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.

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.