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Seanad Éireann díospóireacht -
Thursday, 22 Mar 2007

Vol. 186 No. 14

Pharmacy Bill 2007: Committee and Remaining Stages.

SECTION 1.
Question proposed: "That section 1 stand part of the Bill."

I have great respect and affection for the Minister for Health and Children but to be presented with 97 amendments at 9.30 a.m. today is not fair. Again, I do not blame anyone in particular; it is simply the way it is being done. To be presented with the groups of amendments at 12.30 p.m. today is not fair either. This House does its best to deal with legislation, particularly that introduced in it. This is not the way to do business. I am not trying to be obstructive but the timeframe within which we must operate in this case is not fair to Members who do not have the army of advisers the Minister has at her disposal.

I do not wish to be obstructive either but I share Senator Ryan's concern. This legislation is among the most important we have had for months. The wait for this Bill has, in some instances, been 130 odd years.

I agree with the previous speakers. Yesterday I telephoned the Bills Office numerous times and was told the amendments would be ready at 4 p.m. but they eventually arrived at 8.30 p.m. I am not being critical of the Bills Office but of the Government and the way it has handled this. It is very unfair that so many amendments have been tabled at the last minute and that they are all to be taken on the one day. I hope we can debate the amendments and that we get proper explanations. The Department of Health and Children tends to bamboozle us with amendments at times. I hope there will be detailed explanations for each amendment and that we will be allowed plenty of opportunity to query them.

I accept this is not the normal way we do business. This Bill has been in gestation for a considerable length of time. The amendments we propose have been informed by the response of the Pharmaceutical Society of Ireland, the Irish Pharmaceutical Union and by the debate in the House on Second Stage. Some of the amendments are technical, some change the manner in which members of the society will be elected and the types of persons the bodies identified in the legislation will nominate to the position and some deal with conflict of interest situations, and many Senators were anxious that would be dealt with. As I said on Second Stage, we had intended to deal with it in a different way but on the legal advice of the Attorney General, we have had to deal with it by way of conflict of interest provisions.

I accept the timeframe is short. I can assure Senators it is short for me too. I only saw the amendments late yesterday and the small group of officials working on this Bill have been working all night preparing for this debate. I apologise to the House but the overriding concern is to have this legislation implemented as quickly as possible because of the length of time it has been gestation and the fact we, effectively, have no fitness to practice regime for pharmacists or pharmacies in Ireland.

Question put and agreed to.
SECTION 2.

Amendments Nos. 1, 9, 29 to 31, inclusive, 38, 44, 45, 61, 62 and 103 are related and may be discussed together. Is that agreed?

Some of the amendments that are at the core of what the Minister just mentioned when she very graciously dealt with our complaints, which I will not pursue any further, are hugely significant. I am not sure this is the wisest way to discuss amendments Nos. 61 and 62, in particular, both of which are two pages long. We will ramble all over the place with all these amendments being discussed together. However, I will not object if the House wishes to take them together.

Amendment No. 1 makes passing references to amendments Nos. 61 and 62. It is simply a technical necessity to deal with the others. However, amendments Nos. 61 and 62 are hugely significant amendments and are very welcome. I am not happy that we will suddenly launch into a discussion on what is the nub of the Government's amendments and group them all together. To a degree, I am alerting the House that we are either going to discuss the whole issue of conflict of interest now or not at all. I am not very happy with this grouping.

Acting Chairman

If the Senator is not happy, we will deal with amendments Nos. 61 and 62 separately. We will take amendments Nos. 1, 9, 29 to 31, inclusive, 38, 44, 45 and 103 together. The Senator expressed doubt in regard to amendments Nos. 61 and 62.

While I am uneasy about it, I will agree that the group of amendments be taken together. Taking those two amendments separate from the others is impossible as well. We need to be careful.

Acting Chairman

Is it agreed that we take amendments Nos. 1, 9, 29 to 31, inclusive, 38, 44, 45, 61, 62 and 103 together? Agreed.

Government amendment No. 1:
In page 9, lines 3 and 4, to insert the following subsection:
"(4)Subsection (3) shall not apply to sections 63 and 64.”.

As Senator Ryan has acknowledged, this group of amendments effectively relates to amendments Nos. 61 and 62. Amendment No. 1 is necessitated by the new provisions we are including in respect of conflict of interest. Amendment No. 61 deals with the prohibition of certain economic relationships between pharmacists and medical practitioners, namely, either party having a beneficial interest in the other's practice, including company or corporate relationships and a relationship by way of preferential leasing or tenancy arrangements.

Amendment No. 62 deals with pharmacy and medical practices using shared premises, the type of economic relationships it is considered necessary to prohibit and also the situation where the prescriber or dispenser recommends the other's practice to a patient. We are giving powers to the society and the Medical Council to deal with conflict of interest situations which arise by way of fitness to practice.

Essentially, a pharmacist can be charged only the normal market rent for a pharmacy. If true, the extraordinary stories one hears will be brought to an end under the provisions provided for the society, as well as those pertaining to the Medical Council.

Doctors cannot recommend a particular pharmacy. Obviously, a doctor may inform patients about the opening hours of pharmacies in a particular location and a pharmacist may inform a patient of a doctor's opening hours or location. However, they are not entitled to recommend each other and where there is co-location, there will be an obligation to have separate entrances to the individual facilities. Another issue brought to my attention recently concerned a clinic that was faxing prescriptions to a particular pharmacist. All such practices will be prohibited under the strong conflict of interest provisions I have introduced.

As I noted in my Second Stage debate, I had sought to deal with this issue in a different manner. However, the Attorney General strongly advised that this was not possible and that the proposal under discussion was the appropriate route to take. I have taken this advice, which explains why the substantial amendments are being made now rather than being included in the original Bill. I had envisaged doing this somewhat differently.

In addition to the Pharmaceutical Society of Ireland, the Medical Council is also being given substantial powers regarding conflicts of interest that might arise in respect of medical practitioners. In the first instance, all of this is being done to ensure appropriate behaviour on the part of professionals and that economic interests will not influence what is asked of patients or the manner in which they are dealt with. This would not and cannot be acceptable.

Amendment No. 1 is simply a technical amendment to facilitate amendments Nos. 61 and 62.

I will restate some points I made during the Second Stage debate on the Bill. A prescription is valid nationwide; a prescription written by a doctor can be used in any pharmacy in Ireland. Is the HSE planning to have this stated clearly on prescriptions in the near future? I am aware it is drawing up guidelines in this regard. However, so doing would help remove any misconception or perception of misconduct.

Conflicts of interest are difficult. Previously, I made a point about the prospect of duty free pharmacies to the effect that patients should not be obliged to walk through a pharmacy to either enter or leave a primary care centre. This would be highly intimidating and would not offer choice to patients. There should be no beneficial or economic link between a general practitioner and a pharmacy based in the same premises. However, Members also live in the real world and it is next to impossible for a non-local arriving in Carlow to get an appointment to see a doctor. Moreover, there is a major problem regarding the number of patients per GP in north County Dublin, which I understand to be double the national average. It has been brought to my attention that the high cost of finding a building is a factor in this regard. Although I take the Minister's point, I am also aware that doctors are being told to expand their services, while pharmacists are being urged to have more consultation rooms, etc. While it is all well and good for Members to make such statements in the Chamber, they are not providing any help in this regard. Perhaps the Minister could announce the introduction of a grants package to enable general practitioners to set up in areas that currently lack them or to enable pharmacists to set up in an area or assist them in renovating their premises.

