Michael Harty (Clare, Independent)
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In this third session, we are meeting officials from the Department of Health and representatives from the faculty of radiologists at the Royal College of Surgeons in Ireland, RCSI, to discuss their views of the impact on chiropractors of the transposition of Council Directive 2013/59/EURATOM laying down basic standards for protection from the dangers arising from exposure to ionised radiation. On behalf of the committee, I welcome Dr. Tony Holohan, chief medical officer, Ms. Audrey Hagerty, principal officer, environmental health unit, and Ms. Siobhan McEvoy, chief environmental health officer, from Department of Health, and Dr. Paddy Gilligan, Dr. Niall Sheehy and Dr. John Feeney from the faculty of radiologists at the RCSI.

I draw the attention of witnesses to the fact that by virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of their evidence to the committee. However, if they are directed by the committee to cease giving evidence on a particular matter and they continue to so do, they are entitled thereafter only to a qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person, persons or entity by name or in such a way as to make him, her or it identifiable. I also advise them that any opening statements they have made to the committee may be published on the committee's website after this meeting. Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person or persons outside the House or an official either by name or in such a way as to make him or her identifiable.

I invite Dr. Holohan to make his opening statement. We did not receive the opening statement until this morning. Perhaps Dr. Holohan might keep that in mind for future occasions.

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.

Michael Harty (Clare, Independent)
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I thank Dr. Holohan and invite Dr. Sheehy to make his opening statement.

Dr. Niall Sheehy:

I thank the committee for inviting us to attend. The faculty of radiologists is the professional training body responsible for the training of radiologists and radiation oncologists in Ireland. Our members are medical doctors who have pursued specialist training of at least five years' duration following their medical degrees, are deemed competent via a series of examinations and assessments and are ultimately included on the specialist register of the Medical Council.

We are concerned with the safe and appropriate use of radiation in medicine to accurately diagnose and treat patients. We hold positions on national and European committees that are concerned with radiation protection. We stay abreast of technological developments to ensure we are practising to current international standards to deliver the safest care to patients in Ireland. We must participate in continuing professional development, quality improvement and audit to maintain our registration with the Medical Council.

Radiologists and radiation oncologists meet the definition of "practitioner" in the new basic safety standards legislation and oversee approximately 2 million examinations per year in this country. We work alongside non-radiologist doctors, radiographers, medical physicists and nurses to ensure that radiation doses delivered to patients are as low as possible. This is known as optimisation. Patients are sent to us for radiologic investigation by medical doctors or nurse referrers for radiologic investigation. These are known as referrers. We perform the study if we believe the request to be necessary and appropriate on the basis of referral criteria. This is known as justification. In some cases, we may decide that the risk to the patient does not justify the exposure to radiation and we suggest an alternative investigation. Even at low doses, radiation carries with it a theoretical risk of inducing cancer. All the professionals we have described are registered members of organisations in this State that demonstrate commitment to training and accreditation. They participate with radiologists in hospital radiation safety committees and in research and audit. The recent development of the nurse referrer role is an appropriate model for how to incorporate a new regulated allied health professional into the radiology process. The training of nurse referrers includes the principles of radiation safety and referral. Their practice is audited by local implementation groups.

The committee is focusing its attention on whether chiropractors should be included in the legislation as referrers or practitioners. When compared with the trained and regulated healthcare professionals previously described, we have found no substantive evidence of appropriate training, referral criteria, audit or accountability in published literature from the Irish chiropractic community. We have no knowledge that the criteria and standards set out as basic in the directive by the European Commission are being met. We would not regard the self-audit of 2011 as evidence of such. While we are aware that some chiropractors are practising in a manner that is comparable to referrers and practitioners, this practice is outside the current legislation. There is no current legal basis for chiropractors to act as practitioners. This practice has only been maintained because the current legislation has no enforcement provision. Some radiology departments have performed radiology examinations on chiropractor patients. In such cases, radiologists have judged that the clinical circumstances for radiographic exposure are appropriate and have taken on the onus of becoming the patients' referrer, which is allowed for under the current law. It is important to understand that the chiropractor is not being considered to be a referrer. The radiologist is obliged to follow up the patient if significant findings are detected and further medical treatment is required.

