Activities of Françoise GROSSETÊTE related to 2018/0018(COD)
Plenary speeches (2)
Health technology assessment (debate) FR
Health technology assessment (debate) FR
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU PDF (1 MB) DOC (258 KB)
Amendments (67)
Amendment 43 #
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, 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 and in particular the methodological guidelines and evidence submission template. 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 initiative. The procedural and methodological framework are updated at the frequency deemed necessary by the Commission to ensure that they should be adapted to the evolution of science. In developing the methodological framework, the Commission should consider the specificity and corresponding challenges of certain types of health technologies, advanced therapies or life- prolonging therapies where innovative clinical study designs may be required. These may result in evidential uncertainty at the time of the marketing authorization. As such innovative clinical study designs are often accepted for the purposes of regulatory assessments, the methodology for joint clinical assessments should not prevent these health technologies from reaching patients. The Commission should therefore ensure that the methodology provides for a sufficient level of flexibility to enable an adequate assessment of such health technologies. Such flexibility should include the acceptance of the best available scientific evidence at the time of the submission, including, for instance, data from case control studies, real world evidence, as well as the acceptance of indirect treatment comparators. 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 54 #
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
1. Taking into account the results of the work already undertaken in the EUnetHTA Joint Actions, this Regulation establishes:
Amendment 57 #
Proposal for a regulation
Article 2 – paragraph 1 – point g a (new)
Article 2 – paragraph 1 – point g a (new)
(g a) ‘patient-relevant health outcomes’ means data that captures or predicts mortality, morbidity, health-related quality of life, including pain, recovery rates, length of stay in hospitals and adverse events, including re-admissions, complications, blood loss, infections;
Amendment 98 #
Proposal for a regulation
Article 9 – paragraph 1 – point b a (new)
Article 9 – paragraph 1 – point b a (new)
(b a) the health technology developer requests an update on the grounds that additional evidence is made available for which the Coordination Group would need to reconsider the conclusions of the initial assessment.
Amendment 124 #
Proposal for a regulation
Article 22 – paragraph 1 – introductory part
Article 22 – paragraph 1 – introductory part
1. The Commission shall adopt implementingdelegated acts concerning:
Amendment 125 #
Proposal for a regulation
Article 22 – paragraph 1 – point a – point ii
Article 22 – paragraph 1 – point a – point ii
(ii) the mechanisms for the interaction between health technology bodies and health technology developers during clinical assessments including as regards to the protection of developer's confidential information;
Amendment 128 #
Proposal for a regulation
Article 22 – paragraph 1 a (new)
Article 22 – paragraph 1 a (new)
1 a. The methodologies referred to in paragraph 1(b) shall be developed on the basis of the existing EUnetHTA methodological guidelines and evidence submission templates. They shall be developed and agreed after consultations with all stakeholders, in a transparent manner, regularly updated to reflect the evolution of science and publicly available.
Amendment 129 #
Proposal for a regulation
Article 22 – paragraph 1 b (new)
Article 22 – paragraph 1 b (new)
Amendment 130 #
Proposal for a regulation
Article 22 – paragraph 1 c (new)
Article 22 – paragraph 1 c (new)
1 c. The methodology shall also: a) Provide for a suitable mechanism to create consensus on the identification of the patient-relevant health outcome, taking due account of the roles and preferences of relevant stakeholders, including patients, physicians, regulators, HTA bodies and health technology developers; b) take into account potential changes relating to the relevant comparator at national level due to the rapidly evolving standards of care.
Amendment 147 #
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. When preparing those implementing and delegated acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors and shall consider the work already undertaken in the EUnetHTA Joint Actions.
Amendment 204 #
Proposal for a regulation
Recital 12
Recital 12
(12) In order to ensure a wide application of harmonised rules on clinical aspects of HTA 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. JointCollaborative 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 viewon medical technologies should be conducted on a voluntary basis. A selection of medical devices for jointcollaborative clinical assessments 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). 12Regulation (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 219 #
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17a) The joint scientific consultation, when addressing Orphan medicines, has to ensure that any new approach should not result in unnecessary delays for Orphan Medicinal Products assessment compared to the current situation and taken into account the pragmatic approach undergone through the EUnetHTA.
