Radiation Protection Dosimetry Advance Access published April 12, 2015 Radiation Protection Dosimetry (2015), pp. 1–5
doi:10.1093/rpd/ncv031
EUROPEAN ACTIVITIES IN RADIATION PROTECTION IN MEDICINE Georgi Simeonov* European Commission DG ENER—D3 Radiation Protection, Office EUFO 04/4178, Luxembourg L-2920, Luxembourg *Corresponding author: [email protected]
LEGAL BASIS AND HISTORY OF THE EUROPEAN BASIC SAFETY STANDARDS (BSS) The treaty establishing the European Atomic Energy Community (Euratom)(1) is binding primary law for the 28 member states of the European Union (EU). Since its entry into force in 1958, the Euratom Treaty provides the foundations on which the European institutions and member states share their competencies responsibilities in the field of nuclear energy and radiation protection(2). Article 2 of the Treaty defines the main tasks of the Euratom Community including the establishment and implementation of uniform standards radiation protection of workers and the general public. Chapter III ‘Health and Safety’ of Euratom Treaty offers the legal framework for the establishment of the European Basic Safety Standards (BSS). According to Article 31 of the Euratom Treaty, the BSS are worked out by the European Commission (‘the Commission’, EC) after it has obtained the opinion of a group of independent scientific experts. The first European BSS were adopted in 1959 as Euratom secondary law and were regularly updated afterwards. The Euratom BSS have been supplemented by legislative acts in other areas, such as medical exposure,
protection of outside workers and shipment of radioactive waste. The Commission may issue other, not legally binding, documents that have different status in the hierarchy of EU instruments and include, for example, recommendations, communications and guidance. The European BSS and other legislation issued under Article 31 of Euratom Treaty have to be implemented into national legal systems of the EU Member States within legally established deadlines, normally 2–4 y after adoption. As a consequence, the current EU Member States’ national requirements for radiation protection in medicine are based on Euratom Directives from the 1990s, most notably the BSS Directive 96/29/ Euratom(3) and ‘Medical Exposure Directive’ 97/43/ Euratom (MED)(4). REVISION OF THE EUROPEAN BSS Decision to review and revise the 1990s European legislation in the field of radiation protection was taken circa 2005. The decision was motivated mainly by the ongoing, at that time, revision of the recommendations of the International Commission on Radiological Protection and had the objectives to (i) update the
# The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: [email protected]
Downloaded from http://rpd.oxfordjournals.org/ at CSU Fresno on July 19, 2015
The recently published Council Directive 2013/59/Euratom (‘new European Basic Safety Standards’, EU BSS) modernises and consolidates the European radiation protection legislation by taking into account the latest scientific knowledge, technological progress and experience with implementing the current legislation and by merging five existing Directives into a single piece of legislation. The new European BSS repeal previous European legislation on which the national systems for radiation protection in medicine of the 28 European Union (EU) Member States are based, including the 96/29/Euratom ‘BSS’ and the 97/43/ Euratom ‘Medical Exposure’ Directives. While most of the elements of the previous legislation have been kept, there are several legal changes that will have important influence over the regulation and practice in the field all over Europe—these include, among others: (i) strengthening the implementation of the justification principle and expanding it to medically exposed asymptomatic individuals, (ii) more attention to interventional radiology, (iii) new requirements for dose recording and reporting, (iv) increased role of the medical physics expert in imaging, (v) new set of requirements for preventing and following up on accidents and (vi) new set of requirements for procedures where radiological equipment is used on people for non-medical purposes (nonmedical imaging exposure). The EU Member States have to enforce the new EU BSS before January 2018 and bring into force the laws, regulations and administrative provisions necessary to comply with it. The European Commission has certain legal obligations and powers to verify the compliance of the national measures with the EU laws and, wherever necessary, issue recommendations to, or open infringement cases against, national governments. In order to ensure timely and coordinated implementation of the new European legal requirements for radiation protection, the Commission is launching several actions including promotion and dissemination activities, exchange and discussion fora and provision of guidance. These actions will be based on previous experiences and will rely on the results of recent and ongoing EU-funded projects. Important stakeholders including the Euratom Article 31 Group, the association of the Heads of European Radiological protection Competent Authorities (HERCA) and different European professional and specialty organisations will be involved.
