6 Amendments of Sergio GUTIÉRREZ PRIETO related to 2018/0018(COD)
Amendment 59 #
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, proceduresthe Commission should establish, by means of implementing acts, a common procedural framework for joint clinical assessments and procedures for joint scientific consultations. Where appropriate, while the Coordination Group should establish a common methodological framework. Where appropriate, and in justified cases, distinct rules shouldmust 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 may be taken into account. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.13. The methodology should guarantee high quality and high clinical evidence. Any flexibility in the methodology should be exceptional and adapted to very specific circumstances, but never to the detriment of the quality of health technologies or clinical evidence. Clinical trials are the studies par excellence in the biomedical field, so the use of another type of study, for example, epidemiological studies, should be exceptional and fully justified. The rules to be developed in tertiary legislation should cover the possibilities for improvement of clinical evidence in the cases where further scientific evidence is needed. _________________ 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 78 #
Proposal for a regulation
Article 3 – paragraph 6
Article 3 – paragraph 6
6. Members of the Coordination Group, and their appointed representatives shall respect the principles of independence, impartiality, and confidentiality. Transparency and publicity of the process is essential. In this connection, all clinical data being evaluated shall have the highest level of transparency and publicity in order to gain confidence in the system. In case there is confidential data for commercial reasons, the confidentiality needs to be clearly defined and justified and the confidential data well delimitated.
Amendment 93 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The designated sub-group shall request relevant health technology developers to submit documentation containing the information, data and evidence necessary for the joint clinical assessment. In the interests of transparency, the relationship between evaluators and technology developers must be independent. The evaluators must have guaranteed their independence in the development of their work, without there being neither conditionalities nor interference from the technology developers in the evaluation process. Developers of technologies can be consulted but never participate in the evaluation.
Amendment 132 #
Proposal for a regulation
Article 11 – paragraph 1 – point f
Article 11 – paragraph 1 – point f
(f) cooperation with the notified bodies and expert panelsbetween the European Medicines Agency and the Coordination Group on the preparation and update of joint clinical assessments of medicinal devicesproducts. This cooperation shall take into account that the Coordination Group, due to its competences in clinical aspects, is the competent body to detect and prioritize the emerging technologies based on impact on health.
Amendment 160 #
Proposal for a regulation
Article 22 – paragraph 1 – point b
Article 22 – paragraph 1 – point b
Amendment 163 #
Proposal for a regulation
Article 22 – paragraph 2 a (new)
Article 22 – paragraph 2 a (new)
2 a. The Coordination Group shall draw up the methodologies to be used to carry out joint clinical assessments and consultations and shall define the content of those assessments and consultations. In any event: (a) the methodologies shall be based on high standards of quality, the best available scientific evidence, stemming primarily from double-blind randomised clinical trials, meta-analysis and systematic reviews; (b) the assessment of relative effectiveness shall be based on end-points which are relevant to the patient with useful, relevant, tangible and specific criteria suited to the clinical situation concerned; c) the comparators shall be the reference comparators for the clinical entity concerned and be the best and/or most commonly used technological or process based comparator; d) the technology developers shall, for the purpose of its clinical assessment, provide the Coordination Group with the complete dossier in eCTD format submitted to the European Medicines Agency for centralised authorisation. This package shall include the Clinical Study Report and the data of individual patients in all clinical trials; e) the information to be provided by the health technology developer shall relate to the most up-to-date and public research. Failure to comply with this requirement may trigger a sanctions mechanism. Any flexibility in the methodology shall be exceptional and adapted to very specific circumstances, but never to the detriment of the quality of health technologies or clinical evidence. The methodology must guarantee high quality and high clinical evidence. Since clinical trials are the studies par excellence in the biomedical field, the use of another type of study shall be exceptional and fully justified. The rules to be developed by the Coordination Group shall cover the possibilities for improvement of clinical evidence in the cases where further scientific evidence is needed.