Commission>{JURI}Committee on Legal Affairs</Commission
<Date>{04/10/2013}4.10.2013</Date>
<TitreType>NOTICE TO MEMBERS</TitreType>
(85/2013)
Subject: <Titre>Reasoned opinion by the Spanish Congress of Deputies and the Spanish Senate on the proposal for a Regulation of the European Parliament and of the Council on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use</Titre>
(COM(2013)0472 – C7-0196/2013 – 2013/0222(COD))
Under Article 6 of the Protocol (No 2) on the application of the principles of subsidiarity and proportionality, any national parliament may, within eight weeks from the date of transmission of a draft legislative act, send the Presidents of the European Parliament, the Council and the Commission a reasoned opinion stating why it considers that the draft in question does not comply with the principle of subsidiarity.
Under Parliament’s Rules of Procedure the Committee on Legal Affairs is responsible for compliance with the subsidiarity principle.
Please find attached, for information, a reasoned opinion by the Spanish Congress of Deputies on the above-mentioned proposal.
ANNEX
Reasoned opinion by the Spanish Congress of Deputies and the Spanish Senate on the proposal for a Regulation of the European Parliament and of the Council on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use ((Text with EEA relevance) (COM(2013) 472 FINAL – 2013/0222 (COD) – SWD(2013) 234 FINAL – SWD (2013) 235 FINAL)
BACKGROUND
A. The Protocol on the application of the principles of subsidiarity and proportionality, annexed to the Lisbon Treaty of 2007 and in force since 1 December 2009, provides for a procedure by which national parliaments can monitor the compliance of EU legislative proposals with the principle of subsidiarity. This Protocol has been applied in Spain by means of Law 24/2009 of 22 December 2009 amending Law 8/1994 of 19 May 1994. New Articles 3(j), 5 and 6 in particular of Law 8/1994 form the legal basis for this reasoned opinion.
B. The proposal for a Regulation of the European Parliament and of the Council on fees payable to the European Medicines Agency and for the conduct of pharmacovigilance activities in respect of medicinal products for human use has been approved by the Commission and forwarded to the national parliaments, which have a period of eight weeks in which to assess the initiative's compliance with the principle of subsidiarity. This period terminates on 26 September 2013.
C. On 5 September 2013 the Bureau and spokespersons of the Joint Committee on European Affairs decided to examine the above-mentioned European legislative proposal. A member of the Spanish Parliament, Rubén Moreno Palanques, was appointed rapporteur and the Government was asked to draft the report provided for in Article 3(j) of Law 8/1994.
D. As provided for under the terms of article 3(j) of Law 8/1994 of 19 May, regulating the Joint Committee on European Affairs, the Government has submitted a report, which concludes that the proposal breaches the principle of subsidiarity. Written communications have also been received from the regional parliaments of La Rioja, Cantabria, Catalonia, Aragon and Galicia, notifying acknowledgment or closure of the file or non-delivery of a reasoned opinion.
E. At its meeting of 24 September 2013, the Joint Committee on European Affairs approved this
REASONED OPINION
Article 5(1) of the Treaty on European Union states that ‘the use of Union competences is governed by the principles of subsidiarity and proportionality’. In accordance with Article 5(3) of the same Treaty, ‘under the principle of subsidiarity, […] the Union shall act only if and in so far as the objectives of the proposed action cannot be sufficiently achieved by the Member States, either at central level or at regional and local level, but can rather, by reason of the scale or effects of the proposed action, be better achieved at Union level’.
The proposed Regulation is, like the EU pharmacovigilance legislation, based on a dual legal basis: Article 114 and Article 168(4)(c) of the Treaty on the Functioning of the European Union..
Article 114 states that ‘save where otherwise provided in the Treaties, the following provisions shall apply for the achievement of the objectives set out in Article26. The European Parliament and the Council shall, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee, adopt the measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market.’
