Procedure : 2014/0256(COD)
Document stages in plenary
Document selected : A8-0035/2016

Texts tabled :

A8-0035/2016

Debates :

PV 09/03/2016 - 20
CRE 09/03/2016 - 20
PV 24/10/2018 - 20
CRE 24/10/2018 - 19
CRE 24/10/2018 - 20

Votes :

PV 10/03/2016 - 7.6
CRE 10/03/2016 - 7.6
Explanations of votes
PV 25/10/2018 - 13.4

Texts adopted :

P8_TA(2016)0088
P8_TA(2018)0420

REPORT     ***I
PDF 895kWORD 481k
23.2.2016
PE 552.048v02-00 A8-0035/2016

on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

(COM(2014)0557 – C8‑0142/2014 – 2014/0256(COD))

Committee on the Environment, Public Health and Food Safety

Rapporteur: Claudiu Ciprian Tănăsescu

ERRATA/ADDENDA
AMENDMENTS
DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
 EXPLANATORY STATEMENT
 OPINION of the Committee on Agriculture and Rural Development
 PROCEDURE – COMMITTEE RESPONSIBLE

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

(COM(2014)0557 – C8‑0142/2014 – 2014/0256(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2014)0557),

–  having regard to Article 294(2) and Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0142/2014),

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

–  having regard to the opinion of the European Economic and Social Committee of 21 January 2015(1),

–  after consulting the Committee of the Regions,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on the Agriculture and Rural Development (A8-0035/2016),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

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

Amendment     1

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(1) Directive 2001/82/EC of the European Parliament and of the Council5 and Regulation (EC) 726/2004 of the European Parliament and of the Council6 constituted the Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products. In the light of the experience acquired and following the assessment by the Commission of the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products has been reviewed, and Regulation (EU) No […] of the European Parliament and of the Council7 laying down procedures for the authorisation and supervision of veterinary medicinal products has been adopted.

(1) Directive 2001/82/EC of the European Parliament and of the Council5 and Regulation (EC) 726/2004 of the European Parliament and of the Council6 constituted the Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products. In the light of the experience acquired and following the assessment by the Commission of the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products has been reviewed, and Regulation (EU) No […] of the European Parliament and of the Council laying down procedures for the authorisation and supervision of veterinary medicinal products has been adopted, with a view to harmonisation of the laws of the Member States.

___________

___________

5 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).

5 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).

6 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

6 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

7 Regulation … of the European Parliament and of the Council of … … … on veterinary medicinal products (OJ L …, … … …, p. …).

7 Regulation … of the European Parliament and of the Council of … … … on veterinary medicinal products (OJ L …, … … …, p. …).

Amendment     2

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4) As a consequence of the entry into force of the Treaty of Lisbon, the powers conferred on the Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union. In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the Annex to technical and scientific progress, determining the situations in which post-authorisation efficacy studies may be required, laying down provisions and requirements for granting marketing authorisations subject to certain specific obligations, establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations and laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this Regulation, the maximum amounts of these penalties as well as the conditions and methods for their collection.

(4) As a consequence of the entry into force of the Treaty of Lisbon, the powers conferred on the Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union. In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the Annex with regard to technical and scientific progress so as to facilitate the placing on the market of new medicinal products, determining the situations in which post-authorisation efficacy studies may be required, laying down provisions and requirements for granting marketing authorisations subject to certain specific obligations, establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations and laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this Regulation, the maximum amounts of these penalties as well as the conditions and methods for their collection.

Amendment    3

Proposal for a regulation

Recital 6

Text proposed by the Commission

Amendment

(6) In order to ensure uniform conditions for the implementation of Regulation (EC) No 726/2004, implementing powers should be conferred on the Commission to adopt implementing acts in relation to marketing authorisations for medicinal products for human use. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council1.

(6) In order to ensure uniform conditions for the implementation of Regulation (EC) No 726/2004, implementing powers should be conferred on the Commission to adopt implementing acts in relation to marketing authorisations for medicinal products for human and veterinary use. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council1.

__________________

__________________

1 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

1 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

Amendment    4

Proposal for a regulation

Recital 6 a (new)

Text proposed by the Commission

Amendment

 

(6a) Advances in alternative testing require the creation of a regulatory framework capable of adapting to new developments in this field, including for example the recognition and evaluation of modeling and simulation technologies.

Amendment    5

Proposal for a regulation

Recital 6 b (new)

Text proposed by the Commission

Amendment

 

(6b) Animal testing currently plays a key regulatory and scientific role in the development of medicines, and in relation to the replacement, reduction or refinement of animal testing is subject to Directive 2010/63/EU.

Amendment    6

Proposal for a regulation

Recital 6 c (new)

Text proposed by the Commission

Amendment

 

(6c) In the interest of public health, authorisation decisions adopted under the centralised procedure should be taken on the basis of the objective scientific criteria of quality, safety and efficacy .

Justification

To decrease the timeframe by which Member States adopt the decisions of marketing authorisation of the EMA it is necessary to include non-binding, reference cost-effectiveness assessment of newly approved drugs.

Amendment    7

Proposal for a regulation

Recital 6 d (new)

Text proposed by the Commission

Amendment

 

(6d) Provision should be made for the quality, safety and efficacy criteria laid down in Directives 2001/83/EC and 2001/82/EC to apply to medicinal products authorised by the Union and it should be possible to assess the risk-benefit balance of all medicinal products when they are placed on the market, at the time of the renewal of the authorisation and at any other time the competent authority deems appropriate.

Justification

Cost effectiveness assessment is particularly relevant at the time of renewal of the authorisation, given that the Agency can rely on real-world data.

Amendment    8

Proposal for a regulation

Recital 6 e (new)

Text proposed by the Commission

Amendment

 

(6e) Member States have developed an evaluation of the comparative efficacy of medicinal products aimed at positioning a new medicinal product with respect to those that already exist in the same therapeutic class. Similarly, the Council, in its conclusions on medicinal products and public health, adopted on 29 June 2000, emphasised the importance of identifying medicinal products that presented an added therapeutic value. That evaluation should be conducted in the context of the marketing authorisation.

Justification

To decrease the timeframe by which Member States adopt the decisions of marketing authorisation of the EMA, it is necessary to include non-binding, reference cost-effectiveness assessment of newly approved drugs

Amendment    9

Proposal for a regulation

Article 1 – point 2 a (new)

Regulation (EC) No 726/2004

Article 1 – paragraph 2

 

Present text

Amendment

 

(2a) In Article 1, the second paragraph is replaced by the following:

The provisions of this Regulation shall not affect the powers of Member States' authorities as regards setting the prices of medicinal products or their inclusion in the scope of the national health system or social security schemes on the basis of health, economic and social conditions. In particular, Member States shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indications and pack sizes which will be covered by their social security bodies.

"The provisions of this Regulation shall not affect the powers of Member States' authorities as regards setting the prices of medicinal products or their inclusion in the scope of the national health system or social security schemes on the basis of health, economic and social conditions, provided that Member States take into due consideration the reference comparative evaluation of human medicinal product as referred to in Article 9(4). In particular, Member States shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indications and pack sizes which will be covered by their social security bodies."

Amendment    10

Proposal for a regulation

Article 1 – point 3

Regulation (EC) No 726/2004

Article 2 – paragraph 1

 

Text proposed by the Commission

Amendment

The definitions laid down in Article 1 of Directive 2001/83/EC shall apply for the purposes of this Regulation.