The faculty of radiologists is of the opinion that when people operate outside the law, they make it difficult for those of us who operate within the law to compete for radiation safety resources and equipment, to motivate training of workers and to promote best practices. The faculty of radiologists regards the oversight of a regulated medical or dental practitioner as essential in ensuring patient safety. We regard any system of radiation protection as incomplete without clinical governance structures, appropriate training and audit. We fully support the Minister's position that such basic safety standards are available for Irish patients, as demanded by EU Council Directive 2013/59/EURATOM. These standards were first incorporated after the directive in 1997 and legislated for in 2002. The new directive raises the bar on such requirements. People who did not meet the standards and operated outside the law in 2002 are not likely to meet the higher standards of the new legislation. We regard the provision for enforcement by the independent regulator, HIQA, as the major difference in the new legislation, which the faculty of radiologists wholeheartedly welcomes.

Michael Harty (Clare, Independent)
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The first three members from whom I will take questions are Deputies O'Reilly and Durkan and Senator Colm Burke.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I thank our witnesses for the evidence they have given. I might not be able to wait for answers after I have asked my questions because I am supposed to be somewhere else. I apologise in advance if I have to leave. I will be able to catch up on the answers that are given. My first question is a fairly basic one. We heard from representatives of the Chiropractic Association of Ireland just before the current group of witnesses came before us. They advised us in fairly plain language that they are more than willing to be bound by any regulations that are deemed necessary. They told us they would have no difficulty complying with any standards that the Department or the RCSI might want to set out. They said they would have no difficulty moving away from the current model of self-regulation. They have assured us that it is a fairly robust model. They held their hands up and fully accepted that there may be a need for further regulation. As someone who represented workers for a long time, I can assure the committee that it is rare enough for a group like this to embrace regulation. Dr. Holohan might agree that the opposite is generally the case. People do not usually embrace regulation as wholeheartedly as the chiropractors have indicated they are willing to do. Could the witnesses comment on that?

Dr. Sheehy referred to a lack of evidence of appropriate training. The chiropractors would cite the example of someone who is trained to a certain level and is practising in Dundalk. If the rules change, he or she might not be able to practice here but will be able to go 10 miles up the road to practice in Newry under the same regulations. It seems to me that this is something of a discrepancy, given that we are talking about an actual individual who could practice in both jurisdictions. The regulations are not different. The same EURATOM regulation applies. I ask the witnesses to explain their position in that context. I understand that the training received by chiropractors meets the 2014 education guidelines of the International Commission on Radiological Protection. Maybe the witnesses have an alternative view. They might advise us of that. I am aware that chiropractors use the iRefer guidelines. I am not a professional in this area. As I understand it, those guidelines are considered to be an industry standard.

I know the association has written to the Minister and is patiently awaiting a reply. I appreciate that the Minister is busy and that is fine. Dr. Holohan might be able to advise us on the status of that correspondence.

My final question relates to the national radiation safety committee. Obviously, this is all about ensuring that patients are as safe as they absolutely can be. I understand that the committee will sign off on any legislation that will have to be transposed. I am not quite sure exactly what its role is, how it is constituted or what its status is at the moment. I understand it was dissolved, perhaps not fully, before being reconstituted but I am not clear on that. Given that we are here to discuss issues of patient safety, it would helpful if we could receive some advice in that respect. I am informed that the national radiation safety committee will be considering issues relating to the impact of the transposition. If this process is not finalised, what exactly will the committee be considering? Will it be considering the final draft? What is the status of its role in this process?

Bernard Durkan (Kildare North, Fine Gael)
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I welcome our witnesses. Prior to this, did the HSE expert group that studied the need for this directive express a particular preference or antipathy, for want of a better description, towards the use of other practitioners or the access of other practitioners to X-rays and referrals? Where and from whom did the original request in relation to this directive come? Did it come from Europe? Did it come from a particular country in Europe? Did it come from this country? It seems to me from my experience with the Joint Committee on European Union Affairs that most directives usually originate back home and do the circuit before they come back. This allows us to blame Europe for introducing something for which we had devolved responsibility to Europe, or which we had approved. I do not want to put any of the members of the committee or of the HSE expert group on the spot, but I would like to know whether any of them has ever had to seek the assistance of a chiropractor.

The witnesses have had complaints lodged with them, with the Health Information and Quality Authority or others regarding use of X-ray equipment and the extent of the use of X-rays by chiropractors. Have they ever had complaints made against general practitioners in the HSE for either the excessive use of X-ray services or the reading of X-rays? Have they received complaints regarding the ability of existing practitioners covered by the directive and by all the regulations? I recall at least one case not very long ago with respect to which there were very considerable reservations about the reading of X-rays. It must be fresh in all our minds. I would like a response to that question.

