WRITTEN QUESTION E-2315/03 by Paul Rübig (PPE-DE) to the Commission. Restriction of market access of plasma-derived medicinal products in Australia.
Date: 2003-07-14
Institutions: European Parliament, Provisional data
Subjects: Australia, common commercial policy, exclusive distribution agreement, market access, pharmaceutical industry, trade in organs, trade restriction

C 33 E/250

Official Journal of the European Union

EN

6.2.2004

The Commission is currently analysing the situation in order to determine the exact nature and effects of
the Japanese legislation, in particular the economic impact on European manufactures. The issue as to
whether the legal provisions constitute a breach of the WTO rules is being further assessed.

However, the Commission has already taken up the matter in its bilateral contacts with the Japanese
authorities, including the EU-Japan Regulatory Reform Dialogue.

(1) Directive 2002/98/EC of the Parliament and of the Council of 27 January 2003 setting standards of quality and
safety for the collection, testing, processing, storage and distribution of human blood and blood components and
amending Directive 2001/83/EC, OJ L 33, 8.2.2003.

(2004/C 33 E/257)

WRITTEN QUESTION E-2315/03

by Paul Rübig (PPE-DE) to the Commission

(14 July 2003)

Subject: Restriction of market access of plasma-derived medicinal products in Australia

In Australia, a monopoly arrangement (The Plasma Fractionation Agreement) allows CSL Limited to be the
sole supplier of Australian plasma-derived medicinal products. This is despite that fact that CSL Limited
enjoys the same freedom of trade as European manufacturers in the European Union and in other major
markets.

The safety standards under which plasma-derived medicinal products are being manufactured and
distributed do not differ between CSL Limited and other major manufacturers whose products are being
restricted from the Australian market. Indeed, another severe discrimination exists in the fact that plasma-
derived medicinal products originating from non-Australian sources have to demonstrate improvements in
terms of efficacy and safety to gain market access.

Does the Commission not agree that such a policy is a severe barrier to trade and market access by
discriminating against products that are being manufactured following state-of-the-art technology and
authorised to the market in Member States of the European Union? And does the Commission not agree
that this issue should be raised and discussed at the next WTO round in Cancun in October 2003?

Answer given by Mr Liikanen on behalf of the Commission

(1 September 2003)

By way of initial comment, the Commission points out that all plasma-derived products approved by the
European Agency for the Evaluation of Medicinal Products (EMEA) for marketing in the Union comply
with the strictest safety requirements, regardless of their origin. The basic safety of plasma-derived products
is ensured by a wide variety of measures. Given the similar safety and quality requirements applied in
Australia and in the Union there seems to be no public health justification for measures discriminating
against European products.

The Commission is aware of the situation and agrees that the Plasma Fractionation Agreement in Australia
raises concerns in regard to market access.

According to the Commission’s understanding, access to the Australian market
products produced outside Australia is only permitted in exceptional circumstances.

for plasma-derived

Given the World Trade Organisation (WTO) provisions, WTO members should ensure that products
imported from the territory of any member should be accorded treatment no less favourable than that
accorded to like products of national origin and to like products originating in any other country.

6.2.2004

EN

Official Journal of the European Union

C 33 E/251

The Commission is currently analysing the situation in order to determine the exact nature and effects of
the above mentioned Fractionation Agreement,
the economic impact on European
manufacturers. The issue as to whether the market conditions constitute a breach of the WTO rules
requires further analysis.

in particular

Subject to the results of this analysis, the Commission will take the appropriate steps, e.g. raise the subject
with the Australian authorities or in the appropriate WTO Committee.

(2004/C 33 E/258)

WRITTEN QUESTION E-2316/03

by Armando Cossutta (GUE/NGL) to the Commission

Subject: Knowledge of languages in the Union

(14 July 2003)

Following the widespread introduction of new multi-media technologies, for example DVD technology,
Europeans can buy films and watch them in the various Union languages. However, increasingly often
DVD’s on the market offer films in two language versions at the most, and do not always provide subtitles
for each language version.

1.
Does the Commission not consider that the potential of technologies should be exploited to the full
in order to spread knowledge of Community languages as much as possible, thereby implementing one of
the principal commitments made at the Lisbon European Council?

2. What legislative steps and other measures will the Commission take to ensure that European citizens,
using the technology mentioned, can learn the languages of other European peoples by watching films?

Answer given by Mrs Reding on behalf of the Commission

(4 September 2003)

The Commission fully shares the Honourable Member’s desire to improve the teaching and learning of
languages in the Union.

The Honourable Member may be interested to know that the Commission has recently published a
Communication to the other institutions (1) ‘Promoting language learning and linguistic diversity: an Action
Plan 2004-2006’.

The Communication specifically refers to the potential of new technologies for promoting language
learning:

Every community in Europe can become more language-friendly by making better use of
opportunities to hear and see other languages and cultures, thereby helping to improve language
awareness and learning.

Research shows that the use of sub-titles in film and television can encourage and facilitate language
learning. The power of the media (cid:1) including new media such as DVDs (cid:1) could be harnessed in the
creation of a more language-friendly environment by regularly exposing citizens to other languages
and cultures. The potential for the greater use of sub-titles to promote language learning could be
exploited.

Furthermore, the Commission proposes to launch a study to analyse the potential for greater use of sub-
titles in film and television programmes to promote language learning and to examine ways and means of
encouraging greater use of sub-titled audio-visual material for language learning purposes.