WRITTEN QUESTION E-0002/01 by Rolf Linkohr (PSE) to the Commission. Recycling of medical devices.
Date: 2001-01-17
Institutions: European Parliament, Provisional data
Subjects: direct cost, pharmaceutical product, product safety, waste recycling

19.6.2001

EN

Official Journal of the European Communities

C 174 E/243

Does the Commission not agree that this is an infringement of the free movement of persons, goods

1.
and services enshrined in the EU Treaty?

2.
Does the Commission not consider that any proof of identity with an indication of an address and
bank or giro account in an EU Member State should be sufficient to allow a mobile telephone operator to
conclude a contract?

3. What measures will the Commission take to stop this abuse and thus promote full freedom of
movement in the EU in this sphere?

4.
There is also one mobile operator in Belgium that first demands a guarantee and then does not allow
customers to make calls with the EU and not just in Belgium until after three monthly bills have been paid:

(a) does the Commission consider that a mobile operator can be justified in imposing restrictions on
customers with standard subscriptions with regard to mobile calls within the EU? If not, on what
Treaty provisions or directives does the Commission base its opinion?

(b) what measures can the Commission take to remove restrictions of this kind?

Answer given by Mr Bolkestein on behalf of the Commission

(21 February 2001)

The Commission takes note of the problem that persons from Member States who work a few days a week
in other Member States are unable to take out a subscription for a mobile telephone in some of these
Member States, for example Belgium, simply because they do not have a Belgian identify card or a lease.

The Commission will examine these questions with a view to establishing whether this is a commercial
practice of the mobile telephone operators concerned, or whether this results from national legislation in
the Member States concerned, as well
to the reasons motivating this practice. This will allow the
Commission to make a legal assessment of the issues raised by the Honourable Member and the scope of
action to be undertaken by the Commission.

As soon as the Commission has carried out this analysis, it will provide a more detailed answer.

(2001/C 174 E/261)

WRITTEN QUESTION E-0002/01

by Rolf Linkohr (PSE) to the Commission

(17 January 2001)

Subject: Recycling of medical devices

Each year in the European Union, about 8 bn euro worth of medical devices, which do not need to
1.
be disposable, are thrown away after being used just once. Current knowledge indicates that, from the
point of view of both sterilisation and technical reliability, such devices could be re-used.

Is the Commission aware that, in the European Union as a whole, re-using medical devices could save
several billions of euro?

Does it intend to take action to promote the re-use of such devices? After all, this is a matter which

2.
concerns not only health policy but also the functioning of the internal market?

C 174 E/244

Official Journal of the European Communities

EN

19.6.2001

Answer given by Mr Liikanen on behalf of the Commission

(12 March 2001)

Whether or not medical devices can be re-used depends on the intended purpose of a device as defined by
the manufacturer on the basis of design and technical constraints. Where a manufacturer puts devices on
the market for re-use, such devices are always accompanied with instructions on the appropriate processes
to allow safe re-use, such as cleaning and re-sterilisation, and indications on the expected life of the device.
As regards devices intended for single use, manufacturers have not carried out testing which would
take
demonstrate the performance of
responsibility for re-use.

the device in circumstances of re-use and therefore cannot

The Commission is aware of the re-use of devices intended for single use, but as re-sterilisation can change
the structure of the device and impact on its performance (e.g. existence of (cid:145)sterilised dust(cid:146)), particular
precautions must be taken by the hospitals to verify if safe re-use is feasible and determine the appropriate
reprocessing of the devices. The costs of such testing and corresponding processes are considerable, and
must be taken into account in the evaluation of possible savings. Furthermore, reprocessing of (cid:145)single-use(cid:146)
medical devices falls outside the scope of the Directives on medical devices and on active implantable
medical devices.

The Commission is aware of the implications to Member States(cid:146) national budgets of the present situation.
It has no specific data on the potential costs. In meetings organised by the Commission between Member
State authorities(cid:146) experts and industry, the question of whether the intended purpose of medical devices
should be determined by technical safety-related reasons alone or also on economic considerations is being
discussed. The appropriateness of redesigning (cid:145)single use(cid:146) devices into reusable devices with well established
conditions for use, should be evaluated together with conditions of re-use of single use devices, aiming at
reducing costs while maintaining quality and safety.

(2001/C 174 E/262)

WRITTEN QUESTION E-0011/01

by Glyn Ford (PSE) to the Commission

(17 January 2001)

Subject: Metrication

EU legislation regarding the use of metric units came into force in the UK in 2000.

However, many major supermarkets in the UK have either ignored using metric weights on their labels or
display the price per pound (lb) much more prominently than the price per kg, which contradicts the
Directive(cid:146)s requirements.

What plans does the Commission have to ensure that this Directive is fully implemented in the UK?

Answer by Mr Liikanen on behalf of the Commission

(7 March 2001)

The matter to which the honourable Member refers is the subject of a complaint that has just been made
to the Commission. An investigation is currently under way with regard to the Member State involved in
order to obtain the necessary facts concerning the matter that has been reported.
If necessary, the
Commission will not hesitate to take appropriate action in accordance with the procedure laid down in
Article 226 of the Treaty.