Seanad debates

Tuesday, 20 March 2007

Pharmacy Bill 2007: Second Stage

 

Question proposed: "That the Bill be now read a Second Time."

6:00 pm

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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It has been the intention of my Department, and the wish of the pharmacy profession, to consolidate and expand existing pharmacy legislation in a new Pharmacy Act for many years. Proposals have, however, continually been overtaken by events and in the interim the practice of pharmacy has evolved significantly. Nevertheless, it is clear that without a comprehensive and robust framework of modern legislation, the profession cannot develop and increase its input into the care of patients.

To this end, I received approval from the Government to prepare pharmacy legislation in two Bills. It is the first of these two Bills which is now before the House. In brief, this is a Bill to allow for fitness to practice regulations for pharmacists and pharmacies, and, as a consequence, the removal of restrictions on pharmacists educated in other EU or EEA countries from owning, managing or supervising a pharmacy in Ireland that is less than three years old. It is also proposed to deal with a number of related issues such as an appropriate statutory basis for the Pharmaceutical Society of Ireland and an updated registration scheme for pharmacists and their premises.

The pharmacy review group was established in 2001, principally to examine findings from the OECD on the Irish retail pharmacy sector and the 1996 community pharmacy contractor agreement. The group consulted widely and submissions were received from a range of sources. The group considered the complex legal and other issues surrounding the OECD's recommendations, as well as contractual and professional issues such as medicines management and greater use of generics. The group recommended the removal, following the introduction of new pharmacy legislation, of the restriction on pharmacists educated in other EU or EEA countries from owning, managing or supervising a pharmacy in Ireland that is less than three years old — the derogation under Article 2.2 of Council Directive 85/433/EEC.

The group's recommendations also included proposals on a number of related issues, for example, a stronger statutory basis for the Pharmaceutical Society of Ireland, including the governance of the PSI, wider non-pharmacist representation on its council, updating regulations with respect to the registration of pharmacists including non-EU and EEA graduates, and some matters concerning the delivery of pharmaceutical services in a community setting, such as linguistic and forensic competence, and experience for supervisory pharmacists.

The second Part of the Bill deals with the setting up of the new pharmaceutical society and the allocation of functions which the society will fulfil in its role as regulator of the pharmacy sector. In particular the role of the society will be to "regulate the profession of pharmacy in the State having regard to the need to protect, maintain and promote the health and safety of the public". As with other regulatory legislation the Government has proposed, the public interest comes first here and it is my desire that this should be the main goal for all health sector regulators. This section also sets out in detail the duties of the society in the area of registration, education and qualifications, and the powers the society shall have to conduct its functions in these areas and other related areas.

The principal change provided for in Part 3 is in the area of representation on the council of the society. Currently the council's membership stands at 21, all of whom are pharmacists and, in line with other recent legislation in this area, I propose to increase representation of non-elected members of the council to a majority. A total of 21 members are to be appointed, of whom nine — who would be members of the society — are to be elected by the membership of the society. One academic will be nominated by the colleges engaged in pharmacy education — he or she would also be a member of the Society — and the remaining 11 will be appointed as follows: one will be nominated by the Irish Medicines Board; one will be nominated by the Health Service Executive; one will be nominated by the Minister as being representative of the area of continuing professional education; five will be nominated by the Minister who are not, nor have ever been, pharmacists in this State or any other state; and, finally, three will be persons who have such qualifications, expertise, interests or experience as would, in the opinion of the Minister, enable them to make a substantial contribution to the performance of the society's functions.

It is my intention that the nominated persons, other than those directly elected by the society and the nominee representing a dean of a pharmacy faculty, will all be non-pharmacists. I will ensure that the Bill is amended to reflect this. This approach of widening the representation on the council to include a majority of non-pharmacists is consistent with the approach being adopted for other regulatory bodies in the health sector, for example, the Medical Practitioners Bill 2007 and the Health and Social Care Professionals Act 2005.

This Part also contains important new provisions relating to the making of rules by the society to enable it to carry out the functions assigned under Part 2. In future the rules of the society, as well as being submitted to the Minister and laid before the Houses of the Oireachtas, must be published and comments invited from interested parties. This is an extremely progressive and new development in the opening up of the activities of regulatory bodies to wider scrutiny and a positive step in injecting transparency into the rule-making process for regulatory bodies. Furthermore, the society will have to submit any code of conduct it proposes to the Competition Authority for their opinion on its likely effect on competition and, if the society decides not to accept the authority's opinion, it will be required to attach this opinion, and its reasons for not accepting it, to the draft code of conduct when submitting it for the approval of the Minister. This is an innovative development which will ground in the pharmacy sector an appreciation of the need for proportionate and focused regulation, with an emphasis on patient safety and being mindful of possible disincentives to competition among pharmacy businesses in the delivery of services.

Parts 4 and 5 deal with the registration of pharmacists and pharmacies, and the conduct of pharmacy businesses. Part 4 contains sections dealing with the establishment and maintenance of registers, covering pharmacists and pharmacies, and what constitutes a pharmacy business. A modern and robust registration system, one which allows for the removal of registrants, if deemed necessary and proper, is considered essential by all bodies that have made representations in this regard. The revised registration system will also allow for updating of the registration process for EU/EEA and overseas pharmacists, which has been requested by the pharmaceutical society for some time.

The provisions on registration recognise the rapidly evolving nature of the pharmacy business in recent years, as well as providing a fair and comprehensive system for assessing the qualifications and training of foreign-trained pharmacists who may wish to work in this country. In particular, the regime proposed in the Bill allows not only for the registration of the individual pharmacist but also, for the first time, the registration of pharmacies. This provision stems from the need to recognise and deal with the increasingly complex ownership structure in the pharmacy sector. The inclusion of a registration system for pharmacies is desirable and necessary as the regulation of the business of pharmacy is the last link in the chain of medicinal product control that has not be legally provided for up to now.

Alongside the registration regime, the provisions relating to the conduct of the business of retail pharmacy will ensure that the pharmacy, or the pharmacy side of any business, will be under the personal and whole-time control of an experienced pharmacist with at least three years' relevant post-qualification experience. This provision, and the requirement that registration be an annual process, are important developments in patient safety and in ensuring that responsibility for the conduct of the retail pharmacy business is conducted in an open and accountable fashion. It is important that those in charge of the pharmacy are easily identifiable to all those availing of its services, and to those supervising the procedures in the sector. I am also making it clear that it is an offence to hold oneself out to be a registered pharmacist, or registered pharmaceutical assistant, or to provide what may be termed "skilled pharmaceutical assistance" or to allow someone to do so, knowing that he or she is not so registered. However, this will not interfere with the provision for registered pharmaceutical assistants to provide cover for registered pharmacists, in their temporary absence.

Under Part 6, pharmacists will be subject, for the first time, to fitness to practise provisions. In keeping with the aim of the Bill to extend regulation to the pharmacy business as well as to the individual practitioner, both will be subject to a complimentary and integrated process.

Broadly, the fitness to practise provisions are based on the general template developed for the Health and Social Care Professionals Act 2005. However, the provisions under that template refer to the practice of the individual only. Both the Pharmaceutical Society of Ireland, PSI, and the Irish Pharmaceutical Union, IPU, have expressed reservations about such a narrow focus for their profession. They consider such a fitness to practise system will be unworkable if the practice of pharmacy, as it refers to the business of pharmacy, is not also regulated or, at the very least, if a licensing and registration system for pharmacies is not also introduced. They argue it is not sufficient to deal with fitness to practise of the pharmacist alone because a problem may arise due to practices within the pharmacy business. The two bodies make the point that a pharmacist is more likely than medicine, nursing or other health care professionals to work in a commercial enterprise and, even if disciplined for a problem related to the carrying out of his or her profession, this may have been the result of the practice of that particular business. Removing or disciplining the individual pharmacist would not therefore deal with the underlying problem and the business could continue to operate as before without penalties or sanctions. Accordingly, given the strength of feeling expressed to the effect that the pharmacy sector is unique in the interaction of corporate ownership and professionals in running pharmacies, I have accepted that the registration process and the fitness to practise regimes need to be linked in order that remedies and sanctions, if judged necessary, can be applied evenly to those responsible for the provision of the service and not just to the individual pharmacist.

Part 7 gives the council of the society, through the appointment of authorised officers, the powers it requires to police and investigate whether any offence under the Act, any breach of a code or any professional misconduct has been committed. This section is based on the similar powers given to authorised officers of the Irish Medicines Board and the proposed powers are wide enough to allow the thorough investigation following a complaint or production of evidence of professional misconduct. The searching of premises and the taking of samples are also provided for if necessary. These provisions will give the Pharmaceutical Society the means to ensure the proper professional practice of pharmacy and the protection and safety of the public.

The remaining sections of the Bill deal with largely technical and procedural matters, such as the staffing, meetings and accounts of the society. These provisions are based on best practice and similar provisions contained in recent legislation in the regulatory area.

In tandem with the introduction of new pharmacy legislation, the restriction on pharmacists educated in other EU or EEA countries from owning, managing or supervising a pharmacy in Ireland that is less than three years old, which is a derogation granted under Article 2.2 of Council Directive 85/433/EEC, will be removed. This was recommended by the pharmacy review group and I am delighted to facilitate it by repealing the Pharmacy Act 1962. Ireland will now have one of the most competitive markets for pharmacy professionals in the EU. This can be only good for the profession and it will ensure that overseas trained Irish graduates and non-Irish EU graduates will find it easier to establish themselves in the Irish pharmacy sector. I am confident their different perspectives and competitive impact will keep the sector vibrant and energised in the future within a modern robust and progressive regulatory regime for the 21st century.

There clearly has been rapid growth in the pharmacy sector in recent times, with many possible interactions arising between prescribers and dispensers. The majority of professionally qualified pharmacists and other medical practitioners adhere to the highest standards in carrying out their professional duties. However, it would be remiss of me not to recognise that unacceptable practices may occasionally arise between professionals. The Government has accepted the view of the pharmacy review group on the issue of conflicts of interest between those who prescribe and those who dispense drugs. Therefore, subject to legal consideration, I intend to introduce an amendment on Committee Stage which will address any possible conflicts in a fair and proportionate manner.

The provisions contained in this Bill are intended to put the regulation of the profession of pharmacy in the State on a firm, modern and robust footing, having regard to the need to protect, maintain and promote the health and safety of the public. The Bill, if enacted, will put the society to the forefront of the processes involved in supervising the pharmacy profession and the retail pharmacy business in Ireland. While the Bill deals mainly with these areas, I would again emphasise that concern for the public and safety are its guiding principles. The proposed repeal of all previous Acts with the enactment of this Bill means that a new coherent and all-encompassing legal regime will now be put in place for the society, pharmacy professionals, pharmacies and the public. I am honoured to be able to bring such comprehensive legislation before this House and I urge a thorough and considered examination of its provisions, with a view to its early enactment.