The definitions laid down in Article 1 of Directive 2001/83/EC and, as appropriate, in Article 4 of Regulation (EU) 2015/xxx of the European Parliament and of the Council1a+ shall apply for the purposes of this Regulation.

 

___________________________

 

1a Regulation (EU) 2015/xxx of the European Parliament and of the Council of ... on veterinary medicinal products (OJ L ...).

 

+ OJ: please insert the number and in the footnote, the number, date and OJ reference of Regulation in document COD 2014/0257.

Justification

It is important to include in this article also a reference to the definitions that will be included in the new Veterinary Medicines Regulation in view of the activities and responsibilities of the European Medicines Agency which will continue to include veterinary medicinal products authorised via the Centralised Procedure.

Amendment    11

Proposal for a regulation

Article 1 – point 4 – point a

<DocAmend2>Regulation (EC) No 726/2004

Article 3 – paragraph 2 – point b

 

Text proposed by the Commission

Amendment

(a) in paragraph 2, point (b) is replaced by the following:

(a) paragraph 2 is replaced by the following:

 

"2. Any medicinal product not appearing in the Annex may be granted a marketing authorisation by the Union in accordance with this Regulation, if:

 

(a) the medicinal product contains a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Union; or

‘(b) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interests of patients health at Union level.’,

(b) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interests of patients health at Union level."

Justification

The authorisation procedures for veterinary medicinal products- including the centralised procedure- are now detailed in the new Veterinary Medicines Regulation, therefore the last paragraph of Article 3(2) needs to be removed from Article 3 of this Regulation.

Amendment    12

Proposal for a regulation

Article 1 – point 5 a (new)

Regulation (EC) No 726/2004

Article 6 – paragraphs 4 a and 4 b (new)

 

Text proposed by the Commission

Amendment

 

(5a) In Article 6, the following paragraphs are added:

 

"4a. The Agency shall verify that applicants for marketing authorisations have acted in accordance with Article 13(1) of Directive 2010/63/EU.

 

4b. The Agency shall develop a framework for the regulatory acceptance of alternative models and shall take into consideration the opportunities presented by these new concepts which aim at providing for more predictive medicines. These concepts may be based on human-relevant computer or cellular models, pathways of toxicity, or adverse outcome pathways."

Justification

It is important that EMA checks whether applicants acted in accordance with the 3Rs of the animal testing Directive. To advance the development of alternative models, EMA should develop a framework for the validation of such models.

Amendment    13

Proposal for a regulation

Article 1 – point 5 a (new)

Regulation (EC) No 726/2004

Article 9 – paragraph 4 – point d a (new)

 

Present text

Amendment

 

(5a) In Article 9(4), the following point is inserted:

 

"(da) the comparative evaluation of the human medicinal product;"

Amendment    14

Proposal for a regulation

Article 1 – point 10 a (new)

Regulation (EC) No 726/2004

Article 55 – paragraph 2

 

Present text

Amendment

 

(10a) The second paragraph of Article 55 is replaced by the following:

The Agency shall be responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products.

"The Agency shall be responsible for coordinating the scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products for human use, as provided for in this Regulation, and for veterinary use, as provided for in Regulation (EU) 2015/xxx+."

 

______________

 

+ OJ: please, insert the number of Regulation in document COD 2014/0257.

Justification

Centralised authorisation procedure for veterinary medicinal products is now set in the new Veterinary Medicines Regulation, therefore it is necessary to reflect in Regulation (EC) No 726/2004 that the European Medicines Agency will maintain its role in the authorisation and supervision of veterinary products via the centralised procedure.

Amendment    15

Proposal for a regulation

Article 1 – point 10 b (new)

Regulation (EC) No 726/2004

Article 56 – paragraph 2 – subparagraph 1

 

Present text

Amendment

 

(10b) The first subparagraph of Article 56(2) is replaced by the following:

2. The committees referred to in paragraph 1(a) to (da) may each establish standing and temporary working parties. The committees referred to in paragraph 1(a) and (b) may establish scientific advisory groups in connection with the evaluation of specific types of medicinal products or treatments, to which the committee concerned may delegate certain tasks associated with drawing up the scientific opinions referred to in Articles 5 and 30.

"2. The committees referred to in paragraph 1(a) to (da) may each establish standing and temporary working parties. The committees referred to in paragraph 1(a) and (b) may establish scientific advisory groups in connection with the evaluation of specific types of medicinal products or treatments, to which the committee concerned may delegate certain tasks associated with drawing up the scientific opinions referred to in Article 5 of this Regulation and in Article 141(1) of Regulation (EU) 2015/xxx+."

 

_______________

 

+ OJ: please, insert the number of Regulation in document COD 2014/0257.

Justification

Point 21 of the amending Regulation removes Articles 30-54 of Regulation 726/2004, therefore the reference to Article 30 needs to be corrected and replaced by the corresponding new article of the New Veterinary Medicines Regulation.

Amendment    16

Proposal for a regulation

Article 1 – point 10 c (new)

Regulation (EC) No 726/2004

Article 57 – paragraph 1 – subparagraph 1

 

Present text

Amendment

 

(10c) In Article 57(1), the first subparagraph is replaced by the following:

1. The Agency shall provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Community legislation relating to medicinal products.

"1. The Agency shall provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety, efficacy and comparative assessment of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Community legislation relating to medicinal products."

Amendment    17

Proposal for a regulation

Article 1 – point 10 d (new)

Regulation (EC) No 726/2004

Article 57 – paragraph 1 – subparagraph 2 – point t a (new)

 

Present text

Amendment

 

(10d) In the second subparagraph of Article 57(1), the following point is added:

 

"(ta) cooperating with the Health Technology Assessment Network, with health technology assessment bodies and other national authorities involved in market access, in particular to facilitate their assessment and reduce disparities in patients’ access to health technologies."

Justification

In order to improve timely access to medicines and to acknowledge the Agency's role in facilitating the assessments done by health technology (HTA) bodies or other authorities involved at national level in market access decisions, it is important to reflect this ongoing activity in the list of tasks of the Agency. The need to share data or assessments between medicines agencies and HTA bodies was also acknowledged in Article 13 of the draft amended Transparency Directive and complements Article 15(1) of Directive 2011/24/EU which states that "the Union shall support and facilitate cooperation and the exchange of scientific information among Member States within a voluntary network connecting national authorities or bodies responsible for health technology assessment designated by the Member States."

Amendment    18

Proposal for a regulation

Article 1 – point 10 e (new)

Regulation (EC) No 726/2004

Article 57 – paragraph 1 – subparagraph 2 – point t b (new)

 

Text proposed by the Commission

Amendment

 

(10e) In the second subparagraph of Article 57(1), the following point is added:

 

"(tb) in cooperation with EFSA and ECDC annually publishing a report on the use of antimicrobials for human and veterinary medicine as well as the current situation on the antimicrobial resistance in the Union."

Amendment    19

Proposal for a regulation

Article 1 – point 11

Regulation (EC) No 726/2004

Article 57 – paragraph 2 – subparagraph 1

 

Text proposed by the Commission

Amendment

2. The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC. The database shall subsequently be extended to include any medicinal product authorised in the Union.

