Activities of Soledad CABEZÓN RUIZ related to 2018/0018(COD)

Proposal for a regulation
Recital 4

(4) The outcome of HTA is used to inform decisions concerning the allocation of budgetary resources in the field of health, for example, in relation to establishing the pricing or reimbursement levels of health technologies. HTA can therefore assist Member States in creating and maintaining sustainable and comprehensive healthcare systems ~~and to~~while stimulateing quality innovation ~~that~~and increasing sector competitivity , which will ultimately delivers better outcomes for patients.

2018/05/25
Committee: ITRE

Proposal for a regulation
Recital 11

(11) In accordance with Article 168(7) of the Treaty on the Functioning of the European Union (TFEU), the Member States remain responsible for the organisation and delivery of their healthcare. As such, it is appropriate to limit the scope of Union rules to those aspects of HTA that relate to the clinical assessment of a health technology~~, and in particular, to ensure that the assessment conclusions are confined to findings~~. In this connection, the joint clinical assessment provided for by this Regulation, which will be mandatory for Member States, constitutes a scientific analysis of the relative effects of health technology on clinical outcomes, evaluated in relationg to the chosen comparative ~~effectiveness of a health technology~~indicators and chosen groups or subgroups of patients, taking into account the HTA Core Model criteria. This will include consideration of the degree of certainty on the relative outcomes, based on the available evidence. The outcome of such joint clinical assessments should not therefore affect the discretion of Member States in relation to subsequent decisions on pricing and reimbursement of health technologies, including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non-clinical considerations, and which remain solely a matter of national competence. The assessment conducted by each Member State as part of its national appraisal therefore falls outside the scope of this Regulation. Such appraisals must include: (1) the joint clinical assessment; (2) the data specific to each Member State (suitable comparative indicators and their reimbursement status); the medical need within their health system; information on a national early-access programme, if available; the target group, therapeutic strategy, clinical use); (3) context-specific analyses (suitable comparative indicators, relevant patient subgroups, target population, cost of the health-care system, guaranteed high-quality use); (4) additional context-specific considerations for each Member State (number of patients affected in the Member State, current treatment received by patients in the health system, costs).

2018/05/25
Committee: ITRE

Răzvan POPA, Soledad CABEZÓN RUIZ, Cristian-Silviu BUŞOI, Dan NICA

Proposal for a regulation
Recital 11

(11) In accordance with Article 168(7) of the Treaty on the Functioning of the European Union (TFEU), the Member States remain responsible for the organisation and delivery of their healthcare. As such, it is appropriate to limit the scope of Union rules to those aspects of HTA that relate to the clinical assessment of a health technology~~, and in particular, to ensure that the assessment conclusions are confined to findings~~. In this connection, the joint clinical assessment provided for by the Regulation, which will be mandatory for Members States, constitutes a scientific analyses of the relatives effects of healthy technology on clinical outcomes, evaluated in relationg to the chosen comparative ~~effectiveness of a health technology~~indicators and chosen groups or subgroups of paints, taking into account the HTA Core Model criteria. This will include consideration of the degree of certainty on the relative outcomes, based on the available evidence. The outcome of such joint clinical assessments should not therefore affect the discretion of Member States in relation to subsequent decisions on pricing and reimbursement of health technologies, including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non-clinical considerations, and which remain solely a matter of national competence.

2018/05/25
Committee: ITRE

Proposal for a regulation
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 given the need for greater clinical evidence concerning all of these new technologies. _________________ 11 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). 12 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

2018/05/25
Committee: ITRE

Proposal for a regulation
Recital 14

(14) A coordination group composed of representatives from Member States' health technology assessment of national and regional authorities and bodies should be established with responsibility for overseeing the carrying out of joint clinical assessments and other joint work.

2018/05/25
Committee: ITRE

Proposal for a regulation
Recital 16

(16) In order t~~hat the harmonised procedures fulfil their internal market objective~~o meet their internal market objectives, increase clinical evaluation efficiency, contribute to sustainability of healthcare systems and maximize the quality of innovation , Member States should be required to take full account of ~~the results of~~ joint clinical assessment~~s and not repeat those assessmen~~ results. 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.

2018/05/25
Committee: ITRE

Proposal for a regulation
Recital 19 a (new)

(19 a) The health technology assessment work covered under this Regulation should be separate and distinct from regulatory assessments of the safety and efficacy of health technologies carried out pursuant to other Union legislation and have no bearing on other aspects unrelated to the subject matter of this Regulation adopted in accordance with other Union legislation.

