Clinical trials directive: The Parliament's political dilemna | EurActiv

"This is an analysis of some of the most important amendments submitted by MEPs to the Commission’s draft regulation (COM(2012) 369 final) to revise the clinical trials directive. The proposal will be debated in the Environment Committee in the European Parliament on 24th April. By the February deadline, 731 proposals for amendment had been submitted. The most contentious political questions are probably about disclosure – whether, how and when the results of clinical trials should be disclosed. The Commission’s proposal would require publication of a 'summary of trial results' within a year of the end of the trial. The rapporteur, Glenis Wilmott (S&D), proposes something more - the publication of a 'Clinical Study Report'. Clinical Study Reports are well defined in international regulatory guidelines and by the European Medicines Agency. Short of the publication of raw data, they are the most scientifically useful account of a clinical trial that we have. They are prepared for many, but currently not all, clinical trials. Investigators, researchers, writers, authors and sponsors are well acquainted with them. A few MEPs, notably Margrete Auken, and Michèle Rivasi (Greens/EFA) would go further, requiring full disclosure of raw data, stripped of any personal/private information, within one year of the end of the trial. Other MEPs, mainly EPP and ALDE, support the disclosure of trial summaries, but with the addition of  criteria for what a summary should contain. However, they also seek to limit what must be disclosed, by reference to commercial confidentiality and intellectual property protection. Two shadow rapporteurs, Philippe Juvin (EPP) and Cristian Silviu Buşoi (ALDE), together with  Françoise Grossetête (EPP), support the publication of a trial summary but propose a new annex, setting out what should be contained in such a summary. Their proposal has some similarities with what is proposed in coming years in the US under the Food and Drug Administration Amendments Act of 2007. They also propose amendments that would limit access to information on the database on which the trial summaries would be placed. The Commission proposal would allow various exceptions to disclosure, including personal data and commercial confidentiality. Juvin, Bosoi, Grossetête and others propose a special emphasis on protecting commercial confidentiality for trials intended to support an application for a marketing authorization for a new use. Juvin would add an exception for scientific information that has not been published in a journal.  Juvin, Grossetête and others also propose an exception for information 'undermining intellectual property rights'. Taken together, these amendments would substantially reduce access to information on clinical trials. Take, for example, the added stress on commercial confidentiality. In a series of recommendations for the European Medicines Agency the Ombudsman has set out very clear guidelines or principles, derived from case-law, for determining genuine commercial confidentiality. An amendment giving added weight to commercial confidentiality is likely only to muddy the waters here, and detract from the Ombudsman’s recommendations. The exception for information 'undermining intellectual property' is also unclear and uncertain. Medical journals often insist on 'first publication' for articles submitted but they are also on record as saying that this policy will not be affected by prior disclosure that is required by law. More generally, it would be relatively easy to combine disclosure with the protection of legitimate intellectual property rights. Opinion among MEPs also varies in relation the timing of disclosure of results. In the most extreme case, Christofer Fjellner (EPP) proposes that all clinical trial data should be confidential until a marketing authorisation is granted. One effect of this is that there may never be any publication of results of trials not used in support of a marketing authorization. It would also bring no increase in transparency since the EMA is already committed to publishing trial results after an authorization is granted. Philippe Juvin proposes a two year deadline for publication of trial summaries. As previously mentioned he would also allow a delay in disclosure of information until it is published in a scientific journal. This could allow companies to postpone disclosure indefinitely, merely by claiming that they intend to publish an article in a journal ..."