Have the witnesses received complaints from rival practitioners? I ask that in the broadest sense. Our competitors, even in politics, always keep us on our toes. Sometimes complaints are made by competitors as to the extent to which one does or does not do his or her job, as the case may be. What is the extent, if any, to which complaints have been made by competing practitioners?

My final point relates to HIQA. Some of us have had concerns about the extent to which HIQA, in the past, has applied rules and regulations in certain areas, which I do not propose to go into now. Dr. Holohan will be familiar with them, particularly regarding accommodation for elderly people in nursing homes, etc. I would not necessarily always agree with the conclusions HIQA reached. I am not a practitioner but neither are those in HIQA. That is the extent of my questions although I may come back in at a later stage.

Michael Harty (Clare, Independent)
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I call Senator Colm Burke.

Colm Burke (Fine Gael)
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I thank the witnesses for their presentations and for the work they do. Sometimes we have medical practitioners before the committee and we do not acknowledge their work and the contribution they make to our healthcare sector. It is important that we do so.

We heard from the representatives of the Chiropractic Association of Ireland earlier this morning. One of my questions related to insurance, which is a big issue that has been on my desk for quite a while. In fairness, the regulation covering medical practitioners is in place and it provides that every medical practitioner must have insurance. I introduced a Private Members' Bill in 2012, which was eventually adopted by the Department and has now gone through the whole process. The representatives of the chiropractors advised us this morning that every one of their members has professional indemnity insurance. We are talking about 130 practitioners who are providing a service to the public. They are saying they are regulated in the sense of it being within their own organisation and profession to such an extent that each member has professional indemnity insurance. I am concerned that they are being excluded from a regulation, which makes sure that the standard they have set themselves is maintained.

If they are delivering a high level of service, and some of them are providing an X-ray service, have radiologists come across litigation involving chiropractors where professional radiologists had to give evidence in such cases? If that has not occurred, why can we not incorporate them in the regulation? We are talking about a very small number of practitioners.

Chiropractors will be prevented from making referrals. The witnesses have said that where medical practitioners refer people to radiologists for X-rays, the radiologist reviews whether the X-ray is necessary. If chiropractors refer people for X-rays, what is the concern about regulating them in the sense that they are referring people to professionals who can review and decide whether it is appropriate that an X-ray should be carried out? A radiologist would sign off on that and if the radiologist is happy that it is a reasonable request, what is the concern about including chiropractors in the regulation? That is an important question. We are talking about 130 practitioners in total and about 11 who provide radiology services. It is a very small number. With respect to the 11 practitioners who provide radiology services, we all know that radiology equipment costs a huge amount of money. It is a matter of whether we will now have 11 practitioners who will no longer be able to use very good equipment and it will simply be parked. We are not talking about hundreds of practitioners but about a very small group and about including them in the regulation.

Michael Harty (Clare, Independent)
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To complete the questions, a representative of the chiropractors stated that in 2002 the Department of Health undertook to include chiropractors under the remit of the current regulations by creating a register of chiropractors competent to take and refer X-rays but this work was not completed by the Department. Dr. Holohan might comment on what the problem was in that regard.

Is there a commitment in the Department to the setting up of a regulatory body for chiropractors? Is there an impasse, a commitment or a problem in that respect?. Why is that not happening? We heard from a representative of the chiropractors that even though there are 130 in the country, they order about 4,000 X-rays a year, which is a fraction of the total number of X-rays. Therefore, it is not a huge issue. Obviously it needs to be regulated but it is not a large number of X-rays from a body which is highly motivated and highly skilled. Perhaps Dr. Holohan might answer those questions.

Dr. Tony Holohan:

I thank the Chairman and the members for their questions. I will work my way through the questions one by one if that is in order. I am happy for colleagues from the faculty to interject as they see fit in terms of what I say and some of the questions that would have been referenced to them. I always have the challenge of reading my writing with respect to the questions raised.