In some respects, Members are throwing out the baby with the bath water. Undoubtedly, there are some dodgy practices, with which no one is satisfied. However, patients should have access to doctors and pharmacists. In certain locations such as Cork city there are problems associated with the high cost of buildings and the increase in population. While one option is being ruled out, it does not appear that an alternative is being provided to incentivise people to become involved in either GP services or the pharmaceutical industry in areas that are crying out for them. In other sectors such as the hotel industry major tax breaks are given. However, nothing similar happens in this case.

Primary care are buzz words. Everyone is being told primary care is the future and that it is not desirable to have people in hospital beds or nursing homes. Although the option of remaining in one's home and community is being advocated, support to so do is not being provided. Although I have no difficulty in supporting the Minister's comments, I do not see how she is backing them up with alternatives.

The Minister has gone a long way towards addressing the concerns expressed by many Members during the Second Stage debate regarding both the enormous profits that can be made by individuals and public safety. As the Minister has recognised, it is essential to have a division between the prescriber and the dispenser. I am concerned as to whether the legislation will be retrospective, as a significant number of premises have already been built. For example, amendment No. 62 refers to "premises which, although separate ... are such that public access to the one is available only by way of the other, or ... share a common public entrance with each other". I know of several such arrangements. Will this provision cover them?

Key money, that is, money given to get close to health care centres in the first place, appears to have been a major issue. While it may be included in the Minister's amendment, I have not yet managed to pick it out. Key money appears to have cost between €1 million and €3 million. This would constitute a good start.

I was alarmed by a comment I read in an interview given by a former adviser to the chief executive of the Health Service Executive regarding the Touchstone project in Carlow, which Senator Browne has mentioned. He stated that in respect of the project, he was faced with the opportunity of being able to buy suites at a cost of 20% of their value. As an investment opportunity, it could not be matched by doing things privately. Who is paying the other 80%? Why are such suites being sold off so cheaply? There is no such thing as a free lunch. Such a development alarms me and I do not know whether the legislation covers it.

I am not being picky with the Minister regarding the lateness of the amendments. However, they are vitally important and at the nub of the issue. However, I cannot find a mention of either issue in them. Moreover, is it necessary to specify who will describe what constitutes reasonable rent in an area? Reasonable rent for a newsagent would not be the same as for a pharmacy, in which one stocks goods of a much higher value and so on and for which greater security is needed. This is of some concern to me.

The Minister has attempted to cover, to the best of her ability, the juxtaposition of pharmacists and doctors by getting their respective professional bodies to deal with them. However, I am concerned that the issue of key money does not appear to be covered and I am worried about the retrospective position. Who is paying for the suites being sold at such a cheap price? How will the issue of reasonable rent be worked out?

As for Senator Browne's query, I mentioned during the Second Stage debate that the HSE was preparing to ensure prescriptions would include a reference one's ability to go to any pharmacist. It is important for patients to have such information.

In respect of grants to doctors and pharmacies, there are special arrangements in disadvantaged areas for general practitioners. However, in both cases, these are professional entrepreneurs. In the case of pharmacy, approximately 80% of the business, sometimes more, is paid for by the taxpayer. The manner in which the State pays for the contract of service must be made attractive as otherwise, people would not be involved in the business in the first place. I certainly do not envisage grants.

Rising property values raise issues for health care facilities in terms of being able to compete in a market where it is lucrative to invest in residential, commercial or even industrial property. Recently, I spoke to a local authority on the need to designate by way of zoning particular portions of land for health related facilities, especially residential care. It is increasingly difficult in major urban centres for anybody who wants to provide private residential care to be able to purchase a property and make a reasonable return when the obvious temptation is to invest in residential apartments or housing or commercial activity. It is a major issue.

In the centre of Dublin it is difficult to encourage new entrants into the long-term care market. Most of the facilities built are on the fringe of the city where land values are cheaper. It raises issues and I would like to see it dealt with by way of specific zoning. The same may apply to other health facilities. Ultimately, patients and the health system must pay for the higher costs in attracting people into the business.

Regarding the points made by Senator Henry, the Bill cannot be retrospective in the context of what is already in place. Under the Bill the Medical Council and society will have specific powers to deal with ongoing behaviour. If a blatant economic attraction does not meet with market requirements, it will be a matter for the society to establish whether a normal relationship exists.

We will not prohibit doctors from owning pharmacy buildings or vice versa. We will not prohibit people’s rights to own properties. We seek to deal with conflicts of interest where economic misbehaviour takes place which affects the professionalism of either the pharmacist or the doctor. As Senator Henry stated, patient safety is put at risk in such a situation. To survive, a pharmacist requires a doctor to prescribe. If a patient who does not require a prescription receives one, it is a patient safety issue which is why it is dealt with through fitness to practice provisions, and this is the appropriate route.

The Minister has my sympathies if she received the list of amendments as late as the rest of us. It will be possible to have a pharmacy in the same premises as a medical practice but not with the same entrance. I am concerned not about medical aspects but about competition aspects. If one has a medical centre with a pharmacy in a country town, does its sheer accessibility not immediately threaten in terms of competition any other community pharmacies in the same town?

It is difficult to separate the belief in some type of competition. It may not be market-based competition. It may be quality of service or the fact people feel comfortable with one pharmacist more than another. It may be that women feel happier dealing with a female pharmacist about an issue and men feel more comfortable dealing with a male pharmacist. Is the Minister happy she will not introduce a major distortion in proper competition if functioning pharmacies are next door to a medical centre?

In country towns, an increasing tendency exists to have a single medical centre where all the GPs work. It is an improvement because it provides people with a range of services. However, a single pharmacy next door to it or beside it will have a negative effect on people's willingness to choose. If the number of other pharmacies declines, the long-term effect will be to create a quasi-monopoly. I do not need to tell the present Minister about the evils of monopolies. She made a good political career out of it.

I do not like political monopolies either.

We must stop one at the next general election.

I welcome what the Minister said and urge that prescription validity be written on prescriptions immediately. No reason exists to delay it. The sooner it is done the better and the matter can be solved quickly.

People are unhappy about the key money aspect and I cannot blame them. Perhaps the actions of the private sector are a reflection of the void which exists at present. During my 30 years on the planet, doctors have changed a great deal. We used to have one doctor in a surgery working on his or her own. Now they work in groups and have expanded services. Nationally, we encourage them to introduce other services such as physiotherapy, occupational therapy and speech and language therapy to have a one-stop shop. It is important we provide incentives and assistance.

The value of property has gone through the roof. In Carlow, even a basic small unit costs €500,000 if not more. A general practitioner starting off will have major costs and will pass these on to the patients. The advantage of a primary care team is that if three or four people go in together, it will lessen the financial burden which will be reflected in patients' fees.

Regarding the matter raised by Senator Henry, it is important to state the GPs planning to go into the Touchstone centre will have no economic link with the pharmacy. As far as I understand it, Touchstone will obtain the money directly from the pharmacy and other services in the area.

With regard to Senator Browne's final point I did not think an economic link would exist between the doctor and the pharmacist. I want to know why such generosity is shown by selling the suites at 20% of the market value. Somehow the other 80% will be paid. I support the Minister with regard to generic drugs. Senator Ryan is correct to state this may reduce competition enormously. From what the Minister stated, I feel she is not in a position to stop a pharmacy opening in the same building as a medical centre so that is that and there is nothing we can do about it.

I am also concerned about the fact that many medical centres are built on the fringes of towns because property is not so expensive there. We will have a situation whereby a pharmacy within a desirable medical centre will receive far more business due to convenience. The matter of allowing key money is very important.

