1 10 th Annual European Scientific and Regulatory Affairs Conference New Pharmaceutical legislation: One year experience… 21 November 2006 Bernard Lemoine Leem Executive Vice-President

2 One year after starting the implementation of the new European pharmaceutical legislation, What are the expectations of the pharmaceutical industry ? Speed up patients access to new medicines Improve scientific advice in terms of timelines and procedure Get therapeutic innovation recognized Strengthen transparency and consistency of EMEA procedures

3 Does EMEA meet Industry expectations ?  In terms of regulatory tools : relating to - Accelerated assessment procedure - Conditional marketing authorisation - Decentralised procedure - Compassionate use  What about scientific advice ?  What is requested for being granted an additional year of data protection ?  What about the scope of the Peer review ?

4 With regard to other legislations  First, the one related to the -soon to be- regulation on paediatric medicines - France initiated this Regulation - The Leem strongly supports the development of new paediatric medicines - Pharmaceutical industry is much keen to see how EMEA will implement the Paediatric Committee, the procedures and incentives measures - National incentives are much awaited mainly in France in terms of R&D policy and price setting  Second the legislation related to the Directive on clinical trials - The new legislation took effect in France, in August 2006, implementation process much efficient through fruitful close cooperation between AFSSAPS and Pharma Industry - Yet resulting in redtape and various interpretations by Member States - Therefore need for simplification and harmonisation

5 In conclusion, what about the impact of these new regulations ? Contribute to  strengthening harmonisation of procedures in Member States  improving pharmaceutical industry efficiency facilitating patient access to innovative medicines in the best efficient and quickest manner