Clinical trials: clearer rules, better protection for patients
3 Apr 2014 11:55 AM
Pharmaceutical companies and academic
researchers will have to post the results of all their European clinical trials
in a publicly-accessible database, under a draft law already informally agreed
with EU ministers and passed by Parliament on Wednesday. The law also
facilitates cross-border cooperation to make clinical trials larger, more
viable and more reliable, which should in turn boost efforts to develop special
treatments, e.g. for rare diseases.
"I am delighted that the overwhelming majority of
MEPs backed this deal. 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", said Glenis Willmott (S&D, UK), who
steered the legislation through the European Parliament. Her report was
approved by 594 votes to 17, with 13 abstentions.
"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. By working at EU
level we can reduce the huge cost and burden of conducting trials across
borders" she added.
The
legislation will streamline the rules on clinical trials across Europe,
facilitating cross-border cooperation to enable larger, more reliable trials,
as well as those on products for rare diseases. It simplifies reporting
procedures, and empowers the European Commission to do checks. Once a clinical
trial sponsor has submitted an application dossier to a member state, the
member state will have to respond to it within fixed
deadlines.
Transparency: studies to be made publicly
available
In
negotiations, MEPs amended the draft to improve transparency, by requiring that
detailed summaries be published in a publicly-accessible EU database, including
full clinical study reports to be published once a decision on marketing
authorisation has been taken or the marketing authorisation application has
been withdrawn. Fines would be imposed on sponsors who do not comply with these
requirements.
Background
The
Commission proposal aims to remedy the shortcomings of the existing Clinical
Trials Directive by setting up a uniform framework for the authorisation of
clinical trials by all the member states concerned with a given single
assessment outcome. Simplified reporting procedures, and the possibility for
the Commission to do checks, are among the law’s key
innovations.
Procedure: Co-decision (Ordinary legislative
procedure), first reading agreement