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Dáil Éireann díospóireacht -
Wednesday, 4 Apr 2007

Vol. 635 No. 2

Pharmacy Bill 2007 [Seanad]: Report and Final Stages.

Amendment No. 1 arises out of proceedings on Committee Stage.

I move amendment No. 1:

In page 9, to delete lines 20 to 22 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.".

Does Deputy McManus wish to speak to her amendment?

No, I have already spoken.

I am satisfied that section 5 provides for the dissolution of the old society and the establishment of the new one and that there is no discontinuity. A similar situation is provided for in the Veterinary Practice Act and since Committee Stage, I have sought the views of the Attorney General in respect of this issue.

Amendment, by leave, withdrawn.

Amendments Nos. 2, 12, 13, 16, 18 and 19 arise out of proceedings on Committee Stage, are related and will be discussed together.

I move amendment No. 2:

In page 12, between lines 8 and 9, to insert the following:

"(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.”.

These amendments are grouped together and I note that further amendments are coming from the Minister. Is it 4 April today? These further amendments came in at 6 p.m today. I have difficulty with the fact that we have amendments that have just been received by e-mail from the Minister at 6 p.m. today. It causes a certain amount of difficulty in terms of speaking on amendments we have tabled well on time. It may well be that the Minister has dealt with some of the concerns, but I have a few general points to make.

Due to the fact this legislation has been rushed through both Houses, it is extremely difficult to give it the time, attention and scrutiny it deserves. We are all very conscious that the Bill has been surprisingly controversial because there was and continues to be full accord across this House in respect of its central thrust, which is about regulating the pharmacy sector, setting standards and protecting patients where a lacuna existed for a long time. The point has been made that animals were better protected than humans in respect of this kind of service and that we need to put things right. Despite the existence of common accord, a number of key issues are causing great concern from a number of different perspectives.

I appreciate that, consequent to the points made on Second Stage in the Seanad, the Minister came up with amendments Nos. 63 and 64, which relate to potential conflicts of interest. I welcome the fact she has made an effort in this regard. I must again say I have concerns about the very strong likelihood that this legislation will be challenged in the courts and may prove to be defective because of the terrific speed with which it is being delivered.

There are requirements in amendment No. 2 in respect of 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 touches on the concerns that were already expressed by myself and others on Committee Stage about potential conflicts of interest.

We are witnessing a commercialisation of health care which is new to us and for which we are ill-prepared. We should have a very robust licensing system in place for health facilities before we allow the kind of free-for-all that has developed, be it in the hospital sector or in primary care. We have seen predators coming in who have no direct involvement in the provision of health care and who are out to make money out of health care in a way that we have not seen before. It is very important there is strong regulation and robust legislation that can withstand any legal challenge.

There are also medical practitioners who have a certain justification in complaining that the lavish tax breaks afforded to developers do not apply to general practitioners trying to improve their service and accommodation. They have been attempting to develop primary care centres in a certain vacuum because of the failure of the Government to deliver a proper primary care strategy where all the pieces fit. We have a model of 11 centres that have already been provided or are in the process of being provided. I visited the excellent centre in Virginia, County Cavan. That is a model which presents best practice for anybody looking at a primary care centre. Not all primary care centres must be as developed as that. We can have virtual ones as well, but it is a very good example of best practice. However, it appears the Health Service Executive has no intention of including pharmacy within a primary care centre anywhere. Why has the HSE taken a clear policy decision that pharmacy is not part of a primary care centre and that it does not form part of the programme of primary care which the executive itself has initiated?

We are heading into a difficult area where money is being made and collocation is the source of this. That leads to difficulties regarding conflicts of interest. Codes of conduct, safeguards and productions must be robust and clearly defined in law. The doctors made a point about the Medical Council guidelines, but that is a broad and insufficient safeguard for patients in the area of prescribing and dispensing drugs. Unfortunately, we have bad examples on rare occasions from the past and present of inappropriate relationships between doctors and pharmacists that have been to the detriment of patients and patient care.

When the Minister presents amendments so late in the day, we are never quite sure whether they will make a difference or whether they will mean another land-mine that explodes on the next Minister when somebody challenges it in the courts. Cats and dogs remain better protected than patients in the Irish health care system, even after this debate. We still have a long way to travel before patients are properly protected.

The Minister seems to have got around some of the problems regarding beneficial interest. I am not 100% sure whether it is fully sorted out, but that is what happens when we are flying through legislation on what could possibly be the second last day of the Dáil. The discussion about market rates is still up in the air. I am not sure if the Pharmaceutical Society of Ireland believes it can regulate this market to decide what is a true market rate for a pharmacy. That may be impossible, but time will tell.

We should have a joint council between the PSI and the Medical Council. There is a great need for all these regulatory bodies to start talking to each other. There is also a need for the Minister to correct much of the legislation involved. She has done little to get the bodies talking to each other. She will be aware of the international reports which show the percentage of pharmacists, doctors and health care professionals who have ended up with substance abuse habits. They may abuse the drugs for sale themselves, or they may abuse their privilege and sell on those drugs to others. I am not sure if the Minister has covered those issues in this Bill. That is why I was hoping she would accept our view that there should be a joint council between the two bodies.

Ultimately, a patient safety authority is needed to protect patients, and when Fine Gael and the Labour Party published a policy document last year on a patient safety authority, I think the Minister recognised what we were talking about. All of the regulatory bodies must talk to each other and some body must direct that, which should be the patient safety authority. The Pharmaceutical Society of Ireland must come up with ethical guidelines on how doctors and pharmacists interact and work together.

Let me focus on something in which the Minister believes and on which I support her to some extent, namely, prescribing by nurses. I still have concerns about it and we must be careful on how we move on it. We never defined quite clearly whether a nurse working in the health spa of a five-star hotel could prescribe drugs. At what level can nurses prescribe? Can they prescribe in a hospital or in a GP surgery? The Minister wants the fitness to practise hearings in the Medical Council to take place in public, but the fitness to practise hearings for nurses at An Bord Altranais are never held in public. We raised concerns about the structure of Health Information and Quality Authority and whether it will protect patients. The Leas Cross scandal occurred relatively recently and I think time will tell how well known it was among senior management of the HSE and how nothing happened for quite some time. The inquiry into Our Lady of Lourdes Hospital showed what can go wrong when the structures are not in place.

Has the Bill taken the UK Shipman report into account? That was far more comprehensive than anything we have ever done in this country. There are concerns about what seems to be unusual prescribing of cyclomorph, which is a form of morphine that Harold Shipman used to murder his own patients. Has the Minister taken the recommendations of this report on board? We want to balance things. We do not want to regulate excessively, but the Minister should have taken on board everything in that report when she was framing the Bill. So much takes place that the potential for abuse is huge.

The Minister and her colleagues in Fianna Fáil are pushing a private model that is not like the competitive private model of the Blackrock Clinic or the Beacon Clinic. They are pushing a private model where the State takes up many services from the private sector. Many of the abuses that have occurred worldwide are cases where the State has contracted a great number of services from the private sector. When the Minister talks about abuses in the public system, she is actually talking about abuses that occur when the private model is mixed with the public model.

