Explanatory Memorandum to COM(2013)472 - Fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use - Main contents
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| dossier | COM(2013)472 - Fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal ... |
|---|---|
| source | COM(2013)472  |
| date | 26-06-2013 |
The legal framework of pharmacovigilance for medicinal products for human use marketed within the EU is provided for in Regulation (EC) No 726/2004 i ('the Regulation') and in Directive 2001/83/EC i ('the Directive'). The EU pharmacovigilance legislation for medicinal products for human use has been subject to a major review and an impact assessment that led to the adoption of a revised legislation i in 2010, which strengthens and rationalises the system for safety monitoring of medicines on the European market. This legislation is applicable as of July 2012. It provides for a number of EU-wide procedures to assess pharmacovigilance data which may lead to regulatory action. Some additional amendments to the pharmacovigilance legislation were introduced in 2012 following the Mediator case i.
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 ('the Agency') 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 Agency has therefore acquired pharmacovigilance competences also for nationally authorised medicines, in addition to reinforced competences for centrally authorised medicines.
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.
Since the revised pharmacovigilance legislation only concerns medicinal products for human use, this proposal on fees for pharmacovigilance only covers these medicinal products.
Contents
- RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS
- LEGAL ELEMENTS OF THE PROPOSAL
- BUDGETARY IMPLICATION
- Public Consultation
- Impact assessment
- Remuneration of Member States authorities acting as rapporteurs
- Subsidiarity principle
- Proportionality principle
- Legal basis
- Choice of the legal instrument
- 5. OPTIONAL ELEMENTS
As part of the preparation of this legal proposal on fees for pharmacovigilance, DG SANCO, in close collaboration with the Agency, drafted a concept paper for public consultation. Given that the Union-wide pharmacovigilance procedures foreseen in the revised pharmacovigilance legislation are new procedures, the concept paper used existing procedures that were considered sufficiently similar as benchmarks for the new procedures. In addition, a pharmacovigilance service fee to be charged on an annual basis was considered in the paper, in order to cover those activities of the Agency that benefit industry in general, but for which it is virtually impossible to identify the individual addressee(s).
The Commission launched the public consultation on 18 June 2012 with a deadline for replies on 15 September 2012. In total, 85 replies were received (mainly from industry, but also from the Member States and other stakeholders). The summary of the replies to the public consultation was published on the website of DG SANCO on 29 November 2012. In general, the comments were rather negative, notably as regards the amounts proposed for the fees. They were considered to be too high and without sufficient justification as regards the workload and costs. Grouping of marketing authorisation holders, especially for submitting a single Periodic Safety Update Report, was considered by many as not applicable in practice. Many respondents questioned the benchmarks that were used and considered that pharmacovigilance fees should be rather based on estimations of the time spent and the associated cost of the assessment work. Several industry respondents flagged the risk of possible double charging of the Agency and the Member States, given that many of the competent authorities in the Member States currently charge fees for pharmacovigilance. Particular concerns were expressed by small and medium-sized enterprises, stating that despite the proposed fee reductions in the concept paper, the amounts were still too high. Also many responses from industry associations, representing products such as generic medicinal products, considered that the proposed fee levels would unfairly affect marketing authorisation holders with a large portfolio of products with well-established safety profiles.
In line with the above-mentioned comments, the Impact Assessment report that accompanies this proposal considered several options, based on estimation of cost. This new approach is in line with the recommendations of the European Court of Auditors and the European Parliament to base the payment system for services provided by Member States' authorities on costs.
Consistent with the legal proposal on pharmacovigilance of 2008 and with the EU legislation on pharmacovigilance, all options of legislative action were based on the assumption that the total cost related to pharmacovigilance would be covered through fees. Regulation (EU) No 1235/2010 provides notably for a new wording of article 67 i of Regulation (EC) No 726/2004: 'The Agency’s revenue shall consist of a contribution from the Union and 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.’ Recital 13 notably states that It should be ensured that adequate funding is possible for pharmacovigilance activities by empowering the Agency to charge fees to marketing authorisation holders. and Recital 24 explains that the new legal provisions widen the tasks of the Agency with regard to pharmacovigilance, including the monitoring of literature cases, the improved use of information technology tools and the provision of more information to the general public. The Agency should be enabled to fund these activities from fees charged to marketing authorisation holders.
The selected option foresees two separate types of fees:
Fees for procedures for the assessment of periodic safety update reports, post-authorisation safety studies and pharmacovigilance referrals.
An annual flat fee to be charged to marketing authorisation holders having at least one medicinal product that is authorised in the EU and registered in the database provided for in Article 57(1)(l) of the Regulation. This annual flat fee would cover only the costs of the pharmacovigilance activities of the Agency other than those related to the above-mentioned procedures. Therefore, it is foreseen that the fee revenue from the annual flat fee be retained by the Agency.
Some fee reductions and fee waivers are foreseen in respect of the proposed fees:
· In line with the general EU policy to support small and medium-sized enterprises, reductions for medicinal products for which the marketing authorisation holder is a small or medium-sized enterprise would be granted for all types of fees. Micro enterprises would be exempted from all fees. The reduction rates for small and medium-sized enterprises are based on the comparisons of data of added values per employee in the sector, as a possible measure of profitability of companies. The proposed contribution of small and medium enterprises to the financing of pharmacovigilance was reduced accordingly, whereas micro-enterprises should be entirely exempt from the obligation to pay pharmacovigilance fees.
