Regulatory Focus™ > News Articles > EC's Dalli Proposes New EU Clinical Trials Legislation

EC's Dalli Proposes New EU Clinical Trials Legislation

Posted 29 June 2012 | By Alexander GaffneyLouise ZornozaRegLink

The European Commissioner for Health and Consumers, John Dalli, has announced his intent to propose new legislation to govern clinical trials conducted in the EU.

Appearing at a 27 June 2012 meeting in Washington, DC hosted by the European American Business Council, Dali said he is "committed to putting forward a legislative proposal with the aim of strengthening knowledge and innovation in clinical research."

Dalli said in his opinion, "[the] future procedure for the authorization of clinical trials will need to be fast, efficient and pragmatic" if it is to be improved. Dalli cited the 25% decline in clinical trials conducted in Europe between 2007 and 2011 as one source of frustration, but sought to shift some blame from current EU legislation.

"Let me be clear - the Clinical Trials legislation was not the only reason behind the decline in clinical research in the EU," Dalli said, citing the availability of venture capital and industry's declining productivity as two other factors.

Regardless of the causes of the slow-down in clinical trials registration, the EU "can and [it] will do better," remarked Dalli.

In putting forward the proposal, Dalli said he'll be looking to balance two factors: speed and safety. "We do not want to see clinical trials referred to in the EU… disregarding the rules on the protection of patients," explained Dalli. "To ensure against this, our current legislation already includes the 'equivalence rule,'" which requires clinical trials conducted in a third country to be equivalent to those of the EU's in terms of standards of safety.

"Whatever the financial situation, patient safety must always come first," concluded Dalli.


Read more:

Dalli - Speech to the European American Business Council

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