Some public clinics have been closed down and the work has been transferred to private clinics. It is quite possible that those private clinics will be pushing doctors and other health professionals to increase the work they do on patients from the public system because the public system is paying for it. The same checks and balances in regard to whether these investigations are even needed are often not in place in the public system. VHI or BUPA, because they are private companies, will generally be careful about making sure they do not find themselves in a Deloitte & Touche situation. It would never happen that a private company would pay out €165 million to consultants without having the foggiest notion what is going on. This is what happened in regard to PPARS, however, with consultants being paid €30 million or €40 million without anybody knowing what was happening. That would not happen in the private system because it has better checks and balances in place.

The Minister's drive towards using the private system to pay for public services is not ideal. The same difficulties may arise in respect of her co-location plan if effective governance structures are not in place and procedures are not properly defined. Nothing about the HSE inspires confidence that this will happen. The Minister has talked a good talk in rushing through this legislation. However, for those of us who may have more intimate knowledge of how the health services work and who think the issues through more thoroughly, significant concerns remain which the Minister has not confronted.

I am sure the Minister read the recent report in the Irish Medical Times on the mental health tribunals that were set up under the auspices of the Mental Health Commission according to the provisions of the Mental Health Act 2001. I pointed out on Committee Stage that it is a good idea, of which I remain a strong supporter, that anybody who is admitted to hospital involuntarily should have an opportunity to have that involuntary admission independently reviewed by the Mental Health Commission. Although the system has been operating for only six or seven months, however, the HSE has already raised major concerns with the Minister that it is not working well.

One of the main problems is that it is turning into something of an adversarial system, in which lawyers are involved, rather than the advocacy process that was envisaged to allow patients have their involuntary admissions reviewed. It was not established to provide an opportunity to sue doctors and blame people. Rather, its purpose was to offer a second opinion and to advocate on behalf of these vulnerable patients. Although it was only set up on 1 November 2006, it is already the subject of concern on the part of the Irish Medical Organisation and the HSE. This was something that was planned for five years.

The Minister can dismiss the points I have made but there is no denying the concerns that exist on this issue. One of the best ways forward is to be found through my party's proposal to establish a patient safety organisation. The Minister must kick into touch on these issues by offering her full support to our position. Health services are taking a strange direction. Where there is potential for abuse, it usually occurs. A small minority of people engage in such abuse and it is our duty to protect the majority. We have a particular duty to protect patients in the public health care system.

I expect the Minister will not accept many of the Opposition amendments. I will withdraw my amendment.

I am sure the Minister agrees it would be helpful to have a crystal ball when drawing up legislation. It is often difficult to foresee the long-term consequences of the legislation we enact in this House. Some GPs maintain that the question of beneficial interests has not been settled and they have made representations to some of the Minister's colleagues on this point. They are of the strong view that five years hence, there will be undesirable consequences as a result of this legislation. I cannot tell whether that is the case. The Minister is strongly of the view that this issue has been dealt with thoroughly in the legislation. These GPs contend, however, that it will have a hugely detrimental effect on the roll-out of the primary health care strategy. I hope the Minister will consider what they have said.

Previous speakers stated, as I did on Second Stage, that the role of the pharmacist must be greatly enhanced and thoroughly integrated into the primary health care system. I fully support that view. However, I have raised a particular concern with the Minister in regard to empowering nurses and pharmacists to prescribe medications. This is the issue of antibiotic prescribing. It seems there is no consistency across the board in this regard.

How will we regulate and monitor the prescribing of antibiotics? Are there graphs of data to indicate the practices of particular pharmacists? Patients will invariably go to the pharmacy that is closest to their GP's surgery. In Ringsend, for example, people go straight from the health centre to the nearby pharmacy to get their prescriptions. It should be possible to ascertain quickly which GPs seem most inclined to prescribe antibiotics. In fairness to the Minister, she raised this as an issue of concern at a meeting of the Oireachtas Committee on Health and Children. What concerns me, however, is her assertion that it would take approximately 12 years to change the prevailing mindset in regard to antibiotic prescribing. We must act quicker than that if we are to deal with the related problem of MRSA. There is no doubt the two are related.

I agree with other speakers that this could be the second last sitting day of this Dáil.

I do not think so.

I thought I heard the Taoiseach say yesterday that we will be back after Easter. In fact, what he said was: "We will be back." That means something different.

I would not read anything into that.

The Taoiseach was having a Terminator moment.

A meeting took place today to discuss the Order of Business for the parliamentary week beginning 24 April. I understood Deputy Gormley was a Whip, in which case he should know this.

I am encouraged by that.

Is Deputy Gormley not the Green Party Whip? Has he been promoted from that position?

Deputy Boyle is the Green Party Whip. The Minister's comments are encouraging.

It might be advisable to return to discussion of the Report Stage amendments to the Bill.

We will amend the Bill to say there will be no election.

We do not want to spread panic through the land at the notion of an election approaching.

We certainly know an election is approaching. This is particularly so in the case of Deputy Twomey.

I thank the Minister for her clarification.

This is an issue I have raised with her previously. I wish to ascertain how she intends empowering nurses and enhancing the role of pharmacists while more stringently regulating antibiotic prescribing. The Ceann Comhairle is a doctor and I am sure he understands all of this issue. I seek some indication from the Minister on the matter.

Many of the important points have been made by other speakers. This is a complex issue. This legislation will not put to bed all the concerns expressed by clearly conflicting sets of interests. That reality will continue to present itself from time to time. I am not sure, having tried to inform myself, there is necessarily a formula that will satisfy all of these competing interests. I do not believe that is within any Minister's gift. However, we have a responsibility to ensure that the regulations made under the Bill are both enforceable and enforced. This includes, as many of these amendments refer to, areas directly affecting codes of conduct. This is very important.

This Bill has presented a major challenge. I have no doubt it should, of course, have been published a long time ago. It is seriously overtime but I also have no doubt it presented a challenge to the Minister and her Department. It certainly presented a challenge to the members of the various Opposition groupings in the House. However, we have a responsibility to try to steer the best legislation possible that will help copperfasten public confidence in the pharmacy sector and not only in the obvious way in terms of the traditional family pharmacy presence, in each of our respective communities, that have given long and much appreciated and valuable service to their respective hinterlands but the network across the State where anyone and everyone could, at any time, have to access and avail of the service provided. It is also concerned with the integrity of the sector.

Deputy Twomey has indicated the withdrawal of one of the amendments presented in this grouping but I am not sure which one. I am supportive of the broad thrust of the group of amendments as presented, to which the names of Deputy McManus and others have been appended. I am interested to hear what the Minister has to say in response and how willing she is to accommodate the thoughtful preparation of amendments by several Deputies in preparation for this Stage. I hope the approach will not be the traditional one of rejection, which we have heard so often.

I have read the amendments but I do not have the great knowledge that our previous speakers have shown. Will the Minister tell us whether there will be a total ban on locating pharmacists in health centres? I ask her to be clear about that because it is an issue that has arisen in different areas. If the answer is that there is no ban, will pharmacists be charged a normal rent rather than a large amount of money for inclusion in the health centre? Those are the issues about which I am concerned.

