Skip to main content
Normal View

Joint Committee on Health debate -
Wednesday, 25 Apr 2018

Council Directive 2013/59/EURATOM: Discussion

In this second session we are meeting representatives of the Chiropractic Association of Ireland, CAI, to discuss the impact on chiropractors of the transposition of Council Directive 2013/59/EURATOM laying down basic standards for protection against the dangers arising from the exposure of ionised radiation. On behalf of the committee, I welcome Mr. Tony Accardi, Ms Lyndsey O'Leary, Mr. James Cosgrave and Mr. Richard Brown of the Chiropractic Association of Ireland.

I draw attention 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. If they are directed by the committee to cease giving evidence on a particular matter and they continue to so do in respect of a particular matter, 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 wish to advise that any opening statements 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 outside the Houses or an official either by name or in such a way as to make him or her identifiable. I invite Mr. Tony Accardi of the Chiropractic Association of Ireland to make his opening statement.

Mr. Tony Accardi

As president of the Chiropractic Association of Ireland I thank the members of the Oireachtas Joint Committee on Health for agreeing to meet us today. While our requests are technically complex, the principle is simple. These regulations, as currently drafted, will place the delivery of evidence-based, patient-centred chiropractic care in Ireland at a serious disadvantage. They will remove the capacity of duly qualified chiropractors to conduct X-ray examinations of patients or to refer patients for X-ray. This regulatory change will have a profoundly negative impact on the safe and competent delivery of care that chiropractors provide to thousands of Irish patients each year. I hand over to my colleague, Mr. James Cosgrave, to explain briefly who we are and what we do.

Mr. James Cosgrave

I am a chiropractor practising in Cork for the past 25 years. Chiropractors specialise in the assessment, treatment and management of musculoskeletal disorders, particularly those affecting the spine and related joints. The World Health Organization, WHO, recognises chiropractors as primary healthcare providers, safe to practice competently either independently or as part of healthcare teams at a community level. Chiropractic is statutorily regulated in more than 50 countries around the world. Ireland remains the only English-speaking country in the world that still has no statutory regulation of chiropractors.

The Chiropractic Association of Ireland is the professional association that represents chiropractors and maintains professional standards in the absence of this statutory regulation. The CAI has 110 members working in private clinics nationwide who deliver more than 600,000 treatments per year to patients with musculoskeletal conditions. This a significant treatment volume and it is delivered at no cost to the State. To deliver this level of care effectively, chiropractors require prompt, efficient and well-regulated access to appropriate diagnostic imaging when required. The European Commission has published training requirements for chiropractors to justify, deliver and refer for X-ray procedures. Without exception, our members are meeting these requirements. As part of their five-year, full-time education, chiropractors are trained in the safe and effective use of X-rays and have done so for many years.

In Ireland, chiropractors have been able to refer patients for X-ray for more than 25 years and a number of our members have also had X-ray apparatus in their clinics licensed by the Environmental Protection Authority, EPA, and previously by the Radiological Protection Institute of Ireland, RPII. One member, as far back as 1991, was licensed by the Nuclear Energy Board. We have sought regulation of X-ray by chiropractors for more than 20 years. Members of this committee might be surprised to learn that I made a presentation to an Oireachtas joint committee in 1999 on this very issue of X-ray use by chiropractors. The record shows that the Chairman of the committee at the time, the late Deputy Sean Doherty, advised that the parties should engage further to resolve the situation ahead of the, at that time, upcoming new regulations. There are a lot of similarities to the situation we are in 19 years later.

There was a period of significant activity around the 2002 regulations. The Department of Health did undertake to create a register of chiropractors who could take and refer for X-rays. The CAI fully participated in this process throughout 2003. Progress was going well but it stopped completely in 2004 for an unrelated reason. There was a consultants' dispute at the time.

The Department was in dispute with the Irish Hospital Consultants Association over a medical indemnity issue. As a result, the consultants pulled out of any health committees. One of those was the medical exposures directive advisory group, MEDAG. Therefore, the work of creating the register of chiropractors competent to take X-rays and refer for X-ray was never finished. There was no question at the time that the competencies could not be met. It was simply that the work was never finished. We have a very long paper trail, stretching from 2004 to 2006, from the then principal officer in the Department stating the reason for the delay in creating the register was, in fact, the consultants' dispute and nothing to do with chiropractors' competencies or willingness to engage on this.

The correspondence deserves scrutiny because it gives a very clear indication that the Department gave an undertaking, at the start of the process, of regulating chiropractors under these regulations. Since the time in question, it has been stated that since we are not part of the 2002 regulations, we should not be included in the 2018 regulations but, in fact, the Department has given an undertaking to include us under the 2002 regulations. Nonetheless, during this entire period, chiropractors have had continued access to private X-ray facilities around the country run by Irish Medical Council consultant radiologists. Further, some 11 chiropractors have continued to operate their own X-ray facilities, licensed by the RPII or the EPA, in full compliance with SI 125. These chiropractors participated in a HSE compliance audit in 2012. It is important to point out again that while the 2002 regulations do not specify chiropractors as practitioners, the HSE nonetheless conducted this audit of chiropractors on the basis that they were, in fact, acting in the role of practitioners and had been doing so for many years.

