Opinion of the Economic and Social Committee on the 'Draft proposal for a Council Directive on health protection of individuals against the dangers of ionizing radiation in relation to medical exposures, replacing Directive 84/466/Euratom`

(96/C 212/07)

On 28 November 1995, the Commission decided to consult the Economic and Social Committee, under Article 31 of the Treaty establishing the European Atomic Energy Community, on the above-mentioned draft proposal.

The Section for Energy, Nuclear Questions and Research, which was responsible for preparing the Committee's work on the subject, adopted its Opinion on 14 May 1996. The Rapporteur was Mr von der Decken.

At its 336th Plenary Session (meeting of 29 May 1996), the Economic and Social Committee adopted the following Opinion by 110 votes to one, with two abstentions.

1. Introduction

1.1. The use of ionizing radiation has led to considerable medical advances in terms of diagnosis, therapy and prevention. Since the end of the last century and the introduction of X-rays for diagnostic purposes - the earliest application of ionizing radiation in medicine - the increasing use of radiology and the expansion in applications of ionizing radiation have meant that medical exposure constitutes the principal source of exposure to artificial ionizing radiation for citizens of the European Union.

1.2. According to recent estimates of the Scientific Committee of the United Nations on the effects of atomic radiation (UNSCEAR), people in industrialized countries are currently subjected to an average of one X-ray or nuclear medicine examination per year.

1.3. The health and safety questions associated with the use of ionizing radiation for medical purposes are regulated at the moment by three Community Directives:

- Directive 80/836/Euratom laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation (), which guarantees the protection of practitioners empowered to carry out medical work involving the use of ionizing radiation and ensures strict monitoring of the exposure of the general public to ionizing radiation.

However, this Directive does not contain any specific provisions on the protection of patients against unnecessary exposure when undergoing medical examinations or treatment involving the use of ionizing radiation.

- Directive 84/466/Euratom on the health protection of persons exposed to ionizing radiation for medical purposes (), which complements the Directive laying down the basic standards and which is specifically designed to avoid unjustified or even improper exposure to ionizing radiation during treatment or examination, without calling into question the legitimate use of radiation and the benefits for patients in terms of screening, diagnosis and treatment.

- Directive 93/42/EEC on medical devices (), which lays down the essential health and safety requirements for patients and users, especially as regards protection against ionizing radiation, in connection with the design, manufacture and marketing of medical devices.

1.4. The main aim of the 1984 Directive, on which the Committee delivered its Opinion on 3 July 1980 () and which the present proposal is designed to replace, is to:

- ensure that only practitioners with the necessary skills and experience can carry out medical work involving the use of ionizing radiation;

- guarantee the strict surveillance of radiological and nuclear medical installations and equipment on the basis of acceptability criteria which the Directive asks Member States to fix;

- ensure that inadequate or defective installations are improved and that installations no longer meeting the acceptability criteria are taken out of service or replaced;

- prevent the pointless proliferation of installations in the fields of radiotherapy, radiodiagnosis and nuclear medicine.

1.5. In July 1993 () the Commission forwarded to the Council a proposal for a Directive aimed at replacing the existing Directive on basic radiation safety standards. The proposal was based on the need to strengthen and update the provisions of the existing Directive, bearing in mind the experience acquired in implementing it as well as the scientific and technical progress made in the field of radiation protection.

1.6. Since this proposal for a Directive [Committee Opinion of 23 February 1993 ()] still did not specifically cover the medical uses of ionizing radiation, the Commission considers that, for the same reasons, the time is now ripe to replace the Directive adopted in 1984.

1.7. Whilst reaffirming the validity of the objectives pursued under the Directive in question, the Commission proposes a number of amendments. The most important of these aim:

- to define more clearly the scope of the Directive regarding the exposure of individuals as part of medico-legal, insurance or legal procedures, and to enlarge the Directive's scope to include volunteers in research and individuals helping in the support and comfort of patients;

- to strengthen the provisions regarding application of the principle of 'justification` and 'optimization` in the field of medical exposures;

- to ensure that, in addition to the requirement that ionizing radiation in medical procedures is always used under the responsibility of a practitioner (a requirement already laid down in the 1984 Directive), practical aspects of the medical procedure can be delegated to other individuals authorized by the competent national authorities;

- to develop an obligation to control the quality of installations and to introduce programmes which guarantee quality, including assessments of the doses received by the patient;

- to introduce additional requirements applicable to paediatric exposures, health screening programmes, practices involving high doses, the exposure of pregnant and breast-feeding women and the exposure of carers and volunteers;

- to introduce the concept of potential exposures and to make sure that their probability and magnitude are kept as low as reasonably possible;

- to ask Member States to guarantee the introduction of procedures for auditing the implementation of the requirements of the Directive.