G. SIMEONOV
legislation taking into account the advances in scientific knowledge, the technological developments and the experience with the implementation of current legislation and (ii) consolidate the European legislation for radiation protection by integrating five directives and one recommendation into a single revised European BSS. The actual revision process was followed by procedures of consultation, negotiations and formal adoption (Figure 1), which resulted in the adoption on 5 December 2013 of Council Directive 2013/59/ Euratom (‘new European BSS’)(5). The new European BSS repeal previous radiation protection legislation, including the European BSS from 1996 and the MED from 1997. RADIATION PROTECTION IN MEDICINE IN THE NEW EUROPEAN BSS
health screening and of biomedical research volunteers and carers and comforters. Current ‘medico-legal procedures’ are treated separately as part of the newly defined ‘non-medical imaging exposure’. The MED term ‘prescriber’ is now replaced by ‘referrer’ in order to strengthen the clinical responsibility of the radiological practitioner for justifying the choice of the right examination. There is a whole new set of definitions and requirements relating to the ‘medical physics expert’ (MPE), ‘radiation protection expert’ (RPE) and ‘radiation protection officer’ (RPO). ‘Interventional radiology’ (IR) is now defined and used in multiple requirements emphasising the growing significance of this type of procedures for radiation protection of patients and medical staff. Justification of medical exposure
The 1996 European BSS and the 1997 MED had already provided solid legal basis for radiation protection of patients and medical staff in Europe by, inter alia, introducing the principles of justification and optimisation, establishing distribution of radiation protection responsibilities and training requirements for medical staff, setting requirements for radiological equipment in use, etc. Nevertheless, the new European BSS introduce some changes in order to ensure integration of protection of patients, staff and the workers and to address experiences and developments from the past 10 y. The main changes are discussed in the following. Changes in definitions Medical exposure is now defined as exposure of patients resulting from their treatment, diagnosis or
New general provisions on transparency require information in relation to the justification of classes or types of practices to be made available to undertakings, workers, members of the public as well as patients and other individuals subject to medical exposure. Undertakings acquiring medical radiological equipment have to be provided with adequate information on the risk assessment for patients, and on the available elements of the clinical evaluation (as required by the Medical Devices Directive(6)). The new European BSS introduce new requirements in relation to exposure of asymptomatic individuals, which shall either be part of an approved health screening programme or shall require specific documented justification for that individual by the practitioner, in consultation with the referrer, following guidelines from relevant medical scientific societies and competent authorities.
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Figure 1. European Basic Safety Standards Directive development and adoption process.
EUROPEAN ACTIVITIES IN RADIATION PROTECTION IN MEDICINE
New requirements on information to patients specify that wherever practicable and prior to the exposure taking place, the practitioner or the referrer, as specified by the Member States, shall ensure that the patient or their representative is provided with adequate information relating to the benefits and risks associated with the radiation dose from the medical exposure. Special attention shall be paid to provision of information to asymptomatic individuals. Justification decisions regarding types or classes of practice involving medical exposure now have to take into account, where relevant, also the associated occupational and public exposures.
The requirements for optimisation of protection in radiodiagnostic procedures have been extended to IR and medical exposures for planning, guiding and verification purposes. The establishment and use of diagnostic reference levels (DRL) have now been made mandatory, and their regular review is required. DRL have also been extended to IR. Written protocols are now required not only for each equipment and for broadly defined procedures but also for ‘relevant categories of patients’. New requirement has been introduced with regard to radiotherapy where the delivery of the exposure to target volumes must be appropriately verified. Procedures Written protocols are now required not only for each equipment and for broadly defined procedures but also for ‘relevant categories of patients’. Patient exposure information has to be included in the report of the medical radiological procedure. A MPE has to be involved in procedures involving (relatively) high doses to patients, such as computed tomography (CT) or IR. The tasks of the MPE have been defined in much more detail in the new European BSS. Training and recognition The new European BSS define specific requirements to member states (national governments and competent authorities) to establish legal and administrative framework for education and training in radiation. This framework has to allow for the recognition of services and experts with radiation protection responsibilities, such as the RPE and MPE. Member states have to define national arrangements for recognition of MPE, RPE and other services and experts and to communicate them to the Commission,
Requirements to equipment in use The new European BSS abandon a previous requirement for avoiding unnecessary proliferation of radiological equipment, which was judged unenforceable and unnecessary. The directive strengthens the former requirements for image intensifiers and automatic exposure controls on fluoroscopy equipment. Equipment used for external beam radiotherapy with a nominal beam energy exceeding 1 MeV must have a device to verify key treatment parameters, with the possibility to exempt equipment installed prior to the directive’s transposition deadline (6 February 2018). The revised BSS directive introduces several requirements to IR and CTequipment regarding their capabilities to display relevant patient dose parameters during or after the procedure and to transfer this information to the examination record.
