WRITTEN QUESTION E-3177/03 by Dorette Corbey (PSE) to the Commission. Reuse of medical instruments and accessories.
Date: 2003-10-27
Institutions: European Parliament, Provisional data
Subjects: health costs, health policy, labelling, medical device, public health

C 70 E/232

Official Journal of the European Union

EN

20.3.2004

Answer given by Mr Byrne on behalf of the Commission

(5 December 2003)

With the package of new legislation concerning food safety, the requirements and related controls become
more complete. The Commission has built in some flexibility by introducing the principle of equivalence
in the control proposal and HACCP in the hygiene proposals. Indeed, the approach has totally changed
with the introduction of the integrated chain approach from primary production until sale to the
consumer, with responsibility being given to the producer, with the introduction of a systematic science
based risk analysis and the precautionary principle, with the requirement of full traceability, with the
introduction of modern meat inspection techniques and the application of HACCP. The Commission has
closely ensured that the proposals complied with the provisions of the SPS Agreement of the World Trade
Organisation. Furthermore, it must be pointed out that the newly introduced principles are in compliance
with Codex Alimentarius. Nevertheless, Member States and exporting third countries have to adapt to the
new situation. By the introduction of new legislation, the working methods of producers and controlling
authorities and production and trade structures have to be adapted. As regards developing countries, the
Commission introduced certain provisions in its control proposal. These provisions are aimed at
strengthening, by technical assistance, the capacity of developing countries to implement the EU import
requirements, particularly for drafting the yearly control plans.

At this moment it is not possible to make a statement on the possible influence of the new legislation on
the existing exports to the U as the new legislation is only partially in force. The import requirements of
laying down the
the Regulation of the European Parliament and of the Council of 28 January 2002,
general principles and requirements of food law, establishing the European Food Safety Authority and
laying down procedures in matters of food safety (General Food Law) only come into effect on 1 January
2005. The hygiene package on the control proposal still has to be adopted.

(2004/C 70 E/249)

WRITTEN QUESTION E-3177/03

by Dorette Corbey (PSE) to the Commission

(27 October 2003)

Subject: Reuse of medical instruments and accessories

Medical instruments and accessories account for a significant proportion of the costs of public healthcare.
Reuse of such instruments and accessories can reduce costs by up to 40 % and has significant benefits from
an environmental point of view. However, producers of medical instruments and accessories often mark
their products as ‘single use’, preventing reuse and unnecessarily driving up costs. A further negative
consequence of this approach is that (cid:1) in order to save costs (cid:1) instruments and accessories are often
nonetheless reused, without being treated, cleaned or sterilised in a professional manner. A large
proportion of hospital infections are believed to be the result of unprofessional reuse of accessories and
instruments.

Is the Commission aware of the existence of agreements between producers of medical accessories

1.
and instruments with a view to marking as many products as possible ‘single use’?

2.

Is the Commission prepared to carry out an investigation into such agreements?

Could the Commission give an indication of the benefits of professional reuse in terms of economic

3.
costs, environmental benefits and prevention of hospital infections?

Is the Commission prepared (possibly within the framework of the thematic strategy for recycling) to

4.
promote the reuse of medical instruments and accessories?

20.3.2004

EN

Official Journal of the European Union

C 70 E/233

Answer given by Mr Liikanen on behalf of the Commission

(12 December 2003)

The Commission is not aware of the existence of agreements between producers of medical
1. and 2.
accessories and instruments with a view to marking as many products as possible ‘single-use’ and has
prima facie no reason to examine whether such agreements do exist.

The Commission is not

in a position to provide indications regarding economic costs and
3.
environmental benefits associated with re-use of single-use devices. Hospital infection is a complex issue,
of which the use of medical devices is only a component, probably difficult to identify and isolate.

The Commission shares the point of view of virtually all Member States that re-use of single-use
4.
devices should not be promoted for reasons of health protection. It draws the attention to the fact that
through procurement policy, Member States can promote the use of medical devices designed and placed
on the market as reusable devices. The role procurement policy and other instruments can play in limiting
the generation of waste will be considered in the Commission’s Communication ‘Towards a thematic
strategy on the prevention and recycling of waste’ (1). However, this strategy will not address re-use of
medical instruments and accessories in particular.

(1) COM(2003) 301 final.

(2004/C 70 E/250)

WRITTEN QUESTION P-3184/03

by Olivier Dupuis (NI) to the Commission

(20 October 2003)

Subject: Arrogance of the Lao authorities

On 26 October 1999 five young Laos (cid:1) Thongpaseuth Keuakoun, Sengaloun Phengphanh, Bouavanh
Chanmanivong, Khamphouvieng Sisaat and Keochay (cid:1) were arrested with dozens of other demonstrators
for having organised a peaceful march in Vientiane involving students, teachers, civil servants and Lao
citizens who were calling for democratic reform, measures against corruption, reforms to achieve more
social justice and a multi-party system.

trade agreements and enormous
Four years later, despite numerous appeals and despite preferential
cooperation efforts by the European Union and its Member States, the Lao authorities have not deigned to
make the slightest gesture, even a humanitarian one, towards the five prisoners of conscience. Neither the
International Red Cross nor Member State Ambassadors nor Commission representatives nor officials of
the United Nations and other international organisations have been authorised to visit them in prison.
In addition the Vientiane authorities have not even accepted that they should honour the promises made
by their representative at a parliamentary meeting in Strasbourg to clarify contradictory reports by various
government officials concerning the conditions in which the five desaparecidos of the demonstration of
the 26 October have been brought to justice.

Moreover, according to well-informed sources, it seems that Mr Khamphouvieng Sisaat has not been seen
for over a year, while Mr Thongpaseuth Keuakoun has become very weak and has lost the use of his legs.

Has the Commission received precise and reliable information on the judicial and health situation of the
five desaparecido leaders of the Movement of 26 October?

Does the Commission not think the Lao authorities’ attitude to the European Union in this affair borders
on contempt and far exceeds the limits of decency?