Clinical data on new medicines is now open to patients and researchers11 Nov. 2016
Researchers and patients can access thousands of pages submitted by pharmaceutical companies
As of the 20th of October, the European Medicines Agency (EMA) gives open access to clinical reports for new medicines authorised in the European Union.
For every new medicine, citizens, including researchers and academics, will be able to directly access thousands of pages from clinical reports submitted by pharmaceutical companies. Clinical reports give information on the methods used and results of clinical trials conducted on medicines.
Vytenis Andriukaitis, European Commissioner for Health and Food Safety, said
"Transparency is an essential component in clinical research. Its outcome – whether positive or negative – should be made publicly available."
Learning from the experience of others
With EMA’s proactive approach to providing access to the data, patients and healthcare professionals will be able to find out more information about the data underpinning the approval of medicines they are taking or prescribing.
It will also facilitate the independent re-analysis of data by academics and researchers after a medicine has been approved. This will increase scientific knowledge, and potentially further inform regulatory decision making in the future.
Increased transparency will also benefit innovation. The shared knowledge about a medicine helps developers learn from the experience of others and can lead to more efficient medicine development programmes by reducing duplication of research and de-risking some new developments.
Protecting personal data
This will be a learning curve for the Agency and all its stakeholders, as they start to apply the policy for the first time.
While the policy gives an unprecedented proactive access to clinical data, it also demands the highest standard of protection of patients’ personal data. The process will evolve over time as more experience is gained and may lead to adaptations of EMA’s guidance.