First, regarding the lack of evidence that Deputy O'Reilly raised around appropriate training, the reality is that we have no understanding of training arrangements for chiropractors in this country. They are not part of either the formal healthcare system or, to my knowledge, the formal education system. We are reliant on the statements they have made in that we have no means, or otherwise, of validating it. The reality is that they have not been part of our healthcare system. We have no issue at all with chiropractors, either as individuals or as a collective, but it has never been the case in our healthcare system that they have formed part of what we might call our formal healthcare system. We understand that we differ in that respect from the UK. I cannot honestly advise what the policy basis was for the decision to include them in the UK. I simply know that what was said is true in regard to its standing in the UK. That is not the case throughout most of Europe and most other European countries are in line with the situation here. Many of the points made and the questions raised here, and some of the evidence that was given earlier, to my mind relates as much to the existential nature of chiropracty as part of a formal healthcare system as much as to the specific question to which the committee is giving consideration. During the length of time I have sat on the management team of the Department of Health, which has been quite a number of years at this stage, this question has never arisen.

There was some consideration in the very early 2000s, of which some members may be aware, to the broad question of the inclusion, or otherwise, of a variety of different practitioners, who are not part of the formal healthcare system of regulation. Nothing was advanced in that regard. I cannot honestly recall what the nature of the consideration was around that question. The members might recall that it was part of a commitment, if I remember rightly and I have not read it in recent days, in Quality and Fairness, a health strategy that was published in 2001, but nothing was done to advance that case in specific terms to broaden the system of regulation. Our regulatory function in the Department has been focused on two broad areas in more recent times. One is strengthening the basis of regulation of a variety of practitioners who were already regulated.

The latter include the medical profession, the nursing profession, pharmacy and others where a number of different reforms including lay majorities and others have been introduced, with more public hearings, more differentiation between fitness to practice and poor performance and a range of things of that nature. There is a second strategic intention, which is to broaden the number of practitioners who would be the subject of regulation and those who are part of a formal healthcare system. That is the work which is under way under the Health and Social Care Professionals Council, CORU. The council is working its way through 14 different groupings, each of which would be the subject of a separate system of regulation and specification. None of that architecture or apparatus exists as part of our healthcare system. While I am not saying that we would not, we do not have any plan or proposal to look at that with regard to chiropractic. That is a statement of policy as is in the Department.

I have no knowledge of the iRefer guidelines to which Deputy O'Reilly referred. That is the first I have heard of such a thing. I am not in any sense casting any aspersion on those guidelines. I have never heard of them and do not know what they are. We will be back in touch on the matter and will respond to the correspondence shortly. The Deputy asked a question about the nature of the radiation safety committee. It will stay in existence until the directive comes into force and new arrangements apply. The HSE has, de facto, been carrying out competent authority functions which it is not effectively empowered to carry out and there is not an appropriate separation of powers between provider and regulator. The committee may be aware of this being a finding of the inspection done by the International Atomic Energy Agency in 2015 when it made some negative findings about arrangements here, including that, that there was not separation between the provider and regulatory function. We set out the plan that we had at this point to transpose this directive. We are doing this in our system of licensing, which members may be aware will be before them for pre-legislative scrutiny in the near future. We published the heads of that before Christmas. Each of these might provide a mechanism for us to strengthen the oversight and regulation that would apply in this area. The International Atomic Energy Agency endorsed that strategic direction for how we would propose to respond to the negative findings made at that time. This work is part of us finalising some of our obligations in that regard.

On Deputy Durkan's question about where this originated, it is a process of strengthening and consolidating a set of regulations and updating those that were previously in existence. That is my best understanding, as opposed to it being something that had a specific origin in a specific member state. It is part of a set of obligations that we now have, shared with the rest of Europe. We did not have any different role other than that we may have participated, as a number of experts from this country do, in the development of that kind of knowledge and capacity at a European level. That is what it would have emerged from. On the question of complaints, I am not aware that we have ever received a complaint about a chiropractor or, indeed, a GP regarding the conduct of an X-ray. I am open to correction on that but I do not recall ever hearing of one. The Department is not a complaint-----

Dr. Paddy Gilligan:

There was one case for the board of the Radiological Protection Institute of Ireland, RPII.

Dr. Tony Holohan:

I thank Dr. Gilligan. I am always happy to be corrected.

Dr. Paddy Gilligan:

There was a case and prosecution in 2010 that came to the RPII.

Bernard Durkan (Kildare North, Fine Gael)
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Where was it?

Dr. Paddy Gilligan:

It was in Ballina District Court, based on a visit to the RPII, for non-possession of a licence.

Bernard Durkan (Kildare North, Fine Gael)
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Non-possession of a licence. From whom did it come?

Dr. Paddy Gilligan:

The RPII prosecuted it. That was a case of not having a licence.

