# C_2015242EN.01003901.xml

| 23.7.2015 | EN | Official Journal of the European Union | C 242/39 |
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23.7.2015

EN

Official Journal of the European Union

C 242/39

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Opinion of the European Economic and Social Committee 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) 557 final — 2014/0256 (COD)

(2015/C 242/07)

| Rapporteur: | Ms HEINISCH |
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Rapporteur:

Rapporteur:

Ms HEINISCH

Ms HEINISCH

On 20 and 23 October 2014 respectively, the European Parliament and the Council decided to consult the European Economic and Social Committee, under Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union, 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

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) 557 final — 2014/0256 (COD).

COM(2014) 557 final — 2014/0256 (COD).

The Section for the Single Market, Production and Consumption, which was responsible for preparing the Committee’s work on the subject, adopted its opinion on 16 December 2014.

At its 504th plenary session, held on 21 and 22 January 2015 (meeting of 21 January), the Committee adopted the following opinion by 223 votes with 1 abstention.

| 1. | Conclusions and recommendations |
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1.

Conclusions and recommendations

| 1.1. | The amendment of Regulation (EC) No 726/2004 (1) is part of a regulatory package introducing new rules governing EU veterinary medicines. The regulation in question deletes references to veterinary medicines and thus completely decouples provisions governing veterinary medicines from those governing human medicines. This makes sense in view of the different operating environment of each sphere, and the Committee endorses the change. These proposed changes to the regulation are in our view consistent. No specific proposals for changes to the regulation are presented, nor do they appear necessary. The EESC recommends that the proposal for a regulation be approved in its current form. |
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1.1.

The amendment of Regulation (EC) No 726/2004 (1) is part of a regulatory package introducing new rules governing EU veterinary medicines. The regulation in question deletes references to veterinary medicines and thus completely decouples provisions governing veterinary medicines from those governing human medicines. This makes sense in view of the different operating environment of each sphere, and the Committee endorses the change. These proposed changes to the regulation are in our view consistent. No specific proposals for changes to the regulation are presented, nor do they appear necessary. The EESC recommends that the proposal for a regulation be approved in its current form.

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| 1.2. | On the other hand, the new rules on veterinary medicines that have been proposed concurrently, in the proposal for a regulation COM(2014) 558 final — 2014/0257 (COD), are much more significant than the above-mentioned deletion of references to veterinary medicines in the proposal that is the subject of this opinion. |
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1.2.

On the other hand, the new rules on veterinary medicines that have been proposed concurrently, in the proposal for a regulation COM(2014) 558 final — 2014/0257 (COD), are much more significant than the above-mentioned deletion of references to veterinary medicines in the proposal that is the subject of this opinion.

new rules

| 1.3. | Following an initial inspection of the documents, the Committee also welcomes the proposal for a regulation on veterinary medicines, the proposal amending Regulation (EC) No 726/2004 laying down Community procedures, and the proposal for a regulation on the manufacture, placing on the market and use of medicated feed. However, the Committee believes that a number of points could be improved upon to ensure that the objectives of improving the availability of veterinary medicines, reducing red tape and promoting innovation and competitiveness, as well as enhancing the functioning of the internal market, are really achieved. |
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1.3.

Following an initial inspection of the documents, the Committee also welcomes the proposal for a regulation on veterinary medicines, the proposal amending Regulation (EC) No 726/2004 laying down Community procedures, and the proposal for a regulation on the manufacture, placing on the market and use of medicated feed. However, the Committee believes that a number of points could be improved upon to ensure that the objectives of improving the availability of veterinary medicines, reducing red tape and promoting innovation and competitiveness, as well as enhancing the functioning of the internal market, are really achieved.

| 1.4. | The European institutions must bear in mind that any marketing authorisation for an animal health product has an impact on the food chain and on human health, for example through infiltration and being released in various ways into water as a result of nanotechnology, recycling of waste water and new permeability pathways in certain groundwater systems. |
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1.4.

The European institutions must bear in mind that any marketing authorisation for an animal health product has an impact on the food chain and on human health, for example through infiltration and being released in various ways into water as a result of nanotechnology, recycling of waste water and new permeability pathways in certain groundwater systems.

| 1.5. | On the other hand, the Committee’s remit does not extend to commenting on these proposals in more detail. |
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1.5.

