I move amendment No. 1:
In page 8, subsection (1), line 22, after "section 13” to insert the following:
"and "registered" and connected expressions shall be construed accordingly".
This is a technical amendment to clarify the definition of "registered".
I move amendment No. 2:
In page 9, lines 17 to 19, to delete subsection (1) and substitute the following:
"5.—(1) Notwithstanding the repeal by section 4 of the Pharmacy (Ireland) Act 1875, the Pharmaceutical Society of Ireland shall continue in being subject to and as reconstituted by this Act.".
I tabled the amendment to preserve the continuity of the existence of the society. It does not seem necessary and my legal advice is it should not be necessary for the Minister to insist on dissolving and re-establishing the existing society. There are plenty of examples of bodies established under old legislation that have simply continued when their founding legislation is repealed. It would be much simpler legally to work on that basis and to get rid of the fiction of dissolution and immediate re-establishment which the Minister proposes in the Bill.
Section 5 provides for the dissolution of the old society and the establishment of the new one. There is no discontinuity. A similar situation was provided for in sections 6 and 11 of the Veterinary Practice Act 2005. This is done at the request of the Pharmaceutical Society of Ireland and on the advice of the Attorney General. We believe there is no discontinuity.
Did the Minister consider the alternative of simply continuing?
Does the Deputy mean the alternative of not dissolving it? We did, but for a host of technical and legal reasons related to how the society is constituted, this is the strong advice we have received from the society as well as our legal advisers. I can provide the Deputy with a background briefing in this regard.
I will withdraw the amendment with a view to reintroducing it on Report Stage.
I move amendment No. 3:
In page 9, subsection (2), line 20, after "as" to insert the following:
"Cumann Cógaiseoirí na hÉireann, or, in the English language,".
This amendment, which is in my name and that of Deputy McManus, was put forward in the Seanad by the Labour Party and I agreed to consider it. I am happy to accept it.
I thank the Minister.
Amendments Nos. 4 to 6, inclusive, 19, 20, 25, 30, 31, 34 and 35 are related and may be discussed together.
I move amendment No. 4:
In page 12, between lines 4 and 5, to insert the following subsection:
"(3) Without prejudice to the generality of subsection (2)(a)(ii), the Society’s duty under that provision shall include determining and applying criteria for registration which require compliance with any codes of conduct drawn up for pharmacists and undertakings to comply with such codes.”.
It is impossible to do justice to this Bill for a number of reasons. Combining all of these amendments is simply adding to the difficulty. I must accept the Chair's ruling in this regard but I want to protest very strongly that it is not the way for legislation to be passed through the Oireachtas. The Bill was published without a due period of consideration. It then went to the Seanad, where amendments were introduced at the eleventh hour. The next morning in the Dáil, Deputies were given very limited opportunity to speak on Second Stage of a Bill that we had not had any chance to consider fully. Now, we are in a position where amendments are being bunched together in a way that will lead to further lack of scrutiny.
I am simply operating on the advice I am given. If the Deputy wants to separate the amendments, I have no problem with that and I am sure the Minister will not have a problem either. I am trying to be as fair as possible.
I appreciate that. However, this gives an indication that the normal procedures, which include bringing amendments together, create their own difficulties because of the approach of the Government. This is a Bill we all want to see passed. It is not as if there is deep conflict between the Government and the Opposition. This problem also arises in the area of justice legislation.
Amendment No. 4 concerns the drawing up of codes of conduct and the undertakings to comply with such codes. This is central to the concerns that have been expressed. I want to make clear that amendments I have tabled have largely come from interested parties because I am not in a position to do anything more because of the time constraints. As I have only just seen the grouping of the amendments, I cannot judge properly, but I know amendments I have tabled have been overtaken by the Minister and that some I sought to have withdrawn have not been withdrawn by the Bills Office. I can understand why because the Bill has been going at a breakneck speed. I am trying to play catch-up in terms of amendments I have withdrawn but which have not been withdrawn. We will reach them at some point, at which time I will withdraw them because they should not be there in the first place. It is impossible to do our job properly, which I deeply regret. I consider the Government irresponsible in this regard.
With regard to the amendment, there is an issue with regard to codes of conduct governing arrangements or relationships that have as their ultimate objective the referral of patients and business to particular pharmacies. We need to address this, and the Minister attempted to address it in her Seanad amendment.
We must understand the impact of what is happening in this regard is quite significant for certain people. For example, the Minister and the Opposition have been lobbied by general practitioners who have already embarked on the development of primary care centres. As a lack of thought went into the primary care strategy with regard to dealing with this issue at an early date, we now have GPs who are in difficulties as a result of the definition of the separation that is required between medical practitioner and pharmacist.
What is interesting about the approach the Minister has taken, as far as I can read it, is that while doctors are running into difficulties, the major developers, such as Touchstone, which is growing at an incredible rate and is like an octopus expanding its tentacles in all directions, are not impacted upon by the Bill, which seems extraordinary. I have concerns about the commercialisation of primary care by for-profit organisations, which is something quite separate and as important as the separation between GP and pharmacist in terms of beneficial arrangements. Despite this, it seems the Minister has not dealt with this issue.
The amendment is about determining the criteria of registration that require compliance with any codes of conduct. That is the central work of the society. I ask that the Minister would consider the amendment.
With regard to the Deputy's comments on the rushed nature of legislation, I accept it is rushed and I indicated in both the Dáil Second Stage debate last Friday and in the Seanad that in an ideal world, one would like to take much longer to deal with the legislation. The Bill has been promised for some time. In fact, there is a man in the Visitors Gallery who was the president of the society 27 years ago when he was promised the legislation in a couple of months. His son is now the president of the society. That point proves the length of time this legislation has been in preparation. The Bill is urgent because, effectively, we do not have any fitness to practice regime for pharmacists or pharmacies.
With regard to the beneficial interest, everybody accepts the clinical decision to prescribe should be made on the basis of medical need and on no other basis, and that there should not be any economic benefit to a doctor in prescribing. If we accept that principle, we have to see how, within the Constitution, we can deal with this issue.
The provisions inserted in the Seanad were inserted after very careful legal advice from the Attorney General and they apply to everybody. While I will not mention any company in particular, if a company such as that mentioned by the Deputy is satisfied in this regard, I do not understand why it expressed such unhappiness in the past week or why many people have lobbied so intensively about this. On one level, my efforts in this Bill have been misunderstood. It does not specify that doctors and pharmacists cannot co-locate in the same building, that doctors may not own pharmacies or that pharmacists cannot own doctors' surgeries. The point is that a doctor cannot have a beneficial interest in a pharmacy. For example, doctors cannot gain by knocking on pharmacists' doors to state that 20% of the latter's prescriptions came from the former, who now want their profit. This cannot happen and no such arrangement can exist between the prescriber and the dispenser.
In cases in which such arrangements exist, ongoing behaviour of this type can be the subject of a complaint to the pharmaceutical society, which will deal with it under fitness to practice. However, people have asked me about the implications when a normal relationship exists in which a building is owned or rented and normal market conditions apply. Clearly, it is a highly attractive proposition for the owner of a premises to attract seven or eight doctors to work there and people are entitled to make special arrangements if that can be achieved. The location of a florist beside nine doctors would bring much business to the former. However, the difference between being a florist and being a pharmacist is that a pharmacy depends for much of its business on prescriptions, which constitute its lifeblood. I understand that on average, approximately 70% of those who visit doctors leave with a prescription. The Bill will proscribe activities in which doctors have anything to gain by prescribing or in which pharmacies are run on the basis of profit returning to doctors.
However, there is nothing to prevent doctors coming together. Moreover, the primary care strategy never envisaged a pharmacy going into the same building. It envisaged a network in which all pharmacists would be involved. Clearly a scenario whereby a town had four pharmacies, only one of which was involved in the primary care strategy would not make sense. The primary care strategy was concerned with bringing together health care professionals to work with doctors and pharmacists in the interests of patients.
Some have stated the provisions I have introduced are too weak, while others have claimed they will bring the entire house down. However, where a normal relationship exists, people have nothing to worry about in this regard. I wish to make clear that this legislation will not end arrangements that have been put in place on a purely commercial basis. However, cases in which a doctor gains as a result of the volume of business achieved by a pharmacy based on the doctor's prescribing activities will be matters to be considered under fitness to practice. Such a matter would require examination and my advice is that doctors who are in relationships with pharmacists and vice versa should seek reassurance from the Pharmaceutical Society of Ireland.
Regulations must be introduced after this legislation passes. As it may take people some time to regularise their legal arrangements, I will be reasonable in this regard. Moreover, I understand that two or three people in Ireland are both doctors and pharmacists. I had not been aware of this and they practice as both, which is prohibited in the United Kingdom. In future, it will not be desirable in Ireland to be able to do so. I wish to take advice on this issue from the Pharmaceutical Society of Ireland and the Attorney General before Report Stage to ensure that anything I do in this respect will be fair, reasonable and proportionate.
I introduced some amendments on foot of the review group's findings. I refer to the issue of a separate entrance, which, having considered all the issues, the review group regarded as being very important. Clearly, as far as existing pharmacies that do not have such an entrance are concerned, I will not force them to change their entrance or building. Normal practice is that what is there is there. However, ongoing relationships will be affected by the legislation and anyone can make a complaint if he or she believes it to be warranted. In serious cases, the society can ascertain under fitness to practice whether a relationship that is not kosher exists. This would constitute misbehaviour and would constitute grounds for holding a fitness to practice inquiry by either the Pharmaceutical Society of Ireland or the Medical Council, which is the regulator for doctors. Obviously in the case of someone who is practising as both, it is a matter for both regulatory bodies.
I call Deputy Gormley, followed by Deputy Twomey.
I thank the Minister for her reply in which she went some way towards explaining the issues and perhaps allaying—
I apologise. I erred in that I must bring in Deputy Twomey first, as he has another engagement. I apologise to both Deputies.
The Minister's comments regarding this legislation being rushed are true and it has caused much confusion among both pharmacists and doctors. Moreover, some of her legislative proposals are not correct. For example, the idea that someone who has worked previously as a pharmacist will not be able to sit on the council of the Pharmaceutical Society of Ireland sounds ridiculous. Essentially, someone who is no longer a working pharmacist is being banned from membership of the lay majority on the Pharmaceutical Society of Ireland council. This is foolish and somewhat over the top. Moreover, elements of this legislation almost suggest that any relationship between doctors and pharmacists is somewhat criminal. Some of the Bill's language makes out that if one puts doctors and pharmacists together in any sort of business relationship, criminal activity will ensue therefrom.
That is not correct.
Even terms like "beneficial interest" and "market rates" employed by the Minister are not unclear.
This is a fitness to practise issue rather than a criminal issue.