Accidental and unintended exposures The new European BSS define a whole new set of requirements on accidental and unintended medical exposures. The radiotherapy quality assurance programmes will include a study of risk of accidental or unintended exposures. The operators of diagnostic and therapeutic radiological equipment shall implement a registration and analysis system of events involving or potentially involving accidental or unintended medical exposures. The operators shall declare to the competent authorities the occurrence of significant events, as defined by the authorities, including the results of the investigation and the corrective measures to avoid such events in the future. The referring and the radiological medical practitioners as well as the patient shall be informed about clinically significant unintended or accidental exposures. Finally, member states shall put in place mechanisms for timely dissemination of information regarding lessons learned from significant events involving unintended or accidental medical exposures.
Population dose estimates The new European BSS introduce an explicit requirement to (where appropriate) take into account the age and gender distribution of the exposed population in the national estimates of population doses from radiodiagnostic procedures and IR.
Page 3 of 5
Downloaded from http://rpd.oxfordjournals.org/ at CSU Fresno on July 19, 2015
Optimisation of radiation protection in medical exposure
who should make this information available to all EU countries.
G. SIMEONOV
EUROPEAN BSS IMPLEMENTATION
underway, and preparations have started for a project in radiation protection in medicine.
Commission-funded projects
National implementation of the new European BSS The new Council Directive 2013/59/Euratom defines a deadline of 6 February 2018 by which the EU Member States must bring into force the laws, regulations and administrative provisions necessary to comply with its requirements. The Euratom treaty stipulates that the EU Member States shall communicate to the Commission draft transposing measures after they have been internally agreed but before being adopted. The Commission has the right to issue recommendations to the draft legal and administrative provisions within 3 months of their submission. The aforementioned legal provisions define a challenging schedule within which 28 national legal proposals have to be elaborated, submitted to the Commission, reviewed and some of them possibly revised. The Commission foresees a series of actions to facilitate this process and to ensure its successful completion within the legally defined deadlines. This will include an early establishment of contacts with the responsible competent authorities, collection and continuous update of information about the national implementation plans and activities and exchange of experiences between the EU countries. In more practical terms, the work will be organised as several projects for evaluation of national transposition and implementation of the revised European BSS, starting with a general survey and workshop in late 2014 or early 2015 and continuing with projects in different topical areas. The work on the general project is well
Stakeholder involvement Besides the Commission activities of supervising national transposition of the European law and the project funding provided to facilitate the implementation of legal requirements in practice, the Commission services are reflecting on their wider role of engaging in a stakeholder dialogue in order to galvanise action for improving radiation protection in medicine. The following represents a personal opinion regarding the main elements of European stakeholder engagement, which should be given due consideration in the near future. National competent authorities are directly responsible not only for the adoption of national legal requirements transposing the European legislation but also for their implementation in practice. Regulators should consider establishing an effective system for benchmarking of national implementation of the legal requirements for radiation protection of patients and medical staff, similar to the one established by the Western European Nuclear Regulators Association (WENRA) in other areas (http://www.wenra.org/). The medical use of radiation is characterised by rapid introduction into practice of new radiation-based techniques and technologies, often without enough knowledge of their radiation protection implications. This makes many of the issues in this area hard to resolve through ‘simple’ changes of practice and points to the need of research underpinning practical radiation protection. The European research community should consider radiation protection in medicine as a research topic deserving specific attention. Finally, the medical professionals referring to or applying ionising radiation have a very important role in ensuring that their patients and they are adequately protected. The Commission should work with the professional societies to raise the awareness of radiation protection among the concerned medical professionals.
