english.prescrire.org > Topics > Advancing healthcare policy > Advancing healthcare policy in Europe: a chronological recap of actions > 2017 Recap > Supplementary protection certificates (SPCs) delay access to affordable medicines (9/2017)

Advancing healthcare policy

Advancing healthcare policy in Europe: a chronological recap of actions

A recap of actions in 2017
Supplementary protection certificates (SPCs) delay access to affordable medicines (September 2017)

Brussels, 8 September 2017

33 civil society organisations, including Prescrire, acting together in the name of responsible pharmaceutial research and affordable medicines, called for the European Commission to abolish the mechanism of supplementary protection certificates (SPCs).

> Click here to download the open submission (pdf, 87 Ko)


To: Ms. Lowri Evans, Director General DG GROW
M. Xavier Prats-Monné, Director General DG SANTE
cc: Ms. Aude l’Hirondel, DG SANTE
M. Fabio Domanico, DG GROW
Ms. Olga Solomon, DG SANTE
Ms. Amaryllis Verhoeven, DG GROW

Dear Madam, Sir,

As civil society organisations working on access to medicines and public health, we would like to share with the European Commission and draw your attention to an open submission on supplementary protection certificates (SPCs) for medicinal products in the European Union and their impact on access to affordable medicines for patients. The submission addresses the European Commission’s current review of Regulation EC 469/2009 concerning SPCs for medicinal products, requested under the ‘Council Conclusions on Strengthening the Balance in the Pharmaceutical System in the EU and its Member States’, adopted in June 2016 (point 47).

The prices charged by companies for new medicines have increased steeply over the past decade, to the point they have become unaffordable for many European patients and threaten the financial sustainability of national healthcare systems. Monopolies reinforced through intellectual property and other market exclusivities, such as SPCs, have disproportionally empowered commercial interests over public health needs. Prolonged exclusivity through SPCs has enabled companies to avoid generic competition and to charge unaffordable prices, as demonstrated – in detail and with concrete examples – in the full submission text.

SPCs are counterproductive to stimulating innovation as they create incentives for companies to focus on prolonging monopolies through evergreening strategies. At the same time, companies continue not to invest in areas of unmet public health need.

We therefore recommend that the European Commission i) abolish the SPC mechanism, ii) improve transparency, flexibility and public health impact assessment in the current SPC review process, and iii) stop encouraging the inclusion of SPCs – or similar mechanisms, such as patent term extensions – in free trade agreements with other countries.

We thank you in advance for your consideration and we look forward to hearing from you.

Co-signing organisations

1. Médicins sans Frontières (MSF) Access Campaign
2. Wemos
4. Global Health Advocates France (GHA)
5. Just Treatment
6. Health Action International (HAI)
8. Global Justice Now
9. Médecins du Monde
10. Commons Network
12. UAEM Europe
13. Salud por Derecho
14. All-Ukrainian Network of PLWHA
15. "AGEP'C" Kazakhstan
16. Prescrire
17. Aktionsbündnis gegen AIDS - Action against AIDS Germany
19. Public Eye
20. Health Projects for Latvia
21. Altroconsumo
22. Access to Medicines Ireland (AMI)
23. BUKO Pharma-Kampagne
24. AIDS Action Europe
25. IPPNW Germany
27. The International Society of Drug Bulletins (ISDB)
28. Grupo de Ativistas em Tratamentos (GAT)
29. Hepatitis Scotland
30. Aids Hilfe (Austria)
31. Oxfam
32. European AIDS Treatment Group (EATG)
33. MEZIS e.V. Germany


Dimitri Eynikel, MSF Access Campaign EU Policy and Advocacy Advisor A.I.
T: +32 2 474 75 24, Email: dimitri.eynikel@msf.org

> Click here to download the open submission (pdf, 87 Ko)