WRITTEN QUESTION E-0794/04 by Paul Rübig (PPE-DE) to the Commission. Regulation (EC) No 141/2000 on orphan medicinal products.
Date: 2004-03-11
Institutions: European Parliament, Provisional data
Subjects: drugs classification, market approval, medicinal product, pharmaceutical legislation, product designation

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In accordance with Commission Recommendation 2002/201/EC of 4 March 2002 on the reduction of the
presence of dioxins, furans and dioxin-like PCBs in feedingstuffs and foodstuffs (4) investigations were
initiated to identify the source of contamination and to take measures to reduce or eliminate the source of
contamination. The investigations revealed that one of the causes of the contamination could be the
uncontrolled burning of materials that have been dumped in the countryside.

Following the information provided by the Italian authorities, the contamination was limited to parts of
the province Caserta and to adjacent municipalities in the northern part of Naples. The affected areas were
demarcated. No commercial animal
feed was found with dioxin levels above the maximum levels
established in Directive 2002/32/EC of the Parliament and of the Council of 7 May 2002 on undesirable
substances in animal feed (5) as amended by Commission Directive 2003/57/EC of 17 June 2003 (6).

The Italian authorities have provided guarantees:

(cid:1) to eliminate/remove the mentioned source and to undertake further investigations to identify possible

other sources and to rehabilitate the areas contaminated,

(cid:1) to eliminate the possible sources of contamination,

(cid:1) to continuously monitor the environment, farms, the feedingstuffs used and the products in the

affected areas,

(cid:1) to withdraw contaminated products from the market and to destroy them under controlled conditions.

Given these guarantees and should all the above-mentioned measures be strictly applied, the Commission
is of the opinion that the measures are sufficient to protect public health and the environment.

(1) OJ L 125, 23.5.1996.
(2) OJ L 77, 16.3.2001.
(3) OJ L 321, 6.12.2001.
(4) OJ L 67, 9.3.2002.
(5) OJ L 140, 30.5.2002.
(6) OJ L 151, 19.6.2003.

(2004/C 88 E/0228)

WRITTEN QUESTION E-0794/04

by Paul Rübig (PPE-DE) to the Commission

(11 March 2004)

Subject: Regulation (EC) No 141/2000 on orphan medicinal products

In connection with Regulation (EC) No 141/2000 (1) on orphan medicinal products, we request
clarification on the following questions:

1. Can a medicinal product continue to be designated as an orphan drug if, after it has been designated
as such but before it has received centralised authorisation, other medicinal products containing partly
the same and partly different active ingredients are granted national authorisation in several Member
States to treat the same condition?

2. Can a medicinal product continue to enjoy orphan drug status if the Committee for Proprietary
Medicinal Products (CPMP) has granted approval for its use as a second-line treatment only and the
first-choice drug is not authorised in all Member States?

3. Does the registration by one sponsor of an active ingredient for use as a second-line treatment prevent
another sponsor from obtaining the designation of the same active ingredient as an orphan drug for
use as a first-line treatment?

4. Can a sponsor apply for an active ingredient

to be designated as an orphan drug if national
authorisation has already been granted to an identical medicinal product manufactured by another
pharmaceutical company?

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5. Can an active ingredient be designated as an orphan drug for the treatment of a certain condition even
if doctors are already using it without authorisation to treat that condition and thereby generate large
profits for the sponsor? Can a medicinal product be designated as an orphan drug even if large profits
are being generated by the use of this medicinal product in treating a different condition, profits
which also contribute to funding the development of drugs to treat rare conditions? Is the requirement
laid down in Article 3(1)(a) of Regulation (EC) No 141/2000 met in these cases?

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

Answer given by Mr Liikanen on behalf of the Commission

(20 April 2004)

The issues raised have been addressed in the Commission Communication of July 2003 (1). Following the
first three years of application of the Regulation and in response to a number of requests for interpretation
and clarification, the Commission wished to set out its position on certain matters relating to the
implementation of the designation and market exclusivity provisions. These interpretations were intended
to provide guidance to the European Medicines Evaluation Agency, the Member States, the pharmaceutical
industry and other interested parties. Also, several clarifications were provided in order to avoid a
departure from the spirit of the Regulation. The Communication, therefore, considers points in relation to
Articles 3 (criteria for designation), 5 (procedure for designation and removal from the register), and 7
(Community marketing authorisation) of Regulation (EC) No 141/2000 of the Parliament and of the
Council of 16 December 1999 on orphan medicinal products.

