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EU Regulation on clinical trials for human use
On May 29-30 the central Environment, Public Health and Food Safety Committee (ENVI) of the European Parliament will be called to cast their votes, inter alia, on a ‘Regulation on clinical trials on medicinal products for human use.’ The proposal for a regulation, published July 17 2012, is set to replace the 2001 directive, which “brought about important improvements in the safety and ethical soundness of clinical trials in the EU and in the reliability of clinical trials data. However, the Clinical Trials Directive was arguably heavily criticised” owing to high costs and the feasibility of the trials. The new regulation harmonizes and simplifies evaluation procedures and authorization of proposals of clinical trials of the medicines. Supervising harmonization. On May 17 the working group of the Commission of the Bishops’ Conferences of the European Community (COMECE) sent a reflection titled “Ethical assessment of clinical trials on medicinal products” that calls for the “respect and protection of vulnerable persons and populations” in the framework of the ongoing consultations of the proposal for a Regulation. For the COMECE working group it represents a landmark to ensure harmonization, notwithstanding the autonomy of each member State as relates to intrinsically ethical features and to ensure that “that rules on the assessment of protocols is compatible with the diversity of bodies in charge of this assessment in the countries of the Union”.Distinguishing between “compensation” and “financial gain”. Another important aspect mentioned in the regulation proposal is the respect of fundamental rights in the EU, notably human dignity, the integrity of the human person, the rights of the child, the respect of private and family life. This implies the respect of physical and mental integrity, which leads to “the free and informed consent of the person concerned, according to the procedures laid down by law”, stipulated in the proposal of Regulation. Moreover, the COMECE document guards against the risks contained in the notion of “compensation for participation in the clinical trial”, that should be distinguished from a “financial gain” related to the previously mentioned question of “no incentives”. Thus, “it is essential to define and distinguish a fair “compensation” in the form of a “reimbursement” and using the fact of having “made one’s body available to research” as a source of income for patients”, states the COMECE document. “This delicate ethical question calls for vigilance on the part of every Member State”. Protecting vulnerable brackets. This aspect goes hand in hand with “the respect and the protection of vulnerable populations who could be “unduly used by unscrupulous researchers or companies as easily exploitable objects of experimentation”, “including certain populations or groups of persons, particularly those who are not capable of expressing true informed consent; this includes the populations of countries where it is difficult for them to have proper understanding of clinical trials and their consequences, and where pressure could easily be applied, possibly in the form of offering some sort of gain”.And therefore “medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community”.This is aimed at protecting extra EU populations, notably in developing countries, often used by pharmaceutical companies for clinical trials. The COMECE document devotes utmost attention to the latter case in particular: “It is important to provide assistance to developing countries that helps them build their own R&D capacity to manage their own priority diseases and health needs”. In the document, COMECE highlights the principle whereby “subjects of trials should not be sacrificed in the interests of science or the community of patients, and that every person engaged in a clinical trial must have given consent”. Special cases. Trial medicinal products may not be given to persons who are not capable of giving their consent “except in cases where the same results cannot be obtained by resorting to persons capable of giving their consent and if the foreseeable benefits/ predictable risks ratio is to their advantage”. In urgency situations patient’s consent can be reasonably presumed if all requirements are fulfilled (it is vital to give a sufficiently precise meaning of the terms “minimal risk” and “minimal burden”), the document points out.