Is there any chance that a pharmacy will be charged a large amount of money?

I ask that pharmacists be charged normal rents if there is no ban on locating pharmacists in health centres.

Does the Deputy think they should be charged normal rents?

I leave the Minister to answer that question.

What is the Deputy's view?

I take it we are talking about normal rent.

I would like to hear the Deputy's view on that matter.

I have taken many points but these are the main ones about which I am concerned. I am concerned about the development of the health service.

On Second Stage I gave broad support to the Bill. It was obvious much work had gone into it even though the time to debate it was limited. I share Deputy Gormley's concern about the crystal ball. The amendment tabled in the Seanad seemed to satisfy the pharmacists but it produced another set of problems for general practitioners and the delivery of primary health care. I met a few of them who said it was likely it would be delivered almost exclusively by the private sector if the current circumstances continue. What they have said is that the private sector is likely to withdraw from it. What is the vision for primary health care in ten years' time if there is a disconnect between pharmacists and GPs?

In my constituency a planning application for a medical centre, a pharmacy and a child care facility was lodged. It was perceived there were objections from pharmacists in the area and in the end it was turned down. The point made by Deputy McManus about the commercialisation of medicine is a valid one because we are beginning to see things we would not have seen before, essentially turf wars. I wonder whether we are going the full circle. In the past our health centres used to be called dispensaries. When there was no commercialisation a range of different services was provided from them, albeit, at a much lower level.

I cannot make a value judgment on who is right and who is wrong on this matter. However, I am concerned about some of what has been said to me. If there is no State investment in primary health care and the private sector withdraws how can the strategy be delivered? That is the nub of the problem.

I thank all the Deputies who have contributed to the debate. I am very impressed with the great level of interest shown in the private sector from the Deputies opposite because I am usually attacked here. In fact, there is a contradiction between the emphasis on commercialisation and private interests.

To clarify an issue raised by Deputy Twomey, there is no question of a nurse being able to prescribe in a spa. Nurses will be able to prescribe only in particular health care settings, for example, a palliative care nurse in a palliative care setting and so on. There is no question of a nurse being able to prescribe in a spa, hotel or anything of that kind.

The Deputy asked about the current position regarding the legislation that has been presented to Brussels. It had to go to Brussels and is due to be cleared at the end of three months, which is up in two weeks' time. In conjunction with that, An Bord Altranais is arranging specific training for nurses. The intention is that it will take effect later this year.

Will there be clear regulations as to where nurses can prescribe?

Has An Bord Altranais issued ethical guidelines on prescribing?

It will do that. That is a matter for the regulatory body. As I said on Committee Stage, I regret the rushed nature of the debate and I accept it is rushed. I accept also that the volume of legislation coming from my Department has been a challenge to the Department, the Parliamentary Counsel, Opposition spokespersons and others. Three large Bills are going through the House and will be enacted before the election. The reality is that this legislation has been a long time in gestation. I gave a commitment and I wanted to honour it. I put my officials and the parliamentary draftsman under enormous pressure to deliver on that commitment because if the legislation is not passed before the Dáil is dissolved it all falls. It would certainly be next year before we would have legislation in this area. Effectively in the pharmacy sector, as far as the society is concerned, we do not have a fitness to practise regime.

However, I must say to Deputy Gormley that I believe we will be back here on 24 April and for some time thereafter. I look forward to coming back as Minister for Health and Children. I know the Deputy told me he did not want to be the Minister, but I do. I draw the attention of all spokespersons on health matters to an article that was given to me today entitled "Global trends in healthcare". It states that there is no country where people do not complain about their health system and where people are not calling for reform. Everyone who is interested in being the Minister for Health and Children should note that the document states: "Ministers of health anywhere in the globe must have done something bad in an earlier life or they would not be condemned to the ministry". Perhaps Deputy Gormley had read that when he said he did not want to be the Minister.

I said it would not be my first choice.

Maybe he wrote it himself.

I wish to indicate that I will accept two amendments from Deputy McManus. I already accepted some of her amendments on Committee Stage. I assure the House that this is not a political bias, as most people will understand. It is just that they are good amendments and have been cleared legally.

It is a gender thing.

It is not a gender thing either. I hope I am big, brave and honest enough to accept good amendments from wherever they come. I accepted quite a few in the Seanad or said I would have them checked. The amendments introduced in the Seanad concerning conflicts of interest have caused a lot of interest from all kinds of people. Deputies and Senators have spoken on them, which is the wonderful thing about this democracy. If we all accept as an ethical principle that there should be no beneficial interest between prescribing and dispensing, the question arises as to how one can give legislative effect to that. That is what we sought to do and we took the advice of the Attorney General. In that respect, we did not prohibit co-location, other than that there have to be separate entrances for any new facilities. We did not prohibit any landlord-tenancy arrangements, nor did we say it should be a planning issue. I accept that much confusion and ambiguity have arisen. That is why I am proposing two amendments, one of which is to say landlord and tenancy arrangements are not affected. The other concerns a commercial relationship by way of an owner of a property renting. I was asked by Deputy Sherlock, who did not answer it himself, about normal rent. If one goes to the market and advertises a premises for rent, and if the person who makes the biggest bid is a pharmacist, that is not an issue. That is normal. It may be abnormal in the sense that a flower shop will pay less, I presume, than a pharmacy. Everybody would pay more to be co-located with doctors but it was never envisaged in the primary care strategy that pharmacies and doctors would be located together for a very simple reason. In an average town there is a number of pharmacies, but whatever about bringing a number of doctors together it would be a minefield to have four or five pharmacies in the one location. I could not see that working very well. Therefore, the normal landlord-tenancy relationship will not be affected by this legislation. It was never intended that it would be affected.

We are giving the regulators, under the rubric of fitness to practise, power to ensure no unethical behaviour occurs. That means nobody is prescribing to get a benefit from dispensing or vice versa, if it could happen.

I am also proposing another amendment concerning partners, whether medical or pharmacy partners. A valid point was made to me that if two people are in partnership and one is involved in unethical behaviour, but the other is not aware of that, it would be unfair that the latter person could be before a fitness to practise inquiry. However, there will be a requirement on the other person if they become aware of the unethical behaviour to report it to the regulator within 21 days. That is reasonable. It was never intended, by virtue of a partnership, that the other person would be affected by the unethical behaviour of one of the partners. That point was made to me and I felt it was a good idea to take it on board.

That is the essence of the two amendments. Landlord and tenancy arrangements are not affected, and where one partner is involved in unethical behaviour and the other is not aware of it, obviously it is not a fitness to practise issue for the latter, unless it can be shown they were aware and within 21 days did not report it to the regulator.

