Vote of the Clinical Trials Regulation

The European Parliament has voted through the revised Clinical Trials Regulation on to April 2014 by an overwhelming 594 votes in favour to 17 against and 13 abstentions. The vote means that EPF’s efforts long and active engagement on this dossier will enter a new phase.

EPF’s position is (PDF): improvements on key issues but lack of patient involvement

• EPF welcomed the improved provisions on transparency of clinical trial results. EPF is also notes that at the same time pharmaceutical company AbbVie announced they are dropping their court case against the European Medicines Agency for attempting to publish clinical trial data.
  
  We have strongly supported the European Parliament’s position on transparency, including publication of the clinical study report, throughout the process. We also welcome the fact that all clinical trial results must include a “lay summary”. However this summary is not sufficiently defined to ensure it is fit to meet patients’ information needs. 
  
• The regulation contains more detailed guidance for information to patients and the process of informed consent. But EPF regrets that there is no provision for EU level guidelines – the critical question given the current divergence in the quality and quantity of information provided to patients.
  
• EPF regretted the deletion of mandatory patient involvement in ethics committees alongside lay persons. The adoptive provisions that merely encourage member states to involve lay persons and patients are in our view too weak.
  
• We are also disappointed that there are no specific provisions to improve the cooperation between ethics committees at European level or improve the operational aspects of ethics reviews to ensure their consistent quality.
  
• We are in favour of a mention that trial protocols should include a description about patients’ involvement in the design of the trial. This can encourage sponsors and researchers to involve patients from the start of the research process.
  
• The timelines for assessment have been significantly lengthened compared to the original commission’s proposal. Nevertheless, the compromise stresses the need for a well co-ordinate it process at member state level and retains the concept of tacit authorisation as an incentive for a streamlined process.
  
• The adoption of a single submission through an electronic portal coupled with a coordinated assessment process should lead to a more efficient and swift assessment process. The legal form of regulation should result in more consistent national implementation.

The regulation is now ready for formal adoption by the European Union Council and moves from the European level to enter into implementation at member state level (link to the adoptive text), once it has been published in the EU’s Official Journal. (Link to statement by Commissioner Tonio Borg).

However, it would only be applicable in Member States after it is confirmed that the EU database and electronic portal are fully functional which depends on the European Medicines Agency. After that, there will still be a transitional period for member states and applicants to implement the new system.

For more information, please contact Kaisa Immonen-Charalambous, Senior Policy Adviser, at  kaisa.immonen.charalambous@eu-patient.eu.