Activities of Mireille D'ORNANO related to 2018/0018(COD)
Plenary speeches (1)
Health technology assessment (debate) FR
Amendments (12)
Amendment 175 #
Proposal for a regulation
Recital 1
Recital 1
(1) The development of health technologies is a key driver of economic growth and innovation in the Union. It forms part of an overall market for healthcare expenditure that accounts for 10% of EU gross domestic product, a percentage which, however, varies between Member States. Health technologies encompass medicinal products, medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment.
Amendment 180 #
Proposal for a regulation
Recital 2
Recital 2
(2) Health Technology Assessment (HTA) is an evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing technologies. HTA focuses specifically, as medical assessments generally do, on the added value of a health technology in comparison with other new or existing health technologies.
Amendment 185 #
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 healthcare systems and to stimulate innovation that delivers better outcomes for patients. The organisation of health care systems remains nevertheless a national competence.
Amendment 195 #
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 viewed by some as inefficient, relying on project-based cooperation in the absence of a sustainable model of cooperation. Use of the results of the joint actions, including 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 sufficiently addressed or that they regard it as being only of minimal importance.
Amendment 197 #
Proposal for a regulation
Recital 9
Recital 9
(9) In its 2015 Communication on upgrading the single market10, the Commission declared its intention to introduce an initiative on HTA to increase coordination in order to avoid multiple assessments of a product in different Member States and improve the functioning of the Single Market for health technologies. __________________ 10, an objective which should not call into question an essential and superior principle, namely the improvement of public health. __________________ 10 COM(2015) 550 final, p. 19. COM(2015) 550 final, p. 19.
Amendment 199 #
Proposal for a regulation
Recital 10
Recital 10
(10) In order to ensure a better functioning of the internal market and contribute to a high level of human health protection it is appropriatesome consider that it is necessary to approximate the rules on carrying out clinical assessments at national level and clinical assessments of certain health technologies at Union level, and which also support the continuation of voluntary cooperation between Member States on certain aspects of HTA.
Amendment 202 #
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 respect the principle of the freedom of the Member States to organise themselves and 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 relating to the comparative effectiveness of a health technology. The outcome of such assessments should not therefore under any circumstances 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 208 #
Proposal for a regulation
Recital 14
Recital 14
(14) A coordination group composed of representatives from Member States' health technology assessment authorities and bodies shcould thus be established with responsibility for overseeing the carrying out of joint clinical assessments and other joint work.
Amendment 218 #
Proposal for a regulation
Recital 16
Recital 16
(16) In order that the harmonised procedures fulfil their internal market objective, Member States should be requiredasked to be able to take full account of the results of joint clinical assessments and not repeat those assessments. Compliance with this obligation does not of course 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 231 #
Proposal for a regulation
Recital 22
Recital 22
(22) In order to ensure the efficient use of available resources, it is appropriate to provide for "horizon scanning", to allow the early identification of emerging health technologies that are likely to have the most impact on patients, public health and healthcare systems. Such scanning should facilitate the prioritisation of technologies that are to be selected for joint clinical assessment. The available experience regarding the assessment of health technologies shows, however, that this type of horizon scanning is very difficult to implement and can be risky.
Amendment 241 #
Proposal for a regulation
Recital 29
Recital 29
(29) In order to ensure the smooth establishment and operation of Union-level joint assessments, as well as to safeguard their quality, it is appropriate to provide for a transitional period allowing a progressive expansion of the number of joint assessments carried out annually. The number of assessments to be carried out should be determined with due regard for the resources available and the number of Member States opting freely to participatinge with a view to reaching full capacity by the end of the transitional period. The establishment of such a transitional period should also afford Member States an opportunity to fully align their national systems with the framework for joint work in terms of resource allocation, timing, and prioritisation of assessments.
Amendment 243 #
Proposal for a regulation
Recital 30
Recital 30
(30) During the transitional period, participation in joint clinical assessments and joint scientific consultations should not under any circumstances be mandatory for Member States. This should not affect the obligation of Member States to apply harmonised rules to clinical assessments carried out at a national level. During the transitional period, Member States not participating in the joint work may at any time decide to participate. In order to ensure a stable and smooth organisation of the joint work and the functioning of the internal market, Members States which are already participating should not be allowed to withdraw from the framework for joint work.