In some respects, it could feel like the latter to the pharmacists and doctors involved, who will be brought before their respective councils in respect of issues that the Minister has stated could represent basic commercial partnerships between the two.
The Medical Council and the Pharmaceutical Society of Ireland have a very strong role in regulating both professions and this legislation will strengthen the role of the Pharmaceutical Society of Ireland. This is extremely important because it must be able to stop the practice of bad pharmacists. Moreover, the Medical Council's role is to ensure that bad doctors are also stopped. Regulations have been issued by the Medical Council regarding some of these issues and the Pharmaceutical Society of Ireland had close connections with some of the bad practices that are taking place in respect of doctors and pharmacists' activities. Is it the Minister's opinion that neither professional body can do its job? How serious is the problem?
There is a perception that this legislation is targeted at those pharmacists and doctors who have any form of close relationship with one another. This is how it appears and on the legislation's introduction to the Seanad last Tuesday week, the hard line amendments tabled by the Minister on Thursday night were absent. Something changed and the Select Committee on Health and Children should receive a report on the nature of the serious concerns that exist. I am aware of some sharp practices and am unsure whether this legislation would stop them. The Minister is also aware that things are going wrong.
However, I do not consider it to be such a significant problem. Some pharmacists have primary care centres out of which doctors work and vice versa. There is a need for regulations to ensure this is of benefit to patients’ interests. However, I am unsure whether the proposed legislation will protect patients in the manner suggested by the Minister. It might be rather heavy-handed and this issue should be considered more carefully.
The Minister has steered the Bill through the Dáil extremely rapidly and neither Deputy McManus nor any other member of this committee has had a proper opportunity to consider its potential outcomes. As members considered the Medical Practitioners Bill 2007 in the House last night, the Child Care (Amendment) Bill 2006 on Tuesday and the Health Bill 2006 establishing the Health Information and Quality Authority, HIQA, last week, issues cropped up increasingly regarding this Bill about which they have concerns. Essentially however, the Minister is pounding this through. Members of the committee should be provided with a report regarding complaints of serious misconduct of which the Minister is aware and other problems. For example, an issue has arisen in that third parties may be partially exempt from this legislation if they are neither a doctor nor a pharmacist and are not conducting business together.
I have already been made aware that some groups involved in this feel there is a loophole in respect of making preferential arrangements. The issue arises as to what a market rate is. For example, a very astute member of the HSE is well able to work good deals for the HSE. Could the Minister tell me whether this person is getting below or above market rates for the HSE in respect of primary care centres? Where would the HSE stand on issues like this?
If the Minister is to take this heavy-handed approach towards pharmacists and doctors, there is serious need for us to know what is going on. At the end of the day, the person who matters most is the patient. One of the things this legislation does not cover relates to doctors and pharmacists who work closely together, which is one of the reasons Fine Gael and the Labour Party have put forward the idea of a patient safety authority.
If somebody has a complaint about a relationship such as this, he or she must make the complaint through Part 9 of the HSE legislation, go to the Pharmaceutical Society of Ireland to complain about the pharmacist and go to the Medical Council to make a complaint about the doctor. I do not see how this will help patients when they are trying to work their way through this minefield of regulations and legislation.
If we are really talking about this legislation protecting the patient, the best way forward is to give the Medical Council and the Pharmaceutical Society of Ireland the power to implement their own regulations and regulate their own members. To some degree, that is being done quite effectively. However, this seems to exclude third parties from involvement. One might almost call it sharp practice. I have only heard about many of these things through the grapevine, but the Minister needs to present a strong report to the members of the committee before Report Stage about the things that are going wrong and the complaints being received by the Minister about people abusing their positions, be it ripping off patients or the taxpayer or involvement in criminal activity. The members of the committee need to know this because the Minister is, to some extent, discriminating against doctors and pharmacists in some of the approaches she is taking in this legislation and is treating them almost as though they are criminals.
I do not think the situation is that bad. I know there are problems, but I wonder what the basis of this legislation is and about the reason the Minister introduced some of these amendments last Thursday night. I have also seen legal opinion with regard to the idea of beneficial interest and market rates. Legal opinion is not as crystal clear as the Minister makes out. There are issues around contract and constitutional law. The Minister might have concerns about these issues but hopes this might all just get washed away and that this legislation will quickly pass through here and the Dáil because we are all so involved in getting re-elected within the next seven weeks.
This legislation is seriously flawed and the Minister needs to give us a more in-depth explanatory memorandum about what she is doing here, particularly in respect of what she regards as problems. The Government failed to implement the primary care strategy, which, as the Minister pointed out, did not envisage any involvement of the pharmacist in the primary care centre. One company originated this idea. When the Minister opened some of these centres and even when she addressed the Irish Medical Organisation in Killarney, she lauded the fact that doctors and pharmacists were working together in such close proximity. She is now bringing through legislation which tells us that they are all a bunch of criminals. This was a policy of which the Minister seemed to be very much in favour. Something is seriously going amiss here about which we are not being made aware.
If the Deputy wants me to give an example—
I would like to bring in two other members on the same issue.
I will try to be as brief as possible. The Minister is aware that because of the rushed nature of this legislation and because amendments were put down on Thursday, there has been a panic reaction from GPs who have just discovered that, as they see it, their livelihood could be at stake. I want some clarification because I certainly accept the principle enunciated by the Minister here this morning, which is that prescribing should be done on the basis of medical need and not on the basis of any sort of beneficial interest. Most people on this committee would accept that.
There is a need for some clarification. I accept that the Minister has gone some way towards explaining the issues this morning, there is still a requirement for explanation in respect of the concept of beneficial interest. Does it mean a GP must have actual ownership or part ownership of the pharmacy or does it mean that if a GP or a number of GPs get together, they cannot lease out a room to a pharmacist? I understand some of them have taken out very substantial loans to get together for these co-operatives. Could the Minister explain this to the committee because from what I can gather, she seems to accept that a pharmacy can be in the same building as a GP co-operative?
There seem to be a number of anomalies here, which have been touched on by Deputy McManus. It seems that chains like Touchstone are not precluded. Do they have a beneficial interest if they own the entire building or are they in the same category as GPs?
Another anomaly touched on by a number of lobbying GPs is the fact that some GPs already have practices above pharmacies. I do not think one can say they have any relationship with the pharmacies. Can the Minister tell us whether there is no beneficial interest here and in respect of leasing, in particular? This is one area where I want some explanation.
I join others in welcoming the Minister. In particular, I thank her for her clarification. All of us agree that the relationship between pharmacists and doctors must be clearly defined and of the highest ethical standards. There cannot be any inducement for a pharmacist or doctor to act in any way other than in accordance with the highest ethical standards.
In particular, I welcome the Minister's statement that co-location can exist. The word "market value" is causing some distress to some people, particularly some GPs who have invested money in building modern primary care centres. Obviously, if a room in a health or medical centre was leased to a hairdresser, the market value would be considerably less than if it was leased to a pharmacist. Perhaps the Minister might clarify that?
Some legal opinion states that there might be potential problems down the road. Has the Minister received any legal opinion from the Attorney General on this matter and, if so, can she share it with us?
I assure the committee, particularly Deputy Twomey, who is also a GP, that I am not seeking in this legislation to criminalise doctors or pharmacists. On the contrary, I am trying to put in place an appropriate fitness to practise regime for the pharmacy profession. It is as much about supporting the profession as it is about protecting the public.
For many years, the profession has sought powers of this kind. We are introducing the legislation because the pharmaceutical society is effectively powerless. I received a complaint from a pharmacist about another pharmacist who was receiving faxed prescriptions from a doctor, but the society does not seem to have the power to deal with that unfair practice under the law. A doctor was able to go to a pharmacist and say that, because 20% of the latter's business was gained by virtue of the doctor's presence, the former wanted to share in the profits. Those situations cannot be allowed. Doctors can own or rent pharmacy premises, but the decision to prescribe must be uncontaminated by any economic benefit. If the doctor is the landlord, he or she cannot ask for more money if the volume prescribed is low rather than high. It must be a normal rental relationship.
I accept Deputy Devins's point. Having eight, five or four doctors adjoining a pharmacy is different than a florist or a butcher adjoining a pharmacy. While there are many more people in the first case, the pharmacist's livelihood relies on the doctors. It is clearly a different market situation.
Anyone who has entered into a legal arrangement in good faith will not be affected by this provision, but ongoing behaviour will be affected. Arrangements through which doctors can get shares in pharmacy profits must be brought to an end. There will be a period between the passing of the Bill and the making of regulations on foot of the legislation.
Is it fair or right if, of eight pharmacists in a large town, one is put in an advantageous position vis-à-vis the others? The closer pharmacists are to doctors, the more convenient it is for patients and the better they do. For as long as I can remember, pharmacies tended to be close to doctors. We will not stop that practice or prevent people co-locating. From a legal or constitutional perspective, it would be impossible to do so.
It is good that doctors and pharmacists work together closely. The patient can get the benefit of a second opinion because a pharmacist has a great deal of information about the drugs. Recently, I was told in the House about a Deputy's daughter who had been prescribed X, but was told by the pharmacist that she was too young and would get better. The child was not about to die, but the Deputy believed it was good to have that second opinion. The Deputy, who was not a member of the Government parties, praised the pharmacist.
Independence can be good, but not if the pharmacists and doctors receive benefits rather than rental incomes through their connections. Anyone can own premises. For example, many doctors own pharmacies and many pharmacists might own doctors' surgeries. Many people, including Deputies, own properties, but no one will stop the situations referred to in my example. The Bill will apply to all of those arrangements regardless of who the owners are.
We are regulating the pharmacy profession. If a pharmacist enters into arrangements that, on examination by the society on foot of a complaint, could not be regarded as normal market arrangements, the society can carry out an investigation. The terms "normal market arrangements" and "beneficial interest" are defined in case law, such as in the recent taxi regulation case. Some of our provisions include beneficial interest, but they are not exhaustive. We must provide flexibility because market situations differ. Having a facility on Grafton Street is more expensive than having one in Belmullet. Whether one is a pharmacist, doctor, florist or something else, properties are dearer in some places than others. We are legislating in a way that is flexible, reasonable, proportionate and governed by patient safety and fair competition.
For the past few year years, some of the Deputies in attendance have asked me for this legislation, but that situation seems to have suddenly changed in three days. Like others, I have received telephone calls on the matter. It is good that people in a democracy get involved in the legislative process and make their points of view known.
I like to believe I am fair and reasonable in what I am doing. I am not trying to stop good things happening, new premises or investments. Usually, I am attacked in the committee for encouraging private investment in health care, but I am now being attacked because I am apparently going to close that investment down. I am in favour of doctors, pharmacists and others investing in health facilities and improving them provided it is all done without any economic benefit for the prescriber in prescribing drugs to patients. That is the only event we must ensure does not occur.
