Guido Rasi, executive director of European Medicines Agency in Eurpean Parliament

All diseases “rare” to evade regulation.

No data on elderly polymedicaton or women specific med impacts.

“There is an attempt to circumvent EMA regulations for the approval of new drugs by making every disease a rare one”, in order to take advantage of fast-track approvals with fewer requirements of clinical trials and provision of data on the efficacy and safety of new medical products.

Rasi was questioned by Spanish Socialist Soledad Cabezón on why the EMA did not evaluate the quality of the medicines compared with those already on the market. She also asked whether the EMA had any plans on making transparent the R and D costs of new medicines as well as improving clinical trial transparency for the sake of health technology assessment. Rasi responded by stating that “commercial” questions were not the competence of the EMA but of the member states. Rasi added that EU member states were capable of evaluating the cost-benefit of the new products if they used their resources wisely.

When asked about TTIP Rasi said that he was not following this issue in detail.

MEP Nessa Childers asked Rasi about the impact of medicines on the elderly and women.

Rasi stated that “We don´t have data or a clear scientific model on the inter-action of the many drugs that elerly people take at the same time. The same goes for women who undergo hormonal changes as they get older that changes the way they react to medicines.” He hoped new research with help. Rasi added that “personalized medicine with surrogate indicators” could be a big help to solve the problems of the elderly and women.

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