In this respect, the proposed Regulation is based on Article 114 TFEU as differences between national legislative, regulatory and administrative provisions on medicinal products tend to hinder intra-Union trade and therefore directly affect the operation of the internal market. This Regulation seeks to ensure the availability of the necessary financial resources to apply the streamlined Union procedures for the assessment of serious safety issues for nationally-authorised medicinal products, which have been introduced amongst other things to prevent or eliminate obstacles that could result from parallel procedures at national level. Thereby this Regulation contributes to the well-functioning of the internal market and the common post-marketing surveillance of medicinal products.
In addition, the proposed Regulation is based on Article 168(4)(c) TFEU as it aims at supporting the goal of setting high standards of quality and safety of medicinal products.
According to Article 168(4)(c) TFEU:
4. ‘By way of derogation from Article 2(5) and Article 6(a) and in accordance with Article 4(2)(k) the European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting in order to meet common safety concerns:
(c) measures setting high standards of quality and safety for medicinal products and devices for medical use.’
According to Articles 168(4) and 4(2)(k) TFEU this Union competence is – like Article 114 TFEU - a shared competence which is exercised with the adoption of the proposed Regulation.
The proposed Regulation aims at setting high standards of quality and safety for medicinal products as it ensures the availability of sufficient financial resources to perform the pharmacovigilance activities that are necessary to guarantee that high standards are maintained once the product is authorised.
Nevertheless, Article 168(4)(c) TFEU cannot serve as sole legal basis, since, as set out above, the objectives pursued also include the establishment and functioning of the internal market and the setting of high standards of quality and safety for medicinal products, requiring it to be complemented with the legal basis of Article 114 TFEU.
Ordinary legislative procedure is applied. Since the Treaty on the Functioning of the European Union became applicable, all legislative procedures are normally based on the previous ‘co-decision procedure’, involving both the Council and the European Parliament. Therefore, for legal certainty, it is proposed to create for pharmacovigilance fees a new Regulation of the Council and the European Parliament, which will be subject to the ordinary legislative procedure (Article 294 of the TFEU).
The legal framework of pharmacovigilance for medicinal products for human use marketed within the EU is provided for in Regulation (EC) No 726/2004 (‘the Regulation’) and in Directive 2001/83/EC (‘the Directive’).
This framework has been subject to a major review and an impact assessment that led to the adoption of a revised legislation in 2010 (Regulation (EU) No1235/2010 of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Directive 2001/83/EC (OJ L 348, 31.12.2010)), which strengthens and rationalises the system for safety monitoring of medicines on the European market.
This legislation entered into force in July 2012 and provides for a number of EU-wide procedures to assess pharmacovigilance data which may lead to regulatory action.
5. Some additional amendments to the pharmacovigilance legislation were introduced in 2012 following the ‘Mediator’ case (Directive 2012/26/EU (OJ L 299, 27.10.2012) and Regulation (EU) No 1027/2012 (OJ L 316, 4.11.2012)).
Whilst streamlining the EU-wide post-authorisation safety assessment and monitoring of medicines, the revised pharmacovigilance legislation significantly widened the tasks of the European Medicines Agency (EMA) with regard to pharmacovigilance, irrespective of whether the medicinal products have been authorised via the 'centralised procedure' (in accordance with the Regulation) or via national procedures (in accordance with the Directive). The EMA has thereby acquired pharmacovigilance competences also for nationally authorised medicines, in addition to reinforced competences for centrally authorised medicines.
6. To finance these activities, the revised pharmacovigilance legislation provides for fees to be charged to marketing authorisation holders. These fees should be related to pharmacovigilance activities performed at the level of the EU, notably in the context of the EU-wide assessment procedures. These procedures include scientific assessment carried out by rapporteurs from the national competent authorities of the Member States. These fees are therefore not intended to cover the pharmacovigilance activities of the national competent authorities performed at national level. Member States may accordingly continue to charge fees for the activities performed at national level which should, however, not overlap with the fees laid down in this legal proposal.
