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10th Annual European Scientific and Regulatory Affairs Conference

New Pharmaceutical legislation: One year experience…

21 November 2006

Bernard LemoineLeem Executive Vice-President

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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

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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 ?

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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

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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