Dr. Tony Holohan:

I do not recall ever hearing of a complaint regarding the sort of thing that the Deputy indicated, without putting words in his mouth, such as a patient's experience of care provided by a GP. I am not suggesting that the Deputy is trying to take us to this territory. If the complaint relates to overexposure, it is difficult for patients to have any knowledge of exposure and exposure levels. They put trust in it. My radiology colleagues will be able to speak on that in a much more informed way. The challenge in healthcare is often the basis on which patients complain if they are not really able to have a means to understand the nature of the service and the quality thereof. It can sometimes, but not always, be a useful guide about quality or such.

I take the Deputy's point on HIQA that there has been, on occasion, criticism relating to standards and so on. HIQA will be empowered to be the regulatory body. It is doing a substantial amount of work. We have given substantial new resources to HIQA in the current year to enable it to build its capacity to start the work on developing standards and the competence and capacity to roll this out. Some of the people it has been able to take on from the formal healthcare system are people with substantial capacity, ability, knowledge and so on. We have no basis for this point to express, as a Department, anything other than full confidence in its capacity as an organisation to take on this function.

I take Senator Colm Burke's point about insurance. Deputy Durkan asked the question of us and for clarity, I have never attended a chiropractor. It never entered my head but, luckily, as I understand the services they offer, I have never had the need to have any recourse to avail of such services.

Bernard Durkan (Kildare North, Fine Gael)
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Would Dr. Holohan have any reluctance to attend a chiropractor?

Dr. Tony Holohan:

Yes. I would see no reason to attend a chiropractor. I am the chief medical officer. The Deputy would not expect me to say anything else. I would put my full confidence in the body of general practitioners in this country, to then be referred on to the consultant body.

Bernard Durkan (Kildare North, Fine Gael)
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I am not a practitioner at all but a question arises regarding, for example, to spinal problems. Would Dr. Holohan urge surgery rather than chiropractic treatment?

Dr. Tony Holohan:

I would not urge surgery. I am speaking well outside my comfort zone from an expert point of view but my understanding is that many people who are referred to orthopaedic surgeons for lower back problems are amenable to effective intervention by a range of other professions, not just doctors, such as physiotherapists. A number of different innovations have been introduced into the healthcare system to help to deal with some challenges with waiting times and to have other allied health professionals play a role. They are all part of the formal healthcare system.

Bernard Durkan (Kildare North, Fine Gael)
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Dr. Holohan would not see chiropractic as a helpful addition to the menu of assistance available to people who suffer from back or spinal problems.

Michael Harty (Clare, Independent)
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Sorry, Deputy Durkan. I do not really think we can put the chief medical officer under pressure to give his personal opinions.

Bernard Durkan (Kildare North, Fine Gael)
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He has gone that route himself.

Dr. Tony Holohan:

I would not put it in those terms. Chiropractors are not part of the formal healthcare system. We do not plan and organise our services on the basis of anything other than the professionals who are part of our healthcare system.

Bernard Durkan (Kildare North, Fine Gael)
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If they were part of the formal health system-----

Dr. Tony Holohan:

That is a matter of conjecture and I do not know what role they would play. Speaking personally and honestly, I have very little knowledge or understanding of them. I went through medical school, medical training and all that. Never, in the time I spent in that, did I receive any tuition, knowledge or guidance on the nature of chiropractic, what it is or what it does. I am not saying that is either a good thing or a bad thing. It is simply a statement of fact to support the fact that I have very little understanding of what chiropractic is.

Bernard Durkan (Kildare North, Fine Gael)
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That is interesting.

Dr. Tony Holohan:

They are not part of the formal healthcare system. We have good and detailed policy understanding, since I mentioned physiotherapy in this context, of the role the physiotherapist can play. That is why I can talk in the terms that I am about development of services. To answer the Deputy honestly, I have thankfully never had such recourse.

Senator Colm Burke asked, if there has not been any evidence that radiologists have been called to give evidence of harm, whether that would be a sufficient basis for us. That would not be a sufficient basis for us to take a step or sufficient grounds for us to incorporate this. We are not in the business of excluding anybody. The purpose of this directive is to identify and empower appropriate professionals as either referrers or practitioners, which is what we are doing, and then to empower various competent authorities with the means to be able to ensure that, from the point of view of the protection of the public, the people who are empowered to operate the legislation are the ones operating the legislation and that nobody else is operating it as if they were empowered. That is the intention. It is not about any individual grouping or the naming and exclusion of any individual grouping. It is the empowering of named and identified professionals. There is also an important point for me to address relating to the Senator's question on referral. We have an ordinary use of referral, in the way we talk, in that people do get referred. One person can be referred to another person. Referral under the Act carries with it privileges that are set out in the legislation. Referral in the meaning of the directive is not the same in the sense of if, for example, a chiropractor referred a patient to a GP for an opinion.

