You are on page 1of 2


2002 EN Official Journal of the European Communities C 40 E/201

3. The Commission received a position paper entitled the ‘Application of orphan drug legislation’ from
Transkaryotic Therapies, Inc. (TKT) dated 21 December and a reply was sent on 31 January 2001. This
position paper has been considered with respect to the interpretation of Regulation (EC) No 141/2000 of
the Parliament and of the Council of 16 December 1999 on orphan medicinal products (1) concerning the
two medicinal products which are the subject of this question. The relevance of surrogate markers with
respect to an individual marketing authorisation application is a scientific matter which must be
considered by the relevant scientific body responsible for the examination of a specific application, in this
case the Committee for Proprietary Medicinal Products.

4. Numerous products for both rare and less rare diseases have been granted marketing authorisations
based on surrogate endpoints including products for the treatment of diabetes, hypertension, Gaucher
disease, and nephropathic cystinosis. For all medicinal products authorised on the basis of a scientific
opinion of the CPMP, (centrally approved products) a summary of the data which has been presented, and
the grounds on which the authorisation is based is published in the form of a European Public Assessment
Report (EPAR) following the grant of the marketing authorisation ensuring transparency of the decision
making process to all interested parties including the industry, the medical community and the general

(1) OJ L 18, 22.1.2000.

(2) OJ B 22, 9.2.1965.
(3) OJ L 214, 24.8.1993.
(4) OJ C 335, 6.11.1997.
(5) OJ L 147, 9.6.1975.

(2002/C 40 E/217) WRITTEN QUESTION E-2145/01

by Jeffrey Titford (EDD) to the Commission

(18 July 2001)

Subject: Public library subsidy

1. Is the Commission aware that the European Union is complicit in an anti-competitive trading
situation because it has authorised only one commercial agent for the supply of its literature in the UK,
namely The Stationery Office (TSO)?

2. Is it aware that it has created a monopoly situation in authorising only one agent (TSO) and that that
agent is the only mechanism through which libraries throughout the UK may claim a Public library

3. Is it aware that UK Government publications and the Public library subsidy for them are much more
freely available?

4. What steps does the Commission propose to take to resolve the anti-competitive position it has
taken on the sale and distribution of its own literature?

Answer given by Mrs Reding on behalf of the Commission

(24 October 2001)

1. The Commission and other European institutions as well as agencies sell their publications and other
information services (databases, document delivery, etc.) through a network of sales agents. This network is
managed by the Office for Official Publications of the European Communities (EUR-OP). Sales agents act
on the basis of a contract granting them non-exclusive rights to sell publications and/or other services to
any client anywhere. Any firm wishing to become a sales agent may sign a contract with EUR-OP. There
are currently more than 60 sales agents in the Member States, of which 19 sell paper publications only. In
the United Kingdom there are six agents: one sells books and electronic products, one is a data-base
gateway, one is a document delivery agent and three sell electronic products only.

EUR-OP also sells directly through the Internet (http//

C 40 E/202 Official Journal of the European Communities EN 14.2.2002

The publications sold by EUR-OP are specialised and have small print-runs: a top-selling publication will
have sales in the range of 1 000-1 500 copies in English, but usually the number of copies sold is
substantially lower. For most sales agents, the profit generated by the sale of EUR-OP’s publications only
represents a fraction of their business.

Hence, the fact that in some Member States only one firm sells Community paper publications is a
consequence of the market conditions rather than the result of any specific marketing policy.

2. As explained above, it is EUR-OP’s policy not to limit the number of its partners.

National Public library subsidy systems and the relevant conditions do not fall within the Commission’s

3. Through EUR-OP, the Institutions supply free of charge all or part of their publications to the
following networks: European Documentation Centres, European Depositary Libraries, Info Points Europe,
European Reference Centres, Rural and Development Centres, Urban Forums, Euro Libraries, Euro Info
Centres. For the United Kingdom, a total of 322 organisations are affiliated to these networks, and
specifically 212 public libraries are part of the Euro Libraries network.

The Commission is not in a position to evaluate how this policy compares to the British Government’s
policy regarding the subsidisation of its publications.

4. Given the above explanations, it is clear that the Commission has not taken an anti-competitive
position pertaining to the sale and distribution of its publications and information services.

(2002/C 40 E/218) WRITTEN QUESTION P-2148/01

by W. G. van Velzen (PPE-DE) to the Commission

(10 July 2001)

Subject: Implementation of the third-generation mobile telephony action plan

In connection with the UMTS Communication from the Commission (1) on ‘The Introduction of Third
Generation Mobile Communications in the European Union: State of Play and the Way Forward’ and
following recent developments in this area, the following questions arise:

 In the press much has been written these past few months about the approval given by the German
National Regulatory Authority for the sharing of infrastructure for UMTS networks. Can the
Commission outline the situation as regards infrastructure sharing in the case of other national
regulatory authoritiesMTEXT in the EU?

 In the meantime has the Commission held talks with the European Investment Bank (EIB) about a
competition framework for extending loans to telecom operators and, if so, what form would such a
framework take and what would be the nature and extent of such loans?

 Is Commissioner Liikanen prepared, in September or October 2001, to come before the Committee
on Industry, External Trade, Research and Energy and provide more detailed information on the
implementation of the 3 G Plan, as referred to in the conclusions of the Stockholm Summit?

(1) COM(2001) 141.

Answer given by Mr Liikanen on behalf of the Commission

(5 September 2001)

Following the adoption of the ‘3G Communication’ (1) in March 2001, the Commission raised the issue of
network infrastructure sharing on several occasions when meeting the Member State administrations and
regulators. The Member States in principle share the Commission’s view that network sharing can offer
potential economic benefits as well as facilitating an environmentally friendly implementation of networks.