EU_CTR_MEPs

THE WORLD MEDICAL ASSOCIATION, INC.
L’ASSOCIATION MEDICALE MONDIALE, INC
ASOCIACION MEDICA MUNDIAL, INC
Centre International de Bureaux
Immeuble A « Keynes » Website : www.wma.net Postal Address :
13, chemin du Levant Telephone : (33) 4 50 40 75 75 Boîte Postale 63
01210 FERNEY-VOLTAIRE Fax : (33) 4 50 40 59 37 01210 FERNEY-VOLTAIRE Cedex
France E-mail address : wma@wma.net France
To the
Members of the Committees on
Environment, Public Health and Food Safety (ENVI)
Internal Market and Consumer Protection (IMCO)
Industry, Research and Energy (ITRE)
European Parliament
Brussels
Belgium 7th
February 2013
By e-mail
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL on clinical trials on medicinal products for human use, and repealing Directive
2001/20/EC (COM(2012) 369)
Dear Members of Parliament,
We would like to take the opportunity to raise serious concerns regarding the European
Commission proposal COM(2012) 369 and the upcoming first draft committee report by
Glenis Willmott, MEP:
The European Commission proposal COM(2012) 369 seeks to make fundamental revisions to the
Clinical Trials Directive 2001/20/EC. The Clinical Trials Directive 2001/20/EC is based on and
supplemented by a set of internationally recognized scientific quality standards in the interest of the
safety, reliability and ethical acceptability of clinical research involving human subjects.
Furthermore, it builds on the set of ethical principles and internationally recognized protection
standards as embodied in the Declaration of Helsinki by the World Medical Association (WMA).
The current proposal by the European Commission fails to uphold these basic tenets and disrespects
central ethical principles as embodied in the WMA Declaration of Helsinki. WMA considers such
an approach unacceptable primarily for the following reasons:
WMA page 2
1. The WMA Declaration of Helsinki inter alia requires the prior approval of clinical research
trials by independent ethics committees1
. The proposal does not include an explicit referral
to such a requirement. The European Commission assumes that it is sufficient to leave the
determination of the responsible bodies up to the discretion of the Member States. In view of
recital (50) which reads the “Commission should be able to control whether Member States
correctly supervise compliance with this Regulation. Moreover, the Commission should be
able to control whether regulatory systems of third countries ensure compliance with the
specific provisions of this Regulation and Directive 2001/83/EC concerning clinical trials
conducted in third countries,“ Without the explicit requirement of ethics committees such
safeguards cannot be subject to any control, either by any Member State or by the
Commission.
Thus, the proposal undermines the protection of research subjects and researchers and the
scientific quality and trust in clinical research that ethics committees have helped to
guarantee, not only in the European Union but also in non-EU countries. With its explicit
provisions for the establishment and operation of ethics committees, the Clinical Trials
Directive 2001/20/EC has made a significant contribution to ensuring that independent
ethics committees could be established in accordance with international ethical standards to
protect the rights, safety and well-being of clinical trial subjects, even in countries where this
previously was not the case. To waive the explicit requirement for independent ethics
committees weakens this protection of research subjects in non-EU countries and in several
Member States.
2. The proposed regulation stipulates the requirement of a “therapeutic benefit” (see Art. 28
para. 1 a). This requirement is a misconception about research since a therapeutic benefit
can hardly ever be guaranteed. The Declaration of Helsinki covers all medical research in
humans. The fact that the regulation refers only to clinical trials does not change the need
for a respect for ethical principles.
3. The proposed regulation stipulates unreasonably short timelines for Member States to assess
and review applications. Shortening the time for careful consideration before approval of
research trials risks missing defects in protocols and puts research subjects in danger.
4. The proposed regulation provides that the decision of the reporting Member State as to
whether the conduct of a clinical trial is acceptable and is generally binding for all other
Member States concerned. Disagreement of the Member States concerned about the
conclusion of the reporting Member State is permissible only under very narrow provisions
and cannot be based on grounds of their own different assessment of the question of
acceptability. Such an approach may lead to sponsors of clinical trials seeking locales for
approval of their protocols in places with less rigorous requirements (ethics shopping). And
worse, it may force Member States to grant or accept market authorization based on
ethically or scientifically unacceptable trials.
1
Article 15 of the WMA Declaration of Helsinki states that: “The research protocol must be submitted for consideration, comment,
guidance and approval to a research ethics committee before the study begins. This committee must be independent of the researcher,
the sponsor and any other undue influence. It must take into consideration the laws and regulations of the country or countries in which
the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or
eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing
studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events.
No change to the protocol may be made without consideration and approval by the committee.”
WMA page 3
For these reasons the WMA is deeply concerned that the current draft regulation leads to a
significant paradigm shift that risks putting economic interests before ethics. In addition, in view of
the scope of this regulation, applying as it does to Member States and also to third countries, its
effects might be unpredictable and detrimental for research, the development of safe and ethically
developed medicine, and most importantly, dangerous for research subjects and patients in Europe
and elsewhere.
We urge you to revise the current proposal and stand ready to discuss this further with the
appropriate personnel to achieve an optimal outcome for the people for whom we care.
Sincerely,
Cecil B. Wilson, MD, MACP Dr. Mukesh C. Haikerwal AO
President Chairman of Council
The World Medical Association (WMA) is the global federation of National Medical Associations
representing the millions of physicians worldwide. Acting on behalf of patients and physicians, the
WMA endeavors to achieve the highest possible standards of medical care, ethics, education and
health-related human rights for all people.