Activities of Răzvan POPA related to 2018/0018(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU
Amendments (45)
Amendment 25 #
Proposal for a regulation
Recital 2
Recital 2
(2) Health Technology Assessment (HTA) is an evidence-based, multidisciplinary process that allows competent authorities to determine the relative effectiveness of new or existing health technologies and should be carried out in a systematic, independent and transparent manner. HTA focuses specifically on the added value of a health technology in comparison with other new or existing health technologies.
Amendment 27 #
Proposal for a regulation
Recital 3
Recital 3
(3) HTA covers both clinical and non- clinical aspects of a health technology. The EU co-funded joint actions on HTA (EUnetHTA Joint Actions) have identified nine domains by reference to which health technologies are assessed. Of these nine domains, four are clinical and five are non- clinical. The four clinical domains of assessment concern the identification of a health problem and current technology, the examination of the technical characteristics of the technology under assessment, its relative safety, and its relative clinical effectiveness. The five non-clinical assessment domains concern cost and economic evaluation of a technology, its ethical, organisational, social, and legal aspects. The clinical domains are therefore more suited to joint assessment at EU-level on their scientific evidence base, while t. The assessment of non-clinical domains tends to be moreshould closely related to national and regional contexts and, approaches and competences.
Amendment 28 #
Proposal for a regulation
Recital 4
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 towhile stimulateing quality innovation thatand increasing sector competitivity , which will ultimately delivers better outcomes for patients.
Amendment 29 #
Proposal for a regulation
Recital 8
Recital 8
(8) The European Parliament, in its resolution of 2 March 2017 on EU options for improving access to medicines,9 called on the Commission to propose legislation on a European system for health technology assessment as soon as possible and to harmonise transparent health technology assessment criteria in order to assess the added therapeutic value of medicinehealth technologies compared with the best available alternative taking into account the level of innovation and value for the patients. _________________ 9 European Parliament resolution of 2 March 2017 on EU options for improving access to medicines – 2016/2057(INI).
Amendment 31 #
Proposal for a regulation
Recital 11
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 technologyindicators 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.
Amendment 32 #
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 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).
Amendment 33 #
Proposal for a regulation
Recital 14
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.
Amendment 34 #
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 research 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 37 #
Proposal for a regulation
Recital 16
Recital 16
(16) In order that the harmonised procedures fulfil their internal market objectiveo 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 assessments 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.
Amendment 38 #
Proposal for a regulation
Recital 19 a (new)
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 performance 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.
Amendment 42 #
Proposal for a regulation
Recital 24
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.
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 46 #
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 onthe Coordination Group together with the Commission toshould 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 Coordination Group and 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 49 #
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 of the contents of documents 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, but with the obligation to periodically inform the European Parliament and the Council of these documents and reports. 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 50 #
Proposal for a regulation
Recital 27
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 fundingensure 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.
Amendment 51 #
Proposal for a regulation
Recital 28
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.
Amendment 53 #
Proposal for a regulation
Recital 32
Recital 32
(32) The Commission should carry out an evaluation of this Regulation. Pursuant to paragraph 22 of the Interinstitutional Agreement on Better Law-Making of 13 April 2016, that evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and EU added value and should be supported by a monitoring programme. The results must also be communicated to the European Parliament and Council for approval.
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 58 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Member States shall designate their national authorities and bodies responsible for health technology assessment which inform decision-making as members of the Coordination Group and its sub-groups and inform the Commission thereof and of any subsequent changes. Member States mayshall designate more than one authority or body responsible for health technology assessment which inform decision-making at national level as members of the Coordination Group and one or more of its sub-groups.
Amendment 62 #
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 transparency, independence, impartiality, and confidentiality for specific information.
Amendment 63 #
Proposal for a regulation
Article 3 – paragraph 7
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.