Amendment 222 #
Proposal for a regulation
Recital 19
Recital 19
(19) In all cases the joint work carried out under this Regulation, in particular the joint clinical assessments, should produce high quality and timely results, and not delay or interfere with the CE marking of medical devices or market access of health technologies. This work should be separate and distinct from regulatory assessments of the safety, quality, efficacy or performance of health technologies carried out pursuant to other Union legislation and have no bearing on decisions taken in accordance with other Union legislation. In the framework of HTA, the joint report should not-assess the elements on which the marketing authorisation is based, including the quality, safety, efficacy, bioequivalence, or biosimilarity of the medicinal product which have been already assessed during the marketing authorisation process. Similarly, in the case of orphan medicinal products, the joint report should not re-assess the criteria of the orphan designation. However, assessors and co-assessors should have full access to the data used by the authorities responsible for granting the marketing authorisation of a medicinal product, as well as the possibility of using or generating additional relevant data for the purpose of assessing a medicinal product in the context of a joint HTA.
Amendment 238 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) The Commission, together with Member States, should adapt the framework of joint clinical assessment to vaccines to take into account their preventive nature that brings benefits to individuals and populations over a long time horizon. They should involve the appropriate national bodies in the joint clinical assessment of vaccines.
Amendment 257 #
Proposal for a regulation
Article 2 – paragraph 1 – point e
Article 2 – paragraph 1 – point e
(e) ‘clinical assessment’ means a compilation and evaluation of the available scientific evidence on a health technology in comparison with one or more other health technologies based on the following clinical domains of health technology assessment: the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem, the description and technical characterisation of the health technology, the and its relative clinical effectiveness, and the relative safety of the health technology;
Amendment 271 #
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 simplequalified majority. There decision shall be cone vote per Member Statesidered adopted if 55% of the members of the Coordination Group taking part, representing at least 65% of the population of the participating Member States, vote in favour.
Amendment 285 #
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. They shall fill in a declaration of interest which must be made public via the IT platform referred to in Article 27.
Amendment 295 #
Proposal for a regulation
Article 3 – paragraph 8 – point e – point i
Article 3 – paragraph 8 – point e – point i
Amendment 300 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The sub-group designated in accordance with Article 3(8)(e)Coordination Group shall prepare an annual work programme for approval by the Coordination Groupwhich it shall approve by December 31st of each year.
Amendment 301 #
Proposal for a regulation
Article 4 – paragraph 3 – introductory part
Article 4 – paragraph 3 – introductory part
3. In the preparation of the annual work programme, the designated sub- gCoordination Group shall:
Amendment 304 #
Proposal for a regulation
Article 4 – paragraph 3 – point c
Article 4 – paragraph 3 – point c
(c) consultinform the Commission onabout the draft annual work programme and take into account its opinion.
Amendment 309 #
Proposal for a regulation
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) medicinal products subject to the authorisation procedure provided for in Regulation (EC) No 726/2004, including where an amendment has been made to the Commission Decision to grant a marketing authorisation based on a change in the therapeutic indication or indications for which the original authorisation was granted, with the exception of medicinal products authorised under Articles 10 and 10a of Directive 2001/83/EC; with the exception of medicinal products authorised under Articles 10c and under Article 10 of Directive 2001/83/EC, unless it concerns a new therapeutic indication compared to the reference medicinal product.
Amendment 311 #
Proposal for a regulation
Article 5 – paragraph 1 – point a a (new)
Article 5 – paragraph 1 – point a a (new)
(aa) applications for new therapeutic indications for medicinal products authorised in accordance with Regulation (EC) No 726/2004.
Amendment 314 #
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
Amendment 318 #
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
Amendment 322 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 328 #
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
The Coordination Group shall initiate joint clinical assessments of health technologies on the basis of its annual work programme by designating a sub-group to oversee the preparation of the joint clinical assessment report on behalf of the Coordination Groupfrom among its members an assessor and a co-assessor to carry out the joint clinical assessment. The appointments shall take into account the scientific expertise necessary for the assessment.
Amendment 334 #
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
The joint clinical assessment report shall be accompanied by a summary report and they shall be prepared in accordance with the requirements in this Article and the requirements established pursuant to Articles 11, 22, and 23 and the procedures and work resulting from EUnetHTA joint actions for the joint clinical assessment of pharmaceuticals.
Amendment 343 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The designated sub-gCoordination Group shall request relevant health technology developers to submit documentation containing the information, data and evidence necessary for the joint clinical assessment.