· Moreover, certain fee reductions reflect the risk-based approach of the pharmacovigilance legislation acknowledging the differences in the safety profile of new and more established medicinal products for which time has allowed to collect data. A reduction of the annual flat fee is therefore proposed for authorised generic, homeopathic and herbal medicinal products and for medicinal products authorised on grounds of well-established medical use. However, where these medicinal products are included in the Union-wide pharmacovigilance procedures, the full fees for procedures would apply. Registered homeopathic and herbal medicinal products would be exempted from all fees.
· Finally, as marketing authorisation holders for medicinal products authorised under the Regulation currently pay an annual fee to the Agency for maintenance of the authorisation including pharmacovigilance activities covered by the proposed fee, these marketing authorisations would be exempted from the annual flat fee in order to avoid double charging.
Marketing authorisation holders would be charged as follows:
· Marketing authorisation holders having at least one product involved in a Union-wide pharmacovigilance procedure would be charged a fee for procedures,
· Marketing authorisation holders in the EU[7], with the exceptions explained above, would be charged the annual flat fee.
Therefore, marketing authorisation holders that are not involved in any EU procedure would only pay the annual flat fee component, with the above-mentioned exceptions.
The criteria that were identified as the most decisive in analysing the impact of options were fairness, proportionality and transparency of the overall pharmacovigilance fee system, including the adequacy of the relation between the work carried out and the type and level of fee. Other important criteria considered within the analysis were the stability and the simplicity of the Agency pharmacovigilance fee-system.
Under the selected option, fees are proportionate to the workload and the costs, but cannot be entirely predictable by the inherent nature of the pharmacovigilance activities. In order to avoid extreme cases and to allow for a readable, applicable and usable legislative text, it is proposed that procedure-based fees generate an average fee revenue that is based on the average estimated cost of each procedure.
A combination of procedure-based fees and an annual flat fee has been considered to be the most transparent, cost-based, activity-based and proportionate way of setting the new fees, in order to cover the cost under the new pharmacovigilance legislation. This analysis was carried out in the light of a strong preference expressed by stakeholders for a policy approach based on fairness and transparency. With this approach, the products being part of a pharmacovigilance procedure at EU level will contribute to the financing of the cost of the procedure. This is also in line with the risk-based approach of the pharmacovigilance legislation. At the same time, the cost of general pharmacovigilance activities of the Agency, and only that part of its total pharmacovigilance cost, would be recouped through the annual flat fee charged to marketing authorisation holders who benefit overall from the EU pharmacovigilance system. These activities of the Agency relate notably to the information technology systems, safety data management and literature monitoring.
In order to have a fair system, it was considered necessary to identify a single, chargeable unit as there are different ways in the EU of assigning authorisation numbers to and counting medicinal products. To facilitate adverse reaction reporting and signal detection, it is necessary to describe medicinal products with maximum precision in order to take account of differences in strength, pharmaceutical forms, routes of administration etc. Therefore, the Agency has set up the structure of the database described in Article 57 i of the Regulation to neutralise these differences by means of individual entries. These entries have been chosen as a chargeable unit.
In line with the above-mentioned recommendations of the European Court of Auditors and the European Parliament, it is proposed that rapporteurs from the national competent authorities of the Member States be remunerated according to a fixed scale based on estimations of cost. The amount of remuneration is based on the average procedure costs as estimated for each type of procedure. Where fee reductions apply, the remuneration of the Member States will be adjusted accordingly, including reductions for small and medium-sized enterprises which are in line with the policy of the Union to support small and medium-sized enterprises.
The Agency 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.
The proposal does not go beyond what is necessary to achieve the general objective pursued, i.e. to introduce fees in order to allow the proper implementation of the pharmacovigilance legislation that is applicable since July 2012.
The proposed Regulation is, like the EU pharmacovigilance legislation based on a dual legal basis: Article 114 and Article 168(4)(c) TFEU. 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 ensures the availability of the necessary financial resources to apply the stream-lined Union procedures for the assessment of serious safety issues for nationally authorised 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 Articles 168 i 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.
Article 168(4)(c) TFEU cannot serve as sole legal basis, but needs to be complemented with the legal basis of Article 114 TFEU as it, as set out above, pursues equally as object the establishment and functioning of the internal market, and the setting of high standards of quality and safety for medicinal products.
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 adoption of a proposal for a Regulation on pharmacovigilance fees is aimed at allowing the Agency to have adequate funding in order to properly implement the already applicable pharmacovigilance legislation.
The existing Council Regulation (EC) No 297/95[8] of 10 February 1995 on fees payable to the Agency would 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.
Consistent with the legal proposal on pharmacovigilance of 2008 and with the Pharmacovigilance legislation adopted in 2010, according to which the Agency should be enabled to fund pharmacovigilance activities from fees charged to marketing authorisation holders (see section on Impact Assessment), all options of legislative action, including the option which underpins this proposal, were based on the assumption that the costs related to pharmacovigilance would be covered through fees.
Therefore, no impact on the EU general budget is foreseen in the accompanying financial statement of this proposal.
European Economic Area
The proposed act is of relevance to the EEA.