{"id":3226,"date":"2017-01-18T11:01:55","date_gmt":"2017-01-18T11:01:55","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/EU_CTR_MEPs.pdf"},"modified":"2017-01-18T11:01:55","modified_gmt":"2017-01-18T11:01:55","slug":"eu_ctr_meps-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/eu_ctr_meps-2\/","title":{"rendered":"EU_CTR_MEPs"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

EU_CTR_MEPs<\/a><\/p>\n

THE WORLD MEDICAL ASSOCIATION, INC.
\nL\u2019ASSOCIATION MEDICALE MONDIALE, INC
\nASOCIACION MEDICA MUNDIAL, INC
\nCentre International de Bureaux
\nImmeuble A \u00abKeynes\u00bb Website : www.wma.net Postal Address :
\n13, chemin du Levant Telephone : (33) 4 50 40 75 75 Bo\u00eete Postale 63
\n01210 FERNEY-VOLTAIRE Fax : (33) 4 50 40 59 37 01210 FERNEY-VOLTAIRE Cedex
\nFrance E-mail address : wma@wma.net France
\nTo the
\nMembers of the Committees on
\nEnvironment, Public Health and Food Safety (ENVI)
\nInternal Market and Consumer Protection (IMCO)
\nIndustry, Research and Energy (ITRE)
\nEuropean Parliament
\nBrussels
\nBelgium 7th
\nFebruary 2013
\nBy e-mail
\nProposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE
\nCOUNCIL on clinical trials on medicinal products for human use, and repealing Directive
\n2001\/20\/EC (COM(2012) 369)
\nDear Members of Parliament,
\nWe would like to take the opportunity to raise serious concerns regarding the European
\nCommission proposal COM(2012) 369 and the upcoming first draft committee report by
\nGlenis Willmott, MEP:
\nThe European Commission proposal COM(2012) 369 seeks to make fundamental revisions to the
\nClinical Trials Directive 2001\/20\/EC. The Clinical Trials Directive 2001\/20\/EC is based on and
\nsupplemented by a set of internationally recognized scientific quality standards in the interest of the
\nsafety, reliability and ethical acceptability of clinical research involving human subjects.
\nFurthermore, it builds on the set of ethical principles and internationally recognized protection
\nstandards as embodied in the Declaration of Helsinki by the World Medical Association (WMA).
\nThe current proposal by the European Commission fails to uphold these basic tenets and disrespects
\ncentral ethical principles as embodied in the WMA Declaration of Helsinki. WMA considers such
\nan approach unacceptable primarily for the following reasons:
\nWMA page 2
\n1. The WMA Declaration of Helsinki inter alia requires the prior approval of clinical research
\ntrials by independent ethics committees1
\n. The proposal does not include an explicit referral
\nto such a requirement. The European Commission assumes that it is sufficient to leave the
\ndetermination of the responsible bodies up to the discretion of the Member States. In view of
\nrecital (50) which reads the \u201cCommission should be able to control whether Member States
\ncorrectly supervise compliance with this Regulation. Moreover, the Commission should be
\nable to control whether regulatory systems of third countries ensure compliance with the
\nspecific provisions of this Regulation and Directive 2001\/83\/EC concerning clinical trials
\nconducted in third countries,\u201c Without the explicit requirement of ethics committees such
\nsafeguards cannot be subject to any control, either by any Member State or by the
\nCommission.
\nThus, the proposal undermines the protection of research subjects and researchers and the
\nscientific quality and trust in clinical research that ethics committees have helped to
\nguarantee, not only in the European Union but also in non-EU countries. With its explicit
\nprovisions for the establishment and operation of ethics committees, the Clinical Trials
\nDirective 2001\/20\/EC has made a significant contribution to ensuring that independent
\nethics committees could be established in accordance with international ethical standards to
\nprotect the rights, safety and well-being of clinical trial subjects, even in countries where this
\npreviously was not the case. To waive the explicit requirement for independent ethics
\ncommittees weakens this protection of research subjects in non-EU countries and in several
\nMember States.
\n2. The proposed regulation stipulates the requirement of a \u201ctherapeutic benefit\u201d (see Art. 28
\npara. 1 a). This requirement is a misconception about research since a therapeutic benefit
\ncan hardly ever be guaranteed. The Declaration of Helsinki covers all medical research in
\nhumans. The fact that the regulation refers only to clinical trials does not change the need
\nfor a respect for ethical principles.
\n3. The proposed regulation stipulates unreasonably short timelines for Member States to assess
\nand review applications. Shortening the time for careful consideration before approval of
\nresearch trials risks missing defects in protocols and puts research subjects in danger.
\n4. The proposed regulation provides that the decision of the reporting Member State as to
\nwhether the conduct of a clinical trial is acceptable and is generally binding for all other
\nMember States concerned. Disagreement of the Member States concerned about the
\nconclusion of the reporting Member State is permissible only under very narrow provisions
\nand cannot be based on grounds of their own different assessment of the question of
\nacceptability. Such an approach may lead to sponsors of clinical trials seeking locales for
\napproval of their protocols in places with less rigorous requirements (ethics shopping). And
\nworse, it may force Member States to grant or accept market authorization based on
\nethically or scientifically unacceptable trials.
\n1
\nArticle 15 of the WMA Declaration of Helsinki states that: \u201cThe research protocol must be submitted for consideration, comment,
\nguidance and approval to a research ethics committee before the study begins. This committee must be independent of the researcher,
\nthe sponsor and any other undue influence. It must take into consideration the laws and regulations of the country or countries in which
\nthe research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or
\neliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing
\nstudies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events.
\nNo change to the protocol may be made without consideration and approval by the committee.\u201d
\nWMA page 3
\nFor these reasons the WMA is deeply concerned that the current draft regulation leads to a
\nsignificant paradigm shift that risks putting economic interests before ethics. In addition, in view of
\nthe scope of this regulation, applying as it does to Member States and also to third countries, its
\neffects might be unpredictable and detrimental for research, the development of safe and ethically
\ndeveloped medicine, and most importantly, dangerous for research subjects and patients in Europe
\nand elsewhere.
\nWe urge you to revise the current proposal and stand ready to discuss this further with the
\nappropriate personnel to achieve an optimal outcome for the people for whom we care.
\nSincerely,
\nCecil B. Wilson, MD, MACP Dr. Mukesh C. Haikerwal AO
\nPresident Chairman of Council
\nThe World Medical Association (WMA) is the global federation of National Medical Associations
\nrepresenting the millions of physicians worldwide. Acting on behalf of patients and physicians, the
\nWMA endeavors to achieve the highest possible standards of medical care, ethics, education and
\nhealth-related human rights for all people.<\/p>\n"},"caption":{"rendered":"

EU_CTR_MEPs THE WORLD MEDICAL ASSOCIATION, INC. L\u2019ASSOCIATION MEDICALE MONDIALE, INC ASOCIACION MEDICA MUNDIAL, INC Centre International de Bureaux Immeuble A \u00abKeynes\u00bb Website : www.wma.net Postal Address : 13, chemin du Levant Telephone : (33) 4 50 40 75 75 Bo\u00eete Postale 63 01210 FERNEY-VOLTAIRE Fax : (33) 4 50 40 59 37 01210 FERNEY-VOLTAIRE Cedex […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/EU_CTR_MEPs.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3226"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=3226"}]}}