Fergal Browne (Fine Gael)
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Fine Gael welcomes this Bill as a way of meeting the challenge of guaranteeing public safety. The past number of years have brought significant changes to the role of pharmacies in Ireland and we need to plan for the future.

The Minister stated her intention to introduce amendments on Committee Stage. However, we have not yet seen these amendments. It would be helpful to us if we could have them as soon as possible because it would allow us to determine whether we need to bring our own amendments on certain issues.

The original pharmacy legislation dates from 1875 and was updated in 1890 and 1962. This Bill represents a further step in that process.

As I listened to the Minister's speech, I began to question the effectiveness of this House. When we debated the Irish Medicines Board (Miscellaneous Provisions) Bill 2005, we discussed the issue of illegal drugs. Cocaine, heroin and other illegal drugs are imported on a daily basis and we are hitting only the tip of the iceberg in terms of controlling them. The Internet sale of drugs has also given rise to problems of control. It is all fine and well to pass this Bill but, unless we deal with these wider issues, we are only fooling ourselves. They will not be easy to resolve and I am not sure of the solution. I have long been puzzled, however, as to why this island nation cannot have more control over illegal drug imports. Unfortunately, when people are sick, they will turn to anything they think will make them better. At the very least, taking medicines will have no effect but at worst people could actually become sicker. We have to make people aware of the risks of buying drugs over the Internet. Solving that problem will present a major challenge for everyone but there is no point in deluding ourselves that this Bill will solve all the problems. The Bill addresses the easy aspects but the bigger problem is the illegal drug trade and Internet sale of medicines, over which we have very little control.

What is the composition of the membership of the council and how often will it change? Will ministerial appointees automatically fall at the end of a Government's term in office?

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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Members will serve a five-year term. I assure the Senator they will not be political appointees.

Fergal Browne (Fine Gael)
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I did not see that provision in the Bill. Fine Gael would have preferred the Minister to have established a public patient safety authority, which would have given patients a stronger voice and better safeguards.

Conflict of interest is a key issue for this Bill. A doctor centre will open in Carlow presently which will include a pharmacy. We need to ensure that any pharmacy located in a doctor centre will not give rise to a duty-free type of scenario. In airports, passengers must pass through duty-free shops to reach their terminals. Patients should have the option of remaining with their family pharmacists if they so wish. At present, a prescription is valid for any pharmacy in the country. If I visit a doctor in Carlow today, I can fill my prescription in Donegal tomorrow. However, many people are not aware of that. I am aware that the HSE is introducing guidelines with regard to clearly stating on prescriptions that they can be filled anywhere. As we move to primary care teams in which doctors and specialist therapists share buildings with pharmacies, we must ensure the pharmacy has a separate entrance because patients should not be required to pass through it to access the building. It also must be made crystal clear to patients that they are not under an obligation to buy the drugs in the pharmacy and they have the right to choose any pharmacy they wish.

Clarification is needed regarding nursing staff who are permitted to prescribe drugs. Given that they have not prescribed drugs thus far, will the Minister clarify why that is the case because I expected that to have happened by now?

Private sector interests are looking on with interest as the legislation is debated and they will be keen to know that the amendment to be tabled by the Government on the conflict of interest issue is not vague. They would like clear guidelines to be drafted and they do not want the issue to be adjudicated on by the IPU because that could cause problems down the line. Clarity is needed on the Government amendment and that is why I am keen to see it as soon as possible.

I refer to the number of medical cards in the State, which is linked to this legislation, because the number of patients attending doctors who do not have medical cards has reduced. The original target was that 40% of the population would have medical cards and the percentage is nowhere near that currently. Those aged over 70 automatically qualify for the medical card and that has distorted the figures. What percentage of the population has medical cards, excluding those aged over 70?

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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People are 70% better off in take-home pay. This is about earnings, not percentages.

Photo of Brendan RyanBrendan Ryan (Labour)
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What has that to do with anything?

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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It has to do with reality.

Photo of Terry LeydenTerry Leyden (Fianna Fail)
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Senator Browne without interruption.

Photo of Brendan RyanBrendan Ryan (Labour)
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Doctors are 70% more expensive. Their fees increased——-

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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The Senator would probably give a medical card to everybody.

Photo of Terry LeydenTerry Leyden (Fianna Fail)
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Senator Ryan should refrain from interrupting. He will have an opportunity to contribute shortly.

Photo of Brendan RyanBrendan Ryan (Labour)
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I am responding to the Minister.

Photo of Terry LeydenTerry Leyden (Fianna Fail)
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The Senator is not entitled to do so.

Photo of Brendan RyanBrendan Ryan (Labour)
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Perhaps the Chair will deal with the Minister the same way he is dealing with me.

Photo of Terry LeydenTerry Leyden (Fianna Fail)
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I am sorry, neither the Minister nor the Senator is allowed to interrupt.

Photo of Brendan RyanBrendan Ryan (Labour)
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I was picked on by the Chair.

Photo of Terry LeydenTerry Leyden (Fianna Fail)
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The Senator attracted my attention. Senator Browne should be allowed to continue without interruption by the Senator, the Minister or any other Member.

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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I apologise to Senators.

Fergal Browne (Fine Gael)
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That is okay. The Minister is very well behaved compared with the Minister for Finance when he was in the House two week ago.

Photo of Terry LeydenTerry Leyden (Fianna Fail)
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The Senator should not invite debate.

Fergal Browne (Fine Gael)
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The role of hospital pharmacists is another issue. I was amazed to learn such people exist. I visited St. Luke's Hospital in Kilkenny recently and I saw its huge pharmacy. I did not know hospitals had pharmacies, which dispense not only within the hospital but also to smaller hospitals nearby. Hospital pharmacists have reservations about the legislation and they are wondering whether they will have to re-register because the Bill provides that such pharmacists should register as a retail pharmacy business. Is the Minister aware of their concerns? If so, have they been addressed? Many of the hospital pharmacies have been operated by pharmacists for years who do not have university qualifications. The legislation will provide for them to re-register but will they be phased out over time? This will not be a difficulty for pharmacists who have obtained a university degree but if one has worked in a pharmacy for 50 or 60 years——

Photo of Mary O'RourkeMary O'Rourke (Fianna Fail)
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They are called chemists' assistants.

Fergal Browne (Fine Gael)
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The problem is years ago people could train to be a pharmacist by doing an apprenticeship and, therefore, a different system was in place. Are many people who came through this system still in the industry? While they may not have the qualifications required nowadays, they can still make a significant contribution. There is concern that they will be forced out of business because of the legislation.

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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Does the Senator want me to permit people who are not qualified to practise as pharmacists?

Fergal Browne (Fine Gael)
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No, but pharmacists have achieved their qualifications in different ways. A significant number attended college and obtained a degree in pharmacy before working in the industry but some entered the industry many years ago having taken a different route, especially those in hospital pharmacies.

Photo of Mary O'RourkeMary O'Rourke (Fianna Fail)
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I have never met these people.

Fergal Browne (Fine Gael)
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From the information I have been given, people who work in hospital pharmacies may have different qualifications. Will their qualifications and experience be recognised by the new body?

The pharmacy industry has a good system in place in New Zealand. Pharmacists sit down with their patients to discuss the prescribed medicine and how it should be taken. It is all fair and well for a doctor to prescribe medicine and a pharmacist to dispense it but if the patient does not take it, that is counterproductive. It is difficult to ensure a patient is taking the prescribed medicine correctly. Perhaps the New Zealand model should be embraced.

I welcome the provision whereby people from outside Ireland can own and operate a pharmacy but this is not reciprocated for Irish pharmacists who move to Northern Ireland. I appreciate this issue is outside the Minister's control but it may be worthwhile for her to take it up with her Northern Ireland counterparts. She should discuss with them whether this could be extended to allow Irish pharmacy graduates to open a pharmacy in Northern Ireland. That would be an example of cross-Border co-operation. Given that such a provision will be introduced under this legislation, why should the Northern Ireland authorities not do likewise for our citizens?

7:00 pm

Photo of Camillus GlynnCamillus Glynn (Fianna Fail)
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I welcome the Minister. I commend her on introducing this important legislation, which is in keeping with her reforming role within the Department. She has stepped into the breach where others have feared to tread. A review of the existing pharmacy legislation was needed, since it has been on the Statute Book for more than 130 years. A Bill was introduced in 1962, which provided for restrictions on those who practised pharmacy. Given that Ireland is now a multicultural society and it is a member of a large political bloc, it is ludicrous that the provisions of the 19th century legislation should still be in vogue.

A number of issues have prompted the introduction of this legislation, not least of which is the question of separating responsibilities, to which the Minister referred, and we have all received representations about the conflict of interest issue. It would be highly improper if those who prescribe could also dispense. The PRG recommended that this should not happen and this was underwritten and endorsed by the IPU. I am delighted, therefore, that the Minister has taken on board the recommendation. The terminology of the proposed Government amendment will be interesting but I am sure it will be appropriate, given the Minister's thoroughness in other areas.

I refer to the issue of ordering drugs on-line. While the Minister proposes to deal with this under new legislation concerning the Irish Medicines Board, war must be declared on this practice. I have spoken to a number of pharmacists who believe that the entities supplying drugs on-line are perpetrating a clear fraud. They augment drugs with certain established components to achieve a specified effect and while batch A might be fine, batch B could comprise totally different components and may not be effective. In other words, if one wants medicines, one goes to a doctor for a prescription which is dispensed by a qualified pharmacist. It will be difficult to stop the practice but if there is the political will, it can be done. It will involve all agencies.

The Bill clears the way for people from outside the country to participate in the pharmaceutical profession, which is very important. This is now a multicultural society. There is much expertise in mainland Europe of which we can avail, which is very important.

Section 2 defines "retail pharmacy business" as excluding a medical or dental practice. Should that not also include a veterinary practice? This is especially important since the definition of "medical product" includes veterinary medical products.

Section 7(2)(b) states that the society shall have power to impose sanctions on pharmacists or pharmacy owners. It is not compulsory under the fitness to practise provisions laid out in the Bill for the society to have an inquiry. Can it impose sanctions without holding an inquiry and under what circumstances?

Where the council draws up codes of conduct for pharmacists, why must it submit a draft to the Competition Authority for its opinion? What expertise does the Competition Authority have on the ethics of pharmacy? Can a convicted criminal, who is not a pharmacist, own a pharmacy?