Amendment 347 #
Proposal for a regulation
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2a. Where the health technology under assessment is an orphan medicinal product, the Coordination Group shall consider whether a joint clinical assessment is necessary based on the availability of any additional data and evidence, further than the ones already submitted to the European Medicines Agency for the purposes of establishing a significant benefit assessment pursuant to Regulation (EC) No 141/2000. Where the Coordination Group subsequently concludes that there is no substantive reason or additional evidence to support further clinical analysis beyond the significant benefit assessment already carried by the European Medicines Agency, the conclusions of the joint clinical assessment report shall be in line with the opinion of the Committee for Orphan Medicinal Products.
Amendment 352 #
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The designated sub-gCoordination Group shall appoint, from among its members, an assessor and a co-assessor to conduct the joint clinical assessment. The appointments shall take into account the scientific expertise necessary for the assessment.
Amendment 366 #
Proposal for a regulation
Article 6 – paragraph 6
Article 6 – paragraph 6
6. Where, at any stage in the preparation of the draft joint clinical assessment report, the assessor considers that additional evidence from the submitting health technology developer is necessary in order to complete the report, it may request the designated sub-gCoordination Group to suspend the time period set for the preparation of the report and to request additional evidence from the health technology developer. Having consulted the health technology developer on the time needed to prepare the necessary additional evidence, the request from the assessor shall specify the number of working days for which the preparation shall be suspended. Where new clinical data become available during the process, the health technology developer concerned may also proactively communicate this new information to the assessor.
Amendment 370 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The members of the designated sub-gCoordination 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 381 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. The designated sub-groupassessor and co-assessor shall ensure that stakeholders, including patients 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 384 #
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-gCoordination Group and to the Commission for comments.
Amendment 388 #
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-gCoordination Group and the Commission and submit a final draft joint clinical assessment report and the summary report to the Coordination Group for approval.
Amendment 392 #
Proposal for a regulation
Article 6 – paragraph 12
Article 6 – paragraph 12
12. The Coordination Group shall approvemake every effort to reach a consensus position on the final joint clinical assessment report and summary report, w. Wherever possible by consensus or, where necessary, by a simple majority of Member States a consensus is not possible, it shall act by a qualified majority of the Member States. The divergent opinions shall then be published as part of the joint clinical assessment report and the summary report.
Amendment 408 #
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 412 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
Amendment 416 #
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
Amendment 419 #
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
Amendment 423 #
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
Amendment 441 #
Proposal for a regulation
Article 9 – paragraph 1 – point b a (new)
Article 9 – paragraph 1 – point b a (new)
(ba) the health technology developer requests an update on the grounds that additional evidence is made available for which the Coordination Group would need to reconsider the conclusions of the initial assessment.
Amendment 443 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Coordination Group may carry out updates of joint clinical assessments where requested by one or more of its members. Updates are requested when new information has been published or made available which was not available at the time of the initial joint report. When an update of the joint report is decided, the member who proposed it can update the report and propose it for adoption by other Member States through mutual recognition. When updating the report, the Member State will apply the methods and standards as defined by the Coordination Group. In case Member States disagree with the update and it cannot be adopted by consensus, the case will be referred to the Coordination Group that will decide whether to carry out an update based on this new information. When an update is approved by mutual recognition or after the Coordination Group has carried out an update, the joint report is considered updated.
Amendment 458 #
Proposal for a regulation
Article 13 – title
Article 13 – title
Amendment 459 #
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1
Article 13 – paragraph 1 – subparagraph 1
Following the acceptance of a request for a joint scientific consultation in accordance with Article 12 and on the basis of its annual work programme, the Coordination Group shall designate a sub-group to oversee the preparation of the joint scientific consultation report on behalf of the Coordin, on behalf of the Coordinating Group, scientific consultation with the health technology developer. Appointment of the sub-group members shall take account of the scientific expertise required in each case. In the case of pharmaceutical products, where joint scientific consultation takes place in parallel with the procedure for obtaining a scientific opinion from the European Medicines Agency, the designated sub-group shall coordinate with the Agency to verify consistency between the conclusions of the joint scientific consultation Gproupcess and those of the scientific opinion.
Amendment 460 #
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 2
Article 13 – paragraph 1 – subparagraph 2
Amendment 462 #
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. The designated sub-group shall request the health technology developer to submit the documentation containing the information, data and evidence necessary for the joint scientific consultation. A joint meeting shall be scheduled on this basis, the agenda to be agreed between the designated sub-group and the health technology developer concerned.
Amendment 464 #
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
Amendment 465 #
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
Amendment 466 #
Proposal for a regulation
Article 13 – paragraph 5
Article 13 – paragraph 5
Amendment 467 #
Proposal for a regulation
Article 13 – paragraph 6
Article 13 – paragraph 6
Amendment 468 #
Proposal for a regulation
Article 13 – paragraph 7
Article 13 – paragraph 7
Amendment 471 #
Proposal for a regulation
Article 13 – paragraph 8
Article 13 – paragraph 8
8. The designated sub-group shall ensure that stakeholders, including patientthe health technology developer concerned and 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 476 #
Proposal for a regulation
Article 13 – paragraph 9
Article 13 – paragraph 9
9. Following receipt and consideration of any information and comments provided in accordance with paragraphs 6, 72 and 8, the assessor, with the assistance of the co-assessor, shall finalise the draft joint scientific consultation report and submit the report to the designated sub-group for commentsdesignated sub-group shall forward to the Coordination Group a joint scientific consultation report reflecting any differences of opinion expressed by members of the sub-group in the course of the procedure.
Amendment 477 #
Proposal for a regulation
Article 13 – paragraph 10
Article 13 – paragraph 10
Amendment 481 #
Proposal for a regulation
Article 13 – paragraph 11
Article 13 – paragraph 11
Amendment 489 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The Coordination Group shall communicate the approved joint scientific consultation report to the requesting health technology developer at the latest 10 working daysimmediately following its approval.
Amendment 508 #
Proposal for a regulation
Article 18 – paragraph 3 – subparagraph 1 (new)
Article 18 – paragraph 3 – subparagraph 1 (new)
When preparing the study, the Coordination Group shall ensure that commercially confidential information provided by the health technology developer is adequately protected. To this end, the Coordination Group shall give the health technology developer an opportunity to submit comments with respect to the contents of the study and shall take due account of those comments.
Amendment 513 #
Proposal for a regulation
Article 19 – paragraph 1 – point b
Article 19 – paragraph 1 – point b
(b) collaborative assessments on medical devices; based on the following criteria: – unmet medical needs; – potential impact on patients, public health, or healthcare systems; – significant cross-border dimension; – important Union-wide added value; – available resources; – requiring significant investment in structural or organizational changes or changing clinical pathways.
Amendment 516 #
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 1 (new)
Article 19 – paragraph 1 – subparagraph 1 (new)
Groups of Member States which share a common need identify, define and conduct collaborative clinical assessments on medical devices and in vitro diagnostics, as defined by Article 19(1) (b). The composition of these groups can vary.
Amendment 541 #
Proposal for a regulation
Article 22 – paragraph 1 – point a – point iii a (new)
Article 22 – paragraph 1 – point a – point iii a (new)
(iiia) ensuring that the assessments of medical devices can take place at the appropriate point in time after market launch, allowing for the use of clinical effectiveness data, including real world data. The appropriate time point shall be identified in cooperation with relevant stakeholders.
Amendment 542 #
Proposal for a regulation
Article 22 – paragraph 1 – point b
Article 22 – paragraph 1 – point b
(b) methodologies used to formulate the contents and design of clinical assessments. Common methods as well as data requirements and outcome measures shall take into account the specificities of medical devices and in vitro diagnostics.
Amendment 547 #
Proposal for a regulation
Article 22 – paragraph 1 a (new)
Article 22 – paragraph 1 a (new)
1a. Procedural rules and methodologies referred to in paragraph 1 shall follow the output of the EUnetHTA Joint Actions, be developed and agreed between all stakeholders in a transparent manner, updated periodically and publicly available.
Amendment 548 #
Proposal for a regulation
Article 22 – paragraph 1 b (new)
Article 22 – paragraph 1 b (new)
1b. The methodology mentioned in paragraph 1(b) shall also take into account : – the lifelong effect of a vaccine through appropriate time horizon of the analyses; – indirect effects such as herd immunity; – elements independent from the vaccine as such, for example coverage rates linked to programmes.
Amendment 589 #
Proposal for a regulation
Article 28 – paragraph 1
Article 28 – paragraph 1
No later than two years after the end of the transitional period referred to in Article 33(1), the Commission shall report on the implementation of the provisions on the scope and use of the joint clinical assessments and on the functioning of the support framework referred to in this Chapter.
Amendment 592 #
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. When preparing those implementing and delegated acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors and shall consider the work already undertaken in the EUnetHTA Joint Actions.