REPORT on the proposal for a Council Directive on Health Protection of Individuals Against the Dangers of Ionizing Radiation in Relation to Medical Exposures, Replacing the Directive 84/466/Euratom (COM(96)0465 - C4-0548/96 - 96/0230 (CNS))

    18 April 1997

    Committee on the Environment, Public Health and Consumer Protection
    Rapporteur: Mr Amedeo Amadeo

    By letter of 21 October 1996, the Council consulted Parliament, pursuant to Article 31 of the Euratom Treaty on the proposal for a Council Directive on Health Protection of Individuals Against the Dangers of Ionizing Radiation in Relation to Medical Exposures, Replacing the Directive 84/466/Euratom.

    At the sitting of 23 October 1996 the President of Parliament announced that he had referred this proposal to the Committee on the Environment, Public Health and Consumer Protection as the committee responsible.

    At its meeting of 30 October 1996 the Committee on the Environment, Public Health and Consumer Protection appointed Mr Amadeo rapporteur.

    The committee considered the Commission proposal and the draft report at its meetings of 25 February and 16 April 1997.

    At the latter meeting it adopted the draft legislative resolution unanimously.

    The following took part in the vote : Collins, chairman; Poggiolini, Dybkjær and Lannoye, vicechairmen; Amadeo, rapporteur; Blokland, Bowe, Breyer, Cabrol, De Coene (for Needle), Flemming, Florenz, Garosci (for Leopardi), Graenitz, Grossetête, Hautala (for McKenna), Hulthén, Kokkola, Kronberger, Kuhn, Lange (for K. Jensen), Marinucci, Olsson, Oomen-Ruijten, Pollack, van Putten, Roth-Behrendt, Schleicher, Tamino, Trakatellis, Virgin and White.

    The report was tabled on 18 April 1997.

    The deadline for tabling amendments will be indicated in the draft agenda for the relevant part-session.

    A LEGISLATIVE PROPOSAL - DRAFT LEGISLATIVE RESOLUTION

    Proposal for a Council Directive on Health Protection of Individuals Against the Dangers of Ionizing Radiation in Relation to Medical Exposures, Replacing the Directive 84/466/Euratom (COM(96)0465 - C4-0548/96 - 96/0230 (CNS))

    The proposal is approved with the following amendments:

    Text proposed by the Commission(1)-----------------

    Amendments by Parliament-----------------

    (Amendment 1)

    Article 1

    This Directive lays down the general principles of the radiation protection of individuals undergoing medical exposures and associated practices involving ionizing radiation.The purpose of this Directive is to supplement Directive 80/836/Euratom on the basic safety standards as regards medical exposures.

    This Directive lays down the general principles of the radiation protection of individuals undergoing medical exposures and associated practices involving ionizing radiation.The purpose of this Directive is to supplement Directive 96/29/Euratom on the basic safety standards as regards medical exposures.

    (Amendment 2)

    Article 2, indent 'Potential exposures'

    Potential exposures: exposure with a probability of occurrence that can be estimated in advance for accidents and incidents, such as a failure of equipment, a misadministration, a human error or a computer failure;

    Potential exposures: exposure resulting from events such as equipment failure or faults, or a human error and with a probability of occurrence that can be assessed in advance;

    (1) OJ C 341, 13.11.1996, p.17

    (Amendment 3)

    Article 2, indent 'Medical Physicist'

    Medical Physicist: an expert in radiation physics applied to medical exposures whose training and competence to act is recognized by the competent authorities and who, as appropriate, gives advice on patient dosimetry, on the development and use of complex techniques and equipment and on optimization, on quality assurance, including quality control, and on matters relating to radiation protection as defined in Article 3, as appropriate. This expert might also give advice on radiation protection aspects as regards workers and the public;

    Medical Physicist: an expert in radiation physics applied to medical exposures whose training and competence to act is recognized by the competent authorities and who, as appropriate, gives advice on patient dosimetry, on the development and use of complex techniques and equipment and on optimization, on quality assurance, including quality control, and on matters relating to radiation protection as defined in Article 3, as appropriate.

