EU defends trials directive but commits to make process faster and more efficient
Dalli told attendees at a European American Business Council (EABC) dinner in Washington, DC last week that while the number of trials in Europe has fallen 25 per cent between 2007 and 2011 the EU Clinical Trials Directive – widely criticised for being slow and bureaucratic - is not solely to blame.
“There are many other factors not linked to regulation – R&D commitment by industry, its cooperation with academic research, availability of venture capital as well as return on investment to name a few.”
However, despite this effort to address criticism, Dalli did add that – given the importance of clinical research for both patients and the drug industry – the EU “can and will do better” from a regulatory perspective.
“Clinical trials are of course crucial for the development of new medicines…and are also a key contributor to growth and jobs in the area of public health,” he said adding that “Clinical trials mean research and investment, including inward investment from outside the Union.”
To this end Dalli said: "I am committed to putting forward a legislative proposal with the aim of strengthening knowledge and innovation in clinical research" adding that “The future procedure for the authorisation of clinical trials will need to be fast, efficient and pragmatic.”
One area of focus for Dalli is the ‘equivalence rule’ – which requires that trials conducted outside the EU which are submitted in a marketing authorisation application are conducted according to principles equivalent to the Clinical Trials Directive, particularly regarding patient safety.
“We do not want to see clinical trials referred to in the EU… disregarding the rules on the protection of patients,” he said, adding that “to ensure against this our current legislation already includes the equivalence rule.
“While there are important jurisdictional limits, we have to think of ways to ensure that this is properly enforced."