Political agreement reached on Clinical Trials Regulation

The Permanent Representatives Committee of the Council of the European Union has approved a compromise agreed with the European Parliament on a draft regulation aimed at facilitating and speeding up the authorisation procedure of clinical trials, endorsing a compromise reached between the Lithuanian presidency and representatives of the European Parliament and of the Commission on 12 December. In order to enter into force the draft regulation still needs to be approved formally by the European Parliament at plenary and by the Council. It is forecast to have its formal reading in a plenary session of the European Parliament on March 10th 2014.

Welcoming the agreement, Health Commissioner Tonio Borg said, “While the Commission would have hoped for a more ambitious approach in line with its original proposal, the new Regulation introduces some significant measures which will contribute to boost clinical research in Europe, for example:

  • A streamlined application procedure via a single entry point – an EU portal and database, for all clinical trials conducted in Europe. Registration via the portal will be a prerequisite for the assessment of any application
  • A single authorisation procedure for all clinical trials, allowing a faster and thorough assessment of an application by all Member States concerned, and ensuring one single assessment outcome and authorisation per Member State
  • The extension of the tacit agreement principle to the whole authorisation process which will give sponsors and researchers, in particular SMEs and academics, more legal certainty
  • Improved conditions for conducting multinational clinical trials, which are key for rare and serious diseases
  • Strengthened rules on the protection of patients and informed consent
  • More transparency on the conduct and results of the clinical trial, thanks to a compulsory prior registration on the EU portal
  • The possibility for the Commission to conduct controls in Member States and third countries to ensure the rules are being properly supervised and enforced

While the measure was also welcomed by both industry lobby group EFPIA and the AllTrials.Net pressure group, biotech groups were less pleased with the specific measures. Steve Bates, Chief Executive of the BioIndustry Association, commented that “increasing the timeline to over 100 days for clinical trial approvals for advanced and innovative therapies is unlikely to boost clinical research in the EU,” while a statement from EuropaBio warned that “the compromise text agreed by Member States today is not ambitious enough to meet the objective of securing timely patient access to innovative treatments

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