I will not go into all the issues that were raised earlier but if I had a crystal ball I probably would not be here. If I could predict all the things that were going to happen with the certainty of the crystal ball, I would probably decide to be somewhere else. Legislation is always amended and inevitably legislation is tested in the courts. Circumstances evolve and change and both the medical and pharmaceutical professions have changed. I am a strong fan of encouraging people to invest in health care. Professionals do well in any developed society. I said this to solicitors a number of years ago when we were introducing the Personal Injury Assessment Board and many of them thought they would go out of business. In any developed society of which I am aware, highly educated and highly skilled professionals always do well. I believe in encouraging people to invest in new facilities. We have many strategies — the buzz word — in the Department of Health and Children. In fairness, I do not think anybody contradicts that fact that they were never all costed and put together. If they were everybody would realise it would be an almost impossible task if the State was to fund it all. The primary care strategy is essentially about bringing health care professionals together in a network working for patients. It would not be possible for the State to pay for all the facilities. If it did so it would be at the expense of something else. We currently spend €14 billion, a considerable sum, but it cannot do everything.

I was a fan of tax incentives for general practitioners but it would have to have been cleared by the EU and that is why the idea has not been pursued. If I thought it could be cleared by the EU I would have been keen to push the idea. Perhaps that can be pursued in the new Government but it cannot be done at the moment because it could not happen without EU clearance. There are more stringent rules at EU level concerning tax allowances than a couple of years ago. That is why it is much more difficult and challenging to introduce tax breaks for worthy things like primary care facilities or health facilities generally.

I wanted the Minister to deal with the question of the ban, for my own benefit.

I accept the Deputy is from Mallow where I know a primary care facility is to be put in place.

It is not because he is from Mallow.

It affects other places as well.

Please allow the Minister to continue without interruption.

He is from east Cork and there is an issue there.

The legislation never sought, and does not prohibit, pharmacies and general practitioners from being in the same premises. I made that clear on Committee Stage and there is no doubt about it. To ensure there is no confusion or ambiguity, the legislation says normal landlord-tenancy relationships are not affected by this legislation.

Go raibh maith agat.

We have discussed amendments Nos. 12, 13, 16, 18 and 19. Did the Minister say she was accepting some of those or was she referring to subsequent ones?

I may have been referring to later ones. I am accepting amendments Nos. 9 and 34.

They are not included in this grouping. We will come to them seriatim. Is Deputy McManus pressing the amendment?

Amendment, by leave, withdrawn.

Amendments Nos. 3 and 6a are related and may be discussed together.

I move amendment No. 3:

In page 12, lines 30 and 31, to delete "by the Minister" and substitute "or elected as set out in subsection (3)”.

The Minister needs to clarify the situation concerning amendment No. 6a. I hope she will be able to follow this. As far as I can see, amendment No. 4a is identical to what is now called amendment No. 6a. When it was No. 4a is was supplementary to the principal amendment list. When it became No. 6a, which I presume came in later, it was a substitute for the additional amendment list circulated on 4 April. I presumed it was simply a substitute for what was called No. 4a, but we have had another list of amendments from the Minister, which was also introduced on 4 April. That is a list of additional amendments. I am concerned about being absolutely clear on this matter. Is there a question of amendment No. 6a replacing the later amendments Nos. 28a and 32a from the Minister? That is what I am reading here but I cannot believe that is what is actually happening. Regarding amendment No. 6a it reads “this amendment list is in substitution for the additional amendment list circulated on 4 April 2007”. The additional amendment list has three amendments on it; amendments Nos. 28a, 29a and 32a. Are they being withdrawn?

The second amendment list is in substitution for the additional amendment list, so both cannot be included in the Bill. Either one list or the other should be included.

There are two lists. There is a second additional list of amendments.

Is amendment No. 6a a substitute for amendment No. 4a or is it a substitute for amendments Nos. 28a——

Amendments Nos. 28a and 29a are additional and have nothing to do with amendment No. 6a or amendment No. 4a.

I know but the heading on amendment No. 6a says the list is in substitution for the additional amendment list.

There are two lists and amendment No. 6a is a substitute for amendment No. 4a.

There are three lists.

Amendment No. 6a is a substitute for amendment No. 4a.

I do not know about that. Is the Minister certain of this?

That is correct.

It looks like that but the additional amendment list has three items on it and I want to be certain.

Deputy McManus is looking at the second additional list. Report Stage amendment No. 6a is a substitute for amendment No. 4a. Does Deputy McManus have this list?

It is not a list, it consists of only one amendment.

There is one amendment on the list.

Does the Minister concur with this?

I do concur. Apparently the numbering was done in the Bills Office.

Would Deputy McManus mind if I request clarification? Two sets of amendment No. 4a were circulated: one dated today, 4 April 2007 and one, a further substitute amendment No. 4a, dated tomorrow, 5 April 2007.

Does the Deputy have the second additional list?

I am not responsible for that.

I am afraid it bears the name of the Minister for Health and Children, Deputy Harney, so perhaps she can clarify the matter. It is not surprising that people are confused. If the Minister is not responsible then the person who is does not know what day of the week it is.

It is back to the future.

Today is 4 April and I am certain of that.

That is very good.

There are three lists from 4 April. I want to clarify for the record that amendment No. 6a is a substitute for amendment No. 4a and nothing else.

Yes. I presume the Ceann Comhairle will confirm this.

Are the other additional amendments still part of the new amendment and not being taken out?

We are working off the second list of amendments.

There is no second list; they all have the same title. Perhaps I could put this a different way. Are amendments Nos. 28a, 29a and 37a still included?

We are working off the second additional list of amendments and this is noted at the top of the page.

The Minister has acknowledged that this is included.

Yes and amendment No. 6a aims to deal with what Deputy McManus raised, the issue of whether people elected are automatically appointed.

I understand the substance of the amendment and I would like a brief comment on it to show that the Minister has taken on board the issue I raised. To me it seems a more elegant solution to simply allow people who elect a person to represent them to have this included in the Bill. The Minister is saying here that representative bodies elect their representatives and the Minister cannot refuse to appoint them. This seems like a clumsy and awkward way to provide for the exact same result. Sometimes there is a sense that the Minister has a control requirement that results in these peculiar arrangements. Still I welcome this and withdraw my amendment in favour of the Minister's.

Amendment, by leave, withdrawn.

Amendment No. 4 in the name of Deputy Ó Caoláin has been ruled out of order and does not arise out of committee proceedings.

That is most unfortunate. I am sure the Minister will adopt it regardless, out of goodwill. I am conscious that it has been disallowed.

Amendment No. 4 not moved.

I move amendment No. 5:

In page 13, between lines 41 and 42, to insert the following:

"(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.".

This is an issue I raised on Committee Stage and the Minister indicated she was sympathetic, although she seemed concerned there might not be enough men, rather than women, and that the balance might need to be tipped in the other direction. If that were the case ——

Acting Chairman

Amendment No. 6 in the name of Deputy Ó Caoláin is a logical alternative to amendment No. 5 and amendments Nos. 5 and 6 may be discussed together.

The two amendments are the exact same but that does not matter.

The Minister indicated she might be able to do something about my amendment on Report Stage and I wondered if she has been able to do so.

I wish to speak on amendments Nos. 5 and 6 as they are the same, as Deputy McManus says. These amendments have been presented for consideration by this Minister and other Ministers across a number of portfolios where appointments will be made to specific bodies, councils and so on. Gender equality is the objective. We have dealt with recent legislation where this matter was addressed and we have yet to see a response that gives confidence that this Government will ensure we will have at least a 40% representation of both genders in State bodies, however the remaining 20% balance is distributed between the two. It is very important that we endeavour to achieve these goals and I hope the Minister for Health and Children, Deputy Harney, in one of the last pieces of legislation she is likely to address substantively here in the House, will accede to Deputy McManus's appeal.