If a group of general practitioners developing a medical centre charges a premium rent because there are six or seven GPs there, could it not be argued that the rent received from a pharmacy within the same development is a beneficial interest?
The GPs could get a premium rent from the pharmacy even if they own the business in the building next door. We are not prescribing—
It is important to clarify that point because GPs have joined together.
For that reason, the legislation deals with issues of conflict of interest and fitness to practise instead of detailing a large prescriptive list concerning what is out or in. It would be impossible to deal with legislation of that type. If the society gets a complaint, we are allowing it to investigate and determine whether something was reasonable. I will speak to the society about how, where these arrangements exist, it would be good for pharmacists to contact the society to be reassured. The same is the case in respect of doctors and the medical council.
I will develop that point. We accept that a pharmacy in a medical centre would be in a wonderful position and, as such, a premium rent being charged would be justifiable. One could probably charge a good rent for another business such as a newsagent located in the centre, but the amount would not be as attractive as it would in the case of a pharmacy. Were I a pharmacist in the town, could I argue that the GP developing the medical centre and charging a higher rent has a beneficial interest in the medical centre's pharmacy? It is important that GPs setting up medical centres know where they stand. Would my complaint hold up?
If it is a market rent, the answer is "No". Previously, doctors were single operators, but the more doctors beside a pharmacist, the more beneficial it is because pharmacists rely on doctors. Some 70% of doctors' patients are given prescriptions. The closer pharmacists are to doctors, the greater the market value. We are not preventing that from being the case. However, we are preventing arrangements whereby a doctor can have a share in a pharmacist's profits. The rent will be struck for a number of years. The HSE will insist on GMS prescriptions and information being provided to patients outlining that they can go to any pharmacy, which is important.
That is good.
If the pharmacist does not get a volume of business because people stick with whoever they were with previously, the GP cannot gain.
That is clear.
GPs may lose out during a rent review, but that is a different issue. They cannot gain from their prescribing practices.
Why did the Minister ask whether it would be unfair for one of a town's eight pharmacies to be co-located in a medical centre?
I did not say "co-located". I asked whether it was fair that the pharmacy would have unfavourable arrangements. Likewise, doctors.
Does "unfavourable" include the rent issue?
No. For example, it would be unfavourable if six doctors direct their patients to a single pharmacy because they will get a share of the profits. That would be grossly unfair.
If there is no arrangement and 50% or 70% of the doctors' patients still go to the pharmacy, it is not unfair. Is that the position?
Yes. If there is no direction, unethical behaviour, dispensing to benefit the pharmacy or gain by virtue of whether the patient goes to that pharmacy, nothing is out of order.
There is no discrimination between a GP and a lay person, such as myself, developing a medical centre. The same rules apply.
It is the same.
If there is a complaint about the rent or lease, who decides whether the situation is unfair?
As the matter is being addressed in terms of fitness to practise, if an individual decides an unethical arrangement between doctors and pharmacists is in place, he or she should report it to the pharmaceutical society, Medical Council or both. It is a matter for the society or the council to investigate the complaint. Ultimately it must be decided in court. The legal bar will be high. All fitness to practise cases can be determined in court.
I do not know whether the Minister is being naive or obtuse. If what the Minister states is true it is remarkable that not one primary care centre established by the HSE contains a pharmacy. If it is good public policy the pharmacy requirement should be incorporated into HSE centres. It is not being included for practical reasons. Pharmacies are located in primary care centres to generate profit. Presentations given by developers interested in these projects refer to the general practitioner as the honey pot that can generate trade for the pharmacists. Money is made in this way.
Deputy Cooper-Flynn has made the point that a pharmacy within a primary care centre must pay a higher rate of rent because the arrangement will generate more business. That is the way the world goes around. The market value of a pharmacy within a primary care centre is higher than one outside a primary care centre. The concern is that rental arrangements between the developer or owner of the primary care centre and the pharmacy will be generous because of the amount of money to be made. The Minister for Health and Children does not recognise the way this development is taking place. Companies such as Touchstone Healthcare make a €500 million investment in primary care because they can see financial benefits for their investors. The opening exists because of the lack of clarity in public policy. This may be ideological if the Minister wants the private operators to work in the area but I believe it is due to a failure to address this issue.
I can understand GPs becoming involved in such projects. They do not benefit from the same tax breaks as private hospital developers. They wish to improve services and accommodation. There is a commercialisation drift. One can see a company has mushroomed because of opportunities available. The legislation does not address the matter.
People can choose their doctor or pharmacist but, in reality, arrangements are laid out for people when they are in a primary care centre. We have heard stories of key money being sought and doctors' prescribing levels being an issue. This is worrying. I am not anti-competition, that is not my primary concern. I am concerned about the impact on the patient. Ireland is considered a country that is wide open for pharmaceutical companies to develop business. We do not have over prescription in this country, our level of medicine use is modest in comparison to other European countries. The opening to the market is through primary care centres. It is important to get this Bill right. If the relationship between doctors and pharmacists should be closer, why is it not established in HSE primary care centres?
Every member is aware of the lack of investment in primary care. Large companies with millions to spend and millions to make bring doctors into large centres. GPs are being squeezed in a pincer movement by the lack of Government investment in adequate primary care centres and, on the other side, by commercial companies bringing in doctors to compete with the established doctors. In response, doctors have sought to improve premises but the Government does not provide for it. The Medical Council has seen the dangers of co-location and has issued guidelines. These state that any suggestion that a doctor's judgment or behaviour is being influenced by the arrangements outlined will be investigated fully and may lead to holding an inquiry by the fitness to practise committee. Why is it necessary to penalise doctors for something that no one else, including the Government, is doing for them? Why is the Minister proceeding with this Bill rather than allowing the Medical Council to carry out its job? Doctors who have invested heavily in fulfilling needs are being treated in an oppressive manner.
I wrote to the Medical Council about the last point made by Deputy Cowley. The response is what Deputy Cowley cited.
I am not penalising doctors. If people have nothing to hide, they have nothing to worry about. I never stated it was a good idea to have doctors in the same facility as pharmacists. The primary care strategy never envisaged this. It envisaged doctors, public health nurses, social workers, physiotherapists and pharmacists working as a team. It is a good idea that doctors, pharmacists and other health care professionals work together but this is a different matter to co-location.
Is the Minister saying that it is not a good idea?
For as long as I can remember doctors and pharmacists have worked beside each other. We cannot legislate to stop that. It can be a good idea or a bad one, depending on arrangements. If excessive rents are charged, profits are shared or the centre is provided free of charge to the doctor the taxpayer will pay most of the cost in the end. For patient safety, ethical and financial reasons one must oppose this.
That is not included in the Bill.
Yes, it is. The Medical Council, in the case of doctors, and the Pharmaceutical Society of Ireland, in the case of pharmacists, will investigate such cases. We have explained what beneficial interest includes but it is not exhaustive. We do not state beneficial interest means what is stated and nothing else. We state it includes these things and others and it will be a matter for the fitness to practise inquiry. The legal bar must be high because ultimately these matters will be determined by the courts. Any untoward relationships and arrangements of a business kind on an ongoing basis between doctors as prescribers and pharmacists as dispensers will be an issue to be determined under fitness to practise. Different circumstances will apply in different situations. I have great faith and confidence in the society to conduct inquiries on a fair and transparent basis and deal with these ethical issues with the powers provided to it in this legislation.
Where do the relationships stand of a husband and wife or two siblings who are a doctor and pharmacist in the same area or a pharmacist employed by a GP in a primary care centre with a pharmacy?
The Minister is aware of third-party involvement with a primary care centres because she opened at least two. It is known in some cases that doctors pay a lower rent on their rooms. The basis for this is not specified but it is that the turnover from the pharmacy is the main cash generator of the primary care centre. When those rents come up for review I presume the Minister and the Revenue Commissioners will seek full market value on the rent of those rooms.
On Second Stage I raised the fact that some GPs dispense medication, mainly rural GPs who are a certain distance away from a pharmacy. I must let the Minister know this includes my wife who has a dispensing practice. What rules apply in this situation? The Minister stated future developments could mean a greater role for pharmacists in that they could be able to prescribe medication and in fact they can do so already. What impact will this legislation have on the dual roles of doctors and pharmacists?
It is impossible to let the HSE have great control on this because it is a serious interested partner in most of the new primary care centres. It is heavily involved in renting space whether or not pharmacies are involved. To protect patients should we establish a joint council between the PSI and the Medical Council to review all contracts for primary care centres? In this way no doctor or pharmacist will end up before a fitness to practice committee on the grounds he or she did not fully grasp the consequences of the contracts they signed with each other. Solicitors might draw up contracts without taking due cognisance of what is included in the legislation. Perhaps the right way to do this is not to prosecute and criminalise people over these arrangements but take the opportunity to establish such a joint council to examine contracts.
I still believe we have a serious need for a patient safety authority to link prescribing, dispensing, the practice of medicine and pharmacy and the operation of the HSE. This is a greater issue on patient safety. With regard to getting this legislation right, the reason we are extensively lobbied by GPs and pharmacists is nobody is quite sure what this Bill means, and that includes some Members of the Government as well as the Opposition.
Pharmacists can marry doctors and vice versa and there is no question of interfering with those arrangements. It is dealt with in the provisions covering family relationships and the same rules with regard to unethical behaviour apply in terms of fitness to practice.
I do not like to be personal but does Deputy Twomey's wife receive the drugs from the community pharmacy?
Yes.
Clearly this is a different situation because she does not have a beneficial interest in the business and so is not affected by this. I became aware only yesterday morning that two or three people in the country are both qualified doctors and pharmacists and have a pharmacy and medical practice. I wish to speak with the Pharmaceutical Society of Ireland and the Attorney General with regard to this and I want to flag the issue.
People will not be criminalised. Any legal arrangements made before the passage of the Bill are not affected by it. What will be affected is ongoing behaviour. Profit-sharing occurring in a pharmacy which is co-located with a medical practice would be affected as would excessive rents or discounts.
Contracts have already been made on that basis. Does the Minister state they will not be impacted on and only future ones will be affected?
Ongoing behaviour is impacted on.
If GPs moved into primary care centres on the basis of an inducement that the rent will be deliberately low will they be trapped?
Presumably for a period of time or forever. Is the Deputy asking whether they will pay no rent forever?
That is the whole point. It is the way it works in terms of developers.
A GP entering into an arrangement that he or she will prescribe in order to sustain the pharmacy or direct patients to the pharmacy will be prohibited by the Bill.
That will not be implicit.
That is not the way it works. It is upfront.
I understand profit-sharing arrangements are in place and they will be affected by this.
We do not want to pick out arrangements and state all of them are about profit sharing.
No, I know that.
