Explanatory Memorandum to COM(2005)106 - Amendment of Regulation (EC) No 297/95 on fees payable to the European Medicines Agency - Main contents
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| dossier | COM(2005)106 - Amendment of Regulation (EC) No 297/95 on fees payable to the European Medicines Agency. |
|---|---|
| source | COM(2005)106  |
| date | 31-03-2005 |
The pharmaceutical legislation has recently been revised. In this context, Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation, supervision and surveillance of medicinal products for human and veterinary use and establishing a European Medicines Agency i (EMEA, referred to as “the Agency”) has been adopted by the Council and the European Parliament. It repeals Regulation (EEC) No 2309/93/EC.
As laid down in Article 67 i of the Regulation, the Agency's revenue shall consist of a contribution from the Community and fees paid by undertakings for obtaining and maintaining Community marketing authorisations and for other services provided by the Agency i.
It is acknowledged that the current fee scheme, as laid down in Council Regulation (EC) No 297/95 on fees payable to the EMEA i, does neither take into account the new tasks of the Agency, nor the modifications of existing tasks introduced by the revised legislation. It is therefore necessary to amend it.
When drafting this proposal, the Commission has asked the EMEA to provide extensive feedback based on the experience gained with the application of the current system. In addition, a public consultation was held in July-September 2004, so as to take into account the position of relevant parties, in particular the pharmaceutical industry (see Section 2.4).
Contents
- 2. JUSTIFICATION
- 2.1. Objectives
- 2.2. Experience gained with the application of the current system
- 2.3. Impact of the revised pharmaceutical legislation
- 2.4. Outside consultation
- 3. PRESENTATION OF THE PROPOSAL
- 3.1. Annual fee
- 3.2. Medicinal products for human use
- 3.3. Veterinary medicinal products
- 3.4. Scientific services
- 3.5. Other provisions
- Human
- bio-similar NEW Art. 3(1)(b)
- Veterinary
- bio-similar NEW Art. 5(1)(b)
Three major objectives have been pursued by the Commission in its proposal:
- To adapt the existing fee scheme to the revised legislation and the new responsibilities conferred to the Agency, taking in consideration the experience with the current system;
- To ensure proportionality between the amount of the fees and the nature of the service actually provided by the Agency;
- To alleviate the financial pressure put on applicants, without undermining the Agency’s ability to perform its tasks.
The EMEA has provided the Commission with an in-depth analysis of the operation of the current system i. Forward-looking perspectives, such as the consequences of the EU enlargement or the impact of the revision of the pharmaceutical legislation, were also taken in consideration. This analysis has led to the broad conclusion that the general principles, as well as the overall structure of the fees, have indeed enabled the Agency to fulfil its mission since 1995; they should therefore be maintained. Nevertheless, a number of key issues still require further optimisation.
Firstly, post-authorisation activities have taken an increasing part of the EMEA costs associated with the management of a medicinal product throughout its lifecycle. This is especially relevant for innovative medicines, which constitute the ‘core business’ of the Agency, and which often require special risk management strategies as well as tailor-made pharmacovigilance programmes. Such costs are not adequately covered by the corresponding fees, like the annual fee.
In addition, the Agency’s revenues heavily depend on the payment of initial fees related to new applications. Despite the introduction of the annual fee in 1998, such dependence is still significant, and may hamper the EMEA’s capability to perform long-term, multi-annual tasks, by affecting its financial stability.
In the field of veterinary medicines, experience suggests that the costs of service incurred for the evaluation of these products are of the same order of magnitude as those for medicinal products for human use. However, this has to be balanced with the very specific nature of the animal health market and the related issues. Such specificity should be taken into account in the proposal.
Finally, Council Regulation (EC) No 297/95, as amended, has given flexibility to the Management Board and to the Executive Director of the EMEA to adapt certain fees, under clearly-defined circumstances, to the particular situation of the application and the related product. Likewise, the use of graduated fees has also enabled to better reflect the actual level of scientific input and service provided. In the light of the abovementioned principle of proportionality, such flexibility could be further extended to other types of fees.
