The EU Clinical Trials Regulation has been drafted over and over again and now it would appear that another facet of it will be rethought. Proposals which would have allowed secondary researchers to download, save and print clinical trial data will now not be formally adopted until October. This is because the European Medicines Agency (EMA) would like to clarify wording and practical arrangements.
The secondary use of the clinical trial data (which has to be submitted as part of a marketing authorisation procedure in the new Clinical Trials Regulation) has been hotly contested over the last few months, with the EMA doing a U-turn on its proposals, allowing data to be printed rather than only seen ‘on screen’ with no ability to print, share or download the data. Although there is now “general support” for the aims of the new policy, brought about because European Ombudsman Emily O’Reilly expressed concerns over the ‘on screen’ restriction, the final agreement on the adoption of the policy will not take place until October 2nd, the day after the policy was meant to be implemented.
The EMA has stated that although there is a delay in implementation they remain “committed to introducing this additional measure towards transparency as soon as possible, so as to enhance citizens’ awareness and confidence in the EU authorisation system for medicinal products. The Agency has also underlined several times that the new policy, if approved, will be without prejudice to the provisions of Regulation (EC) No 1049/2001 on access to documents and the new clinical trial Regulation (EC) No 536/2014, which will become applicable in 2016 at the earliest.”
The ability to use clinical trial data in secondary research raises issues of commercial sensitivity and how intellectual property will be protected in the new policy. These are key issues which need to be addressed for the industry at large. Join us on September 9th to discuss the Clinical Trials Regulation and its impact at our inaugural Clinical Trials Briefing. Download the brochure now.