Transcript GREECE Report on bioethics and national law

Clinical Research Conference 2012
Legal, Ethical, and Social
Dimensions of Clinical Research
Takis Vidalis, Ph. D.,
Hellenic National Bioethics Commission
Lawyer, Expert EU
European Law: Current Image
Three sources of legislation:
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1. The Oviedo Convention and the additional
Protocol on Biomedical Research
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2. The EU Directives for interventional studies
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3. The national legislation (regarding, in
particular, the national authorities in charge)
The Oviedo Convention system I
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Relevant for some countries only (after
ratification)
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Legally binding instruments, with
overriding legal effect
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So far, Greece has ratified only the
Convention (not the Protocol)
The Oviedo Convention system II
Basic rules:
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For persons able to consent
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a) There is no alternative of comparable effectiveness,
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b) Potential risks are not disproportionate to potential benefits,
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c) The research project has been approved by the competent body after independent
assessment of both the scientific and the ethical part,
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d) The persons undergoing research have been informed of their rights and the
safeguards prescribed by law for their protection, and,
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e) The necessary consent has been given expressly, specifically and is documented.
Such consent may be freely withdrawn at any time.
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For persons not able to consent.
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a) The research must yield real and direct benefits for the health of the person
concerned,
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b) It must be impossible to conduct research of comparable effectiveness on individuals
capable of giving consent,
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c) Specific authorization in writing from the legal representative of the person
concerned must be obtained,
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d) The person concerned does not object
The Directives system I
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Relevant for all EU countries
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Legally binding instruments, with
overriding legal effect
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For countries participating in the Oviedo
Convention system, both systems have the
same legal effect (therefore a harmonizing
interpretation is needed)
The Directives system II
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Directive 2001/20/EC
Basically, it follows the principles of conduct of research laid down in the Oviedo
Convention. Additional points of interest are:
a) In regard to trials on adults capable of consent, special reference is made to the
protection of privacy and the personal data of participants, and to insurance or indemnity
covering the liability of trial operators,
b) In all cases of persons incapable of consent (adults or minors), special care must be
taken to minimize pain, discomfort, fear and other disease-related risks throughout the
trial
d) clinical trials must be approved by ethical review boards (“ethics committees”)
Directive 2005/28/EC (GCP Directive)
Provisions on subjects’ recruitment
Provisions on accurate reports, data interpretation, verification and confidentiality
Ethics committees as registries
Responsibility of sponsors
The need for a change of the Directives
system
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“Disproportionate regulatory requirements”
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“High costs and a lack of harmonisation of the applicable rules
necessary for multinational clinical trials”
“A significant decline of clinical trials in the EU (between 2007 and
2011 the number of clinical trials conducted in the EU fell by 25%)”
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A bureaucratic system?
The draft of a new instrument
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“Regulation” instead of “Directives” (direct
implementation, without national legislative intervention)
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Simplification of procedures
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A possibility for the Commission to conduct controls
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More transparency
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Risk-proportionality considerations
Important points of change
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A ‘single portal’ to submit an application
A clear distinction between cooperation in [scientific] assessment and
aspects of an intrinsic nature where the assessment is made by each
Member State individually (informed consent, liability)
The Regulation does not regulate or harmonise the precise functioning
of Ethics Committees
Clinical trials in emergency situations
‘Co-sponsorship’
Conditions where it is not necessary to provide a specific damage
compensation (insurance or indemnification)
The Regulation provides a national obligation to set up a national
indemnification mechanism
Some questions
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Do we really need ethics committees in clinical trials?
If yes, is it justified to make a distinction between the scientific
assessment of a trial (needing a unified approach) and its ethical
evaluation (which is left to national authorities)? Are there ethical
differences in Europe regarding the participation of a person in clinical
research?
Can we suggest a harmonizing interpretation of the new regulation and
of the ethics approval clause of the Oviedo Convention (and its
additional protocol on biomedical research), for the EU countries
participating in the latter?
Are there safe criteria for “emergency” clinical trials?
Conclusion
Ethics without bureaucracy! How feasible?
Thank you!
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