22/01/2016 Social Affairs, Health and Sustainable Development
“The death of a patient in Rennes during a clinical trial of a new medicine shows, once again, the importance of ensuring absolute transparency of all clinical test results,” said Liliane Maury Pasquier (Switzerland, SOC), rapporteur for “Public health and the interests of the pharmaceutical industry: how to guarantee the primacy of public health interests?”.
“In this regard, I can only but regret the recent decision of the European Medicines Agency (EMA) to postpone to 2018 the implementation of the new European Directive which will oblige laboratories to declare their studies and publish their results,” added Ms Maury Pasquier.
In its Resolution 2071 (2015) adopted last June, PACE recommended, among other things, the adoption of a stricter marketing authorisation policy, including by making it mandatory to publish the results of all clinical tests relating to the medicine for which authorisation is being requested.