WRITTEN QUESTION E-2393/02 by Jules Maaten (ELDR) to the Commission. European policy on the funding of orphan medicines.
Date: 2002-08-02
Institutions: European Parliament, Provisional data
Subjects: EU financing, European Medicines Agency, drugs classification, market approval, medicinal product, monopoly, pharmaceutical legislation, tax exemption

6.2.2003

EN

Official Journal of the European Union

C 28 E/231

Older drivers seem to be over-represented in specific accident types (i.e. turning left at a T-junction,
changing lane, merging or leaving from a parking position). AGILE focuses on two key milestones: a)
developing the required knowledge to establish national policies for delivering certification to fitness to
drive to the elderly; b) helping as much as possible older age groups to continue driving safely as enhanced
mobility leads to increased well-being.

The Commission does not have the intention to impose a maximum age limit for holding a driving
licence.

The Commission does not consider that this kind of research project stigmatises older people. It is more
the contrary, as the project will develop appropriate training and consultation courses to help older drivers
overcome their driving problems as well as a methodology to embattle current negative stereotypes about
elderly drivers. This will
lead towards enhancing public awareness and acceptance of elderly driving
abilities. It is emphasised that the assessment methods targeted are not meant to present a new barrier for
elderly drivers but instead they are expected to simplify and rationalise the currently used assessment
process for most of them. It will help to find appropriate methods and aids for older people to remain safe
drivers.

This research project is not designed to benefit the insurance companies. Given the aforementioned
purpose of this study, it is not expected that the results of this research project will be used to make
distinctions between drivers.

(2003/C 28 E/261)

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?

Does the Commission plan, in drawing up the budget for the EMEA, to take account of the extra

3.
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

C 28 E/232

Official Journal of the European Union

EN

6.2.2003

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.

At present, thanks to a specific Community subsidy, the Agency is in a position (for the year 2002)
1.
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.

(2003/C 28 E/262)

WRITTEN QUESTION E-2406/02

by Jean Lambert (Verts/ALE) to the Commission

Subject: Exile of 13 Palestinian militants from the West Bank

(7 August 2002)

In May 2002, 13 Palestinian militants were expelled from the West Bank following their siege of the
Church of the Nativity in Bethlehem. These men have now been dispersed across Cyprus, Italy, Greece,
Spain, Ireland, Portugal and Belgium.

Please could the Commission inform me:

(cid:1) Under what conditions will these men be kept?

(cid:1) Will they be held in security facilities in the various locations in Europe?

Answer given by Mr Patten on behalf of the Commission

(23 September 2002)

The Commission thanks the Honourable Member for his question on the conditions under which
Palestinian militants expelled from the West Bank following the siege of the Church of the Nativity in
Bethlehem are being held in a number of Member States.

Since this matter does not come within the Commission’s remit, it does not have the information required
to answer this question.