20 Amendments of Elisabetta GARDINI related to 2018/0018(COD)
Amendment 274 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Coordination Group shall act by consensus, or, where necessary, voteo consensus is reached, by a simple majority. There shall be one vote per Member State.
Amendment 280 #
Proposal for a regulation
Article 3 – paragraph 5
Article 3 – paragraph 5
5. Members of the Coordination Group shall appoint their representatives in the Coordination Group and the sub-groups in which they are members, on an ad-hoc or permanent basis, and inform the Commission of their appointment and any subsequent changes. The members of the sub-groups will be appointed by a vote in the Coordination Group. The appointments shall take into account the expertise necessary for the objectives of the sub-group.
Amendment 281 #
Proposal for a regulation
Article 3 – paragraph 5 a (new)
Article 3 – paragraph 5 a (new)
5a. Members of the Stakeholder Network shall appoint their representatives to be members of the Coordination Group and the sub-groups, on an ad-hoc or permanent basis, and inform the Commission of their appointment any subsequent changes. The appointments shall take into account the expertise necessary for the objectives of the sub-group.
Amendment 291 #
Proposal for a regulation
Article 3 – paragraph 8 – point d
Article 3 – paragraph 8 – point d
(d) ensure appropriate involvement of stakeholders in its workand adequate representation of patients, when pursuing its work. Such consultations shall, where applicable, be incorporated in the final joint assessment report;
Amendment 298 #
Proposal for a regulation
Article 3 – paragraph 10
Article 3 – paragraph 10
10. The Coordination Group may establish separate sub-groups deemed necessary to conduct their mandate for the following categories of health technology: medicinal products, medical devices, and other health technologies.
Amendment 312 #
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
Amendment 315 #
Proposal for a regulation
Article 5 – paragraph 1 – point b – subparagraph 1 a (new)
Article 5 – paragraph 1 – point b – subparagraph 1 a (new)
The Commission shall, by means of Delegated Acts, include in Article 5 paragraph 1 of this Regulation a specific product category of medical devices if at least five Member States are systematically performing health technology assessments on the same specific product category of medical devices.
Amendment 317 #
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
Amendment 320 #
Proposal for a regulation
Article 5 – paragraph 1 – point c – subparagraph 1 a (new)
Article 5 – paragraph 1 – point c – subparagraph 1 a (new)
The Commission shall, by means of Delegated acts, include in Article 5 paragraph 1 of this Regulation a specific product category of in vitro diagnostic medical devices if at least five Member States are systematically performing health technology assessments on the same specific product category of in vitro diagnostic medical devices.
Amendment 376 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. The designated sub-group shall ensure that stakeholders, including patients and clinical experts, are given an opportunity to providPatients, healthcare professionals and clinical experts must be consulted and their recommendations are considered equally to that of the sub-group and the cComments durission, ing the preparation of the draft joint clinical assessment report and the summary report and set a time-frame in which they may submit comments.
Amendment 387 #
Proposal for a regulation
Article 6 – paragraph 11
Article 6 – paragraph 11
11. The assessor, with the assistance of the co-assessor, shall take into account the comments of the designated sub-group and, the Commission and stakeholders, including patient advocates and clinical experts, and submit a final draft joint clinical assessment report and the summary report to the Coordination Group for approval.
Amendment 405 #
Proposal for a regulation
Article 6 – paragraph 14 a (new)
Article 6 – paragraph 14 a (new)
Amendment 452 #
Proposal for a regulation
Article 11 – paragraph 1 – point f a (new)
Article 11 – paragraph 1 – point f a (new)
(fa) mechanisms for the appeals on the joint clinical assessment.
Amendment 474 #
Proposal for a regulation
Article 13 – paragraph 8
Article 13 – paragraph 8
8. The designated sub-group shall ensure that stakeholders, including patients and clinical experts are given an opportunity to providPatients, healthcare professionals and clinical experts shall be consulted and their recommendations are given equal consideration to those from the sub-group and the cComments durission, ing the preparation of the draft joint scientific consultation report and set a time-frame in which they may submit comments.
Amendment 537 #
Proposal for a regulation
Article 22 – paragraph 1 – point a – point iii
Article 22 – paragraph 1 – point a – point iii
(iii) the consultation of patients, clinical experts, and other stakeholders in clinical assessments and the duly justified replies.
Amendment 562 #
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications. The organisations to be addressed by the call shall be legally established European umbrella patient associations representing different disease areas, consumer organisations, non- governmental organisations in the field of health and healthcare professionals.
Amendment 567 #
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
2. The Commission shall publish the list of stakeholder organisations included in the stakeholder network, which shall be not- for-profit organisations, with no conflict of interest.
Amendment 568 #
Proposal for a regulation
Article 26 – paragraph 3 – introductory part
Article 26 – paragraph 3 – introductory part
3. The Commission shall organise ad- hocregular meetings between the stakeholder network and the Coordination Group in orderat least once a year in order to promote a constructive dialogue. The role of stakeholder network shall be to:
Amendment 574 #
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
4. On the request of the Coordination Group, the Commission shall invite patients and clinical experts nominated by the stakeholder network to attendparticipate in meetings of the Coordination Group as observersin a full-member participatory role.
Amendment 577 #
Proposal for a regulation
Article 26 – paragraph 5
Article 26 – paragraph 5
5. On the request of the Coordination Group, the stakeholder network shall support the Coordination Group in the identification of patient and clinical expertise for the work ofto join the sub-groups. The funding referred to in paragraph 1 shall include funding for the participation of the Stakeholder Network members and any external contributors, including patients and experts, invited to consult for the work of the Coordination Group or its sub-groups.