12 Amendments of Inés AYALA SENDER related to 2018/0018(COD)
Amendment 183 #
Proposal for a regulation
Recital 4
Recital 4
(4) The outcome of HTA is used to inform decisions concerning the allocation of budgetaryHealth technology assessment is an important tool for promoting high- quality innovation, for steering research towards addressing the unmet (diagnostic, therapeutic or procedural) needs of health systems and clinical and social priorities, and for improving scientific evidence used to inform clinical decision-making, efficiency in use of resources in, the field of health, for example, in relation to establishing the pricing or reimbursement levels of health technologisustainability of health systems, patient access to these health technologies, and the competitiveness of the sector through greater predictability and more efficient research. Member States use the outcome of HTA to augment the scientific evidence that informs decisions to introduce health technologies into their systems, or in other words, to inform decisions on how to allocate resources. HTA can therefore assist Member States in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients.
Amendment 187 #
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4a) Cooperation in the field of HTA can extend beyond pharmaceutical products and medical devices. It may also cover areas such as diagnostics used to supplement treatment, surgical procedures, prevention, screening and health promotion programmes, information and communications technology (ICT) tools, health-care organisation plans and integrated care processes. Different demands are involved in assessing different technologies, depending on their specific features, meaning that a cohesive approach which can cater for these different technologies is needed in the field of HTA. Moreover, in specific areas such as treatments for rare diseases, paediatric medicines, precision medicine and advanced therapies, the added value of cooperation at EU level is likely to be even greater.
Amendment 192 #
Proposal for a regulation
Recital 6
Recital 6
(6) While Member States have carried out some joint assessments within the framework of the EU co-funded joint actions, the production of output has been inefficient, relying on project-based cooperation in the absence of a sustainable model of cooperation. Use of the results of the joint actions,. This was done in three stages, under Article 15 of Directive 2011/24/EC, through three joint actions, each with specific objectives and a specific budget: EUnetHTA 1, 2010 to 2012 (EUR 6 million); EUnetHTA 2, 2012 to 2015 (EUR 9.5 million); and EUnetHTA 3, launched in June 2016 with an end date of 2020 (EUR 20 million). Given the timescales for these actions and in the interests of continuity, this regulation establishes a more sustainable way of ensuring the continuation of the joint assessments. The main outcomes of this cooperation to date includinge their joint clinical assessments, at Member State- level has remained low, meaning that the duplication of assessments on the same health technology by HTA authorities and bodies in different Member States within identical or similar timeframes has not been sufficie ‘HTA CoreModel’ assessment model, which provides a framework for HTA reports; a database for sharing projects that are planned, ongoing or recently published by individual agencies (POP database); a data- and knowledge base for the storage of information and the stage reached in the assessment of promising technologies, or on the request for supplementary studies arising from the HTA; and a set of methodological guides and support tools for ETS agencies, including guidelines for adapting reports from one countlry addressed. to another.
Amendment 200 #
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 this Regulation, which will be mandatory for Member States, constitutes a scientific analysis of the relative effects of health technology on efficacy, safety and effectiveness, commonly referred to as clinical outcomes, evaluated in relationg to the comparative effectiveness of a health technologyindicators currently deemed appropriate 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) details of how this joint clinical assessment is adapted to the national context, by means of established procedures and with due account for the data specific to each Member State (suitable comparative indicators and their reimbursement status; the medical need in the health system; information on a national early-access programme and, if available, the target group, therapeutic strategy and clinical use); (3) context- specific analyses (relevant patient subgroups, target population, cost of the health-care system and 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 and ethical, social and organisational considerations).
Amendment 207 #
Proposal for a regulation
Recital 13
Recital 13
(13) In order to ensure that joint clinical assessments carried out on health technologies remain accurate and relevant, relevant, of high quality and based on the best scientific evidence available at any given time, it is appropriate to establish conditionsa flexible, regulated procedure for the updating of assessments, in particular when new evidence ore additional data become available subsequent to the initial assessment thast may augment the potsciential tofic evidence and thus increase the accuracquality of the assessment. in a definitive manner at any given time.
Amendment 211 #
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-makingappoint members of their bodies to conduct such assessments, at national or regional level, as members of the Coordination Group. The designated authorities and bodiesmembers appointed should ensure an appropriately high level of representation in the Coordination Group and technical expertise in its sub-groups, taking into account the need topossibility of provideing expertise on the HTA of medicinal products and medical devices.
Amendment 225 #
Proposal for a regulation
Recital 20
Recital 20
(20) In order to facilitate effective participation by health technology developers in joint clinical assessments, such developers should, in appropriate cases, be afforded an opportunity to engage in joint scientific consultations with the Coordination Group to obtain guidance on the evidence and data that is likely to be required for the purposes of clinical assessmentHealth technology developers may conduct joint scientific consultations with the Coordination Group or working groups set up for this purpose and made up of professionals from state or regional assessment bodies to obtain guidance on the clinical needs of research and the optimal design of studies to obtain the best possible evidence and maximise research efficiency. Given the preliminary nature of the consultation, any guidance offered should not bind either the health technology developers or HTA authorities and bodies.
Amendment 240 #
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28a) The Coordination Group, composed of national and/or regional authorities and bodies responsible for health technology assessment, with proven capacity, independence and impartiality, shall draw up the methodology for ensuring high quality of work as a whole. The Commission shall provide administrative support for the joint work of the Coordination Group, which, after consultation with the stakeholders, shall submit the final report on this work.
Amendment 255 #
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 asystematic collection of scientific information, a critical evaluation and a synthesis of these procedures comparing the health technology in comparisquestion with one or more other health technologies based on the following clinical domains of health technology assessmentor existing procedures, constituting a benchmark for a particular clinical indication and based on the best clinical scientific evidence and on useful, relevant clinical criteria, taking into account the following clinical domains: the description of the health problem addressed by the health technology and the current use of other health technologies or processes addressing that health problem, the description and technical characterisation of the health technology, the relative clinical effectiveness, and the relative safety of the health technology;
Amendment 279 #
Proposal for a regulation
Article 3 – paragraph 5
Article 3 – paragraph 5
5. Members ofr experts from national or regional evaluation authorities or bodies serving in the Coordination Group shall be appoint their representatives in the Coordination Group and theed for a term of three years and may be reappointed once for a further three years. Member States may terminate such appointments where this is warranted by the requirements of the appointment. However, in view of the workload, the composition of sub- groups in which, or the specific knowledge required, they are members, on an ad-hoc or permanent basis, and inform the Commission of theiray be more than one evaluation expert per country, without prejudice to the principle that, for the purposes of decision-taking, each Member State shall have one vote only. The Commission, the Council, and the European Parliament shall be informed of all appointments and any subsequent changespossible terminations of appointment.
Amendment 333 #
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. For the medicinal products referred to in Article 5(1)(a), the Coordination Group shall adopt the joint clinical assessment report within 90 days.
Amendment 391 #
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. Divergent positions and the grounds on which they are based must be recorded in the final report. The choice of the comparator(s) and the results must be justified and documented in the final report. The final report shall also include the results of the joint scientific consultation conducted pursuant to Article 13.