The audit findings were very good. They stated very clearly that it is encouraging to note that chiropractors have taken steps to implement quality assurance and safety mechanisms, and that virtually all practices have written protocols with regard to safety, justification and optimisation. The CAI has endeavoured to self-regulate any gaps left by the absence of the register that was promised in 2002. We still continue to seek full participation in the relevant statutory structures rather than engaging in self-regulation. The new regulations, to be signed by the Minister, Deputy Harris, in the coming weeks neglect to include chiropractors under their remit altogether, even though the European guidelines on the training of medical practitioners to carry out these roles make it very clear that chiropractors meet the standards required - in the EURATOM directive and the transposition regulations. We met Department officials in February and had an exchange of views but we are unaware of any progress made on this to date. As a result, chiropractors now face being unable to refer for X-ray or take an X-ray for the first time in over 25 years. The Department is fully aware that the equivalent new regulations in the United Kingdom do specify chiropractors are fully competent to take and refer for X-rays, so it is widely understood that the competencies required for chiropractors in Ireland to carry out the same roles are not the issue.

At this time, we are not seeking any additional rights over and above what was agreed by the Department in 2002. We are asking for our use of X-ray to be regulated, as we have always done. We fully endorse the Department's desire to have proper regulation in the area. We still stand ready to engage on any practical solutions the Department might suggest to resolve matters. We fully support the statutory imposition of minimum training standards and of required clinical governance and auditing.

I shall now hand over to my colleague Mr. Richard Brown, from the World Federation of Chiropractors. He will explain the international context.

Mr. Richard Brown

I thank the Chairman and members of the committee for permitting me to address them briefly today on the international perspective as it relates to this issue. The World Federation of Chiropractic, WFC, is the global voice of the chiropractic profession. We represent the national associations of chiropractors in over 90 countries, spread across seven world regions. Our role is to advance the chiropractic profession and to promote high standards of education, conduct and practice.

Members will have heard that there are some 110 chiropractors in the CAI. Members may regard the profession as small but, in a global context, they will note there are upwards of 110,000 chiropractors in the world today. Most of these are clinicians caring for patients and their communities. Others are researchers, academics, health policy experts or public health advocates. Chiropractic, therefore, is an established, respected and valued global healthcare profession.

Since 1997, the WFC has been an NGO in official relations with the World Health Organization, WHO. As members already heard, the WHO recognises chiropractic as a primary contact healthcare profession. Back in 2005, the WHO published guidelines on basic training and safety in chiropractic. These guidelines clearly set out the requirements of chiropractic educational programs, which include training on radiation protection, radiography and radiology. They set out practical training in the taking of X-rays and interpretation of X-rays. It should, therefore, come as no surprise that the safe and effective use of ionising radiation in the form of X-rays is a core component of every single chiropractic training programme around the world.

Quite rightly, members will all wish to be satisfied as to the quality of education of chiropractors. As they have already heard, chiropractors undergo a minimum of four years' full-time education at masters level. Thousands of hours of basic science and clinical sciences training form the curriculum, and competency is tested at every stage. Upon graduation, chiropractors engage in continuous professional development, quality improvement measures and auditing of their work.

Chiropractic is offered at over 40 educational institutions worldwide. Three of these programmes are in the United Kingdom, namely, at AECC University College, the University of South Wales and BPP University. A fourth, at London South Bank University, will open its doors later this year. These programmes are both nationally and internationally accredited, ensuring quality assurance at a number of levels.

Let us return to the issue of X-rays, a critical component of effective and accurate diagnosis. In the world today, over 85% of practising chiropractors exercise their competency in taking X-rays, interpreting X-ray films and referring for diagnostic imaging, including X-rays. Chiropractors in every one of the 50 states in the United States, every province in Canada, every territory in Australia, and in England, Scotland, Wales and Northern Ireland are entitled to take, read and order X-rays. They take the role of employer, practitioner, operator and referer.

In the United Kingdom specifically, a 2006 multi-stakeholder document, Clinical Imaging Requests from Non-Medically Qualified Professionals, contained the policy statement from the Society and College of Radiographers. It stated it is perfectly in order for radiographers to accept requests from non-medically qualified referers provided the referer is adequately trained and remains competent to refer, and provided that there are written local agreements and protocols. In the same document, the General Chiropractic Council, which is the regulator, stated chiropractors are autonomous primary healthcare practitioners competent to provide diagnostic triage. The majority are fully trained to take as well as interpret images and interpret reports from radiologists. It is stated that when requesting imaging protocols they will provide a clear diagnostic rationale based on a well-founded clinical impression.

