38 Amendments of Julia REDA related to 2018/0018(COD)
Amendment 47 #
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 obligationAccording to the national needs, Member States should have the right to complement joint clinical assessment with additional clinical evidence. In addition, this does not prevent Member States from carrying out 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 55 #
Proposal for a regulation
Recital 21
Recital 21
Amendment 58 #
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21 a) Joint scientific consultations should 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 should be made available to the general public.
Amendment 61 #
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 tothe Coordination Group should 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 should be taken into account. 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 65 #
Proposal for a regulation
Recital 26
Recital 26
(26) In order to ensure that this Regulation is fully operational and to adapt it to technical and scientific development, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect ofCoordination Group will decide on the contents of documents and data to be submitted, reports, and summary reports of clinical assessments, the contents of documents for requests, and reports of joint scientific consultations, and the rules for selecting stakeholders. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.14 In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council should receive all documents at the same time as Member States' experts, and their experts systematically should be granted access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 14Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission of 13 April 2016 on Better Law-Making (OJ L 123, 12.5.2016, p. 1).
Amendment 69 #
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 74 #
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 majorityo consensus is reached, vote by a two-thirds majority. The documentation should be transparent, and votes documented. Dissensions and minority opinions should be motivated and included in the assessment. There shall be one vote per Member State.
Amendment 77 #
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 without the right to vote and a co-chair elected from the members of the group for a set term to be determined in its rules of procedure.
Amendment 79 #
Proposal for a regulation
Article 3 – paragraph 8 – point a a (new)
Article 3 – paragraph 8 – point a a (new)
(a a) adopt rules on conflicts of interest for the functioning of the coordination groups and the conduction of joint clinical assessments and joint scientific consultations.
Amendment 81 #
Proposal for a regulation
Article 4 – paragraph 3 – point c
Article 4 – paragraph 3 – point c
(c) consult the Commission on the draft annual work programme and take into account its opinion.
Amendment 84 #
Proposal for a regulation
Article 5 – paragraph 1 – point b a (new)
Article 5 – paragraph 1 – point b a (new)
(b a) other medical devices considered to be major innovations or with a potentially significant impact on national health care systems.
Amendment 88 #
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. The Coordination Group shall select the medical devices referred to in paragraph 1 points (b), (ba) and (c) for joint clinical assessment based on the following criteria:
Amendment 90 #
Proposal for a regulation
Article 5 a (new)
Article 5 a (new)
Article 5 a Methodological standards 1. Joint clinical assessments should be based on standards of evidence-based medicine. The added therapeutic value should be demonstrated on patient- relevant end points: mortality, morbidity, quality of life, according to the situation. 2. The manufacturers shall provide all data from all sponsored studies in the indication under assessment. In case of non-compliance to provide full data, the joint assessment shall be interrupted or even discontinued. The names of those manufactories who failed to provide all the necessary data shall be made public.
Amendment 91 #
Proposal for a regulation
Article 5 b (new)
Article 5 b (new)
Article 5 b Conduct of comparative trials against standard treatment 1. Health technology developers shall conduct at least one randomized clinical trial comparing their new drug with an active comparator considered among the best current proven interventions at the time the trial was designed (standard treatment), or the most common intervention when no standard treatment exists. The developer is expected to comply with established guidelines on development of products and to take into account the current medical knowledge to establish the best comparative alternative. 2. Full results of comparative trials, including raw and individual patient data (clinical study reports), shall be made available at the time of applications for a marketing authorization and shall be included in HTA applications. As soon as the joint clinical assessment is finalized, all information and datas shall be made publicly available as provided for by Regulation 1049/2001. 3.If the developer obtained scientific advice on data and evidence requirements, and did not follow the advice, the developer shall be asked to justify the deviation from the advice given.
Amendment 94 #
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 the information, all available data and evidence, including both negative and positive results as well as studies in which the technology has been used, necessary for the joint clinical assessment.
Amendment 100 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
Amendment 102 #
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 on procedural aspects.
Amendment 103 #
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 majoritytwo-thirds of Member States. Diverging views shall be outlined in the report.
Amendment 105 #
Proposal for a regulation
Article 6 – paragraph 13
Article 6 – paragraph 13
Amendment 108 #
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 109 #
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 110 #
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Following the submission of the modified approved joint clinical assessment report and summary report, and where the Commission considers that the modified 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 report and summary report, in the List of Assessed Health Technologies.
Amendment 111 #
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. If the Commission concludes that the modified approved joint clinical assessment report and summary report do not comply with the substantive and procedural requirements laid down in this Regulation, it shall decline to include the name of the health technology in the List. The Commission shall inform the Coordination Group thereof, setting out the reasons for the non-inclusion. The obligations laid down in Article 8 shall not apply with respect to the health technology concerned. The Coordination Group shall inform the submitting health technology developer accordingly and include summary information on those reports in its annual report.
Amendment 114 #
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. According to the national needs, Member States shall have the right to complement the report with additional clinical evidence;
Amendment 121 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. Member States shall notify the Commission of the outcome of a health technology assessment on a health technology which has been subject to a joint clinical assessment within 30 days from its completion. That notification shall be accompanied by information on how the conclusions of the joint clinical assessment report have been applied in the overall health technology assessment. The final report must be made publicly available. The Commission shall facilitate the exchange of this information between Member States through the IT platform referred to in Article 27.
Amendment 123 #
Proposal for a regulation
Article 9 a (new)
Article 9 a (new)
Article 9 a 1. The Coordination Group may consider to carry out updates of joint clinical assessments at the moment of the renewal of the marketing authorization after five years pursuant to Article 14 of Regulation (EU)726/2004. 2. Should additional important evidence become available significantly prior to the renewal of the marketing authorisation, the Coordination Group may also consider carrying out an update on joint clinical assessment.
Amendment 136 #
Proposal for a regulation
Article 13 – paragraph 8
Article 13 – paragraph 8
8. The designated sub-group shall ensure that stakeholders, including patients, consumers 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 139 #
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 simpletwo- thirds majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4.
Amendment 140 #
Proposal for a regulation
Article 13 – paragraph 12 a (new)
Article 13 – paragraph 12 a (new)
12 a. Delegates participating in the elaboration of joint scientific consultations for a health technology shall not participate in the joint clinical assessment of this particular technology.
Amendment 141 #
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 once the joint clinical assessments have been completed.
Amendment 142 #
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.
Amendment 144 #
Proposal for a regulation
Article 16 – paragraph 1 – point d
Article 16 – paragraph 1 – point d
(d) the consultation of patients, consumers, clinical experts and other relevant stakeholders;
Amendment 146 #
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. Declarations on conflicts of interest shall be made publicly available for all stakeholder. Experts with conflicts of interest shall not participate in the process.
Amendment 148 #
Proposal for a regulation
Article 18 – paragraph 2 – point b
Article 18 – paragraph 2 – point b
(b) patient and consumer organisations;
Amendment 153 #
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 158 #
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, consumers, clinical experts, and other stakeholders in clinical assessments. The declarations of conflicts of interest of consulted stakeholders shall be made publicly available.
Amendment 164 #
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 adopt:
Amendment 178 #
Proposal for a regulation
Article 31
Article 31