I wish to follow up on a point made by Senator Browne on prescription validity and the point raised by Senator Henry. When a doctor prescribes a certain brand of drug, he or she should also write a note on the prescription to state if the particular brand is not available, another brand is to be used, possibly a generic drug. It would make it more economical, not for the pharmacist but certainly for the patient and for the State from the point of view of the General Medical Service.

I welcome the amendments on where a pharmacy can be situated, whether in a health centre or outside it. This is ground-breaking legislation and is new to all of us. It will settle down when it is implemented and we see it up and running. The ethical area will come into play. Pharmacists will be governed by their own ethical guide, as will doctors. If they are in breach of this ethical guide, they will face the rigours of a fitness to practise regime and, possibly, be found guilty of professional misconduct. Matters will settle down. Although I can understand the frustrations and worries expressed, when this new legislation pans out and is implemented, matters may not be as bad as we believe.

We have all heard the frightening stories of prescriptions being passed down a chute from a doctor's surgery to a pharmacy below. We have heard stories about patients being intimidated by being told that if they do not go to a certain pharmacy within a health unit, the doctor will not be able to get them a bed in a certain nursing home. These incidents occur but we do not condone them for one moment. They will be faced up to by doctors and pharmacists with their own regulatory authorities when such fitness to practise provisions are put in place.

I will not deal with a particular company because this legislation is not about a particular set of circumstances. We are not prohibiting co-location. For as long as I can remember, doctors and pharmacists have been in close proximity to each other. What we are seeking to ensure is that a doctor cannot have an interest in the pharmacy business and vice versa. We are also ensuring any rent paid must be at the normal rate. This may differ in areas, as it would perhaps be more expensive in the centre of Dublin than in Carlow or elsewhere. We are giving both regulatory bodies very strong powers in these matters. It will be professional misconduct to enter into an agreement where above normal market rent is being charged for a premises. For example, if it were the case that a doctor’s rent was subsidised and a pharmacist’s rent was hiked, I would have a significant number of concerns. The primary concern would be for the taxpayer, because as the purchaser of 80% of drugs, we would be paying for this. Nobody will do it on the basis of charity.

I have no philosophical or other objection to people making profits. As I stated the other evening, if people could not make profits, they would not be in business and if we did not have profit, we would not have much innovation in the provision of drugs, therapies and health care treatment. Most are funded by private providers rather than governments worldwide. We are looking to ensure patient safety will not be put at risk and that vulnerable cases will not be exploited using economic measures to blatantly discriminate against or favour one set of circumstances over another. That is not acceptable.

When I brought the Bill to the Cabinet, we sought to deal with the matter in a different fashion but we were strongly advised that we could not do so for constitutional and other legal reasons. The Attorney General advised us that this was the appropriate route and, on reflection, it is a good one because we are now giving powers not just to the Pharmaceutical Society of Ireland but the Irish Medical Council also. I have written to the council about some of these matters, as under its existing powers, it is not in a position to deal with these issues. We are amending the Medical Practitioners Act 1978 through a new Bill before the other House which will be presented in this House shortly. We are including both bodies in these amendments, which is good.

I am a strong fan of competition which drives innovation and delivers better value for money for consumers. It has been argued that as the State pays every pharmacist in the country the same price for the same products, this may not be very competitive. Competition is not perfect by any means. My good friend Senator Minihan keeps me well informed about developments in the pharmacy business and tells me how difficult things are.

He does not look hungry to me.

They could be much more difficult if we had a different system in place. I know a new contract with pharmacists is about to be negotiated and hope we will get even better value from the taxpayer's perspective, given the strong legislation we are introducing. I am sure we will get value.

In so far as I, or any Minister, can in legislation such as this, we are using the powers available to us in what I hope is an appropriate manner. The Pharmaceutical Society of Ireland and the Irish Medical Council will have powers to deal with these issues under the fitness to practise provisions. We are not being too prescriptive, indicating that certain elements are out. Clearly, each case will be considered on its own merits.

Provided the Bill goes through the Seanad today and will be before the Dáil tomorrow, when will it take effect? I presume it will go through Committee Stage in the Dáil next week.

It will happen when the Bill is signed into law.

Immediately. There will be no time delay.

We must bring forward regulations. I am informed that we will consult the organisations, but it will happen as quickly as possible. The Bill will be signed into law but, as with other primary legislation, will be implemented by way of regulations.

I wish to ask about the need to review the matter because it may not work out as we envisage. What will happen if a doctor and pharmacist are husband and wife? How will the Bill affect this?

The same provisions apply, whether people are related.

The matter is covered.

It is allowed for.

It is covered in the Bill.

What does the Senator mean by "it is allowed for"? We are certainly not prohibiting doctors from marrying pharmacists or vice versa. The provisions apply in all situations.

I am conscious that it can be difficult to trace companies. People may own property in the name of a company. Therefore, it could be difficult to trace who owns such a building.

As I stated, we are providing that a pharmacist has to be in charge of the corporate entity. A supervising pharmacist must be in charge of each retail community pharmacy. A person must also have overall responsibility for the chain for the reasons mentioned by the Senator such as the difficulties encountered in accessing corporate entities.

Before we move from this amendment, I look for clarification. I accept the Minister's comments on commercial rent, but can the provision be evaded by an arrangement prior to taking up occupancy via key money? The going rate for rent will be charged.

That is difficult enough, but can the provision be got around with a demand for a substantial key money payment in advance of taking over the premises?

The society will have the power to deal with the issue.

Will it?

Are there any plans to review the issue?

I could say yes; the standard answer is that there will be constant reviews. The legislation has been awaited since 1875 and I know there were amendments in 1962. We should be realistic, as these are significant new powers and we must allow them to take their course. They will be broadly welcomed by both professions and certainly by the regulatory bodies.

Amendment agreed to.
Question proposed: "That section 2, as amended, stand part of the Bill."

I wish to discuss the definition of a retail pharmacy business. Am I clear in understanding a retail pharmacy business will cover hospitals?

No. We are not making hospitals retail pharmacy businesses. What we are covering is a situation where hospitals supply drugs to outpatients, as happens with certain drugs. A person has to come back to hospital for a certain anti-depressant drug called Clozaril, which requires the taking of a blood test every two weeks because it can be highly dangerous. This can only be done in a hospital environment. There are issues surrounding premises and the pharmacy in a hospital for which we are not legislating. It will be a major task, probably to be dealt with in the next Bill or perhaps through the licensing regime we hope to introduce for hospitals. A pharmacist practising anywhere is covered by the provisions of this legislation but we are not making hospital pharmacies into retail community pharmacies. Somebody asked me the other evening if that was the case; we have had the issue clarified and it is definitely not the case.

Will all hospitals——

They will be included in the register.

Will people working in all hospitals be encouraged to register with the society?

They must do so under this legislation. As I understand it, they notify the society but will now have to register.

Will smaller clinics such as fertility clinics be included?

It is important to clarify that hospitals have two types of pharmacies. For example, in St. James's Hospital, there is a public——

The retail pharmacy will be covered in the normal way.

I accept that, but what of the hospital pharmacy? Pharmacists who work for hospitals are concerned and it is important to allay their fears regarding matters of fitness to practise and the creation of the public pharmacy as a separate identity, as arranged by the hospital. For example, it could be called St. James's Pharmacy and could be a limited company. Is it the recommendation of the Minister to public hospitals that they should register their pharmacies separately? There is a simple way to address the matter and to take hospital pharmacists' concerns into account.