2. General comments

2.1. The Committee agrees with the Commission that the Council Directive of 3 September 1984 is in urgent need of revision, and endorses the main Commission proposals bearing in mind the detailed comments on the individual articles made below in section 3.

2.2. The Committee notes with great regret the Commission's discovery that not all Member States have managed over a period of 12 years to implement the 1984 Directive in full. Above all, the inventories of radiological equipment required under Article 3 have not been drawn up.

2.3. The Committee thinks it is particular important that the practical recommendations appended to the 1984 Directive are to be incorporated in the body of the Directive.

2.4. Despite being incomplete, the data presented by the Commission regarding the frequency of radiological applications and the doses used indicate that the radiation to which the general public is thereby exposed is still by far the largest man-made source of exposure; in some areas such as computer-controlled tomography the level of exposure is constantly rising. This being so, Articles 4 and 5 (relating to justification and optimization) represent the main thrust of the draft.

2.5. There is still agreement among experts and the public at large that the correct radiodiagnostic indication has a major influence on the number of applications and the population doses, which could be reduced somewhat. Efforts have been made in this area for many years at a wide variety of levels, but so far no effective way of solving the problem has been found. The Committee thinks that the draft may be of some assistance here.

2.6. The Committee agrees with the Commission that the urgent need to restrict the general public's exposure to radiation as a result of inappropriate radiological applications will require a series of measures. This series of measures includes: training; monitoring; determining responsibilities; drawing up indication criteria; and raising awareness of the problem. These measures are taken into consideration to a considerable extent in the Commission's draft.

3. Specific comments

3.1. Article 2 - Definitions

3.1.1. It emerged during discussions that in some cases the terms and their definitions in the various languages do not tally with national usage and have not been translated accurately. For example: 'exposure` is used to mean both the process of being exposed to radiation and the dose level, while 'medico-legal` has been translated in German as 'gerichtsmedizinisch` (relating to forensic medicine).

3.1.2. The Commission is advised to revise the whole list, with special regard to the specific meanings in each language.

3.2. Article 3 - Scope

3.2.1. Article 3(1)(b)

3.2.1.1. In view of the growing frequency and importance of the cases where radiodiagnostic examinations are required on medico-legal, insurance or legal grounds, the Committee welcomes the inclusion of these cases in Article 3(1)(b). There is an urgent need for provisions in these fields.

3.2.1.2. The Committee is obliged to point out, however, that special problems are raised by including such cases. Firstly, in legal cases the risks which exposure involves are not generally offset by any direct benefits for the health of the persons undergoing the exposure. However, this is required by the Directive which states that all risks shall be justified in terms of benefits.

3.2.1.3. The question of responsibility is not clear either, since in legal cases decisions are mainly taken on non-medical grounds.

3.2.1.4. The Committee proposes amendments to Articles 4 and 6 which relate to the problems of legal cases (see 3.3.2.2 and 3.5.3 below). However, the Committee cannot propose a definitive solution. The whole issue still has to be discussed thoroughly.

3.3. Article 4 - Justification

3.3.1. Article 4(2)

3.3.1.1. In the past attempts to influence the distribution of installations on the basis of needs have had only a limited effect and the Directive does not seem to have any effective ideas on the matter either. The Committee therefore proposes that the purpose of the planned measures should be to avoid the unsupervised rather than the unnecessary proliferation of installations. This will reduce the need for administrative and legal machinery to clarify whether installations are necessary. So far there has been a noticeable need for such machinery but it has been relatively ineffective.

3.3.2. Article 4(3)

3.3.2.1. The Committee thinks that special importance should be attached to the dissemination and use of previous diagnostic information in connection with the justification of all individual medical exposures. This requirement should be listed in a separate point in Article 4, which should also state that modern communications technologies are available for this purpose to an increasing extent.

3.3.2.2. The following phrase should be added to the end of Article 4(3): 'Special attention shall be given for those exposures where there is no direct health benefit for the person undergoing the exposure, and especially for exposures on medico-legal, insurance and legal grounds.`

3.3.3. Article 4(6)

3.3.3.1. The Committee would stress that it regards the ban on X-ray examinations without image intensification and the call for automatic dose rate control as an important and effective step towards reducing the radiation dose and improving the quality of the diagnosis.