2018/05/25
Committee: ITRE

Proposal for a regulation
Recital 24

(24) In order to ensure the inclusiveness and transparency of the joint work, the Coordination Group should engage and consult widely with interested parties and stakeholders. However, in order to preserve the integrity of the joint work, rules should be developed to ensure the independence and impartiality of the joint work and ensure that such consultation does not give rise to any conflicts of interest. Furthermore, these rules and all consultations must be made public.

2018/05/25
Committee: ITRE

Proposal for a regulation
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 toshould establish ~~a common procedural and methodological framework for clinical assessments, procedures~~, by means of implementing acts, a common procedural framework for joint clinical assessments and ~~procedures for~~ joint scientific consultations~~. Where appropriate~~, while the Coordination Group should establish a common methodological framework. Where appropriate, and in justified cases, distinct rules ~~should~~must 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 may be taken into account. 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).

2018/05/25
Committee: ITRE

Proposal for a regulation
Recital 27

(27) In order to ensure that sufficient resources are available for the joint work and stable administrative support provided for under this Regulation, the Union should ~~provide funding~~ensure stable and permanent public provide funding under the Multiannual Financial Framework for the joint work and voluntary cooperation, and for the support framework to support these activities. The funding should cover the costs of producing joint clinical assessment and joint scientific consultation reports. Member States should also have the possibility to second national experts to the Commission in order to support the secretariat of the Coordination Group.

2018/05/25
Committee: ITRE

Proposal for a regulation
Recital 28

(28) In order to facilitate the joint work and the exchange of information between Member States on HTA, provision should be made for the establishment of an IT platform that contains appropriate databases and secure channels for communication. The Commission should also ensure a link between the IT platform and other data infrastructures relevant for the purposes of HTA such as registries of real world data. The IT platform should ensure the publication and transparency for both the joint scientific consultations and the joint technology assessment, regarding all the clinical data employed, the studies, the methodology, the clinical results, the stakeholders consulted, the observations made, and the final reports.

2018/05/25
Committee: ITRE

Proposal for a regulation
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~~the Commission should establish, by means of implementing acts, a common procedural framework for joint clinical assessments and ~~procedures for~~ joint scientific consultations~~. Where appropriate~~, while the Coordination Group should establish a common methodological framework. Where appropriate, and in justified cases, distinct rules ~~should~~must 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 may be taken into account. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.13. The methodology should guarantee high quality and high clinical evidence. Any flexibility in the methodology should be exceptional and adapted to very specific circumstances, but never to the detriment of the quality of health technologies or clinical evidence. Clinical trials are the studies par excellence in the biomedical field, so the use of another type of study, for example, epidemiological studies, should be exceptional and fully justified. The rules to be developed in tertiary legislation should cover the possibilities for improvement of clinical evidence in the cases where further scientific evidence is needed. _________________ 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).

2018/06/13
Committee: IMCO

Proposal for a regulation
Article 3 – paragraph 7

7. The Commission shall publish a list of the designated members of the Coordination Group and its sub-groups on the IT platform referred to in Article 27. The Commission shall regularly update any changes to this list or related information to the Coordination Group.

2018/05/25
Committee: ITRE

Proposal for a regulation
Article 5 – paragraph 1 – point c a (new)

(c a) other medical devices considered to be of interest on the basis of the criteria set out in paragraph 2.

2018/05/25
Committee: ITRE

Proposal for a regulation
Article 3 – paragraph 6

6. Members of the Coordination Group, and their appointed representatives shall respect the principles of independence, impartiality, and confidentiality. Transparency and publicity of the process is essential. In this connection, all clinical data being evaluated shall have the highest level of transparency and publicity in order to gain confidence in the system. In case there is confidential data for commercial reasons, the confidentiality needs to be clearly defined and justified and the confidential data well delimitated.

2018/06/13
Committee: IMCO

Proposal for a regulation
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. In the interests of transparency, the relationship between evaluators and technology developers must be independent. The evaluators must have guaranteed their independence in the development of their work, without there being neither conditionalities nor interference from the technology developers in the evaluation process. Developers of technologies can be consulted but never participate in the evaluation.

2018/06/13
Committee: IMCO

Proposal for a regulation
Article 8 – paragraph 1 – point a a (new)

(a a) Paragraph 1(b) shall not prevent Member States from carrying out assessments on the added clinical value of the technologies concerned as part of national or regional appraisal processes which may consider clinical as well as non- clinical data and evidence specific to the Member Sates concerned which did not form part of the joint clinical assessment and witch are necessary to complete the general assessment of healthy technology.

