Activities of Daniel DALTON 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 (16)
Amendment 43 #
Proposal for a regulation
Recital 12
Recital 12
(12) In order to ensure a wide application of harmonised rules on clinical aspects of HTA and enable pooling of expertise and resources across HTA bodies, it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council,11 which incorporate a new active substance, and where those medicinal products are subsequently authorised for a new therapeutic indication. Joint clinical assessments should also be carried out on certain medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council12 which are in the highest risk classes and for which the relevant expert panels have provided their opinions or views. A selection of medical devices for joint clinical assessment should be made based on specific criteria. _________________ 11 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). 12Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
Amendment 46 #
Proposal for a regulation
Recital 15
Recital 15
(15) In order to ensure a Member-State led approach to joint clinical assessments and scientific consultations, Member States should designate national HTA authorities and bodies which inform decision-making as members of the Coordination Group. The designated authorities and bodies should ensure an appropriately high level of representation in the Coordination Group and technical expertise in its sub- groups, taking into account the need to provide expertise on the HTA of medicinal products and medical devices.
Amendment 51 #
Proposal for a regulation
Recital 18
Recital 18
Amendment 53 #
Proposal for a regulation
Recital 19
Recital 19
(19) In all cases the joint work carried out under this Regulation, in particular the joint clinical assessments, should produce high quality and timely results, and not delay or interfere with the CE marking of medical devices or market access of health technologies. This work should be separate and distinct from regulatory assessments of the safety, quality, efficacy or performance of health technologies carried out pursuant to other Union legislation and have no bearing on decisions taken in accordance with other Union legislation.
Amendment 62 #
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.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 83 #
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
Amendment 85 #
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
Amendment 86 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 112 #
Proposal for a regulation
Article 8 – paragraph 1 – introductory part
Article 8 – paragraph 1 – introductory part
1. Member States shallmay decide to:
Amendment 122 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. Member States shallmay notify the Commission of the outcome of a health technology assessment on a health technology which has been subject to a joint clinical assessment within 30 days from its completion. That notification shallmay be accompanied by information on how the conclusions of the joint clinical assessment report have been applied in the overall health technology assessment. The Commission shall facilitate the exchange of this information between Member States through the IT platform referred to in Article 27.
Amendment 131 #
Proposal for a regulation
Article 11 – paragraph 1 – point f
Article 11 – paragraph 1 – point f
Amendment 145 #
Proposal for a regulation
Article 16 – paragraph 1 – point f
Article 16 – paragraph 1 – point f
Amendment 151 #
Proposal for a regulation
Article 19 – paragraph 1 – point b
Article 19 – paragraph 1 – point b
Amendment 152 #
Proposal for a regulation
Article 19 – paragraph 1 – point c
Article 19 – paragraph 1 – point c
(c) health technology assessments on health technologies other than medicinal products or medical devices;
Amendment 167 #
Proposal for a regulation
Article 25 – paragraph 1 – point f
Article 25 – paragraph 1 – point f
Amendment 179 #
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. When preparing those implementing and delegated acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors.