21 Amendments of Tiemo WÖLKEN related to 2018/0018(COD)
Amendment 251 #
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
1. Taking into account the results of the work already undertaken in the EUnetHTA Join Actions, this Regulation establishes:
Amendment 265 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Member States shall designate their national authorities and bodies responsible for health technology assessment as members of the Coordination Group and its sub-groups and inform the Commission thereof and of any subsequent changes. Member States mayshall designate more than one authority or body responsible for health technology assessment at national level as members of the Coordination Group and one or more of its sub-groups.
Amendment 273 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Coordination Group shall act by consensus, or, where necessary, vote by simplequalified majority. There shall be one vote per Member State.
Amendment 286 #
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 transparency, independence, impartiality, and confidentiality.
Amendment 289 #
Proposal for a regulation
Article 3 – paragraph 8 – point c
Article 3 – paragraph 8 – point c
(c) ensure regular cooperation with all relevant Union level bodies to facilitate additional evidence generation necessary for its work;
Amendment 293 #
Proposal for a regulation
Article 3 – paragraph 8 – point d
Article 3 – paragraph 8 – point d
(d) ensure appropriate involvement of all relevant stakeholders in its work;
Amendment 297 #
Proposal for a regulation
Article 3 – paragraph 9
Article 3 – paragraph 9
9. The Coordination Group may meet in different configurations for the following categories of health technology: medicinal products, medical devices, in vitro diagnostic medical devices and other health technologies.
Amendment 299 #
Proposal for a regulation
Article 3 – paragraph 10
Article 3 – paragraph 10
10. The Coordination Group may establish separate sub-groups for the following categories of health technology: medicinal products, medical devices, in vitro diagnostic medical devices and other health technologies.
Amendment 308 #
Proposal for a regulation
Article 4 – paragraph – point c a (new)
Article 4 – paragraph – point c a (new)
(ca) consult civil society organisations, patient associations, social partners, consumer organisations, healthcare professionals and non-governmental organisations in the field of health technology assessment.
Amendment 329 #
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
The Coordination Group shall initiate joint clinical assessments of health technologies on the basis of its annual work programme by designating a sub-group to oversee the preparation of the joint clinical assessment report on behalf of the Coordination Group. Member States may propose additional comparator, which from their point of view represents the relevant evidence-based standard of care in their Member State. In case this proposal has not been taken into account, the relevant Member State may use the mechanism referred to in Article 8 – paragraph 1 a (new).
Amendment 337 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The designated sub-group shall request relevant health technology developers to submit comprehensive documentation containing the information, data and evidence necessary for the joint clinical assessment. The relationship between evaluators and health technology developers, however, must be independent and impartial. Developers of health technologies can be consulted but not actively participate in the evaluation process.
Amendment 356 #
Proposal for a regulation
Article 6 – paragraph 5 – point a
Article 6 – paragraph 5 – point a
(a) an analysis of the relative effects of the health technology being assessed on the patient-relevant health outcomes chosen for the assessment compared to one or more comparator treatments to be determined by the Coordination Group;
Amendment 377 #
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 expertcivil society organisations, patient associations, social partners, consumer organisations, healthcare professionals and non- governmental organisations, are given an opportunity to provide comments during 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 398 #
Proposal for a regulation
Article 6 – paragraph 12
Article 6 – paragraph 12
12. The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a simplequalified majority of Member States.
Amendment 427 #
Proposal for a regulation
Article 7 – paragraph 6 a (new)
Article 7 – paragraph 6 a (new)
6a. All relevant data and information shall be available to the public in a user- friendly and easy-readable manner.
Amendment 457 #
Proposal for a regulation
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
3a. Article 12 (2) and 12 (3) shall not apply for medicinal products.
Amendment 485 #
Proposal for a regulation
Article 13 – paragraph 12
Article 13 – paragraph 12
12. The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by a simplequalified majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4.
Amendment 495 #
Proposal for a regulation
Article 16 – paragraph 1 – point d
Article 16 – paragraph 1 – point d
(d) the consultation of patients, clinical expertscivil society organisations, patient associations, social partners, consumer organisations, healthcare professionals and non- governmental organisations, and other relevant stakeholders;
Amendment 531 #
Proposal for a regulation
Article 22 – paragraph 1 – introductory part
Article 22 – paragraph 1 – introductory part
1. Taking into account the results of the work already undertaken in the EUnetHTA Joint Actions, the Commission shall adopt implementing acts concerning:
Amendment 561 #
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 and represented within the stakeholder network shall be civil society organisations, patient associations, social partners, consumer organisations, healthcare professionals and non- governmental organisations in the field of health technology assessment.
Amendment 579 #
Proposal for a regulation
Article 27 – paragraph 1 – introductory part
Article 27 – paragraph 1 – introductory part
1. TBuilding on the work already undertaken by the EUnetHTA Joint Actions, the Commission shall develop and maintain an IT platform containing information on: