Activities of Gesine MEISSNER related to 2018/0018(COD)
Plenary speeches (1)
Health technology assessment (debate) DE
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 (69)
Amendment 43 #
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. 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). 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 46 #
Proposal for a regulation
Recital 15
Recital 15
(15) In order to ensure a Member-State led approach to joint clinical assessments and scientific consultations, Member States should designate national HTA authorities and bodies which inform decision-making as members of the Coordination Group. The designated authorities and bodies should ensure an appropriately high level of representation in the Coordination Group and technical expertise in its sub- groups, taking into account the need to provide expertise on the HTA of medicinal products and medical devices.
Amendment 51 #
Proposal for a regulation
Recital 18
Recital 18
Amendment 53 #
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.
Amendment 62 #
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. 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 68 #
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28 a) Given the sensitive nature of health information, the confidential handling of data should be safeguarded at all times.
Amendment 83 #
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
Amendment 85 #
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
Amendment 86 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 96 #
Proposal for a regulation
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2 a. The designated sub-group shall request, in addition to the data referred to in paragraph 2, data from relevant sources, such as patient registries, databases or European Reference Networks, where that data is deemed necessary to complete the information provided by the health technology developers and to perform a more accurate clinical assessment of the health technology.
Amendment 106 #
Proposal for a regulation
Article 6 – paragraph 13
Article 6 – paragraph 13
13. The assessor shall ensure the removal of any information of a commercially sensitive nature from the approved joint clinical assessment report and the summary report. The assessor shall consult the developer on the report before its publication. The developer shall have a period of 30 working days to respond in order to identify any information it considers confidential and to justify the commercially sensitive nature of that information. In the event of disagreement between the assessor and the developer, the assessor and the co- assessor shall decide.
Amendment 131 #
Proposal for a regulation
Article 11 – paragraph 1 – point f
Article 11 – paragraph 1 – point f
Amendment 143 #
Proposal for a regulation
Article 16 – paragraph 1 – point d
Article 16 – paragraph 1 – point d
(d) the consultation of patients, healthcare professionals, clinical experts and other relevant stakeholders;
Amendment 145 #
Proposal for a regulation
Article 16 – paragraph 1 – point f
Article 16 – paragraph 1 – point f
Amendment 147 #
Proposal for a regulation
Article 18 – paragraph 2 – introductory part
Article 18 – paragraph 2 – introductory part
2. In the preparation of the study, the Coordination Group shall consultbe conscious of breakthrough innovations and seek the input of all relevant stakeholders with the aim of exploring new possibilities in innovation. The Coordination Group shall consult all relevant stakeholders, including but not limited to:
Amendment 149 #
Proposal for a regulation
Article 18 – paragraph 2 – point c a (new)
Article 18 – paragraph 2 – point c a (new)
(c a) healthcare professionals;
Amendment 151 #
Proposal for a regulation
Article 19 – paragraph 1 – point b
Article 19 – paragraph 1 – point b
Amendment 152 #
Proposal for a regulation
Article 19 – paragraph 1 – point c
Article 19 – paragraph 1 – point c
(c) health technology assessments on health technologies other than medicinal products or medical devices;
Amendment 155 #
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 establish, after consulting all relevant stakeholders:
Amendment 159 #
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, healthcare professionals, clinical experts, and other stakeholders in clinical assessments.
Amendment 167 #
Proposal for a regulation
Article 25 – paragraph 1 – point f
Article 25 – paragraph 1 – point f
Amendment 174 #
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
4. On the request of the Coordination Group, the Commission shall invite patients, healthcare professionals and clinical experts nominated by the stakeholder network to attend meetings of the Coordination Group as observers.
Amendment 176 #
Proposal for a regulation
Article 27 a (new)
Article 27 a (new)
Article 27 a Common rules on data 1. The Commission shall be empowered to adopt delegated acts in accordance with Article 31 concerning data collection, interoperability of data and the comparability of data. 2. Assessors and co-assessors shall 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 purposes of assessing a medicinal product in the context of a joint HTA. 3. The confidential handling of data shall be safeguarded at all times.
Amendment 179 #
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.
Amendment 189 #
Proposal for a regulation
Recital 5
Recital 5
(5) The carrying out of parallel assessments by multiple Member States and divergences between national laws, regulations and administrative provisions on the processes and methodologies of assessment can result in health technology developers being confronted with multiple and divergent requests for data. It can also lead to both duplications and variations in outcomes that increase the financial and administrative burdens that act as a barrier to the free movement of the health technologies concerned and the smooth functioning of the internal market. However, producing assessments that are not relevant for reimbursement decisions in certain Member States may delay the implementation of innovative technologies and thus access of patients to beneficial innovative treatments.
Amendment 203 #
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. 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). 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 220 #
Proposal for a regulation
Recital 18
Recital 18
(18) The establishment of a time-frame for the joint clinical assessments for medical devices should take into account the highly decentralised market access pathway for medical devices and the availability of appropriate evidence data required to carry out a joint clinical assessment. As the required evidence may only become available after a medical device has been placedRegulations (EU) 2017/745 and (EU) 2017/746 set new requirements for high-quality data on the safety and efficacy of medical devices and in-vitro medical devices, which include clinical investigations and evidence on the clinical benefit onf the market and in order to allow for the selection of medical devices for joint clinical assessment at an appropriate time, it should be possible for assessments of such devices to take place following market launch of medical devicesdevices. Therefore medical devices and in-vitro medical devices shall not be part of the EU joint assessment.
Amendment 223 #
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 accesset access of health technologies. This work focusses solely on the efficacy of health technologies. This work and 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.
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 254 #
Proposal for a regulation
Article 2 – paragraph 1 – point b a (new)
Article 2 – paragraph 1 – point b a (new)
(ba) assessments of a ‘medical device’ may also mean the assessment of a method composed of more than one medical device or a method composed of a medical device and a defined care chain of other treatments.
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 260 #
Proposal for a regulation
Article 2 – paragraph 1 – point g a (new)
Article 2 – paragraph 1 – point g a (new)
(ga) ‘patient-relevant outcomes’ or ‘patient relevant endpoints’ means data that captures or predicts mortality, morbidity, health related quality of life (including pain, recovery rates and time, length of stay in hospital), adverse events (including re-admissions, complications, blood loss, infections).
Amendment 277 #
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-a chair elected from the members of the group for a set term to be determined in its rules of procedure. The Commission shall attend the meetings as an observer.
Amendment 305 #
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 313 #
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
Amendment 319 #
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
Amendment 321 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 341 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The designated sub-group shall request relevant health technology developers to submit documentation containing the information, data and evidence necessary for the joint clinical assessment. For medicinal products referred to in Article 5 (1)(a), this shall include: (a) the submission file; (b) an indication of the marketing authorisation status; (c) if available, the European public assessment report (EPAR), including the Summary of Product Characteristics (SPC); (d) where applicable, the results of additional studies requested by the Coordination Group and available to the health technology developer; (e) where applicable and if available to the health technology developer, already available HTA reports on the health technology concerned; (f) information on studies and study registries available to the health technology developer.
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 358 #
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 outcomeclinical endpoints chosen for the assessment compared to the assessed comparative therapies;
Amendment 363 #
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 the available evidence. The conclusions do not include an appraisal of the clinical efficacy of the health technology assessed or any recommendations for such an appraisal.
Amendment 390 #
Proposal for a regulation
Article 6 – paragraph 12
Article 6 – paragraph 12
12. The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a simple majority of Member States. Diverging positions and the grounds on which they are based should be recorded in the final report. This shall include a sensitivity analysis if there are: – different opinions on studies to be excluded due to severe bias or – diverging positions if studies shall be excluded as they do not reflect the up- to-date technological development or – controversies on the definition of irrelevance thresholds regarding patient- relevant endpoints. The choice of the comparator(s) and patient-relevant endpoints must be medically justified and documented in the final report. Where applicable, the final report shall also include the results of the joint scientific consultation carried out in accordance with Article 13.
Amendment 407 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Where the Commission considers that there are no legal obstacles to the inclusion of the approved joint clinical assessment report and summary report comply with the substantiin a list of technologies that have aund procedural requirements laid down in this Regulation,ergone a joint clinical assessment (hereafter referred to as ‘the list of assessed technologies’ or ‘list’) 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 "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 413 #
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 procedurlegal 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 420 #
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 procedurlegal 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 424 #
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 procedurlegal 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 426 #
Proposal for a regulation
Article 7 – paragraph 6
Article 7 – paragraph 6
6. For those health technologies included on the List of Assessed Health Technologies, the Commission shall publish the approved joint clinical assessment report and summary report on the IT platform referred to in Article 27 and make them available to the submitting health technology developer at the latest 105 working days following their inclusion in the List.
Amendment 433 #
Proposal for a regulation
Article 8 – paragraph 1 – point a a (new)
Article 8 – paragraph 1 – point a a (new)
(aa) This shall not prevent the Member States from complementing the joint clinical assessment with clinical assessments comparing the technology against a comparator which represents the best available standard of care in this Member State or assessing the technology in a different care context how the technology is applied which, despite the Member States request during the scoping phase, will not form part of the joint clinical assessment and which is necessary to complete the health technology assessment in that Member State. Any such measure should be justified, necessary and proportionate to achieving this aim.
Amendment 434 #
Proposal for a regulation
Article 8 – paragraph 1 – point a b (new)
Article 8 – paragraph 1 – point a b (new)
(ab) The Member State shall notify the Commission and the Coordination Group of their intention to complement the joint clinical assessment together with a justification for doing so no later than 2 weeks after the Coordination Group has laid down the specific requirements for the joint assessment of the specific technology.
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 451 #
Proposal for a regulation
Article 11 – paragraph 1 – point f
Article 11 – paragraph 1 – point f
Amendment 453 #
Proposal for a regulation
Article 11 – paragraph 1 – point f a (new)
Article 11 – paragraph 1 – point f a (new)
(fa) a mandatory stakeholder participation with hearings and the opportunity to address written statements at the beginning of the assessment and before the draft report is finalised, including all relevant health technology developers, their associations on national and European level, all relevant medical societies on national and European level and patient organisations on national and European level.
Amendment 498 #
Proposal for a regulation
Article 16 – paragraph 1 – point f
Article 16 – paragraph 1 – point f
Amendment 507 #
Proposal for a regulation
Article 18 – paragraph 2 – point e
Article 18 – paragraph 2 – point e
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 509 #
Proposal for a regulation
Article 19 – paragraph 1 – introductory part
Article 19 – paragraph 1 – introductory part
1. TIf deemed necessary by the Member States, the Commission shall support any further cooperation and the exchange of scientific information among them. The format and scope of the cooperation shall be solely determined by the Member States on:.
Amendment 510 #
Proposal for a regulation
Article 19 – paragraph 1 – introductory part
Article 19 – paragraph 1 – introductory part
1. The Commission shall support cooperation and the exchange of scientific information among Member States on:.
Amendment 511 #
Proposal for a regulation
Article 19 – paragraph 1 – point a
Article 19 – paragraph 1 – point a
Amendment 512 #
Proposal for a regulation
Article 19 – paragraph 1 – point b
Article 19 – paragraph 1 – point b
Amendment 514 #
Proposal for a regulation
Article 19 – paragraph 1 – point c
Article 19 – paragraph 1 – point c
Amendment 515 #
Proposal for a regulation
Article 19 – paragraph 1 – point d
Article 19 – paragraph 1 – point d
Amendment 518 #
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. TIf deemed necessary the Coordination Group shallmay be used to facilitate the cooperation referred to in paragraph 1.
Amendment 519 #
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
Amendment 521 #
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
Amendment 523 #
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 23 shall apply to: joint clinical assessments carried out in accordance with Chapter II. Member States may also apply these rules and methodology to clinical assessments of medicinal products and medical devices carried out by them.
Amendment 525 #
Proposal for a regulation
Article 20 – paragraph 1 – point a
Article 20 – paragraph 1 – point a
Amendment 528 #
Proposal for a regulation
Article 20 – paragraph 1 – point b
Article 20 – paragraph 1 – point b
Amendment 551 #
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. The financing of the work of the Coordination Group and its sub-groups and activities in support of that work involving its cooperation with the Commission, with the European Medicines Agency, and with the stakeholder network referred to in Article 26 shall be ensured by the Union. The Union's financial assistance to the activities under this Regulation shall be implemented in accordance with Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council.18 The joint work on HTA shall be conducted without the direct or indirect funding by developers of health technologies. __________________ 18 Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1).