Clinical trials: the pursuit of a difficult balance.
The new Regulation on clinical trials aims at relaunching clinical research in Europe while ensuring the highest standards of protection of trials subjects.
On 17 July last, the European Commission published its Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use (COM(2012)369final). This Regulation will repeal and replace Directive 2001/20/EC of 4 April 2001 currently in force, a highly contested piece of EU legislation.
Clinical trials are “investigations of medicines in humans where the medicines are applied outside normal clinical practice on the basis of a research protocol” (Executive Summary of the Impact Assessment Report). Such tests are made with the objective of ascertaining their safety or efficacy. The proposed Regulation (and the Directive currently in force) aim exactly at regulating such investigations so as to guarantee that they are conducted only if “the rights, safety and well-being” of the subjects of the trials are protected and if the data generated in the trial are going to be “reliable and robust” (Article 3 of the Proposal).
Unlike the current Directive, which comprises 22 Articles and no Annexes, the new Regulation, according to the Proposal, will have 93 Articles and 5 Annexes. A major change, however, is the change of legal format to a Regulation, with all the consequences that stem from this change. The Commission justifies the necessity for a Regulation with the argument that differing transpositions and applications of the Directive (in the Member States) have contributed to a decrease of 25% in clinical trials conducted in the EU in the period 2007 to 2011 (although almost half – 13% – was in 2011). There has been a soaring devolving of clinical trials to the so-called BRIC countries; a phenomenon that has also affected, for example, the United States.
Hence the goals of the present Proposal are clear: fostering EU's attractiveness and competitiveness in clinical trials, thereby boosting clinical research in Europe and contributing to the growth policy of the Europe 2020 agenda. This is to be achieved by simplifying the rules for conducting clinical trials, speeding up and streamlining the authorization and reporting procedures which will spare researchers from submitting largely identical information on the clinical trial separately to various bodies and Member States. The model adopted is the one of a simplified authorization procedure for assessment of the application by all Member States concerned who may be interested in communicating their own considerations to the reporting Member State, ensuring one single assessment outcome. Authorities in Member States will be held to the same timeframe for assessment. Multinational clinical trials in Europe (almost all large trials are carried out in more than one Member State) will be easier to conduct. The definition of a category of ‘low intervention clinical trials’ will permit a better differentiation of obligations – concerning reporting and insurance for example – according to the risk-profile of the trial. The IT infrastructure – comprising an EU portal as one single entry point for all information and an EU database to store such data – will also play key roles in achieving the intended goals. About 800 million euros per year are expected to be saved in regulatory costs at the end of the day.
Still another tool is considered paramount. Transparency in the conduct and results of clinical trials prevents redundancy and duplication, ensuring as well that even clinical trials with unfavourable results are made public. It is also indispensable for guaranteeing that a clinical trial conducted outside the EU complies with principles equivalent to those of the Regulation as regards the subject’s rights and safety, and the reliability and robustness of data generated.
The Secretariat of COMECE welcomes this Proposal and in particular the rules aimed at the protection of subjects of clinical trials in third – namely, less developed – countries. The protection of vulnerable persons (also including minors, adults incapable of consent, subjects of emergency trials) is a major concern expressed on 12 May 2011 in the contribution of the Secretariat to the European Commission’s public consultation on the concept paper on the Revision of the Clinical Trials Directive. Some considerations on the concept paper were also the subject of a previous article published in issue no. 138 of europeinfos. The Reflection Group of Bioethics of COMECE, which met on 12 October last, is now preparing an Opinion highlighting, not only the main strengths and achievements of the new Proposal, but also, naturally, its main deficiencies.
With the entering into effect of the new Regulation foreseen for 2016, the ordinary legislative procedure is now starting. On 12 October last, at the European Parliament, the rapporteur, Ms. Glenis Willmott (S&D, UK), was appointed (shadow rapporteur is Mr. Philippe Juvin – EPP, FR).
Because of the high ethical values at stake, the Secretariat of COMECE will continue to follow this dossier closely and europeinfos’ readers will be kept informed about all relevant considerations and developments which subsequently take place.