Activities of Michèle RIVASI related to 2018/0018(COD)
Shadow reports (1)
RECOMMENDATION FOR SECOND READING on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU
Amendments (80)
Amendment 36 #
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 it 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 40 #
Proposal for a regulation
Recital 21
Recital 21
Amendment 41 #
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21 a) 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 44 #
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 shall 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 48 #
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. _________________ 14 Interinstitutional 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 52 #
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 59 #
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 shall 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 61 #
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 64 #
Proposal for a regulation
Article 3 – paragraph 8 – point a a (new)
Article 3 – paragraph 8 – point a a (new)
(a a) adopts rules on conflict of interest for the functioning of the coordination groups and the conduction of joint clinical assessments and joint scientific consultations.
Amendment 71 #
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 74 #
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 innovation or with potential significant impact on national health care systems.
Amendment 76 #
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 77 #
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 endpoints: 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 will be interrupted or even discontinued. The names of those manufactories who failed to provide all the necessary data, shall be made public.
Amendment 78 #
Proposal for a regulation
Article 5 b (new)
Article 5 b (new)
Article 5 b Conduct of Comparative trials against standart 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 intervention 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) should be made available at the time of applications for a marketing authorization and included in HTA applications. As soon as the joint clinical assessment is finalized, all information and datas should 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 will be asked to justify the deviation from the advice given.
Amendment 82 #
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 use, necessary for the joint clinical assessment.
Amendment 84 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
Amendment 86 #
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 87 #
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 need to be outlined in the report.
Amendment 88 #
Proposal for a regulation
Article 6 – paragraph 13
Article 6 – paragraph 13
Amendment 90 #
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 91 #
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 92 #
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 93 #
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 95 #
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 97 #
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 99 #
Proposal for a regulation
Article 9 a (new)
Article 9 a (new)
Article 9 a 1. The Coordination Group should 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 becomes available significantly prior to the renewal of the marketing authorisation, the Coordination Group should also consider carrying out an update on joint clinical assessment.
Amendment 102 #
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
1. The Commissionordination Group shall develop, by means of implementing acts, procedural rules for:
Amendment 105 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
Amendment 107 #
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 108 #
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 109 #
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 may not participate in the joint clinical assessment of this particular technology.
Amendment 110 #
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 111 #
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 112 #
Proposal for a regulation
Article 16 – paragraph 1 – introductory part
Article 16 – paragraph 1 – introductory part
1. The Commissionordination Group shall develop, by means of implementing acts, procedural rules for:
Amendment 114 #
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 115 #
Proposal for a regulation
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
The Commissionordination Group shall be empowered to adopt delegated actrules in accordance with Article 31 concerning:
Amendment 116 #
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 must be publicly available for all stakeholder and experts with conflict of interests shall not participate in the process.
Amendment 118 #
Proposal for a regulation
Article 18 – paragraph 2 – point b
Article 18 – paragraph 2 – point b
(b) patient and consumer organisations;
Amendment 121 #
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 122 #
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 123 #
Proposal for a regulation
Article 22 – paragraph 1 – introductory part
Article 22 – paragraph 1 – introductory part
1. The Commissionordination Group shall adopt implementing acts concerning:
Amendment 126 #
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 shareholders must be publicly available.
Amendment 131 #
Proposal for a regulation
Article 22 – paragraph 2
Article 22 – paragraph 2
Amendment 132 #
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 146 #
Proposal for a regulation
Article 31
Article 31
Amendment 212 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) Health professionals, patients and the public who use and pay for health technologies need to know whether a new health technology is an improvement or not on existing health technologies, in terms of benefits and risks. Joint clinical assessments therefore aim to determine the added therapeutic value of new or existing health technologies in comparison with other new or existing health technologies. This is done by undertaking comparative assessment based on comparative trial data. In order to ensure that the therapeutic value of health technologies can be properly assessed, it is essential that comparative trials are done against the current best proven intervention (standard treatment) or against the current most common treatment where no standard treatment exists.
Amendment 214 #
Proposal for a regulation
Recital 15 b (new)
Recital 15 b (new)
(15b) In order to streamline the process and to make sure that joint clinical assessments are based on robust data, comparative trial data should be made available at the time of applications for marketing authorisations. Timely availability of data from comparative trials would go a long way towards facilitating HTA activities, saving time and resources, and benefitting patients and society thanks to a focus on real therapeutic advances.
Amendment 216 #
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. CAccording to national needs, Member States should have the right to complement the joint clinical assessments with additional clinical evidence. In addition, compliance with this obligation 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 226 #
Proposal for a regulation
Recital 21
Recital 21
Amendment 230 #
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21a) Joint scientific consultations should concern the clinical style design and the determination of best comparators based on the best medical practices in the interest of patients. The process should be transparent with the results of joint scientific consultations being made publicly available.