2. The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC. The database shall subsequently be extended to include any medicinal product for human use authorised in the Union.

Justification

Veterinary medicinal products are no longer included in the Article 57 (database), but will be covered by a new database to be developed under the new Veterinary Medicines Regulation, therefore it is important to clarify that the term of “any medicinal product” referred here in Article 57 concerns medicinal products for human use only.

Amendment    20

Proposal for a regulation

Article 1 – point 13

Regulation (EC) No 726/2004

Article 61 – paragraph 1 – subparagraph 1

 

Text proposed by the Commission

Amendment

1. Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human.

1. Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human Use.

Justification

Correction.

Amendment    21

Proposal for a regulation

Article 1 – point 13 a (new)

Regulation (EC) No 726/2004

Article 62 – paragraph 2

 

Present text

Amendment

 

(13a) Article 62(2) is replaced by the following:

2. Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products for human use who, taking into account Article 63(2), would be available to serve on working parties or scientific advisory groups of any of the Committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise.

"2. Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products who, taking into account Article 63(2), would be available to serve on working parties or scientific advisory groups of any of the Committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise.

The Agency shall keep an up-to-date list of accredited experts. The list shall include the experts referred to in the first subparagraph and other experts appointed directly by the Agency. The list shall be updated.

The Agency shall keep an up-to-date list of accredited experts. The list shall include the experts referred to in the first subparagraph and any other experts appointed by the Agency or the Commission. The list shall be updated."

Justification

There are also other experts appointed by the Agency or the Commission that participate in the Agency's activities. The more generic wording includes, for instance, experts in veterinary medicinal products.

Amendment    22

Proposal for a regulation

Article 1 – point 14

Regulation (EC) No 726/2004

Article 62

 

Text proposed by the Commission

Amendment

(14) in Article 62(3), the second subparagraph is deleted;

(14) Article 62 is amended as follows:

 

(a) in paragraph 1, the third subparagraph is replaced by the following:

 

"When consulting the scientific advisory groups referred to in Article 56(2), the Committee shall forward to them the draft assessment report(s) drawn up by the rapporteur or the co-rapporteur. The opinion issued by the scientific advisory group shall be forwarded to the chairman of the relevant Committee in such a way as to ensure that the deadlines laid down in Article 6(3) of this Regulation and in Article 40(3) of Regulation (EU) 2015/xxx+ are met.";

 

(b) in paragraph 1, the fourth subparagraph is replaced by the following:

 

"The substance of the opinion shall be included in the assessment report published in accordance with Article 13(3) of this Regulation and Article 40(11) of Regulation (EU) 2015/xxx+.";

 

(c) in paragraph 3, the second subparagraph is deleted;

 

______________

 

+ OJ: please, insert the number of Regulation in document COD 2014/0257.

Justification

Point 21 of the amending Regulation removes Articles 30-54 of the Regulation, therefore the references to Article 31(3) and 38(3) need to be corrected and replaced by the corresponding new articles of the New Veterinary Medicines Regulation in subparagraphs 3 and 4 of paragraph 1 - the deletion of second subparagraph in paragraph 3 as per the Commission proposal is maintain under point (c).

Amendment    23

Proposal for a regulation

Article 1 – point 14 a (new)

Regulation (EC) No 726/2004

Article 64 – paragraph 1

 

Present text

Amendment

 

(14a) Article 64(1) is replaced by the following:

1. The Executive Director shall be appointed by the Management Board, on a proposal from the Commission, for a period of five years on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and elsewhere. Before appointment, the candidate nominated by the Management Board shall be invited forthwith to make a statement to the European Parliament and to answer any questions put by its Members. His mandate may be renewed once. The Management Board may, upon a proposal from the Commission, remove the Executive Director from his post.

"1. The Executive Director shall be appointed by the Management Board, on a proposal from the Commission, for a period of five years on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and elsewhere. Before appointment, the candidate nominated by the Management Board shall be invited forthwith to make a statement to the European Parliament and to answer any questions put by its Members. His mandate may be renewed once by the Management Board, in consultation with the Commission. The Management Board may, upon a proposal from the Commission, remove the Executive Director from his post."

Justification

Clarification of the role of the Management Board at the time of renewal of the mandate of the Agency's Executive Director.

Amendment    24

Proposal for a regulation

Article 1 – point 14 b (new)

Regulation (EC) No 726/2004

Article 66 – points a and j

 

Present text

Amendment

 

(14b) Article 66 is amended as follows:

 

(a) point (a) is replaced by the following:

(a) adopt an opinion on the rules of procedures of the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use (Article 61);

"(a) adopt an opinion on the rules of procedures of the Committee for Medicinal Products for Human Use (Article 61 of this Regulation) and the Committee for Medicinal Products for Veterinary Use (Article 140 of Regulation (EU) 2015/xxx+);";

 

(b) point (j) is deleted.

 

_____________

 

+ OJ: please, insert the number of Regulation in document COD 2014/0257.

Justification

Point 21 of the amending Regulation removes Article 79 of the Regulation, therefore the reference to Article 79 in Article 66 needs to be eliminated; also the correct references to the new Veterinary Medicines Regulation have to be made.

Amendment    25

Proposal for a regulation

Article 1 – point 15

Regulation (EC) No 726/2004

Article 67 – paragraph 3 – subparagraph 1

 

Text proposed by the Commission

Amendment

(15) the first subparagraph of Article 67(3) is replaced by the following:

(15) Article 67(3) is replaced by the following:

‘The Agency’s revenue shall consist of a contribution from the Union, fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for other services provided by the Agency, or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC and charges for other services provided by the Agency.’

"The Agency’s revenue shall consist of:

 

(a) a contribution from the Union;

 

(b) a contribution from any European third country with which the Union has concluded agreements;

 

(c) the fees paid by undertakings for obtaining and maintaining Union marketing authorisations for human and veterinary medicinal products and for other services provided by the Agency, as provided for in this Regulation and in Regulation (EU) 2015/xxx+ , or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC;

 

(d) charges for any other services provided by the Agency; and

 

(e) other sources of income, including any ad-hoc grants within the scope of Title VI of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council1a.

 

The European Parliament and the Council (‘the budgetary authority’) shall re-examine, when necessary, the level of the Union contribution, referred to in point (a) of the first subparagraph, on the basis of an evaluation of needs and by taking account of the level of fees."

 

________________

 

+ OJ: please, insert the number of Regulation in document COD 2014/0257.

 

1a Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, s. 1).

Justification

It is necessary to make a clarification with regards to the wording of this article, so as to have a clear delineation between the different types of revenues that make up the Agency’s budget, including the reflection of the current contribution from EEA countries, the fees payable to the Agency that will continue to cover activities in relation to both human and veterinary medicinal products, as well as other sources of income.

Amendment    26

Proposal for a regulation

Article 1 – point 15 a (new)

Regulation (EC) No 726/2004

Article 67 – paragraph 3 – subparagraph 1 a (new)

 

Present text

Amendment

 

(15a) In Article 67(3), the following subparagraph is inserted after subparagraph 1:

 

"In order to safeguard fluctuations in fee revenue, any positive budget outturn of a financial year (N) shall be set aside as assigned revenue and serve as a reserve in the event that actual fee revenue be below budgeted appropriations. The total amount of such a safeguard fund shall not exceed the Agency's appropriations for the fee revenue of the past year."