2018/05/25
Committee: ITRE

Proposal for a regulation
Article 11 – paragraph 1 – point f

(f) cooperation ~~with the notified bodies and expert panels~~between the European Medicines Agency and the Coordination Group on the preparation and update of joint clinical assessments of medicinal ~~devices~~products. This cooperation shall take into account that the Coordination Group, due to its competences in clinical aspects, is the competent body to detect and prioritize the emerging technologies based on impact on health.

2018/06/13
Committee: IMCO

Proposal for a regulation
Article 24 – paragraph 2 a (new)

2 a. In any event, the Union shall ensure stable and permanent public funding under the Multiannual Financial Framework.

2018/05/25
Committee: ITRE

Proposal for a regulation
Article 22 – paragraph 1 – point b

~~(b) methodologies used to formulate the contents and design of clinical assessments.~~deleted

2018/06/13
Committee: IMCO

Proposal for a regulation
Article 22 – paragraph 2 a (new)

2 a. The Coordination Group shall draw up the methodologies to be used to carry out joint clinical assessments and consultations and shall define the content of those assessments and consultations. In any event: (a) the methodologies shall be based on high standards of quality, the best available scientific evidence, stemming primarily from double-blind randomised clinical trials, meta-analysis and systematic reviews; (b) the assessment of relative effectiveness shall be based on end-points which are relevant to the patient with useful, relevant, tangible and specific criteria suited to the clinical situation concerned; c) the comparators shall be the reference comparators for the clinical entity concerned and be the best and/or most commonly used technological or process based comparator; d) the technology developers shall, for the purpose of its clinical assessment, provide the Coordination Group with the complete dossier in eCTD format submitted to the European Medicines Agency for centralised authorisation. This package shall include the Clinical Study Report and the data of individual patients in all clinical trials; e) the information to be provided by the health technology developer shall relate to the most up-to-date and public research. Failure to comply with this requirement may trigger a sanctions mechanism. Any flexibility in the methodology shall be exceptional and adapted to very specific circumstances, but never to the detriment of the quality of health technologies or clinical evidence. The methodology must guarantee high quality and high clinical evidence. Since clinical trials are the studies par excellence in the biomedical field, the use of another type of study shall be exceptional and fully justified. The rules to be developed by the Coordination Group shall cover the possibilities for improvement of clinical evidence in the cases where further scientific evidence is needed.

2018/06/13
Committee: IMCO

Proposal for a regulation
Recital 19 a (new)

(19a) The recently adopted Regulations (EU) No 2017/745 concerning medical devices and (EU) 2017/746 concerning in vitro diagnostic medical devices provide for the authorisation of such devices on the basis of the principles of transparency and safety and not on efficacy. However, the gradual increase in the supply of medical devices to address clinical conditions has heralded a paradigm shift towards a new model in which the market is highly fragmented, innovation is chiefly incremental and clinical evidence is lacking, which means that closer cooperation and more frequent exchanges of information between assessment bodies are needed. It is therefore necessary to move towards a centralised authorisation system that assesses devices on the basis of safety, efficacy and quality. This is one of the areas in which the Member States are calling for greater collaboration on a future European ETS. Twenty Member States, together with Norway, currently have health technology assessment systems for medical devices in place and 12 Member States, together with Norway, have established guidelines and are engaging in initial dialogues. EUnetHTA has been conducting high-quality evaluations of the relative efficacy of medical devices based on a methodology that can be taken as a benchmark in this proposal.

2018/06/18
Committee: ENVI

Proposal for a regulation
Article 5 – paragraph 2 – point e a (new)

(ea) the application from the health technology developer;

2018/06/18
Committee: ENVI

Proposal for a regulation
Article 6 – paragraph 7

7. The members of the designated sub-group or the Coordination 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.

2018/06/18
Committee: ENVI

Proposal for a regulation
Article 9 – paragraph 1 – point b a (new)

(ba) at the request of a Member State that considers that there is new clinical evidence.

2018/06/15
Committee: ENVI

Proposal for a regulation
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, subject to the provisions of the previous article;

2018/06/15
Committee: ENVI

Proposal for a regulation
Article 22 – paragraph 1 – point a – point iii

(iii) the consultation of patients, clinical experts, and other stakeholders in clinical assessments, subject to the provisions of the previous article.

2018/06/15
Committee: ENVI