WRITTEN QUESTION E-2314/03 by Paul Rübig (PPE-DE) to the Commission. Restriction of market access of plasma-derived medicinal products in Japan.
Date: 2003-07-14
Institutions: European Parliament, Provisional data
Subjects: Japan, common commercial policy, labelling, market access, pharmaceutical industry, pharmaceutical product, trade in organs, trade restriction

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The campaign website will soon be available in all Union languages. The different language versions of the
campaign materials are in the process of being finalised,
following consultations with the relevant
stakeholders (national authorities, the social partners and non-governmental organisations (NGOs)) on the
adaptation of the campaign materials in each Member State. The initial presentation of the website in three
languages was intended to avoid delays in the launching of the campaign. This way of proceeding is in line
the
with the practice adopted for other websites of
Parliament, where some pages are available in a limited number of languages. It is in the interest of
transparency to make information available as soon as possible rather than to wait for the availability of all
Community languages.

the Community Institutions,

including that of

the application of

The Honourable Member also asks about
language tests for certain jobs and
requirements concerning the level of knowledge requested. On the discriminatory practice of applying
‘mother tongue’ or ‘native speaker’ qualifications in job advertisements, the Commission explained its
position concerning this problem in general in numerous replies to written questions. The Honourable
Member is therefore referred to the replies of the Commission given to Written Questions: No E-4100/00
by Mr Staes (3), E-0779/01 by Mr Staes (4), E-1356/01 by Mr Gemelli (5), E-1681/01 by Mr Staes (6), E-1682/
01 by Mr Staes (6), E-2331/01 by Mr Ferrer (7), E-2900/01 by Mr Staes (7), E-2901/01 by Mr Staes (7),
E-2944/01 by Mr Staes (7), E-3189/01 by Mr Rothley (7), E-3572/01 by Mr Staes (8), E-0941/02 by
Mr Staes (9), E-2764/02 by Mr Staes (10), E-1733/03 by Mr Leinen (11) and E-2018/03 by Mr Staes (12).

With regard to the Honourable Member’s question about ‘affirmative action’, the case-law of the Court of
Justice in sex discrimination cases (13) sets clear limits to the scope of measures designed to overcome the
disadvantages suffered by particular groups in the labour market. These limits prohibit the use of measures
which promote the appointment of workers who are less well qualified for the job on the grounds that
they are members of a disadvantaged or discriminated group.

Finally, the Commission sees no risk of firms which are acting ‘in good faith being stigmatised because of a
lack of ethnic diversity’.

(1) Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons
irrespective of racial or ethnic origin (cid:1) OJ L 180, 19.7.2000 and Council Directive 2000/78/EC of 27 November
2000 establishing a general framework for equal treatment in employment and occupation (cid:1) OJ L 303, 2.12.2000.
(2) Council Decision 2000/750/EC of 27 November 2000 establishing a Community action programme to combat

discrimination (2001 to 2006) (cid:1) OJ L 303, 2.12.2000.

(3) OJ C 174 E, 19.6.2001.
(4) OJ C 235 E, 21.8.2001.
(5) OJ C 350 E, 11.12.2001.
(6) OJ C 93 E, 18.4.2002.
(7) OJ C 134 E, 6.6.2002.
(8) OJ C 160 E, 4.7.2002.
(9) OJ C 229 E, 26.9.2002.
(10) OJ C 92 E, 17.4.2002.
(11) OJ C 11 E, 15.1.2004, p.221.
(12) See page 201.
(13) e.g. judgements in C-450/93 Kalanke of 17.10.1995; C-409/95 Marschall of 11.11.1997.

(2004/C 33 E/256)

WRITTEN QUESTION E-2314/03

by Paul Rübig (PPE-DE) to the Commission

(14 July 2003)

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

The Japanese Diet passed new legislation in 2002 requesting annual forecasts of anticipated shipments by
domestic and foreign manufacturers of blood- and plasma-derived products. Although one purpose of this

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new law (Blood Collection and Blood Donation Mediation Control Law/Showa 31 (1956) Law No 169) is
to ensure adequate supply of blood products in Japan, the primary intention of the law is to promote
domestic self-sufficiency.

Under this new law, each year a blood materials supply and demand plan will be developed and the
Japanese Government will recommend importing companies to reduce their shipments if it is determined
that imports are reducing demand for domestically-sourced blood products. Companies that refuse to
comply with these recommendations may have their business licences terminated.

The possible labelling requirements that could require foreign manufacturers to specify that their products
originate from remunerated sources also create an issue of major concern and could have discriminatory
effects.

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.

Concerning the Amendment of the Enforcement Ordinance referred to by the Honourable Member, the
Commission is aware of the legal provisions and shares the concerns of the Honourable Member. There
should be no trade restrictions imposed that cannot be justified on legitimate grounds.

According to the Commission’s understanding, the above-mentioned Japanese legal provisions contain two
elements of concern:

(cid:1) a supply and demand plan;

(cid:1) a new labelling requirement.

According to the Technical Barriers to Trade (TBT) Agreement, World Trade Organisation’s (WTO)
Members should ensure that technical regulations are not prepared, adopted or applied with view to or
with the effect of creating unnecessary obstacles to international trade. In addition, 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.

Legal provisions, which tend to discriminate between sources of blood donorship or countries of origin, or
unfairly to imply (cid:1) without scientific basis (cid:1) that products derived from unpaid domestic donors are safer
than imported products derived from paid donors, give rise to concerns. As the Honourable Member will
be aware, however, Directive 2002/98/EC (1) does require Member States ‘to encourage voluntary and
unpaid blood donations with a view to ensuring that blood and blood components are in so far as possible
provided from such donations’ (Article 20).

There is no need for differentiated labelling if the quality and safety of the products are assured as
equivalent.

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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.