Justification

It is necessary to ensure that the Agency can deliver the services required by the legislation. A reserve fund could help to deal with potential unpredicted shortfalls in fee revenue.

Amendment    27

Proposal for a regulation

Article 1 – point 15 b (new)

Regulation (EC) No 726/2005

Article 67 – paragraph 6 – subparagraph 1 a (new)

 

Present text

Amendment

 

(15b) In Article 67(6), the following subparagraph is added:

 

"The draft establishment plan shall contain the number of staff required by the Agency to provide the services financed through fees and the number of staff financed by the Union budget."

Justification

It is necessary to ensure that the Agency has sufficient resources to deliver the services required by the legislation.

Amendment    28

Proposal for a regulation

Article 1 – point 15 c (new)

Regulation (EC) No 726/2004

Article 67 – paragraph 8

 

Present text

Amendment

 

(15c) Article 67(8) is replaced by the following:

8. On the basis of the estimate, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty.

"8. On the basis of the estimate, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan concerning the staff financed by the Union budget and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty."

Justification

It is necessary to ensure that the Agency has sufficient resources to deliver the services required by the legislation.

Amendment    29

Proposal for a regulation

Article 1 – point 15 d (new)

Regulation (EC) No 726/2004

Article 67 – paragraph 9 – subparagraph 2

 

Present text

Amendment

 

(15d) In Article 67(9), the second subparagraph is amended as follows:

The budgetary authority shall adopt the establishment plan for the Agency.

"The budgetary authority shall adopt the establishment plan for the staff financed by the Union budget for the Agency."

Justification

It is necessary to ensure that the Agency has sufficient resources to deliver the services required by the legislation.

Amendment    30

Proposal for a regulation

Article 1 – point 15 e (new)

Regulation (EC) No 726/2004

Article 68

 

Present Text

Amendment

 

(15e) Article 68 is replaced by the following:

1. The Executive Director shall implement the budget of the Agency.

"1. The Executive Director shall implement the budget of the Agency.

2. By 1 March at the latest following each financial year, the Agency's accounting officer shall communicate the provisional accounts to the Commission's accounting officer together with a report on the budgetary and financial management for that financial year. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of the Financial Regulation applicable to the general budget of the European Communities(19) (hereinafter referred to as the "general Financial Regulation").

2. By 1 March of the following financial year, the Agency's accounting officer shall send the provisional accounts to the Commission's Accounting Officer and to the Court of Auditors

3. By 31 March at the latest following each financial year, the Commission's accounting officer shall submit the Agency's provisional accounts to the Court of Auditors, together with a report on the budgetary and financial management for that financial year. The report on the budgetary and financial management for the financial year shall also be forwarded to the European Parliament and the Council.

3. By 31 March of the following financial year, the Executive Director shall send the report on the budgetary and financial management to the European Parliament, the Commission, the Council and the Court of Auditors.

4. On receipt of the Court of Auditors' observations on the Agency's provisional accounts, pursuant to Article 129 of the general Financial Regulation, the Executive Director shall draw up the Agency's final accounts under his own responsibility and submit them to the Management Board for an opinion.

4. By 31 March of the following financial year, the Commission's accounting officer shall send the Agency's provisional accounts, consolidated with the Commission's provisional accounts, to the Court of Auditors.

 

On receipt of the Court of Auditors' observations on the Agency's provisional accounts pursuant to Article 148 of the Financial Regulation applicable to the general budget of the Union, the accounting officer shall draw up the Agency's final accounts and the Executive Director shall submit them to the Management Board for an opinion.

5. The Management Board of the Agency shall deliver an opinion on the Agency's final accounts.

5. The Management Board shall deliver an opinion on the Agency's final accounts.

6. The Executive Director shall, by 1 July at the latest following each financial year, forward the final accounts to the European Parliament, the Council, the Commission and the Court of Auditors, together with the Management Board's opinion.

6. The accounting officer shall, by 1 July following each financial year, send the final accounts to the European Parliament, the Council, the accounting officer of the Commission and the Court of Auditors, together with the Management Board's opinion.

7. The final accounts shall be published.

7. The final accounts shall be published in the Official Journal of the European Union by 15 November of the following year.

8. The Agency's Executive Director shall send the Court of Auditors a reply to its observations by 30 September at the latest. He shall also send this reply to the Management Board.

8. The Executive Director shall send the Court of Auditors a reply to its observations by 30 September.

9. The Executive Director shall submit to the European Parliament, at the latter's request, any information required for the smooth application of the discharge procedure for the financial year in question, as laid down in Article 146(3) of the general Financial Regulation.

9. The Executive Director shall submit to the European Parliament, at the latter's request, any information required for the smooth application of the discharge procedure for the financial year in question, in accordance with Article 165(3) of the Financial Regulation applicable to the general budget of the Union.

10. The European Parliament, on a recommendation from the Council acting by a qualified majority, shall, before 30 April of year N + 2, give a discharge to the Executive Director in respect of the implementation of the budget for year N.

10. On a recommendation from the Council, the European Parliament shall, before 15 May of year N + 2, give a discharge to the Executive Director in respect of the implementation of the budget for year N.

11. The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They may not depart from Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities(20), unless specifically required for the Agency's operation and with the Commission's prior consent.

11. The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They shall not depart from Commission Delegated Regulation (EU) No 1271/2013 unless specifically required for the Agency's operation and with the Commission's prior consent."

Amendment    31

Proposal for a regulation

Article 1 – point 16

Regulation (EC) No 726/2004

Article 70

 

Text proposed by the Commission

Amendment

(16) Article 70 is replaced by the following:

deleted

‘Article 70

 

1. The Commission shall, on the basis of the principles set out in paragraph 2, adopt implementing acts in accordance with the procedure laid down in Article 87(2) specifying:

 

(a) the structure and the level of the fees and charges referred to in Article 67(3);

 

(b) the services for which charges may be collected;

 

(c) the conditions under which small and medium-sized enterprises may pay reduced fees, defer payment of fees or receive administrative assistance;

 

(d) the rules defining the remuneration for work carried out by the member of the relevant committee or the coordination group who acts as a rapporteur; and

 

(e) the conditions for payment and remuneration.

 

The fees shall be set at such a level as to avoid a deficit or a significant accumulation of surplus in the budget of the Agency and be revised when this is not the case.

 

2. When adopting the implementing acts referred to in paragraph 1, the Commission shall take the following into account:

 

(a) fees shall be set at such a level as to ensure that the revenue derived from them is, in principle, sufficient to cover the costs of the services delivered and shall not exceed what is necessary to cover the costs;

 

(b) the level of the fees shall take into account the results of a transparent and objective evaluation of the costs of the Agency and the costs of the tasks carried out by the national competent authorities;

 

(c) the specific needs of SMEs shall be taken into account, as appropriate, including the possibility of splitting payments into several instalments and phases;

 

(d) on public health grounds the fee may be totally or partially waived for a particular category of medicinal products;

 

(e) the structure and amount of fees shall take into account whether information has been submitted jointly or separately;

 

(f) under exceptional and duly justified circumstances and upon acceptance by the Agency, the whole fee or part of it may be waived;

 

(g) the remuneration for the work of the rapporteur shall be paid in principle to the national competent authority employing the rapporteur or, where the rapporteur is not employed by the national competent authority, the Member State that nominated him;

 

(h) the time of payment for the fees and charges shall be fixed taking due account of the time limits under the provisions of this Regulation and Regulation (EU) No […]’;

 

Justification

The structure and level of fees payable to the Agency as well as the remuneration to the national competent authorities cannot be set by an implementing act. The Parliament should be fully involved in the setting of Agency fees, throughout a full co-decision process.

