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

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

• dr. Cees Smit (NPCF/EGAN)
• EPF Annual Meeting
• May 19, Brussels

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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

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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

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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

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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

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Response EPF January 19, 2010 (3)

• Finally, EPF welcomes the Commissions 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

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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

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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
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JR 2005
Years Ref Jan
Raaijmakers (2005, UU)
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The theory levels of patient participation in
clinical research ref www.patientpartner-europe.
eu
Driving force
Co-researcher
Reviewer
Advisor
Information provider
Research subject
06/12/2015
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Outcome PatientPartner survey
Driving Force
Co-researcher
Reviewer
Advisor
Information Provider
Research subject
06/12/2015
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(No Transcript)
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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
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37 of POs financially support research
Distribution by disease type
Distribution by country
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What kind of research do patients fund?
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Development costs of a new drug
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The productivity gap

• Input 50 80 miljard RD 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)

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For further information

• smit.visch_at_wolmail.nl