Some GPs received cheaper rent on their premises, not on the explicit grounds that they would prescribe but the market arrangement was that the pharmacy had a better chance of making a profit if it had close proximity to a general practice. As the Minister clearly pointed out it is merely a business arrangement which developed. It was not written into the contracts that the GP promised to ensure the pharmacy has X turnover and to increase it by so much per year. The pharmacy was established and the GP was induced to come into the centre.
Legal arrangements already in place cannot be set aside. Clearly, if ongoing prescribing is influenced by getting a gain-----
That is wrong and everybody accepts it is illegal.
I wish to clarify a matter with regard to Deputy Twomey's spouse as my officials advise me I did not do so. The drugs in question come from a retail pharmacy and are not covered by these provisions. The GP's power to dispense is not affected and he or she has no economic gain or beneficial interest in the pharmacy down the road. The GP does not receive a share of the profits. He or she procures the drugs and dispenses them to the patient. It is for reasons of convenience.
The same theory applies to hospital pharmacists. They do not have a beneficial interest either.
That is correct.
Are they covered by the Bill?
They are covered by it because they are pharmacists. As I understand it, Deputy Twomey is referring to a doctor who dispenses under the GMS who procures the drugs, prescribes them and gives them to the patient.
Will the Minister clarify the situation whereby GPs agree to go into a primary care centre and a developer gives them a great deal so they pay low rent because they are the honeypot? The Minister is saying that if a time limit is set on the deal, those GPs will end up paying the full market value for their premises, even though the only reason they moved in was the offer of low rent from the developer.
If a legal arrangement is in place in perpetuity, that cannot be affected. We cannot undo the past or give retrospective effect to legal arrangements.
Most rental arrangements are reviewed after a certain period.
Perhaps.
Is the Minister saying it will be at the point of review?
It could be.
Sorry, "could" is not clear.
It is a matter for the regulatory body to decide whether the behaviour is appropriate or whether undue influence or economic benefits affected the doctor's prescribing and the pharmacist's dispensing. It would decide whether an economic relationship between the two influenced their behaviour.
It is all right for a developer to create the conditions that allow profits to be made by taking advantage of a private care centre.
The onus is on the professionals concerned. We are regulating pharmacists, although this provision also applies to doctors. We are not regulating developers. There is no regulatory body in Ireland for developers or property owners.
Therefore, we are absolutely correct in saying developers will continue to be able to take advantage of this arrangement.
No, they will not because the onus will be on the professional to abide by the legislation. The professional will be prohibited from entering into certain arrangements which do not meet normal market conditions if his or her behaviour is dictated by an economic interest in a business.
It is not necessarily a matter of behaviour, although that can enter into it.
If one prescribes because one has a beneficial interest in a pharmacy, that will be affected by this legislation.
There is no difference in whether a developer or anyone else owns the property.
We are regulating pharmacists not developers.
The legislation—
Clearly, in regulating this way, the legislation will have an impact on developers in terms of the arrangements they can make.
Would developers be impacted in the same way as GPs?
Yes, because the GP is a developer for this purpose. The GP is influenced in respect of his or her prescribing and beneficial interest in the business rather than in the development sense. It is not a matter of owning the building. A GP could own a shopping centre in which a doctor and three pharmacies are located. Dundrum shopping centre could be owned by GPs regardless of what this legislation provides for.
We are not discussing that.
What matters is whether the GP benefits by virtue of who dispenses the products. If he or she does so, that is covered by this legislation.
The GP benefits where a developer offers arrangements for GPs to come into a primary centre at low rent and with other benefits.
Yes.
The message is sign the contract before the Bill passes, make sure it is in perpetuity and it will be fine.
Normal market relationships are not affected by this Bill.
The whole point of this is defining what we are speaking about. In terms of the market, it makes enormous sense to locate GPs beside a pharmacy and not charge them rent.
If the pharmacy has to pay for that, it is not a normal market condition.
Of course it is a normal market condition.
It is not.
If there is no regulation, that is exactly what it is.
I agree that has been the case but from now on, if somebody constructs a building and offers a space which is paid for by a pharmacist, that is not a normal market situation. Under this legislation's fitness to practise regime, that can be investigated by the society.
A lay person would not be affected.
A lay person or any person can be involved. The Pharmaceutical Society of Ireland regulates pharmacists not developers or builders. The onus will be on the professionals entering these relationships to ensure proper behaviour and anyone who has doubts should seek the guidance of the society, which comprises a fair and reasonable body of people and possesses a range of expertise.
Who will make the complaint? If I am a lay developer who brings in a doctor at a low rent and a pharmacist at an excessive rent, who will say I am doing wrong?
Another pharmacist could complain, as could a doctor.
Would such a complaint stand up to scrutiny?
Complaints must be investigated.
Against whom would the complaints be made? In the case I described, a pharmacist may be complaining about a lay developer.
I do not know how many times I have to say this. The Pharmaceutical Society of Ireland will not be regulating developers, builders or Deputies. It will be regulating pharmacists and pharmacies. A pharmacist is obliged to make a complaint if he or she becomes aware of improper behaviour under this legislation.
Is that wrong?
We do not want somebody who prescribes drugs to have a beneficial interest in a business which dispenses drugs. For ethical and patient safety reasons, that should be an uncontaminated decision. We have to decide how we provide for that but it would be impossible to be very prescriptive in terms of covering all the possible arrangements. The alternative is the way I have approached the matter, with the advice of the Attorney General, which is to give the power to the regulatory bodies to deal it as a fitness to practise issue.
The society can investigate whether a normal business relationship exists, if the doctor or pharmacist owns the premises and if the rent is at normal market level. If somebody else owns the premises, the society can ask whether the doctor or pharmacist has entered into an arrangement which would not comply with normal market conditions. It will be a matter for the society to carry out its own research to determine that. I am certain that, if somebody is struck off the register as a result of these provisions, the case would end up in the High Court and the legal bar would be set high, so the society would act in this area only after carrying out extensive investigation and research. We are not trying to criminalise anybody; we are simply trying to put in place a regime which will meet public and patient safety, ethical requirements and fair standards of competition, which everybody understands and which is transparent and open to investigation.
I agree with much of what the Minister said. However, I am concerned that large numbers of medical centres will be owned in the future by private operators who are neither GPs nor pharmacists, whereas the latter will be prohibited from establishing centres.
The onus in this legislation is on doctors and pharmacists to enter into appropriate arrangements. Whether they enter these arrangements with a developer, a florist or Dunnes Stores is irrelevant because only their behaviour will be subject to investigation.
It is possible that the behaviour of pharmacists and GPs would be acceptable in an arrangement with a private developer but not where a GP set up the centre.
No.
It could be argued that a private developer who charged an exorbitant rent to a pharmacist would not be in the wrong if that is what the market dictated.
The society will decide in the case of the pharmacist whether a payment was excessive.
That is impossible to determine.
We cannot legislate to decide market rents in every situation.
Two shops on a street in my home town could be charged vastly different rents even though they have the same square footage and are only 50 yd. apart.
The Minister has not answered my question on whether she has concerns about the legislation in regard to the possibility that pharmacists may be able to prescribe as well as dispense within the next ten years. Has she given any consideration to establishing a joint council between the Medical Council and the Pharmaceutical Society of Ireland which would review all contracts? That might answer some of the concerns raised. Deputy Flynn is not far off the point because it is not illegal to charge GPs low rent if the landlord is not a pharmacist or a doctor.
We are not trying to stop a person buying Grafton Street and setting the rent for No. 1 at a certain amount and the rent for No. 10 at another. If the market rent for a particular building in a particular place is determined by the volume of business in the area we expect people to charge that rent.
That is the whole point. The value of a pharmacy in a primary care centre is far greater than in a main street, well away from the main thoroughfare. A doctor is induced to set up by a low rent and then becomes a cash cow.
It will not be possible to do that in the future.
Of course it will.
People can be given discounts, as in any normal market.
Then you can charge pharmacists a high rent or key money.
You cannot have a situation where one is allowed a discount but another pays an excessive rent because that would be unethical and would not comply with this legislation.
The market value of a pharmacy in a primary care centre is far greater than that of the GP's clinic. The relationship between the two provides the value and the pharmacy generates the income.
If these are centres, as I understand many are, with pharmacies, physiotherapists, occupational therapists, the public health nurse and other health care professionals then there are advantages for all of them, particularly those which charge private fees, which of course, does not apply to the public health nurse or the social workers. When professionals charge private fees and one depends on the other, such as where a patient must go to a doctor and a physiotherapist who are collocated, there will be advantages for both.
The Minister needs only to look at her own drugs Bill to see there is no comparison.
That is why we are doing this. It will make sure an excessive rent is not charged to the pharmacist to support the other operation, because that could not be justified in any circumstances. It will be a matter for the Pharmaceutical Society of Ireland to determine that issue. As with any business which requires customers to visit the premises, as opposed to using the telephone or buying on-line, being collocated with a number of doctors is a big advantage and will generate a bigger rent because of the number of people who will visit.
Is the Minister saying the Pharmaceutical Society of Ireland can now assess rents as well?
No, it will decide under fitness to practise rules whether an arrangement entered into by a pharmacist is appropriate.
If it is deemed inappropriate what is the next step?
If, on receipt of a complaint, the Pharmaceutical Society of Ireland carries out a inquiry into fitness to practise the ultimate penalty is being struck off.
If somebody complains about the rent arrangements, who decides on whether the rent is appropriate for the area or not?
The Pharmaceutical Society of Ireland or the Medical Council would have to establish that in the course of an inquiry into fitness to practise. The legal bar would have to be high.
They are not going to look into rates.
Where is that provision in law? The Dáil has just passed a Bill on the Medical Council and I do not recall any mention of that.
Under the fitness to practise provision the Medical Council will have power to make inquiries.
I am not sure doctors would be very good at working out rental rates for general practice.
Would auctioneers not have to be used for that purpose?
Yes.
I would have thought they could provide advice.
That is a valid point. If a joint council was set up between the Medical Council and the Pharmaceutical Society of Ireland to review contracts it could see if there was any inducement to either party that might be considered illegal or bad practice. However, neither the Pharmaceutical Society of Ireland nor the Medical Council has much expertise in the market rates of properties in towns, villages and cities across Ireland. That is the problem with throwing terms like "beneficial interest" and "market rates" into legislation without fully explaining them.
Regulation, and making sure contracts are safe from the point of view of patients, are very much the responsibility of the Medical Council and the Pharmaceutical Society of Ireland but those two bodies should set up a joint committee to look at every contract so that we can deal with the issues in a proactive, rather than a reactive, way.