The revision of the pharmaceutical legislation has a direct impact on the Agency’s mission and responsibilities. Regulation (EC) No 726/2004 provides for new tasks, as well as modifications of already-existing ones.
Post-authorisation activities have been substantially strengthened. For instance, the Agency has to record the status of marketing authorisations for medicinal products granted in accordance with Community procedures, by monitoring when and where products are actually marketed in the Member States, or cease to be i. Besides, the maintenance of marketing authorisation dossiers and of the various databases provided for in the legislation has to be managed by the Agency i. Finally, the risk-benefit balance of authorised medicinal products is subject to permanent follow-up i.
Regulation (EC) No 726/2004 foresees new kinds of scientific services to be provided by the EMEA, such as the evaluation of traditional herbal medicinal products i, or the assessment of applications for medicinal products intended exclusively for markets outside the Community, in the context of cooperation with the World Health Organisation i. New types of fees have therefore to be created, not only for these services but also for those which were not taken into account in the last revision of Council Regulation (EC) No 297/95, like the consultation on ancillary substances incorporated in medical devices i, or the certification of plasma master files and vaccine antigen master files i.
New provisions in Regulation (EC) No 726/2004 on generics and similar biological medicinal products i also call for the definition of related fees. In this respect, it is anticipated that the average cost for the assessment of similar biological medicinal products, although lower than for a full, stand-alone dossier, will still be significantly higher than for a standard generic.
Lastly, it is specified in the revised legislation that provisions shall be adopted by the Commission, establishing the circumstances in which small and medium-sized enterprises (SMEs) may pay reduced fees, defer payment of the fee, or receive administrative assistance i. Thus, the situation of SMEs has to be considered separately, i.e. outside the scope of the present proposal.
Interested parties, in particular the pharmaceutical industry, have been consulted. In July 2004, the Commission launched an external consultation on its draft proposal, and received eight contributions from industry associations, regulators, and individual companies. Some of them, especially the ones from industry associations, were the result of wider, internal consultation. Contributions were carefully taken in consideration for the refinement of the Commission’s draft.
The vast majority of respondents welcomed the proposal, the opportunity to comment, and explicitly supported the outlined objectives and key principles. In particular, the principle of proportionality between the fees, the corresponding services, and the related costs, was strongly emphasised.
A comparison of the current fees vs. the proposal, including references to the relevant Articles, is annexed to the Explanatory Memorandum.
In view of the abovementioned considerations, the general structure of the fees and the underlying principles have not been changed. Moreover, given the increase that was already implemented in March 2003, most of the fees have been kept to the same level, or slightly reduced.
As mentioned in Section 2.2, costs related to post-authorisation activities are, at present, not appropriately covered. If no action is taken, this discrepancy could increase with the entering into force of the revised legislation and the new responsibilities of the Agency. While it is required by law that activities relating to pharmacovigilance and to market surveillance shall receive adequate public funding commensurate with the tasks conferred i, such funding alone may not be sufficient to fully cover administrative costs described in Section 2.3, e.g. maintaining up-to-date marketing authorisation dossiers and the various databases. Besides, the EMEA’s financial stability is affected by its dependence on initial fees linked to new applications. For these reasons, it is hence proposed to increase the annual fee, both in the human and veterinary sectors, by 10%.
Most of the fees for services related to medicinal products for human use have been kept to the same level. In addition to the annual fee increase (see Section 3.1), it is suggested:
- to reduce the fee for generic medicinal products, in order to better reflect the actual cost of the evaluation of the marketing authorisation application;
- to harmonise extension fees, Type II variation fees, and fees associated with the submission of additional presentations of a given medicinal product;
- to reduce the fee for Type IA variations, so as to better reflect the administrative nature of the service provided.