That could be regarded as a referral in terms of its common meaning but it is not a referral under the legislation. It is important not to conflate those interpretations. I do not suggest the Deputy is doing so but it has been done in some public discussion on the issue.

A commitment of which I have seen documentary evidence was made in 2002. I do not understand the reasons for it not moving forward and am not aware of the discussions in that regard. Now, a substantial number of years later, any such question must be considered in the context of the directive and a strengthened set of arrangements from Europe that seek in broad terms to tighten up the arrangements that already exist in respect of the use of radiation for the purposes of protecting patients and the wider public from exposure.

As to the wider question asked by the Chair, there has been no commitment to set up a body for the purpose of regulating chiropractors or others. That has never been expressly considered. That is not to say that it would not be given positive consideration but, rather, it has never been considered.

Michael Harty (Clare, Independent)
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Dr. Holohan referred to chiropractors as not being part of the formal healthcare system.

Dr. Tony Holohan:

Yes.

Michael Harty (Clare, Independent)
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Would they be required to become part of that system in order for them to be regulated?

Dr. Tony Holohan:

Yes. Regulation would effect a set of arrangements whereby the nature of the content, obligations, accountability and oversight of any given profession would be set out with substantial clarity. It is not just a list of designated individuals but, rather, contains a significant amount of detail. Substantial detail in terms of scope of practice has been set out in some of the more recent work in regard to regulated professions as part of CORU. The relationship of that scope of practice to the practice of other practitioners would be worked out and negotiated in great detail before ultimately being set out in legislation or legal frameworks under legislation. It would have to have regard to the level and standards of education and training and so on, but we currently have no arrangements in this country in that regard and we, as an organisation, have little formal understanding or knowledge of them at this point. All of those kinds of details would be specified for any profession that had to be brought to and through a system of regulation, just as they are for the medical and nursing professions and those which have been regulated for a long period.

Colm Burke (Fine Gael)
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What is the problem with chiropractors having the power to refer on for radiology or extra services? The radiologists are the experts who will decide whether or not it is appropriate that there be an X-ray. What is the concern in terms of chiropractors having that power and that being removed from them under the proposed regulation?

Dr. Tony Holohan:

The arrangement described by the Senator is a situation whereby an individual is referred by a chiropractor, possibly by way of letter, to a GP or other medical practitioner.

Colm Burke (Fine Gael)
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No, referred specifically for an X-ray to a radiologist, who is the expert and can decide whether or not it is appropriate. Under the proposed system, the chiropractor would have to send the person back to the GP, who would then have to refer on to the radiologist. What is the problem with a person who has an expertise in a particular area deciding it appropriate that before he or she carries out any further treatment the patient should be reviewed by way of X-ray, and referring the patient to a professional radiologist who can decide whether an X-ray is appropriate?

Dr. Tony Holohan:

Referrals to specialists in our hospital system operate through our general practitioners. That is how our system is organised.

Colm Burke (Fine Gael)
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I acknowledge that. However, some radiologists work in a private capacity.

Dr. Tony Holohan:

That is a different matter.

Colm Burke (Fine Gael)
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Yes, but the proposal will remove that power from them. A chiropractor will have to apologise and send the patient back to his or her GP, who will then refer the patient for an X-ray.

Dr. Tony Holohan:

My colleagues may have a view on this issue. A situation involving a radiologist working in the private system who receives correspondence such as a referral by a chiropractor will not be covered by this legislation. It would be entirely open to the radiologist to decide if he or she wants to conduct that X-ray. If that is done, he or she is doing so as a practitioner under this regulation and there is no problem in that regard in terms of the regulation. The ultimate accountability in such situation would clearly lie with the radiologist making the determination.

Dr. Paddy Gilligan:

I wish to back up the comments of Dr. Holohan in terms of us not anticipating a change in that regard. That the radiologist will become the referrer in the absence of a prescriber is not explicitly dealt with in the new legislation but the provision should be maintained.

