The European Parliament has approved new measures to force researchers to make their clinical trial results available, with fines available to deal with non-compliance.
MEPs voted by an overwhelming majority to pass the new EU Clinical Trials Regulation, which will require pharma and academic researchers to post all their European Clinical Trial results – including for negative studies.
The law, which is expected to take effect in 2016, will also facilitate cross-border cooperation on trials – potentially improving efforts to study rare diseases by opening up a greater pool of patients and reducing costs.
The legislation was steered through the Parliament by the UK’s Glenis Willmott, who said she was delighted by the backing given by her fellow MEPs.
“It will make trials more transparent, give hope to patients needing new and better treatments, and boost the number of skilled research jobs here in Europe.
“The new law will also offer hope to the millions of people in Europe suffering from rare diseases, by making cross-border trials much easier to conduct. There are simply not enough patients in one country alone to develop new or improved treatments for rare diseases.”
The changes will simplify reporting procedures and empower the European Commission to carry out checks, with fixed deadlines for member states to respond to product application dossiers from clinical trial sponsors.
In a bid to improve trial transparency, detailed summaries – including full clinical study reports – will have to be published in a publicly-accessible EU database, once a decision on marketing authorisation has been taken or the marketing authorisation application has been withdrawn.
European pharma body EFPIA said the adoption of the new Clinical Trials Regulation would “help foster a more harmonised approach to clinical trials in the EU, with a single submission and overall streamlined assessment process”.
It added: “EFPIA also welcomes the legislation’s approach to transparency, which respects the need to protect personal patient data and commercially confidential information.”
But the body added it would be critical that the Commission and EMA interpret the law in such as way as to “respect patient privacy, the integrity of regulatory decision-making and incentives for companies to make long-term investments in biomedical research”.