Back pain is the single biggest cause of disability on the planet. Chiropractors manage musculoskeletal disorders, including back and neck pain, at all stages of the life course. Their judicious use of X-rays plays an important role in directing safe, effective care.

My colleagues around the world, not least those in the United Kingdom, United States, Canada and Australia, many of whom trained alongside CAI chiropractors, are shaking their heads in dismay over the prospect of Ireland seeking to prohibit chiropractors, as highly trained skilled health professionals, from exercising their scope of practice and competency. The WFC respectfully submits that to do so cannot be in the best interest of either patients or the public.

Mr. Tony Accardi

I thank the committee once again for affording us the opportunity to present our case today. My colleagues, whom members have met, in addition to Ms Lyndsey O'Leary and Ms Olivia O'Leary Veal, who are X-ray licence holders, are willing to take questions at this time.

I thank the delegates for the opening statements. We will now hear observations from members. The first to contribute are Senator Colm Burke and Deputy Louise O'Reilly.

I thank the delegates for their very comprehensive presentation on the work they are doing.

With regard to the services currently being provided, the delegates said some chiropractors use their own X-ray equipment and others make referrals.

Could I get clarification on medical indemnity insurance? Does each practising chiropractor have professional indemnity insurance? In particular, do those who are doing extras and giving reports have professional indemnity insurance? Will the witnesses outline the number of people in total who are practising chiropractors in this country? What is the number in real terms? Will the witnesses explain the number who have and use X-ray equipment? The issue arises that if people do not have X-ray equipment, to whom would they normally refer people? Would they refer people to hospitals or private providers of X-rays? I ask about professional indemnity insurance because I came across a person providing an X-ray service but when an issue arose, it turned out the person did not have that professional indemnity insurance. I am not talking about a chiropractor in this case, just in case anybody is worried about it. An error was made in the case I mention and it is a major issue. I have been very involved in legislation relating to this in the past four or five years to ensure all healthcare professionals have insurance. It should be clarified.

I presume the amendment of the proposed regulations would be quite minor in order to include chiropractors. It is not a case of drafting new regulations but rather including rather than excluding chiropractors. I thank the witnesses for the presentation.

I thank the witnesses for their evidence. I have two questions, with one relating to a submission we have not yet heard. It relates to the training. We will hear from radiologists that "when compared with the trained and regulated health care professionals previously described, we have found no substantive evidence of appropriate training, referral criteria, audit or accountability". Will the witnesses outline for us their training levels and how they compare with training levels in the North or England, where this practice is allowed? Do they do something different 50 or 60 miles up the road that people are not doing here? It would be helpful to explain that for us so we can understand the process.

If the Department continues on the path it has indicated and chiropractors are not brought into the process, what practical effect will it have on work and the ability of witnesses to carry out their work? The comments on going back to 1999 are interesting. Is it correct to say that between 1999 and today, the practice has continued without any adverse occurrences? Is there a reason we should be concerned? It strikes me that in 1999 the association was willing to engage with regard to regulations and satisfying the criteria that might be put in place. I assume the state of play is still the same and the association is still happy to engage on this. In the discussions with the Department, has there been an indication of any minimum standards that should be fulfilled that the association is not currently fulfilling? Has the association been advised of anything not being done that the Department would like it to do?

If the witnesses bank those questions, I will bring in Deputies Durkan and O'Connell in order to complete contributions from members.

I have stated my interest in this area from the outset. I am totally supportive of the need to retain X-ray facilities for chiropractors. I say this because there is an obvious need to keep the highest possible standards and to have qualifications of international repute. The degree of training must be observed and updated in line with international standards. Safety regulations must apply with X-rays at all times. I strongly urge that in all cases, high standards must apply and there must be a level playing pitch.

As the Chairman knows, I have on many times in the past criticised the existence of waiting lists for virtually everything in the country but particularly in the health service. One does not have to wait very long for an X-ray by a chiropractor, which is very beneficial for the patient. Nobody else seems to worry about such things but the patient is most concerned about that. A patient can go to a chiropractor and have an X-ray and result within ten minutes. That does not happen in most other places. It could and probably should happen but it does not. I, therefore, strongly support an effort to ensure the full degree of services already available through chiropractors continue to be made available, including X-rays. This can happen if the adequate qualifications apply to ensure patient and practitioner safety with regard to ionising radiation.

I thank the witnesses for coming in today and I apologise for them being delayed for so long this morning. The quote mentioned by Deputy O'Reilly was something I pulled from the statement last night as well when I read it. It is "we have found no substantive evidence of appropriate training, referral criteria, audit or accountability in published literature from the Irish chiropractic community." Reading around this, it almost suggests that there is no evidence. Perhaps the evidence is there but it just was not collated or given in the appropriate fashion.