As regards complaints and incidents, I am a member of the national radiation safety committee. Since 2009, we have had a radiation incident reporting system to which facilities reported multiple exposures, over-exposures or any incidents relating to diagnostic radiology or radiotherapy. Approximately 40 to 50 incidents are reported per year and there is a smaller number of incidents. We have not had any reports from chiropractors to date but that may or may not reflect good or bad practice.

Colm Burke (Fine Gael)
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Moving away from the area of radiology, I wish to raise the practice of people now providing scanning services, which is totally unregulated. I recently heard of a person who had a scan on a Saturday and was advised that the baby she was carrying had died but there was no mechanism in place to refer her on to a medical practitioner. A mother was left in limbo over a weekend to deal with that new information provided by someone offering private scanning. There is no regulation of that area.

Dr. Tony Holohan:

It is likely that was ultrasound scanning, given the nature of the procedures done to determine pregnancy and so on. The fact that it was on a pregnant woman makes it highly unlikely to have involved ionising radiation.

Colm Burke (Fine Gael)
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I accept that but I compare that situation with that of chiropractors who provide a service and are prepared to refer on to specialists who provide a very comprehensive service. We seem to be excluding people who are providing a service and regulation and who have insurance and I am concerned by that.

Dr. Tony Holohan:

I understand what the Senator is saying. Several of those points have been made to us but we have no knowledge of that other than those declarations and statements. The reality is that the proposed and previous regulations do not make provision for people other than those I have mentioned and who we propose. We are still working on this as an organisation and, as I said, we hope to finalise our thinking on the matter over the coming weeks and bring it to a level of finality. However, Senator Burke's use of the word "referral" is not in accordance with the intended meaning of the word as set out in the legislation. A definition of "refer" and so on is set out in the directive.

Bernard Durkan (Kildare North, Fine Gael)
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I have an innocuous question. In the run up to this requirement, what discussions took place between the HSE expert group and chiropractors? Obviously, if major changes are going to take place, the normal routine would be to have discussions with the bodies most likely to be affected. Has the Health Information and Quality Authority, HIQA, in its present capacity, had discussions with chiropractors as to the advisability of regulations or the extent thereof? Has the Department had discussions with chiropractors regarding the extent of the proposals, how it might affect them and how they might be required before being admitted into the formal health regime in this county?

Dr. Tony Holohan:

My colleagues may be able to assist me in answering in terms of setting out some of the detail of the consultation. We ran a consultation process last summer and invited people to come forward.

We heard from a number of bodies. We took additional steps to select the representative body and the chiropractors who were holders of licences. My understanding is that we did not hear anything from them as part of that consultation.

Bernard Durkan (Kildare North, Fine Gael)
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Who was consulted?

Dr. Tony Holohan:

A range of different bodies was consulted. Obviously, the HSE will be a substantial source of expertise from our point of view. The expertise in this country, such as it is, resides in two main sources. At the practitioner level, it resides within the public services. From a professional point of view, it resides with the professional training bodies. The Faculty of Radiology is the pre-eminent such body in terms of medical practice and use of radiation. We would have had engagements-----

Bernard Durkan (Kildare North, Fine Gael)
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And consultations.

Dr. Tony Holohan:

-----with those kinds of bodies as well as with HIQA. In the ordinary course of engagement on legislation, we always engage with those bodies that are, in effect, going to be at the front and at the centre in the effective operation of legislation and regulation. That is exactly what we did in this case. We are still continuing with that process. It is not at an end.

Bernard Durkan (Kildare North, Fine Gael)
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Did consultation take place with the professionals in chiropractics who say they have a recognised qualification at master's level? Obviously, some have less and some have more. Did the Department engage in such consultation? Did the expert group engage in consultation in an effort to identify how best it might proceed in bringing this within the national health regime?

Dr. Tony Holohan:

The regime I was referring to is more relevant to the wider context, which is the existential nature of chiropractics as a service and as part of the public health system. That is not the question that is before us now or that we were consulting on. As far as I am aware, we have received no representations, in a broad sense, in respect of that.

Bernard Durkan (Kildare North, Fine Gael)
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It is an important question. I would have thought that in order to come to a conclusion on how to proceed in a particular situation, there is automatically a requirement to consult the profession that is about to be affected by the proposal.

Dr. Tony Holohan:

We would have taken the view that chiropractors had an opportunity to engage in our consultation process, but did not do so. They came to us by way of correspondence. We had engagement with them. A meeting took place with them. As I have said, we have not completed our consideration. The other point is that chiropractors who provide services in the way described by the Deputy are doing so outside the terms of the regulations as they currently exist.

