Activities of Kerstin WESTPHAL related to 2018/0018(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU
Amendments (25)
Amendment 38 #
Proposal for a regulation
Recital 1
Recital 1
(1) The development of health technologies is a key driver of to improving health policies through access to more progressive health tecohnomic growth and innovation in the Union. Itlogies, and thus achieving a high level of health protection. At the same time, health technologies are an innovative sector of the economy which forms part of an overall market for healthcare expenditure that accounts for 10% of EU gross domestic product. Health technologies encompass medicinal products, medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment.
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 57 #
Proposal for a regulation
Recital 21
Recital 21
(21) Joint clinical assessments and joint scientific consultations necessitate the sharing of confidential information between health technology developers and HTA authorities and bodies. In order to ensure the protection of such information, information provided to the Coordination Group in the framework of assessments and consultations should only be disclosed to a third party after a confidentiality agreement has been concluded. In addition, it is necessary for any information made public about the results of joall available clinical data and publically available scientific evidence from health technology developers. The clinical data employed, the studies, the methodology and the clinical results used should be made public. The highest possible level of public openness int scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive naturedata and assessments will allow progress to be made in biomedical research and ensure the highest possible level of confidence in the system.
Amendment 66 #
Proposal for a regulation
Recital 28
Recital 28
(28) In order to facilitate the joint work and the exchange of information between Member States on HTA, provision should be made for the establishment of an IT platform that contains appropriate databases and secure channels for communication. The Commission should also ensure a link between the IT platform and other data infrastructures relevant for the purposes of HTA such as registries of real world data. All relevant data should be made available to the public.
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 75 #
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 simplea two-thirds majority. There shall be one vote per Member State.
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 95 #
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 documentation containing the information, data and evidence necessary for the joint clinical assessment. The relationship between evaluators and health technology developers must be independent and impartial. Developers of health technologies can be consulted but never participate actively in the evaluation process.
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 104 #
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 simpletwo-thirds majority of Member States.
Amendment 115 #
Proposal for a regulation
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
(a) not carry out ause the joint clinical assessment or an equivalent assessment procesreports oin a health technology included in the List of Assessed Htheir health Ttechnologies or for which a joint clinical assessment has been initiatedy assessments at Member State level;
Amendment 118 #
Proposal for a regulation
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) apply joint clinical assessment reports, in their health technologynot duplicate the joint clinical assessments at Member State level.
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 134 #
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. The designated sub-group shall request the health technology developer to submit the documentation containing the information, data and evidence necessary for the joint scientific consultation. All relevant data and information shall be available to the public.
Amendment 137 #
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 simpletwo- thirds majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4.
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.