Section 18(1)(k) states that pharmacies must have counselling areas. Does this apply to new pharmacies only? Are the regulations retrospective? Are existing pharmacies supposed to install counselling areas? If so, how long will they have to do so? Does section 29(f) conflict with section 17(5)(a)?

In regard to section 35(2), should a complaint made to the council not be in the form of a sworn affidavit? In regard to section 38(4), is it not compulsory under High Court rules for the pharmacist or pharmacy owner to give the committee information?

In regard to section 46(1)(d), is there a lifetime of admonishment? Does it disappear off the record after a period of time? Will an admonishment be held against the pharmacist if he or she tries to move to another state? In other words, will he or she pay ad infinitum for the sins of the past?

In regard to section 64, notice shall be given for a full inspection or audit. It is acceptable to have a spot check without notice but not a full inspection. These are some of the questions which arise in respect of this Bill with which I am sure the Minister will deal in the fullness of time.

The Minister said it all in her contribution, including what the Bill will do and how it will move forward. The Bill gives details of membership, governance, accountability, registration, the carrying out of retail pharmacy business, pharmaceutical assistants and holding oneself out to be a registered pharmacist. People take time out of their lives to undergo a very protracted course, namely, pharmacy, and their professional qualification should not be undermined by chancers. The removal of the derogation is a very important component of this Bill. The Minister alluded to the amendment she proposes to table and Senator Browne and I repeated that, if only to underline it. This is very important legislation which, as the Minister said, brings pharmaceutical practices in this country into the 21st century.

Mary Henry (Independent)
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I welcome the Minister and the Bill. One can see how badly needed it is when one sees the dates of some of the Acts being repealed, such as 1790 and 1870. It is astonishing that we still must use these Acts, so it is good to see them repealed.

The Pharmaceutical Society of Ireland, for whom I have great regard, is both a regulatory and a representative body. The Minister continues this in the Bill. It is the situation in the United Kingdom but I gather it is thinking of trying to separate the two parts of the society. Has the Minister read its thoughts on that? The situation with the Medical Practitioners Bill is different because the regulatory and representative aspects of the medical profession are represented differently, as I am sure the Minister knows only too well. The Veterinary Practice Act, brought in by the Minister for Agriculture and Food, separates the regulatory and representative aspects of that profession.

I am glad the Minister will deal with the conflict of interest between prescribing and dispensing. This has worried many people recently with the changes in the health care centres being set up. I read that the Taoiseach said it had not been envisaged that there would be pharmacies in the health care centres when set up, which I had also thought. In the past — apart from a very small number of dispensing practices in parts of rural Ireland — it was essential that there was clear blue water between those who prescribed and those who dispensed. The pharmacy review group also made that very clear when it reported in 2003.

When one looks at the sixth Shipman report, one can see why, in practice, it is so important that there are vigilant pharmacists keeping an eye of what prescribers — members of my profession — are doing. It stated that it is now generally accepted that the involvement of a pharmacist in the process of providing medication to a patient acts as a safety check against error. It further stated that where prescribing and dispensing functions are carried out by the same person, or within the same commercial or professional entity, there is a potential for loss of professional objectivity or even abuse. In the case of Dr. Harold Shipman, it was reckoned that there had been far too cosy a relationship between the pharmacist supplying the injectable opiates and Dr. Shipman. This led to a great deal of trouble.

The situation in regard to health care centres is very worrying. In centres being set up by four or five doctors, tenders are being invited for a pharmacy in the centre. I heard that key money of €1 million or more is being asked in some cases and that rents of €150,000 to €300,000 are being asked. If this is the case, the doctors will rely on rent from the pharmacist, which is not a good relationship. I do not know whether the Minister thought this would happen.

It has been brought to my attention that in one area, the Health Service Executive is involved in selling the land for the new health care centre. I had envisaged, as I am sure many others did too, that there would be social workers and occupational health workers — probably people employed by the State — in these centres rather than giving someone a huge commercial advantage over others in the area. As I said, this could lead to a really serious conflict of interest between the dispenser and the prescriber. I hope the Minister addresses that very carefully.

Apparently, the Minister will clarify the definition of a "retail pharmacy". I gather it will cover hospitals but will it cover all hospitals? There is no definition in the Bill of a "hospital". Will it cover private hospitals or day hospitals? We really need to know what hospitals will be covered. Will it cover fertility clinics? Some of these places supply pharmaceutical products directly to the public. I am not saying there is anything the matter with what they are doing but they supply pharmaceutical products directly to the public and we need to know who will be allowed to prescribe. Will methadone clinics be covered? It is very important that major hospitals have the right to so do because they are trying to do things like increase the incidence of having chemotherapy administered at home in order that patients with cancer, whose immune systems are compromised, are not obliged to run the risk of going to hospital and contracting infections. Important matters must be addressed in this regard and HIV and AIDS patients are also generally encouraged to take the treatment at home. Moreover, pharmaceutical companies will only supply some drugs for schizophrenics and so forth through hospitals because of their side-effects such as changes in blood counts. The companies want to ensure that pharmacists can induce patients to report to the phlebotomist immediately to reduce, in so far as possible, any side-effects that may arise.

I am unsure whether pharmacists working in industry are covered by this Bill. Moreover, trainee pharmacists also should be included. As the registered pharmacist cannot have eyes in the back of his or her head all the time, the latter group should be included. What is the issue regarding pharmacists who are involved in industry? In addition, from the perspective of the three-year registration period that will be needed before one can set up a pharmacy, it is very important to include hospital pharmacists. Otherwise, no one will work in hospital pharmacies which are vital because, frequently, such people perform postgraduate research work of enormous value. Moreover, medical teams would be sorely compromised if they did not have such people involved in their clinical trials and so forth.

Senator Glynn raised the issue of the risks associated with the Internet, and he is correct. However, Members must also consider the risks regarding counterfeit drugs. The description of the premises that the Minister's inspectors will be permitted to inspect should be very wide. For example, the legislation should allow for the inspection of boats and aircraft as counterfeit drugs are getting into Ireland and there is a huge market for them. This must be addressed and it is most important that these matters are properly covered.

The three year rule is very important as people should have experience before starting a pharmacy. In addition, this must also apply to EU graduates because many Irish people have been obliged to qualify abroad owing to the high points needed for pharmacy, which is caused by the serious limitation in places. However, Senator Browne was correct to state that while someone from Newry will be able to practice in Dundalk and to start a shop, the reverse is not true. The rest of the EU should follow Ireland's current actions.

In addition, although the Bill states a person must have linguistic ability, it says nothing about an examination. Members encountered trouble when this issue was discussed in respect of nurses coming to Ireland. I have been informed that were nurses who come from other EU countries obliged to take an examination to ensure their English is good enough, Irish people would also be so obliged. If this is what is required, so be it. One hopes they would all pass.

At present, the Bill describes the pharmacy schools as pharmacy faculties. I presume this is a mistake because we have schools of pharmacy and there are no such faculties at present. In addition, the Pharmaceutical Society of Ireland should be allowed to continue to do things it did in the past, such as awarding honorary fellowships. The Minister and I might be able to get one from it one day and it would be a pity if it were unable to award them. People who have received such awards have regarded them highly. They are usually given to those who have been involved in research work, teaching or something similar.

Photo of Mary O'RourkeMary O'Rourke (Fianna Fail)
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That would be nice.

John Minihan (Progressive Democrats)
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It would.

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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The Senator and I should propose each other.

Photo of Mary O'RourkeMary O'Rourke (Fianna Fail)
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The other Members would go along to applaud.

Mary Henry (Independent)
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The Competition Authority has been mentioned. While I can understand why the Minister would want to refer matters to the Competition Authority, the society should have sent its code of conduct to the Minister first. Thereafter, if the Minister believed it was necessary, she could have referred it to the Competition Authority.

The Bill does not mention recertification, on which the Minister was very keen in respect of the Medical Council. Drugs change almost hourly and I seem to have MIMS Ireland to hand continually, trying to look up drugs that are mentioned to me. While this may be a matter for the future, it will be an important issue for the Minister to address.

I am also concerned about the establishment of registers on the Internet. While openness and transparency are desirable, I am unsure whether the names of pharmacists and pharmaceutical assistants should be listed. I presume their addresses will not be included. Has the Minister discussed this proposal with the Garda Commissioner, Noel Conroy? He spoke the other day about draft rules for pharmacies to try to improve safety. The lives of pharmacists and their assistants could be in danger because drug addicts do not merely want to get hold of illegal drugs. They also want perfectly legal ones, such as opiates, steroids, anxiolytics, any sort of analgesics and even codeine cough bottles. I am really concerned about including people's names like this because it would be all too easy to establish, for example, that a particular person would be the keyholder every third night. Moreover, apart from putting that person at risk, the risk of theft of drugs would be much higher. The Minister should reconsider this measure.

The Bill also makes some very good points that may be difficult for existing pharmacies to adhere to at present. I hope this will not mean they will be obliged to go out of business. For example, I refer to the requirement for a private area to which one could take a person to discuss his or her medication. While this is an excellent idea, I was in a pharmacy this afternoon in which it was obvious that the pharmacist wanted to talk privately to another person who was waiting for a prescription. While she did her best to take him to one side to talk, it would be very difficult for the pharmacy in question to acquire immediately a private area. One cannot bring people behind the counter to where the drugs are kept as that would be open to abuse all too easily. I hope existing pharmacies will not be closed down simply because they are unable to fulfil this requirement. They should be required to so do when they are being reconfigured or being built. However, such an obligation would be very onerous on them.

I welcome the Bill. I have prepared many amendments that I intend to table next Thursday and I hope the Minister will receive some of them very well.

It is important to emphasise the existence of those who are known as shadow directors. They have been problematic in the past in other businesses. When dealing with directors, managers and so forth, the Minister must ensure that shadow directors, that is, those who act as directors without being listed as such, are also dealt with. There is much money in the pharmaceutical business and a great deal of it could be at stake if one had people who were in any way involved with any sort of laissez-faire attitude towards what was going on there. The Minister should ensure that such people are also covered by these necessary regulations. I am sure they will be welcomed by the medical profession as well as the pharmaceutical profession. However, I am especially anxious that the Minister would provide clarity on the position in respect of prescribers and dispensers. This is a road we have never gone down before and I would like to see it made into a cul-de-sac.

