Tuesday 11. August 2020
#169 - March 2014


Challenges for EU public health policy


As the revision of the clinical trials Regulation comes close to its end, new priorities are set by the Greek Presidency.

Although still with some fragilities - namely concerning the absence of a requirement of direct benefit to vulnerable subjects – a compromise text regarding the revision of the clinical trials Regulation as recently achieved represents a not negligible improvement to the Proposal of the Commission and now allows the Greek Presidency to focus on different dossiers in the field of public health policy.


Following the publication of a proposal for a ‘Regulation on clinical trials on medicinal products for human use’ on 17 July 2012 by the EU Commission, the Reflection Group of Bioethics of COMECE issued an Opinion in which some basic principles with regard to this matter were emphasised. In particular, it was stated that vulnerable people (including minors) must be specially protected; persons who are not able to give consent should directly benefit from the trial. The Proposal was also analysed in issue no. 138, of May 2011, of Europeinfos (see also issue no. 154, of November 2012).


At the European Parliament, the Committee on the Environment, Public Health and Food Safety adopted a report on 10 June last whereby some improvements in crucial aspects of the Proposal were introduced in relation to informed consent, protection of vulnerable people and the mandatory intervention of Ethics Committees for the assessment of the trials' protocols.


Afterwards, four trilogue meetings among the EU institutions took place, from 8 November to 12 December last. During the negotiations some important issues were identified: including the authorisation of clinical trials - tacit approval in the event deadlines are not met faced firm opposition in the Council based, in particular, on patient safety concerns; the clinically relevant benefit and the direct benefit to vulnerable subjects which was supported in the Council; exemption from the requirement of informed consent in the particular case of cluster trials (trials normally involving a large number of subjects, not selected on individual criteria, that receive the same treatment as they would have received if they had not been included in the trial) which faced opposition in the Council; Ethics committees; and the possibility for a Member State to opt-out of a trial.


In the final compromise text, which has already been adopted by the Permanent Representatives Committee on 20 December last but is still subject to confirmation in the European Parliament (the vote in the Plenary is scheduled for 2 April next), deadlines were generally increased but the tacit approval was upheld. A general requirement of direct benefit to vulnerable subjects was not carried and a simplified, presumed informed consent was foreseen for cluster trials. However, it was now made clear that any Member State can refuse to approve a trial whenever an "ethics committee has issued a negative opinion which in accordance with national law is valid for the entire Member State”. And a provision was introduced recognising that a Member State can prohibit or restrict the use of abortifacients or medicinal products containing narcotic substances.


Health priorities of the Greek Presidency

With the dossier on the revision of the Regulation on clinical trials well on its way to its close, the Hellenic Presidency of the Council of the European Union (which runs until 1 July 2014) will focus on other policy challenges in the field of public health: the proposals for a Regulation on medical devices and for a Regulation on in-vitro diagnostic medical devices (see article in Europeinfos issue no. 157, of February 2013), the proposal for a Regulation on fees payable for pharmacovigilance activities carried out by the European Medicines Agency and the proposal for the transparency Directive. This latter aims, among others, at improving access to innovative medicinal products and at fostering generic medicines into the market.


Besides that, the Presidency of the Member State most hit by the financial crisis and by the restrictive fiscal policies that followed it, naturally wishes to focus attention on the response of health systems to such constraints and on their sustainability, as well as on the impact of migration on such systems. Linked to that, the Presidency will highlight the contribution of e-health solutions to the sustainability and efficiency of those systems: Greece will host an e-Health Forum scheduled for 12-14 May in Athens. Finally, a High-Level Conference on nutrition and physical activity will also be hosted by the Presidency.


José Ramos-Ascensão




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