I received a detailed submission that I will give to the Minister's officials. The concerns put forward about fitness to practise and buildings in which to work are sincere and genuine and I want to ensure pharmacists are satisfied in that regard.

I must be honest. I have a good and useful note and, rather than reading it, I will circulate it to Members. It is our latest clarification.

I acknowledge that hospital pharmacists comprise an important group of professionals in the health care system. They are highly qualified and, while I do not want to offend anyone, they earn much less than their retail counterparts.

We will not deal with that this evening.

We have met most of their concerns about the legislation, but there are issues relating to premises. Some of the hospital pharmacies I have seen are in pokey little places. If there were basements, that is where they would be. We are not addressing that issue in this legislation, but the jury is out on whether it should be dealt with in the second Bill or through the licensing regime for hospitals. Everyone should have appropriate facilities.

In terms of fitness to practise, the registration of the pharmacies and so on are required under this legislation. I understand that the majority of pharmacists notify the society, but they must register with the society from now on.

I also wish to voice my concern to the Minister. I welcome that these issues are being addressed by the Bill and that the Minister will deal further with hospital pharmacies and pharmacists in the second Bill. She was right to say those pharmacists comprise an important group of professionals. I can empathise with their belief that they have been forgotten in this debate because they are not the front or sexy end of the market. Rather, they are behind closed doors. If there were a basement in every hospital, the pharmacies would probably be found there instead of on the high street in big, shiny shops. However, they do an important job in acute hospitals.

Currently, 49 hospitals are registered. Like Senator Henry, I ask the Minister to keep pressure on the Health Service Executive to ensure those hospitals are registered. This must be done to ensure hospital pharmacists work within the remit of the Bill and within a safe parameter for everyone involved. All pharmacists will be covered by this Bill, but I look forward to the second Bill. Am I to understand that hospital pharmacists will be dealt with in this Bill in terms of fitness to practise?

Yes. As they supply drugs, they also fall under the same supply provisions as retail community pharmacies. From now on, all hospital pharmacies must be registered. I do not know how many of our 53 acute hospitals have pharmacy departments. While 49 of the 53 hospitals are registered and there are other settings with pharmacy departments, all such places must be registered under the Bill. I understand that the legal advice made available to us by hospital pharmacists in respect of these issues is the same as ours.

Acting Chairman

I remind Members of the limited period for Committee Stage. We will not reach many amendments because we are spending a considerable length of time on this amendment.

This is the most significant amendment.

We are taking a majority of amendments. Will the Minister clarify whether there is a need for hospital pharmacists to register as retail pharmacy businesses and whether three years' retail pharmacy experience is necessary for a hospital pharmacist?

No. It is important to have a career structure in the hospital pharmacy sector. I understand that there are three levels. One must have three years of experience to go from the basic level to the next level and five years to go from the basic level of the supervisory level. I do not propose changing that good career structure. Instead of 70 graduates, there will be 160. This year, many pharmacists will qualify in Ireland and be available to the hospital sector and the pharmacy sector in general.

Are pharmacists in industry covered?

Not if they are not dispensing.

Pharmacists going into industry would not need to register under the Bill.

I will return to the matter of hospital pharmacists because there is a valid question to be raised. On this section——

To address Senator Browne, spouses are specifically mentioned in the amendment. In case the Senator is worried, we are not preventing them from marrying one another.

I want to clarify something in the definitions in section 2(2), which states: "References in this Act to the sale and supply or the sale or supply of a medicinal product include references to the keeping, preparing, compounding or dispensing of the medicinal product." I have no difficulty with the provision in respect of preparing, compounding and dispensing, but what of carers who give medicines to people who do not have their whole faculties? They are keeping medicines. I am not trying to be awkward. We are trying to maximise home help services. Home helpers ensure that medicines are kept out of the reach of elderly persons, for example.

No more than a parent would for a child.

The word is "keeping".

That is storage.

It is in the context of pharmacists. We are not regulating home carers through the pharmacy society.

I am not suggesting that, but I have enough experience to know events that are never the intention of those who draft legislation can occur. Before this legislation reaches the far end of the other House, I ask that the drafter be sure that he or she has not introduced a regulation to make life impossible for carers, home helpers and so on.

I misunderstood. I believed the Senator was suggesting that we should include those people. Someone must be conducting a business within the meaning of the Act to fall under these provisions. The people referred to by the Senator, whose opinion I share, would not be in that position.

Recently, I was told by a medical officer in my Department that half the people on blood pressure tablets should not be and half of the people who should be on them are not. It is a crazy statistic, but not just an Irish one. We have a great deal to learn about medication.

We have a long way to go to catch up with the French.

Question put and agreed to.
Sections 3 and 4 agreed to.
SECTION 5.

I move amendment No. 2:

In page 9, lines 16 to 18, to delete subsection (1) and substitute the following:

"5.—(1) Notwithstanding the repeal by section 4 of the Pharmacy (Ireland) Act 1875, the Pharmaceutical Society of Ireland shall continue in being subject to and as reconstituted by this Act.".

My eminent legal adviser is sceptical about the idea of dissolving the society and drawing a distinction between the old and new societies. I will say no more than that on it. I hope the Minister will assure me that there will not be a discontinuity.

We have provided for continuity. We are proposing some amendments on how the new people will be elected, etc., under the old society. I am advised that we have provided for continuity.

Amendment, by leave, withdrawn.

I move amendment No. 3:

In page 9, subsection (2), line 19, after "as" to insert the following:

"Cumann Cógaiseoirí na hÉireann, or, in the English language,".

Tá sé mar nós ag Páirtí an Lucht Oibre consistency a lorg sa reachtaíocht. We have always looked for consistency in the naming of new bodies. They should have an official title in Irish. This is not a question of play-acting. In cases of conflict, the authoritative version of the basic document of this nation, Bunreacht na hÉireann, is the Irish language version. A good case can be made for including the Irish language in legislation in this way. When uncertainty exists, the Supreme Court is bound by the Irish language version of the Constitution. A thick document that describes the anomalies between the English and Irish versions of Bunreacht na hÉireann has been published. I have suggested that the official title of the Pharmaceutical Society of Ireland under this legislation should be Cumann Cógaiseoirí na hÉireann. Similar provisions have been made when many other agencies have been established. I will not argue the point with the Minister. If she wants to refer it to the official translators, she can do so. I have outlined the principle that underpins this amendment.

Níl mo chuid Gaeilge chomh flúirseach is a bhí. I am happy to accept the point the Senator has made. I will consult the Office of the Chief Parliamentary Counsel to ensure the wording of the amendment is correct. If it is, I will revisit it on Report Stage.

I thank the Minister.

Amendment, by leave, withdrawn.
Section 5 agreed to.
Section 6 agreed to.
SECTION 7.

I move amendment No. 4:

In page 10, subsection (1)(b), line 34, after “promote” to insert “and ensure”.

This is probably a quibble, but I am good at them. Section 7(1)(b) of the Bill states that one of the principal functions of the society will be “to promote a high standard of education and training for persons seeking to become pharmacists”. I think the society will have to do more than that. It will not simply promote high standards in the education of pharmacists; it will have a regulatory function to ensure that standards are maintained. I propose that the society will have “to promote and ensure a high standard of education”. In the case of engineering, which is my own profession, the role of Engineers Ireland in the accreditation of engineering degrees is not just to try to encourage people to be accredited, but also to choose a standard which people must meet before they can say they have been recognised as an engineer in this State. It is a question of ensuring that standards are upheld, as well as promoting those standards. I will not argue about the word, but I think the point needs to be made.

