Companies Face Complex Clinical Trials Regulatory Environment in EU
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Companies Face Complex Clinical Trials Regulatory Environment in EU

Life sciences firms in the European Union (EU) must comply with a challenging regulatory environment when conducting clinical trials (CTs), due to the regional differences in CT regulations among the member states.

"In Europe, all clinical trial tests must be approved by local, regional, and national ethics committees. Each drug can require multiple approval stages as the approval process is geared toward individual studies," noted Christopher Bryce, Marsh Life Sciences Practice Leader, EMEA.  "Further, issuance of insurance certificates can turn into a complex process, with stringent government requirements prior to drug studies."

The Clinical Trials Directive of 2004 was  introduced to EU member states in an attempt to standardize research activity in clinical trials throughout the European Community and provide a framework for the efficacy of a clinical trials test. However, the directive required that each member state transpose the regulations into national law, which led to the regional differences.

"A recent example includes the decree implemented by The Italian Ministry of Employment, Health, and Social Policies, effective March 14, 2010,” noted Claudio Santoro, Marsh Life Sciences Industry Practice Leader, Italy. "The Decree changes the scope of insurance cover arranged for clinical trials undertaken in Italy, and can affect any trial in Italy regardless of the company's headquarters." 

The key differences include introduction of minimum required limits and a standard mandatory certificate format.

The European commission held a "public consultation" at the end of 2009 (the conclusions were published in March 2010), soliciting views from stakeholders — including pharmaceuticals, medical groups, regulators, and academia — about the efficacy of the EU Clinical Trials Directive 2004, according to Bryce.  Approximately 100 responses were collected, consistently indicating a need for changes in the system, including a suggestion for a "pan-European" approach to insurance.

Any changes to the EU regulations will require the approval of the 27 member states and will challenge strong and distinct national positions on patient safety. It is unclear at this point how the EU Directive will change.

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