Hopefully this is one of the last pieces of legislation I am likely to address substantively here in the House before the election, in any case.

As I said on Committee Stage, nine of the members are elected and, at the moment, 38% of the members of the society are women including two former presidents, the current vice-president and two former registrars. In health care professional grades and professional positions in health care generally there is now a majority of female students. This amendment is too prescriptive, especially when nine of the 21 members are elected.

I am sure Deputy Ó Caoláin will take this in the spirit it is meant but half of the members of my party in this House are female while none of the members of his party in this House are female. It is not always easy to get the desirable outcome.

We are working hard on it.

I strongly favour gender balance as I think it leads to more objective decision making but I think it is happening organically. This amendment is too prescriptive. I believe the issue in the future will be having a male presence of 40% in such societies. If one looks at pharmacy students, medical students, therapy students and nursing students today one will hardly see a man in the room.

These are good days but I like a balance and do not want men to be absent. Decision making is better when there are men and women involved.

How is a level of 40% ensured?

If that criterion was applied in this House Deputy Ó Caoláin might not be here and that would not be a good thing. I would be pleased to accept the amendment if the Minister appointed the entire board but nine members will be elected. I also understand that eight of the elected members are female.

It is a pity the Minister will not include the proposed provision in the legislation. While I agree that co-decision making and gender balance tends to result in improved decision making, what matters most is not which gender is excluded or in a small minority but the gender imbalance. The Minister is hopeful about the pharmacy sector and her hopes may be well-placed but she should not harbour illusions about achieving gender balance in the Oireachtas because it will take hundreds of years at the current rate. This disturbing feature of parliamentary decision-making, in a country in which half the population is female, places an onus on Members to ensure the balance we want but may not live to see in the House is at least provided for in State boards and regulatory bodies. We must also ensure it holds firm in the future, irrespective of the nature or composition of the sector in question. It frequently occurs that those making decisions at senior level in predominately female sectors are predominately male. A number of obvious examples come to mind. Ensuring a balanced arrangement in a board or structure protects people of both genders. I regret the Minister will not accept the amendment.

Amendments of this nature are not repeatedly placed before Ministers as fillers. My party has a strong belief in gender equality. All our representatives in Europe are women.

I am very impressed.

We have two MEPs and are far from being impaired by their input. One cannot make a direct analogy with the make-up of the respective political groupings in the House, although parties must consciously strive to achieve gender balance. It is important to ensure women from across the range of experience, particularly among the various health interests, make an input. We should encourage and facilitate a greater balanced input by males and females and these amendments are constructed to achieve that end.

As the Minister noted, the Oireachtas is probably the most unbalanced Parliament from a gender point of view.

It is unbalanced in several respects. It would not be so bad if it were only in terms of gender.

As someone who has held power and authority in the Chamber, has the Minister considered the possibility of allocating a specific number of seats in the House under a list system? The political and electoral systems are structured in such a way as to make it extremely difficult for those with young families to get elected. No one is under any illusions about the amount of work needed to come through the system. The political system militates against women reaching positions from which they could be elected to the House, albeit not deliberately. Getting elected is difficult for everyone but particularly young women. Perhaps we should introduce a list system under which Members of one or other gender would be selected if the House failed to reach a minimum gender balance. Other European parliaments operate this system to good effect and a similar type of system could be helpful here. A list system would allow seats to be distributed on a pro rata basis, the method used to appoint committee members and allocate speaking slots among the parties.

I am not sure we can change the electoral system in the Pharmacy Bill.

We surely can not.

Forcing solutions on democracies does not work. To take teaching and nursing as examples, both professions are predominately female — 80% to 90% of nurses and teachers are, I believe, female — yet women frequently exclude themselves from positions as trade union representatives in these professions. They do so for good reasons, including on family grounds, but they also make career choices for other reasons. I would love to have more women Members but the Oireachtas and politics in general are not family friendly.

Hear, hear.

This debate is taking place at 9.50 p.m. Those of us fortunate enough to live in the Dublin region will be able to travel home tonight, whereas at least two of the Deputies present have probably been away from home for the past couple of days. This is not easy for men or women and much more could be done to make parliamentary structures more family friendly. While such changes could encourage more women to become involved in politics, this is a major cultural issue. We made significant strides in this regard in the 1980s but have slipped back since then. Political representation is a wider issue than the pharmacy profession and not one for this debate.

Amendment, by leave, withdrawn.
Amendment No. 6 not moved.

I move amendment No. 6a:

In page 13, between lines 43 and 44, to insert the following:

"(7) The Minister may not refuse to appoint to the Council a person nominated under paragraph (a) or (b) of subsection (3) or selected under paragraph (f) (as read with subsection (5)) or (g) of subsection (3).”.

Amendment agreed to.

Acting Chairman

Amendments Nos. 7 and 8 are related and may be discussed together by agreement.

I move amendment No. 7:

In page 14, between lines 30 and 31, 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,”.

The amendment proposes to introduce a requirement for consultation in drawing up codes of conduct. A similar amendment proposed in the Seanad, which named the Irish Pharmaceutical Union, was withdrawn having been found to be flawed. This amendment proposes that before drafting or giving effect to a code of conduct — such codes have a significant impact on those working in the sector — the board shall consult bodies which are representative of the pharmacy sector, and with any other person or body the council considers appropriate.

Although the amendment is harmless, I presume the Minister does not propose to accept it. It proposes a form of inclusion which is beneficial as it would ensure the process takes account of the views of those who work in the sector and will be required to comply with the code of conduct. They will not make the decision on the code — the decision making process is clear — but will have some sense of ownership of the requirements imposed on them. This would lead to greater responsibility, more engagement by professionals, enhanced understanding of what is required of them and possibly even better public awareness of the requirements and duties included in a code of conduct. This kind of process is of benefit in itself but it would also ensure the code of conduct developed is the best one for patients. In that sense, I hope an amendment such as this can be accepted by the Minister because it firmly sets the idea that when one is developing a code of conduct, the people must be engaged in that development. It is not that they will necessarily determine the outcome but that they feed in and the system of any code will be more robust as a consequence of that kind of inclusion.

This is fairly straightforward. It raises some of the issues to which I referred regarding a joint council of the Pharmaceutical Society of Ireland and the Medical Council. Nothing in the Bill suggests the body that regulates pharmacists must talk to the body that regulates doctors or vice versa. Complaints can be made about either pharmacists or doctors but they are expected to go to their own regulatory body.

Doctors now work closely with pharmacists, and practice nurses are becoming much more important within primary care and take a much greater role. There are also more advanced nurse practitioners as well as physiotherapists, speech and language therapists and occupational therapists, all of whom will be working as teams within the community. However, the regulations for all these practitioners state they must be boxed off and treated separately. If there is a problem with a doctor, it goes to the Medical Council, while a problem with a pharmacist goes to the Pharmaceutical Society of Ireland.

