17 Amendments of Piernicola PEDICINI related to 2018/0018(COD)
Amendment 186 #
Proposal for a regulation
Recital 4
Recital 4
(4) The outcome of HTA is used to inform decisions concerning the allocation of budgetary resources in the field of health, for example, in relation to establishing the pricing or reimbursement levels of health technologies or to identifying new and emerging technologies suitable for public funding. HTA can therefore assist Member States in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients.
Amendment 205 #
Proposal for a regulation
Recital 12
Recital 12
(12) In order to ensure a wide application of harmonised rulfoster collaboration among Member States on clinical aspects of HTA and enable pooling of expertise and resources across HTA bodies reducing waste and inefficiencies in healthcare, 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). 12 Regulation (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 217 #
Proposal for a regulation
Recital 16
Recital 16
(16) In order that the harmonised procedures fulfil their internal market objective, Member States should be required to take full account of the results of joint clinical assessments and not repeat those assessments. Compliance with this obligation does not prevent Member States from carrying out complementary clinical assessments or non-clinical assessments on the same health technology, or from drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non-clinical data and criteria. It also does not prevent Member States from forming their own recommendations or decisions on pricing or reimbursement.
Amendment 232 #
Proposal for a regulation
Recital 22
Recital 22
(22) In order to ensure the efficient use of available resources, it is appropriate to provide for “horizon scanning”, to allow the early identification of emerging health technologies that are likely to have the most impact on patients, public health and healthcare systems, as well as to steer research strategically. Such scanning should facilitate the prioritisation of technologies that are to be selected for joint clinical assessment.
Amendment 249 #
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 275 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Coordination Group shall act by consensus, or, where necessary, vote by simple majority. There shall be one vote per Member State. Votes shall be recorded. Dissensions and minority opinions should be motivated and also included in the assessment.
Amendment 342 #
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 all the information, data and evidence necessary for the joint clinical assessment. Non-compliance with this obligation shall lead to the application of penalties.
Amendment 375 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. The assessor shall provide the draft joint clinical assessment report and the summary report to the submitting health technology developer for fact-checking purposes and set a time-frame in which the developer may submit comments.
Amendment 380 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. The designated sub-group shall ensure that stakeholders, including patients, consumer organisations and clinical experts, are given an opportunity to provide comments during the preparation of the draft joint clinical assessment report and the summary report and set a time- frame in which they may submit comments.
Amendment 385 #
Proposal for a regulation
Article 6 – paragraph 10
Article 6 – paragraph 10
10. Following receipt and consideration of any comments provided in accordance with paragraphs 7, 8, and 9, the assessor, with the assistance of the co-assessor, shall finalise the draft joint clinical assessment report and summary report, and submit those reports to the designated sub-group and to the Commission for comments. All comments shall be published on the IT platform referred to in Article 27.
Amendment 395 #
Proposal for a regulation
Article 6 – paragraph 12
Article 6 – paragraph 12
12. The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a simple majority of Member States. Votes shall be recorded. Dissensions and minority opinions should be motivated and also included in the assessment.
Amendment 431 #
Proposal for a regulation
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
(a) not carry out a clinical assessment or an equivalent assessment process on a health technology included in the List of Assessed Health Technologies or for which a joint clinical assessment has been initiated;
Amendment 438 #
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
1a. Paragraph 1 shall not prevent Member States from carrying out complementary assessments as part of their own context-specific appraisal processes, without unnecessarily duplicating the work done at EU level.
Amendment 470 #
Proposal for a regulation
Article 13 – paragraph 8
Article 13 – paragraph 8
8. The designated sub-group shall ensure that stakeholders, including patients, consumer organisations and clinical experts are given an opportunity to provide comments during the preparation of the draft joint scientific consultation report and set a time-frame in which they may submit comments.
Amendment 479 #
Proposal for a regulation
Article 13 – paragraph 10
Article 13 – paragraph 10
10. Where the joint scientific consultation is carried out in parallel with scientific advice given by the European Medicines Agency, the assessor shall seek to coordinate with the Agency as regards the consistency of the conclusions of the joint scientific consultation report with those of the scientific advicetiming.
Amendment 503 #
Proposal for a regulation
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
Amendment 545 #
Proposal for a regulation
Article 22 – paragraph 1 – point b a (new)
Article 22 – paragraph 1 – point b a (new)
(ba) a sanctions mechanism in the event of non-compliance by the technology developer with the requirements concerning the available information to be provided.