2 Amendments of Estefanía TORRES MARTÍNEZ related to 2018/0018(COD)
Amendment 244 #
Proposal for a regulation
Recital 31
Recital 31
(31) In order to ensure that the support framework continues to be as efficient and cost-effective as possible, the Commission should report on the implementation of the provisions on the scope of the joint clinical assessments and on the functioning of the support framework no later than two years after the end of the transitional period. The report may in particular consider whether there is a need to move this support framework to a Union agency and introduce a fee-paying mechanism through which health technology developers would also contribute to the financing of the joint work.
Amendment 282 #
Proposal for a regulation
Article 3 – paragraph 6
Article 3 – paragraph 6
6. Members of the Coordination Group, and their appointed representatives shall respect the principles of independence, impartiality, and confidentiality. Members of the Coordination Group, their designated representatives and other experts shall not have any financial or other type interest in the health technology industry, which could jeopardise their impartiality. They shall undertake to act independently and in the public interest and shall make an annual declaration of their financial interests. All indirect interests that could be linked to the health technology industry shall be recorded on the IT platform referred to in Article 27 and made accessible to the public. At every meeting, members of the Coordination Group, their designated representatives and other expert shall declare any specific interest that could be considered to adversely affect their independence in relation to agenda items. Appropriate steps shall be taken when specific interests are found to exist. When a conflict of interest arises, the Coordination Group stakeholder, designated representative or expert in question should be excluded from the decision-making process.