Amendment 248 #
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 268 #
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. Procedures undertaken by the Coordination Group shall be transparent with meeting minutes and votes documented and made publicly available. There shall be one vote per Member State.
Amendment 278 #
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 302 #
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 316 #
Proposal for a regulation
Article 5 – paragraph 1 – point b a (new)
Article 5 – paragraph 1 – point b a (new)
(ba) other medical devices considered to be major innovations or with potential significant impacts on national health care systems;
Amendment 323 #
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 326 #
Proposal for a regulation
Article 5 a (new)
Article 5 a (new)
Article 5a Methodological standards: standard of care, comparator and endpoints 1. Joint clinical assessments shall be based on the highest standards of evidence-based medicine. Added therapeutic value shall be demonstrated on patient-relevant endpoints: mortality, morbidity, quality of life, according to the situation. 2. Health technology developers shall provide all data from all sponsored studies in relation to the health technology under assessment. In the case of non- compliance with this requirement, the joint assessment may be postponed or terminated. The names of health technology developers who fail to provide all data shall be published on the IT platform established in Article 27.
Amendment 327 #
Proposal for a regulation
Article 5 b (new)
Article 5 b (new)
Article 5b Conduct of comparative trials against standard treatment 1. Health technology developers shall conduct at least one randomised clinical trial comparing the health technology under assessment with an active comparator considered among the best current proven interventions at the time of the design of the trial (‘standard treatment’), or the most common intervention where no standard treatment exists. The health technology developer shall comply with established guidelines on development of products and shall take into account the most up to date medical knowledge when determining the best comparator. 2. Full results of the comparative trials, including raw and individual patient data (clinical study reports) should be made available at the time of the applications for a marketing authorisation and included in HTA applications. As soon as the joint clinical assessment is finalised, all information and data should be made publicly available as provided for by Regulation 1049/2001 as well as being published on the IT platform established in Article 27. 3. If the health technology developer obtained scientific advice on data and evidence requirements via the joint scientific consultation, and did not follow the advice, they shall justify the deviation from the advice given.
Amendment 338 #
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 necessary for the joint clinical assessment, including both negative and positive results as well as all studies in which the technology has been used, necessary for the joint clinical assessment. Health Technology developers shall be obliged to submit all of the requested data.
Amendment 373 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
Amendment 386 #
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 393 #
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 simpletwo thirds majority of Member States. Any diverging views or minority opinions shall be outlined in both the final joint clinical assessment report and the summary report.
Amendment 400 #
Proposal for a regulation
Article 6 – paragraph 13
Article 6 – paragraph 13
Amendment 410 #
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 414 #
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 421 #
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 425 #
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 432 #
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 national needs, Member States shall have the right to complement the report with additional clinical evidence;
Amendment 439 #
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 446 #
Proposal for a regulation
Article 9 a (new)
Article 9 a (new)
Article 9a 1. The Coordination Group shall consider carrying out an update of a joint clinical assessment at the moment of the renewal of the marketing authorisation after five years pursuant to Article 14 of Regulation (EU)726/2004. 2. Should additional relevant evidence become available prior to the renewal of the marketing authorisation, the Coordination Group shall also consider carrying out an update of the joint clinical assessment.
Amendment 473 #
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 480 #
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 conclustiming of the Agency and shall start the assessment once the opinions of the joint scientific consultation report with those of the scientific adviceEuropean Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has been issued.
Amendment 484 #
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 487 #
Proposal for a regulation
Article 13 – paragraph 12 a (new)
Article 13 – paragraph 12 a (new)
12a. Members of the Coordination Group participating in the elaboration of joint scientific consultations for a health technology shall not also participate in the joint clinical assessment of the same health technology.
Amendment 491 #
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 496 #
Proposal for a regulation
Article 16 – paragraph 1 – point d
Article 16 – paragraph 1 – point d
(d) the consultation of patients, consumer organisations, clinical experts and other relevant stakeholders;
Amendment 502 #
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 conflict of interest shall be made publicly available for all stakeholders and those with conflicts of interest shall not participate in the process.
Amendment 505 #
Proposal for a regulation
Article 18 – paragraph 2 – point b
Article 18 – paragraph 2 – point b
(b) patient and consumer organisations;
Amendment 536 #
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, consumer organisations, clinical experts, and other stakeholders in clinical assessments. The declarations of conflicts of interest of consulted stakeholders shall be made publicly available.
Amendment 584 #
Proposal for a regulation
Article 27 – paragraph 2
Article 27 – paragraph 2
2. The Commission shall ensure appropriate levels ofpublic access to the information contained in the IT platform for Member State bodies, members of the stakeholder network, and the general public.