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Transparency of clinical trials and good governance should be included in the EMA extended mandate

By 9 September 2021September 21st, 2021No Comments

Brussels, 9 September 2021 

On occasion of the ongoing trilogues on the European Medicines Agency (EMA) extended mandate, Members of the European Alliance for Responsible R&D and  Affordable Medicines urge the Council to ensure the new Regulation enhances clinical  trial transparency and upholds good governance.  

As explained in a letter published today, it is crucial that information on clinical trials is  made available in a timely, user-friendly, and complete manner. This is key to avoid  unnecessary duplications and to accelerate the development of new therapies and  vaccines, especially during a public health emergency.  

An amendment proposed by the European Parliament (amendment 107; EP text) made reference to clinical trials transparency. It is now crucial that the Council’s  position includes this amendment.  

If the EU wishes to be better prepared and to have a more effective response to future  health crises, it will need to ensure the availability and accessibility of medicines across  Member States. Reinforcing the role of the European Medicines Agency would be a  critically needed step towards better preparedness and response to public health  emergencies. In doing so, the EU should not miss the opportunity of ensuring  transparency in clinical trials and reaffirming its role as a global leader in this area. 

Alliance Members also support the EP proposed amendments regarding the adoption of an inclusive definition of shortages of medicines (i.e. one comprising shortages  caused by the withdrawal of products from the market for commercial reasons), the  participation of patients and consumers in related governance and activities of the  involved Steering Groups, and the inclusion of requirements for transparency and  conflict of interest. 

Finally, the letter also highlights the need to ensure that the monitoring dashboard of  the new Clinical Trials Information System (CTIS) is made publicly accessible in full. 

Read the full letter

1. Access to Medicines Ireland


3. Asociación por un Acceso Justo al Medicamento (AAJM)

4. The European Consumer Organisation (BEUC)

5. BUKO Pharma-Kampagne

6. Centre for Research on Multinational Corporations-SOMO

7. Consilium Scientific

8. Corporate Europe Observatory (CEO)

9. CurbingCorruption

10. Drugs for Neglected Diseases initiative (DNDi)

11. EPHA


13. France Assos Santé

14. Global Health Advocates (GHA)

15. Health Action International

16. International Society of Drug Bulletins (ISDB)

17. Médecins du Monde

18. Médecins Sans Frontières (MSF) Access Campaign

19. NoGracias

20. Prescrire

21. Public Eye

22. Salud por Derecho

23. Test Aankoop/Test Achat

24. The Pharmaceutical Accountability Foundation+

25. Transparency International Global Health

26. TranspariMED

27. Universities Allied for Essential Medicines – UAEM

28. Wemos


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

Marcin Rodzinka-Verhelle, Global Health Advocates,