REFERENCES 1. Treaty establishing the European Atomic Energy Community, consolidated version. Official Journal C-84 of 30 March 2010. 2. Kilb, W. The European Atomic Energy Community and its primary and secondary law. International Nuclear Law: History, Evolution and Outlook, OECD 2010, NEA No. 6934 3. Council Directive 96/29/Euratom of 13 May 1996, laying down basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation. Official Journal L-159 of 29 June 1996, 1. 4. Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of
Page 4 of 5
Downloaded from http://rpd.oxfordjournals.org/ at CSU Fresno on July 19, 2015
The Commission funds projects to support the implementation of the European legal requirements for radiation protection in medicine. The recently finalised, ongoing and planned for the near future projects are shortly described in the following. The Commission recently published Radiation Protection Reports (http://ec.europa.eu/energy/ nuclear/radiation_protection/publications_en.htm). RP174: European Guidelines on Medical Physics Expert, RP175: Guidelines on Radiation Protection Education and Training of Medical Professionals in the EU and RP178: Referral Guidelines for Medical Imaging—Availability and Use in the EU. Two more reports, study on population doses from medical exposure (http://ddmed.eu) and guidance on risk analysis of accidental and unintended exposures in radiotherapy (http://www.accirad.eu), will be published later this year. New Commission project on DRL for paediatric imaging (http://www.eurosafeimaging.org/pidrl) started in December 2013 under the leadership of the European Society of Radiology.
EUROPEAN ACTIVITIES IN RADIATION PROTECTION IN MEDICINE ionizing radiation in relation to medical exposure, and repealing Directive 84/466/EURATOM. Official Journal L-180 of 09 July 1997, 22. 5. Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/
Euratom, 96/29/Euratom, 97/43/Euratom and 2003/ 122/Euratom. Official Journal L-13 of 17 January 2014. 6. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Official Journal L-169 of 12 July 1993; amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007. Official Journal L-247 of 21 September 2007.
Downloaded from http://rpd.oxfordjournals.org/ at CSU Fresno on July 19, 2015
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doi:10.1093/rpd/ncv031
EUROPEAN ACTIVITIES IN RADIATION PROTECTION IN MEDICINE Georgi Simeonov* European Commission DG ENER—D3 Radiation Protection, Office EUFO 04/4178, Luxembourg L-2920, Luxembourg *Corresponding author: [email protected]
LEGAL BASIS AND HISTORY OF THE EUROPEAN BASIC SAFETY STANDARDS (BSS) The treaty establishing the European Atomic Energy Community (Euratom)(1) is binding primary law for the 28 member states of the European Union (EU). Since its entry into force in 1958, the Euratom Treaty provides the foundations on which the European institutions and member states share their competencies responsibilities in the field of nuclear energy and radiation protection(2). Article 2 of the Treaty defines the main tasks of the Euratom Community including the establishment and implementation of uniform standards radiation protection of workers and the general public. Chapter III ‘Health and Safety’ of Euratom Treaty offers the legal framework for the establishment of the European Basic Safety Standards (BSS). According to Article 31 of the Euratom Treaty, the BSS are worked out by the European Commission (‘the Commission’, EC) after it has obtained the opinion of a group of independent scientific experts. The first European BSS were adopted in 1959 as Euratom secondary law and were regularly updated afterwards. The Euratom BSS have been supplemented by legislative acts in other areas, such as medical exposure,
protection of outside workers and shipment of radioactive waste. The Commission may issue other, not legally binding, documents that have different status in the hierarchy of EU instruments and include, for example, recommendations, communications and guidance. The European BSS and other legislation issued under Article 31 of Euratom Treaty have to be implemented into national legal systems of the EU Member States within legally established deadlines, normally 2–4 y after adoption. As a consequence, the current EU Member States’ national requirements for radiation protection in medicine are based on Euratom Directives from the 1990s, most notably the BSS Directive 96/29/ Euratom(3) and ‘Medical Exposure Directive’ 97/43/ Euratom (MED)(4). REVISION OF THE EUROPEAN BSS Decision to review and revise the 1990s European legislation in the field of radiation protection was taken circa 2005. The decision was motivated mainly by the ongoing, at that time, revision of the recommendations of the International Commission on Radiological Protection and had the objectives to (i) update the
# The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: [email protected]
Downloaded from http://rpd.oxfordjournals.org/ at CSU Fresno on July 19, 2015
