4 Amendments of Monika BEŇOVÁ related to 2018/0018(COD)
Amendment 176 #
Proposal for a regulation
Recital 1
Recital 1
(1) The development of health technologies is a key driver of economic growth and innovation for the benefit of all citizens in the Union. It forms part of an overall market for healthcare expenditure that accounts for 10% of EU gross domestic product. Health technologies encompass medicinal products, medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment.
Amendment 179 #
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 on the added value of a health technology in comparison with other new or existing health technologies. , and recognises the beneficial effects which these new or existing technologies may have for the health of all citizens in the Union.
Amendment 191 #
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. There are also economic benefits for Members States that can be gained through the reduction of duplications and variations in outcomes.
Amendment 250 #
Proposal for a regulation
Recital 34
Recital 34
(34) Since the objectives of this Regulation, namely to approximate the rules of the Member States on carrying out clinical assessments at national level and establish a framework of mandatory joint clinical assessments of certain health technologies at Union level, cannot be sufficiently achieved by the Member States alone, but can rather, by reason of their scale and effects, be better achieved at Union-level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,. The Regulation objectives are namely to approximate the rules of the Member States on carrying out clinical assessments at national level, and establish a framework of mandatory joint clinical assessments of certain health technologies at Union level.