1.
A medicinal product can continue to be designated as an orphan drug if, ‘after it has been designated
as such but before it has received centralised authorisation, other medicinal products containing partly the
same and partly different active ingredients are granted national authorisation in several Member States to
treat the same condition’. However, Article 5(12) states that: ‘A designated orphan medicinal product shall
be removed from the Community Register of Orphan Medicinal Products: (a) at the request of the sponsor;
(b) if it is established before the market authorisation is granted that the criteria laid down in Article 3 are
no longer met in respect of the medicinal product concerned; (c) at the end of the period of market
exclusivity as laid down in Article 8.’ With reference to Article 5(12)(b), section B.2.3 of the Commission
Communication of July 2003 mentioned above, states: ‘The Commission interprets this as meaning that
the criteria for orphan designation shall be reviewed before a marketing authorisation is granted’.

2.
The second question implies that orphan designation was based on significant benefit. Assessment of
significant benefit is for the Committee on Orphan Medicinal Products (COMP). Section A.4 paragraph 5 of
the same Commission Communication states: ‘With respect to potential availability of the product to the
Community population, a medicinal product that is authorised and available in all Member States may
constitute a significant benefit compared with a similar product that is authorised in a limited number of
Member States only’.

The same active substance can be designated more than once for the same or overlapping therapeutic

3.
indications.

4.
A sponsor may apply for orphan designation in the situation described in this question. However, the
COMP would need to assess whether the medicinal product will be of significant benefit to those affected
by that condition. Section A.4 paragraph 5 of the Commission Communication is also relevant here.

The objective of Regulation (EC) No 141/2000 is stated in its Article 1:

5.
‘The purpose of this
Regulation is to lay down a Community procedure for the designation of medicinal products as orphan
medicinal products and to provide incentives for the research, development and placing on the market of
designated orphan medicinal products’. Furthermore,
‘some
conditions occur so infrequently that the costs of developing and bringing to the market a medicinal
product to diagnose, prevent or treat the condition would not be recovered by the expected sales of the
medicinal product; the pharmaceutical
industry would be unwilling to develop the medicinal product
under normal market conditions; these medicinal products are called orphan.’ The criteria of Article 3(1)(a),
to be judged by the COMP, could be met even if a sponsor had made profits in the situations described in
this question i.e. profits had been made from unauthorised use of the medicinal product in the condition

the first recital of the Regulation states:

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for which designation is sought or from use of the medicinal product for another condition. Article 1 of
the Regulation is clear: incentives are provided for research, development, authorisation and placing on the
market of medicinal products.

(1) OJ C 178, 29.7.2003.

(2004/C 88 E/0229)

WRITTEN QUESTION E-0795/04

by Patricia McKenna (Verts/ALE) to the Commission

(11 March 2004)

Subject: Derrybrien wind farm bogslide

Further to the Commission’s answer to my question P-3350/03 (1), the reports that were commissioned by
just published, confirm the
ESB subsidiary, Hibernian Wind Power Ltd, and Galway County Council,
responsibility of the wind farm project for the major landslide, and also for several earlier small ones. They
identify many areas of the site that are similarly at risk, thereby showing in particular that a landslide
directly above the village cannot be excluded due to low stability levels. However, the two reports pay
scant attention to the impact of dynamic forces on the peat, and most of the safety analysis appears to be
based on static loadings only. Thus the effects of heavy truck and crane movements on floating roads,
as well as those of explosives used on site, are effectively ignored. Furthermore, safety as examined is more
concerned about on site risks, not off site. These reports are cross-referenced, and show a remarkable
consistency, and it is known that the two sets of consultants met on this question, raising further doubts
about their real independence.

To help secure the future of wind energy in Ireland, will the Commission now insist that the planning
process be undertaken from the beginning, based on a proper and complete EIS relating to the actual
project proposed, and also require that any continuation be conditional on a fresh planning approval? Will
the Commission assist the locals in commissioning a truly independent study of the project and its impact,
as they have proposed, with the primary aim of avoiding further environmental damage and injury or even
loss of life, which would surely arise from a landslide above Derrybrien village?

(1) OJ C 78 E, 27.3.2004, p. 528.

Answer given by Mrs Wallström on behalf of the Commission

(27 April 2004)

The Commission confirms that, in the framework of several complaints, it has received copies of the two
reports referred to by the Honourable Member. It also confirms that it has received further extensive
documentation relating to the various development consent procedures that have been followed in
connection with the wind-farm project at Derrybrien. Pending the conclusion of its examination of these
documents, it would be premature for the Commission to comment in detail on the appropriate next steps
to take.

(2004/C 88 E/0230)

WRITTEN QUESTION E-0798/04

by Mihail Papayannakis (GUE/NGL) to the Commission

Subject: Amfilokhia and the Ramsar Convention

(11 March 2004)

According to complaints from local organisations, 120 eucalyptus trees over one hundred years old have
been cut down at the entrance to the town of Amfilokhia in Arta, following a decision taken by the