Activities of Nicola CAPUTO related to 2018/0018(COD)
Plenary speeches (2)
Health technology assessment (debate) IT
Health technology assessment (debate) IT
Amendments (10)
Amendment 172 #
Proposal for a regulation
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114, 168(4) and 168(7) thereof,
Amendment 174 #
Proposal for a regulation
Recital 1
Recital 1
(1) The development of health technologies is a key drikey to achieving the high leverl of economic growth and innovation in the Union. Ithealth protection that health policies must ensure. 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 228 #
Proposal for a regulation
Recital 21
Recital 21
(21) Joint clinical assessments and joint scientific consultations may necessitate the sharing of commercial confidential information between health technology developers and HTA authorities and bodies. In order to ensure the protection of such information, information provided to the Coordination Group in the framework of assessments and consultations should only be disclosed to a third party after a confidentiality agreement has been concluded. In addition, it is necessary for any information made public about the results of joint scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive nature.
Amendment 236 #
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 will be exceptional and adapted to very specific circumstances, but never to the detriment of the quality of health technologies or clinical evidence. According to Eurordis the methodology for orphan medicinal products should have the same rigor, the same scientific standards, the same quality products even if there is fewer data and higher uncertainty. Moreover, 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. __________________ 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 245 #
Proposal for a regulation
Recital 31
Recital 31
(31) In order to ensure that the support framework continues to be as efficient and cost-effective as possible, the Commission should report on the implementation of the provisions on the scope of the joint clinical assessments and on the functioning of the support framework no later than two years after the end of the transitional period. The report may in particular consider whether there is a need to move this support framework to a Union agency and introduce a fee-paying mechanism through which health technology developers would also contribute to the financing of the joint work.
Amendment 284 #
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 should 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 371 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The members of the designated sub-group, in a minimum time frame of 30 work days, shall provide their comments during the preparation of the draft joint clinical assessment report and the summary report. The Commission may also provide comments.
Amendment 449 #
Proposal for a regulation
Article 11 – paragraph 1 – point c
Article 11 – paragraph 1 – point c
(c) determining the detailed procedural steps and their timing, and the overall duration of joint clinical assessments;
Amendment 544 #
Proposal for a regulation
Article 22 – paragraph 1 – point b – subpoint 1 (new)
Article 22 – paragraph 1 – point b – subpoint 1 (new)
The health technology developer shall conduct at least one randomized controlled clinical trial, comparing its health technology in terms of clinically relevant outcomes with an active comparator considered among the best current proven intervention at the time the trial was designed (standard treatment), or the most common intervention when no standard treatment exists. The technology developer shall provide the data and results of conducted comparative trials in the documentation dossier submitted for the joint clinical assessment.
Amendment 546 #
Proposal for a regulation
Article 22 – paragraph 1 a (new)
Article 22 – paragraph 1 a (new)