WRITTEN QUESTION E-0848/01 by John Bowis (PPE-DE) to the Commission. Contradiction between EU orphan drug legislation and national measures resulting in restricted access to innovative therapies.
Date: 2001-03-22
Institutions: European Parliament, Provisional data
Subjects: EU research policy, biotechnology, market approval, medical research, medicinal product, pharmaceutical legislation

13.11.2001

EN

Official Journal of the European Communities

C 318 E/135

(2001/C 318 E/143)

WRITTEN QUESTION E-0848/01

by John Bowis (PPE-DE) to the Commission

(22 March 2001)

Subject: Contradiction between EU orphan drug legislation and national measures resulting in restricted

access to innovative therapies

Does the Commission agree that the growing trend across Europe to restrict patient access to new
therapies, by limiting reimbursement on the basis of pharmacoeconomic appraisals, runs counter to;

(cid:129) the principle of centralised authorisation through the EMEA? This is of particular concern for
innovative biotechnology therapies for life-threatening, seriously debilitating or rare diseases for which
no or limited alternative therapies are available and for which the EMEA has sole responsibility for
advising on marketing authorisations. These marketing authorisation decisions are taken on the basis
of quality, safety and efficacy criteria;

(cid:129) the EU Orphan Drug legislation which aims to ensure patient access to innovative therapies by
supporting (cid:145)research into, and the development and the availability of orphan medicinal products(cid:146)
(Article 9 of Regulation (EC) No 141/2000 (1) of the European Parliament and of the Council)?

Can the Commission confirm that it wishes to promote access to innovative therapies, encourage the
development of healthcare biotechnology in Europe, address unmet medical needs and ensure a high level
of health protection in Europe?

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

Answer given by Mr Liikanen on behalf of the Commission

(1 June 2001)

The Commission can confirm that it wishes to promote access to innovative therapies, encourage the
development of healthcare biotechnology in Europe, address unmet medical needs and ensure a high level
of health protection in Europe. As part of its work towards the achievement of this objective it introduced
Regulation (EC) No 141/2000 of 16 December 1999, on Orphan Medicinal Products (1), which was
adopted by the Council and Parliament in 1999. The Regulation on Orphan Medicinal Products aims to
support the development of medicinal products to meet unmet medical needs in the area of rare diseases
by offering incentives for companies developing such treatments. These incentives include a 10 year
market exclusivity period, fee reductions or waivers for marketing authorisation related activities, advice on
issues relating to the design of clinical trials for these products and automatic access to the centralised
marketing authorisation procedure which ensures that a medicinal product, once authorised may
immediately be placed on the market in all Member States.

A number of complementary measures has also been initiated at a Community level and support for the
sharing of information and transnational collaboration on rare diseases is provided within the Community
action programme on rare diseases. Specific research opportunities to support research into rare diseases
In addition, the Fifth Framework
also come within the scope of the Fifth Framework programme.
programme also places a high emphasis on biotechnology research.

In accordance with Article 9 of the Regulation on Orphan Medicinal Products, the Commission has
published a first inventory of national and Community measures aiming to support research, development
and availability of orphan medicinal products, in which the Community measures and complementary
national measures are delineated. This may be found at the following web-site address: http://pharmacos.
eudra.org/orphanmp/doc/inventory.pdf

Pricing and social security related activities remain national competences and are outside the scope of the
Orphan Medicinal Product Regulation.

Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the
authorization and supervision of medicinal products for human and veterinary use and establishing

C 318 E/136

Official Journal of the European Communities

EN

13.11.2001

a European Agency for the Evaluation of Medicinal Products (2) plays an important role in promoting
access to these products throughout the Community. This Regulation is currently under review with a view
towards strengthening the provisions of this regulation in this regard.

(1) OJ L 18, 22.1.2000.
(2) OJ L 214, 24.8.1993.

(2001/C 318 E/144)

WRITTEN QUESTION E-0860/01

by Christopher Huhne (ELDR) to the Commission

(22 March 2001)

Subject: Commission advisory committees

Will the Commission provide a list of all its advisory committees and indicate:

1.

2.

3.

4.

their terms of reference;

the frequency of their meetings;

the names of their current members;

the availability of their papers and minutes;

5. whether meetings are open to the public?

Answer given by Mr Prodi on behalf of the Commission

(24 April 2001)

The list of advisory committees is published annually as an annex to the budget. The terms of reference are
indicated in the same list. The frequency of meetings depends on the Commission(cid:146)s need to consult them.
The list of participants, including organisations, is published in an annex to the Commission Decision
setting up the committee. The papers and minutes of the Committees are made available to Parliament in
accordance with the provisions of the framework agreement. The meetings are not usually public. The
Honourable Member is also requested to refer to the answer given to his Written Question E-0861/01 (1).

(1) See p. 136.

(2001/C 318 E/145)

WRITTEN QUESTION E-0861/01

by Christopher Huhne (ELDR) to the Commission

(22 March 2001)

Subject: Implementing committees

Will the Commission provide a list of all EU implementing committees set up under Article 202, together
with their terms of reference (and the legislation from which they derive), the frequency of their meetings,
the names of the current members, the availability of its papers and minutes, and indicate whether
meetings are open to the public?

Answer given by Mr Prodi on behalf of the Commission

(24 April 2001)

The Honourable Member will find most of the information he requests in the List of committees which
assist the Commission in the exercise of its implementing powers (1). The frequency of meetings varies