The recently published Council Directive 2013/59/Euratom (‘new European Basic Safety Standards’, EU BSS) modernises and consolidates the European radiation protection legislation by taking into account the latest scientific knowledge, technological progress and experience with implementing the current legislation and by merging five existing Directives into a single piece of legislation. The new European BSS repeal previous European legislation on which the national systems for radiation protection in medicine of the 28 European Union (EU) Member States are based, including the 96/29/Euratom ‘BSS’ and the 97/43/ Euratom ‘Medical Exposure’ Directives. While most of the elements of the previous legislation have been kept, there are several legal changes that will have important influence over the regulation and practice in the field all over Europe—these include, among others: (i) strengthening the implementation of the justification principle and expanding it to medically exposed asymptomatic individuals, (ii) more attention to interventional radiology, (iii) new requirements for dose recording and reporting, (iv) increased role of the medical physics expert in imaging, (v) new set of requirements for preventing and following up on accidents and (vi) new set of requirements for procedures where radiological equipment is used on people for non-medical purposes (nonmedical imaging exposure). The EU Member States have to enforce the new EU BSS before January 2018 and bring into force the laws, regulations and administrative provisions necessary to comply with it. The European Commission has certain legal obligations and powers to verify the compliance of the national measures with the EU laws and, wherever necessary, issue recommendations to, or open infringement cases against, national governments. In order to ensure timely and coordinated implementation of the new European legal requirements for radiation protection, the Commission is launching several actions including promotion and dissemination activities, exchange and discussion fora and provision of guidance. These actions will be based on previous experiences and will rely on the results of recent and ongoing EU-funded projects. Important stakeholders including the Euratom Article 31 Group, the association of the Heads of European Radiological protection Competent Authorities (HERCA) and different European professional and specialty organisations will be involved.
G. SIMEONOV
legislation taking into account the advances in scientific knowledge, the technological developments and the experience with the implementation of current legislation and (ii) consolidate the European legislation for radiation protection by integrating five directives and one recommendation into a single revised European BSS. The actual revision process was followed by procedures of consultation, negotiations and formal adoption (Figure 1), which resulted in the adoption on 5 December 2013 of Council Directive 2013/59/ Euratom (‘new European BSS’)(5). The new European BSS repeal previous radiation protection legislation, including the European BSS from 1996 and the MED from 1997. RADIATION PROTECTION IN MEDICINE IN THE NEW EUROPEAN BSS
health screening and of biomedical research volunteers and carers and comforters. Current ‘medico-legal procedures’ are treated separately as part of the newly defined ‘non-medical imaging exposure’. The MED term ‘prescriber’ is now replaced by ‘referrer’ in order to strengthen the clinical responsibility of the radiological practitioner for justifying the choice of the right examination. There is a whole new set of definitions and requirements relating to the ‘medical physics expert’ (MPE), ‘radiation protection expert’ (RPE) and ‘radiation protection officer’ (RPO). ‘Interventional radiology’ (IR) is now defined and used in multiple requirements emphasising the growing significance of this type of procedures for radiation protection of patients and medical staff. Justification of medical exposure
The 1996 European BSS and the 1997 MED had already provided solid legal basis for radiation protection of patients and medical staff in Europe by, inter alia, introducing the principles of justification and optimisation, establishing distribution of radiation protection responsibilities and training requirements for medical staff, setting requirements for radiological equipment in use, etc. Nevertheless, the new European BSS introduce some changes in order to ensure integration of protection of patients, staff and the workers and to address experiences and developments from the past 10 y. The main changes are discussed in the following. Changes in definitions Medical exposure is now defined as exposure of patients resulting from their treatment, diagnosis or
New general provisions on transparency require information in relation to the justification of classes or types of practices to be made available to undertakings, workers, members of the public as well as patients and other individuals subject to medical exposure. Undertakings acquiring medical radiological equipment have to be provided with adequate information on the risk assessment for patients, and on the available elements of the clinical evaluation (as required by the Medical Devices Directive(6)). The new European BSS introduce new requirements in relation to exposure of asymptomatic individuals, which shall either be part of an approved health screening programme or shall require specific documented justification for that individual by the practitioner, in consultation with the referrer, following guidelines from relevant medical scientific societies and competent authorities.
Page 2 of 5
Downloaded from http://rpd.oxfordjournals.org/ at CSU Fresno on July 19, 2015
Figure 1. European Basic Safety Standards Directive development and adoption process.
EUROPEAN ACTIVITIES IN RADIATION PROTECTION IN MEDICINE
New requirements on information to patients specify that wherever practicable and prior to the exposure taking place, the practitioner or the referrer, as specified by the Member States, shall ensure that the patient or their representative is provided with adequate information relating to the benefits and risks associated with the radiation dose from the medical exposure. Special attention shall be paid to provision of information to asymptomatic individuals. Justification decisions regarding types or classes of practice involving medical exposure now have to take into account, where relevant, also the associated occupational and public exposures.
The requirements for optimisation of protection in radiodiagnostic procedures have been extended to IR and medical exposures for planning, guiding and verification purposes. The establishment and use of diagnostic reference levels (DRL) have now been made mandatory, and their regular review is required. DRL have also been extended to IR. Written protocols are now required not only for each equipment and for broadly defined procedures but also for ‘relevant categories of patients’. New requirement has been introduced with regard to radiotherapy where the delivery of the exposure to target volumes must be appropriately verified. Procedures Written protocols are now required not only for each equipment and for broadly defined procedures but also for ‘relevant categories of patients’. Patient exposure information has to be included in the report of the medical radiological procedure. A MPE has to be involved in procedures involving (relatively) high doses to patients, such as computed tomography (CT) or IR. The tasks of the MPE have been defined in much more detail in the new European BSS. Training and recognition The new European BSS define specific requirements to member states (national governments and competent authorities) to establish legal and administrative framework for education and training in radiation. This framework has to allow for the recognition of services and experts with radiation protection responsibilities, such as the RPE and MPE. Member states have to define national arrangements for recognition of MPE, RPE and other services and experts and to communicate them to the Commission,
Requirements to equipment in use The new European BSS abandon a previous requirement for avoiding unnecessary proliferation of radiological equipment, which was judged unenforceable and unnecessary. The directive strengthens the former requirements for image intensifiers and automatic exposure controls on fluoroscopy equipment. Equipment used for external beam radiotherapy with a nominal beam energy exceeding 1 MeV must have a device to verify key treatment parameters, with the possibility to exempt equipment installed prior to the directive’s transposition deadline (6 February 2018). The revised BSS directive introduces several requirements to IR and CTequipment regarding their capabilities to display relevant patient dose parameters during or after the procedure and to transfer this information to the examination record.
Accidental and unintended exposures The new European BSS define a whole new set of requirements on accidental and unintended medical exposures. The radiotherapy quality assurance programmes will include a study of risk of accidental or unintended exposures. The operators of diagnostic and therapeutic radiological equipment shall implement a registration and analysis system of events involving or potentially involving accidental or unintended medical exposures. The operators shall declare to the competent authorities the occurrence of significant events, as defined by the authorities, including the results of the investigation and the corrective measures to avoid such events in the future. The referring and the radiological medical practitioners as well as the patient shall be informed about clinically significant unintended or accidental exposures. Finally, member states shall put in place mechanisms for timely dissemination of information regarding lessons learned from significant events involving unintended or accidental medical exposures.
Population dose estimates The new European BSS introduce an explicit requirement to (where appropriate) take into account the age and gender distribution of the exposed population in the national estimates of population doses from radiodiagnostic procedures and IR.
Page 3 of 5
Downloaded from http://rpd.oxfordjournals.org/ at CSU Fresno on July 19, 2015
Optimisation of radiation protection in medical exposure
who should make this information available to all EU countries.
G. SIMEONOV
EUROPEAN BSS IMPLEMENTATION
underway, and preparations have started for a project in radiation protection in medicine.
