4 Amendments of Michèle RIVASI related to 2016/2169(DEC)
Amendment 4 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Notes that the budget of EMA does not allow the Agency to have experts fully independent from the pharmaceutical industry;
Amendment 5 #
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2 b. Notes that several experts of the Agency still have links with the pharmaceutical industry, notably through grants;
Amendment 6 #
Draft opinion
Paragraph 2 c (new)
Paragraph 2 c (new)
2 c. Notes that the conflict of interests' policy of the Agency still needs to be improved, despite its 2015 reform; notes furthermore that revolving doors are not prevented since there is no cooling-off period for experts receiving grants from the private sector before joining the Agency and after leaving it;
Amendment 15 #
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Notes that the Agency launched a pilot project on "adaptive pathways" in March 2014; recalls that that project aims to accelerate marketing approvals for some specific medicines but raises numerous public health concerns; by shifting the burden of evidence from pre- marketing to post-marketing authorisation, the procedure in that pilot project can undermine the safety assessment of medicines; recalls that assessment of acceleration of authorisations in the United States has shown that more medicines were withdrawn once they had been put on the market, while the French independant medicine "Journal Prescrire" reported that, since 2006, 27% of the medicines authorised through an accelerated procedure in the Union were "unacceptable"1a _________________ 1a (Prescrire, april 2016, n°390, p.295)