Amendment 65 #
Proposal for a regulation
Article 3 – paragraph 8 – point a a (new)
Article 3 – paragraph 8 – point a a (new)
(a a) conduct health technology assessments activities and manage the general governance of joint works in an independent and transparent way;
Amendment 66 #
Proposal for a regulation
Article 3 – paragraph 8 – point c
Article 3 – paragraph 8 – point c
(c) ensure cooperation with all relevant Union level bodies to facilitate additional evidence generation necessary for its work;
Amendment 67 #
Proposal for a regulation
Article 3 – paragraph 8 – point d
Article 3 – paragraph 8 – point d
(d) ensure appropriate involvement of all relevant stakeholders in its work;
Amendment 70 #
Proposal for a regulation
Article 3 – paragraph 10 a (new)
Article 3 – paragraph 10 a (new)
10 a. Each national authority and body responsible for health technology assessment as members of the Coordination Group and its sub-groups, and each member and staff of each national authority and body responsible for health technology assessment shall in accordance with Union or Member State law be subject to a duty of professional secrecy both during and after their term of office, with regard to any confidential information which has come to their knowledge in the course of the performance of their tasks or exercise of their powers.
Amendment 73 #
Proposal for a regulation
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) medicinal products subject to and at the time of 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, and those medicinal products authorised under Article 8 (3) of Directive 2001/83/EC not incorporating a new active substance;
Amendment 79 #
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 Group. With respect to medicinal products, the Coordination Group shall initiate joint clinical assessments in accordance with the EMA pre-notification of medicinal products prior to marketing authorisation applications.
Amendment 81 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The designated sub-group shall requestmeet with relevant health technology developers to submiton the scope of the assessment and documentation containing the information, data and evidence necessary for the joint clinical assessment to be submitted.
Amendment 83 #
Proposal for a regulation
Article 6 – paragraph 5 – point a
Article 6 – paragraph 5 – point a
(a) an analysis description of the relative effects of the health technology being assessed on the patient-relevant health outcomes chosenagreed for the assessment;
Amendment 85 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. The designated sub-group shall ensure that stakeholders experts, including patients and clinical experts identified to by the Stakeholder network or by the health technology developer, 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 96 #
Proposal for a regulation
Article 8 – paragraph 1 – point a a (new)
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.
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 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 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 133 #
Proposal for a regulation
Article 23 – paragraph 1 a (new)
Article 23 – paragraph 1 a (new)
2. The data and evidence referred in paragraph 1(a)(i) shall be limited to the best available evidence at the time of the submission for clinical assessment and may include data from other sources than randomized clinical trials.
Amendment 134 #
Proposal for a regulation
Article 24 – paragraph 2 a (new)
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.
Amendment 136 #
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications. The Commission services shall take the following criteria into account when assessing applications:
Amendment 137 #
Proposal for a regulation
Article 26 – paragraph 1 – point i (new)
Article 26 – paragraph 1 – point i (new)
(i) demonstrated current or planned engagement in HTA development (activity reports, work plans, position papers, active working groups, EU-funded actions);
Amendment 138 #
Proposal for a regulation
Article 26 – paragraph 1 – point ii (new)
Article 26 – paragraph 1 – point ii (new)
(ii) professional expertise relevant to the aims of the Pool at EU level;
Amendment 140 #
Proposal for a regulation
Article 26 – paragraph 1 – point iv (new)
Article 26 – paragraph 1 – point iv (new)
(iv) geographical coverage of several Member States, with preference for a balanced coverage;
Amendment 142 #
Proposal for a regulation
Article 27 – paragraph 1 a (new)
Article 27 – paragraph 1 a (new)
1 a. Following the end of the transitional period referred to in Article 33(1), with respect to medicinal products, the identification of emerging health technologies shall follow the EMA pre- notification of medicinal products prior to marketing authorisation applications.
Amendment 143 #
Proposal for a regulation
Article 27 – paragraph 2
Article 27 – paragraph 2
2. The Commission shall ensure appropriate levels of accesinteractive access and availability and access in all EU languages to the information contained in the IT platform for Member State bodies, members of the stakeholder network, and the general public.
Amendment 145 #
Proposal for a regulation
Article 27 – paragraph 2 a (new)
Article 27 – paragraph 2 a (new)
2 a. All confidential data provided by a manufacturer shall be covered by a clear confidentiality agreement. The Commission shall also ensure the protection of confidential data against unauthorised access or disclosure, and ensure the integrity of data stored against accidental or unauthorised destruction, accidental loss or alteration.
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.