Amendment    32

Proposal for a regulation

Article 1 – point 16 a (new)

Regulation (EC) No 726/2004

Article 70 a (new)

 

Text proposed by the Commission

Amendment

 

(16a) The following Article is inserted:

 

"Article 70a

 

With regard to the level and the structure of the fees referred to in Article 67(3) of this Regulation, Regulation (EC) No 297/95 and Regulation (EU) No 658/2014 shall be applicable until an amendment of Regulation (EC) No 297/95 or any other relevant provisions on fees are adopted and become applicable."

Justification

The current Regulation No 297/95 on the general regime of the European Medicines Agency fees and the Pharmacovigilance Fee Regulation EU (No) 658/2014 should remain as a transitional legal basis until the revision of Regulation (EC) No 297/95 or any other provisions on fees are adopted and become applicable, to ensure that the Agency does not face any period without possibility to charge fees and to remunerate the Rapporteurs.

Amendment    33

Proposal for a regulation

Article 1 – point 16 b (new)

Regulation (EC) No 726/2004

Article 82 – paragraph 3

 

Present text

Amendment

 

(16b) Article 82(3) is replaced by the following:

3. Without prejudice to the unique, Union nature of the content of the documents referred to in points (a) to (d) of Article 9(4) and in points (a) to (e) of Article 34(4), this Regulation shall not prohibit the use of two or more commercial designs for a given medicinal product for human use covered by a single marketing authorisation.

"3. Without prejudice to the unique, Union nature of the content of the documents referred to in points (a) to (d) of Article 9(4), this Regulation shall not prohibit the use of two or more commercial designs for a given medicinal product for human use covered by a single marketing authorisation."

Justification

Point 21 of the amending Regulation removes Articles 30-54 of the Regulation, therefore the reference to Article 34(4) in Article 82(3) needs to be deleted.

Amendment    34

Proposal for a regulation

Article 1 – point 18

Regulation (EC) No 726/2004

Article 86

 

Text proposed by the Commission

Amendment

 

 

At least every ten years, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation, and in Chapter 4 of Title III of Directive 2001/83/EC.

At least every five years, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation, in Chapter 4 of Title III of Directive 2001/83/EC and in Regulation (EU) 2015/...+ .

 

______________________

 

+ OJ: please, insert the number of Regulation in document COD 2014/0257.

Justification

The technical requirements for registration of veterinary medicinal products within the EU should be assessed comprehensively, including the division of powers between the EU and the Member States and the scope and scale of responsibilities of EMA, whose activities must also be justified in the corresponding budget proposals. For this purpose, it is necessary to have a robust analysis of a clearly defined legal framework.

Amendment    35

Proposal for a regulation

Article 1 – point 20

Regulation (EC) No 726/2004

Article 87b – paragraph 2

 

Text proposed by the Commission

Amendment

2. The delegation of power referred to in Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.

2. The delegation of power referred to in Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) shall be conferred on the Commission for a period of five years from the date of entry into force of this Regulation. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

Justification

Delegated power conferred on the European Commission should be set for a limited period of time.

(1)

  [OJ C 0, 0.0.0000, p. 0. / Not yet published in the Official Journal].


EXPLANATORY STATEMENT

Background

Directive 2001/82/EC of the European Parliament and of the Council on veterinary medicinal products and the Regulation 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, represent the European Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products.

In September 2014, following an assessment of the functioning of the internal market in this sector, the Commission published a proposal to bring together the rules on Veterinary Medicines under one Regulation on veterinary medicinal products, repealing and replacing Directive 2001/82/EC on veterinary medicinal products and amending Regulation (EC) No 726/2004, in order to delete any references to veterinary medicines and thus completely decouple provisions governing veterinary medicines from those governing human medicines.

Main elements of the proposal

In its current proposal to Amend Regulation 726/2004, the Commission seeks to:

•  Delete from Regulation (EC) No 726/2004 the provisions regarding the granting and maintaining of marketing authorisations for veterinary medicinal products and transferring them to the new Regulation:

  Title III on the "Authorisation and supervision of veterinary medicinal products" is deleted from the structure of the Regulation as the centralized procedure is being moved to the new Regulation on Veterinary Medicines;

  references to veterinary medicines, the Standing Committee on Veterinary Medicinal products and the CVMP are deleted;

  references to veterinary medicinal products are deleted from the Annex;

•  Establish certain principles applicable to fees payable to the Agency, including the need to take into account the specific case of SMEs

•  Adapt the regulation EC No 726/2004 to the Lisbon Treaty;

  Align the provisions on regulating fees to the Lisbon Treaty;

  Align the powers conferred to the Commission under Regulation (EC) No 726/2004 to Articles 290 and 291 (delegated and implementing acts) of the Treaty on the Functioning of the European Union.

The position of the rapporteur

Your Rapporteur broadly endorses the proposal and welcomes the alignment to the Lisbon Treaty. He welcomes the decoupling of marketing authorisations for veterinary medicinal products from those for human medicinal products, to take account of the specific needs of the veterinary sector.

However, your Rapporteur believes that the proposal should still be improved in some areas. Consequently, he does not agree with the Commission proposal as regards the structure and level of fees payable to the Agency, nor, the remuneration to the national competent authorities being set by an implementing act. The Parliament should be fully involved in the setting of Agency fees as was in the case of the Pharmacovigilance legislation. Therefore, your rapporteur proposes a full co-decision process in this regard.

Your rapporteur is suggesting some amendments to clarify and update the principles applicable to fees payable to the Agency, including the clarification of Art 67(3) that describes the different sources of Agency revenues for both human and veterinary medicinal products. In the rapporteur's view, the wording of this article should be clarified so as to separate the different types of revenue that make up the Agency’s budget. The rapporteur wants to ensure that the current Regulation is in line with the revised Framework Financial Regulation from 1 January 2014, including giving the Agency the right to have access to other sources of financing that would support its work on public health projects, such as the Innovative Medicines Initiative or the FP7.

Furthermore, there is a need for a cross-reference with the new Veterinary Medicines Regulation, and the role of EMA in the authorisation and supervision of veterinary products via the centralised procedure should be clearly stated.

In addition, the Rapporteur reinforces the commitment from the Commission to ensure that the new measures take into account the specificities of the veterinary sector and that the fees remain affordable for the veterinary industry in order to promote the development and availability of new medicines in the EU.

For clarification purposes, the rapporteur has "fine-tuned" the proposal updating terminology and legal references throughout the text.

Finally, the rapporteur firmly believes that the current Regulation No 297/95 on the general regime of EMA fees and the Pharmacovigilance Fee Regulation EU (No) 658/2014 need to remain as the legal basis until the revision of Regulation (EC) No 297/95, or any other provisions on fees are adopted and become applicable.


