20 Amendments of Peter LIESE related to 2018/0018(COD)
Amendment 182 #
Proposal for a regulation
Recital 3
Recital 3
(3) HTA covers both clinical and non- clinical aspects of a health technology. The EU co-funded joint actions on HTA (EUnetHTA Joint Actions) have identified nine domains by reference to which health technologies are assessed. Of these nine domains, four are clinical and five are non- clinical. The four clinical domains of assessment concern the identification of a health problem and current technology, the examination of the technical characteristics of the technology under assessment, its relative safety, and its relative clinical effectiveness. The five non-clinical assessment domains concern cost and economic evaluation of a technology, its ethical, organisational, social, and legal aspects. The scientific aspects of the clinical domains are therefore more suited to joint assessment at EU-level on their scientific evidence base, while the assessment of non-clinical domains tends to be more closely related to national and regional contexts and approaches.
Amendment 201 #
Proposal for a regulation
Recital 11
Recital 11
(11) In accordance with Article 168(7) of the Treaty on the Functioning of the European Union (TFEU), the Member States remain responsible for the organisation and delivery of their healthcare. As such, it is appropriate to limit the scope of Union rules to those aspects of HTA that relate to the scientific aspects of the clinical assessment of a health technology, and in particular, to ensure that the assessment conclusions are confined to findings relating to the comparative effectiveness of a health technologyis confined to the descriptive analysis and the degree of certainty on the relative effects with no ranking or qualification of the level of effects of a health technology. The summary assessment of the scientific analysis contains value judgements and is therefore reserved for the appraisal at national level. The outcome of such assessments should not therefore affect the discretion of Member States in relation to subsequent decisions on pricing and reimbursement of health technologies, including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non-clinical considerations, and which remain solely a matter of national competence.
Amendment 256 #
Proposal for a regulation
Article 2 – paragraph 1 – point e
Article 2 – paragraph 1 – point e
(e) ‘joint clinical assessment’ means a compilation and evaluationdescriptive analysis of the available scientific evidence on a health technology in comparison with one or more other health technologies based on the scientific aspects of the following clinical domains of health technology assessment: the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem, the description and technical characterisation of the health technology, an descriptive analysis of the relative clinical effectiveness, and the relative safety of the health technology;
Amendment 272 #
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 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 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 355 #
Proposal for a regulation
Article 6 – paragraph 5 – introductory part
Article 6 – paragraph 5 – introductory part
5. The conclusions of the joint clinical assessment report shall be limited to the following:
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 359 #
Proposal for a regulation
Article 6 – paragraph 5 – point a
Article 6 – paragraph 5 – point a
(a) an descriptive scientific analysis of the relative effects of the health technology being assessed on the patient-relevantclinical health outcomes chosen for the assessment;
Amendment 362 #
Proposal for a regulation
Article 6 – paragraph 5 – point b
Article 6 – paragraph 5 – point b
(b) the degree of certainty on the relative effects based on the available evidence. The assessment shall be based on the clinical endpoints established according to international standards of evidence-based medicine, in particular with regard to improving the state of health, shortening the duration of the disease, prolonging survival, reducing side effects or improving the quality of life. Reference should also be made to subgroup-specific differences.
Amendment 399 #
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 407 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Where the Commission considers that there are no legal obstacles to the inclusion of the approved joint clinical assessment report and summary report comply with the substantiin a list of technologies that have aund procedural requirements laid down in this Regulation,ergone a joint clinical assessment (hereafter referred to as ‘the list of assessed technologies’ or ‘list’) it shall include the name of the health technology which has been the subject of the approved report and summary report, in a list of technologies having undergone joint clinical assessment (the "the ‘List of Assessed Health Technologies" or the "List")’ at the latest 30 days after receipt of the approved report and summary report from the Coordination Group.
Amendment 413 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Where, within 30 days of receipt of the approved joint clinical assessment report and the summary report, the Commission concludes that the approved joint clinical assessment report and summary report do not comply with the substantive and procedurlegal requirements laid down in this Regulation, it shall inform the Coordination Group of the reasons for its conclusions and request it to review the report and summary report.
Amendment 420 #
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Following the submission of the modified approved joint clinical assessment report and summary report, and where the Commission considers that the modified approved joint clinical assessment report and summary report comply with the substantive and procedurlegal requirements laid down in this Regulation, it shall include the name of the health technology which has been the subject of the report and summary report, in the List of Assessed Health Technologies.
Amendment 424 #
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. If the Commission concludes that the modified approved joint clinical assessment report and summary report do not comply with the substantive and procedurlegal requirements laid down in this Regulation, it shall decline to include the name of the health technology in the List. The Commission shall inform the Coordination Group thereof, setting out the reasons for the non- inclusion. The obligations laid down in Article 8 shall not apply with respect to the health technology concerned. The Coordination Group shall inform the submitting health technology developer accordingly and include summary information on those reports in its annual report.
Amendment 436 #
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
1a. This shall not prevent the Member States from complementing the joint clinical assessment with clinical assessments comparing the technology against a comparator which represents the best available evidence based standard of care in this Member State which, despite the Member States request during the scoping face, will not form part of the joint clinical assessment and which is necessary to complete the health technology assessment in that Member State. Any such measure should be justified, necessary and proportionate to achieving this aim. Any national assessment complementing the joint clinical assessment should follow the methodology established in accordance with Article 22. Member States shall notify the Commission and the Coordination Group of their intention to complement the joint clinical assessment together with a justification for doing so no later than 2 weeks after the Coordination Group has laid down the specific requirements for the joint assessment of the specific technology.
Amendment 486 #
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.