60 Amendments of Nessa CHILDERS related to 2018/0018(COD)
Amendment 206 #
Proposal for a regulation
Recital 12
Recital 12
(12) In order to ensure a wide appfacilictation of harmonised rules on clinical aspects of HTAe a wide use of joint work 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). 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 213 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) Joint scientific consultations shall concern the clinical study design, the determination of best comparators based on the best medical practice in the interest of patients. The process should be transparent. Joint scientific consultations results shall be made available to the general public.
Amendment 215 #
Proposal for a regulation
Recital 15 b (new)
Recital 15 b (new)
(15b) The purpose of joint clinical assessments is to determine the added therapeutic value of new or existing technologies in comparison with other new or existing health technologies. Comparative assessment is undertaken by HTA bodies, who base their decision on comparative trial data with reference to the best standard therapies or the most common available treatment.
Amendment 247 #
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 262 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Member State Coordination Group on Health Technology Assessment (the ‘Coordination Group’) is hereby established as an independent scientific body.
Amendment 269 #
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 simplea two thirds majority. There shall be one vote per Member State. Proceedings and votes shall be documented, including dissenting views.
Amendment 276 #
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
4. Meetings of the Coordination Group shall be co-chaired by the Commission and a co-chair elected from thean elected members of the group for a set term to be determined in its rules of procedure.
Amendment 288 #
Proposal for a regulation
Article 3 – paragraph 8 – point a a (new)
Article 3 – paragraph 8 – point a a (new)
(aa) adopt rules on conflicts of interest to ensure the integrity and independence of the coordination groups, joint clinical assessments and joint scientific consultations;
Amendment 290 #
Proposal for a regulation
Article 3 – paragraph 8 – point d
Article 3 – paragraph 8 – point d
(d) ensure appropriate involvement of stakeholders in its workconsultation of stakeholders and experts in its work, namely patients, consumers, healthcare professionals, which shall be documented, including publically available declarations of interest from the stakeholders consulted; restrictions shall apply where conflicts of interest occur;
Amendment 303 #
Proposal for a regulation
Article 4 – paragraph 3 – point c
Article 4 – paragraph 3 – point c
(c) consultinform the Commission onf the draft annual work programme and take into account its opinion.;
Amendment 307 #
Proposal for a regulation
Article 4 – paragraph 3 – point c a (new)
Article 4 – paragraph 3 – point c a (new)
(ca) consult with stakeholders who are independent from commercial interests.
Amendment 325 #
Proposal for a regulation
Article 5 a (new)
Article 5 a (new)
Article 5a Standards and comparative trials 1. In order to ensure evidence-based methodological standards in joint clinical assessments, the added therapeutic value should be demonstrated on patient- relevant endpoints such as mortality, morbidity or quality of life. The manufacturers shall provide all data from all sponsored studies in the indication under assessment. Joint assessments shall be discontinued or disregarded by Member States in case of non- compliance. 2. Marketing authorisation applicants shall conduct at least one randomised clinical trial comparing new medication with an active comparator among the best current intervention at the time of trial design, i.e. standard treatment, or the most common intervention when no standard treatment exists. The sponsor is expected to comply with established product development guidelines and to take up-to-date medical knowledge into account so as to establish the best comparative alternative. Full results of comparative trials, including raw and individual patient data (clinical study reports) shall be made available upon application for a marketing authorisation and included in HTA applications. Upon conclusion of the joint clinical assessment, all information and data shall be made publicly available pursuant to Regulation 1049/2001/EC. If the sponsor obtained but failed to follow scientific advice on data and evidence requirements, the sponsor shall justify this deviation.
Amendment 339 #
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 comprehensive documentation containing theall information, studies, data and evidence necessary for the joint clinical assessmentavailable, both positive and negative, including the clinical study report for the joint clinical assessment. Health technology developers who fail to submit all data requested shall be liable to penalty.
Amendment 357 #
Proposal for a regulation
Article 6 – paragraph 5 – point a
Article 6 – paragraph 5 – point a
(a) an analysis of the relative effects of the health technology being assessed on the patient-relevant health outcomes chosen for the assessment, including mortality, morbidity and quality of life;
Amendment 364 #
Proposal for a regulation
Article 6 – paragraph 5 – point b
Article 6 – paragraph 5 – point b
(b) the degree of certainty on the relative effects based on theall available evidence and conducted against the best standard therapies.