Why is Ireland so different from other jurisdictions? I can only assume it is because there is no undergraduate university course for chiropractic services, so perhaps the profession does not have what pharmacists or physiotherapists have in the form of an academic body in Ireland providing the degree course. Therefore, we depend on people coming in with training from other jurisdictions. I completely understand concerns that people may have with ionising radiation X-ray units in clinics but I wonder is there any evidence that those units are not being monitored and manned properly, or that there is any risk to the neighbourhoods surrounding practices with such facilities? Will the witnesses indicate how many patients the group is seeing on a weekly or annual basis? They might deem this as taking a weight from the health service by dealing with them in their centres. I visited a chiropractic clinic recently and was very impressed by the professionalism of the set-up. It was what I would consider very progressive and like a large GP surgery. It was not just a fly-by-night operation and the person had practised for years.

Following on from the point on indemnity insurance to which my colleague, Senator Burke, referred, and he was referring to the actual machines, when it comes to something being missed, as can happen in any profession, what is the recourse for the patient? If an X-ray is taken of a lower back and if the issue is not mechanical but is, for example, cancer and that is missed, is there any example of what happens next? How is it regulated? Is there any regulation? Does it just go into the ether?

I looked at the regulations for here and the proposed regulations for the UK and I am concerned that we seem to be an outlier. Why can Ireland not match up with what the UK is doing? Do the witnesses have any suggestions as to how they, as a group, could get their house in order? They appear to be well trained and providing a good service, but somehow they operate in a grey area and perhaps will become extinct. Do they have any suggestions as to how, if we as a committee could feed back to the Minister to give the witnesses two or three years to sort out their housekeeping, they could assist us in this regard?

Before the witnesses start answering those questions, perhaps they might refer to the definitions of practitioner and referrer because they seem to be central to the issue with regard to being a practitioner who is entitled to refer for X-rays. As has been mentioned, in 2002 the Department undertook to include chiropractors in the regulation, but 16 years later this has not happened. Perhaps the witnesses will explain how that could have happened. Is there statutory regulation for chiropractors in the other countries that have been mentioned? Is Ireland different from other countries in that it does not have a process for statutory regulation? Are chiropractors acting as radiologists and radiographers in the process of taking X-rays, or are they referrer, radiographer and radiologist in the process at present, whereby some chiropractors have access to X-ray facilities?

We have had a lot of questions from five different members but perhaps the witnesses will take them as they wish.

I omitted dentists from people who carry out X-rays. They do it very well and I want to include them.

Mr. Tony Accardi

Mr. Cosgrave will comment on the practitioner and referrer definitions.

Mr. James Cosgrave

Must I answer the questions in sequence?

Mr. James Cosgrave

I thank Deputy O'Connell for her questions. We have never asked to be self-regulating. We have asked to be within the regulatory remit of this new statutory instrument and the existing one, SI 478/2002. We have been left outside this. We have consistently asked to be included and to be regulated and held accountable. It is very straightforward. If we are included in the regulations our members will be held accountable. Either they are able to perform the tasks as required by statute or they are not, but it does provide a mechanism for the relevant authority, in this case HIQA, to remove anybody who is not able to operate their duties in a responsible fashion. We feel the lack of statutory regulation of chiropractors' use of X-ray is absolutely undesirable. We have been on the record for more than 20 years as seeking to be involved under the statutory remit of the appropriate regulations.

On the question regarding the use of X-ray apparatus by chiropractors, they are acting as referrer and practitioner, much in the same way as dentists and it is quite routine in dental practice. Chiropractors are trained to interpret the films from a diagnostic perspective, but in most cases radiology reports will also be provided from outside sources.

On the insurance front, it is a compulsory requirement for all members of the Chiropractic Association of Ireland to hold malpractice insurance and insurance that will cover any eventuality. Any of our members using X-ray apparatus is covered under the appropriate insurance. There has never been an issue arising with regard to insurance and X-ray use by any of our members. There are 130 chiropractors in the country, 110 of whom are members of our association, which is approximately 85%, and a total of 11 chiropractors in the State are licensed to have X-ray apparatus. This means 99 chiropractors do not have X-ray apparatus and they have been making referrals to private diagnostic clinics throughout the country. These include the Consultants Private Clinic in Cork and there is also a large private provider of X-ray and MRI services in the State. We have access to refer our patients to these facilities.

Regulation 14.4 caters for people who are not specified as referrers, and at this point in time I am not specified under SI 478 as a prescriber, as it allows for the radiologist in charge to act as the referrer and receive the referral in the event of a referral being made by somebody like me, who is not listed under the current regulations. This situation has worked incredibly well for the past 16 years. I have been referring patients to Irish Medical Council consultant radiologists in the State for 25 years. I have been receiving reports back from those radiologists, and it has been a fantastic service and access has been great. We also have the backup and security of a consultant radiologist's report. This has been working very well, hence the number of X-ray licences issued to chiropractors throughout the country has actually decreased from the 18 licences issued a few years ago to 11 now because there has been good private access and many of our members have utilised this.

