What changed

ORDINARY LEGISLATIVE procedure

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

(First reading without prior interinstitutional negotiations)

on the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast)

Follow up to the European Parliament legislative resolution on the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast)

(COM(2023)0231 – C90146/2023 – 2023/0130(COD))

1. Rapporteur: Tiemo WÖLKEN (S&D / DE)

(Ordinary legislative procedure – recast)

2. Reference numbers: 2023/0130 (COD) / A9-0022/2024 / P9_TA(2024)0099

The European Parliament,

3. Date of adoption of the resolution: 28 February 2024

– having regard to the Commission proposal to Parliament and the Council (COM(2023)0231),

4.– Legalhaving basis:regard to Article 294(2) and Article 114(1) of the Treaty on the Functioning of the European UnionUnion, pursuant to which the Commission submitted the proposal to Parliament (C90146/2023),

5. Competent Parliamentary Committee: Committee on Legal Affairs (JURI)

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

6. Commission's position: takes note of the amendments proposed by the European Parliament, while reserving its detailed position on these until the opening of interinstitutional negotiations.

– having regard to the opinion of the European Economic and Social Committee of 27 September 2023,

– having regard to the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts,

– having regard to Rules 110 and 59 of its Rules of Procedure,

– having regard to the report of the Committee on Legal Affairs (A9-0022/2024),

A. whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the Commission proposal does not include any substantive amendments other than those identified as such in the proposal and whereas, as regards the codification of the unchanged provisions of the earlier acts together with those amendments, the proposal contains a straightforward codification of the existing texts, without any change in their substance;

1. Adopts its position at first reading hereinafter set out, taking into account the recommendations of the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

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

Amendment 1

Proposal for a regulation

Recital 2

Amendment 2

Proposal for a regulation

Recital 3

Amendment 3

Proposal for a regulation

Recital 8

Amendment 4

Proposal for a regulation

Recital 9

Amendment 5

Proposal for a regulation

Recital 13

Amendment 6

Proposal for a regulation

Recital 24

Amendment 7

Proposal for a regulation

Recital 30

Amendment 8

Proposal for a regulation

Recital 32 a (new)

Amendment 9

Proposal for a regulation

Recital 33

Amendment 10

Proposal for a regulation

Recital 38

Amendment 11

Proposal for a regulation

Recital 39

Amendment 12

Proposal for a regulation

Recital 41 a (new)

Amendment 13

Proposal for a regulation

Recital 45

Amendment 14

Proposal for a regulation

Recital 60

Amendment 15

Proposal for a regulation

Article 2 – paragraph 1 – point 12 a (new)

Amendment 16

Proposal for a regulation

Article 3 – paragraph 1 – point b

Amendment 17

Proposal for a regulation

Article 3 – paragraph 3

Amendment 18

Proposal for a regulation

Article 5 – paragraph 2 – introductory part

Amendment 19

Proposal for a regulation

Article 5 – paragraph 2 – point a – point i

Amendment 20

Proposal for a regulation

Article 5 – paragraph 2 – point a – point ii

Amendment 21

Proposal for a regulation

Article 5 – paragraph 2 – point a – point iii

Amendment 22

Proposal for a regulation

Article 5 – paragraph 2 – point a – point iv

Amendment 23

Proposal for a regulation

Article 8 – paragraph 1 – point d a (new)

Amendment 24

Proposal for a regulation

Article 8 – paragraph 1 – point d b (new)

Amendment 25

Proposal for a regulation

Article 11 – paragraph 1 – introductory part

Amendment 26

Proposal for a regulation

Article 11 – paragraph 1 – point f a (new)

Amendment 27

Proposal for a regulation

Article 15 – paragraph 1 – point a

Amendment 28

Proposal for a regulation

Article 16 – paragraph 2

Amendment 29

Proposal for a regulation

Article 18 – paragraph 2 a (new)

Amendment 30

Proposal for a regulation

Article 20 – paragraph 1

Amendment 31

Proposal for a regulation

Article 23 – paragraph 1

Amendment 32

Proposal for a regulation

Article 24 – paragraph 1

Amendment 33

Proposal for a regulation

Article 24 – paragraph 2

Amendment 34

Proposal for a regulation

Article 24 – paragraph 3

Amendment 35

Proposal for a regulation

Article 24 – paragraph 5 a (new)

Amendment 36

Proposal for a regulation

Article 25 – paragraph 3 a (new)

Amendment 37

Proposal for a regulation

Article 26 – paragraph 2

Amendment 38

Proposal for a regulation

Article 26 – paragraph 4 – point c a (new)

Amendment 39

Proposal for a regulation

Article 26 – paragraph 6

Amendment 40

Proposal for a regulation

Article 26 – paragraph 9

Amendment 41

Proposal for a regulation

Article 26 – paragraph 9 a (new)

Amendment 42

Proposal for a regulation

Article 26 – paragraph 10

Amendment 43

Proposal for a regulation

Article 26 – paragraph 12 a (new)

Amendment 44

Proposal for a regulation

Article 27 – paragraph 1

Amendment 45

Proposal for a regulation

Article 28 – paragraph 3 – point a

Amendment 46

Proposal for a regulation

Article 28 – paragraph 3 – point a a (new)

Amendment 47

Proposal for a regulation

Article 28 – paragraph 3 – point c

Amendment 48

Proposal for a regulation

Article 29 – paragraph 3

Amendment 49

Proposal for a regulation

Article 29 – paragraph 3 a (new)