On the other hand, the Committee’s remit does not extend to commenting on these proposals in more detail.

2.   Introduction

Introduction

| 2.1. | The rules governing the production, distribution and use of veterinary medicines were codified in 2001 (Directive 2001/82/EC (2)). The regulation governing, inter alia, the centralised authorisation procedure and the European Medicines Agency (Regulation (EC) No 726/2004) was recast at the same time. These texts regulated the authorisation, production, marketing, pharmacovigilance and use of veterinary medicines over their whole life cycle. The annexes to Directive 2001/82/EC also specified information to be submitted with an application for authorisation. Regulation (EC) No 726/2004 likewise set out rules on veterinary medicines (alongside those on human medicines) and regulated cooperation with the European Medicines Agency. |
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2.1.

The rules governing the production, distribution and use of veterinary medicines were codified in 2001 (Directive 2001/82/EC (2)). The regulation governing, inter alia, the centralised authorisation procedure and the European Medicines Agency (Regulation (EC) No 726/2004) was recast at the same time. These texts regulated the authorisation, production, marketing, pharmacovigilance and use of veterinary medicines over their whole life cycle. The annexes to Directive 2001/82/EC also specified information to be submitted with an application for authorisation. Regulation (EC) No 726/2004 likewise set out rules on veterinary medicines (alongside those on human medicines) and regulated cooperation with the European Medicines Agency.

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| 2.2. | The rules on granting and managing authorisations for veterinary medicinal products are now to be deleted from Regulation (EC) No 726/2004 and transferred to a new regulation on veterinary medicines. That new regulation is to cover every type of authorisation for veterinary medicines in the Union, both centralised and national procedures. |
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2.2.

The rules on granting and managing authorisations for veterinary medicinal products are now to be deleted from Regulation (EC) No 726/2004 and transferred to a new regulation on veterinary medicines. That new regulation is to cover every type of authorisation for veterinary medicines in the Union, both centralised and national procedures.

| 2.3. | The costs of the procedures and services arising under this Regulation are to be passed on to the manufacturers and distributors of the products in question, or those applying for the authorisation. The principles applicable to fees payable to the European Medicines Agency are laid down to this end. These also include rules that allow for the particular needs of SMEs, in accordance with the provisions of the Lisbon Treaty. |
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2.3.

The costs of the procedures and services arising under this Regulation are to be passed on to the manufacturers and distributors of the products in question, or those applying for the authorisation. The principles applicable to fees payable to the European Medicines Agency are laid down to this end. These also include rules that allow for the particular needs of SMEs, in accordance with the provisions of the Lisbon Treaty.

| 2.4. | The Treaty of Lisbon, which entered into force on 1 December 2009, makes a distinction between the power conferred on the Commission to adopt non-legislative acts of general application to supplement or amend certain non-essential elements of a legislative act under Article 290 TFEU (delegation procedure) and the power to adopt implementing acts under Article 291 TFEU (implementing procedure). |
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2.4.

The Treaty of Lisbon, which entered into force on 1 December 2009, makes a distinction between the power conferred on the Commission to adopt non-legislative acts of general application to supplement or amend certain non-essential elements of a legislative act under Article 290 TFEU (delegation procedure) and the power to adopt implementing acts under Article 291 TFEU (implementing procedure).

| 2.5. | These two powers are governed by entirely separate legal frameworks. |
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2.5.

These two powers are governed by entirely separate legal frameworks.

| 2.5.1. | Use of delegating powers is provided for in the following non-binding instruments:






  — | Communication from the Commission to the European Parliament and the Council on the implementation of Article 290 of the Treaty on the Functioning of the European Union (3), |
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2.5.1.

Use of delegating powers is provided for in the following non-binding instruments:

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Communication from the Commission to the European Parliament and the Council on the implementation of Article 290 of the Treaty on the Functioning of the European Union (3),

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| — | Common Understanding on Delegated Acts concluded between the Parliament, the Council and the Commission, |
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Common Understanding on Delegated Acts concluded between the Parliament, the Council and the Commission,

| — | Articles 87a and 88 of the Rules of Procedure of the European Parliament, as amended by the Decision of 10 May 2012 (4). |
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Articles 87a and 88 of the Rules of Procedure of the European Parliament, as amended by the Decision of 10 May 2012 (4).

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| 2.5.1.1. | The Committee recently adopted a detailed information report on the delegation of powers, and strongly recommends this as an aid to understanding the present opinion (5). |
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2.5.1.1.

The Committee recently adopted a detailed information report on the delegation of powers, and strongly recommends this as an aid to understanding the present opinion (5).

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| 2.5.2. | Use of the implementing powers provided for under Article 291 of the TFEU is regulated by these legally binding instruments:






  — | Regulation (EU) No 182/2011 (6) (hereinafter referred to as the Comitology Regulation), which provides for two procedures: the advisory procedure and the examination procedure, |
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2.5.2.

Use of the implementing powers provided for under Article 291 of the TFEU is regulated by these legally binding instruments:

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Regulation (EU) No 182/2011 (6) (hereinafter referred to as the Comitology Regulation), which provides for two procedures: the advisory procedure and the examination procedure,

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| — | Decision 1999/468/EC (7) (hereinafter referred to as the Comitology Decision), amended in 2006 in order to strengthen the powers of scrutiny of the Parliament and the Council, which provides for the regulatory procedure with scrutiny. |
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Decision 1999/468/EC (7) (hereinafter referred to as the Comitology Decision), amended in 2006 in order to strengthen the powers of scrutiny of the Parliament and the Council, which provides for the regulatory procedure with scrutiny.

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| 2.5.3. | The regulatory procedure with scrutiny has been used to adopt implementing measures which amend non-essential elements of legislative acts. The wording of Article 5a of the Comitology Decision (8) is very similar to the definition of delegated acts. A delegated act as defined in Article 290 TFEU is a quasi-legislative act adopted by the Commission in order to supplement or amend certain ‘non-essential elements of the legislative act’. |
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2.5.3.

The regulatory procedure with scrutiny has been used to adopt implementing measures which amend non-essential elements of legislative acts. The wording of Article 5a of the Comitology Decision (8) is very similar to the definition of delegated acts. A delegated act as defined in Article 290 TFEU is a quasi-legislative act adopted by the Commission in order to supplement or amend certain ‘non-essential elements of the legislative act’.

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| 2.5.4. | Given this similarity, Article 5a of the Comitology Decision and the regulatory procedure with scrutiny have remained in force provisionally between 2009 and 2014, as the Commission wanted to use this period to adapt the existing regulatory procedure with scrutiny provisions to the delegated acts regime. |
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2.5.4.

Given this similarity, Article 5a of the Comitology Decision and the regulatory procedure with scrutiny have remained in force provisionally between 2009 and 2014, as the Commission wanted to use this period to adapt the existing regulatory procedure with scrutiny provisions to the delegated acts regime.

| 2.5.5. | In response to a call from the European Parliament (9), the Commission has therefore undertaken, with the Council’s support, an alignment exercise involving a number of regulations, directives and decisions (10). |
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2.5.5.

In response to a call from the European Parliament (9), the Commission has therefore undertaken, with the Council’s support, an alignment exercise involving a number of regulations, directives and decisions (10).

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3.   Commission proposals

Commission proposals

| 3.1. | The Commission has published three proposals for a regulation:






  — | 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) 557 final), |
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3.1.

The Commission has published three proposals for a regulation:

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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) 557 final),

| — | Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products (COM(2014) 558 final), |
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Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products (COM(2014) 558 final),

| — | Proposal for a Regulation of the European Parliament and of the Council on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC (11) (COM(2014) 556 final). |
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Proposal for a Regulation of the European Parliament and of the Council on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC (11) (COM(2014) 556 final).

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| 3.2. | This regulatory package is intended to completely decouple the provisions governing human medicines from those governing veterinary medicines. |
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3.2.

This regulatory package is intended to completely decouple the provisions governing human medicines from those governing veterinary medicines.

| 3.3. | To achieve this, the first of the above-mentioned proposals removes all references to veterinary medicines contained in 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. |
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3.3.