I think I can accept this amendment, subject to it being in order. The Senator has made a valid point. If there is a problem with it, we can change it later.

I thank the Minister.

Amendment agreed to.

I move amendment No. 5:

In page 11, subsection (2)(a)(iv), line 8, after “education” to insert “and training”.

I assume that the word "training" has been left out of this section of the Bill. The phrase "education and training" is used in several places in the Bill. I have looked for examples in the Bill of either the word "education" or the word "training" being left out, and tabled amendments to ensure that both words are included.

I will accept this amendment.

We should sort out the concepts of "education and training" for once and for all. We have never got our heads around the difference between them. That is why amendments of this nature are proposed all the time.

The word "training" is a vocational term.

Amendment agreed to.
Government amendment No. 6:
In page 11, subsection (2)(b), between lines 29 and 30, to insert the following:
"(iv) to conduct or arrange for the conduct of examinations of persons who are applying or might apply for registration,".

Senator Henry has already spoken about this issue.

Amendment agreed to.

I move amendment No. 7:

In page 11, subsection (2)(b), after line 45, to insert the following:

"(x) confer honorary fellowships.".

I am quite keen on this proposal. I once thought the Minister and I might get ourselves lined up for honorary fellowships some day.

When somebody told me an organisation intended to make me an honorary fellow, I thought I should get rid of its power to do so as quickly as possible. That is a joke. The society no longer wants to have that power. I did not have a problem with it.

The Pharmaceutical Society of Ireland is currently able to confer honorary fellowships.

That is right. Is it appropriate for a regulatory body to be able to do that? I will not go to war about this matter. I understand that the society no longer wants to have this power.

Those on whom the honour was conferred seemed to feel it was a good honour.

I am told that quite a long amendment would be required to make the change suggested by the Senator. Can I return to the matter on Report Stage?

Of course.

I will confer with the members of the society who are in Leinster House as we speak.

I share the Minister's wariness about allowing a body with such an important regulatory function to confer honorary fellowships. It would be a good idea only if the fellowships amounted to no more than titles. I have heard stories over the years about people finding back doors into various bodies. It is obvious that none of the stories is entirely verifiable. It seems to me that a good case can be made for clarifying precisely what honorary fellowships might mean if they are to be allowed. They should not allow people to practise as pharmacists or imply that such people have some experience in the pharmacy sector.

As somebody who has been honoured with honorary doctorates, I am always amused when I see someone who has been given such an award referring to himself or herself as "Doctor".

I do not envisage that somebody with a fellowship from the Pharmaceutical Society of Ireland will feel that the honour entitles him or her to practise as a pharmacist.

All right.

Perhaps I would be very happy to accept such an award if it entitled me to work in this area. I do not think it would bestow such benefits on me, however. I will speak to the representatives of the society. I have been informed that a major amendment would be required. If that is the case, we might not be able to include a provision of this nature. I will return to the matter on Report Stage.

The Minister is quite right in the way she uses her honorary doctorates. Some people include them in their references to their qualifications. There was a time when doctors of philosophy, for example, did not use the title of "Doctor" other than when they were working in academia or something like that. There are doctors and professors in many spheres. I would not like people to start calling themselves "fellows" for the sake of aggrandisement. I am aware that the society has given honorary fellowships as accolades to those who have helped the pharmacy sector.

That is right.

I will not get all hurt if the Minister does not accept this proposal.

Amendment, by leave, withdrawn.

Acting Chairman

As amendments Nos. 8, 19, 27 and 36 are related, they may be discussed together, by agreement.

I move amendment No. 8:

In page 11, after line 45, to insert the following subsection:

"(3) Without prejudice to the generality of subsection (2)(a)(ii), the Society’s duty under that provision shall include determining and applying criteria for registration which require compliance with any codes of conduct drawn up for pharmacists and undertakings to comply with such codes.”.

I think there is a need for a clearer and more explicit statement of the need for codes of conduct to apply to the profession. I accept that such codes are mentioned earlier in this section, but the reference should be somewhat more explicit. The determination of codes of conduct should be a clear part of the functions of the society. Section 7(2)(a)(iii) states that one of the duties of the society will be to “draw up codes of conduct for pharmacists”. I propose not only that such codes be “drawn up for pharmacists and undertakings” but also that those who will be bound by them will have to “comply” with them. I am somewhat wary of voluntary codes of conduct. I am well aware of the glorious joys of the operation of the drinks industry’s voluntary code of conduct in relation to the advertising of alcoholic drinks. I do not suggest that there are any similarities between the two industries. Codes of conduct should be enforceable.

The codes will not be voluntary. Section 12 outlines the manner in which codes of conduct will be given effect. I intend to ensure, subject to the agreement of the Competition Authority, that a code of conduct will not be used in a restrictive way, for example, as a barrier to entry. The Senator's proposal has already been covered in the Bill.

Amendment, by leave, withdrawn.

I move amendment No. 9:

In page 11, after line 45, to insert the following subsection:

"(3) Without prejudice to the generality of subsection (2)(a)(iii), the Society’s duty under that provision shall include the drawing up of codes of conduct for pharmacists which make detailed provision for conflicts of interest, and, without limitation, for such conflicts as might arise as a result of certain relationships and arrangements between pharmacists and medical practitioners, or persons connected with them (including those relating to the letting of premises), and which require certain declarations and disclosures to be made in that regard.”.

We have already dealt with this issue.

I will withdraw the amendment.

Amendment, by leave, withdrawn.
Question proposed: "That section 7, as amended, stand part of the Bill."

I am a little intrigued by section 7(2)(b)(ii), which states that the society will have the power to “impose sanctions on pharmacists whom it finds (whether or not after an inquiry) to be unqualified or unfit to practise”. Is it consistent with natural justice to be able to punish a person without the holding of an inquiry? That is the only question I have on this section.

I am advised it is in order.

For what it is worth, I record that I do not believe it is.

If a person knowingly contravenes a provision of a code or makes a declaration or disclosure to the society that is false and is proven subsequently to be false or misleading, what sanctions are in place to address that, or will such a contravention be deemed an offence?

It is an offence under the Act to give false or misleading information. It is probably dealt with under failure to comply with regulations under section 18.

I wish to seek clarification on the point made by Senator Ryan about it being possible to strike a person off the register without the holding of an inquiry.

On the point raised by Senator Ryan, from my experience of having been a member of the Medical Council, in regard to mediation or in the case of the Medical Council where there is a health committee, such a practitioner would not go before a fitness to practise committee but yet there would be genuine concerns about his or her practice which would render restrictions being imposed. In the case of a pharmacist, that might also follow suit. Is there provision for the establishment of a health committee for pharmacists?

There is.

In that case I would agree with the provisions of the Bill.

The Bill provides for this in a case where, for example, a pharmacist would agree to a different process such as mediation rather than going before the fitness to practise committee. It provides for this as a result of the outcome of such a process.

Question put and agreed to.
SECTION 8.
Question proposed: "That section 8 stand part of the Bill."

The section provides that "The Minister may, by order (a) confer on the Society such additional functions, connected with those which it has, (b) make such provision ...”. There is no suggestion of consultation with the public or with the society. Perhaps I missed such a provision but as the section stands it provides that the Minister may by order confer additional functions. Much of this legislation is about transparency and providing for major improvement in that respect. Given that the attitude of the profession has been positive about the need for transparency, it seems extraordinary there would not be some process of consultation with the society and with the public in this regard.