The legislation falls down on the issue of market rates because, to the best of my knowledge, there are no auctioneers either in the Pharmaceutical Society of Ireland or the Medical Council. Even if there were, values would still be hotly disputed. I do not know if it is possible to interfere with the market in that way. There are ways of protecting patients and that is our primary objective. The Pharmaceutical Society of Ireland should be strengthened in the way the Medical Council has been strengthened. There will be more benefits for patient safety if a joint committee is set up to look after every single contract to ensure there are no ethical or fitness to practise issues for the doctors or pharmacists involved.
It is extremely difficult to determine market rates. If Dunnes Stores became the anchor tenant in a major shopping centre and a bookshop wanted to set up there the bookshop could not avail of the same rent as a jeweller or another high value business.
They could and that is the point. The open market rent is determined by the business that comes to an area. I am not an expert in property but if there is a unit of 1000 sq. ft. next to the entrance to Dunnes Stores in a shopping mall businesses will pay much higher rents to set up there.
To some degree the market decides.
That is the open market rent.
In this case, the GP is the anchor tenant.
Yes.
That would be a very strong argument in a primary care dispute. The point could be argued that the GP was entitled to set up at the lower rent because that is the way the market operates.
Perhaps.
The Minister has just made the case for the GP.
That is provided the GP is not doing anything to gain from prescribing by virtue of the pharmacist dispensing his prescriptions and the GP receiving a percentage.
The GP receives the benefit in low rent.
Yes, provided that is not sustained by an excessive rent for the pharmacist. The Medical Council is given the powers over doctors by this Bill. It and the Pharmaceutical Society of Ireland can meet if they wish but they have very separate functions.
Why does the Minister not set up a committee?
Allow the Minister to speak.
We are not having joint inquiries.
I do not propose joint inquiries.
We do not need to set up a structure for the two bodies to talk to each other.
We must suspend as there is a vote.
A fitness to practise inquiry may be warranted in the case of the pharmacist involved but not the doctor, or vice versa. They can talk to each other but there is no merit in setting up joint processes.
They could jointly look at contracts.
They are not going to try to approve all contracts. We are concerned with fitness to practise.
The Minister will have to take market value out of this legislation.
The Minister was making a response and she may continue. We will break at 12 noon so we will try to get as much as we can in before that.
I had responded to the issue and I will just repeat what we are seeking.
Yes.
We are seeking to prevent arrangements that could jeopardise patient safety and be unethical, where a doctor has a beneficial interest in how the pharmacy does and vice versa. This would be over and above normal landlord to tenant relationships. The Bill prohibits the arrangement for the contrived, regulated or acknowledged profit between the pharmacy and the doctor.
It is an issue of market value and establishing an open market rent, and it is not for any fitness to practise provision to establish that type of market value. I wonder if it is possible to write in while members of the Irish Auctioneers and Valuers Institute, IAVI, or some such institute, are part of a consulting body to establish that a rent is fair.
We do not have an amendment to that effect. As I said earlier, the society will have to ensure that, in determining these issues under fitness to practise, it can stand the test of the courts. Ultimately, people censured or struck off under fitness to practise have the right to go to court. Anything established would have to pass a legal bar that is set very high and, therefore, I do not believe the society will engage in a fitness to practise inquiry without having all the expertise available to establish that what happened in a particular situation was unethical and rendered the pharmacist unfit to continue to practise. The Deputy can take it that any expertise required to establish such facts would be availed of, with experts called as key witnesses in such inquiries.
I have been advised by the Bills Office that many more amendments have been added to what we already have so we should try to move on.
Did the Chairman say more amendments are coming in?
Yes, there are more amendments coming in that, apparently, the Bills Office left out. I was advised of this as the meeting went on this morning.
Are these amendments from the Minister?
No, some of Deputy McManus's amendments may come in.
That would not surprise me because the amendments I sought to remove have not been removed.
I can assure the Deputy that I do not mean this in a glib way. We are waiting on more to come down and will inform her when we have them.
We do not have any more amendments.
I think the amendments may be from Deputies McManus and Twomey. I was only advised of this in the last few minutes.
Deputy Stanton was wondering how this will work.
What does the Chairman mean when he refers to amendments coming in?
The amendments have already been tabled and were left out at the time of publication. There is nothing wrong with this. I will not use the word sinister because we dispensed with it long ago. The amendments were placed some days ago and were inadvertently left out by the Bills Office.
What happens if the amendments refer to a section we have already passed?
I think we will have to jump that ditch when we come to it. We will not dwell on that aspect of this matter. Can we move on to Deputy McManus's amendment in section 7?
We took a large number of amendments together but they have not all yet been moved.
We are taking amendment No. 4 in section 7.
I beg the Chairman's pardon, I thought we were moving on from that.
I am asking that the amendment be made, taking into account all of the related amendments I read out some time ago that were discussed together. I am compelled to ask the question in the context of amendment No. 4 only. Unless the Deputy wanted to separate some.
I will withdraw the amendments on the basis that I may resubmit on Report Stage. When will Report Stage be held? We were talking about having Committee Stage next Wednesday.
Report Stage will be next Wednesday.
Will Report Stage be held on the same day as Committee Stage?
This is Committee Stage.
I asked when Report Stage will be held.
Report Stage will be next Wednesday.
Amendments Nos. 7, 8, 10, 11, 59 and 60 are related and may be discussed together. If Deputy McManus wishes to separate any of these amendments, she may do so.
I move amendment No. 7:
In page 12, subsection (2), lines 26 and 27, to delete "by the Minister" and substitute "or elected as set out in subsection (3)”.
I had requested that amendment No. 8 be withdrawn but for some reason this has not happened. Amendment No. 7 relates to the issue of appointments being made and this came up with regard to Medical Council appointments as well. We need to move on from the idea that bodies asked to nominate an appointee can be overruled by the Minister because the nomination is not favoured.
The election, as set out in subsection (3), applies to people who would be nominated by the Irish Medicines Board or the Health Service Executive, HSE. This seems a better way to include people and give them a sense of ownership regarding the structure that has been established.
I tabled an amendment to the Medical Council Bill and I do not want people to think the Minister would not accept the nominees of the society, so I will bring in a similar amendment in this case. That will cover Deputy McManus's point.
I appreciate and welcome that but if the Minister is to accept the nominees, why not allow their election to the boards? What is the difference?
The procedure for the appointment of all such boards and regulatory bodies is that they be appointed on the same basis and get their authorisation under statute from the Minister. This is a formality that applies to the Medical Council, health and social care professionals and all the other groupings. I hope that accepting an amendment which sees that members elected are accepted by the Minister, as I did in the case of the Medical Council, will be satisfactory.
I remind members that we have only four hours left and have around 70 more amendments to go through.
We may have more than four hours left because this need not end today.
It does not have to end today but our next session is next Wednesday.
I appreciate that but I do not feel competent in doing my job in these circumstances. I am trying to keep up with amendments that I have difficulty absorbing and groupings have been applied. I appreciate the Chairman is in a difficult position but I do not think we should rush through this on the basis that it must end today. I wish it could but that is not necessarily the case.
I was trying to change the atmosphere and suggest that if something does not require discussion, we should not discuss it. I understand, however, that Deputy McManus feels it is important that we talk about these points.
Talking is what we are paid to do.
Some might dispute that.
I do not want to stifle discussion as I, myself, am wasting time at this stage.
Amendments Nos. 9 and 18 are cognate and may be discussed together.
I move amendment No. 9:
In page 13, subsection (3)(g)(i), line 20, to delete “pharmacy faculties” and substitute “schools of pharmacy”.
To give continuity to the administration of the society, this amendment allows for nine representatives of the members of the society in the new society's first council to be chosen by the old council members. These members will subsequently be elected in accordance with rules to be made by the new council under section 11(2)(b). This is being done for continuity reasons.
Is that the response to amendment No. 9?
Yes.
The provision in the Bill refers to schools of pharmacy.
I apologise. Our numbers are different because of the way they were numbered by the Bills Office. I beg your pardon, Deputy.
In the Seanad Senator Henry, and I understand Senator Ryan, made the point that they are now known as schools of pharmacy rather than pharmacy faculty. I have agreed to change it to schools of pharmacy instead of pharmacy faculty.
I move amendment No. 10:
In page 13, to delete lines 26 to 30 and substitute the following:
"(4) In—
(a) making nominations under subsection (3)(a) and (b), the bodies there referred to, and
(b) making appointments in pursuance of subsection (3)(c), (d) and (e), the Minister,”.
This amendment is to correct the double (d) reference in subsection (4)(b).
I move amendment No. 11:
In page 13, between lines 33 and 34, to insert the following subsection:
"(5) In relation to the first Council appointed after the establishment of the Society, the 9 persons referred to in subsection (3)(f) shall be members of the Council of the old Society selected for the purposes of this section by the members of the Council of the old Society before its dissolution.”.
I move amendment No. 12:
In page 13, between lines 35 and 36, to insert the following subsection:
"(6) Not less than 40 per cent of the members of a Body shall be men and not less than 40 per cent shall be women.".
The purpose of this amendment is obvious. It concerns gender balance and ensuring that decision making and power is shared between men and women. I appreciate that always creates difficulties because people find it easy to make arguments against it but I know the Minister is sympathetic to the spirit of the amendment. I am conscious that both of us operate in a world where only 13.5% of us are female in a national Parliament, which is a damning characteristic, particularly when we consider that in sub-Saharan Africa the percentage is higher. It is important that I raise this issue at every opportunity and that we consider how women can be facilitated to play their part in decision making. In regard to this legislation, I hope the Minister might adopt a positive view.
I am positive about the raison d’être for the amendment. The society has had two past female presidents and the current vice-president is a woman. Some of its registrars were women. I do not mean to be smart but the way the health care professions are going, the problem may be the 40% men rather than the 40% women . If I were nominating all the members I would agree that 40% of its membership should be women but since nine of them are elected and another is nominated by the pharmacy school, I cannot guarantee what will happen in those elections. I give the Deputy an undertaking, however, that in the nominees I put forward and in my advice to the society I will ask it to bear that in mind. We will probably have 40% of the membership female from what I see happening, perhaps not in the next council but in one shortly thereafter. I understand the current membership is 38% female.
I accept the Minister's point and withdraw the amendment.
Amendments Nos. 13, 14 and 17 are related and may be discussed together.
I move amendment No. 13:
In page 14, subsection (1), between lines 23 and 24, to insert the following:
"(a) before drafting or giving effect to a code of conduct, consult with bodies which are representative of the pharmacy sector, and with any other person or body the Council considers appropriate,”.