We need a mechanism whereby all the regulatory organisations are to some degree compelled to communicate on complaints that have been made. If this mechanism were in place, it might prevent some of the concerns that have been expressed to the Minister. There is a serious need in this regard.

The basis of the Fine Gael-Labour Party proposal for a patient safety authority was the establishment of some form of overarching body. It seems amazing that the accountancy profession has such an overarching body — I think the Minister set it up — whereas patients do not. As we are moving to this point, having to some degree forced the Minister to move to it, it is important we should go the full way and establish a patient safety authority that will compel the regulatory organisations to communicate better with each other.

The amendment specifically states that the doctors' and pharmacists' representative bodies should also see the codes of ethics that have been drawn up for them, which would happen in any case. That input will come, as we have seen with regard to other legislation. However, legislation is needed to begin to force these regulatory bodies to communicate with each other. While I do not suggest they should be compelled to do so, it should be natural that these organisations would talk to each other.

With regard to the accounting profession, the supervisory body was established because there are different branches of accountancy which each has regulatory functions. At the tribunals, the role of accountants in signing off on audited accounts was seriously questioned in many cases. It could be argued that if the accountants had done their job, many of the tribunals would not have been necessary. It was felt by many that if one were part of the larger group of accountants, one would never be called before the regulatory body whereas if one was a smaller fish, one would be disciplined. When that matter was examined — in my previous role, I established a group to consider the matter — there were two options, namely, State regulation, which I do not favour, or the establishment of a body that would supervise the regulators in accounting. That is very different from what Deputy Twomey suggests in this regard.

The principle remains the same.

It is not in any way the same.

The same concerns have been expressed about patients.

The purpose of that was to supervise how the bodies operated. The Deputy is not suggesting a supervisory body that will supervise how the Pharmaceutical Society of Ireland or the Medical Council regulate. He is suggesting that we have a body at the level of which the various regulatory bodies would meet. These bodies have very separate functions. One does not need to prescribe in law for people to talk to each other, for God's sake. The Deputy and I can talk to each other.

Sometimes it is needed because there is often not the required communication between regulatory organisations.

Every time there is a problem in this country, people either call for more legislation or some other body. Sometimes we simply need to make the bodies that exist work. This proposal is too prescriptive and bureaucratic.

It is not that difficult. It can be done. The Minister has set up a commission to investigate this matter, so she is not totally against the principle of what I suggest.

We set up a group to consider whether we would have State regulation of accountants or whether we would do something——

I was referring to the commission on patient safety.

Patient safety is at the heart of all this.

The Minister accepts some of the principles.

These bodies must regulate in the public interest. They are not representative bodies for either the doctors or the pharmacists. They exist to regulate the profession in the public interest and to support the profession. They have very separate functions. Perhaps some day we will have one regulatory body for all health care professions.

I assumed the Minister had read our policy. Maybe——

The Deputy made this point on Committee Stage last week. It would be extraordinarily bureaucratic, excessively prescriptive and unnecessary. There is sufficient authority for the Pharmaceutical Society of Ireland and the Medical Council to engage with each other. There is no difficulty with that. If we begin legislating and formalising that——

A patient safety authority is wider.

I am not trying to be unfair to the Deputy as I know he has been helpful but he raised this earlier and I did not agree to it.

With regard to consulting, which was raised by Deputy McManus, of course this will happen. Again, I do not believe we need to be prescriptive with regard to who one consults and when one consults them. In fact, as with the Medical Practitioners Bill, there has been widespread consultation with pharmacy interests in the preparation of this Bill, which has been strengthened. This is normal practice nowadays and is a good thing. We do not need specifically to write it into the Bill for it to happen.

Amendment, by leave, withdrawn.
Amendment No. 8 not moved.

I move amendment No. 9:

In page 16, line 12, to delete "a" where it secondly occurs and substitute "the".

I accept the amendment.

I feel a great glow of achievement.

So the Deputy should.

I remember going through an entire agricultural Bill and the only point that was accepted was a full-stop I had put in by way of an amendment.

The Deputy has come a long way.

Amendment agreed to.

Acting Chairman

Amendments Nos. 10 and 11 are related. The amendments may be discussed together.

I move amendment No. 10:

In page 20, line 35, to delete "may" and substitute "shall".

The amendment proposes to change the requirement on the Minister in regard to making regulations. The Bill states: "The Minister may, for the purposes of the health, safety and convenience of the public, make regulations about all or any of the following matters in respect of retail pharmacy businesses". When one reads this, it raises the question that if there are health and safety issues, there must be an onus on the Minister to deal with them. It is not a matter of choice so that if there are health and safety issues in the retail pharmacy business, the Minister might or might not deal with them by way of regulation. That seems an irresponsible approach. If these issues arise, the Minister shall make the regulations. If they do not arise, the Minister will not do so.

The danger is that the subsection could be interpreted as suggesting the choice is with the Minister whether to pay attention to health, safety and convenience of the public issues. That is not good enough. We are talking about patient safety. This is a practical, immediate way to protect patients and to establish a certain requirement on the Minister to live up to his or her responsibility. Ministers are very good at making everybody else live up to their responsibility but, in this instance, I would have thought it was more appropriate to be crystal clear on what must be done in regard to the health, safety and convenience to the public. This point was raised by the hospital pharmacists, who feel it is vital from a patient safety point of view because it allows for the setting of standards both for practice and pharmacy premises and will ensure quality and safety of pharmacy service. It must also apply to the practice of all pharmacists and their premises, including hospital pharmacists in hospital pharmacy departments.

Committee Stage is a bit of a blur now because of the amount of material covered in debate, but as I recall, the Minister indicated then that hospital pharmacies would not necessarily be subject to regulation because of their nature. If we intend bringing in a regulatory framework which is significantly different from the current situation where there is practically no regulatory framework, let us do it right and let us get the responsibilities in place. This is obviously a ministerial responsibility.

There is no timeframe for the implementation of the regulations. This is often an issue with legislation and regulations often take forever to materialise, despite being written into law. However, they are at least written into law. This morning I raised an issue relating to the tobacco legislation for which secondary legislation is required, but we are still waiting for it and nobody seems to know when we will get it. That goes back a couple of years.

It is not as if this amendment imposes an unrealistic or unfair requirement on the Minister. It simply says that where there are issues of health safety or convenience for the public, the Minister "shall" make regulations. I urge the Minister to ensure the amendment is accepted.

Deputy McManus has explained the need for the amendment very well. I hope the Minister will understand that when it comes to patient safety, there should be no leeway. Protection of patients should not just be at the discretion of the Minister. Rather, the Minister should be obliged to protect patients. We have heard much during this debate about patient safety. I hope the Minister understands from where we are coming on this. She may argue that it is self-evident that if there was a problem, any responsible Minister would act to protect patients. However, I would like to see it copperfastened and set down in law that the Minister must and "shall" act. I see no major difficulty in that regard, but I am sure the Minister will have a reasonable explanation.

