EMA policy on clinical trial data publication
Better access to clinical trial data while protecting patients’ privacy and commercially confidential information.
Brussels, 3 October 2014
Yesterday, the European Medicines Agency (EMA) Board adopted the wording of the Agency’s new policy intended to further increase the availability of clinical trials data for medicinal products authorised in the EU.
This new policy aims to ensure that all clinical study reports supporting an application for a centralised marketing authorisation are systematically made public once the regulatory procedure for authorisation is concluded. By enabling the general public to access this data, it is hoped that these measures will contribute to increasing citizens' understanding and confidence in the EU authorisation system for medicines.
EuropaBio supports this step towards better access to clinical trial data. In particular we welcome recognition of the importance of the protection of patients' personal data and the willingness to consult stakeholders to define the details related to access to patients’ data. As clinical trial sponsors, EuropaBio members have the moral and legal obligation to appropriately protect personal data and they welcome the EMA’s recognition of this important area.
Emmanuel Chantelot, Chair of EuropaBio’s Healthcare Council stated: "Data privacy is of paramount importance in biotech-specific clinical fields such as rare diseases. Information should be released in a way that protects the privacy and confidentiality of individuals. This is important for all clinical research, including trials in the area of rare diseases which include, by nature, only a very limited number of participants with a very specific clinical profile".
Whilst EuropaBio supports the idea of making more information available for scientific research purposes, we are concerned that the possibility to download, save and print the clinical trial data, including some commercially confidential information (CCI), may encourage some entities to misappropriate such CCI to seek regulatory approval for a product in other geographical areas. Therefore EuropaBio calls on the EMA to closely monitor the implementation of this policy and limit any attempt to misuse the information for commercial purposes.
Nathalie Moll, Secretary General of EuropaBio noted: “In the wake of the new Clinical Trials Regulation and the Access to Document Regulation, the new EMA policy demonstrates that the demand for increased access to clinical trial information is being met and we hope it will contribute to increasing patients’ confidence in the centralised authorisation system for medicinal products across Europe”.