Activities of Michèle RIVASI related to 2021/2132(DEC)
Shadow opinions (1)
OPINION on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2020
Amendments (6)
Amendment 1 #
Draft opinion
Paragraph 1
Paragraph 1
1. Emphasises the important role of the European Medicines Agency (‘the EMA') in protecting and promoting publichuman and animal health by making independent, science-based recommendations on the quality, safety and efficacy of medicines, and providing scientific advice and regulatory incentives to stimulate the development and improve the availability of innovative new medicines;
Amendment 4 #
Draft opinion
Paragraph 2
Paragraph 2
2. Notes that, owing to the global COVID-19 pandemic, 2020 was an extremely challenging year for the EMA, requiring a shift in its priorities and extreme agility and resilience to maintain the EMA’s activities while supporting enhanced collaboration between Member States to manage the supply of medicines and global efforts to combat the pandemic in a new and challenging environment;
Amendment 5 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Stresses that despite the majority of funding coming from private sources, the EMA is a public authority; underlines that the perception of the EMA’s independence and integrity is crucial and therefore a high degree of transparency needs to be ensured through all its activities to avoid regulatory capture and ensure citizens maintain their faith in the marketing authorisation system in the Union;
Amendment 8 #
Draft opinion
Paragraph 10
Paragraph 10
10. Welcomes the proposal to extend the EMA’s mandate but expresses concern that the addition of significant new tasks and its increasing workload over the years has not been accompanied by sufficient corresponding increases in the EMA's staff and resources, and that such a shortage of staff puts the continuity of its operations under significant pressure and threatens the quality of the EMA's work;
Amendment 11 #
Draft opinion
Paragraph 11
Paragraph 11
11. AcknowledgWelcomes the revised policy on the handling of competing interests of the Management Board, which took effect from 1 July 2020 and the practice of systematic ex-ante controls on all declarations of interest submitted by Management Board members together with the requirement that those members undertake training before their declaration of interest can be submitted;
Amendment 12 #
Draft opinion
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Notes with satisfaction the exceptional transparency measures the EMA implemented with regard to medicines for COVID-19, including accelerated publication timelines for clinical data and providing more information to the general public such as publication of the product information with details of the conditions of use at the time of the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) on the marketing authorisation application; publication of the full European public assessment report (EPAR), within three days of authorisation by the Commission; publication of clinical data submitted to the EMA in support of the applications for COVID-19 medicines after the authorisation of a medicine and once personal data have been anonymised; and the publication of the full risk management plan for authorised COVID- 19 medicines; invites the EMA to apply the same transparency measures to all products regulated by the EMA;