It is understood. I note it is not explicitly stated and perhaps I can consider that for Report Stage. It is clearly understood that one would not send the society notice of a set of additional functions without having consulted and spoken to its members, checking if there is the necessary capacity and other related issues.

The Minister and I are long enough here to know common sense has nothing to do with legislation.

We do not want to be too prescriptive. Normal relationships can deal with some of these matters.

There is also the question of consulting the public.

We are here to represent the public. How does one consult the public? Consultation is often an excuse to do nothing.

It could be addressed by providing wording to the effect that it is the intention of the Minister to add to the powers of the Pharmaceutical Society of Ireland——

After consulting the public.

——and any submissions should be made within three weeks.

Let us not be so prescriptive. Clearly, any extension of functions, I imagine, would obviously be done after fairly wide consultation. I cannot anticipate off the top of my head a situation that could arise——

I probably look at Government from a different point of view from the Minister

——where the members of the society would wake up one morning and suddenly have a host of new functions.

Question put and agreed to.
SECTION 9.
Question proposed: "That section 9 stand part of the Bill."

Subsection (2)(a)(i) states, “including the formulation and testing of experimental curricula”. Is that intended for pharmacists, pharmaceutical assistants or some other group? I am not clear about that.

It is the formulation and testing of experimental curricula. I am advised it is the education departments of universities that will be encompassed by that provision.

The education departments.

The pharmacy schools.

I hope it means the society will encourage universities to examine new ways of teaching and learning.

That is the idea.

Wearing the hat of something of an academic, I point out that the days of boring old lecturers standing in front of even more bored students should be ending. There is a great deal of learning by doing and problem-based learning which seems, for a profession such as pharmacy or many other professions, an ideal and better way of learning. If we want to try new ways, we should not let legislation stand in the way of it. If that is what this provision means, I would welcome it.

Question put and agreed to.
SECTION 10.

Amendments Nos. 11 to 13, inclusive, and 18 are related to amendment No. 10 and amendment No. 14 is an alternative to amendments Nos. 13 and 15. Therefore, amendments No. 10 to 15, inclusive and 18 may be discussed together.

I move amendment No. 10:

In page 12, subsection (2), lines 22 and 23, to delete "by the Minister" and substitute "or elected as set out in subsection (3)”.

We are discussing a number of amendments together. The Labour Party is unhappy with the fact that it is the Minister who appoints the council. The council should be appointed by following the legislation. That is the reason we suggest in amendment No. 10 that the council shall consist of 21 persons appointed or elected as set out in subsection (3). It is a self-governing profession to a considerable extent and I invite the Minister to examine another way of establishing the council other than the Minister being the appointer of the members. I believe that was included by accident. Some other people who have read the Bill, although they are not in the profession, see this as a sinister attempt to take over but I do not believe that is the case. The Minister has enough to do without taking over the pharmaceutical profession.

I do not like the idea of the members of the council being appointed by the Minister and I would like her to examine the suggestion in our amendment.

Our other amendment concerns the members of the society. It must be clear that the nine members must be elected and not selected by the council. The section provides that the council shall consist of nine members of the society who have been selected by its members but it ought to state who have been elected by its members.

Regarding the nine members, if that needs to be clarified, we must clarify it. It is the intention that they will be elected. In the event of only nine people putting themselves forward, obviously there would not be an election but I envisage more than nine will come forward. There is a good deal of interest in being involved with the society.

Regarding the issue of appointment by the Minister, that issue arose with the medical practitioners. We have a consistent approach whereby all regulatory bodies are appointed by the Minister. It is not the intention that the Minister would not accept the nine candidates put forward. I have given an undertaking that I will make that clear in the Medical Council legislation because some people were saying that if the Minister does not like the doctors elected, she will pick her own. That is not the case. It is automatic. Everybody will be appointed on the same basis and hopefully on the same day. It is to be consistent with all other regulatory bodies that we are doing it in this way. If there is any concern that the Minister would not appoint the people put forward by the society, I am happy to clarify that is not the intention.

On the question of the election of members, we will bring forward an amendment to clarify that it will be by election rather than selection. If only nine candidates come forward, I suppose it would still be an election.

I want to make two points. It is unfortunate the legislation does not specify that representatives of patient advocacy groups will be included on the council. I have been involved with the group MRSA and Families which has done great work in promoting awareness of MRSA. It is important to acknowledge the role of the public and the patient advocacy groups and this could be specified in the legislation.

Members of the Oireachtas are debarred from being on such councils and this is the worst form of inequality but it does not appear to arise in this case. I am not suggesting Members should be on the council but neither should we be automatically debarred. I ask the Minister to clarify whether Members are entitled to be members of the council. I reiterate that I am not seeking to be nominated to the body. At times it appears to be an offence to be a Member of the Oireachtas.

Serving Members of the Oireachtas may not be members of the council of the society. I have strong opinions on this issue because I regard it as a conflict for a Member of the Oireachtas to be a member of a society. The first duty of a member of a society is to that society, whether that is the Medical Council or any other regulatory body and therefore the Schedule of the Act precludes Members of the Oireachtas from being members.

It is difficult to define patient groups as there are many of them and there is not a single group known as the patients' organisation which could then be written into legislation. The many different groups include Patient Focus, the Patients' Association, the group referred to by the Senator and a number of other groups including that focusing on organ retention. Those representing the wider public interest as opposed to the professional or educational interest have a role to play in these regulatory bodies. It would be the intention to appoint people with a particular perspective which they could bring to regulation which is being done in the public interest. This legislation is a regulation in the public interest and to protect patients and it is also to support the profession by having good and appropriate regulation and high standards of professionalism which is underlined in everything we seek to achieve.

Knowing that the Minister desired to have lay majorities on all the professional councils, I wish to inform her that the Medical Practitioners Bill does not have a provision for a lay majority on the Medical Council.

It was an oversight on my part which I knew the Senator would notice.

I acknowledge it has been rapidly rectified.

I have no problem with a lay majority. However, during the passage of the Veterinary Practice Bill it was discussed that one can run short of professionals to put on each of a number of committees. Even if committee membership is reduced to five members, which is a minimum number for any committee, a body will have run out of professionals by the time four committees have been set up.

To clarify the position for the Senator, it is the case with both this Bill and the Medical Practitioners Bill that a person does not need to be a member of the council to be on a committee. Members may be recruited.

I wished to have that clarified.

The burden on members of a council such as this and the Medical Council, of which Senator Feeney has experience, is such that it is almost impossible to find either professional or lay people to participate. It was stated to me recently that no private sector employer would grant an employee time off to participate in some of these regulatory bodies because a fitness to practise hearing can run for quite a length of time. The power is being given to the society to recruit to committees people who are not on the council and this affords the kind of flexibility to fulfil their functions.

I thank the Minister for clarifying the issue. It is a pity pharmacists who may have doctoral and bachelor of science degrees could be appointed but those with the qualification of MPSI cannot.

On this council?

They could be appointed by one of the nominees but they are not specified in the legislation.

They are not specified but I think they could be appointed. The Minister might have more pharmacists appointed than she thinks.

I may have misunderstood the Senator. I thought the Senator was suggesting that the Bill should specify a medical practitioner.

No. The Bill states that a medical practitioner may be appointed to the health committee but I had not seen that one could appoint pharmacists to other committees, but it is obvious one can.

Does the Senator mean appointed to the Medical Council?

No, I mean the proposals in this Bill. I was concerned that with there being only nine pharmacists, unless pharmacists with bachelor of science degrees or doctoral degrees were appointed who were nominated by the various groups——

They can be recruited onto the committees by the society.