I support amendment No. 10 which proposes to delete the word "may" and substitute the word "shall". I also support amendment No. 11. I urge the Minister to support amendment No. 11 and ask her to note the substantial difference between the thrust of amendment No. 11 and that of amendments Nos. 7 and 8 which were discussed earlier and which spoke of the council. They proposed the council should "consult with bodies which are representative of the pharmacy sector, and with any other person or body the Minister considers appropriate". However, in the case of amendment No. 11 it is the Minister rather than the council who is being urged to consult bodies which are representative of the pharmaceutical sector in determining new regulations. He or she should also consult any other person or body the Minister considers appropriate.

We must recognise there are a number of bodies which the Minister should consult on the introduction of new regulations. Whoever is the incumbent at the time will have to make that determination because the amendment leaves it to his or her judgment as to who is considered appropriate. In my view, those appropriate must include the Pharmaceutical Society of Ireland, PSI, the Medical Council, An Bord Altranais and the Dental Council.

I will go even further. As a Deputy from the Border counties, I suggest good and best practice into the future, in line with the Taoiseach's response to me on this issue last week, would mean we should look at these matters on an all-island basis and should have the maximum co-operation, consultation and cohesion in terms of the delivery of health care in all its dimensions. This must include the areas of regulations, codes of conduct etc. that will apply. We need to pool our collective resources and experiences in order to arrive at the best formula. In this instance, I believe there should be consultation with the appropriate counter bodies north of the Border.

I understand the PSI has also encouraged this position and that it would like to see the maximum consultation taking place with the appropriate other bodies. We need to recognise the importance of maximum consultation. Regulation is very important. We are aware the prescription and dispensing of drugs is a lucrative business. While the majority of practitioners — general practitioners, medical doctors and dispensing pharmacists — operate and maintain the highest standards at all times, there is always a risk that some may fall prey to temptation. The suggestion has been made here previously that some people in the sector see the public purse as a honey pot for over-prescription because of the lucrative return therefrom.

Regulation is of significant importance. We need to recognise that while there are competing aspects in the roles played by GPs and pharmacists, there are clearly more coinciding interests. Therefore, the careful consideration of the standard of regulation is essential. Amendment No. 11 is geared towards ensuring the best possible arrangement and formula for introducing new regulations into the future. The crossover consultation is essential in this regard. Any Minister in the position of this Minister would, in acting responsibly, wish to take this course. Therefore, the amendment merits inclusion in the legislation and I commend it to the Minister.

I assure Deputies that consultation is the norm nowadays. Not much can happen without consultation, but there are some areas where it does not happen. We dealt with a health insurance risk equalisation Bill some time ago and there were reasons that there could not be consultation on that matter. Generally speaking, however, apart from occasions when somebody could get an advantage through consultation, it is normal. If we replace "may" with "shall", the provision will be extremely prescriptive and put the Government into a straitjacket which may not be necessary. If it is in the interest of patient safety, the Minister may do this but by inserting "shall" the Minister must do this in respect of a host of matters. It may not be necessary to make regulations. There might be a different way to deal with the matter.

Primary legislation, and the courts recently, have ensured that Ministers cannot, through regulations or statutory instruments, set aside primary legislation and do things that it does not intend. It is equally true that if one puts into primary legislation a requirement to do something one must do it for a host of situations in which it might not be necessary. I am not in a position to accept the amendment.

Will the Minister address amendment No. 11?

The argument is the same. Consulting is the norm.

The Minister's answer was very particular on the question of "may" or "shall". Amendment No. 11 is not as prescriptive because it states "the Minister considers appropriate". That leaves the door open to the Minister's judgment. It is not as clearly defined as amendment No. 10. Accordingly, the response does not suit the argument.

Amendment No. 11 relates to amendment No. 10 in using "shall" which makes the Minister do something and saying that, before doing so, the Minister should consult with the pharmacy sector. Is that right?

It includes with any other professional body the Minister considers appropriate. If the Minister thinks it appropriate, she would surely do it.

I gave a recent example off the top of my head in which there was no consultation. There may be times when one would not consult but the norm is to consult. Good practice in the making of legislation and good business in the art of politics mean that people consult. The great strength of this democracy is that we consult with people affected by legislation and listen to their views. One does not have to agree with their views, or can dismiss those views, but at least one is aware of them so that one is informed in the making or amending of legislation of the perspective of those who have a view on it.

This process is much more developed than it was when I first entered this House. There is widespread consultation with interested parties on the making of law and regulations. In this instance they may not necessarily all be from the pharmacy sector. There could be others who have an interest in this legislation, for example, from the educational point of view, the Irish Medicines Board, or others who have a bearing on safety issues. I ask the Deputies to accept in good faith that these things happen as a matter of routine but not to put us in a legislative straitjacket.

Amendment, by leave, withdrawn.
Amendments Nos. 11 to 13, inclusive, not moved.

Acting Chairman

Amendments Nos. 14, 28, 28a, 29, 29a, 30, 31 and 32a are related and may be discussed together, by agreement.

I move amendment No. 14:

In page 24, between lines 10 and 11, to insert the following:

"25.—(1) It shall be an offence for any person carrying on a retail pharmacy business, or any partner, connected relative or connected person, servant or agent of such person—

(a) directly or indirectly to make, offer or provide to any medical practitioner or any partner, connected relative or connected person of such practitioner, any payment, inducement, consideration in money or money’s worth or financial or other benefit of any kind, in consideration of, or by way of reward for, or in any way relating to—

(i) the value or volume (or both) of medicinal products prescribed by that medical practitioner, or

(ii) the direct or indirect direction, encouragement or referral by that medical practitioner of his patients to purchase or obtain medicinal products prescribed by him or her from such pharmacist or pharmacy, or both,

(b) to enter into, or be party to, any agreement, arrangement or understanding, under which, directly or indirectly, any payment, inducement, consideration in money or money’s worth or financial or other benefit of any kind, is made, offered or provided to any medical practitioner or any partner, connected relative or connected person of such practitioner, in consideration of, or by way of reward for, or in any way relating to -

(i) the value or volume (or both) of medicinal products prescribed by that medical practitioner, or

(ii) the direct or indirect direction, encouragement or referral by that medical practitioner of his patients to purchase or obtain medicinal products prescribed by him or her from such pharmacist or pharmacy, or both,

(c) directly or indirectly to make, offer or provide to any medical practitioner or any partner, connected relative or connected person of such practitioner, any payment, inducement, consideration in money or money’s worth or financial or other benefit of any kind, or to enter into, or be party to, any agreement, arrangement or understanding, under which, directly or indirectly, any such payment, inducement, consideration in money or money’s worth or financial or other benefit of any kind, is to be made, offered or provided to any medical practitioner, partner, connected relative, or connected person of such practitioner, the direct, or indirect consequence or effect of which would, or could, be to—

(i) increase the value or volume (or both) of medicinal products prescribed by that medical practitioner, or

(ii) cause the direction, encouragement or referral by that medical practitioner of his patients to purchase or obtain medicinal products prescribed by him or her from such pharmacist or pharmacy, or both.

(2) For the purposes of this section, "connected relative" shall have the meaning assigned to it in paragraph 9 of Schedule 1 to this Act, and “connected person” shall have the meaning assigned to it in section 2(a) of the Ethics in Public Office Acts 1995 and 2001.