Things will change after the introduction of the new regulations, if they remain unamended. I will no longer have the ability to refer to a member of the faculty of radiologists here to have an examination done on a patient. Instead, I will have to refer the patient back to his or her GP and, obviously, provide all of the clinical information as to why I feel the X-ray would be justified, and the GP may or may not make the referral. It means every patient will have to take an extra step. It will delay things and slow them down. Some patients will end up in the public system again and will congest things further. The new president of the National Association of General Practitioners recently said patients could soon wait up to six weeks for a GP appointment, which is curious. It seems very much in contrast to some of the Sláintecare recommendations, on which members of the committee worked tirelessly, to slow down access to diagnostic imaging and delay things. Chiropractors have been working with these arrangements for many years and it has worked very efficiently to the patients' benefit. We are not talking about a huge number of X-rays per year. We have approximately 600,000 visits per year and we certainly refer a very small percentage of patients for X-ray. It is thought that at present chiropractors take 3,000 to 4,000 X-rays per year, which is hugely at variance with the 1.5 million to 2 million X-rays being taken by other providers in the State. We are not talking about a huge number of X-rays but, nonetheless, when an X-ray is required and used it is a very important diagnostic tool to which we must have access. This change will completely remove access to that diagnostic tool for chiropractors.

Will Mr. Cosgrave distinguish between the various types of referrals required? X-ray is one and MRI and CAT scans are others. Is there a difference between them?

Mr. James Cosgrave

Typically we do not refer for CAT scans. Part of regulation 14.4 states the radiologist receiving the referral must be satisfied the study is required and necessary.

No, the main referrals will be for simple lumbar spine or cervical spine or knee or hip X-ray. We tend to use a lot more MRI nowadays. Therefore, the amount of X-ray referral is actually decreasing, not increasing, and I think this trend will continue. I can see in the foreseeable future that MRI will be much more readily available and utilised much more often. MRI does not involve ionising radiation. Nonetheless, the fact that chiropractors will potentially not be listed as referees under the new regulations could interrupt access for MRI referrals because the assumption is that the private facilities may well be unhappy to take referrals for MRI if chiropractors are locked outside these new regulations completely, even though MRI does not involve ionising radiation.

Mr. Tony Accardi

Deputy O'Reilly asked us to outline training levels, comparing Ireland to Northern Ireland and England. Perhaps Ms Olivia O'Leary Veal could take that question.

Ms Olivia O'Leary Veal

I might defer to Mr. Brown on the international level to draw the comparison between the UK-based and the Republic-based systems.

Mr. Richard Brown

I think one of the original questions was why is Ireland so different from other jurisdictions? It seems as though one of the barriers to regulation of the profession has centred around domestic chiropractic education and the need for a chiropractic educational institution in the country before regulation can be contemplated. I respectfully draw the attention of the committee to three other jurisdictions in Europe which are regulated but have no educational facility in the country. Most notably, Norway is a case in point. Norway has approximately 800 chiropractors. They have a wide scope of practice. They have wide practice rights, including the prescription of sick leave and referral to diagnostic imaging and to physiotherapy autonomously as a profession. They have used this facility very widely, and chiropracting is very well utilised.

Can they take X-rays in Norway?

Mr. Richard Brown

They have referral rights for X-rays. Most chiropractors in Norway have a very easy facility to be able to refer into local facilities.

However, fundamentally, Mr. Brown has drawn the comparison between Norway and here. Are chiropractors in Norway allowed to have X-ray units in their practices?

Mr. Richard Brown

No, they are not.

It is not really a good comparison, then, with all due respect. Of the few countries, is there any other jurisdiction that has no school of chiropractors and in which chiropractors are allowed to take X-rays in their practices?

Mr. Richard Brown

That is unregulated or regulated?

Mr. Brown referred to either three or four a minute ago that had no undergraduate chiropractic degree or whatever. In any of those cases, are they allowed to take X-rays in their private clinics?

Mr. Richard Brown

Autonomously, in Europe, the other two jurisdictions were Cyprus and Lichtenstein. Chiropractors there do not have the right to own X-ray equipment but they do have referral rights. Outside Europe, I refer to Australia, the US and Canada. Chiropractors there all have the right to own and operate X-ray facilities within their practices. When we consider the numbers of chiropractors globally, which I referred to, they represent approximately 85% of chiropractors in the world today within these jurisdictions.

Is it the case that if one has the right of referral, one does not need X-ray facilities in one's practice?

Mr. James Cosgrave

It seems to be the case that there is much less of a likelihood that one would need one, given that 100 of our members do not hold X-ray apparatus. Some 10% do.

Is it that the 10% that do do so because they do not have referral rights?

