6 Amendments of Evelyne GEBHARDT related to 2018/0018(COD)
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 50 #
Proposal for a regulation
Recital 17
Recital 17
(17) The time-frame for joint clinical assessments for medicinal products should, in as far as possible, be fixed by reference to the time-frame applicable to the completion of the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004. Such coordination should ensure clinical assessments can effectively facilitate market access and contribute to the timely availability of innovative technologies for patients. As a rule, the process should be completed by the time of the publication of the Commission decision granting marketing authorisation to avoid that the joint clinical assessments result in delays and may disadvantage the patient's access procedures.
Amendment 60 #
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 to 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. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.13In developing such framework, the Commission should ensure that the assessments provide for an equal and high standard and focus on the aim of safe and patient-relevant health policies that seek to achieve best value. _________________ 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 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 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.