24 Amendments of Dita CHARANZOVÁ related to 2018/0018(COD)
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 68 #
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28 a) Given the sensitive nature of health information, the confidential handling of data should be safeguarded at all times.
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 96 #
Proposal for a regulation
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2 a. The designated sub-group shall request, in addition to the data referred to in paragraph 2, data from relevant sources, such as patient registries, databases or European Reference Networks, where that data is deemed necessary to complete the information provided by the health technology developers and to perform a more accurate clinical assessment of the health technology.
Amendment 106 #
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 30 working days to respond in order to identify any information it considers confidential and to justify the commercially sensitive nature of that information. In the event of disagreement between the assessor and the developer, the assessor and the co- assessor shall decide.
Amendment 131 #
Proposal for a regulation
Article 11 – paragraph 1 – point f
Article 11 – paragraph 1 – point f
Amendment 143 #
Proposal for a regulation
Article 16 – paragraph 1 – point d
Article 16 – paragraph 1 – point d
(d) the consultation of patients, healthcare professionals, clinical experts and other relevant stakeholders;
Amendment 145 #
Proposal for a regulation
Article 16 – paragraph 1 – point f
Article 16 – paragraph 1 – point f
Amendment 147 #
Proposal for a regulation
Article 18 – paragraph 2 – introductory part
Article 18 – paragraph 2 – introductory part
2. In the preparation of the study, the Coordination Group shall consultbe conscious of breakthrough innovations and seek the input of all relevant stakeholders with the aim of exploring new possibilities in innovation. The Coordination Group shall consult all relevant stakeholders, including but not limited to:
Amendment 149 #
Proposal for a regulation
Article 18 – paragraph 2 – point c a (new)
Article 18 – paragraph 2 – point c a (new)
(c a) healthcare professionals;
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 155 #
Proposal for a regulation
Article 22 – paragraph 1 – introductory part
Article 22 – paragraph 1 – introductory part
1. The Commission shall adopt implementing acts concerningordination Group shall establish, after consulting all relevant stakeholders:
Amendment 159 #
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, healthcare professionals, clinical experts, and other stakeholders in clinical assessments.
Amendment 167 #
Proposal for a regulation
Article 25 – paragraph 1 – point f
Article 25 – paragraph 1 – point f
Amendment 174 #
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
4. On the request of the Coordination Group, the Commission shall invite patients, healthcare professionals and clinical experts nominated by the stakeholder network to attend meetings of the Coordination Group as observers.
Amendment 176 #
Proposal for a regulation
Article 27 a (new)
Article 27 a (new)
Article 27 a Common rules on data 1. 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. 2. Assessors and co-assessors shall have full access to the data used by the authorities responsible for granting the marketing authorisation of a medicinal product, as well as the possibility of using or generating additional relevant data for the purposes of assessing a medicinal product in the context of a joint HTA. 3. The confidential handling of data shall be safeguarded at all times.
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.