Photo of Mary O'RourkeMary O'Rourke (Fianna Fail)
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I welcome the Minister to the House, as well as the production, at last, of this highly important Bill. I believe it is one of two the Minister hopes to introduce. I hope the second Bill will also receive an airing in both Houses, if the Minister has time, because although this Bill contains some admirable measures, in the main it appears to me to be a mechanism for the establishment of the regulatory body. I listened to all of the speakers because I am interested in the topic. We waited a while for this Bill and I am glad the Minister brought it to this House first because it is getting an interesting and knowledgeable airing here, as most topics do. I wish to comment on pharmacists but not because the Visitors Gallery is full of them. They are the most unsung heroes and heroines of the world today.

In my local pharmacy I meet people who are worried, distraught or upset about their ailments and the prognosis on their states of health or those of their families. They have their prescriptions and are waiting to meet the chemist and hoping to catch his or her eye. This is why I was extremely interested in the discussion about a counselling or advice area. Most pharmacies do not have an area to which a person could be brought quietly and his or her fears talked through.

One cannot simply close the chemist shop. The one I go to does not have an inch of space and it is covered in merchandise. A most admirable pharmacist is in charge and when he is not there somebody else is. I do not know where anybody will go to have their angst addressed in this particular "chemist shop", as we always called it long ago.

They cannot be closed. Perhaps planning permission could be obtained to add on a small room where one could receive advice. People have great faith in pharmacists, sometimes more than they have in doctors. I apologise to Senator Henry. I do not know why this is. People seem to believe the gospel from a pharmacist's mouth. I have seen people leave much brighter than when they went in, clutching their packages with whatever is in them.

I know from my own experience that pharmacists have a moderating influence in society which is never strongly spoken or written about. It is a remarkable influence. In old history books one read about pharmacists making brews and I was not surprised to hear Acts dating from 1790 and 1890. One can imagine what was being dispensed then when quaint notions were held about what one needed, such as applying leeches and blood letting which has a modern context in the haemochromatosis debate.

This is a good Bill. However, I am also concerned about a matter raised by Senator Henry. We will open our gates to pharmacists from other countries to come here and practice. We had a Senator's meeting today at which Senator Feeney was asked several questions on this and it was of great interest. What will happen if a nice young Spanish woman or man works at a pharmacy here with spoken knowledge of English but not with the proficiency to go into great detail?

How will we ensure linguistic ability if we open our doors? We must address this. They are very welcome and I do not put up any barriers against it. However, how will it work in practice? Their qualifications will be recognised and they will be working here. It will not be managed well if we have little counselling bivouacs but the person providing the counselling is not proficient in the language.

Why are Irish pharmacists not allowed go to Spain or the Slovak Republic to practise their profession? Is Ireland the only country to open up? Will other countries be compelled to do so? I am all for an open Europe with no barriers and services available everywhere. However, these are the minutiae which arise when we declare we must open up our borders.

I like the idea of having non-professional pharmacists on the board which the Minister will appoint. I attended a meeting with medical people in Mullingar about the Medical Practitioners Bill. They are up in arms about having non-medical people on the board. I could not get behind their objections. I was not able to probe it and they could not tell me why. I suggested ordinary people would supply a lot of common sense.

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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Senator Feeney was an excellent member of the august body and she is not a doctor yet.

Photo of Mary O'RourkeMary O'Rourke (Fianna Fail)
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She was full of common sense and she still is.

Photo of Brendan RyanBrendan Ryan (Labour)
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They will never let her be a doctor now.

Photo of Mary O'RourkeMary O'Rourke (Fianna Fail)
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They did not like the idea that non-professional people should be on these boards. I see the Minister will change the membership and authorise such heinous people as those who are not pharmacists to be on the board and it is worthwhile. They bring a different perspective. Come to think of it, we should have politicians who are not politicians as Members of the Dáil and Seanad. That would be rather good.

History tells us this is a profession as old as time and the Minister will place it in a modern framework with the regulatory body. It will be fit for Europe, the world and the Ireland of the 21st century. It is well past time we had it and it is good that we will have it. This Bill will only realise half of the objectives of the Pharmaceutical Society of Ireland. The second Bill will be required to bring coherence to their being, strategy and future. If the Department prepares it the Seanad will facilitate it at whatever hour and seek to give it its imprimatur prior to the general election.

The Minister will be well remembered for introducing the Bill in a modern, coherent form and for having it debated here and in the other House. I wish it well and look forward to hearing Senator Henry's amendments. I am sure they will be like herself, practical and full of common sense.

Photo of Brendan RyanBrendan Ryan (Labour)
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I am tempted to use my time to debate with the Minister about the relationship between economic growth and the underprovision of medical cards, but I will not. Perhaps I will have another opportunity to do so. It is one of the great failures of the Government but it is not for tonight's debate.

As a member of one self-regulating profession married to a member of another self-regulating profession I am aware that the public is more than a little sceptical about the degree to which professions are allowed, encouraged or enabled to regulate themselves. However, subject to a number of the caveats I will make, I do not think an alternative exists other than having peer group reviews of standards, performance and quality. The mass of regulation and bureaucracy necessary to regulate professions is enormous.

Some of the distinctions between professions and trades have been lost because of the upskilling of trades. However, we do not have a similar self-regulatory format for trades. The trade unions are neither willing nor able to do it. I am wary of self-regulating professions. A more extreme example is not the pharmacy, medical or engineering professions but another eminent profession divided in two — I will put it like that and not state any more — which is not a great advertisement for self-regulation. There is an enormous capacity to define the public interest as the barrister's interest, for example, and anything that threatens their position is always a threat to at least one of the institutions of State, if not more. That is the language used.

The Bill is very welcome but I would begrudgingly say it is a little late. I met representatives of the pharmacy profession about a year ago and there appears to be a degree to which underperforming pharmacists, to put it generously, are poorly regulated, if not unregulated. It is almost impossible to prevent somebody not fit to practise from continuing to work, which is alarming. It has been to the credit of the profession that by informal means, if not others, it managed to dissuade the more badly performing members from continuing to practise when it did not have the powers to do so. The Bill is welcome in that regard.

We must recognise that the practice of pharmacy is entirely different now from what it was 25 or 30 years ago. The days of pharmacists making up medicines and putting together individual ingredients are part of history. They have instead become the gatekeeper between the medical profession and the public, as they are a point of referral in both directions and a point of quality assurance. My other half would not thank me for suggesting pharmacists have a role in checking the inadequacies of the medical profession but pharmacists might take a different view of doctors also. Nevertheless, they have a major role to play.

It should also be said the profession has changed. For all my childhood and until recently in my adult life, pharmacies were run by one person or a family. They were very much part of a local community; even in cities this was true. They have now, essentially, become part of multinational organisations which bring with them both advantages and disadvantages. They bring advantages of scale and capacity in having a range of products and perhaps expertise. That is the good side but the bad side is that they remove the personal aspect such as knowledge of families, the history of individuals, the relationship with doctors and familiarity with the styles and prescribing patterns of doctors. This is particularly evident outside the big cities where it perhaps never occurred. It is lost with multinationals because their capacity to be more efficient is based, to a degree, on homogenisation. The Bill genuinely endeavours to grapple with the issue but it is very difficult to provide for the same regulation of a profession which was based on an individual owning an individual pharmacy and which now has most of its professionals as employees of a multinational. We must read it carefully. That is the reason I wish we had more time to deal with it. I do not wish to start an argument but we are trying to regulate the profession. Nominally what is being said is the same but there are different organisations.

There is a third role for pharmacists which does not arise in this instance but of which I would be aware. In the manufacturing of pharmaceuticals there are international regulations relating to having qualified pharmacists involved in the production process. I would have liked to pursue that issue. That said, the legislation is welcome.

I have dealt with the issues of regulation and registration. Another area of importance is the professional qualifications directive, etc. I wish to make a related point to the Minister and the House in general. This legislation, like all legislation, contains a list of Acts. I am almost fed up making this point after 25 years. Although it is 50 years since the first of the European treaties was signed, we still do not have a similar part indicating related European directives. Some 70% of our legislation originates either directly or indirectly from within the European Union, yet we still pretend it is all our own. I cannot pick up a piece of legislation and see which directives of the European Union it may well refer to. I knew a directive was referred to in this Bill but I had to search through it to find the reference. I would be put to the pin of my collar to find a copy of the directive and put further to it to even understand it. Whatever about our legislation, European directives are profoundly difficult. I believe they are written by people determined to ensure the rest of us do not understand what they are doing. The directives are difficult to comprehend.

I ask the same question raised by other Members as to why the mutual recognition of qualifications at the core of this matter does not apply in both directions.

Photo of Mary O'RourkeMary O'Rourke (Fianna Fail)
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Yes.

Photo of Brendan RyanBrendan Ryan (Labour)
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The argument made to me by the profession seems extraordinary in that a pharmacist qualifying in Britain can practise in Dundalk but a pharmacist qualifying in this State cannot practise in Newry. To put it crudely, it is not fair and is a barrier to trade. It means multinationals can operate here but nobody can set up an Irish multinational unless he or she employs pharmacists qualified in other countries. This must be resolved. The profession would be entitled, if it so chose, to head for the European Court of Justice to insist that the anomaly be ironed out. It seems to be entirely unfair.

There are many issues of detail in the Bill to which we can refer on Committee Stage. I welcome some aspects, in particular. Having a lay majority is a very good idea. If the medical profession decides to bear down on me between now and the Seanad elections — I may have 6,000, 8,000 or 10,000 eligible to vote for me — so be it. It is time they learned that lay people are not a threat to the professions. My own profession would be terrified if the regulatory body for engineers had a lay majority. There is a difference between having a lay majority and having lay people who are the agents of others. The first loyalty of members of a body such as the Irish Medical Council, the Pharmaceutical Society of Ireland or a similar organisation would be to the profession. Such persons cannot serve two masters.

Photo of Geraldine FeeneyGeraldine Feeney (Fianna Fail)
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Hear, hear.

Photo of Brendan RyanBrendan Ryan (Labour)
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That is extremely important.

I refer, in particular, to Schedule 1 to the Bill. I have asked this question before but have never received an entirely satisfactory answer. Schedule 1 states "a person who discloses confidential information obtained as a result of involvement with the Society, shall be guilty of an offence". I have a problem with the definition of confidential information and always have had. Confidential information includes "information declared by the Council to be confidential" and "proposals of a commercial nature or tenders submitted to the Council". That is standard.

To go back to the composition of the council, is a representative nominated by the Health Service Executive precluded from discussing business with the HSE? This is very important. Would the first loyalty of such a person be to the profession of pharmacy or the HSE? If it is to the HSE, he or she will be in breach of the law; if it is not, what is the point of having the person concerned on the council, unless he or she has certain good qualities or understands the thinking of the HSE?

