Council Decision (EU) 2025/30 of 17 December 2024 on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning the amendment of Annex II (Technical regulations, standards, testing and certification), Annex X (Services in general) and Protocol 37 (containing the list provided for in Article 101) to the EEA Agreement (Health Technology Assessment) (Text with EEA relevance)
Date: 2024-12-17
Institutions: Council of the European Union
Subjects: EEA Joint Committee, European Economic Area, clinical trial, exchange of information, health care, health technology, innovation, medical device, protocol to an agreement, revision of an agreement




L_202500030EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/30


9.1.2025







            COUNCIL DECISION (EU) 2025/30
         
of 17 December 2024
         
on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning the amendment of Annex II (Technical regulations, standards, testing and certification), Annex X (Services in general) and Protocol 37 (containing the list provided for in Article 101) to the EEA Agreement (Health Technology Assessment)
(Text with EEA relevance)


THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168 in conjunction with Article 218(9) thereof,


Having regard to Council Regulation (EC) No 2894/94 of 28 November 1994 concerning arrangements for implementing the Agreement on the European Economic Area (1), and in particular Article 1(3) thereof,


Having regard to the proposal from the European Commission,

Whereas:







(1)


The Agreement on the European Economic Area (2) (the ‘EEA Agreement’) entered into force on 1 January 1994.












(2)


Pursuant to Article 98 of the EEA Agreement, the EEA Joint Committee may decide to amend, inter alia, Annex II (Technical regulations, standards, testing and certification), Annex X (Services in general) and Protocol 37 (containing the list provided for in Article 101) to the EEA Agreement.












(3)


Regulation (EU) 2021/2282 of the European Parliament and of the Council (3) should be incorporated into the EEA Agreement.












(4)


Annex II (Technical regulations, standards, testing and certification), Annex X (Services in general) and Protocol 37 (containing the list provided for in Article 101) to the EEA Agreement should therefore be amended accordingly.












(5)


The position of the Union within the EEA Joint Committee should therefore be based on the attached draft decision,





HAS ADOPTED THIS DECISION:



Article 1
The position to be adopted on behalf of the Union within the EEA Joint Committee on the proposed amendment of Annex II (Technical regulations, standards, testing and certification), Annex X (Services in general) and Protocol 37 (containing the list provided for in Article 101) to the EEA Agreement, shall be based on the draft decision of the EEA Joint Committee attached to this Decision.


Article 2
This Decision shall enter into force on the date of its adoption.




Done at Brussels, 17 December 2024.


For the Council


The President


               BÓKA J.





(1)  
            OJ L 305, 30.11.1994, p. 6.

(2)  
            OJ L 1, 3.1.1994, p. 3.

(3)  Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, p. 1).






            DRAFT
         
DECISION OF THE EEA JOINT COMMITTEE No …
of …
amending Annex II (Technical regulations, standards, testing and certification), Annex X (Services in general) and Protocol 37 (containing the list provided for in Article 101) to the EEA Agreement


THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:







(1)


Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (1) is to be incorporated into the EEA Agreement.












(2)


Annexes II and X and Protocol 37 to the EEA Agreement should therefore be amended accordingly,





HAS ADOPTED THIS DECISION:



Article 1
Annex II to the EEA Agreement shall be amended as follows:






1.


The following is inserted after the seventeenth paragraph of the introductory part of Chapter XIII:

                              ‘The EFTA States shall be fully associated with the work of the Member State Coordination Group on Health Technology Assessment, including its subgroups, as established by Article 3 of Regulation (EU) 2021/2282 of the European Parliament and of the Council and shall have the same rights and obligations within it as the EU Member States.
By way of derogation from the previous paragraph, the members designated by the EFTA States shall not be entitled to participate in votes. However, where voting takes place, positions of the members designated by the EFTA States shall be recorded separately upon their request.
Pursuant to Article 12(2) of Regulation (EU) 2021/2282, where consensus cannot be reached, divergent scientific opinions by the EFTA States, including the scientific grounds on which those opinions are based, shall be incorporated in the reports.’
                           










2.


The following is inserted after point 22k (Commission Implementing Regulation (EU) 2022/1255) of Chapter XIII:






‘23.



32021 R 2282: Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, p. 1).
The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:
Paragraph 4(a) of Protocol 1 to this Agreement shall not apply to Article 3.’
                                    














3.


The following is inserted in the introductory part of Chapter XXX:

                              ‘The EFTA States shall be fully associated with the work of the Member State Coordination Group on Health Technology Assessment, including its subgroups, as established by Article 3 of Regulation (EU) 2021/2282 of the European Parliament and of the Council and shall have the same rights and obligations within it as the EU Member States.
By way of derogation from the previous paragraph, the members designated by the EFTA States shall not be entitled to participate in votes. However, where voting takes place, the positions of the members designated by the EFTA States shall be recorded separately upon their request.
Pursuant to Article 12(2) of Regulation (EU) 2021/2282, where a consensus cannot be reached, divergent scientific opinions by the EFTA States, including the scientific grounds on which those opinions are based, shall be incorporated in the reports.’
                           










4.


The following point is inserted after point 15 (Commission Implementing Regulation (EU) 2020/1207) of Chapter XXX:






‘16.



32021 R 2282: Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, p. 1).
The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:
Paragraph 4(a) of Protocol 1 to this Agreement shall not apply to Article 3.’
                                    










Article 2
The following is added in point 2 (Directive 2011/24/EU of the European Parliament and of the Council) of Annex X to the EEA Agreement:

                  ‘, as amended by:






—



32021 R 2282: Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 (OJ L 458, 22.12.2021, p. 1).’
                     






Article 3
The following point is inserted in Protocol 37 to the EEA Agreement:






‘50.


Member State Coordination Group on Health Technology Assessment (Regulation (EU) 2021/2282 of the European Parliament and of the Council).’






Article 4
The text of Regulation (EU) 2021/2282 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.


Article 5
This Decision shall enter into force on …, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*1).


Article 6
This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.




Done at Brussels, …


For the EEA Joint Committee


The President




The Secretaries


To the EEA Joint Committee






(1)  
            OJ L 458, 22.12.2021, p. 1.

(*1)  [No constitutional requirements indicated.] [Constitutional requirements indicated.]



ELI: http://data.europa.eu/eli/dec/2025/30/oj
ISSN 1977-0677 (electronic edition)