SUU, Alm.del - 2010-11 (1. samling) - Endeligt svar på spørgsmål 255: Spm. om at ministeren offentligt har tilkendegivet, at han er åben for forsøg med bevidstløse uden samtykke. Jf. Ritzau telegram den 1. oktober 2010, til indenrigs- og sundhedsministeren

Dear Commissioner John DalliAs announced in letters of 1 February and 1March 2010 regarding the public consulta-tion paper concerning the functioning of the “Clinical Trials Directive” 2001/20/EC aDanish committee has reviewed the Danish Biomedical Research Ethics CommitteeSystem../.Enclosed you will find a copy of the report from the committee. The report carefullyaddresses many aspects of the Danish Research Ethics Committee System and putsforward 40 recommendations to strengthen the committee system. The recommenda-tions are based on the fundamental approach that ethics and research are closely con-nected, and that quality research must have an ethic dimension integrated in order tosucceed.In chapter 7 of the report you will find the recommendations, while chapter 6 containsthe analysis on which the recommendations are based. Among other things the reportrecommends changes in the organisational structure of the Danish Research EthicsCommittee system to ensure more uniformity in the decisions made by the regionalResearch Ethics Committees. The report also recommends several initiatives regardingquality management and control of research projects.Furthermore the report recommends that the possibility to conduct research in emergen-cy situations is enhanced (recommendation number 28, page 73 and 107). As men-tioned in my letter of 1 March 2010, the issue of emergency clinical trials is much de-bated in Denmark. In order to give patients the best possible treatment it is essential thatthere is evidence for the effect of treatments. For some groups of patients this requiresthat the treatment is tested in emergency situations.From a Danish point of view it is very important that the issue of conducting clinicaltrials in emergency situations is addressed on a European level, both in situations wherethe intervention is presumed to benefit the patient and in the situations where the inter-vention could benefit the patient group, if not the patient directly. It is my expectationthat discussions regarding research in emergency situations could be taken into accountwhen considering the revision of the GCP-directive. The aim should be to improve thepossibilities to perform emergency clinical trials involving pharmaceuticals.One solution could be to accept that the consent from the patient or the patient’s legalrepresentative is givenafterthe intervention on the condition that the intervention ispresumed to benefit the patient. Naturally, such a solution would demand extremely

thorough considerations in the Research Ethics Committee. In these cases it could e.g.be mandatory to receive a medical expert’s opinion regarding the trial before approvingthe application.Regarding research that may not benefit the patient directly but is presumed to benefitthe patient group, the additional protocol to the convention on human rights and biome-dicine concerning biomedical research, 2005, from the Council of Europe could be ofsome inspiration for the European debate. In article 19 (2) regarding research on per-sons in emergency clinical situations, it is stated that such research can take place pro-vided that the research has“the aim of contributing, through significant improvement inthe scientific understanding of the individual's condition, disease or disorder, to theultimate attainment of results capable of conferring benefit to the person concerned orto other persons in the same category or afflicted with the same disease or disorder orhaving the same condition, and entails only minimal risk and minimal burden.”Denmark would welcome a discussion on whether this could be a solution. The respectfor the patient must not be compromised, however, if it is in situations where the inter-vention only entails minimal risk and minimal burden for the patients it might be possi-ble to ensure the interest of both the patients and the research. As well as in situationswhere the intervention is of directly benefit for the patient as for the situations where itis of benefit for the patient group the Research Ethics Committee must examine theprotocols with intensive considerations.I hope that the Commission will address the issue of emergency clinical trials as soon aspossible, and I look forward to the important debate in order to create better possibili-ties for research in emergency clinical situations for the benefit of both the patients andthe development of health research in Europe.