Mr. James Cosgrave

In some areas, yes. Some of those licenceholders are in rural areas.

Mr. Tony Accardi

There was a question about undergraduate programmes in Ireland. We are actively pursuing that. There is an organisation called Promoting Chiropractic Education that has been developed in England. It produced the groundwork for the London Southbank programme that Mr. Cosgrave mentioned. It will help us develop a programme in Ireland, and we are actively pursuing that, as I said. As a matter of fact, a number of years ago, an entire curriculum was developed for our programme, so we hope to have something up and running possibly in three or four years.

If I may, Chairman, someone referred to the fact that 18 X-ray licences were issued to chiropractors a few years ago. There are 130 chiropractors in the country, 110 of whom are affiliated to the CAI. There were 18 who had X-ray machines and now there are 11. Is that due to the cost of maintaining such units or to the fact that the private operators with diagnostic stand-alone setups might be more efficient, or is there any other reason? Within the profession - of the 110 or the 130 or 140 - do chiropractors refer within their own practices? Would it be normal for a chiropractor without an X-ray machine to refer to a chiropractor who has one - in other words, no referral to the radiographer or the radiologist? Do referrals happen within the practice?

Mr. James Cosgrave

There is some inter-referral, absolutely, but such cases are very much in the minority. In most of the population centres where there is good access to private facilities, patients tend to be referred into those. As to the reason for the decrease in the number of licences, if I may backtrack again to 2002, we are talking about only three X-ray apparatus licensed to chiropractors at that time. It grew to 18 at one point. It has now decreased again to 11. X-ray apparatus is expensive. It is a facility that must be very well maintained, it is absolutely not cheap and, for many people starting practices, if there is a very good private provider run by radiologists in the locale that is willing to accept referrals when justified, that is a very good situation to have. There has been greater reliance on MRI in recent years as well, so many chiropractors now favour MRI. This trend will increase, although I do not see a time when X-ray will ever be obsolete as a diagnostic tool. It has been used by doctors and chiropractors for over 100 years and will continue to be so, although I think the numbers of chiropractors even seeking X-ray licences will come down. Under the new regulations, obviously, we might not even have that capacity.

Mr. Tony Accardi

Deputy O'Connell asked about any evidence of X-ray units not being monitored properly and whether the community is at risk. Perhaps Ms O'Leary might respond.

Ms Lyndsey O'Leary

X-ray licences are licensed from the Environmental Protection Agency, which basically regulates us. Every three years there is an inspection. We must have a radiation protection adviser, RPA. We have an Irish-registered radiation protection adviser who is also a hospital-based RPA. The licence is heavily regulated. There are many hoops to jump through. It costs money every year. One must have one's X-ray machine digitally inspected as well, so the regulations are fairly extensive.

Ms Olivia O'Leary Veal

There are stringent procedures under SI 125/2000. There are many obligations on the licence holder to come to a standard that is accepted across all professions. The Environmental Protection Agency is the regulatory body and considered the competent authority in the area. There must be justification for the application for the licence initially and then one must satisfy the criteria yearly to satisfy an inspection report. Many of the chiropractic facilities within the State have been regularly inspected by the Environmental Protection Agency, and in this sense there is quite inherent regulation within the processes. One will not be passed for re-license throughout the following year if one does not submit one's reports under the radiation protection adviser who is there. There are therefore many checks within the processes in Ireland already. However, the status is not as we would like it to be. We do operate in rather a grey area, but we are doing our best to comply with the regulations and what is being demanded of us as a profession under the system under which we exist.

Mr. Tony Accardi

Deputy O'Connell asked about having our house in order. I reiterate that the Chiropractic Association of Ireland is very much in tune with self-regulation. We try to follow the Health and Social Care Professionals Act 2005.

The Act requires professions to be regulated and among the main criteria are accountability and expertise. The association certainly has a significant proportion - 85% - of the practitioners in the chiropractic field. We have a written constitution and there is open democratic decision-making within the association. We have our codes of ethics and this is our robust fashion of disciplining any chiropractor who has breached those codes of conduct. We are also committed to continued professional development.

I think Deputy O'Connell was asking how long would it take for the Chiropractic Association of Ireland to be able to satisfy the Health and Social Care Professionals Act or other criteria. Mr. Accardi is essentially saying that there would not be a time lag. He is saying that if we were to speak to the Minister and advise him to give chiropractors a certain amount of time to get themselves up to speed, a huge amount of time would not be required.

Mr. Tony Accardi

No, we have everything in order.