I am clear about that proposal now.

I was unenthusiastic about the nine members being selected. My amendment No. 18 is a thoughtful contribution and helped by the Bills Office is a transposition of the Minister for Agriculture and Food, Deputy Coughlan's and my methods of getting people elected to the first and subsequent veterinary councils and it has been considered by the vets as being successful. She and I put a lot of time and thought into that proposal.

I will reflect on the Senator's amendment No. 18 and introduce a Government amendment to specify all those points.

I am pleased to hear that. The Minister, Deputy Coughlan will be pleased.

We have been informed by the Senator's very good amendment and we just need to clear it legally.

It is important to make it clear that such members are elected even if there are only nine because the word "selected" is not the ideal word.

The Minister has stated she is of the opinion that Oireachtas Members should be debarred from membership. I do not like a blanket ban and would prefer if people were considered on an individual basis. Senator Henry has a wealth of experience in the medical world which is not matched by any of us and Senator Feeney has a wealth of experience from the Medical Council. I am always concerned by these rules of general exclusion because the House likes to see equality observed. If an existing member of the Pharmaceutical Society of Ireland were elected in a future election to either House, would he or she be required to step down?

There is a member in the other House and he is a Minister of State at the Department of Health and Children.

But what if he or she is already a member of the council?

He or she would be required to vacate the position.

It would not be a case of declaring an interest and continuing.

On the point made by Senator Browne, I am such a person in so far as I was not a Senator when I was appointed to the Medical Council in 1999. I was elected to the Seanad in 2002. My position was unique in that I was on the fitness to practise inquiry hearing into Dr. Michael Neary. This was an ongoing inquiry which had been running for 18 months. For practical and financial reasons and to accommodate both Dr. Neary and the patients involved, it was decided that I would remain on the council until the end of that inquiry. I agree with the Minister that there were times when as a Member of the Oireachtas I felt a little unwelcome in Lynn House, particularly during discussion of the Medical Practitioners Bill and I would have hand, act and part in the passing of that legislation. No one person in particular made me feel uncomfortable but it was a communal effort that made me feel a little uncomfortable at times.

To refer to Senator Browne's point, I am glad neither this legislation nor the Medical Practitioners Bill prohibits members of a local authority from being members. People from a community who have been elected to a local council have something to offer. From my own experience I do not believe it would work out successfully to have a Member of the Oireachtas as a member. I was perceived as being very close to the then Minister for Health and Children, Deputy Martin and whether that was a right or a wrong perception, I felt a little uncomfortable at times as a result.

Amendment, by leave, withdrawn.
Government amendment No. 11:
In page 12, subsection (3), lines 34 to 37 and in page 13, lines 1 and 2, to delete paragraph (d).
Amendment agreed to.
Government amendment No. 12:
In page 13, subsection (3), between lines 7 and 8, to insert the following:
"(f) 11 (including the persons referred to in paragraphs (a) to (d)) shall be persons who are not and never have been—
(i) registered as pharmacists or (before the coming into operation of Part 4) as pharmaceutical chemists or dispensing chemists and druggists,
or
(ii) registered outside the State or otherwise qualified there as pharmacists,".
Amendment agreed to.
Amendment No. 13 not moved.
Government amendment No. 14:
In page 13, subsection (3)(f), line 9, after “members” to insert the following:
"in accordance with rules made undersection 11(2)(b)”.
Amendment agreed to.
Amendment No. 15 not moved.

Acting Chairman

Amendments Nos. 16 and 26 are related and may be discussed together.

I move amendment No. 16:

In page 13, subsection (3)(g)(i), line 14, to delete “pharmacy faculties” and substitute “Schools of Pharmacy”.

We will probably come back with an amendment on that issue.

They are all known as schools of pharmacy, rather than pharmacy faculties. They are so touchy in the universities.

They have great representation here.

I do not represent the universities. I represent their graduates.

It is the same thing. I will come back on the issue.

On Report Stage.

Amendment, by leave, withdrawn.

I move amendment No. 17:

In page 13, between lines 29 and 30, to insert the following subsection:

"(6) Not less than 40 per cent of the members of a Body shall be men and not less than 40 per cent shall be women.".

All I have ever asked for is consistency on the issue of a gender balance. I do not have an enormous issue with it, but governments insist on it in some places but not in others. The teaching staff in my place of work at CIT elect two members to the board of governors. We are instructed that one of them must be female. When this was first mooted, about 85% of the staff were male and it was difficult to find a woman who wanted to do it. However, it was public policy. If we believe it is appropriate, we should either make it universal or drop it. The suggestion in the amendment is that not less than 40% of the members of a body should be men and not less than 40% should be women, the joke being about what to do with the other 20%.

There should be an attempt made at striking a gender balance. Many of these professions are dominated by men. About 80% of the INTO membership are female, but not the executive. I am not sure it is enough to say women who are able will rise to the top. Conflicting demands impose more on women than on men. If institutional space is not created for them, these conflicting demands will not be met. If 40% of a body's membership are women, it will have a willingness to respond to the extra demands placed on women owing to domestic circumstances and so on. If there is no significant presence of women on the board of a body, the minority of women will have to put up with the male way of doing things.

This amendment is worthwhile. It is worthwhile promoting the involvement of women in their professional bodies. Sometimes they can be easier to deal with than men. I saw the figures for the political parties which have put forward candidates for the election to the Dáil and the Minister's party has done very well, as has the Labour Party. However, other parties have not done as well. It is worthwhile promoting the involvement of women. They will not get there, unless there is encouragement.

I am a strong fan of encouraging women to take up decision-making positions. If this was a council onto which the Minister was appointing all the members, I would probably accept the amendment. However, the members of the society will elect nine persons and it would be very prescriptive to tell them that four of them should be women. There are six Senators in this House representing the universities, only one of whom is female.

Senator Ryan has just lost his job.

I have more worries about my seat than that.

If we were to say to the universities that 40% of their candidates for seats in the Seanad had to be women, I do not know which of the male Senators here would have to give way. Half of the Dáil Deputies in my party are female.

I attend many health care conferences and there has been a complete transformation from my last job when I would look across the room to see if any woman was in the place. The opposite is now often the case because the health profession is dominated by women. I recently visited UCD where about 80% of the members of the medical society are female. That is the future. I do not know what is happening in pharmacy.

It is much the same.

Much of it has to do with the points system. We all acknowledge that women are brighter than men.

But we do not all acknowledge it.

We must be pragmatic and sensible. The argument was made when I brought forward the HIQA Bill that 70% of the members of the board would end up being female by virtue of the positions they held. Being over-prescriptive is not the way to go. I was in Norway last week. Eight of the 17 Ministers are female owing to the quota system. Therefore, a woman in the Norwegian Parliament has a great chance of becoming a Minister, as there is almost always a position in the Cabinet. There are wider cultural and societal issues as to why trade union representatives are often male in professions dominated by women. I am sure Mr. Liam Doran will not mind me mentioning the fact that he is secretary general of the Irish Nurses Organisation. Mr. Des Kavanagh is general secretary of the Irish Psychiatric Nursing Association. Women are in the majority in the electorate for these roles. In appointing members it would be my intention to strike a good gender balance in so far as possible.

Amendment, by leave, withdrawn.
Question proposed: "That section 10, as amended, stand part of the Bill."