    (Amendment 4)

    Article 2, indent 'Quality Assurance'

    Quality Assurance: all those planned and systematic actions necessary to provide adequate confidence that a structure, system or component will perform satisfactorily in service. Satisfactory performance in service implies the optimum quality of the entire procedure. In the case of radiodiagnostic procedure, the consistent production of adequate diagnostic information with minimum exposure of both patients and personnel. In the case of a radiotherapeutic procedure optimum exposure of patients and minimum exposure of personnel;

    Quality Assurance: all those planned and systematic actions necessary to provide adequate confidence that a structure, system or component will perform satisfactorily in service. Satisfactory performance in service implies the optimum quality of the entire procedure.By optimum quality is meant:(a) in the case of radiodiagnostic procedure, the consistent production of adequate diagnostic information with minimum exposure of patients and optimum exposure of workers;(b) in the case of radiotherapeutic procedure, the optimum exposure of patients and workers;

    (Amendment 5)

    Article 4(1), second subparagraph

    The prescriber and the practitioner will always check if previous diagnostic information or medical records relevant to the planned exposure are available and consult these data to avoid unnecessary examinations.

    The prescriber and the examining doctor shall be involved in the process of justification, taking specific responsibility in accordance with the provisions laid down by the Member State.

    (Amendment 6)

    Article 4(1)a (new)

    Every radiological unit must have the possibility of consulting a medical physicist for the necessary advice on the exposure.

    (Amendment 7)

    Article 4(4)

    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.

    Avoid 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.

    (Amendment 8)

    Article 5(4)a (new)

    Member States shall adopt measures to ensure that equipment and installations which do not meet predetermined acceptability criteria are taken out of service or replaced.

    (Amendment 9)

    Article 5(5)

    In radiotherapeutic practices, a medical physicist shall be closely involved. In diagnostic nuclear medicine practices, a medical physicist shall be involved as appropriate. For other radiodiagnostic practices, a medical physicist shall be available for consultation on optimization and quality assurance, including quality control, as appropriate, and also to give advice on matters relating to radiation protection concerning medical exposures, as required.

    In radiotherapeutic practices, a medical physicist shall be closely involved. In diagnostic nuclear medicine practices, a medical physicist shall be involved as appropriate. The medical physicist must check any work done on the equipment used for radiotherapy. For other radiodiagnostic practices, a medical physicist shall be available for consultation on optimization and quality assurance, including quality control, as appropriate, and also to give advice on matters relating to radiation protection concerning medical exposures, as required. The medical physicist will also check the suitability of the equipment on the basis of the exposure/diagnostic benefit ratio, laying down maximum and minimum reference criteria to be respected.

    (Amendment 10)

    Article 10(1) third indent a (new)

    - exposure for therapeutic purposes

    (Amendment 11)

    Article 11(2)

    If pregnancy cannot be excluded, depending on the type of medical exposures, special attention shall be given to the justification, particularly the urgency, and to the optimization of the medical exposure both for the mother and the unborn child.

    If pregnancy cannot be excluded, and unless the health of the woman will be seriously affected, medical exposure involving in particular the pelvic and abdominal regions shall be avoided.

    (Amendment 12)

    Article 13(2)

    In the case of a patient undergoing a treatment with radionuclides Member States shall ensure that the practitioner provides the patient or legal guardian, before leaving the hospital or clinic, with written instructions as appropriate on the reduction of doses to persons in contact with the patient and with information on the risks of ionizing radiation.

    In the case of a patient undergoing a treatment with radionuclides Member States shall ensure that the examining doctor provides the patient or legal guardian, before leaving the hospital or clinic, with written instructions as appropriate on the reduction of doses to persons in contact with the patient and with information on the risks of ionizing radiation.

    Legislative resolution embodying Parliament's opinion on the Proposal for a Council Directive on Health Protection of Individuals Against the Dangers of Ionizing Radiation in Relation to Medical Exposures, Replacing the Directive 84/466/Euratom (COM(96)0465 - C4-0548/96 - 96/0230 (CNS))

    (Consultation procedure)

    The European Parliament,

    - having regard to the Commission proposal to the Council, COM(96)0465 - 96/0230 (CNS)[1],

    - having been consulted by the Council pursuant to Article 31 of the Euratom Treaty (C4-0548/96),

    - having regard to Rule 58 of its Rules of Procedure,

    - having regard to the report of the Committee on the Environment, Public Health and Consumer Protection (A4-0146/97),

    1. Approves the Commission proposal, subject to Parliament's amendments ;

    2. Calls on the Commission to alter its proposal accordingly, pursuant to Article 189a(2) of the EC Treaty ;

    3. Calls on the Council to notify the Parliament should it intend to depart from the text approved by Parliament ;

    4. Asks to be consulted again should the Council intend to make substantial modifications to the Commission proposal ;

    5. Instructs its President to forward this opinion to the Council and Commission.

    • [1] OJ C 341, 13.11.1996, p.17

    B EXPLANATORY STATEMENT

    I. BACKGROUND

    1. A number of directives exist on protection against radiation. Article 2 (b) of the Euratom Treaty provides for the existence within the European Community of uniform basic standards to protect the health of workers and the public in general from the dangers of ionizing radiation. A directive covering these standards was in fact first adopted in 1959 and has been subject to a number of subsequent amendments. The most recent revision of the Basic Safety Standards Directive (96/29/EURATOM) was adopted by the Council in 1996. However, this directive and its predecessors do not deal with radiation protection during medical exposures.

