WRITTEN QUESTION E-2393/02

by Jules Maaten (ELDR) to the Commission

(2 August 2002)

Subject: European policy on the funding of orphan medicines

For a number of years now the European Union has had a policy on orphan medicines. This policy is contained in Regulation (EC) 141/2000(1), and includes total or partial exemption from the payment of an authorisation fee for the marketing of an orphan medicine (Article 7(2) of the Regulation).

In practice, producers of orphan medicines accorded a 50 % reduction in the fee. For purposes of comparison, in the USA the reduction is 100 %.

1. Does the Commission consider that a 50 % reduction is fair?

2. Does the Commission plan to set a specific percentage for this fee? If so, does it plan to treat these subsidies differently on the basis of various factors and scenarios, such as specific characteristics of diseases?

3. Does the Commission plan, in drawing up the budget for the EMEA, to take account of the extra costs of the EMEA procedure in the context of orphan medicines?

(1) OJ L 18, 22.1.2000, p. 1.

Answer given by Mr Liikanen on behalf of the Commission

(4 September 2002)

The current procedure laid down by Regulation (EC) 141/2000(1) aimed at promoting the development and authorisation of orphan medicinal products has so far enabled 110 medicinal products to be designated as orphan medicinal products from among more than 200 applications submitted. From this point of view, the Commission considers that the application of this procedure has already been a success.

In this context, the incentives available appear useful, proportionate and effective: they have led to a far greater number of applications than might otherwise have been expected. Two of these incentives

apply at Community level: a reduced level of fees charged by the European Agency for the Evaluation of Medicinal Products and the establishment of market exclusivity for the medicinal products authorised. The effectiveness of this specific procedure therefore rests on these two pillars, and the effectiveness of one can be measured only in the context of the effectiveness of the other.

1. At present, thanks to a specific Community subsidy, the Agency is in a position (for the year 2002) to grant a reduction of 100 % in the fees linked to development assistance (protocol assistance) and 50 % in the fees linked to registration. In the light of the above-mentioned results, the reductions offered do appear to be effective. Consideration could also obviously be given to increasing to 100 % the rate of exemption from marketing authorisation fees and to reducing the fees charged for maintaining the authorisation (post-marketing). This question would have to be discussed within the overall budgetary framework of the Agency. Nevertheless, partial or total exemption from fees represents only a part of the economic incentive intended by the legislator; market exclusivity constitutes in this respect an essential economic aspect.

2. In the light of the above-mentioned results, the Commission does not consider it necessary to establish by legislation a precise rate of fees for orphan medicinal products; the current procedure, which leaves the Agency room for manoeuvre, appears the most appropriate. In theory, it enables a flexible application in order to take into account the specific characteristics of certain medicinal products and/or illnesses treated.

3. The Agency's budget is established by its Executive Board. When this budget is being drawn up, account must obviously be taken of any additional expenses linked to the procedure for evaluating orphan medicinal products. The special Community contribution allocated under Article 7 of the above-mentioned Regulation is intended to be used exclusively by the Agency to waive, in part or in total, the fees normally charged by the Agency. If the additional expenses to which the Honourable Member refers are not ordinarily covered by fees, these expenses should therefore be covered from other Agency receipts (fees, general Community contribution), irrespective of the fact that these expenses are linked to orphan medicinal products. The Executive Board is the only body competent in this respect to determine any such arrangements.

(1) OJ L 18, 22.1.2000.