15 Amendments of Lucy ANDERSON related to 2018/0018(COD)
Amendment 42 #
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5 a) A stronger focus should be put on a better and more effective outcome for patients. Therefore, the opinion of civil society organisations, patient associations, social partners, consumer organisations, healthcare professionals and non- governmental organisations dealing with health technology assessment should be taken into consideration for the purposes of clinical assessment of health technologies as provided for in this Regulation.
Amendment 67 #
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28 a) The cooperation between Member States on HTA should be based on the principles of good governance, objectivity, independency and transparency. All Member States should have the right to make genuine commitments.
Amendment 82 #
Proposal for a regulation
Article 4 – paragraph 3 – point c – point i (new)
Article 4 – paragraph 3 – point c – point i (new)
i) consult civil society organisations, patient associations, social partners, consumer organisations, healthcare professionals and non-governmental organisations in the field of health technology assessment.
Amendment 89 #
Proposal for a regulation
Article 5 – paragraph 2 – point e – point i (new)
Article 5 – paragraph 2 – point e – point i (new)
i) points arising from the annual meeting of the stakeholder network;
Amendment 101 #
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, civil 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 119 #
Proposal for a regulation
Article 8 – paragraph 1 – point b – point i (new)
Article 8 – paragraph 1 – point b – point i (new)
i) Paragraph 1(b) shall not prevent Member States from carrying out assessments on the added clinical value of the technologies concerned as part of national or regional appraisal processes which may consider clinical as well as non-clinical data and evidence specific to the Member State concerned which did not form part of the joint clinical assessment and which are necessary to complete the general assessment of health technology.
Amendment 150 #
Proposal for a regulation
Article 18 – paragraph 2 – point e – point i (new)
Article 18 – paragraph 2 – point e – point i (new)
i) civil society organisations, social partners, consumer organisations, healthcare professionals and non- governmental organisations in the field of health technology assessment
Amendment 157 #
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 such as civil society organisations, patient associations, social partners, consumer organisations, healthcare professionals and non-governmental organisations in clinical assessments.;
Amendment 166 #
Proposal for a regulation
Article 24 – paragraph 2 – point 1 (new)
Article 24 – paragraph 2 – point 1 (new)
(1) The Union shall guarantee a sufficient, stable and continuing public funding of the Coordination Group. In any case, this public funding shall be conducted without any direct or indirect involvement of HTA developers.
Amendment 168 #
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 stakeholder organisation shall at least have members of civil society organisations, patient associations, social partners, consumer organisations, healthcare professionals and non-governmental organisations dealing with health technology assessment.
Amendment 169 #
Proposal for a regulation
Article 26 – paragraph 1 – point 1 (new)
Article 26 – paragraph 1 – point 1 (new)
(1) The European Parliament shall also have a qualified representative in the stakeholder network. The representative shall report to the European Parliament on a regular basis about the recent developments within the stakeholder network.
Amendment 170 #
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. In any case, all members of the stakeholder network shall have no conflict of interest with and shall not be receiving any funding from health technology developers.
Amendment 171 #
Proposal for a regulation
Article 26 – paragraph 3 – introductory part
Article 26 – paragraph 3 – introductory part
3. The Commission shall organise ad- hoc meetingmeetings on a regular basis between the stakeholder network and the Coordination Group in order to:
Amendment 172 #
Proposal for a regulation
Article 26 – paragraph 3 – point a
Article 26 – paragraph 3 – point a
(a) update stakeholders on the work of the group; all members of the stakeholder network shall have access to all relevant data and information;
Amendment 173 #
Proposal for a regulation
Article 26 – paragraph 3 – point b
Article 26 – paragraph 3 – point b
(b) provide for an exchange of information on the work ofbetween the Coordination Group and the stakeholder network.