Amendment 50

Proposal for a regulation

Article 29 – paragraph 5

Amendment 51

Proposal for a regulation

Article 30 – paragraph 4

Amendment 52

Proposal for a regulation

Article 30 – paragraph 4 a (new)

Amendment 53

Proposal for a regulation

Article 32 – paragraph 1 – subparagraph 1 a (new)

Amendment 54

Proposal for a regulation

Article 32 – paragraph 5 a (new)

Amendment 55

Proposal for a regulation

Article 33 – paragraph 4

Amendment 56

Proposal for a regulation

Article 35 – paragraph 1

Amendment 57

Proposal for a regulation

Article 35 – paragraph 2 – point j a (new)

Amendment 58

Proposal for a regulation

Article 35 – paragraph 2 – point k

Amendment 59

Proposal for a regulation

Article 35 – paragraph 2 – point n

Amendment 60

Proposal for a regulation

Article 35 – paragraph 2 – point o

Amendment 61

Proposal for a regulation

Article 35 – paragraph 11 a (new)

Amendment 62

Proposal for a regulation

Article 44 – paragraph 2

Amendment 63

Proposal for a regulation

Article 44 – paragraph 3

Amendment 64

Proposal for a regulation

Article 45 – paragraph 3

Amendment 65

Proposal for a regulation

Article 57 – paragraph 2

ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he has received input from the following entities or persons in the preparation of the report, until the adoption thereof in committee:

The list above is drawn up under the exclusive responsibility of the rapporteur.

9.11.2023

LETTER OF THE COMMITTEE ON LEGAL AFFAIRS

Mr Adrián Vázquez Lázara

Chair

Committee on Legal Affairs

BRUSSELS

Subject: Opinion on the Proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast) (COM(2023)0231 – C90146/2023 – 2023/0130(COD))

Dear Mr Chair,

The Committee on Legal Affairs has examined the proposal referred to above pursuant to Rule 110 on recasting of Parliament's Rules of Procedure.

Paragraph 3 of that Rule reads as follows:

“If the committee responsible for legal affairs considers that the proposal does not entail any substantive changes other than those identified as such in the proposal, it shall inform the committee responsible for the subject matter thereof.

In such a case, over and above the conditions laid down in Rules 180 and 181, amendments shall be admissible within the committee responsible for the subject-matter only if they concern those parts of the proposal which contain changes.

However, amendments to parts of the proposal which remain unchanged may, by way of exception and on a case-by-case basis, be accepted by the Chair of the committee responsible for the subject matter if he or she considers that this is necessary for pressing reasons relating to the internal logic of the text or because the amendments are inextricably linked to other admissible amendments. Such reasons must be stated in a written justification to the amendments.”

Following the here attached opinion of the Consultative Working Party of the Legal Services of the Parliament, the Council and the Commission, which has examined the recast proposal, and in keeping with the recommendations of the Rapporteur, the Committee on Legal Affairs considers that the proposal in question does not include any substantive changes other than those identified as such and that, as regards the codification of the unchanged provisions of the earlier act with those substantive amendments, the proposal contains a straightforward codification of the existing text, without any change in its substance.

In conclusion, at its meeting of 7 November 2023, the Committee on Legal Affairs unanimously decided to recommend that the Committee on Legal Affairs, as the committee responsible, proceed to examine the above proposal in accordance with Rule 110.

Yours sincerely,

Adrián Vázquez Lázara

Encl.: Opinion of the Consultative Working Party

Annex

Brussels, 26 September 2023

OPINION

FOR THE ATTENTION OF THE EUROPEAN PARLIAMENT

THE COUNCIL

THE COMMISSION

Proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products

COM(2023)0231 of 27.4.2023 – 2023/0130(COD)

Having regard to the Inter-institutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts, and in particular to point 9 thereof, the Consultative Working Party consisting of the respective legal services of the European Parliament, the Council and the Commission met on 13 July 2023 for the purpose of examining the aforementioned proposal submitted by the Commission.

At that meeting, an examination of the proposal for a Regulation of the European Parliament and of the Council recasting Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products resulted in the Consultative Working Party’s establishing, by common accord, as follows.

1. The following should have been marked with the grey-shaded type generally used for identifying substantive amendments:

- in recital 43, the deletion of the first sentence of recital 5 of Regulation (EU) 2019/933;

- in recital 59, the deletion of the first and second sentences of recital 27 of Regulation (EU) 2019/933;

- in Article 11(1), introductory wording, and in Article 11(2), the adding of the words ‘as soon as possible’.

2. The following should have been identified as formal adaptations:

- in the title of the act, the replacement of the word ‘concerning’ with the word ‘on’;

- in Article 8(1), point (d), the adding of the words ‘for a medicinal product’;

- in Article 8(2), the replacement of the words ‘extended duration’ with the words

‘extension of the duration’.

In consequence, examination of the proposal has enabled the Consultative Working Party to conclude, without dissent, that the proposal does not comprise any substantive amendments other than those identified as such. The Working Party also concluded, as regards the codification of the unchanged provisions of the earlier act with those substantive amendments, that the proposal contains a straightforward codification of the existing legal text, without any change in its substance.

F. DREXLER E. FINNEGAN D. CALLEJA CRESPO

Jurisconsult Jurisconsult Director-General

PROCEDURE – COMMITTEE RESPONSIBLE

FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE