Dr. Tony Holohan:

I accept full responsibility for that. I am joined this morning by Audrey Hagerty, principal officer, food and environmental health unit, and Siobhán McEvoy, chief environmental health officer.

I thank the Chairman and the committee for the opportunity to address them on Council Directive 2013/59/EURATOM, also known as the basic safety standards directive. There will be many acronyms and if there are any the committee needs me to clarify I am happy to do so. I am pleased to address the committee alongside the faculty of radiologists of the RCSI, which is the pre-eminent medical body to speak authoritatively on the subject of radiation, radiation exposure and its use. I hope to provide the committee with an overview of the directive and the approach being taken by the Department in its transposition with regard to the designation of referrers and practitioners. That is the medical chapter of the directive.

Overall responsibility for the directive rests with the Department of Communications, Climate Action and Environment. The Department of Health is transposing the medical provisions in the directive into Irish law by way of a statutory instrument that will repeal the existing SI 478 of the 2002 European Communities (Medical lonising Radiation Protection) Regulations 2002 and its amendments.

The directive is essential legislation the purpose of which is to protect the public, patients, workers and others from all forms of ionising radiation. lonising radiation has many beneficial applications, particularly in healthcare. However, as the use of ionising radiation increases, so does the potential for health hazards if not properly used or contained. According to the European Commission, medical procedures are the largest man-made source of radiation exposure of the population. It states that when a medical procedure is initiated and conducted appropriately all medical benefits it provides outweigh the risk associated with the radiation exposure. Without appropriate precautions, however, patients may be exposed to radiation without real clinical need or benefit, resulting in potential real harm for individual patients. There is a public health risk if there is a proliferation of radiation facilities and an unjustified increase in the use of ionising radiation. The directive enhances and strengthens a number of concepts in radiological protection including enhanced justification requirements; it places an increased emphasis on the provision of information on the risks relating to radiation exposure and capturing and reporting on individual patient doses; provisions relating to accidental and unintended consequences are also strengthened.

In transposing the medical provisions of the directive, the Department of Health sought the advice of the HSE's medical exposure radiation unit, MERU, and a group it established to inform the transposition process. The HSE is the competent authority and regulator in respect of the existing regulations, which will change after the transposition. The Department also worked with the Health Information and Quality Authority, HIQA, which will be the competent authority in the new regulations, the Department of Communications, Climate Action and Environment and the basic safety standards directive steering group which comprises the two Departments, HIQA and the Environmental Protection Agency, EPA, which is the empowered agency under the Department of Communications, Climate Action and Environment. It engaged with several professional bodies and other groups.

The directive is quite prescriptive and there are only certain provisions where member states have discretion in its transposition. In order to garner information and views on the provisions where Ireland had discretion, the Department conducted a consultation exercise in June 2017. It posted the consultation on its website and notified likely stakeholders. It also sought the assistance of the EPA, which issues licences for the custody and use of ionising radiation equipment, to contact all licence holders to notify them of the consultation process.

The designation of referrers and practitioners for the purposes of medical exposures to ionising radiation is one area where member states have discretion, reflecting the subsidiarity in respect of organisation of health services at national level. The directive defines referrers and practitioners with certain roles and responsibilities attaching to same; member states are required to designate health professionals as appropriate. In the definition of the directive and transposed in our proposed regulations, a "referrer" is a health professional who is entitled to refer individuals for medical radiological procedures to a practitioner and a" practitioner" is a health professional who is entitled to take clinical responsibility for an individual medical exposure.

For the purposes of transposing the directive, my advice has been that we proceed on the basis that nurses, doctors, dentists and radiographers be designated as appropriate. The Department sought the advice of the MERU group on the designations and had regard to the consultation inputs. Several representations have been made to the Department, including from chiropractors, requesting that groups not previously designated be considered to be designated in the new regulations. It is imperative that the directive is transposed as soon as possible to provide clarity and certainty to the system generally and to provide the best safety protections to people who need to avail of medical radiological procedures. It is also required to enable HIQA assume its responsibilities as competent authority. The Department is working to finalise the transposing regulations in the coming weeks. I am happy to take any questions the Chairman or the committee have about this.