Clinical Trials: the lack of patient involvement a backward step
The Trilogue negotiations on the clinical trials regulation concluded on 20 December 2013, when Member States adopted a common position. EPF has published a statement on the compromise text, and we will circulate a detailed analysis of the Regulation to our members in the next weeks with the aim of developing a comprehensive position paper.
The compromise reached includes positive as well as negative aspects. On the positive side, first of all we welcome the requirement that trial protocols should include a description of how patients were involved in the design of the trial. This was a key request from EPF, as we believe that knowing this is a factor in the evaluation will encourage sponsors and researchers to involve patients from the start in developing therapies that meet their needs.
We also believe that the legal form of Regulation should ensure a more consistent application of the law in Member States, compared to the previous Directive which was notorious for the divergence of its implementation.
Although the timelines for assessment have been significantly lengthened from the original Commission proposal, the compromise nevertheless stresses the need for a well-coordinated process at Member State level and retains tacit authorisation as an incentive. The adoption of single submission through an electronic portal, coupled with coordinated assessment, should lead to a more streamlined and efficient assessment of trial applications.
We welcome the improved provisions for transparency of all clinical trial results, whether positive or negative. EPF strongly supported the position of the rapporteur, UK MEP Glenis Willmott, on transparency including the publication of the Clinical Study Report.
We also welcome the fact that all clinical trials results must include a “lay summary”, which will be available on a publicly accessible, user-friendly EU clinical trials database.
The way this lay summary is defined in the legislation, however, is not sufficiently clear and will require careful implementation to make sure it really meets patients’ information needs.
On the negative side, we are disappointed that a key provision supported by the patient community and the European Parliament to mandate patients’ involvement in ethics committees was weakened by Member States. The regulation does encourage Member States to involve lay persons and patients in ethics review, but given this is not mandatory it will require careful monitoring.
Regarding information to patients and informed consent, the compromise contains both negatives and positives. Clearly an important outcome of our advocacy is that the articles concerning informed consent contain much more detailed guidance, aimed at improving the quality of information given to patients and the process of informed consent. This is to be welcomed.
However, we regret the lack of any mention of the need to develop EU-level guidelines addressing core elements and main principles of information and informed consent. This was critical, given the current unacceptable variation in the quality and quantity of information provided to patients. Our position was supported by the European Parliament, but regrettably Member States took the view that information is a purely national competence. EPF will continue to advance best practice in this area, as we believe it will be necessary even for the purpose of checking compliance with the Regulation.
The December vote reflects the desire to reach an agreement before the end of the current mandates of the Commission and Parliament, so that the legislation can be passed this year.
Now that the ENVI committee has endorsed the compromise text, the next step is the vote by the entire European Parliament in plenary session, which has been rescheduled for 2 April 2014.
Assuming the proposal passes and is then adopted by the Council, it will then be published in the official Journal of the EU. According to the law, the regulation will ‘enter into force’ 20 days after publication in the official Journal.
However, it would only be applicable in Member States after it is confirmed that the EU database and electronic portal are fully functional. How long that will take depends on the European Medicines Agency, particularly on the resources given to the Agency to implement the database, but in any case this will not be less than 2 years. 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 email@example.com.