It cannot be a two-way system. One should not tell the five genuine lay people they cannot talk to anyone without being in breach of the law while those nominated as representatives of bodies can. Either something is confidential for everyone or it is not. If it is confidential for the public, it must be so for everyone, including the Minister.

People say the idea of the nominating agency not knowing what its nominee is doing is ludicrous, but it is not. If the loyalty of the individual to the profession is not written clearly, the council will not be what it should be, namely, a body looking after its profession. It would juggle the conflicting views of a Government, which may want to regulate costs, and the HSE. The council also includes a medical practitioner, whose loyalty is primarily to the council as long as it operates within the law.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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The Senator has one minute remaining.

Photo of Brendan RyanBrendan Ryan (Labour)
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Regarding the famous conflict of interest, it is not sufficient to say doctors cannot own pharmacies and pharmacists cannot own medical practices. Headline stories of €1 million in key money allowing a pharmacy to locate in a medical centre——

Photo of Mary O'RourkeMary O'Rourke (Fianna Fail)
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Is that hello money?

Photo of Brendan RyanBrendan Ryan (Labour)
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Yes. People are talking about €1 million. That practice is profoundly unhealthy and should be prohibited. If it is allowed to occur outside large urban areas, such as in Mallow, Mitchelstown, my home town of Athy or Dingle, which has a single health centre, it would threaten the existence of other pharmacies and would be anti-competitive and unfair. People should have a choice. For good or ill, all our health services have been based on choice, but to allow a single pharmacy that sort of physical monopoly is to do the opposite.

This difficult matter, in respect of which I have proposed a six-page amendment, must be confronted. If it is not, there will be serious issues regarding how pharmacy will develop as a practice, that is, it will become a monopoly within health centres. We could discuss other matters, but I will deal with them on Committee Stage.

John Minihan (Progressive Democrats)
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I wish to declare an interest at the outset in that, while I am not a qualified pharmacist, I own a community pharmacy. I welcome Senator Henry's proposal to offer honorary fellowships or degrees. I hope something could be organised for myself in the short term in case the situation in the weeks ahead does not work out as I expect it to.

Photo of Mary O'RourkeMary O'Rourke (Fianna Fail)
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We will get one for the Senator.

Photo of Geraldine FeeneyGeraldine Feeney (Fianna Fail)
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He would need to be inducted.

John Minihan (Progressive Democrats)
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It could be handy, but I do not know whether the Bill would allow me to practise. Perhaps we could examine the matter.

Photo of Mary O'RourkeMary O'Rourke (Fianna Fail)
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The Senator could wear his mortar board in the House.

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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It would be more difficult for the Senator. He would be also regulated.

John Minihan (Progressive Democrats)
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I welcome the Minister and compliment her on bringing this legislation before the House. The pharmacy profession has been waiting 130 years for it and it is delighted the Minister has seen fit to commit to enact the legislation soon.

Prior to being a Member of the House, I managed and worked in a pharmacy for seven years. In that time, I saw the vital role played by pharmacists and their unnoticed work in delivering our health care. Their knowledge of pharmacology and medications and their interactions with people with chronic illness are vital. Often, I despair at people's lack of knowledge about the role of a pharmacist, how he or she checks medications, interactions and side effects and how he or she counsels patients. For the pure pharmacists, those working in the community area, it is not a question of sales or profit. It is about providing an important service.

Pharmacists could keep a daily log of the number of times they must interact with general practitioners to correct prescriptions. A pure retail business would be concerned with selling and bringing in money, not checking or interacting. In reality, a locum doctor might not be up to speed with a patient's medication and some patients do not disclose their medication. For example, they may not say they are asthmatics because they do not consider ventolin or becodite to be a drug. This would have implications for what the doctor prescribed, but when the prescription arrives at the pharmacy, the pharmacist, who has built a relationship with the patient, knows. He or she will contact the doctor and the prescription will be changed. If a log were kept by pharmacies, one would be amazed by the number of times the professional training and expertise of the pharmacist is exercised daily by spotting such irregularities.

With interest, I noticed how the role of community pharmacies has expanded in other jurisdictions. The legislation we are considering will provide a framework for developments in the public interest and will ensure that patients who interact with pharmacists on a daily basis will be protected. However, we must be aware of the points made by previous speakers regarding the situation in Europe. The removal of the derogation will be of benefit to the many pharmacists trained outside this country, but an Irish pharmacist is not allowed to open or operate a business in other jurisdictions. We must level the European pitch.

A traditional feature of community pharmacy is the personal relationship between the patient and the pharmacist, which is based on trust, confidence and historical association. It is important to keep the connection. Like previous speakers, I am concerned about the relationships developing between pharmacists and health centres. It is seldom that I agree with anything Senator Ryan says, but his point on health centres was vital. There must be a clear distinction between the pharmacist's role as the dispenser and the prescriber's role. If one pays significant money, be it key or rental money, to a prescriber upstairs, one is being driven by profit and turnover. That is not what we want from pharmacists because it would not be in the interest of the patient or the public.

Whatever amendments are to be tabled, they will prop up the Bill and prove how successful it will be. We must ensure there is patient safety, regulation and no associations. We have all heard of examples and it works both ways in certain cases, but there cannot be any association.

We have to consider the community pharmacies throughout the country. Everybody talks about the profits being made by people, but it must be understood that more than 75% of the drugs which are dispensed through the general medical services scheme are paid for by the State. When one considers that under the drug payment scheme, the State pays everyone for expenditure on medicines in excess of €85 a month, it is clear the State probably pays for between 85% and 90% of drugs. We often hear about the profit margin of pharmacists on the private dispensing of medicines, but they make no profit on drugs which are dispensed under the general medical services scheme. Those drugs are dispensed at cost price, with a dispensing fee. It is a misnomer to suggest otherwise. The 2005 figures for the income earned by pharmacists from dispensing fees are interesting. Some 23% of pharmacists earned less than €60,000 in that year and a further 27% earned between €60,000 and €100,000. There is a myth about the earnings of pharmacists, particularly in the communities.

We have to be careful to protect the link between community pharmacy and patients. I was somewhat disappointed to note that the Bill refers to "retail pharmacy". I would be much happier if we referred to "community pharmacy" rather than to "retail pharmacy". That is one of the many issues I will raise on Committee Stage. The term "community pharmacy" reflects better the role played by such operations. It makes a distinction between community, hospital and industrial pharmacists. The Competition Authority has a role in this regard. Over many years, I have pointed out to those involved in the pharmacy profession that politicians, legislators, the media and the Competition Authority view them as retailers rather than professionals who play an integral part in the delivery of health services. We have to get the right message across. The profession has endeavoured to do that in recent years by informing politicians and the public of its unique role.

I hope we can turn the tide by developing a fantastic relationship between pharmacists and the Health Service Executive, which can provide many services. The amount of contact between the public and the health profession is not more than the amount of contact between the public and the pharmacy profession. Each person visits a pharmacy 20 times a year, on average. The connection between pharmacists and the people should be used properly in areas like screening and medical advice. Advances have been made in many parts of our medical regime, such as the manner in which medication is managed. It would be in the greater interest of the HSE to view pharmacists as professionals, to avail of their services and to use their contact with the public to develop various aspects of the health strategy.

I would like to speak briefly about the role of pharmacists in society. While I welcome the Minister's proposals in this regard, she should ensure that language proficiency is to the fore in the new fitness to practice system. We can ensure that pharmacists have qualifications, examinations and certificates, but we should also ensure they can communicate. If they cannot do so, they will be driven back to the dispensary upstairs or in the back of the shop, which is not what we want. Pharmacists should be in the front of the shop, where they can deal with customers and patients by advising them about drugs. If they are not proficient in the English language, will they be able to provide the advice and service we need? I accept that Senator O'Rourke's Spanish pharmacist might be very welcome in Athlone.

It is important that this legislation provides for a means of disciplining pharmacists, when necessary. Similar provisions are part of the regulatory systems of most professions. As we saw in the Shipman case, which has been mentioned, and the Neary case in this country, havoc can be created within a profession by the deeds of just one person. It is important that pharmacists who do not practice properly are subject to disciplinary proceedings of some type, if necessary.

I welcome the Minister's intention to introduce an amendment pertaining to the relationship between doctors and pharmacists. I hope the amendment will be made as soon as possible. It is most important that we get this aspect of the legislation right. I mention this issue because it is important that we maintain the traditional clear distinction between doctors and pharmacists. I welcome the Minister's decision to take on board the recommendations of the Government's pharmacy review group. We should bear in mind that if we do not get this aspect of the legislation right, we will do a disservice to this tremendous Bill.

I compliment the Minister for Health and Children and her officials. I know she made a commitment to the pharmacy profession to introduce this legislation. She said she would endeavour to have it enacted before the general election. I hope Senators will facilitate its early passage through the House. The members of the profession have given a broad welcome to this Bill, which is long overdue. They have quite successfully lobbied a number of politicians to raise some valid questions on Committee Stage. I look forward to the Committee Stage debate, when I am sure we will work through the various issues.

I am concerned about the training of over-the-counter pharmaceutical staff. People do not fully appreciate that a great deal of the medication which is sold over the counter is rightly restricted to pharmacies. A Senator spoke earlier about runs on codeine and similar products. When I worked in the retail pharmacy sector, I saw such runs coming up. It is vital to ensure that staff are trained properly. In fairness to the pharmacy profession, it ensures that its over-the-counter staff are trained to certain standards but I would like that to happen on a more professional basis.

I await eagerly the Committee Stage debate, when many issues will be raised and all aspects of the legislation will be considered in detail. I look forward to considering the amendments that will be proposed by the Minister, Deputy Harney. I hope all Senators will support the early passing of the Bill by this House, which will allow it to be sent to the Dáil and enacted before the forthcoming general election.

Photo of David NorrisDavid Norris (Independent)
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I am a little surprised that this speaking slot has come so soon. I am glad I came to the Chamber because this is a good opportunity to contribute to the debate. I had arranged to share half of the time allotted in this debate to my colleague, Senator O'Toole, who is not here. Can I propose that the Senator be allowed to share time with me if he materialises and wants to take half of my time?

Photo of Paddy BurkePaddy Burke (Fine Gael)
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Is that agreed? Agreed.

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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The way the debate is going, we will probably have enough time for separate speaking slots for both Senators.

Photo of David NorrisDavid Norris (Independent)
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That is excellent. I am sure Senator O'Toole has quite a lot to say.

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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Senator Norris can keep all his time for himself.

John Minihan (Progressive Democrats)
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We would be happier if Senator Norris used just half of his time.

Photo of Geraldine FeeneyGeraldine Feeney (Fianna Fail)
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He should take his own time.

