Implementation of the EU-law. Tom Van Paepegem Quality co-ordinator D.R.U.G.

Transcription

1 Implementation of the EU-law Tom Van Paepegem Quality co-ordinator D.R.U.G.

2 History (1) World War II: Experiments by Nazi-doctors 1946: Nüremberg process 1947: Nüremberg codeddd

3 History (2) 10 basic ethical principles of the Nüremberg Code: Voluntary consent of the human subject is absolutely essential. The experiment might not be at random or unneccessary in nature. The experiment must be based on the results of animal experimentation. The experiment should avoid all unnecessary physical and mental suffering and injury. Death or disabling injury might not be the expected outcome of the experiment. The degree of risk to be taken should never exceed the humanitarian importance of the problem to be solved by the experiment. Subjects must be protected against every possibility of injury, disability or death. The experiment should be conducted only by scientifically qualified persons. The subject is free to bring the experiment to an end through all stages of the experiment. The scientist must be prepared to terminate the experiment if continuation might result in injury, disability, or death of the subject.

4 History (3) 1962: Thalidomide incident (Softenon ) Drug was not registered Women did not known they were participating in a clinical trial 1964: Declaration of Helsinki World Medical Association (see previous speaker)

5 History (4) Different regulations by different countries: UK: ABPI report on good clinical research practice France: bonne practiques cliniques Germany: Grundsätze des BMJFFG für die Ordnumngsgemäβe Durchführund der Klinischen Prüfung Nordic Guidelines 1991: European guideline on GCP for non-registered drugs

6 History (5) 1993: WHO GCP guideline 1994: Austrian drug law including EU-GCP 1995: Swiss drug law including EU-GCP

7 History (6) 1996: ICH/GCP (International Conference on Harmonisation): Europe Japan North-America 2001: European guideline on GCP for all drugs

8 Important aspects EU-law (1) Applicable to all interventional clinical trials Clinical trials on minors: No incentives or financial inducements, except compensation Ethics Committee should have paediatric expertise or should have taken advice in the fields of paediatrics Clinical trials on incapacitated adults not able to give informed consent: No incentives or financial inducements, except compensation Ethics Committee should have expertise in the relevant disease or should have taken advice in the field of the relevant disease and patient population

9 Important aspects EU-law (2) Approval Ethics Committee (EC): Single opinion per country (explicit) Leading EC and local EC Taking into consideration: Relevance Risks Protocol and Investigator s Brochure Suitability investigator, facilities Recruitment of subjects and information for the subjects Indemnity Financial aspects Timelines: 60 calendar days (some exceptions: GMO, gene therapy, somatic cell therapy) Hierarchy in leading EC

10 Important aspects EU-law (3) Approval Competent Authority (implicit): Taking into consideration: Safety aspects related to the product Timelines: 60 calendar days (some exceptions: GMO, gene therapy, somatic cell therapy)

11 Important aspects EU-law (4) Following GCP required by law (EC, investigator, sponsor) CAVE: investigator-initiated clinical trials (= academic trials) The institution is the sponsor needs to fulfill all requirements of the sponsor as defined by GCP (insurance, monitoring, safety reporting, annual reporting, written quality management system, )

12 Important aspects EU-law (5) Safety reporting: Serious adverse event (SAE): Ethics Committees Investigators Expedited reporting (24-48h) Suspected unexpected serious adverse event (SUSAR): Ethics Committees Investigators Competent authorities Death or life-threatening: 7 calendar days Others: 15 calendar days

13 Belgian situation EU-law implemented (not only interventional trials, but also all experiments) Timelines Monocentric phase I clinical trials: 15 calendar days Other trials: 28 calendar days One clock-stop No-fault insurance for all experiments on human beings