OPINION of the Committee on Agriculture and Rural Development (23.7.2015)

for the Committee on the Environment, Public Health and Food Safety

on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

(COM(2014)0557 – C8‑0142/2014 – 2014/0256(COD))

Rapporteur: Stanislav Polčák

SHORT JUSTIFICATION

BACKGROUND - THE COMMISSION PROPOSAL

The Commission states that Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency must be amended as a consequence of its proposal –submitted in parallel- to repeal Directive 2001/82/EC on veterinary medicinal products. Through those two proposals the centralised marketing authorisation for veterinary products is being separated from that for medicines for humans; for this purpose, all provisions regarding granting and maintaining marketing authorisations for veterinary medicinal products are deleted from Regulation (EC) No 726/2004. The new Regulation on veterinary medicinal products will thus cover all routes granting marketing authorisations for veterinary medicinal products in the Union – both at centralised and national level.

The Commission motivates this modification by recalling that “needs of the veterinary sector differ substantially from those of the human sector in relation to medicines. In the veterinary sector there are many different animal species, which creates both a fragmented market and the need for major investments in order to extend the authorisation of medicines existing for one animal species to another.”

A more specific issue addressed by the Commission is the costs of the procedures and services associated with the operation of this Regulation. For this purpose, the Commission establishes certain principles applicable to fees and charges payable to the Agency and proposes that feeds and charges should be set through implementing acts (Article 291 of the Treaty).

THE POSITION OF THE RAPPORTEUR

The rapporteur has some concerns about the approach followed by the Commission and is therefore proposing amendments to improve problematic issues. He would like to make the following points:

•  Although the issue of registration and post-marketing surveillance of veterinary medicinal products authorized through the centralized procedure is removed from Regulation 726/2004, the scope and responsibilities of the European Medicines Agency (EMA) continue to involve both human and veterinary medicinal products (e.g., Article 57(1) is retained without significant changes). It is thus necessary to ensure a proper link between Regulation 726/2004 and the proposed new Regulation on veterinary medicinal products;

•  The Committee for Veterinary Medicinal Products (CVMP) continues to be part of EMA and its establishment must, therefore, be carried out as an integral part of Regulation 726/2004. Its activities must be part of the EMA budget and EMA should use common infrastructure so as to avoid undue duplication;

•  It is not clear for which reason the appointment of representatives to the CVMP should take place under different rules than the appointment of representatives to other committees of EMA. The newly proposed procedure for appointing members of the CVMP (see Article 140 of the proposal for a Regulation of veterinary medicinal products), defines only vaguely the role of the Management Board of EMA and leads to a high degree of uncertainty;

•  The proposed action is fundamentally changing the distribution of powers within the EU, whereas it is not supported by the Commission’s impact assessment. The structure and amount of fees payable to EMA have a major impact on the funding and functioning of the entire regulatory network and thus a direct impact on Member States and their national budgets. This issue of fees cannot therefore be considered as a "non-essential" part of Regulation (EC) 726/2004;

•  The technical requirements for registration of veterinary medicinal products within the EU should be assessed comprehensively, including the division of powers between the EU and the Member States and the scope and scale of responsibilities of EMA, whose activities must also be justified in the corresponding budget proposals. For this purpose, it is necessary to have a robust analysis of a clearly defined legal framework;

•  Although the technical requirements for veterinary medicinal products will be regulated by the proposed new Regulation on veterinary medicinal products, there are areas (e.g. the setting of fees and charges) which require the participation of a “comitology” committee (i.e. committee within the meaning of Regulation (EU) No 182/2011). It is therefore absolutely necessary to include in the amended Regulation 726/2004 a reference to the Standing Committee for Veterinary Medicinal Products;

•  The Commission considers the issue of medicines for rare diseases and outnumbered species - newly defined as "limited markets" - as one of the main reasons to revise the veterinary pharmaceutical legislation. It is, thus, necessary to ensure that the budgetary requirements for EMA, which were definitely part of Regulation 726/2004, are maintained. For this reason, Article 79 of Regulation 726/2004 should not be deleted.

AMENDMENTS

The Committee on Agriculture and Rural Development calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to take into account the following amendments:

Amendment     1

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(1) Directive 2001/82/EC of the European Parliament and of the Council5 and Regulation (EC) 726/2004 of the European Parliament and of the Council6 constituted the Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products. In the light of the experience acquired and following the assessment by the Commission of the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products has been reviewed, and Regulation (EU) No […] of the European Parliament and of the Council7 laying down procedures for the authorisation and supervision of veterinary medicinal products has been adopted.

(1) Directive 2001/82/EC of the European Parliament and of the Council5 and Regulation (EC) 726/2004 of the European Parliament and of the Council6 constituted the Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products. In the light of the experience acquired and following the assessment by the Commission of the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products has been reviewed, and Regulation (EU) No […] of the European Parliament and of the Council laying down procedures for the authorisation and supervision of veterinary medicinal products has been adopted, with a view to harmonisation of the laws of the Member States.

___________

___________

5 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).

5 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).

6 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

6 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

7 Regulation … of the European Parliament and of the Council of … … … on veterinary medicinal products (OJ L …, … … …, p. …).

7 Regulation … of the European Parliament and of the Council of … … … on veterinary medicinal products (OJ L …, … … …, p. …).

Amendment     2

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4) As a consequence of the entry into force of the Treaty of Lisbon, the powers conferred on the Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union. In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the Annex to technical and scientific progress, determining the situations in which post-authorisation efficacy studies may be required, laying down provisions and requirements for granting marketing authorisations subject to certain specific obligations, establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations and laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this Regulation, the maximum amounts of these penalties as well as the conditions and methods for their collection.

(4) As a consequence of the entry into force of the Treaty of Lisbon, the powers conferred on the Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union. In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the Annex with regard to technical and scientific progress so as to facilitate the placing on the market of new medicinal products, determining the situations in which post-authorisation efficacy studies may be required, laying down provisions and requirements for granting marketing authorisations subject to certain specific obligations, establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations and laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this Regulation, the maximum amounts of these penalties as well as the conditions and methods for their collection.

Amendment     3

Proposal for a regulation

Recital 6

Text proposed by the Commission

Amendment

(6) In order to ensure uniform conditions for the implementation of Regulation (EC) No 726/2004, implementing powers should be conferred on the Commission to adopt implementing acts in relation to marketing authorisations for medicinal products for human use. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council8.

(6) In order to ensure uniform conditions for the implementation of Regulation (EC) No 726/2004, implementing powers should be conferred on the Commission to adopt implementing acts in relation to marketing authorisations for medicinal products for human and veterinary use. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council8.

___________

___________

8 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

8 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

Amendment    4

Proposal for a regulation

Article 1 – point 3

Regulation (EC) No 726/2004

Article 2 – paragraph 1

 

Text proposed by the Commission

Amendment

ʻThe definitions laid down in Article 1 of Directive 2001/83/EC shall apply for the purposes of this Regulationʼ.

ʻThe definitions laid down in Article 1 of Directive 2001/83/EC and in Regulation (EU) 2015/... (Veterinary Medicinal Products)shall apply for the purposes of this Regulationʼ.

Justification

Although the issue of registration and post-marketing surveillance of veterinary medicinal products authorized through the centralized procedure is removed from this Regulation, the scope and activities of the European Medicines Agency (EMA) continue to involve both human and veterinary medicinal products (e.g., Article 57(1) is retained without significant changes). It is thus necessary to ensure a proper link between Regulation 726/2004 and the new Regulation on veterinary medicinal products.