Photo of David NorrisDavid Norris (Independent)
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I will take my time. I will speak at a reduced speed.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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How much time does the Senator wish to use?

Photo of David NorrisDavid Norris (Independent)
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The Chair should be able to tell me how much time I have.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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The Senator has ten minutes.

Photo of David NorrisDavid Norris (Independent)
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That will be more than ample. I will speak at a reduced rate because I inhaled almost an entire Georgian ceiling a week or so ago, and consequently I have a lung infection.

Photo of Geraldine FeeneyGeraldine Feeney (Fianna Fail)
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Did the Senator not find a good pharmacist?

8:00 pm

Photo of David NorrisDavid Norris (Independent)
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I have speedread the Minister's speech. I welcome some of the things she said, although I would like some of them to be spelled out. Although I have been and continue to be critical of the health service — I will probably criticise it again on the Order of Business tomorrow — I salute the Minister, Deputy Harney, for putting her head firmly in the lion's den, which was a remarkably courageous thing to do. Some of the changes the Minister has been making will not come on stream politically, in effect, until after she has departed not this life but the Department of Health and Children. The decision to which I refer highlighted the Minister's unusually altruistic attitude.

The first point I wish to make is the fact that towards the end of the Minister's speech, she addressed the question of conflict of interest. This is probably the most important element that is missing from the Bill. She said that as a result of lobbying and changes in conditions, she intends to introduce an amendment on Committee Stage that will address any possible conflicting situations of that nature in a fair and proportionate manner. It is not only a question of possible conflicting situations but a question of existing and scandalous situations in terms of conflict of interest.

For example, the fact is that health centres are being built and suites are being made available to people at knock-down rates; I am told 20% is the going rate. These sorts of inducements sometimes follow on from a situation where people are interviewed and asked what is their client base, their prescription role and the value of them. I have in my hand, lest there be the slightest doubt, a form of tender for a premises known as The Pharmacy, The Medical Centre, Knock Road, Castlerea, County Roscommon, in which it is stated that the final date for submissions is 5.30 p.m. on 30 August 2005. The Minister might be interested in what it states in terms of the nature of the offer. It is addressed to a firm of solicitors and states:

I [and there is a space for the names to be filled in] ... HEREBY OFFER subject to the conditions and provisions set out in attached conditions of tender to acquire by Lease the premises described in the attached Conditions of Tender at the annual rent of One Hundred and Fifty Thousand Euro [€150,000] (Exclusive) (subject to review in accordance with the Lease) together with any financial inducements [this is a lovely piece] that you are prepared to offer to the Landlord in the sum of [and it is rather engagingly left blank] or any other inducements that you are prepared to offer to the Landlord, which should be made in writing and attached to this Tender. As a gesture of goodwill the equivalent of 10% of the amount you are prepared to offer is to be paid over to the Landlord on the signing of the Agreement to Lease.

I regard that as completely scandalous. Of course there is a conflict of interest; there is an existing conflict of interest. It is not a potential one, a possible one or something that might happen in the future. It is something that was apparently fairly widespread two years ago. It is not only appropriate but utterly essential that the Minister introduces precisely the kind of amendment she spoke about because the conflict of interest here could not possibly be more clear and explicit.

I was engaged in other matters and I do not know if the Shipman report was mentioned. I notice the Minister is nodding to indicate it was. In that case I will confine myself to one quotation from it which addresses this matter directly. I will not give the context of it because if the Shipman report was referred to, it was probably by my colleague, Senator Henry, who knows a great deal about this matter and she probably put it into context so there is no need for me to do so. However, she may not have quoted this part which, to my mind, contains the core of the argument. The report states: "It is now generally accepted that the involvement of a pharmacist in the process of providing medication to a patient acts as a safety check against error." It goes on to state that: "[W]here prescribing and dispensing functions are carried out by the same person or within the same commercial or professional entity, there is a potential for the loss of professional objectivity or even abuse." Despite this, for reasons of commercial profit and not for the interests or welfare of the patients or citizens of Ireland, this is a situation which appears to be developing. While there are large pharmaceutical chains which we all know, there are smaller chains or businesses where considerable profit is being secured. I welcome the fact the Minister will introduce an amendment on Committee Stage. It cannot be introduced quickly enough but it must be clear, specific and obviate this unpleasant practice.

A gentleman, who will be well known to the Minister, a senior adviser to Professor Drumm whom I will not name as that would be unfair, left the Health Service Executive and took up a new position in one of these groups, Touchstone. With engaging frankness, he said the following: "In our project in [a certain midland town] ... we were faced with the opportunity of being able to get suites at a cost of 20 per cent of their value, so from an investment opportunity it was something we couldn't match by doing things privately." That says it all. Who is handing out something at 20% of its value? I have heard of below cost selling but, to use another midlands expression, that beats Banagher.

I turn to another question of conflict of interest, that of independent regulations, which is a bee in my fairly capacious bonnet. I have been pursuing this issue with disastrous results for myself, as I have suffered the treatment I received from the news media for daring to speak out on the Defamation Bill, but I propose to continue to do so. The more it annoys them, the more I like it. For example, the newspapers claim there should be independent regulation of everybody else, including the medical profession and architects, except when it comes to newspapers. It wants to nominate half the board and to pay for it, but how independent can that be?

With regard to the question of regulation and representation, I notice that the Minister in her speech spoke about a new pharmaceutical society. Does that mean it is proposed there will be a second one? I see the Minister shaking her head to indicate "No". It should mean that because these functions should be separated. That is not only my view but a view I take as a principle. If the Minister wants to check the record, she will find that I have said this about every profession in every Bill that has been introduced.

It is also the view of the University of Dublin whose graduates I have the honour of representing. I received a letter from a distinguished academic in the pharmacy area which states:

The Pharmacy Bill published last week retains the existing structure of a combined regulatory and representative body. This is not a proper structure for the governance of a healthcare profession. A single professional body with a multiplicity of potentially conflicting purposes, including both the regulation of and advocacy for the profession of pharmacy is neither in the best interests of patients nor of the profession.

Again we have advice from the top that there should be a separation and independent regulation.

In Ireland there has been a tradition in this area, and we understand that. The Pharmaceutical Society of Ireland has served this country well. I am not making negative comments on its historical contribution. However, we must look to the future. As legislators, it is our responsibility to improve the position. If we look across the water to the United Kingdom, the position here used to prevail there but it is moving away from that and a new position has been recently proposed, namely, the creation of a separate general pharmaceutical council, which is similar to the General Medical Council, and another body to take on leadership. It is essential to have a separate body to regulate the profession. This is the point I wish to make on that issue.

I wish to make a final point on a matter which I hope was mentioned. It concerns people who get their pharmacy qualifications abroad owing to the lack of places in Ireland and who are discriminated when they return to this country. I wish to cite the case of a Dubliner who attended Trinity College. She is married to a pharmacist who qualified in Nottingham but is from Northern Ireland, which is not a million miles away and is part of the territory that was until recently claimed by this Government. He has been working as a pharmacist for four years and would like to open his own pharmacy in Ireland, but the problem is he would have to raise approximately €1 million to buy a pharmacy that is more than three years old.

The Minister may be addressing this issue and perhaps she will refer to it. This pharmacist would have to employ an Irish qualified or New Zealand or Australian qualified pharmacist because he would not be allowed to work in his own pharmacy. These pharmacists usually charge about €80,000 a year. The maddening aspect of the law as it stands, which I hope has been addressed in the Bill, is that although his qualifications are good enough for him to be employed as a locum or supervising pharmacist in any pharmacy over three years old, he cannot be employed in a brand new one. It is a bizarre situation. It is Kafkaesque. There are a series of contradictions here. I appeal to the Minister, if she has not addressed them in the Bill, a subject about which I am sorry to say I am not completely clear, I ask her to do so. The major point concerns the conflict of interest, while a related point concerns the independence of the regulatory body and the body which deals with fitness to practise. I suggest we deal with the points relating to definitions when amendments are being considered on Committee Stage.

Photo of Geraldine FeeneyGeraldine Feeney (Fianna Fail)
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I welcome the Minister and the Bill. To say it is long awaited is to put it mildly as the existing pharmacy regulation is 130 years old. The medical practitioners legislation is 30 years old. Even though the regulation is 130 years old, one never hears about pharmacists — community, hospital or industrial — getting themselves into trouble or kicking up a storm or being demanding. They must be among the quietest professionals in the country. I know a number of them and acknowledge that they are the unsung heroes of the health professions. I do not say this because there are some present in the Visitors Gallery.

I grew up in Tullamore, a small town in the midlands. My parents knew their pharmacist all their lives, as they had grown up with him. When the doctor was not available or sometimes when there may not have been money available to go to the doctor, the pharmacist would have been their first port of call. They were always given good advice and relied upon him. I live in Sligo and have a wonderful pharmacist. I will make him blush because he is in the Visitors Gallery. I use the term "wonderful" because I am known to his father for the past 25 years. I am a creature of habit; I have the same doctor, pharmacist and butcher. I do not like change in my life.

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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The same politics.

Photo of Geraldine FeeneyGeraldine Feeney (Fianna Fail)
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Indeed. It is easy for me to say what I am going to say next. Everybody should be encouraged to build a relationship with a pharmacist, just as we build a relationship with a doctor. I had a meeting today with two pharmacists who made the same point as Senator Minihan made and which he knows from experience, as he was the manager of a pharmacy. A pharmacist may have more time to speak to a patient than a busy doctor in a busy surgery. He or she will take the time to explain that the prescribed medicine may interfere with other prescribed medication. Patients should be made aware of the side effects of medication and the hazardous effects of jumping from pharmacy to pharmacy. The nation would be better off financially and health-wise if patients did not change pharmacies. Senator Minihan has worked in a pharmacy. He is not a pharmacist but has managed a pharmacy and can speak first-hand about his experience.

I commend the Minister highly for introducing the Bill and the one she will introduce next week. During the years Ministers for Health have talked about bringing forward a pharmacy Bill and a medical practitioners Bill. I acknowledge that doctors will have their turn next week; therefore, I will not refer to that Bill.

This Bill was first mooted in June 2005 in a two-page document. Rather than introduce the Bill then, the Minister spent 18 months working on it. Today she has introduced an excellent 62-page document. While we do not agree with some of the proposals, it is to be hoped these can be dealt with on Committee Stage. I welcome all areas of the Bill which is innovative and has been worth the wait.