(3) For the purposes of this section, references to any payment, inducement, consideration in money or money's worth or financial or other benefit of any kind, shall include a reference to rent and other consideration in money or money's worth relating to the making available of premises to a person carrying on a retail pharmacy business, and references in this section to any agreement, arrangement or understanding shall include a reference to any agreement, arrangement or understanding (including a lease of premises) by means of which such premises is made available.".

There is considerable concern about making sure that an unhealthy relationship is not created between a medical practitioner and a pharmacist. This legislation is likely to be tested in the courts so it is important to make it as robust as possible.

The Minister often says that she does not want to be prescriptive but there is a danger in that approach of becoming careless and leaving openings for clever lawyers to argue successfully positions that were never intended. This amendment is quite prescriptive but it is important to consider it fairly, with a view to ensuring that its goal, which is to protect patients is achieved.

No one can have had more than a cursory glance at the other amendments in the group which came in just before we started to speak on the Bill. Some came in at 6 p.m. this evening when it was impossible to get legal advice. They seem to be doing something other than I intend because they ensure that, for example, property relations are not included in any way and saying that the pharmacist is not guilty of professional misconduct and that these are protections of the pharmacist in respect of the legislation. This is very unsatisfactory and it is difficult to be competent to judge these amendments when one has not seen them before. We are flying blind which is not a satisfactory way for parliament to scrutinise and process legislation. I regret this because I believe in the ethical basis of this Bill. This is important legislation which deserves a better and more competent Government that would have ensured it was brought in earlier.

The Minister repeatedly tells us that we will be back for a week or so after Easter. If that is the case, why are we dealing with this legislation at 10.20 p.m. with amendments that came in a couple of hours ago? If the Dáil is returning and there will be an Order of Business, the Pharmacy Bill deserves the space and time between Committee and Report Stages allowed for under the normal process. The Ceann Comhairle laid down strong guidelines for a two-week period between the publication of a Bill and Committee Stage and a reasonable time between then and Report Stage. We do not have that time. If we are coming back after Easter, what is the Minister's excuse for unnecessarily rushing through this complex Bill which directly affects patients?

I support this amendment, perhaps the most important we have reached. It seeks to eliminate what in the worst cases would be corrupt relationships between pharmacists and general practitioners. I have met the Pharmaceutical Society of Ireland which has outlined some of its findings in pharmacy inspections. Clearly, we should all be concerned at the evidence presented, especially relating to general practitioner direction of patients to specific pharmacies. Such a relationship is inappropriate and can create enormous problems in communities. Other worrying indicators of worst practice include the discovery of General Medical Service prescription pads in a pharmacy's controlled drugs safe. More seriously, they found evidence of flagrant breaches in the management of controlled drugs. For the second time this evening, the spectre of Harold Shipman enters our deliberations. The PSI is 100% behind ensuring the highest standard of regulation is introduced in order that such practices are outlawed and the regulations are fully enforceable and enforced, which is hugely important.

The major new factor in this issue is the primary care centres run privately with pharmacies in situ. These are covered in later amendments relating to sections 63 and 64. Those sections are absolutely necessary and the PSI points to the inappropriate relationship between pharmacists and the proprietors of such centres. In some places, existing pharmacies have even been approached for “hello” money so that they would have a special place in the consideration for access to these prime locations. It must be ensured that sight is not lost of the historic and important contribution the traditional family pharmacy has made to communities throughout the State. The Minister has made it clear she does not intend to outlaw the proposition of co-location, which is correct, but nevertheless there is a responsibility on every one of us to ensure, where abuses can arise, that special doctor-chemist arrangements do not apply or the super rents referred to earlier and other such practices. They cannot be tolerated.

Deputy McManus referred to the late sitting. Many people have worked since 7.30 a.m. or 8 a.m. today and I wish we had a longer period to debate the legislation. However, there is a broad consensus and I do not detect great disagreement about the legislation, as everybody acknowledges the need for it. I gave a commitment, which it was important to honour, to introduce the legislation this session, and that is what I have done.

The conflict of interest issue arose in parts of the country and unethical behaviour resulted with prescribing doctors contaminated by a beneficial interest in a pharmacy. Doctors, pharmacists, Members and the public accept that is undesirable and the pharmacy review group drew attention to the need to prohibit that practice. To address this, I tabled amendments on Committee Stage in the Seanad because the Attorney General strongly advised that dealing with the conflict of interest issue by way of property related provisions would be unconstitutional and would be subject to a legal minefield that would be impossible to enforce.

I stated when the Bill was published that my intention was to table amendments, which were being prepared by the Parliamentary Counsel. However, the amendments caused confusion in that it was felt landlord and tenancy arrangement would be prohibited and, in one case, we were told the planning authorities might not grant planning approval and An Bord Pleanála could refuse an application on appeal for planning approval. Clearly, the intention is not to interfere with normal landlord tenancy arrangements. My intention is to give the regulatory bodies the power to ensure no unethical behaviour occurs among doctors or pharmacists. Pharmacists can, therefore, own medical practices and vice versa and pharmacies can be collocated with medical practices.

However, the issue in this section is prescription being affected by a beneficial interest in the profits of the pharmacy. Once normal market conditions apply, the landlord puts up his sign, advertises his premises and the highest bidder secures it, whoever that may be. If it happens to be a pharmacist, that is not an issue. My attention was drawn to a scenario where in a partnership, one partner could act unethically without the other partner being aware of it. Clearly, I do not want the other partner, who is innocent, involved in a fitness to practise inquiry and, therefore, I am introducing a provision to ensure that does not arise. Given all the circumstances, we have struck a fair balance. We have given the appropriate power to the regulatory bodies, which will eventually be tested in court. The test is a high legal bar.

Deputy Ó Caoláin and others mentioned private facilities. General practice is a private enterprise and it is supported by the State through the General Medical Service scheme. A retail pharmacy is a private enterprise which is heavily supported by the State's procurement of medication on behalf of the public. I see nothing wrong with professionals engaging in private enterprise, and whether they make a good return for their efforts by way of salary or profit is not an issue, nor is it an issue for the majority of people. The issue from a patient's perspective is quality of service. The Bill has struck the right balance and the regulatory bodies have been appropriately empowered to examine ethical issues in the way the pharmacy review group intended and many Members and the public support.

Amendment, by leave, withdrawn.
Amendments Nos. 15 and 16 not moved.

Acting Chairman

As it is now 10.30 p.m, I am required to put the following question in accordance with an order of the Dáil of this day: "That amendment No. 34 and the amendments set down by the Minister for Health and Children and not disposed of are hereby made to the Bill, Fourth Stage is hereby completed and the Bill is hereby passed."

I thank the House and, in particular, the Bills Office for facilitating the speedy passage of this legislation. It is historic from the perspective of the pharmacy profession and pharmacists and I thank everybody involved. I am sorry it was so rushed but we have produced a good piece of modern legislation for the regulation of the profession and pharmacies.

I acknowledge the apology I received from the Bills Office. There was a lot of difficulty on Committee Stage and I appreciate it very much.

Question put and agreed to.
Barr
Roinn