WRITTEN QUESTION E-3462/01 by Cristiana Muscardini (UEN) to the Commission. Rules governing the therapeutic use of liquid oxygen.
Date: 2002-01-04
Institutions: European Parliament, Provisional data
Subjects: European standard, approval, competence of the Member States, drafting of EU law, medical device, oxygen, public health, respiratory disease

C 134 E/234

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6.6.2002

As regards the document originating from the Commission’s financial control service, the Commission
would like to stress the fact that, as this was an internal financial control service note and not a finalised
official report, it contained some elements which had not been fully corroborated when it was written.
This document and all related documents thus count as exceptions under Regulation (EC) No 1049/2001,
Article 4(1b), protecting the privacy and personal data of individuals, and Article 4(2.3), justifying non-
disclosure after a request for access to documents.

Contrary to the claim made by the Honourable Member, Article 197 (formerly Article 140) of the EC
Treaty, whilst stipulating that Members have the right to obtain answers to the questions they put to the
Commission, does not give them automatic right of access to confidential documents. Requests to access
documents must be made in accordance with the above-mentioned Regulation governing public access to
documents. As regards inter-institutional relations, the framework agreement signed on 5 July 2000
specifies the terms for the transmission of any confidential documents which are requested by the
Parliament.

Finally, the Honourable Member seems to be implying that the Commission’s answer to Written Question
E-1174/01 (2) is incorrect. It is clear that the answers given have been taken out of context. The above-
mentioned question referred to a questionnaire to which Mr Lamy replied before Parliament’s hearing on
the investiture of the new Commission. The aim of this questionnaire was to identify the risks of any
possible conflict of interest posed by Mr Lamy’s role as a member of the board at Crédit Lyonnais, and the
reply to the above-mentioned question referred specifically to this matter.

As indicated in the reply to Parliament’s questionnaire and as confirmed in the answer to Written Question
E-1174/01, in his role as a Director of Crédit Lyonnais Mr Lamy met Commission officials formally only
once, between 1 and 3 May 1998. Mr Lamy has indeed had contacts with Commissioners and
Commission officials, in his capacities as the former head of President Delors’ cabinet, a member of the
board of the European Movement in France, and in other fields entirely unrelated to his role at Crédit
Lyonnais.

The meeting to which the Honourable Member refers, which is mentioned in the annexes of one of the
documents requested, was held at the request of the European Anti-Fraud Office (EAFO, in conjunction
with UCLAF), as one of the many hearings comprising an UCLAF investigation.

(1) OJ C 115 E, 16.5.2002, p. 99.
(2) OJ C 318 E, 13.11.2001, p. 219.

(2002/C 134 E/248)

WRITTEN QUESTION E-3462/01

by Cristiana Muscardini (UEN) to the Commission

(4 January 2002)

Subject: Rules governing the therapeutic use of liquid oxygen

Increasingly often medical conditions linked to respiratory failure and their treatment, especially long-term
treatment, make it necessary to reject electrical oxygen generators (which are not portable) in favour of
liquid oxygen using portable cryogenic equipment. Patients suffering from these ailments often have
problems, either because a medical prescription is still required in certain parts of the country or the
Community, or because the connections for the apparatus have not yet been standardised. Furthermore, it
has not yet been approved for use on various modes of transport, which means that oxygen patients are
less mobile.

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Official Journal of the European Communities

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In view of this situation and in order to ensure that patients receive the treatment most suited to their
needs, can the Commission say:

? whether it has powers to harmonise legislation on this subject;

? if so, whether it considers it appropriate to draw up standards unifying and establishing criteria for the

prevention and treatment of chronic respiratory insufficiency;

? whether it considers that oxygen patients are entitled to dignity and quality of life, even though they

are receiving long-term treatment?

Answer given by Mr Liikanen on behalf of the Commission

(15 February 2002)

Liquid oxygen equipment, intended to be used for medical purposes, is considered a medical device, and
therefore is covered by Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (1).
Essential requirements, and a conformity assessment, covering the quality, safety and performance of the
device, must be met, before the device can be put on the market and into service.

Standards for portable liquid oxygen devices, including connectors, are currently being developed by the
European Committee on Standardisation (CEN), following a mandate given by the Commission on the
basis of Directive 93/42/EEC. The adoption of these standards is expected for the second half of 2003. The
Commission is following closely these activities.

According to the EC Treaty, a high level of human health protection shall be ensured in the definition and
implementation of all Community policies and activities. Dignity and quality of life are certainly covered,
as a right, in this definition. However rules governing medical prescription or treatment, fall under the
competence of Member States, as laid down in article 152 of the EC Treaty, Public Health. The same
Treaty’s article applies to the definition of criteria for treatment, which is the responsibility of the medical
profession in each Member State. They define the best policy in diagnosing and in rehabilitating the
patients.

Finally, the use of portable liquid oxygen generating devices for medical use, by aircraft passengers, is
subject
to aircraft operational safety requirements. These are the Joint Aviation Requirements for
Operations (JAR-OPS), adopted by the Joint Aviation Authorities (JAA) (2). The Commission plans to
convert these requirements progressively into Community legislation.

(1) OJ L 169, 12.7.1993.
(2) The JAA is an associated body of the European Civil Aviation Conference (ECAC), representing the civil aviation
regulatory authorities of the European States who have agreed to co-operate in developing and implementing
common safety regulatory standards and procedures. Currently, 25 states are full member, whereas 11 states are
candidate member or associated member of the JAA.

(2002/C 134 E/249)

WRITTEN QUESTION P-3467/01

by Samuli Pohjamo (ELDR) to the Commission

(10 December 2001)

Subject: Implementation of the EU’s objective programmes should be simplified

The monitoring and checking of the implementation of the EU’s objective programmes has been tightened
up. The list of acceptable expenses has been shortened and the administration has become more
complicated. Payments for projects are mainly disbursed on an ex-post basis. This creates problems,
particularly for those carrying out small projects, since the launching stage of projects involves a
disproportionately high proportion of own funding.

In practice this has meant that regional actors, such as universities, research institutes, businesses and
citizens’ organisations, are pulling out of the implementation of EU programmes.