Many of you are aware of the issues that have come about in recent years following the EU Clinical Trials Directive of 2001 (see my September blog posting). There is some faint cause for hope however that things might change for the better in the future. The EU is currently assessing the functioning of the Clinical Trials Directive and how it can be improved.
In this context, they will also look at insurance issues, cf. point 5.2.1. (pg 22) of their public consultation document found at: http://ec.europa.eu/enterprise/pharmaceuticals/clinicaltrials/clinicaltrials_en.htm
I have been invited to meet the EU's Enterprise and Industry Directorate-General for Pharmaceuticals to discuss some of these insurance issues. My hope would be to raise some of the concerns JLT clients have expressed and some of the issues that they come up against including the increasing request for limits not easily supported by insurance and other requests such as risk assessments to prove insurance limits are adequate.
Whilst it may be too optimistic to expect legislative change it would be worthwhile if the only outcome was that the EU have a greater appreciation of how some of these issues may affect the use of EU territories in trials and I have a greater appreciation of why they make the decisions on the Directive that they do!
If any companies wish me to raise specific country issues or would like, in principle, to help form an industry lobbying group, then please contact me on my details below;