This concerns a requirement to consult. In giving effect to a code of conduct there should be consultation with the representative bodies and anybody else the council considers appropriate. When this issue arose in the Seanad concern was expressed about specifying a particular body but my experience in the area of pharmacy is that there has been a helpful and responsible response from the representative body. My experience of the Medical Council is that it has been pursuing best practice and modernisation of the council and much of the drive came from the professionals. To be fair, there is an understanding of the need to modernise, improve and regulate the pharmacy profession and deal with any rogue pharmacists. I have no doubt that the good relationship that has been built up with regard to this Bill should be encouraged into the future. If people believe they are not engaged in the process, they are less likely to participate in it, abide by any codes that are applied and perhaps less likely to understand the purpose of some of the requirements placed on them. I hope the Minister accepts the amendment, which is fairly innocuous. We are all aware that consultation can be minimalist — it can sound good without having much behind it — or else there can be genuine discussion and dialogue. Our experience with pharmacy is that, generally speaking, the type of connection that has been built up is welcome and I ask that this amendment be included.
I am advised that before regulations are made the draft code must be published, obviously for consultation purposes. It is clear that would be the practice. I understand section 11(5)(b) provides for that.
Section 11?
Deputy McManus is referring to consulting in advance. I will take advice on this matter before Report Stage. The Deputy's point is a valid one.
I will withdraw the amendment and may table it on Report Stage.
I move amendment No. 14:
In page 14, subsection (1), between lines 23 and 24, to insert the following:
"(a) consult with any person or body which are representative of the pharmacy sector, and with any other person or body the Council considers appropriate,”.
This amendment was discussed earlier and decided upon. I will withdraw it and may table it on Report Stage.
Amendment No. 15 is in the name of Deputy McManus.
We amended the Bill in the Seanad to include this — that the experience shall be in that State, certified in accordance with Article 3(3), which is what I understand Deputy McManus is trying to achieve in this amendment.
Are we talking about changing from—
It now reads "After three years professional experience —"—
No. I have withdrawn that. That was withdrawn but it was not taken out by the Bills Office.
I move amendment No. 16:
In page 20, subsection (1), line 29, to delete "may" and substitute "shall".
This amendment was suggested by the Hospital Pharmacists Association of Ireland. I ask the Minister to comment on its concerns because it is in a unique position. It is concerned that its members may not be able to continue to provide the care they currently provide. I am aware there have been changes in the Bill and it may be that these matters have been dealt with but this amendment, which the association requested to be put forward, refers to the setting of standards both for practice and pharmacy premises, which will ensure the quality and safety of pharmacy services. This section must apply to the practice of all pharmacists and their premises, including the hospital pharmacists and hospital pharmacy departments. The association seeks that the Minister shall, rather than may, make regulations. It states that although the Minister has not issued clarification on hospital pharmacy departments she indicated in the Seanad committee that hospital pharmacy departments would be registered in name only and would not have standards of practice or premises applied, as indicated in section 18 of the Pharmacy Bill. The association further states it is imperative from a patient safety point of view that hospital patients are treated on an equal basis to those attending their community pharmacy, thus, hospital pharmacy departments must not be excluded from this or any other section of the Bill.
That appears to be an essential patient safety precaution. I realise there is a question mark over whether the hospital pharmacy is included, and the answer from the Minister may well be that there is an element of retail in hospital pharmacies and that, therefore, it will be covered but I suspect this entire legislation will be challenged in the courts. Already, we have had a confused debate this morning. We must be very clear about what is and is not covered. The hospital pharmacy is an important part of hospital provision. We all have concerns about the conditions in our hospitals across the board, including issues related to prescriptions, which need to be protected by good protocols or some type of regulatory framework that recognises that the hospital pharmacist is as important a provider in the health service as a retail pharmacist in the marketplace.
The hospital pharmacy is a vital part of the dispensing system. Hospital pharmacists provide an excellent service for people being discharged from hospital and I understand they are included in this legislation. There are approximately 49 hospitals in which pharmacies are covered. A number of pharmacies have yet to be covered and they will be dealt with on a case-by-case basis. Perhaps the Minister will inform us of the guidelines she will consider in that regard.
There are aspects of hospital pharmacies that are not dealt with in terms of their size, space, heating, lighting, cleanliness, use of equipment etc. Will the Minister comment on that?
Concerns have been raised by the hospital pharmacists about this Bill. The Minister dealt with some of them in the debate on the Bill in the Seanad but she might clarify the exact position. It has been drawn to my attention that some pharmacists are working in hospitals, who might not have the three years' relevant retail experience because they may have taken up a job in a hospital immediately after qualifying. The Minister might allude to that also.
In regard to dispensing drugs on an outpatient basis or to patients on discharge from hospital, hospital pharmacists are covered. The experience of a hospital pharmacist counts for the three years' experience to open a retail community pharmacy. I accept that the standards of the pharmacy in the hospital are not covered by this legislation. That should be dealt with either in the next pharmacy Bill, which will address many technical issues, or perhaps, more appropriately, through the Health Information and Quality Authority or a licensing regime for hospitals. That would be appropriate. I have not seen all the pharmacies in hospitals but some of them are located in the darkest corner and there are many issues around that. All hospital pharmacies will have to register. I understand approximately 49 do so currently. We have 53 acute hospitals so I presume the others will have to register if they dispense to people being discharged from hospital on an outpatient basis. As some drugs can be dangerous they are dispensed on an outpatient basis but that is done in the pharmacy.
The hospital pharmacists have issues concerning standards and the technical area, which has not been dealt with in this legislation but will be more appropriately dealt with in either the next pharmacy Bill, under a licensing regime or the accreditation scheme as operated by the Health Information and Quality Authority.
The hospital pharmacies will not be subject to the same type of legislation in terms of cleanliness, equipment—
The person will be regulated, yes. In terms of fitness to practise and so on, the same rules apply to the pharmacist.
In the case of a hospital pharmacist who may not have the three years' retail experience on his or her CV, having taken up a job in a hospital pharmacy and being there for a shorter period—
Does the Deputy mean a pharmacist who supervises a hospital pharmacy?
Yes.
The years the pharmacist has worked in the hospital pharmacy will count as experience.
A pharmacist does not need to have three years' retail experience if his or her experience is not in a retail pharmacy?
No, a pharmacist does not have to work in the retail sector. If a pharmacist works in a hospital pharmacy and wants to open a community pharmacy if the pharmacist has three years' experience of working in the hospital pharmacy—
That counts as well.
—that would qualify.
How stands Deputy Connolly's amendment?
I will withdraw it for consideration on Report Stage.
I move amendment No. 18:
In page 23, subsection (1), line 33, to delete "pharmacy faculties" and substitute "schools of pharmacy".
I propose to suspend the sitting until 12.30 p.m. I note many of the remaining amendments are in the name of Deputy McManus who has had to leave the meeting.
Amendments Nos. 27 to 29, inclusive, are related to amendment No. 26. Amendments Nos. 26 to 29, inclusive, will be discussed together.
I move amendment No. 26:
In page 25, subsection (1)(a), line 4, after “person” to insert “being a registered pharmacist”.
The HPAI states that the hospital pharmacy partners must be registered with the Pharmaceutical Society of Ireland. I believe we covered this earlier.
We included that amendment in the Seanad.
Amendments Nos. 33 and 36 are related and may be discussed together by agreement.
I move amendment No. 33:
In page 27, subsection (4), line 28, to delete "judgement" and substitute "judgment".
This is a technical amendment to allow certain descriptions to be used in connection with the registered pharmacy business. This was an omission in earlier drafts.
I move amendment No. 34:
In page 27, between lines 34 and 35, to insert the following subsection:
"(3) A person other than a registered retail pharmacy business who holds himself, herself or itself out as a registered retail pharmacy business shall be guilty of an offence.".
I move amendment No. 35:
In page 28, between lines 23 and 24, to insert the following subsection:
"(6) A person does not commit an offence under this section by using, in a public description of a registered retail pharmacy business, an expression mentioned in subsection (5).”.
I move amendment No. 36:
In page 29, line 28, to delete "judgement" and substitute "judgment".
I move amendment No. 37:
In page 29, between lines 28 and 29, to insert the following:
" "registered" in relation to a complaint against a pharmacist or retail pharmacy business includes a pharmacist or retail pharmacy business which was registered at the time when the circumstances constituting the grounds of the complaint occurred although not registered when the complaint is made or later.".
This issue was raised in the Seanad and I promised to look at it. It was agreed that the Bill did not provide for the taking of disciplinary action against a registrant if they were no longer registered. This would have precluded the investigation of incidents and their follow-up under the fitness to practise procedures. In the circumstances of a latter application to re-register, the findings of the investigation would then inform the council as to the suitability of a person or pharmacy business for re-registration. This is where somebody de-registers to avoid fitness to practise procedures and then comes back. It is more than a technical amendment but it was an omission not to include that provision. Deputy McManus has tabled a similar amendment but my amendment obviously deals with it.
Amendments Nos. 38 and 39 are related and may be discussed together.
I move amendment No. 39:
In page 30, between lines 12 and 13, to insert the following subsection:
"(11) The registered medical practitioner has, when advising that committee, the same protections and immunities as a judge of the High Court.".
Both amendments have the same intent. The issue whether the medical practitioner appointed to a committee had, by way of him or her providing a professional opinion, the same or equivalent protection as other members of the committee was raised by Senators Henry and Ryan. It is clear that he or she is not a full member of the committee and therefore it was appropriate that this protection be extended. That concerns somebody who gives advice, for example, a doctor to a fitness to practice committee, to ensure that they have immunity from prosecution. That point was raised and I think it is a good provision. Deputy McManus's amendment sought to achieve the same thing.
I move amendment No. 40a:
In page 30, subsection (3), line 32, after "made" to insert "by or".
I am happy to accept that amendment before the Deputy withdraws it.
Amendments Nos. 41 and 42 are related and may be discussed together.
I move amendment No. 41:
In page 32, subsection (2)(c), line 41, to delete “specifies.” and substitute the following:
"specifies,
(d) invite the registered pharmacist or pharmacy owner to submit observations.”.
This amendment is to allow the committee to invite the registered pharmacist or pharmacy owner to give additional information voluntarily which they consider would be helpful to the matters being considered. It was already open to them under section 4 to do so voluntarily. This amendment allows the committee to invite a contribution.
I move amendment No. 42:
In page 33, subsection (4), line 4, after "so" to insert the following:
"and submit observations although not invited to do so".
I move amendment No. 43:
In page 35, subsection (1), line 8, after "the" where it firstly occurs to insert "High".
That provision has been included in the Bill since it was drafted.
I move amendment No. 43a:
In page 38, subsection (1), line 20, after "owner" to insert the following:
"in respect of whom a complaint has been substantiated or".
This issue is dealt with in the Medical Practitioners Bill. The legal advice and that of the Medical Council — and I presume it would be the same from the Pharmaceutical Society — is to await the adjudication of the court.
Yes, of course. The Minister is correct. I will withdraw the amendment. That is expected in June, is it not?
The hearing is in June, yes.
Will the Minister be required to come back with legislation?
If necessary, yes.
