----

(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 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:

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 — without scientific basis — 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.

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.

----