Mr. James Cosgrave

There was a question on the training requirements the Department has set out. In this case, the Department has not set out training requirements for us at all. The training requirements are set out in the EURATOM directive to be transposed. The European Commission published guidelines on what exactly chiropractors had to do and what level of training was required in 2014. Curiously, these guidelines were prepared by the European Society of Radiology, of which the Irish Faculty of Radiologists is a member society. The guidelines clearly state requirements for chiropractors referring for, justifying and delivering radiography procedures. At no point have we been looking for a free pass on anything where regulation is concerned. We are asking to be regulated as required. We want our members to be held accountable. If the Department is willing to present us requests to sign up to obligations, we are willing to meet those requests. To date, we have not been given any specific feedback from the Department on what might assist but we remain very willing to engage. We would be exceptionally happy to be held accountable and to employ whatever criteria are required under the new regulations. We absolutely sign up to the idea of audit, minimum standards for training and the most exceptionally high levels of patient safety. We are in full agreement with the thrust of the regulations. What we are not in agreement with is the fact that chiropractors have been left outside the remit. They are not being regulated. Their use of X-rays is being prohibited and we cannot really come to terms with that.

The interpretation of the same directive in the UK recognises me as competent to be a referrer and a prescriber but in Ireland, that will not be the case. This involves the same directive and the same training and involves the same European guidelines. However, there is a very different interpretation in Ireland, one which is based on defined professions as opposed to competencies.

We have submitted a proposal to the Minister for Health, Deputy Harris, which will allow him to regulate us within the regulations. It would provide a very simple measure which would allow this to be resolved promptly. In due course, perhaps regulation under CORU and the Health and Social Care Professionals Act 2005 will provide a more comprehensive resolution for this. We have not had any feedback to date on what information to bring to the table. We have offered information on our undergraduate training and continuous professional development but to date there has been radio silence. We are not getting any feedback from the Department on our request. It has not been a "No" and it has not been a "Yes".

Do the witnesses have any figures on the number of X-rays per head of population seen by chiropractors in Ireland versus the number seen in other countries? If chiropractors have 10,000 patients, are they all getting three X-rays in a lifetime? How does that compare internationally? Is there any indication that there is an overuse of X-ray or any sort of imaging in the Irish context? I am conscious of a recent article in The Lancet, which is considered a very well respected journal. The article referred to over-prescription of X-rays and magnetic resonance imaging, MRI. I am summarising a large document here. It does not just refer to chiropractors but to all referrals. The article claimed there is no improvement in outcomes in the majority of cases and an increase in interventions and surgeries. This is part of a broader discussion around overdiagnosis. Do the witnesses have any evidence that chiropractors in Ireland are X-raying people more than in other jurisdictions?

Mr. James Cosgrave

I do not have comparative data. I do not have any evidence either way on that. I can tell the Deputy-----

No data at all - so we do not know if it is true or not. Do the witnesses have any data on it?

Mr. James Cosgrave

I do not have any data on that.

Ms Lyndsey O'Leary

We know how many exposures take place per year. The HSE did an audit on us in 2011. It found that 3,000 X-rays were taken by chiropractors in Ireland. If that is compared with some information I got this morning to the effect that 2 million X-rays are taken per year in Ireland, we find that 3,000 is 0.0015% of the total. It is not as though we are X-raying every patient who comes through the door. That was a HSE audit in 2011.

Mr. James Cosgrave

I might add that the dosage per examination from chiropractors falls somewhere between dental and medical examinations. Obviously we are not referring for or carrying out computerised tomography, CAT, scans. We are referring for plain film radiography, so the dosage is thought to be in or around 0.1 mSv.

Mr. Tony Accardi

X-rays are normally taken on the first visit of a new patient. The 130 chiropractors in the country may have up to 50,000 new patient visits a year between them. With only 3,000 being X-rayed, that is quite a small percentage.

In the witnesses' estimation, what is the difference in attitude between Ireland and the UK in relation to X-ray facilities for chiropractors? What is the fundamental difference between the two jurisdictions?

Mr. Richard Brown

One question is what are the fundamental differences between the situation here in Ireland and the situation 60 miles up the road in Northern Ireland. The fundamental difference is that in the United Kingdom, chiropractors are permitted to take and read X-rays. They are permitted to operate X-ray units in their clinics, as well as to refer patients to other facilities for diagnostic imaging. They are entitled to do both of those things and they do so. Following on from Deputy O'Connell's questions-----

To go back to that question, what is the underlying reason for that?

That was actually the crux of my question. I know there is a difference in practice. Chiropractors are entitled to make the referrals in Newry but they may not be so entitled in Dundalk, although they may have the same qualifications and practice at the same level. Mr. Cosgrave made the point that if he went to the North he would be completely covered to practise, whereas he may not be in this State. That is what I was trying to get at. There may be no difference in the person but there is a difference in what the law will and will not allow them to do.

Mr. Richard Brown

The Deputy is absolutely correct. That is the scenario. On the surface it seems rather perverse that one can jump in a car and get an X-ray at a chiropractor in the North without any problems, as one can here at present. Under the proposals, however, the situation would be dramatically different. I was particularly keen to outline the educational institutions in the UK because many of the members of the CAI are graduates of UK institutions.