Commission-funded projects
National implementation of the new European BSS The new Council Directive 2013/59/Euratom defines a deadline of 6 February 2018 by which the EU Member States must bring into force the laws, regulations and administrative provisions necessary to comply with its requirements. The Euratom treaty stipulates that the EU Member States shall communicate to the Commission draft transposing measures after they have been internally agreed but before being adopted. The Commission has the right to issue recommendations to the draft legal and administrative provisions within 3 months of their submission. The aforementioned legal provisions define a challenging schedule within which 28 national legal proposals have to be elaborated, submitted to the Commission, reviewed and some of them possibly revised. The Commission foresees a series of actions to facilitate this process and to ensure its successful completion within the legally defined deadlines. This will include an early establishment of contacts with the responsible competent authorities, collection and continuous update of information about the national implementation plans and activities and exchange of experiences between the EU countries. In more practical terms, the work will be organised as several projects for evaluation of national transposition and implementation of the revised European BSS, starting with a general survey and workshop in late 2014 or early 2015 and continuing with projects in different topical areas. The work on the general project is well
Stakeholder involvement Besides the Commission activities of supervising national transposition of the European law and the project funding provided to facilitate the implementation of legal requirements in practice, the Commission services are reflecting on their wider role of engaging in a stakeholder dialogue in order to galvanise action for improving radiation protection in medicine. The following represents a personal opinion regarding the main elements of European stakeholder engagement, which should be given due consideration in the near future. National competent authorities are directly responsible not only for the adoption of national legal requirements transposing the European legislation but also for their implementation in practice. Regulators should consider establishing an effective system for benchmarking of national implementation of the legal requirements for radiation protection of patients and medical staff, similar to the one established by the Western European Nuclear Regulators Association (WENRA) in other areas (http://www.wenra.org/). The medical use of radiation is characterised by rapid introduction into practice of new radiation-based techniques and technologies, often without enough knowledge of their radiation protection implications. This makes many of the issues in this area hard to resolve through ‘simple’ changes of practice and points to the need of research underpinning practical radiation protection. The European research community should consider radiation protection in medicine as a research topic deserving specific attention. Finally, the medical professionals referring to or applying ionising radiation have a very important role in ensuring that their patients and they are adequately protected. The Commission should work with the professional societies to raise the awareness of radiation protection among the concerned medical professionals.
REFERENCES 1. Treaty establishing the European Atomic Energy Community, consolidated version. Official Journal C-84 of 30 March 2010. 2. Kilb, W. The European Atomic Energy Community and its primary and secondary law. International Nuclear Law: History, Evolution and Outlook, OECD 2010, NEA No. 6934 3. Council Directive 96/29/Euratom of 13 May 1996, laying down basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation. Official Journal L-159 of 29 June 1996, 1. 4. Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of
Page 4 of 5
Downloaded from http://rpd.oxfordjournals.org/ at CSU Fresno on July 19, 2015
The Commission funds projects to support the implementation of the European legal requirements for radiation protection in medicine. The recently finalised, ongoing and planned for the near future projects are shortly described in the following. The Commission recently published Radiation Protection Reports (http://ec.europa.eu/energy/ nuclear/radiation_protection/publications_en.htm). RP174: European Guidelines on Medical Physics Expert, RP175: Guidelines on Radiation Protection Education and Training of Medical Professionals in the EU and RP178: Referral Guidelines for Medical Imaging—Availability and Use in the EU. Two more reports, study on population doses from medical exposure (http://ddmed.eu) and guidance on risk analysis of accidental and unintended exposures in radiotherapy (http://www.accirad.eu), will be published later this year. New Commission project on DRL for paediatric imaging (http://www.eurosafeimaging.org/pidrl) started in December 2013 under the leadership of the European Society of Radiology.
EUROPEAN ACTIVITIES IN RADIATION PROTECTION IN MEDICINE ionizing radiation in relation to medical exposure, and repealing Directive 84/466/EURATOM. Official Journal L-180 of 09 July 1997, 22. 5. Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/
Euratom, 96/29/Euratom, 97/43/Euratom and 2003/ 122/Euratom. Official Journal L-13 of 17 January 2014. 6. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Official Journal L-169 of 12 July 1993; amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007. Official Journal L-247 of 21 September 2007.
Downloaded from http://rpd.oxfordjournals.org/ at CSU Fresno on July 19, 2015
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