Bernard Durkan (Kildare North, Fine Gael)
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We are aware of that, but we are talking about compliance with a new regulation. I suggest that the extent to which the professionals in this area, as they see themselves,-----

Dr. Tony Holohan:

Yes.

Bernard Durkan (Kildare North, Fine Gael)
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-----need to be consulted is an obvious question-----

Dr. Tony Holohan:

We are not-----

Bernard Durkan (Kildare North, Fine Gael)
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-----that we need-----

Dr. Tony Holohan:

We sought to consult them.

Bernard Durkan (Kildare North, Fine Gael)
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The Department sought to consult them.

Dr. Tony Holohan:

We did so because we agree with what the Deputy is saying.

Bernard Durkan (Kildare North, Fine Gael)
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They did not respond.

Dr. Tony Holohan:

No.

Bernard Durkan (Kildare North, Fine Gael)
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They might have something to say about that. However, I will let Dr. Holohan continue.

Dr. Tony Holohan:

That did not stop us from engaging with them when they sought further engagement. We have no difficulty in talking to anybody.

Bernard Durkan (Kildare North, Fine Gael)
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Has provision been made for any intention on the part of the Department to conclude that discussion or dialogue before the directive comes into operation?

Dr. Tony Holohan:

The directive will not come into operation until the Minister signs the regulations.

Bernard Durkan (Kildare North, Fine Gael)
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We know that.

Dr. Tony Holohan:

We have to bring a number of pieces to some finality-----

Bernard Durkan (Kildare North, Fine Gael)
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That is not my question.

Dr. Tony Holohan:

I understand. I mention that in answering the question. As well as giving further policy consideration to this matter, we are still in dialogue with a number of organisations. We have not completed our full consultation.

Bernard Durkan (Kildare North, Fine Gael)
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The process is not completed yet.

Dr. Tony Holohan:

The process is not completed until it is completed. Ultimately, we will present the Minister with the final proposed set of regulations. As part of that, we will receive legal advice. We expect to get legal advice on the broad totality of this very shortly. That will be part and parcel of the final analysis of what will go into the regulations.

Bernard Durkan (Kildare North, Fine Gael)
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Will the consultation process be completed to the Department's satisfaction before this is presented to the Minister for enactment?

Dr. Tony Holohan:

We will not present something to the Minister for him to sign unless we believe we have heard and understood the perspectives and points of view of all the relevant organisations we need to hear from.

Michael Harty (Clare, Independent)
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I thank Dr. Holohan.

Dr. Niall Sheehy:

I would like to clarify some points that have arisen. A comment was made about iRefer. For the information of the committee, iRefer is a set of guidelines issued by the Royal College of Radiologists in the UK with regard to efficient and safe referral for radiology. We endorse iRefer, which is an international gold standard.

A number of comments made by members, including what Senator Burke said about insurance, come back to the issue of statutory regulation. As radiologists and other doctors are legally registered with the Medical Council, they need to have insurance. Doctors who are not part of the Medical Council can be prosecuted. Issues with poor performance by radiologists, which have arisen in the past, are remediable to the Medical Council. Doctors can and do have their licences to practice removed or restrained by Medical Council practitioners. We are not a self-regulating body.

The question of the referrers' clause has been clarified by the chief medical officer. As we said in our submission, there is a huge amount of confusion about the terminology used when someone is doing a referral, doing a prescription or doing a test. Essentially, in radiology terms, in most cases it is a radiographer who takes an X-ray of one's spine. A radiographer is not legally permitted to do this unless he or she has received a referral from someone who is allowed to refer under the legislation. At present, this can be a medical doctor or a nurse referrer. If a chiropractor sends in a request to a radiology department, the radiologist or the practitioner in charge can look at that request and say that it is justified. In such circumstances, that radiologist is legally deemed to be giving the referral to the radiographer that permits him or her to perform the examination. Our understanding is that this will continue under the new legislation. This practice should not change, as we understand it, but perhaps that can be clarified further.

The final question that was asked related to competing practitioners. This is not the issue for us. As we heard in previous testimony, most of the radiology examinations referred by chiropractors are being done in the radiology system. A small volume of studies is being done outside of that. I do not think my colleagues have anything else they would like to say.

Michael Harty (Clare, Independent)
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On behalf of the committee, I thank the Faculty of Radiologists from the NCSI and Dr. Holohan and his colleagues from the Department of Health for coming in to give evidence today.