Taking into account the specific nature of the animal health market and the commercial and regulatory environment in which the related companies evolve, it is proposed to keep all fees related to veterinary medicinal products to the same level, apart from the annual fee (see Section 3.1), and the fee for Type IA variations, which has been reduced for the reason outlined above.
New types of fees have been defined for a wide range of scientific services provided by the Agency. These are related to (see Section 2.3):
- opinions on traditional herbal medicinal products;
- assessment of applications for medicinal products intended exclusively for markets outside the Community, in the context of cooperation with the World Health Organisation.
- consultation of the Committees on ancillary substances, including blood derivatives, incorporated in medical devices;
- evaluation and certification of plasma master files and vaccine antigen master files;
Experience acquired by the EMEA on these services has shown that they can lead to the mobilisation of significant scientific, administrative and financial resources. This is further reflected by the proposed levels of the fees.
As already laid down in Council Regulation (EC) No 297/95, substantial flexibility has been given to the Management Board and the Executive Director of the EMEA for the practical implementation of this Regulation. In particular, the option to draw-up detailed lists of reduced fees for certain services, under well-defined conditions, has been extended to other fee categories.
As mentioned in Section 2.3, a specific fee has been defined for similar biological medicinal products. The calculation of the fee is based on the complex nature of these medicines, the expected costs for the dossier evaluation, and the particular status of this emerging and fast-growing market.
Regarding due date and belated payment, the time period within which fees shall be payable has been extended from 30 to 45 days. Moreover, a special deferral rule has been proposed for applications concerning medicines to be used in human pandemic situations (such as pandemic influenza vaccines).
Finally, an indexation clause has been introduced, in order to easily adapt the fees to inflation variations.
(in Euros) Current Proposal Dif. Ref.
Full fee base 0% Art. 3(1)(a)
addit. strength/form 0% Art. 3(1)(a)
addit. presentation 0% Art. 3(1)(a)
Reduced fee base generic -22% Art. 3(1)(b)
addit. strength/form -61% Art. 3(1)(b)
addit. presentation 0% Art. 3(1)(b)
Extension fee new strength/form etc. max 20% Art. 3(1)(c)
new presentation -50% Art. 3(1)(c)
Type I variation IA -57% Art. 3(2)(a)
IB 0% Art. 3(2)(a)
Type II variation max 0% Art. 3(2)(b)
Renewal 0% Art. 3 i
Inspection max 0% Art. 3 i
Transfer 0% Art. 3 i
Annual fee max 10% Art. 3 i
Referral 0% Art.
Scientific advice max 0% Art. 8 i
Scientific services max NEW Art. 8 i
Administrative services max 0% Art. 8 i
Full fee base 0% Art. 5(1)(a)
addit. strength/form 0% Art. 5(1)(a)
addit. presentation 0% Art. 5(1)(a)
Full fee vaccines vaccines immunologicals 0% Art. 5(1)(a)
addit. strength/form/pres. 0% Art. 5(1)(a)
Reduced fee base generic 0% Art. 5(1)(b)
addit. strength/form 0% Art. 5(1)(b)
addit. presentation 0% Art. 5(1)(b)
Reduced fee vaccines vaccines immunologicals 0% Art. 5(1)(b)
addit. strength/form/pres. 0% Art. 5(1)(b)
Extension fee new strength/form etc. max 0% Art. 5(1)c
new presentation 0% Art. 5(1)c
vaccines (vaccines merged) 0% Art. 5(1)c
Type I variation IA -57% Art. 5(2)(a)
IB 0% Art. 5(2)(a)
Type II variation max 0% Art. 5(2)(b)
vaccines 0% Art. 5(2)(b)
Renewal 0% Art. 5 i
Inspection max 0% Art. 5 i
Transfer 0% Art. 5 i
Annual fee max 10% Art. 5 i
Referral 0% Art.
MRL fee base 0% Art.
amend/extend existing MRL 0% Art.
clinical trials 0% Art.
Scientific Advice max 0% Art. 8 i
Scientific services max NEW Art. 8 i
Administrative services max 0% Art. 8 i