To achieve this, the first of the above-mentioned proposals removes all references to veterinary medicines contained in 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.

| 3.4. | In the Regulation of the European Parliament and of the Council on veterinary medicinal products (COM(2014) 558 final), the provisions governing veterinary medicines are then recast. Among other things, the centralised authorisation procedure is also to be introduced for veterinary medicines, although other authorisation procedures (national procedures, decentralised procedures and the mutual recognition procedure) remain available. Another objective of the new rules is to reduce the red tape associated with changes to authorisations of veterinary medicines. |
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3.4.

In the Regulation of the European Parliament and of the Council on veterinary medicinal products (COM(2014) 558 final), the provisions governing veterinary medicines are then recast. Among other things, the centralised authorisation procedure is also to be introduced for veterinary medicines, although other authorisation procedures (national procedures, decentralised procedures and the mutual recognition procedure) remain available. Another objective of the new rules is to reduce the red tape associated with changes to authorisations of veterinary medicines.

| 3.5. | The basic objective of this regulation is sound and the EESC endorses it. However, a detailed analysis of the proposal for a regulation would not fall within our remit. |
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3.5.

The basic objective of this regulation is sound and the EESC endorses it. However, a detailed analysis of the proposal for a regulation would not fall within our remit.

| 3.6. | The third proposal for a Regulation — on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC (COM(2014) 556 final) — is intended to finally fix uniform EU-wide conditions for the production and use of medicated feed. The provisions of Directive 90/167/EEC, which sets out the conditions under which medicated animal feed may be manufactured, placed on the market and used within the EU, were couched in general terms, and this proposal makes them more specific and binding. The intention is to ensure that the internal market for medicated feed is competitive and innovative, and that it operates smoothly, while guaranteeing a high level of protection of human and animal health. |
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3.6.

The third proposal for a Regulation — on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC (COM(2014) 556 final) — is intended to finally fix uniform EU-wide conditions for the production and use of medicated feed. The provisions of Directive 90/167/EEC, which sets out the conditions under which medicated animal feed may be manufactured, placed on the market and used within the EU, were couched in general terms, and this proposal makes them more specific and binding. The intention is to ensure that the internal market for medicated feed is competitive and innovative, and that it operates smoothly, while guaranteeing a high level of protection of human and animal health.

| 3.7. | The European institutions must bear in mind that any marketing authorisation for an animal health product has an impact on the food chain and on human health, for example through infiltration and being released in various ways into water as a result of nanotechnology, recycling of waste water and new permeability pathways in certain groundwater systems. |
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3.7.

The European institutions must bear in mind that any marketing authorisation for an animal health product has an impact on the food chain and on human health, for example through infiltration and being released in various ways into water as a result of nanotechnology, recycling of waste water and new permeability pathways in certain groundwater systems.

| 3.8. | In summary, the EESC basically welcomes the decoupling of the rules for human and veterinary medicines, as well as the proposed new rules on veterinary medicines. Particularly welcome are the extension of the centralised authorisation procedure and the proposals on simplifying administrative procedures relating to applying for and managing authorisations for veterinary medicines. |
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3.8.

In summary, the EESC basically welcomes the decoupling of the rules for human and veterinary medicines, as well as the proposed new rules on veterinary medicines. Particularly welcome are the extension of the centralised authorisation procedure and the proposals on simplifying administrative procedures relating to applying for and managing authorisations for veterinary medicines.

Brussels, 21 January 2015.

The President of the European Economic and Social Committee

Henri MALOSSE

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(1)  OJ L 136, 30.4.2004, p. 1.

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(2)  OJ L 311, 28.11.2001, p. 1.

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(3)  COM(2009) 673 final, 9.12.2009.

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(4)  Doc. A7-0072/2012.

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(5)  Information Report on Better Regulation: Implementing acts and delegated acts (INT/656).

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Better Regulation: Implementing acts and delegated acts

(6)  OJ L 55, 28.2.2011, p. 13.

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(7)  OJ L 184, 17.7.1999, p. 23.

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(8)  Council Decision of 17 July 2006 (OJ L 200, 22.7.2006, p. 11).

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(9)  EP Resolution of 5 May 2010 (P7-TA (2010) 0127), point 18.

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(10)  Statements by the Commission (OJ L 55, 28.2.2011, p. 19).

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(11)  OJ L 92, 7.4.1990, p. 42.

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