Tuberculosis: European and Developing Countries Clinical Trials Partnership

15.12.2010

Question for written answer E-011109/2010
to the Commission
Rule 117
Bart Staes (Verts/ALE) , Alf Svensson (PPE) , Kartika Tamara Liotard (GUE/NGL) , Eva-Britt Svensson (GUE/NGL) , Nirj Deva (ECR) , Linda McAvan (S&D) , Keith Taylor (Verts/ALE) , Jim Higgins (PPE) , Pavel Poc (S&D) , Eva Joly (Verts/ALE) , Ioannis A. Tsoukalas (PPE) , Nessa Childers (S&D) , Judith Sargentini (Verts/ALE) , Michael Cashman (S&D) , Bill Newton Dunn (ALDE) , Peter Skinner (S&D) , Fiona Hall (ALDE) , Gay Mitchell (PPE) , Catherine Bearder (ALDE) , Bairbre de Brún (GUE/NGL) , Eija-Riitta Korhola (PPE) , Vilija Blinkevičiūtė (S&D) , Eleni Theocharous (PPE) , Silvana Koch-Mehrin (ALDE) , Michèle Rivasi (Verts/ALE) , Nuno Melo (PPE) , Cristian Silviu Buşoi (ALDE) and Maurice Ponga (PPE)

TB is a significant global health concern and is the second leading cause of death from infectious disease worldwide. Between 1.6 and 2 million people worldwide die every year from the disease.

EU funding has been instrumental in generating a robust pipeline of innovative TB vaccine candidates, enabling their early-stage development via phase I and IIa clinical studies. Unfortunately, current funding mechanisms — including the European and Developing Countries Clinical Trials Partnership (EDCTP) — allocate very limited funding to the very costly late-stage clinical trials (Phases IIb and III) which are vital in order to demonstrate the vaccine safety and efficacy necessary for licensing. A single Phase III clinical trial involving multiple trial sites costs in the region of EUR 100 million.

As a result, serious doubts exist as to when — or whether — any of the current European TB vaccine candidates will progress to licensing and be made available to those who need them most.

Does the Commission agree that EU funding mechanisms should be adjusted to ensure that innovative vaccines for ‘neglected diseases’ progress to licensing?

What action is the Commission planning — including via the EDCTP — with a view to directing more funding in existing EU budgets towards Phase IIb and Phase III clinical trials for European tuberculosis vaccine candidates which have entered Phase I and Phase IIa clinical trials?

Is it the Commission's intention to propose that the EDCTP budget be increased and, if so, by how much?

How much of this significantly increased budget for the EDCTP will the Commission specifically allocate to Phase IIb and Phase III clinical trials for existing tuberculosis vaccine candidates which have entered Phase I and Phase IIa clinical trials? When will such funding become available?

Will the rules for any new EDCTP budget provision permit funding to be channelled into the development and building of clinical trial sites, including epidemiology studies?

Is the Commission looking at the possibility of introducing competitive funding mechanisms for the late-stage clinical development of innovative new vaccines that address ‘neglected diseases’ such as TB?

OJ C 265 E, 09/09/2011