3.4. Article 5 - Optimization

3.4.1. Article 5(1)

3.4.1.1. The establishment and use of reference levels for the doses used in radiodiagnostic examinations is welcomed by the Committee. However, because of the need to ensure a uniform minimum standard with regard to the quality of the diagnosis and the exposure of all EU citizens to radiation, it should not be left to the Member States to establish such reference levels. Ways must be found of harmonizing the compiling of a list of reference levels and this list should apply equally in all Member States. This approach also tallies with the demands of the manufacturers of installations, who base the technical specifications for their installations on these reference levels and believe that the delegation of this task to the Member States would be likely to hamper trade.

3.4.2. Article 5(5)

3.4.2.1. The requirements regarding medical physicists are welcomed. There has been positive feedback in this area in recent years and the practice has now become well established.

3.5. Article 6 - Responsibility

3.5.1. Article 6(1)

3.5.1.1. It is a long established principle in medicine that doctors are responsible for whatever happens in their specialist field or in a field over which they have control. In such a complex field as medicine it is more often than not the rule that several doctors have to work together. A Directive on radiation protection should only legislate on such a setup when it is a question of ensuring that the prescribers and the practitioners have adequate specialist knowledge and can take specialist action. Accordingly the Committee welcomes the fact that the responsibility for using radiation is delegated to the practitioner although with regard to the justification process the practitioner may have to liaise with the prescriber in accordance with Article 4(4) of the proposal.

3.5.1.2. However, the main purpose of this point is to specify that one specialist is basically responsible for the use of radiation rather than to divide up responsibility between various doctors. Accordingly, the term 'overall clinical responsibility` may give the wrong idea and should be replaced by 'responsibility`.

3.5.2. Article 6(2)

3.5.2.1. Article 6(2) stipulates that part of the work can be delegated, but only to persons who are authorized 'by the competent authorities` to work in specialist areas. The Committee thinks that for special areas of work (e.g. the work of medical technicians or medical physicists) it may make sense to require such an authorization, which guarantees adequate specialist knowledge. Generally, however, the only requirement should be 'appropriate training`.

This also tallies with the fact that for most of the specialist fields listed there are no corresponding authorization procedures in the Member States.

3.5.3. Article 6(3)

3.5.3.1. Something along the following lines should be added in a new Article 6(3): 'The Member States shall ensure that for exposures carried out on medico-legal, insurance or legal grounds, too, the question of who is responsible for the decision is clarified unequivocally.`

3.6. Article 7 - Training

3.6.1. Article (4)

3.6.1.1. Because of the importance of a proper indication for the overall number of radiological examinations and for their possible reduction, the Committee expressly welcomes the plan to give practitioners documents listing basic recommendations for the indication or contra-indication of radiodiagnostic measures in special, frequently recurring cases.

3.7. Article 10 - Special practices

3.7.1. Article 10(1)

3.7.1.1. Because of the special importance of radiation protection in cases where radiation is used on children, the Committee would like to propose changes to the text where there is a danger of misinterpretation. In the phrase 'routine paediatric medical exposures` the word 'routine` should not be used since it also has the meaning of 'unvarying - possibly requiring less attentiveness`, whereas here it is used to indicate a frequent as opposed to an occasional activity. Since this point expressly concerns not only work performed by paediatricians, the German term 'kinderaerztliche Expositionen` (exposures by paediatricians) should be replaced by 'Strahlenanwendungen an Kindern` (radiation applications on children). (This change does not concern the English text.)

3.7.1.2. In the same and the following paragraph very precise and special requirements are laid down for 'high dose techniques`. The Committee considers these requirements to be justified in the case of the two examples quoted (interventional radiology and computer-controlled tomography), but would like to have a general definition of the term.

3.7.2. Article 10(2)

3.7.2.1. By analogy with the previous point, allowance should be made in the German text for the fact that the majority of the examinations in question are not carried out by paediatricians but by other practitioners specializing in radiodiagnosis. Therefore, the text should read 'Strahlenanwendungen an Kindern` (radiation applications on children). (Again, this change does not concern the English text.)

3.8. Article 15 - Estimates of population doses

3.8.1. The reference should be to Article 3 instead of Article 2.

Done at Brussels, 29 May 1996.

The President

of the Economic and Social Committee

Carlos FERRER

() Directive of 15 July 1980, as amended by Directive 84/467/Euratom of 3 September 1984 - OJ No L 146, 17. 9. 1980, p. 1, and OJ No L 265, 5. 10. 1984, p. 4.

() OJ No L 265, 5. 10. 1984, p. 4.

() Directive of 14 June 1993 - OJ No L 169, 12. 7. 1993, p. 1.

() OJ No C 230, 8. 9. 1980, p. 1.

() OJ No C 245, 9. 9. 1993, p. 5.

() OJ No C 108, 19. 4. 1993, p. 48.