The adoption of a proposal for a Regulation on pharmacovigilance fees is aimed at allowing the EMA to have adequate funding in order to properly implement the already applicable pharmacovigilance legislation. The existing Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the Agency would therefore continue to apply, whereas the proposed Regulation would apply to pharmacovigilance fees for activities laid down in the applicable pharmacovigilance legislation. The two legal instruments would be complementary.
Since the revised pharmacovigilance legislation only concerns medicinal products for human use, this proposal on fees for pharmacovigilance only covers these medicinal products.
9. In the second half of 2012, the Commission carried out a public consultation. Of the 85 contributions received, most came from the industry and warned about the imposition of excessive fees, the need to avoid a double tax burden at European level on overlapping activities, and the need to take into account the existence of numerous small and medium-sized enterprises, as well as enterprises providing a wide range of services the safety of which is sufficiently well documented, such as in the case of generic medicines.
10. The Proposal calls, on the one hand, for fees to be levied on procedures for the assessment of periodic safety update reports, post-authorisation safety studies and pharmacovigilance referrals, while on the other hand it proposes an annual flat fee to cover the costs of the EPA’s pharmacovigilance activities, other than those linked to the above-listed procedures and payable by the holders of trading licences with at least one medicinal product authorised within the EU and registered in the relevant database. The Proposal allows for exemptions for small and medium-scale enterprises, in accordance with the risk profile of medicinal products, as in the case of generics, and title-holders who are already paying an annual fee to the EMA.
11. Generally speaking, the proposal is a necessary one, as the tasks imposed by the new pharmacovigilance legislation should be adequately remunerated.
12. Nevertheless, this Regulation has major repercussions for Spain and for the functioning of the Spanish Agency for Medicines and Medical Products.
We consider that the distribution of fees between the EMA and the Member State acting as rapporteur for a given procedure is unequal. The main and most arduous part of the work is carried out by the rapporteur Member State, as it is the one required to undertake the scientific assessment, which is a lengthy and highly qualified process. The EMA is responsible for coordinating the procedure. It is therefore hard to see why there should be such a disparity in some cases between the fees paid by EMA and to the Member State (e.g. in the case of post-authorisation safety studies, EUR43000 for the EMA and EUR18200 for the rapporteur Member State). On the other hand, it is impossible to predict the fee payable to the Member State acting as rapporteur, as it depends on the number of pharmaceutical companies involved and their level of income. However, the scientific work calls for a reliable prediction of the fee amount.
The flat fee which the EMA intends to charge for each medicinal product authorised in the EU relates to a series of tasks already provided in existing pharmacovigilance legislation, but for which no fees had hitherto been envisaged. On the one hand, it could come into conflict with the flat fee levied by the Member States on medicinal products authorised under national procedures; on the other, some of the tasks listed as being subject to the fee also involve the Member States, without any provision for the payment of fees (maintaining the Eudravigilance database, signal generation).
The proposal for a Regulation provides for changes in the fees to be made by means of Commission delegated acts. This should never be the case, when it raises the possibility that fees currently applied to the Member States could be reduced.
13. Concerning this proposal’s application of and compliance with the principle of subsidiarity, the introduction to this Proposal for a Regulation establishes that:
‘The Agency (EMA) is a European decentralised Agency established under the Regulation and hence the decision on its funding and charging of fees is to be taken at the EU level. The new pharmacovigilance legislation provides a legal base for the Agency to charge fees for pharmacovigilance. Hence, only the Union can act to enable the Agency to charge fees for pharmacovigilance. Only pharmacovigilance activities that are performed at EU level and involving the Agency are covered by this proposal. As regards pharmacovigilance activities remaining at national level, the EU is not competent and Member States may still continue charging national fees accordingly.’
Accordingly, the fees established in the proposal are as follows:
1. Fee for assessment of periodic safety update reports
2. Fee for assessment of post-authorisation safety studies
3. Fee for assessments in the context of referrals initiated as a result of the evaluation of pharmacovigilance data
4. Annual flat fee