6 Amendments of Michèle RIVASI related to 2020/2157(DEC)
Amendment 2 #
Draft opinion
Paragraph 9
Paragraph 9
9. Takes note that the EMA received 20 reports of improprieties from an external source in 2019 and that 13 of the cases received in 2019 and 11 cases received in previous years were closed; calls on the EMA to analyse the causes of those improprieties;
Amendment 3 #
Draft opinion
Paragraph 10
Paragraph 10
10. NWelcomes the efforts of EMA to strengthen its policies on transparency in relation to drugs and vaccines against COVID-19; notes that the authorisation process for a vaccine against COVID-19 will require a speedy and transparent process within the EMA; notes that specific attention should be paid to the transparency of data from clinical trials as regards such vaccines; welcomes the EMA decision to publish the clinical study reports of drugs and vaccines against COVID-19 within three days after marketing authorisation; encourages the EMA to publish data from clinical trials before marketing authorisation and failing that, in a timely manner; calls on the EMA to request that the sponsors of clinical trials make their clinical trials protocols public before marketing authorisation;
Amendment 4 #
Draft opinion
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Welcomes the efforts of EMA to increase transparency around its activities, in particular the efforts made in favour of significantly simplified clinical trials reporting for universities and hospitals and other improvements that have led to more clinical trials resultsbeing reported;
Amendment 5 #
Draft opinion
Paragraph 10 b (new)
Paragraph 10 b (new)
10b. Calls on the EMA to continue increasing the level of transparency around its activities; in particular calls on the EMA to resume as soon as possible its policy on the publication of clinical data for medicinal products for human use (‘Policy 0070’) which was suspended in December 2018 and has still not been reinstated today;
Amendment 6 #
Draft opinion
Paragraph 10 c (new)
Paragraph 10 c (new)
10c. Notes with concern that the EMA still does not authorise requests for access to documents via email and regrets that long delays of more than a year are the norm in terms of answering those requests; calls on the EMA to publicly set, and comply with, clear timeframes for responding to such requests from now on;
Amendment 7 #
Draft opinion
Paragraph 10 d (new)
Paragraph 10 d (new)