    2. In 1984 the Council adopted Directive 84/46/EURATOM Laying Down Basic Measures for the Radiation Protection of Persons Undergoing Medical Examination or Treatment. This was intended to complement the directive on basic safety standards for workers and the general public; 84/466 presented basic measures aimed at improving the radiation protection of patients while at the same time not losing sight of the potential benefits (early recognition, diagnosis or therapy) of the use of radiation.

    3. The Commission feels it is necessary to update the earlier directive for a number of reasons:

    - since the original directive came into force over a dozen years ago, there has been a huge increase in incidences of medical exposures in the course of examination or treatment ;

    - there have been significant advances in scientific knowledge and technology ;

    - with the coming into force of the Treaty of European Union, the new articles 3(o), and 129 in particular, gave the Community a specific competence for public health. Article 129 speaks of the Community's role in "ensuring a high level of human health protection" and says that health protection requirements are to form "a constituent part of the Community's other policies" ;

    - a number of international bodies have issued updated recommendations covering all aspects of radiation protection including medical exposures.

    4. The changes proposed by the Commission

    A number of changes are proposed in the text, the main ones being :

    - a whole new section (Article 2) is introduced defining the terms used in the directive;

    - the scope of the directive has been set out much more clearly, to include specific references to medical exposure of individuals in the course of medico-legal insurance or legal procedures and to the exposure of volunteers in medical and biomedical research programmes ;

    - the provisions covering justification and optimisation to medical exposures are expanded and set out much more clearly ;

    - although, as in the earlier directive, use of ionizing radiation may only be effected under the responsibility of a practitioner (defined in Article 2 as "a medical doctor, dentist or other health professional, who is entitled to take overall clinical responsibility for individual medical exposures in accordance with national legislation"), practical aspects may be delegated to other individuals authorized by the competent (national) authorities ;

    - the original requirements concerning the quality control of installations are now expanded to include the establishment of quality assurance programmes including assessments of patient doses ;

    Member States are made responsible for auditing the implementation of the requirements of the directive ;

    - there are specific references relating to handling medical exposures of pregnant and breastfeeding women, those helping or accompanying patients undergoing diagnosis or treatment, and volunteers.

    Opinion of rapporteur

    It is now only a few years to the third millennium and the European Council must promote the adoption of Community action programmes on safety in the context of personal safety.

    Protection of the health of individuals against the dangers of ionizing radiation in relation to medical exposure is particularly important in this connection.

    It has to be borne in mind that although radiological diagnosis provides undoubted benefits from preventive examinations aimed at early diagnosis, the increasingly frequent use of radiological methods of diagnosis has disadvantages for individuals because of the harmful effects of the radiation.

    Growing public awareness in all Community countries also presents a challenge in this sector. There is ever-increasing pressure for high levels of information, education and health training to be available to the individual citizen, the health professional, technico-professional or commercial operator in the sector, managers in charge of health services or institutions, authorities responsible for small and large communities, demanding increasing levels of responsibility. The message is obvious:

    - reduce necessary medical radiation by using alternative methods, even if they cost more ;

    - eliminate radiation for unnecessary examinations ;

    - protect workers and the population against radiation in general by taking wide-ranging initiatives.

    Guaranteeing the quality of life means taking the necessary initiatives in planning, organization, management and control to ensure complete protection for the individual against the dangers of radiation, in particular that resulting from medical exposure.

    These are the reasons underlying this proposal for a directive, which, although it has come late is designed to ensure implementation of these worthy principles to benefit mankind by the year 2000.

    In conclusion, the rapporteur welcomes the Commission's proposal as a practical response to the increased use of ionizing radiations in medical practice, in the dozen or so years since the coming into force of Directive 84/466 EURATOM, and as a response to scientific and technical progress in this area. The rapporteur also wishes to point out that the definition of 'practitioner' may cause serious misunderstanding since it could mean a non-specific individual, not therefore qualified to use radiological instruments. On the basis of the above comments, your rapporteur has tabled a number of amendments.