The ethics of the clinical trials pose new challenges for EU policy
The new public consultation launched by the European Commission opens an opportunity to reinforce the protection of clinical trials’ subjects
Around 4000 clinical trials are authorised every year in the EU, meaning that, given an average 2-3 year duration, about 10,000 trials are ongoing in EU at any given time. In this background, the European Commission has submitted a Concept Paper for public consultation concerning the Revision of the 10-year old Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The Commission plans to present a legislative initiative in 2012.
Clinical trials are a key issue in the field of Research and Bioethics, encompassing ethical and legal values, principles and rights that include the protection of human life and the physical and mental integrity of individuals; social solidarity and the balance between personal interests and rights and the interests of science and of society; the proportionality between risks and benefits; the right to privacy and the informed consent, to name only a few.
Among the rules defined in the Clinical Trials Directive, of particular relevance are the ones in Articles 3 to 5, on the protection of clinical trials’ subjects, specially minors and incapacitated adults, not able to give informed legal consent. In both cases the Directive lays down further rules of protection that shall apply: that the respective research should “relate directly to a clinical condition from which the minor concerned” – or the incapacitated adult – “suffers”. As far as incapacitated adults are concerned, the clinical condition must be “life-threatening or debilitating”, although, as regards minors, it is admitted that, alternatively, the research be “of such a nature that it can only be carried out on minors”. Furthermore, regarding protection of the former subjects it is explicitly required that there be “grounds for expecting that administering the medicinal product to be tested will produce a benefit to the patient outweighing the risks”, whereas such a condition is not foreseen for paediatric clinical trials.
In the specific context of the “concept paper” one can identify two aspects of major ethical relevance. The first is tackled in Consultation Item no. 16 and refers to emergency clinical trials not regulated in the current Directive. Such clinical trials are carried out in emergency situations –e.g. stroke or heart attack – when obtaining prior, informed consent from the subject or prior authorization from his legal representative may not be feasible.
The other ethical aspect highlighted in the “concept paper” and the object of Consultation Item no. 17 refers to clinical trials performed in third-countries, namely developing countries. In this case, the general position is that compliance with good clinical practice and fundamental ethical standards shall be required, no matter where the clinical trial is performed, this being a necessary consequence of the universal validity of the principles of the protection and guarantee of fundamental human rights and human dignity.
Notwithstanding, the core aspect of the “concept paper” and the consultation is the future of cooperation among Member States in assessing and following up applications for clinical trials, with three models being considered, some more centralised than others: a single submission (of the application) with separate assessment (by Member States); single submission with subsequent central assessment; and single submission with subsequent ‘coordinated assessment procedure’. It is noteworthy that a larger or smaller practical impact on the diversity of ethical options among Member States in this specific field will depend, to a greater extent, on the model eventually adopted.
The abovementioned are some of the reasons why the COMECE Secretariat considers this consultation an opportunity to take a stance regarding the necessary ethical framework within which the clinical trials should be carried out and, at the same time, to secure the Catholic Church and the European Bishops’ Conferences as key dialogue partners and “stakeholders” in this specific field of European policy.