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European Clinical Trial Directive (Directive 2001/20/EC)

European Clinical Trial Directive (Directive 2001/20/EC). dr. Cees Smit (NPCF/EGAN) EPF Annual Meeting May 19, Brussels. European Clinical Trial Directive. 1998/1999 Concerns expressed by European Patient Organisations Recommendation: one European research/registration file

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European Clinical Trial Directive (Directive 2001/20/EC)

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  1. European Clinical Trial Directive(Directive 2001/20/EC) dr. Cees Smit (NPCF/EGAN) EPF Annual Meeting May 19, Brussels

  2. European Clinical Trial Directive 1998/1999 • Concerns expressed by European Patient Organisations • Recommendation: one European research/registration file 2004 – 2006: Implementation at MS level 2007 (Evaluation EU/EMEA October 3, 2007, London) • More paper work, bureaucracy • 1 Directive, 27 Member States Implementations • Less research, less academic research • Higher prices, higher insurance premiums, • Less research money/grants • Patients not represented in Research Ethic Committees

  3. The current situation • Numerous articles and case-studies have postulated that Directive 2001/20/EC, the ‘Clinical Trial Directive’ has failed to promote efficient clinical research in Europe and to better protect the study participants • However, there are more causes for the decreasing clinical research activity in Europe (if so!) than the legal framework alone • Consultation EC end 2009, response EPF

  4. Response EPF January 19, 2010 (1) • Questionnaire EC highly technical • The effectiveness of clinical trials throughout the EU is of fundamental importance for EPF and its members. • EPF and its members very active in this area: • So input drawn on evidence from Value+, • PatientPartner (VSOP, EGAN, EFGCP), Involve, Respect, EMA/EPF, Europa Donna, IDF-EU

  5. Response EPF January 19, 2010 (2) • Meaningful patients’ involvement in clinical trials processes (Eurordis charter OD) • Access to quality information at all stages • Informed consent in an accessible language • Clinical trials for paediatric patients • Transparancy regarding clinical trials across EU incl. learning from trials that have failed • Access to treatment after the trial

  6. Response EPF January 19, 2010 (3) • Finally, EPF welcomes the Commission’s initiative to consult the public on the Directive • EPF is committed to work with the Commission and other relevant stakeholders in translating the vision and the core issues outlined in their response into more effective, patient-centred EU legislation on clinical trials

  7. Commissioner John Dalli • Recently told the Parliament that the Clinical Trials Directive is going to be reopened, but it is not clear yet whether it will be a light revision of the text or a full revision of the text. • A first draft is expected by Winter 2011

  8. Drug development process End of patent Patent request effective patent-period clinical research fundamental pre-clinical research Ph. 1 Phase 3 Phase 4 Phase 2 post marketing research Registration launch product 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 JR 2005 YearsRef: Jan Raaijmakers (2005, UU)

  9. The theory: levels of patient participation in clinical research ref: www.patientpartner-europe.eu Drivingforce Co-researcher Reviewer Advisor Information provider Research subject 9 11/03/2014

  10. Outcome PatientPartner survey DrivingForce Co-researcher Reviewer Advisor Information Provider Research subject 10 11/03/2014

  11. www.eurordis.org Role of Patient Groups in Research and their Priorities for the Future Fabrizia Bignami Eurordis Therapeutic Development Director Rare Disease Day Workshop Brussels, 1 March 2010

  12. 37% of POs financially support research Multisyst Neurology Dermato >75% 60-75% Musculosk Ophthalmo Metabolic 45-60% 30-45% Neuromusc Oncology Cardiovasc 15-30% <15% Haemato Others Umbrella Distribution by disease type Distribution by country

  13. What kind of research do patients fund? 81 % Basic research 57% Therapeutics 56% Diagnosis 54% Epidemiology / Natural history of the disease 46% Human and Social Science 24% Assistance technologies / Daily life 19% Research infrastructures

  14. Development costs of a new drug

  15. The ‘productivity’ gap • Input: $ 50 – 80 miljard R&D spending/year • Output: 5 – 6 ‘first in class’ drugs/year • Payers/HTA adding C + E criteria further reduce the number of products that will reach the patient (Hans-Georg Eichler, TI Pharma, April 28, 2010)

  16. For further information smit.visch@wolmail.nl

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