European Parliament legislative resolution of 13 December 2021 on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU (10531/3/2021 — C9-0422/2021 — 2018/0018(COD))
Date: 2021-12-13
Institutions: Committee on Economic and Monetary Affairs, Committee on Employment and Social Affairs, Committee on Industry, Research and Energy, Committee on Legal Affairs, Committee on Women’s Rights and Gender Equality, Committee on the Environment, Climate and Food Safety, Committee on the Internal Market and Consumer Protection, European Parliament
Subjects: EU Member State, clinical trial, exchange of information, health care, health technology, innovation, medical device, public health, scientific cooperation








C_2022251EN.01015301.xml










30.6.2022   


EN


Official Journal of the European Union


C 251/153






P9_TA(2021)0484
Health technology assessment ***II
European Parliament legislative resolution of 13 December 2021 on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU (10531/3/2021 — C9-0422/2021 — 2018/0018(COD))
(Ordinary legislative procedure: second reading)
(2022/C 251/19)

The European Parliament,






—


having regard to the Council position at first reading (10531/3/2021 — C9-0422/2021),










—


having regard to the reasoned opinions submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Czech Chamber of Deputies, the German Bundestag, the French Senate and the Polish Sejm, asserting that the draft legislative act does not comply with the principle of subsidiarity,










—


having regard to the opinion of the European Economic and Social Committee of 23 May 2018 and of 27 April 2021 (1),










—


having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2018)0051),










—


having regard to Article 294(7) of the Treaty on the Functioning of the European Union,










—


having regard to the provisional agreement approved by the committee responsible under Rule 74(4) of its Rules of Procedure,










—


having regard to Rule 67 of its Rules of Procedure,










—


having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Food Safety (A9-0334/2021),












1.


Approves the Council position at first reading;












2.


Notes that the act is adopted in accordance with the Council position;












3.


Instructs its President to sign the act with the President of the Council, in accordance with Article 297(1) of the Treaty on the Functioning of the European Union;












4.


Instructs its Secretary-General to sign the act, once it has been verified that all the procedures have been duly completed, and, in agreement with the Secretary-General of the Council, to arrange for its publication in the Official Journal of the European Union;












5.


Instructs its President to forward its position to the Council, the Commission and the national parliaments.






(1)  OJ C 283, 10.8.2018, p. 28 and OJ C 286, 16.7.2021, p. 95.

(2)  OJ C 449, 23.12.2020, p. 638.