Amendment 369 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The members of the designated sub-group 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 372 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
Amendment 374 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. The designated sub-group shall ensure that stakeholders, including patientpatients, consumers, healthcare professionals and clinical experts, are given an opportunity to provide commentsconsulted 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. The declarations of interests of all consulted stakeholders must be made public and restrictions shall apply where conflicts of interest occur.
Amendment 383 #
Proposal for a regulation
Article 6 – paragraph 10
Article 6 – paragraph 10
10. Following receipt and consideration of anyll 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 commentsfor comments. All comments shall be made public on the platform referred to in Article 27.
Amendment 389 #
Proposal for a regulation
Article 6 – paragraph 11
Article 6 – paragraph 11
11. The assessor, with the assistance of the co-assessor, shall take into account the comments of the designated sub-group and the Commission and submit a final draft joint clinical assessment report and the summary report to the Coordination Group for approval.
Amendment 396 #
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 Statestwo thirds of Member States, with dissenting views and their motivations to be included in the report.
Amendment 401 #
Proposal for a regulation
Article 6 – paragraph 13
Article 6 – paragraph 13
Amendment 409 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Where the Commission considers that the approved joint clinical assessment report and summary report comply with the substantive and procedural requirements laid down in this Regulation, it shall include the name of the health technology which has been the subject of the approved report and summary report, in a list of technologies having undergone joint clinical assessment (the "List of Assessed Health Technologies" or the "List") at the latest 30 days after receipt of the approved report and summary report from the Coordination Group.
Amendment 415 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Where, within 30 days of receipt of the approved joint clinical assessment report and the summary report, the Commission concludes that the approved joint clinical assessment report and summary report do not comply with the substantive and procedural requirements laid down in this Regulation, it shall inform the Coordination Group of the reasons for its conclusions and request it to review the report and summary report.
Amendment 417 #
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
Amendment 418 #
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
Amendment 422 #
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
Amendment 429 #
Proposal for a regulation
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
Amendment 435 #
Proposal for a regulation
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) applytake joint clinical assessment reports into account, in their health technology assessments at Member State level and, where national authorities deem it necessary, complement them with additional clinical evidence.
Amendment 447 #
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
1. The Commission shall develop, by means of implementing acts,ordination Group shall develop procedural rules for:
Amendment 455 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
Amendment 456 #
Proposal for a regulation
Article 12 – paragraph 1 – subparagraph 1
Article 12 – paragraph 1 – subparagraph 1
Health technology developers may request a joint scientific consultation with the Coordination Group for the purposes of obtaining scientific advice concerning data and evidence likely to be required as part of a joint clinical assessmentclinical aspects pertaining to the optimal design of scientific studies and research, so as to obtain the best scientific evidence.
Amendment 469 #
Proposal for a regulation
Article 13 – paragraph 7
Article 13 – paragraph 7
7. The assessor shall provideublish the draft joint scientific consultation report to the submitting health technology developer and set a time-frame in which the developerand set a time-frame in which the health technology developer, patients, consumers and health care professionals may submit comments.
Amendment 472 #
Proposal for a regulation
Article 13 – paragraph 8
Article 13 – paragraph 8
8. The designated sub-group shall ensure that stakeholders, including patients and clinical expert, consumers and healthcare professionals 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 478 #
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 advic's timeframe.
Amendment 482 #
Proposal for a regulation
Article 13 – paragraph 12
Article 13 – paragraph 12
12. The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by a simplequalified two-thirds majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4. Dissenting views shall be included in the final joint scientific consultation report.
Amendment 488 #
Proposal for a regulation
Article 13 – paragraph 12 a (new)
Article 13 – paragraph 12 a (new)
12a. Delegates and experts participating in joint scientific consultations for a given health technology shall not participate in the joint clinical assessment of this technology.
Amendment 490 #
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. The Coordination Group shall include anonymised summary information on the joint scientific consultations in its annual reports and the IT platform referred to in Article 27. The scientific consultation reports shall be made public upon completion of the joint clinical assessments.
Amendment 493 #
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Member States shall notmay carry out a scientific consultation or an equivalent consultation on a health technology for which a jointcomplementary scientific consultation has been ins necessitiated and where the contents of the request are the same as those covered by the joint scientific consultationby circumstances at national level.
