and data exclusivities and incentives for the development of new antibiotics). It also addresses limitations to the use of compulsory licenses.

Among the general recommendations that civil society organisations believe should guide the new EU pharmaceutical strategy are:

  1. Ensure that access and affordability of safe and effective pharmaceuticals are addressed in all aspects of the EU pharmaceutical strategy.
  2. Ensure transparency for R&D costs and in all steps of the process.
  3. Remove incentives that impede access to affordable medicines and consider the harmful effects of incentives that act as barriers for the use of flexibilities to ensure access to medicines.
  4. Do not add new incentives without clear evidence, and transparent and inclusive discussions about their potential benefits for patients and society.
  5. Remove unnecessary barriers to competition and address abuses of the system and unfair practices.
  6. Bring coherence to the system by aligning R&D policies with access to affordable medicines policies.
  7. Give serious consideration to alternative new models of organising, financing, and incentivising R&D for areas of unmet medical needs. This will help address the high and rising costs of medicines to treat diseases in these areas, as well as the persisting lack of development in some diseases of greatest unmet need.
  8. When public funding is used to support R&D, targeted obligations in the form of conditionalities and transparency should be used to guarantee public return on public investment.
  9. The role of non-profit parties such as academia and research institutes should be enhanced and supported to cover disease areas with low commercial interest.
  10. Prioritize and support the needs of public health and patients when making changes to the current legislative framework.

Read the full note here.

List of signatories

  1. Consumer Association the Quality of Life (EKPIZO)
  2. Access to Medicines Ireland
  3. Global Health Advocates
  4. Médecins du Monde France
  5. Médecins du Monde Germany
  6. NoGracias
  7. SOMO-Centre for Research on Multinational Corporations
  8. Asociación por un Acceso Justo al Medicamento, Spain
  9. Prescrire
  10. Pharmaceutical Accountability Foundation, Netherlands
  11. Wemos foundation
  12. Salud por Derecho
  13. Médicos del Mundo España


Rosa Castro, European Alliance for Responsible R&D and Affordable Medicines,