EMA announces that the Clinical trial data will be shared: patients prevail
After a lengthy debate over access of clinical trial data, the European Medicines Agency (EMA) have released a press statement confirming that clinical trial data of medicinal products with marketing authorisation in Europe will be made public. This policy will take effect for all products to be submitted after 1 January 2015, while sponsors of previously authorised products will have to release their data by June 2015. Data can be viewed and downloaded to ensure that it can be analysed and re-evaluated as required. Companies may be allowed to suggest redaction of certain proprietary information; however the final decision will remain at the discretion of EMA. This policy is paramount in protecting patient rights and abides by the Transparency Directive of the European Union. While Europe is the first to implement this landmark decision, it is hoped that other regulatory agencies would follow suit.