Amendment 494 #
Proposal for a regulation
Article 16 – paragraph 1 – introductory part
Article 16 – paragraph 1 – introductory part
1. The Commission shall develop, by means of implementing acts,ordination Group shall develop procedural rules for:
Amendment 497 #
Proposal for a regulation
Article 16 – paragraph 1 – point d
Article 16 – paragraph 1 – point d
(d) the consultation of patients, clinical expertonsumers, healthcare professionals and other relevant stakeholders;
Amendment 499 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
Amendment 500 #
Proposal for a regulation
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
The Commission shall be empowered to adopt delegated acts in accordance with Article 31 concerningordination Group shall adopt rules on:
Amendment 501 #
Proposal for a regulation
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) the rules for determining the stakeholders to be consulted for the purpose of this Section, including rules on conflicts of interest. Declarations of interest shall be made publicly available for all stakeholders and experts consulted. Stakeholders and experts with conflicts of interest shall not participate in the process.
Amendment 506 #
Proposal for a regulation
Article 18 – paragraph 2 – point b
Article 18 – paragraph 2 – point b
(b) patient and consumer organisations;
Amendment 520 #
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. The cooperation referred to in paragraph 1 points (b) and (c) may be carried out using the procedural rules established in accordance with Article 11 and the common rules established in accordance with Articles 22 and 23by the Coordination Group.
Amendment 524 #
Proposal for a regulation
Article 20 – paragraph 1 – introductory part
Article 20 – paragraph 1 – introductory part
The common procedural rules and methodology established in accordance with Article 22 and the requirements established in accordance with Article 23by the Coordination Group shall apply to:
Amendment 529 #
Proposal for a regulation
Article 20 – paragraph 1 – point b
Article 20 – paragraph 1 – point b
Amendment 533 #
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 adopt:
Amendment 535 #
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, clinical experts, and other stakeholders in clinical assessmentsonsumers, healthcare professionals and other experts in clinical assessments. The declarations of interest of all consulted stakeholders shall be made publicly available and restrictions shall apply where conflicts of interest occur.
Amendment 549 #
Proposal for a regulation
Article 23 – paragraph 1 – introductory part
Article 23 – paragraph 1 – introductory part
The Commission shall be empowered to adopt delegated acts in accordance with Article 31 concerningordination Group shall determine:
Amendment 554 #
Proposal for a regulation
Article 24 – paragraph 2 a (new)
Article 24 – paragraph 2 a (new)
2a. The Union shall ensure stable and permanent public funding under the multiannual financial framework.
Amendment 555 #
Proposal for a regulation
Article 25 – paragraph 1 – point a
Article 25 – paragraph 1 – point a
(a) host on its premises and co-chair the meetings of the Coordination Group on its premises;
Amendment 556 #
Proposal for a regulation
Article 25 – paragraph 1 – point b
Article 25 – paragraph 1 – point b
(b) provide the secretariat for the Coordination Group and provide administrative, scientific and IT support;
Amendment 557 #
Proposal for a regulation
Article 25 – paragraph 1 – point d
Article 25 – paragraph 1 – point d
(d) verify that the work of the Coordination Group is carried out in an independent and transparent manner, according to the rules of procedure established;
Amendment 558 #
Proposal for a regulation
Article 25 – paragraph 1 – point e
Article 25 – paragraph 1 – point e
(e) facilitate cooperation with the European Medicines Agency on the joint work on medicinal products including the sharing of confidential information;
Amendment 560 #
Proposal for a regulation
Article 25 – paragraph 1 – point f
Article 25 – paragraph 1 – point f
(f) facilitate cooperation with the relevant Union level bodies on the joint work on medical devices including the sharing of confidential information.
Amendment 563 #
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria, agreed by the Coordination Group, established in the open call for applications. Members of the stakeholder network shall be not-for- profit organisations representing non- commercial entities.
Amendment 570 #
Proposal for a regulation
Article 26 – paragraph 3 – introductory part
Article 26 – paragraph 3 – introductory part
3. The Commission shall organise ad- hoc meetings between the stakeholder network and the Coordination Group in order to:
Amendment 590 #
Proposal for a regulation
Article 31
Article 31