Amendment     5

Proposal for a regulation

Article 1 – paragraph 1 – point 10 a (new)

Regulation (EC) No 726/2004

Article 55 – paragraph 2

 

Present text

Amendment

 

(10a) in Article 55, the second paragraph is replaced by the following:

‘The Agency shall be responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products.’

‘The Agency shall be responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products for human and veterinary use.’

Amendment     6

Proposal for a regulation

Article 1 – paragraph 1 – point 10 a (new)

Regulation (EC) No 726/2004

Article 56 – paragraph 1 – point b

 

Present text

Amendment

 

(10a) in Article 56(1), point (b)is amended as follows:

ʻ(b) the Committee for Medicinal Products for Veterinary Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for veterinary use;

ʻ(b) the Committee for Medicinal Products for Veterinary Use, which shall be responsible for preparing the opinion of the Agency on any question concerning the admissibility of files submitted in accordance with the centralised procedure, the granting, variation, suspension or revocation of an authorisation to place a centrally authorised veterinary medicinal product on the market arising in accordance with Regulation (EU) 2015/... (Veterinary Medicinal Products)and for pharmacovigilance for centrally authorised veterinary medicinal products as well as tasks conferred to it under Regulation (EC) 470/2008. At the request of the Executive Director of the Agency or the Commission representative, the Committee for Medicinal Products for Veterinary Use shall also draw up opinions on any scientific matters concerning the evaluation of veterinary medicinal products. The Committee shall take due account of any requests from Member States for an opinion. The Committee shall also prepare an opinion in other cases provided for under Regulation (EU) 2015/... (Veterinary Medicinal Products). The opinion of the Committee shall be made publicly accessible;ʼ

Amendment     7

Proposal for a regulation

Article 1 – paragraph 1 – point 10 a (new)

Regulation (EC) No 726/2004

Article 57 – paragraph 1 – subparagraph 2 – points ta, tb, tc (new)

 

Text proposed by the Commission

Amendment

 

(10a) in Article 57(1), the following points are added:

 

"(ta) co-ordination of the provision of information on active substances of veterinary medicinal products authorised under Union procedures, for the purpose of implementing a review system (Monograph system);

 

(tb) assisting Member States in providing information on active substances of veterinary medicinal products authorised under procedures other than the Union procedures, for the purpose of implementing a review system (Monograph System);

 

(tc) setting up a free of charge public database that lists information on active substances of veterinary medicinal products according to the review system (Monograph System), and updating that database on a regular basis. That listed information shall be presented in an easily understandable manner."

Amendment     8

Proposal for a regulation

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

Regulation (EC) No 726/2004

Article 57 – paragraph 2a (new)

 

Text proposed by the Commission

Amendment

 

(11a) in Article 57, the following paragraph is added:

 

'(2a) The database set up in accordance with point (c) of paragraph 1 of this Article, shall contain data on physico-chemical, ecotoxicological and behavioural properties of the active substance and its respective metabolites. The database shall list information on all veterinary medicines marketed in the Union. The Agency shall prepare a list of all veterinary medicines and active substances marketed in the Union in accordance with Article 51 of Regulation (EU) 2015/... (Veterinary Medicinal Products).'

Amendment    9

Proposal for a regulation

Article 1 – point 13

Regulation (EC) No 726/2004

Article 61 – paragraph 1

 

Text proposed by the Commission

Amendment

(13) Article 61(1) is replaced by the following:

deleted

‘1. Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human.

 

The alternates shall represent and vote for the members in their absence and may act as rapporteurs in accordance with Article 62.

 

Members and alternates shall be chosen for their role and experience in the evaluation of medicinal products for human use as appropriate and shall represent the competent national authorities.’

 

Justification

It is not clear for which reason the appointment of representatives to the Committee for Veterinary Medicinal Products (CVMP) should take place under different rules than the appointment of representatives to other committees of EMA. The newly proposed procedure for appointing members of the CVMP (see Article 140 of the proposal for a Regulation of veterinary medicinal products), defines only vaguely the role of the Management Board of EMA and leads to a high degree of uncertainty.

Amendment    10

Proposal for a regulation

Article 1 – point 14

Regulation (EC) No 726/2004

Article 62 – paragraph 3 – subparagraph 2

 

Text proposed by the Commission

Amendment

(14) in Article 62(3), the second subparagraph is deleted;

deleted

Justification

This is closely linked to the proposed deletion of Article 70 which changes the setting of fees and charges, including transfer of powers to EU institutions. The Commission proposal has not provided any relevant justification, whereas the proposed measures go beyond what is needed to align Regulation 726/2004 with the proposed new Regulation on veterinary medicinal products. Due to the lack of proper justification, there can be no objective assessment of the impact of the proposed measures.

Amendment     11

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EC) No 726/2004

Article 67 – paragraph 3 – subparagraph 1

 

Text proposed by the Commission

Amendment

The Agency’s revenue shall consist of a contribution from the Union, fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for other services provided by the Agency, or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC and charges for other services provided by the Agency.

The Agency’s revenue shall consist of a contribution from the Union, fees paid by undertakings for obtaining and maintaining Union marketing authorisations for medicinal products for human and veterinary use, and for other services provided by the Agency in accordance with this Regulation and Regulation (EU) 2015/... (Veterinary Medicinal Products), or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC and charges for other services provided by the Agency.

Amendment    12

Proposal for a regulation

Article 1 – point 16

Regulation (EC) No 726/2004

Article 70

 

Text proposed by the Commission

Amendment

(16) Article 70 is replaced by the following:

deleted

‘Article 70

 

1. The Commission shall, on the basis of the principles set out in paragraph 2, adopt implementing acts in accordance with the procedure laid down in Article 87(2) specifying:

 

(a) the structure and the level of the fees and charges referred to in Article 67(3);

 

(b) the services for which charges may be collected;

 

(c) the conditions under which small and medium-sized enterprises may pay reduced fees, defer payment of fees or receive administrative assistance;

 

(d) the rules defining the remuneration for work carried out by the member of the relevant committee or the coordination group who acts as a rapporteur; and

 

(e) the conditions for payment and remuneration. The fees shall be set at such a level as to avoid a deficit or a significant accumulation of surplus in the budget of the Agency and be revised when this is not the case.

 

2. When adopting the implementing acts referred to in paragraph 1, the Commission shall take the following into account:

 

(a) fees shall be set at such a level as to ensure that the revenue derived from them is, in principle, sufficient to cover the costs of the services delivered and shall not exceed what is necessary to cover the costs;

 

(b) the level of the fees shall take into account the results of a transparent and objective evaluation of the costs of the Agency and the costs of the tasks carried out by the national competent authorities;

 

(c) the specific needs of SMEs shall be taken into account, as appropriate, including the possibility of splitting payments into several instalments and phases;

 

(d) on public health grounds the fee may be totally or partially waived for a particular category of medicinal products;

 

(e) the structure and amount of fees shall take into account whether information has been submitted jointly or separately;

 

(f) under exceptional and duly justified circumstances and upon acceptance by the Agency, the whole fee or part of it may be waived;

 

(g) the remuneration for the work of the rapporteur shall be paid in principle to the national competent authority employing the rapporteur or, where the rapporteur is not employed by the national competent authority, the Member State that nominated him;

 

(h) the time of payment for the fees and charges shall be fixed taking due account of the time limits under the provisions of this Regulation and Regulation (EU) No […]’;

 

Justification

The proposed action is fundamentally changing the distribution of powers within the EU whereas it is not supported by any relevant impact assessment by the Commission. The structure and amount of fees payable to EMA have a major impact on the funding and functioning of the entire regulatory network and thus a direct impact on Member States and their national budgets. This issue cannot therefore be considered as a "non-essential" part of Regulation (EC) 726/2004.