I refer to proposals on the membership of the board. I take my hat off to the Minister. It will be argued that in other countries there is not a lay majority on either the medical council or the pharmacy society but I ask what is wrong with how it is beginning. This country introduced a smoking ban before anywhere else in the world and we were hailed from the highest heaven. I do not see anything wrong with the proposals. It is not a question of bringing people in off the street and appointing them as political appointees. The Minister will nominate good people to the board. I have first-hand experience, as I served as a lay member of An Bord Altranais and the Medical Council. I met no other non-medical person serving on either of those boards who did not have at heart the interests of the society they were representing.

I am delighted to see pharmacists will have fitness to practise procedures. Pharmacists will welcome this provision, as it means safety for them but most of all it will provide safeguards to ensure patient safety. I presume the procedure and sanctions will be similar to those of the Medical Council, the three lower procedures being to advise, admonish and censure and the more serious being suspension with or without conditions. The final procedure involves erasure. These procedures ensure safety for the practitioner, as well as the patient.

I am delighted to note that section 17 of the Bill allows for registration of the pharmacy unit as well as the pharmacist, an issue to which Senator Minihan alluded. The Minister really means business because any breach of the conditions of the Bill will carry serious penalties. I hope if conditions are breached, that the penalties will be doled out to the offender.

Some parts of the Bill will require tweaking. Senator O'Rourke alluded to Irish graduates being unable to enter the market elsewhere in Europe. Many UK graduates practise in Ireland. I am delighted that the derogation has been dropped. There are few places available in the pharmacy schools in this country. Therefore, it is to be welcomed that Irish people can go abroad to the United Kingdom to be trained where the training provided is second to none. It differs from the Irish model in that students learn the theory as well as the practice and such graduates make excellent pharmacists.

The relationship between subscriber and dispenser has been outlined by other speakers. I refer the Minister to the blueprint by which medical centres were established. They were set up as multidisciplinary centres with the doctor as the mainstay, as well as with a nurse, a physiotherapist, possibly a dietician and other related health professionals. Pharmacists and dentists are out in the community, with whoever else we as patients need to consult.

I look forward to Committee Stage and hope the Minister will consider the contributions made by Senators. It has come across loud and clear from both the pharmaceutical society and the pharmaceutical union that she has given an amount of time to both bodies and has listened to their concerns and taken them on board, for which I compliment her.

The problem faced by hospital pharmacists came to my attention only this morning. They may have patients coming in and out of hospital on a regular basis, in particular cancer patients, some paediatric patients and others with mental health conditions. Chemo drugs for cancer patients are dispensed through the hospital pharmacy. Certain paediatric conditions may require blood testing on a daily basis, in conjunction with the dispensing of medication and it makes sense that this is dispensed from the hospital pharmacy. Psychiatric patients are sometimes hospitalised while this takes place. Hospital pharmacists have genuine concerns and, while I have read the Bill, I am not sure if section 5 addresses the point. Will a hospital pharmacist have to become a retail unit to continue dispensing as a hospital pharmacist? I see the Minister is shaking her head so I hope that is not the case. I hope they will fall under this legislation and be regulated as their colleagues in the community pharmacies are regulated.

Fitness to practise and all the other things introduced by this legislation should also apply to hospital pharmacists. We do not hear much from them and until today, to my shame, I have never given them much thought. These pharmacists look after sick people in acute hospital beds and now that I am aware of them I will push their case with the Minister and will raise it with her on Thursday.

Photo of Terry LeydenTerry Leyden (Fianna Fail)
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I welcome the Minister for Health and Children to the House and compliment her for bringing this Bill before the Oireachtas before the end of the term of this Government. It is a very important Bill and must be enacted urgently. The registration of pharmacists and pharmacies is of vital importance to the well-being of the public.

In the past there were very restrictive practices relating to the setting up of new pharmacies. When I was chairman of the Western Health Board there was an objection to the establishment of a pharmacy in Knock, even though approximately 1 million pilgrims visited the village every year. Regulations imposed by the then Minister, Deputy Noonan, restricted the establishment of a new pharmacy by requiring the approval of an existing pharmacy in an adjoining town as a prerequisite. That regulation was watered down to some extent but the Bill before us will create a more level playing pitch.

The present society is agreeable to being disbanded and reconstituted, which is unusual for such an organisation. The new organisation will have 21 members, nine of whom will be, as the Minister said, elected by the Irish Pharmaceutical Union under a democratic system based, I presume, on the old approach for the election of pharmacists to the health boards. The IPU will have a role and it represents 1,600 members throughout the country but the HSE has refused to enter into discussions with it on terms and conditions for its members, unlike other medical unions which have regular contacts with the HSE. I cannot understand why that is the case and I raised the matter on 8 February in this House after discussions with IPU representatives. The Minister should arrange a review of the Competition Authority regulations because it is important the IPU have a direct relationship with the HSE on a formal basis as a representative union of so many members.

I also raised the question of pharmacies being attached to large medical practices. Members of the IPU provide services attached to large medical practices, which are starting to develop throughout the country. As the Minister knows, a number of practitioners come together and build a new, privately-owned health centre in which consultants take rooms. However, as has been mentioned in the House, the IPU has expressed great concern about the situation because there is no incentive for a medical practitioner to prescribe cheaper, generic drugs if a pharmacy is attached to the practice nor is there any incentive not to prescribe drugs at all. As the Minister knows, MRSA prompted an over-prescription of antibiotics, which were given out like smarties because everybody who went in felt they had to come out with a prescription.

Fergal Browne (Fine Gael)
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It is more than that. That was just a factor.

Photo of Terry LeydenTerry Leyden (Fianna Fail)
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Some doctors were not too happy with my comments in that regard but, as a Member of this House, I represent the public as well as my electorate and I felt it necessary to speak out about a situation which was detrimental to competition and to rural towns. In some towns there is only one pharmacy and that is attached to a big practice. Between €1 million and €2 million is being asked in so called hello money for pharmacies and, as the saying goes, "If you are not in you cannot win". It is a major challenge and the Minister must be aware of it.

Photo of Paddy BurkePaddy Burke (Fine Gael)
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The Senator should name and shame.

Photo of Terry LeydenTerry Leyden (Fianna Fail)
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I see new applications for planning permission in rural towns and often find there is only one pharmacy, and that will not give rise to competition. Typically, a door leads from the medical practice to the pharmacy, through which one must go to leave the building. There are two shop fronts but shared access so it is very convenient to get one's prescription from the friendly pharmacy without having to drive further down the town. That is not addressed in the Bill, which does not impose any restrictions in that regard. The new society will have no power to restrict pharmacies as to where they are located. Many IPU members are engaged in such an arrangement to the detriment of other members and will have the benefit of the arrangement into the future.

It would be beneficial if medical practices completed prescriptions clearly and they should be printed rather than scribbled. Non-nationals will be allowed to dispense drugs and it is very important a prescription is clear and contains no ambiguity as to the drug, the number of days for which it is prescribed and the number of tablets required. We should not allow non-nationals to practise in Ireland unless we have reciprocal rights in their country. The Minister should ensure, through the Bill, that Irish pharmacists have the right to practice in Northern Ireland, Britain, France, Italy or wherever. We are entitled to seek reciprocal rights in this area.

I commend the Minister on introducing the Bill. She will hopefully get it through the Dáil before the end of its lifetime.

I compliment pharmacists on the work they do. During the time in which I have been involved in public life, pharmacists have received only the highest praise in respect of that work. They dispense drugs to the public and provide great advice. Many people receive a great deal of advice from their pharmacists and are often cured as a result. In some instances, pharmacists do not receive the same rewards as the doctors who provide people with prescriptions.

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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I thank those Members who contributed to the debate. As the House is aware, it is hoped to take Committee and Remaining Stages on Thursday. It is the intention to have the Bill enacted into law before our impending rendezvous with reality.

I thank the officials of my Department for producing the Bill. I put them under enormous pressure when I gave a commitment to the presidents of the Pharmaceutical Society of Ireland and the IPU that the legislation would be enacted on my watch. I was determined this would be the case. When I use the term "on my watch", I am referring to my watch before the general election. I am not anticipating that I will not be back here after the election to steer through the second Bill. I accept the legislation is not a panacea and that it does not deal with all the issues. The second Bill to which I refer will deal with definitions of "community pharmacies", "pharmacy services", etc. It would have been impossible, in the timeframe we set ourselves, to deal with all of these matters in one Bill.

We are very far behind in this area in comparison, for example, to the medical profession, in respect of which legislation was enacted in 1978. Effectively, as far as pharmacists are concerned, there is no fitness to practise regime in this country. That position is not tenable.

I have attended many functions relating to pharmacies in the past two and a half years and I was informed at one such event that 27 years ago the then Minister for Health — I do not want to single him out because I am sure it was not his fault — gave a commitment to the father of the president to whom I spoke that the Bill would shortly be introduced. Pharmacology is obviously a family business and I would not begrudge that.

On liberalisation, I do not accept the argument that we should not do it unless others do it first. In that context, Senator Feeney referred to the smoking ban. When we have embraced innovation and been ambitious, we have done extraordinarily well. What has guided me in introducing this legislation is the fact that many of the people to whom we refer are Irish citizens. There was previously only one pharmacy school in Ireland and it was extraordinarily difficult to gain entry to it. Many Irish people studied overseas as a result and then felt they were at a huge disadvantage in their own country. As Senator Minihan indicated, even though he is not a pharmacist, he owns a pharmacy. However, a qualified pharmacist cannot do so unless he or she is supervised. I came to the conclusion that the latter is extremely unfair. The majority of people who will benefit from the enactment of this legislation — it is clear we cannot discriminate against the citizens of other EU countries — will be our own citizens.

The question of language competency will be a matter for the society to decide on. The society will set the timeframe in this regard. All EU pharmacists must — unlike those who qualify outside the Union, where language can be a requirement of registration — be registered. It will be a matter for the society to set the standard and the timeframe by which that standard must be met. As regards language, it is not merely a case of being fluent in English. One of the challenges for health care professionals at every level is to be able to communicate with patients. Some health care professionals in this country have a long way to go in that regard. I am not referring to the English language capabilities of these individuals but rather to the manner in which they seek to explain matters to patients. People often inform me that they were obliged to rely on a nurse to outline their position because they did not understand the language used by the consultant or that he or she did not communicate the relevant information in a patient-friendly way. The position in this regard is changing but it is doing so slowly. This is a major issue for those involved in health care.

I am a strong fan of empowering all health care professionals to do more. In the chain of care to the patient, the pharmacist has an important role to play. Reference was made to generic substitution. It is not just generic substitution. I would like a situation to develop where pharmacists, perhaps because they have more competence in respect of drugs than doctors or because they are aware that certain drugs might be more suitable for particular patients, would be free to substitute one product for another. I would like us to move in that direction. If we want to ensure that patient care and safety are paramount, I am of the view that it would be appropriate to do so.

At one of the first conferences I attended as Minister for Health and Children, I learned that approximately 10% of people's experiences in hospitals involve adverse events. This is a worldwide statistic because we do not have data in this regard in Ireland. However, I have no doubt the position here is similar. Many of the adverse events to which I refer — thankfully an extremely small percentage of them involved fatal consequences — involve the administration of medication. Certain pills that do different things are contained in similar packaging. Busy nurses — I am not singling them out — can make mistakes when administering medication. Approximately 16% of adverse events are accounted for by mistakes in the administration of medication. That figure is very high. We must, therefore, be extremely cautious and careful when it comes to dispensing and administering medication.

I was somewhat taken aback when Senator Browne referred to people who are not qualified. I would like to discuss that matter with my officials because I am not aware that there are people working in hospitals who are not qualified.

Fergal Browne (Fine Gael)
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On a point of information, I was referring to those who qualified under different circumstances.

Rory Kiely (Fianna Fail)
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The Minister, without interruption.

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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I want to be helpful and I am not being critical of the Senator.

Fergal Browne (Fine Gael)
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I was referring to older pharmacists.

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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I will discuss the matter with my officials to ensure, in so far as possible, we can put right what may be a difficulty. It is generally the case with legislation that we "grandfather" either premises that do not fit modern requirements or perhaps qualifications and give people periods of time in which to meet the standard, which is reasonable. I will check the position in that regard with my officials.

When I was growing up, my family availed of the services of a single chemist. I suspect that my parents, who migrated from Galway to Dublin, frequented his shop because he was a native of Galway. My memory of him is one of a man who worked extraordinarily hard seven days a week. I told this story recently in respect of doctors and many of them were of the opinion that I was suggesting that they should work 24 hours a day, seven days a week. However, I was not suggesting that.

People receive extraordinary service from their pharmacists. The latter are professionals and are among the brightest individuals in the country. One must be extremely intelligent to gain entry to pharmacy school. Even with a second school, it is incredibly difficult for people to obtain a place. The position is similar for physiotherapists, occupational therapists, doctors and language therapists. We are attracting into the health care system the brightest people in the country. That is a fact.

Reference was made to the making of profits. From a philosophical and pragmatic point of view, I have no difficulty with individuals making profits. People would not be in business if they could not make profits. If there were no profits to be made in the area of health, most of the research that pharmaceutical companies carry out — worldwide, this work is 80% funded by such companies and 20% funded by governments — would not happen. A large amount of the money invested in research never sees the light of day. A higher percentage of research does not pass what is referred to in the business as level 3. In other words, it does not proceed to the next stage. The figure in this regard is rising all the time. If companies could not make money from products which succeed and which can be developed and commercialised, they would not be in the business.

I do not see the making of profit as a bad thing. I have just returned from a trip to Scandinavia. I was interested to learn that socialist governments there have brought in private companies to run the hospitals. If I was to suggest that we should follow suit, according to Deputy Rabbitte, all hell would break loose. I visited one hospital in Stockholm which brought in a private company and it has had extraordinary results. This is what governments are doing to seek to provide better services for patients. What motivates me is better services for patients.

No doubt those, whether doctors, pharmacists or whoever, who are well qualified and who work hard are entitled to a decent living, and nobody should begrudge that. Nobody is trying to stop that. What I want to ensure is fair competition. The sole reason there is a reference to the Competition Authority approving the code is to ensure that codes are not used as barriers to entry or in an anti-competitive way.

Obviously the Bill covers pharmacists wherever they practise. It does not deal with definitions, as I stated earlier, and it does not deal with the hospital setting, but if there is a complaint, records can be sought and all the powers contained in this Bill apply as much to a pharmacist working in a hospital as to one working in the retail community sector. For the information of Senator Minihan, we could not used the definition "community pharmacist" for legal reasons on the advice of the Parliamentary Counsel. I must inquire privately what the precise reason for this is and make him, and everyone else, aware of it. I am not certain what was the legal difficulty, but there was one.

When I originally took this Bill to the Government, it contained provisions on conflict of interest and property issues. The advice of the Attorney General, which as a member of the Government I am obliged to accept as he is the constitutional law officer of the State, was that we could not do it in that way because of property rights and a great many constitutional issues, and that is why we are doing it differently in the amendment I am bringing forward which I will be happy to circulate later. There is a real challenge in this regard. It is not easy to deal with the changing structure of the pharmacy sector. For example, we could not legislate for market share. That would be prohibited. Obviously, every pharmacy must have a supervising pharmacist and every corporate entity must have a pharmacist in charge of the overall corporate body. That is appropriate to ensure the provisions of this legislation apply.

I see the society as the regulator in the public interest. It is not a representative body in the way that people suggested. The society possesses advocacy powers and maybe that should be examined. I do not know whether the advocacy powers are related to patient safety, professional education or whatever, but it is not the union of pharmacists, which the IPU is. I compliment Senator Glynn on reading into the record of the House the submission of the IPU, which I am sure was gratified to know that its work was not in vain. I read it too, and we will be clarifying some of the issues of concern.

How long the admonishment would last, for one year, five years or whatever, is a matter for the society or, ultimately, a matter for the court because these matters may be appealed to the court. I must inquire whether the society can inform other regulators in other countries. I would hope it could but I want to check to ensure that is the case.

The nominees' term is four years. Perhaps it should be five. Four years is a rather short term and we might look at that. Clearly, the nominees are not political people. On the idea that a regulatory body would change if the Government changed, this is not the United States of America where everybody gets a position based on whether he or she supported the party in office. I think that is not a good system, certainly not in public bodies. It is a matter of inspiring public confidence in regulation and that is the reason I am so keen to introduce a lay majority. The other profession says such a situation does not exist anywhere else in the world, but I am delighted to see that the White Paper published in the UK two weeks ago states that the professions should not hold a majority and we are moving in the same direction. It is all about inspiring public confidence in regulation, which is very important.

The persons nominated by the Minister, or, indeed, by the Health Service Executive or the Irish Medicines Board, are not on the council to represent their nominator. The reason I included those bodies as nominators was to show that we are trying to get people who have something to offer and it is not a question of merely picking names off the top of my head or anybody else's head. I would be happy to include other bodies if people felt that they were appropriate to nominate to the society.

Clearly, the confidentiality rules that apply to the individuals nominated by the Minister apply equally to the people nominated by the HSE or the Irish Medicines Board. Often this is misunderstood. For instance, often I am asked in the other House what is happening at the Medical Council in particular inquiries. I am not informed. I have no right to be informed. It is entirely confidential. The Minister cannot interfere in the operations of the council and I know no more than anybody else knows. In fact, I read in the newspaper of its recent inquiry. I was not informed of it officially. The council did not have any such obligation, nor should it. The council acts independently and the same will apply to the pharmaceutical society.

Clearly, if I, as Minister, have concerns, I will bring them to the attention of the regulatory bodies, just as I have done to the Medical Council in some issues. If there were issues I felt the regulatory body should address, I would bring them to the society in my capacity as somebody with responsibility for health, but not as somebody who was trying to interfere in the day-to-day activities of the council.

We will provide in the legislation that there must be a separate entrance to a pharmacy. I take the point that this should not give rise to a duty-free type scenario. Although that may be the case in Dublin duty-free, it is not the case in other countries where one may happily go from the entrance to an airport into one's plane without walking through duty-free. I take the point made and we are making an amendment in that regard.

The society will be able to deal with a matter about which it has had considerable concern for quite some time, that is, underperforming pharmacists. Clearly, the issue of competence assurance is not as developed as I would like. It is an area on which we need to work together. It is certainly not as developed as the medical profession in medical regulation, but the days of a professional qualifying and practising for his or her entire working life without continuing education are over. It will be a matter for regulators to ensure this is the case because matters, and especially those in the area of medicine, change rapidly.

How one regulates for the Internet is an issue that concerns governments across the world. If somebody can tell me how I might be able to regulate for the Internet, I will be more than happy to do so. Some things are not possible.

MRSA was mentioned. I refer again to my visit last week to Norway, Denmark and Sweden, all of which have a good MRSA record. On the MRSA map produced recently, they are in the green zone which is the good zone. Ireland is in the red zone and there is an orange zone between the green and red ones. There are two issues that affect MRSA. Antibiotics is by far the largest one and we in Ireland have an obsession of going to the doctor looking for antibiotics. The number of people I meet who are on antibiotics for something as simple as a head cold is incredible. It will take quite a long number of years, perhaps 20 or 25 years, for us to change that. We must involve pharmacists and doctors in a national effort. Patients must also be involved because if they go to the doctor and do not get a prescription, then they feel the doctor is not quite interested in their ailment.

The other issue is personal hygiene, hand washing, etc., between attending patients. In Sweden, for example, doctors rarely wear ties because of the difficulty of it touching the patients and picking up all kinds of infection, and they all wear their uniforms. I understand they do not wear their uniforms to the supermarket. I am not saying the doctors here do but I frequently see health care workers in their uniforms shopping in the supermarket. If we in Ireland want to reduce the incidence of health infections, especially MRSA, we must deal seriously with these crazy practices. As Members will be aware, one third of us in this Chamber have MRSA. I will not specify which third but that is the statistic.

Photo of Camillus GlynnCamillus Glynn (Fianna Fail)
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Innocent.

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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I do not know about that.

Fergal Browne (Fine Gael)
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As long as it stays on the skin one is fine. If it goes into one's blood, one is finished.

Photo of Mary HarneyMary Harney (Minister, Department of Health and Children; Dublin Mid West, Progressive Democrats)
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I have taken detailed notes and I will deal with them on Committee Stage. I have dealt with the main points and there are some issues on which I need to seek clarification from my officials. I look forward to Committee Stage on Thursday. I acknowledge the support and advice my Department received from the society and the IPU. We received a great deal of assistance in framing this legislation. I am sure it will not solve all the problems identified but it will play an important role in putting in place a modern regulatory framework for pharmacists and pharmacies which will be appropriate to the times in which we live. The second Bill will deal with service definition and technical issues pertaining to premises, which are a minefield.

I thank the Seanad for allowing me the time to deal with this matter and for facilitating the completion of this House's debate on the Bill by Thursday evening.

Question put and agreed to.

Committee Stage ordered for Thursday, 22 March 2007.

Rory Kiely (Fianna Fail)
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When is it proposed to sit again?

Photo of Geraldine FeeneyGeraldine Feeney (Fianna Fail)
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Tomorrow at 10.30 a.m.