14 Amendments of Pavel TELIČKA related to 2018/0018(COD)
Amendment 26 #
Proposal for a regulation
Recital 2
Recital 2
(2) Test Health Technology Assessment (HTA) is an evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing technologies. HTA focuses specifically on the added value of a health technology in comparison with other new or existing health technologies.
Amendment 35 #
Proposal for a regulation
Recital 16
Recital 16
(16) In order that the harmonised procedures fulfil their internal market objective, Member States should be required to take full account of the results of joint clinical assessments and not repeat those assessments. Compliance with this obligation does not prevent Member States from carrying out additional clinical analyses to the extent that they are missing from the joint clinical assessment and are deemed necessary within the national health technology assessment context. Member States remain free to carry out non-clinical assessments on the same health technology, or from drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non-clinical data and criteria. It also does not prevent Member States from forming their own recommendations or decisions on pricing or reimbursement.
Amendment 45 #
Proposal for a regulation
Recital 25
Recital 25
(25) In order to ensure a uniform approach to the joint work provided for in this Regulation, implementing powers should be conferred on the Commission tothe Coordination Group shall establish a common procedural and methodological framework for clinical assessments, procedures for joint clinical assessments and procedures for joint scientific consultations. Where appropriate, distinct rules should be developed for medicinal products and medical devices. In the development of such rules, the Commission should take into account the results of the work already undertaken in the EUnetHTA Joint Actions. It should also take into account initiatives on HTA funded through the Horizon 2020 research programme, as well as regional initiatives on HTA such as the Beneluxa and Valletta Declaration initiatives. Implementing powers should be conferred on the Commission to establish procedures for joint clinical assessments and procedures for joint scientific consultations. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.13 _________________ 13 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 80 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The designated sub-group shall requesmeet relevant health technology developers to submit documentationagree on the scope of the assessment and on documentation from relevant sources including clinical trials but also inter alia patient registries, databases or European Reference Networks, containing the information, data and evidence necessary for the joint clinical assessment.
Amendment 89 #
Proposal for a regulation
Article 6 – paragraph 13
Article 6 – paragraph 13
13. The assessor shall ensure the removal of any information of a commercially sensitive nature from the approved joint clinical assessment report and the summary report. The assessor shall consult the developer on the report before its publication. The developer shall have a period of 7 working days to point out which information it considers confidential and to justify the commercially sensitive nature of that information.
Amendment 94 #
Proposal for a regulation
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
(a) not carry out a clinical assessment or an equivalent assessment process on a health technology included in the List of Assessed Health Technologies or for which a joint clinical assessment has been initiated; Member States shall have the right to complement the clinical evidence in the joint clinical assessment report according to their national context. Additional clinical evidence cannot deny the conclusions reached in the joint clinical assessment report.
Amendment 100 #
Proposal for a regulation
Article 10 – paragraph 1 – point a – point ii
Article 10 – paragraph 1 – point a – point ii
(ii) select medicinal products referred to in Article 5(1)(a) for joint clinical assessment based on the selection criteria referred to in Article 5(2).following cumulative criteria: (a) Unmet medical needs; (b) Potential impact on patients, public health, or healthcare systems; (c) Significant cross-border dimension; (d) Major Union-wide added value; (e) The available resources;
Amendment 104 #
Proposal for a regulation
Article 11 – paragraph 1 – point a a (new)
Article 11 – paragraph 1 – point a a (new)
(a a) The application of the selection criteria referred to in Article 10 (a) (ii)
Amendment 113 #
Proposal for a regulation
Article 16 – paragraph 1 – point d
Article 16 – paragraph 1 – point d
(d) the consultation of patients, health professionals, clinical experts and other relevant stakeholders;
Amendment 119 #
Proposal for a regulation
Article 18 – paragraph 2 – point c a (new)
Article 18 – paragraph 2 – point c a (new)
(c a) Health professionals
Amendment 120 #
Proposal for a regulation
Article 19 – paragraph 1 – point d
Article 19 – paragraph 1 – point d
(d) the provision of additional evidence necessary to support health technology assessments, including computer modeling and simulation data.
Amendment 127 #
Proposal for a regulation
Article 22 – paragraph 1 – point b
Article 22 – paragraph 1 – point b
(b) methodologies used to formulate the contents and design of clinical assessments, based on the common tools and methodologies for cooperation developed after many years of cooperation through EUnetHTA Joint Actions, BeNeLuxA and Valletta.
Amendment 135 #
Proposal for a regulation
Article 25 – paragraph 1 – point e
Article 25 – paragraph 1 – point e
(e) facilitate cooperation with the European Medicines Agency on the joint work on medicinal products including the sharing of confidential information; The sharing of confidential information needs to be proportionate to and aligned with the requirements for the joint clinical assessments and be discussed and agreed by the health technology developer or other relevant stakeholders;
Amendment 144 #
Proposal for a regulation
Article 27 – paragraph 2 – point 1 (new)
Article 27 – paragraph 2 – point 1 (new)
(1) 3.Common rules on Data a) The Commission shall be empowered to adopt delegated acts in accordance with Article 31 concerning data collection, interoperability of data and the comparability of data. b) The confidential handling of data shall be safeguarded at all times