I move amendment No. 44:
In page 40, line 1, to delete "may" and substitute "shall".
I have taken this on board from the Seanad. This strengthens the legislation by providing that the council "shall" instead of "may", in the public interest, give public notice of disciplinary actions against a pharmacist or pharmacy business. It is changed to reinforce that unless there are public interest reasons, then the results of a disciplinary hearing should be made public. It is nevertheless considered important that the council retain discretion to consider whether it is always in the public interest to publicise such findings.
I move amendment No. 45:
In page 41, subsection (3), line 35, after "section 51“ to insert ”or 52”.
Amendment No. 46 in the name of Deputy Twomey has been discussed with amendment No. 21.
May we discuss amendment No. 46?
Yes.
I move amendment No. 46:
In page 43, between lines 10 and 11, to insert the following subsection:
"(5) The Society shall disclose any beneficial interest to the Oireachtas Joint Committee on Health and Children by 31 December in any given year.".
This relates to what was discussed earlier. There is still a certain amount of confusion. Unfortunately, I was in and out of the committee this morning. The Minister has not cleared up issues like beneficial interests, market rates, and the roles of the Medical Council and the Pharmaceutical Society of Ireland in monitoring the relationship between doctors and pharmacists.
Earlier I also asked the Minister about the changing role of the pharmacist in prescribing and dispensing.
I apologise because I meant to deal with that this morning. We are not providing for pharmacists to prescribe.
Has the Minister such plans?
No.
I thought there were such plans.
It is being sought but there is certainly no plan to do it for some of the issues we discussed earlier.
While pharmacists cannot prescribe, they can give out medication to a person coming out of hospital, for example.
There is an emergency dispensing provision only.
Even though we had a fairly broad discussion on this issue earlier, I must withdraw this amendment for resubmission on Report Stage. That would give us a better opportunity to read through our discussion this morning to see exactly what the Minister has in mind in the legislation and in the amendments she has made to it, to ensure that all — patients, first, pharmacists and doctors — are protected and to look at the role of the Medical Council and the PSI. We probably need to discuss the matter with the Medical Council and the PSI to see if they have any concerns about the legislation up to this point.
Amendment No. 47 in the name of Deputy McManus has already been discussed with amendment No. 21.
I move amendment No. 47:
In page 43, subsection (5)(a)(ii), to delete lines 29 to 31 and substitute the following:
"(II) is ascertained, directly or indirectly, by reference to the receipts or profits of a registered retail pharmacy business or a medical practice, or directly or indirectly by reference to any arrangement between the persons referred to in subsection (2)(a) of section 64 providing for, acknowledging or regulating a financial benefit to any of them arising from, or facilitated by, the level of the rent or other consideration concerned, or both,”.
I am not clear on whether this matter has been dealt with by the Minister. It has been argued to me that this section is currently flawed. The amendment would tighten up the definition already being interpreted restrictively as covering only an express linking of the rent or consideration of the tenancy with receipts and profits of the pharmacy business and medical practice. The arrangements being tariffed would necessarily be less than express.
The strong legal advice is that this is the appropriate way to proceed and not to be too prescriptive, and to depend on the reasoned judgment of both regulatory bodies in this case. There are also issues of constitutional rights. This legislation is not trying to deal with landlord and tenant legislation. It is simply dealing with fitness to practise-type issues where monetary consideration could affect practice. That is essentially what we are seeking to do here.
As I stated earlier, there are one or two issues on which I want to reflect and get advice, both from the society in the first instance and then from the Attorney General, on people who are both pharmacists and doctors. I must admit I was not aware that persons practise as both and there may be such an issue that we need to address in advance of Report Stage.
Constitutional rights are being raised now. There are requirements being imposed in this legislation — even the question of separate entrances. I would have thought that the Minister can be prescriptive. The general point I am making is that the Minister can be prescriptive in parts of this legislation to quite a detailed degree, and yet not in other parts of it. I will look at my amendment again and may need to resubmit it on Report Stage.
I move amendment No. 48:
In page 44, subsection (1)(b), to delete lines 24 to 26 and substitute the following:
"(ii) share a common public entrance with each other,
if there is an arrangement of the kind described in subsection (2).”.
This is a technical issue. We were advised the comma, by virtue of being in the wrong place, could be interpreted very differently in the courts. The amendment is simply changing a comma.
I am advised that if amendment No. 48 is agreed, amendment No. 49 cannot be moved. These amendments overlap and must be discussed together. Otherwise, amendment No. 49 would fall with the question on amendment No. 48 and there would not be an opportunity to debate it. It is all about one comma.
It is about more than one comma.
It is a pity it is not that easy.
I am just changing it to ensure it is clear.
While I do not wish to quibble, amendment No. 49 has nothing to do with a comma.
It does because it brings the sentence out to the margin so that it applies to two subsections rather than one. That is the advice. I am not a lawyer. Lawyers wrote to us on behalf of people.
Did they write because of the lines being wrongly defined?
It was to ensure that it referred to two subsections rather than just one.
I am advised that amendment No. 49 in name of Deputy McManus cannot be moved for the reason I gave earlier. I ask Deputy McManus to take time to go through it to assure herself that there is nothing devious, underhand or otherwise involved here.
One would have to be a lawyer to understand the significance of it. Basically, lines 25 and 26 which read, "if there is an arrangement of the kind described in subsection (2)", must be outdented towards the margin to ensure it relates to all of section 64(1)(b), which is above it.
Is that acceptable?
That is the pottiest explanation I have ever heard. Although I am not arguing, it is just daft that one cannot discuss an amendment because of lines being changed by way of a previous amendment.
I am making the amendment now.
Is the Minister stating she can accept amendment No. 49? I thought she stated she could not.
I am proposing amendment No. 48. I do not know whether we have made the amendment. I am simply proposing that we move the reference out to the margin to ensure it refers to both.
We have no difficulty with that. The difficulty is that my amendment now falls.
My apologies. That is a matter for the Chair.
I accept the Chair's ruling. May I resubmit the amendment on Report Stage?
Yes.
I move amendment No. 50:
In page 44, lines 27 to 36, to delete subsection (2) and substitute the following:
"(2) A registered pharmacist, an owner of a retail pharmacy business, a registered medical practitioner, or a medical practice shall not enter into an arrangement amongst themselves which provides for, acknowledges or regulates a financial benefit accruing to any of them arising from the prescription and dispensing of medicinal products, or arising from or facilitated by the collocation or juxtaposition described in subsection (1), or both.”.
In its current form, section 64 only prevents an arrangement between pharmacists and GPs in instances of collocation. Irrespective their locations, it is neither desirable nor appropriate that a pharmacist might benefit from an arrangement with a GP based on the volume of drugs sold or prescribed. I am aware that the Minister agrees with the latter. The prohibition arrangements set out in section 64(2) should not, therefore, be contingent upon collocation.
By virtue of collocation, that is not an issue. Normal rental relationships or property issues are not in dispute. Nothing arises in that regard.
An issue arose not long ago in respect of a GP who was a relative of a pharmacist got into deep water because prescription drugs were being ordered from the latter's pharmacy and brought to the surgery to be dispensed. The two individuals involved were censured as a result of the incident. It does not only apply in the context of collocation.
I am informed that the behaviour to which the Deputy refers is inappropriate.
Of course it is inappropriate. How is it dealt with under the Bill?
It is covered in section 64.
It is covered.
Yes.
In section 64.
It is actually covered in section 63, which defines "beneficial interest" and states, "and a person shall be regarded, for the purposes of this section, as having a beneficial interest in such a practice or business if his or her spouse or dependent child has such an interest in it".
The Minister misunderstood the point I was making. I was referring to the location, the fact that they are related is irrelevant.
What is the Deputy's point?
As I understand it, the doctor—
The same thing applies. If a doctor has a beneficial interest in a pharmacy business—
Regardless of whether it is collocated.
Yes. This provision does not deal with collocation. Section 64 states:
(2) An arrangement is of the kind referred to in subsection (1) if it—
(a) is between the owner of the registered retail pharmacy business referred to in that subsection or the registered pharmacist in whole-time charge of that business and a registered medical practitioner practising in the medical practice—
If, therefore, a doctor owns a pharmacy located one mile away from his surgery or if he has a profit-sharing or beneficial interest in that pharmacy, the same thing applies. That is why the issue of people who are both pharmacists and doctors may cause a problem and I will be advised to take advice on this matter from the society and the Attorney General. I understand that three or four people may be affected by this provision and I need to take advice in respect of it.
What would be the position if a nursing home was filling prescriptions for patients at a pharmacy located outside the area in which that home is based?
The Deputy is referring to circumstances in which a nursing home is procuring prescription drugs on behalf of patients. Clearly, patients are free to purchase drugs at any pharmacy. If one lives in Cork, one is free to travel to Dublin to have a prescription filled and vice versa. However, it is unlikely that people would do that.
What would be the position if a nursing home was procuring all its patients' medicines from a pharmacy located 30 miles away?
We are not regulating nursing homes under the Bill. The issue would be whether the pharmacist would be doing anything untoward. Unless he or she was engaging in improper behaviour, it would not be covered.
If, therefore, a nursing home with 100 patients was obtaining its medicines from a pharmacy located 50 miles away, there would be no difficulty.
Not as far as I am aware. Unless the pharmacist was involved in malpractice or if fitness to practise issues arose, the scenario outlined by the Deputy would not be covered. The Bill is concerned with regulating pharmacists. In addition, a provision is being inserted into the Medical Practitioners Bill to deal with the position vis-à-vis doctors. I do not know what rules apply in respect of nursing homes. I will take advice on the matter because it is not something of which I was previously aware.
If a pharmacy was located on the ground floor of a primary care centre and if 80% of its turnover emanated from the GPs operating out of the centre, it is possible that the matter would be investigated by the Pharmaceutical Society of Ireland. If, however, a nursing home was obtaining patients' medicines from a pharmacy located 50 miles away, there would be no reason to investigate.
If a complaint was made against the pharmacist involved to the effect that he or she was doing something untoward to seduce — I hate using words of this nature because they are sensational in nature — or attract business from the home or that there was an improper connection between those who owned or operated the home and the pharmacist, the Pharmaceutical Society of Ireland could then investigate the matter in respect of the pharmacist's behaviour. However, it would not be able to investigate the behaviour of the nursing home. I will take advice on the matter.
The Bill only regulates the pharmacy profession and pharmacies, it does not regulate nursing homes. Perhaps the Deputy is referring to circumstances where a pharmacy might have a connection to or a beneficial interest in a nursing home and where something untoward might be happening. I will consider whether this would be grounds for the making of a complaint that would be worthy of a fitness to practise inquiry.
If, therefore, a GP who was also dispensing medicine was using a community pharmacy located 50 miles away, there would be no difficulty unless it could be proven that something untoward was happening.