Amendment    13

Proposal for a regulation

Article 1 – point 18

Regulation (EC) No 726/2004

Article 86

 

Text proposed by the Commission

Amendment

ʻArticle 86

̒Article 86

At least every ten years, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation, and in Chapter 4 of Title III of Directive 2001/83/EC.ʼ;

At least every five years, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation, in Chapter 4 of Title III of Directive 2001/83/EC and in Regulation (EU) 2015/... (Veterinary Medicinal Products).ʼ;

Justification

The technical requirements for registration of veterinary medicinal products within the EU should be assessed comprehensively, including the division of powers between the EU and the Member States and the scope and scale of responsibilities of EMA, whose activities must also be justified in the corresponding budget proposals. For this purpose, it is necessary to have a robust analysis of a clearly defined legal framework.

Amendment    14

Proposal for a regulation

Article 1 – point 19

Regulation (EC) No 726/2004

Article 87 – paragraph 1

 

Text proposed by the Commission

Amendment

1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use established by Article 121 of Directive 2001/83/EC. The Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use established by Article 121 of Directive 2001/83/EC and by the Standing Committee on Veterinary Medicinal Products set up by Regulation (EU) 2015/... (Veterinary Medicinal Products). Those committees shall be committees within the meaning of Regulation (EU) No 182/2011.

Justification

Although the technical requirements for veterinary medicinal products will be regulated by the proposed new regulation on veterinary medicinal products, there are areas (e.g. the setting of fees and charges) which require the participation of a “comitology” committee (i.e. committee within the meaning of Regulation (EU) No 182/2011). It is therefore absolutely necessary to include in the amended Regulation 726/2004 a reference to the Standing Committee for Veterinary Medicinal Products.

Amendment    15

Proposal for a regulation

Article 1 – point 20

Regulation (EC) No 726/2004

Article 87 b – paragraph 2

 

Text proposed by the Commission

Amendment

2. The delegation of power referred to in Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.

2. The delegation of power referred to in Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) shall be conferred on the Commission for a period of five years from the date of entry into force of this Regulation.

Justification

It is an established principle of Parliament that the delegation of power conferred on the Commission should not be for an indeterminate period. This period should be set at five years.

Amendment    16

Proposal for a regulation

Article 1 – point 21

 

Text proposed by the Commission

Amendment

Articles 30 to 54, Articles 79, 87c and 87d and point 2 of the Annex are deleted.

Articles 30 to 54, Articles 87c and 87d and point 2 of the Annex are deleted.

Justification

The Commission considers the issue of medicines for rare diseases and outnumbered species - newly defined as "limited markets" - as one of the main reasons to revise the veterinary pharmaceutical legislation. It is, thus, necessary to ensure that the budgetary requirements for EMA, which were definitely part of Regulation 726/2004, are maintained. For this reason, Article 79 of Regulation 726/2004 should not be deleted.

PROCEDURE

Title

Amendment to Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

References

COM(2014)0557 – C8-0142/2014 – 2014/0256(COD)

Committee responsible

       Date announced in plenary

ENVI

20.10.2014

 

 

 

Opinion by

       Date announced in plenary

AGRI

20.10.2014

Rapporteur

       Date appointed

Stanislav Polčák

22.10.2014

Discussed in committee

24.3.2015

 

 

 

Date adopted

15.7.2015

 

 

 

Result of final vote

+:

–:

0:

38

3

0

Members present for the final vote

John Stuart Agnew, Richard Ashworth, Paul Brannen, Daniel Buda, Nicola Caputo, Michel Dantin, Paolo De Castro, Albert Deß, Diane Dodds, Herbert Dorfmann, Norbert Erdős, Edouard Ferrand, Luke Ming Flanagan, Beata Gosiewska, Martin Häusling, Anja Hazekamp, Esther Herranz García, Jan Huitema, Peter Jahr, Elisabeth Köstinger, Zbigniew Kuźmiuk, Philippe Loiseau, Giulia Moi, Ulrike Müller, Maria Noichl, Marit Paulsen, Marijana Petir, Jens Rohde, Bronis Ropė, Jordi Sebastià, Lidia Senra Rodríguez, Czesław Adam Siekierski, Marc Tarabella, Janusz Wojciechowski, Marco Zullo

Substitutes present for the final vote

Bas Belder, Maria Heubuch, Momchil Nekov, Stanislav Polčák, Sofia Ribeiro, Molly Scott Cato, Miguel Viegas


PROCEDURE – COMMITTEE RESPONSIBLE

Title

Amendment to Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

References

COM(2014)0557 – C8-0142/2014 – 2014/0256(COD)

Date submitted to Parliament

10.9.2014

 

 

 

Committee responsible

       Date announced in plenary

ENVI

20.10.2014

 

 

 

Committees asked for opinions

       Date announced in plenary

ITRE

20.10.2014

IMCO

20.10.2014

AGRI

20.10.2014

 

Not delivering opinions

       Date of decision

ITRE

5.11.2014

IMCO

5.11.2014

 

 

Rapporteurs

       Date appointed

Claudiu Ciprian Tănăsescu

25.11.2014

 

 

 

Discussed in committee

18.3.2015

6.5.2015

 

 

Date adopted

17.2.2016

 

 

 

Result of final vote

+:

–:

0:

53

0

3

Members present for the final vote

Marco Affronte, Margrete Auken, Pilar Ayuso, Zoltán Balczó, Ivo Belet, Simona Bonafè, Biljana Borzan, Nessa Childers, Alberto Cirio, Mireille D’Ornano, Seb Dance, Angélique Delahaye, Jørn Dohrmann, Ian Duncan, Stefan Eck, Eleonora Evi, José Inácio Faria, Francesc Gambús, Elisabetta Gardini, Gerben-Jan Gerbrandy, Jens Gieseke, Julie Girling, Matthias Groote, Françoise Grossetête, Andrzej Grzyb, Jytte Guteland, Anneli Jäätteenmäki, Jean-François Jalkh, Karin Kadenbach, Giovanni La Via, Peter Liese, Norbert Lins, Valentinas Mazuronis, Joëlle Mélin, Susanne Melior, Massimo Paolucci, Gilles Pargneaux, Piernicola Pedicini, Marcus Pretzell, Davor Škrlec, Renate Sommer, Dubravka Šuica, Tibor Szanyi, Claudiu Ciprian Tănăsescu, Nils Torvalds, Glenis Willmott, Jadwiga Wiśniewska, Damiano Zoffoli

Substitutes present for the final vote

Clara Eugenia Aguilera García, Nicola Caputo, Herbert Dorfmann, Martin Häusling, Merja Kyllönen, James Nicholson, Alojz Peterle, Jasenko Selimovic, Bart Staes

Date tabled

23.2.2016

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