WRITTEN QUESTION E-3539/02 by Chris Davies (ELDR) to the Commission. Preferential-priced medicines illegally reimported into the EU.
Date: 2002-12-11
Institutions: European Parliament, Provisional data
Subjects: customs inspection, customs regulations, developing countries, medicinal product, preferential price, re-import

13.3.2004

EN

Official Journal of the European Union

C 65 E/15

(2004/C 65 E/015)

WRITTEN QUESTION E-3525/02

by Concepció Ferrer (PPE-DE) to the Commission

(10 December 2002)

Subject: Obstacles to trade in the applicant countries

In July 2002, the Spanish Secretary of State for Trade processed some 20 complaints from exporters
concerning trade obstacles caused by administrative and fiscal problems in the applicant countries. 48 % of
the complaints related to Poland and 28 % to the Czech Republic.

The sectors most affected were agri-foods, chemicals, pharmaceuticals,
furniture, footwear, building materials, capital equipment and automobile parts.

textiles, plastics, wood and

What action is the Commission taking or going to take with a view to preventing such obstacles to trade
from proliferating once enlargement has actually taken place?

Answer given by Mr Verheugen on behalf of the Commission

(30 January 2003)

The Commission considers the smooth functioning of the internal market from the first day of accession
of the new Member States as being of primary importance. In order to ensure that this will be the case,
intensive monitoring of commitments made under the relevant chapters of the acquis is already being
undertaken and will continue until the date of accession. In the event that major disruptions are deemed
likely, the Commission reserves the right to invoke the ‘safeguard clause’ announced by the Commission
on 9 October 2002 and now accepted by all parties. The safeguard clause in the accession treaty will allow
the Commission for a period of three years following accession, if it is considered necessary, to take
appropriate action to ensure the orderly implementation of Community law, particularly in areas such as
the Internal Market (including food safety) and Justice and Home Affairs. Decisions can be taken already
prior to accession.

Upon accession the administrative and informational architecture ensuring the free movement of goods in
the current Member States will become operational automatically. No transition periods have been
negotiated as regards the principles of mutual
the EC Treaty.
The obligations of new Member States to ensure the removal of all obstacles to the free movement of
goods will therefore be the same as those currently in place amongst the fifteen existing Members. These
obligations apply regardless of whether the goods concerned are covered by harmonised product
legislation or not. In the event of non-respect of these obligations, the Commission will examine the
possibility of infringement proceedings on the same basis as is currently the case in the Member States.

recognition and Articles 28-30 of

(2004/C 65 E/016)

WRITTEN QUESTION E-3539/02

by Chris Davies (ELDR) to the Commission

(11 December 2002)

Subject: Preferential-priced medicines illegally reimported into the EU

Is the Commission aware that significant quantities of not-for-profit medicines destined for African
countries are being illegally reimported back to the EU for sale at a higher price? If so, what measures are
in place to ensure that current customs controls at EU borders are being effectively implemented, and does
the Commission intend to introduce further additional measures to address this growing problem?

C 65 E/16

Official Journal of the European Union

EN

13.3.2004

Answer given by Mr Lamy on behalf of the Commission

(17 January 2003)

The Commission is indeed aware of the problem of low priced medicines destined for developing country
markets that are being imported into the Community.

Importation of medicines coming from third countries into a Member State is subject to the holding of an
authorisation as laid down in Directive 2001/83/EC of the Parliament and of the Council of 6 November
2001 on the Community code relating to medicinal products for human use (1).

Action against unauthorised importation of low priced medicines is currently only possible for products
protected by intellectual property rights. If goods covered by either trademark or patent protection on a
Community market are appearing without permission of the right holder, he/she may take action in the
national courts against the importer and ensure that the goods are removed from circulation.

The Commission has in the context of the Community Programme for action on communicable diseases
and poverty reduction proposed a Council Regulation (2), adopted by the Commission on 30 October
2002, to prevent tiered priced medicines sold to developing countries from entering the Community
market. This Regulation, once in force, will enable the customs authorities to detain goods suspected to be
tiered priced medicines (whether covered by intellectual property protection or not) at the Community
borders until the national authorities issue a decision on the character of the merchandise and the use that
can be given to these goods.

The Commission firmly believes that improved means to prevent import of low priced pharmaceuticals to
be traded on Community markets, as outlined above, will encourage the pharmaceutical
industry and
exporters to supply sufficient volumes of essential medicines to poor countries at affordable prices.

(1) OJ L 311, 28.11.2001.
(2) COM(2002) 592 final.

(2004/C 65 E/017)

WRITTEN QUESTION E-3551/02

by Charles Tannock (PPE-DE) to the Commission

(12 December 2002)

Subject: Article 23 legislation in Hong Kong and the rights of Falun Gong practitioners throughout China

What is the opinion of the Commission on the introduction of the controversial Article 23 legislation or
anti-subversion law, and is the Commission concerned about the threat to the ability of those who wish to
peacefully practise Falun Gong activities either in Hong Kong or in the rest of China to practise their
beliefs unimpeded or without threat of arbitrary arrest? Has the Commission raised the issue of Falun
Gong with the Chinese government, and does the Commission believe that the increase in the numbers of
Falun Gong followers should be seen primarily as a desire on the part of many people to return to older,
spiritual Chinese codes of behaviour rather than as a threat to the political dominance of the Communist
Party itself?

Has the Commission also expressed concern over threats to religious freedom in China, and is the
Commission hopeful that the new leadership under Hu Jintao will address this issue more readily in the
future?

Answer given by Mr Patten on behalf of the Commission

(9 January 2003)

The Commission is aware of the initiative taken by the Hong Kong Government to start a consultative
process in view of enacting Article 23 of the Basic Law. In addition the Commission appreciates the
importance and political sensitivity of the issue in the global Chinese context. However, as the consultation