If issues relating to beneficial interests or fitness to practise arose, it could be dealt with. However, GPs generally give patients prescriptions. There are GPs such as the Deputy's spouse who purchase and dispense medicines. Obviously, his spouse does not have a beneficial interest. If, however, there is a connection because there is a beneficial interest in one assisting the other, such a situation would be covered by the legislation. Whether they are collocated is not the issue. Even if they were not collocated and if their business were a distance apart, they would be covered by the legislation if one had a beneficial, financial or profit-sharing interest in the other.
However, there is no restriction with regard to where medicines may be purchased.
No. As stated earlier, the HSE will be requiring a notice to be placed on GMS prescriptions to the effect that patients may go to any pharmacy they wish to have them filled. That is a good thing and perhaps it should be extended to all prescriptions. I would like to reflect on how it might be possible to facilitate the latter. It is important to advise patients. It would be inappropriate to advise a person to go to either a particular pharmacy or doctor, except where the pharmacy might stock a product not sold elsewhere or where the doctor might possess some skill that other doctors in the area do not possess. In the normal course of business, however, it is not possible to refer one to the other.
If a pharmacist substitutes a medicine for that listed on a prescription, what is the sanction imposed?
Pharmacists must dispense as prescribed. The pharmacy profession has sought the power to allow its members to substitute medicines.
What sanction would be imposed under the legislation if they substituted a medicine?
Apparently they are not entitled to do so. I am advised that it could be a fitness to practise issue.
If, therefore, a pharmacist substituted a generic brand for the medicine prescribed by a doctor, he or she would be subjected to a fitness to practise hearing.
Pharmacists do not have prescribing rights and could, therefore, be the subject of such a hearing.
If the medicine listed on a prescription appears under its pharmacological name, a pharmacist has the right to supply any generic brand of that drug.
I am not an expert in this area but my advisers indicate that the scenario outlined by Deputy Devins would not involve substitution. To return to Deputy Twomey's point, pharmacists are not free to substitute drugs for those listed on prescriptions.
I refer to a common antibiotic such as Clonamox, which is generic Amoxicillin. There are ten different brands of generic Amoxicillin. Pinamox is similar and if the general practitioner prescribes Clonamox and the patient is given Pinamox, is that a substitution?
Is that the same class? I am not a doctor or pharmacist but I am advised it is a substitution and that it is, therefore, not allowed.
That means the pharmacist could be exposed to a fitness to practice claim.
Apparently so.
That is a little harsh.
Has that ever happened? Is the Deputy suggesting this happens all the time?
It happens out of convenience. The pharmacist might not stock all the different generics.
Is one more expensive than another?
There is a price difference. It would not be much in the case of the two antibiotics I mentioned but, in other cases, it might be more significant. Pharmacists should not be in the position of having to telephone the GP every time they run out of Clonamox to ask if they can dispense Pinamox. Technically, pharmacists could face a fitness to practice inquiry unless they telephone the GP
It is perfectly acceptable to telephone the GP. They can talk to each other. The Deputy has made a valid point. I am not familiar with the names of many drugs but a number of pharmacists have sought the power to substitute. Among the issues that arise is whether they have a beneficial interest in favouring one antibiotic over another and so on. That is why when nurses were facilitated to prescribe, such issues did not arise.
What does the Minister mean by "a beneficial interest in favouring one antibiotic over another"?
If a pharmacist could substitute and one was more expensive than the other, there would be a financial gain. Many issues arise relating to substitution.
They are not dealt with in this section.
No, but the Deputy asked earlier whether I would provide for pharmacists to prescribe. The discussion is about whether pharmacists can substitute and one of the issues is whether they would have a beneficial interest in dispensing one drug rather than other. This issue does not arise where nurses are concerned but it should be debated on another day.
I have two questions. From time to time, pharmacists experience shortages of drugs. One may be prescribed something but when one goes to the pharmacist, he or she may not have it in stock. What does a pharmacist do in that scenario?
I understand a pharmacy assistant can be left in charge of the pharmacy for a period. Is that impacted on by the legislation?
There is no change in that regard.
With regard to the shortage of drugs, the Department seeks to manage the supply. If a pharmacist does not have a prescribed drug, he or she would have to contact the doctor involved. I am advised companies supply the products and if they withdraw a product, the State might not be aware and, therefore, there may not be a supply. Where the Department becomes aware of this, alternative supplies are sourced. A pharmacist would be required to contact the doctor to ascertain whether another drug should be dispensed.
By telephone?
Yes.
Amendment No. 52 is an alternative to amendment No. 51 and both may be discussed together by agreement.
I move amendment No. 51:
In page 45, between lines 35 and 36, to insert the following:
" "premises" is not restricted to land and buildings;".
Senator Ryan suggested that the definition of "premises" was very restrictive and it should cover boats, planes and so on. Rather than define the various places there could be a premises for this purpose, the legal advice is to add "not restricted to land and buildings" and that would cover everything.
I move amendment No. 53:
In page 45, paragraph (a), line 37, before “a” to insert “computer data,”.
I seek the insert of the term "computer data" to make the reference more specific.
I am advised that is covered. We dealt with that in the Seanad as well. Accessing or viewing data even from a virtual storage place as well as a computer is enough to come within the remit of the subsection.
Is the Minister certain about that?
Yes, because I obtained advice from the Attorney General subsequent to the Seanad debate as the Labour Party raised it in the House.
I move amendment No. 54:
In page 48, subsection (3)(n), line 11, after “facilities” to insert the following:
"or courier facilities or other means of transportation".
The amendment seeks to include courier facilities or other means of transportation in the section.
We took that on board in the Seanad.
I do not see it.
The words "by any other means" in page 48, line 16, cover that.
I move amendment No. 55:
In page 52, subsection (3), line 11, after "capacity" to insert the following:
"including a shadow director within the meaning of section 27 of the Companies (Amendment) Act 1990".
I inserted a new subsection (4) to address this.
I missed that.
I move amendment No. 57:
In page 52, line 31, to delete subsection (2).
I move amendment No. 58:
In page 53, line 21, to delete "is".
This is a technical amendment to clarify what is meant by subsection (3)(a)(i) to (v).
I move amendment No. 59:
In page 55, paragraph 1(2), line 7, to delete "(d), and” and substitute “and (e), and”.
I move amendment No. 60:
In page 55, paragraph 1(2), line 8, before "and" to insert "(as read with section 10(5))”.
Amendments Nos. 61 and 62 are related and will be discussed together.
I move amendment No. 61:
In page 55, paragraph 2, between lines 23 and 24, to insert the following:
"(2) A disqualification under subparagraph (1)(a), (c), (d) or (e) shall not take effect until the ordinary time for appealing against the adjudication, conviction or, as the case may be, order has expired, or if an appeal is brought, it (or any further appeal) is determined in a way which upholds the adjudication, conviction or order or is abandoned.”.
As a result of debate in the Seanad, I agreed the normal appeals procedure should be exhausted before someone is disqualified from office. There are no appeals possible to paragraph (b) “makes a composition arrangement with creditors”, or paragraph (f), “is sentenced to a term of imprisonment”. The appeal in this case is to the sentence, not the finding of guilt.
The Medical Council has issued ethical guidelines to all members of the council. Will similar guidelines be issued for pharmacists?
That is a good idea and I will put it to the society.
I move amendment No. 63:
In page 56, paragraph 4(1), line 3, after "Vice-President" to insert "who shall be registered pharmacists".
I dealt with this in the Seanad and made an amendment there to deal with the issue and stipulated that the vice president must be a pharmacist.
I move amendment No. 64:
In page 59, paragraph 9, between lines 6 and 7, to insert the following:
"(8) A disclosure under this paragraph or paragraph 10 shall be recorded in a register together with particulars of any interest of members of the Authority or persons to whom paragraph 10 applies, and the register shall be available to public inspection during office hours.”.
This amendment deals with a register of interests and is similar to one I raised on the Medical Practitioners Bill. We seek a register of interests of members of the authority to ensure transparency. Also, on the Medical Practitioners Bill I raised the issue of the Minister's requirement that the standards in public office requirements should apply to members of the authority. The Minister did not know whether this applied to members co-opted onto sub-committees.
I am seeking legal advice on that and if it is required, I will amend that Bill and this one.
I move amendment No. 65:
In page 60, paragraph 11, between lines 9 and 10, to insert the following:
"(4) Reference to this paragraph is inserted in Part I of the Third Schedule to the Freedom of Information Act 1997.".
It is appropriate to make provision in the Bill for the extension of the Freedom of Information Act to the new body. At the very least, reference to this section should be inserted in the Schedule to the Freedom of Information Act 1997 so it would not prevent disclosure of information under the Act.
The society is covered by the Freedom of Information Act, but I recognise the Deputy's call to mention it here. I will have a look at the issue before Report Stage.
Amendments Nos. 66 and 67 are related and will be discussed together.
I move amendment No. 66:
In page 60, paragraph 12(2), line 14, after "surplus" to insert the following:
"including any surplus following disposal of assets".
This amendment will ensure that the disposal of any surplus arising from the disposal of assets of the society will be ring-fenced for particular purposes connected with pharmacy.
I move amendment No. 68:
In page 62, after line 44, to insert the following:
"Accountability to Houses of the Oireachtas
22. When required by a committee of either or both Houses of the Oireachtas, the President of the Society shall appear before the committee to account for the general administration of the Society.".
I have no doubt that the current president of the society and most reasonable people would have no problem appearing before the committee. However, it would not do any harm to include a provision in the Bill to provide for this.
I will look at this for Report Stage.
Earlier I expressed my concerns about what may be wrong with regard to this close relationship and the exchanges that actually take place. Will the Minister give the committee some sort of report before Report Stage on the factors that have guided her in the making of her amendments?
It might be helpful, but I will have to discuss it with the registrar of the society if he was to talk to spokespersons—
Would someone from both the Medical Council and the Pharmaceutical Society of Ireland talk to us?
— on some of the issues raised concerning possible conflicts and other areas. While people have made the case to me on some issues, I am not as well briefed as they are. I mentioned already the fact that prescriptions were faxed to a particular pharmacy from a particular place. Clearly there is an issue whether the prescriber has a beneficial interest in doing that. Otherwise, why does it happen? Is it the case a doctor would look for a share of profits on the basis that X amount of prescriptions have gone to that pharmacy? Perhaps the registrar will brief Deputies if it is not unethical to do so. I think that could be helpful.
Would the Minister try to see that the final form of the Bill before Report Stage is provided to us as early as possible?
I will do that.
I move amendment No. 68a:
In page 62, after line 44, to insert the following:
"Annual service plan and corporate strategy
22. The Society shall prepare an annual service plan and a corporate strategy.".
I accept this amendment which relates to the society preparing an annual service plan and corporate strategy.