They have undergone exactly the same level of training as chiropractors who remained in the UK to practise, with the rights that they have to practise in terms of ionising radiation and practice generally. The proposals would create quite a significant differential in the competency and scope of practice in exercising the competency between chiropractors practising in Ireland and chiropractors in the United Kingdom, who, essentially, have undergone exactly the same training from exactly the same institutions.

Are chiropractors in the UK or Northern Ireland regulated differently from those in the Republic?

Mr. Richard Brown

The regulation in the United Kingdom is under the Chiropractors Act 1994 which provided for establishment of the General Chiropractic Council. The General Chiropractic Council is the statutory regulator of the chiropractic profession.

Is the fundamental difference that there is a statutory regulatory authority in the United Kingdom but there is not here?

Mr. Richard Brown

That is a difference, but the enforcement of ionising radiation regulations in the UK, although it is quoted within the Chiropractors Act and the code of practice, falls to the Health and Safety Executive in the UK. In terms of compliance, the Health and Safety Executive is the enforcing agency. My colleagues can speak more on compliance enforcement here in Ireland.

On that point, the submission from the faculty of radiologists states, "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." Is the fundamental difference that there is not enforcement here but there is elsewhere, and this regulation will bring in enforcement?

Ms Olivia O'Leary Veal

At present, we are covered under two separate pieces of legislation that govern ionising radiation. SI 125 of 2000 would concern the holding and monitoring, and licensing, of the equipment. However, as a profession, we lack the protection of the statutory regulation here. That precludes us from being included in the regulations as they stand currently. In the UK, the two processes are separate. Originally, when the Chiropractors Act was brought into the UK, it was not mandated that statutory regulation was necessary for chiropractors to be able to X-ray. We believe this is a disadvantage to us as a profession as we stand because there is no statutory protection afforded to us. We are allied to the best practice of voluntary regulation which is based on the UK model of statutory regulation. The Chiropractic Association of Ireland would represent the chiropractors in the implementation of the necessary clinical governance and fitness to practise in the absence of there being a statutory model.

Most practitioners in any field have complaints from time to time. Would they be aware of any complaints about the operation of X-ray equipment, the carrying out of X-rays or the referral for X-rays?

In the context of giving us an idea of what preparation they could have made or have made, have they been aware that this directive has been coming down the tracks for some time?

Mr. James Cosgrave

If I could speak first as a referrer rather than a X-ray taker, the ability to refer is fundamental. In the event of a significant issue arising on an X-ray, it is important that the pathways are in place to ensure the patient gets to see the correct person, consultant or GP without delay. Great effort is taken to ensure that there is no delay in onward referral when indicated and hence I have never experienced a complaint arising as a result of non-referral. In terms of onward referral, I would have a good relationship with the other consultants my patients might require to see in the area.

Nonetheless, with 600,000 patient visits a year, somebody will be unhappy about something. That could be the patient who has been kept waiting or did not get better or the patient felt he or she got worse. I am not aware of complaints that have arisen specifically out of a delayed referral in anything to do with X-ray. In the event of an X-ray that is deemed to be non-diagnostic, for instance, which is what I think the Deputy is asking, any time there is an issue raised to the association, the association deals with it promptly and urgently, contacts the member involved and discusses the situation to find out what has happened and what is the source of the complaint.

On behalf of the committee, I thank the witnesses for coming in to give evidence this morning on behalf of the Chiropractic Association of Ireland.

The committee will suspend for a few moments to allow the next group of witnesses to come in.

Sitting suspended at 12.45 p.m. and resumed at 12.52 p.m.

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 the 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.

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.

The first three members from whom I will take questions are Deputies O'Reilly and Durkan and Senator Colm Burke.

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 practise here but will be able to go 10 miles up the road to practise 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 practise 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?

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.

I call Senator Colm Burke.

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.

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 chiropractice 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 practise 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.

Dr. Paddy Gilligan

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

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.

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.

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.

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.

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

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.

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.

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.

Dr. Holohan referred to chiropractors as not being part of the formal healthcare system.

Dr. Tony Holohan

Yes.

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.

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.

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.

I acknowledge that. However, some radiologists work in a private capacity.

Dr. Tony Holohan

That is a different matter.

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.

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.

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.

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 to act 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.

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-----

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.

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.

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.

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.

-----need to be consulted is an obvious question-----

Dr. Tony Holohan

We are not-----

-----that we need-----

Dr. Tony Holohan

We sought to consult them.

The Department sought to consult them.

Dr. Tony Holohan

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

They did not respond.

Dr. Tony Holohan

No.

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.

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.

Dr. Tony Holohan

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

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.

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.

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.

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 practise 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.

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.

The joint committee adjourned at 1.50 p.m. until 9 a.m. on Wednesday, 2 May 2018.
Top
Share