I wish to ask the Minister a question about section 10 that also relates to the Schedule. The duty of confidentiality of council members is clear. As an advocate of freedom of information, I am not happy about the idea that anything declared to be confidential must be confidential. Having said that, there is a clear obligation in respect of confidentiality. Will the Minister clarify that the person nominated by the Irish Medicines Board and the person nominated by the HSE will be bound by the same confidentiality clause and will not be able to report back to the Irish Medicines Board or the HSE on their activities? I asked this question on a previous occasion about another Bill and the relevant Minister said they could so report.

Civil servants are appointed to boards of public bodies which apply a confidentiality clause. Does that clause apply to them? There should be no exceptions. If we are to have a lay majority, it must be clear that their first commitment is to the success and proper running of the council. I would welcome it if the Minister would state those two people will be bound by the same confidentiality regulations as everyone else.

I agree with Senator Ryan. However, it was normally the non-professional person on the board of which I was a member who insisted on maintaining confidentiality. The tendency to leak information always gives rise to problems. It is normally the professionals on boards, rather than lay members or those representing particular interest groups, who are most guilty of leaking information. I agree with the Senator that confidentiality is extremely important, particularly in the case of the Pharmaceutical Society of Ireland or the Irish Medical Council. However, I do not know what we can do to ensure the confidentiality provisions will be so tight that leaks will not emerge.

When things began to go wrong for the former blood transfusion board, the Department of Health and Children's representative on it was severely criticised because, as far as I recall, she maintained confidentiality. People on various boards and those at the HSE have a difficult task at times.

Senator Henry is correct. During some of the inquiries under company law, great criticism was also levelled when members of the Central Bank did not report to Revenue. The confidentiality clause will apply to everyone. As stated in the section, however, it will not prohibit the making of reports to Ministers or whatever body to which the council might agree to make such a report. Confidentiality is paramount. Those on the council will not be present to represent the bodies of which they are members; they will be there because of the wider perspective they can bring. If a members believes there is anything untoward happening which should be brought to public attention, he or she would either be obliged to obtain the agreement of the council to release information in respect of it or resign.

As I stated on Second Stage, many asked me about the recent practitioners inquiry. When I informed them that I did not have a clue about what was happening, they were astonished. I have no right to know what is going on because confidentiality applies.

There have been breaches of confidentiality across a host of areas in recent years. The essence of a professional — be he or she a doctor, pharmacist, lawyer, politician or Minister — is that he or she should be able to maintain confidentiality. When I am asked to address schoolchildren, I am occasionally asked what advice I would give them. My reply is often that it is important to be somebody who can be trusted. I provide them with the example that if one tells one's best friend something and he or she betrays one's confidence, one will never trust him or her again. The same applies in respect of professionals. If one went to a doctor and discovered later that he or she had told someone else about one's health, one would naturally be furious as a result of this major breach of the doctor-patient relationship and the lapse in his or her professionalism. One would never return to that doctor's surgery. The same applies to many other professionals.

Those who will sit on the council will be bound by the same confidentiality rules, regardless of whether they are nominated by the HSE or the Irish Medicines Board or elected by the society. Their duty will be to the society in the first instance. The only opportunity they will have to bring matters to the attention of others will be through formal reports or a decision to be communicated by letter.

I do not believe in blanket confidentiality clauses. I am of the view that the basic principle regarding the exemptions which apply to freedom of information is that people should do their business in public, except where it needs to be done in private. This would enable those who have legitimate professional concerns of the type to which Senator Henry referred in respect of the blood transfusion board to raise them with the body by which they were appointed. Blanket confidentiality is an attempt to silence lay people. Many public servants on boards to a degree feel entitled to discuss with their managements matters about which the other members are unaware. On previous occasions when discussing similar confidentiality clauses with other Ministers, I was informed that civil servants must be in a position to inform their Departments about what they are doing on particular boards. My view is that the law states they cannot do so.

There are different situations. I am not providing in the legislation or in the Medical Practitioners Bill that there will be a representative of the Minister on the council. I gave consideration to that matter but ruled it out because, as is the case with other bodies, he or she would be there to represent the Minister. In my previous job the Minister had representatives on different boards and they reported to the Minister. The situation to which I refer is different from that which applies in this instance. The members of the council will not be representing the HSE or the IMB; they will be there in their own right by virtue of either their election, if they are members of the society, or their nomination. Their duty will be to the society.

At the press conference to launch the Bill I was asked why the council's meetings could not be held in public. Journalists would love everything to be held in public in order that they might report on matters of this nature. However, we must be pragmatic and sensible. Organisations must be able to do business in private. Could anyone run a business if all meetings involving boards of directors had to be held in public? Would it be possible to run political parties in such circumstances? We must be sensible in the way we legislate in these areas. We are discussing a regulatory body with enormous powers which will be in a position to effectively end people's careers and withdraw from them their livelihoods. The society must be able to operate in a professional way. We must be able to trust it and have confidence in those who will serve on it. I have no reason not to trust those individuals.

The society was handicapped because it was obliged to operate under extremely archaic legislation. As stated on a number of occasions, effectively there was no fitness to practise regime in place for pharmacists in Ireland. The Bill will provide the society with a modern regulatory framework and greatly enhance its authority and power to be able to intervene and initiate proceedings in the interests of both patients and the profession.

Question put and agreed to.
Amendment No. 18 not moved.
Section 11 agreed to.
SECTION 12.
Amendment No. 19 not moved.
Question proposed: "That section 12 stand part of the Bill."

I understand what the Minister is concerned about in this section and agree with her. I refer to the idea that a body such as the council might use its powers to restrict entry to the profession. We are aware of at least one, if not two professions, that have done a remarkable job for 80 or 90 years. I look forward to the day when legislation stating the membership of the Bar Council will be appointed by the Minister will be introduced.

If I ever become Minister for Justice, Equality and Law Reform, I would be delighted to introduce such legislation.

The Minister would have my enthusiastic support and that of my party if she did so.

In fairness, the Bar Council has opted, on a voluntary basis, for a lay majority.

The disciplinary committee of the council has a lay majority but the council does not.

My sources, of which I have a few, inform me that the council has opted for a lay majority.

I thought the Minister had a few good sources in the profession.

I do. I also have a few in the pharmacy profession, other than Senator Minihan.

If the Competition Authority is dissatisfied with the code of conduct, will the matter ultimately be resolved by the council noting that fact and publicising it or do the authority's powers extend to being able to pursue the matter further? Will the authority be in a position to use its powers to change the code of conduct? Will there merely be a procedure that will involve the issuing of a notification to the effect that the authority is not satisfied with some aspect of the code of conduct?

I am wary of the Competition Authority. Some of its recent rulings have been quite daft. For instance, that the Health Service Executive cannot negotiate with the Irish Pharmaceutical Union is daft. It will place an enormous burden on the HSE and will not achieve anything in terms of value for money, either for the State or for consumers. However, that is a separate day's discussion.

Is there a residual power? What will happen afterwards? Will the Competition Authority effectively be able to pursue the council to change these? They can still publish and operate them. I take it the Minister understands my point.

I reiterate an earlier point about the need to review. The council will publish the code of conduct and lay it before both Houses of the Oireachtas, but I wonder could we insert a review on the operation of it on a two or three-year basis. Like much legislation which comes before this House, we all get enthusiastic and think it will work brilliantly and, unfortunately, a few months or years later, it may not work out exactly as planned. It would be helpful if a review was built into the legislation to allow all interested parties monitor and learn whether it is working as we and other bodies planned initially.

On reviews, I stated earlier that I have an ambition, following the general election when I hope to return to the Department of Health and Children, to establish in this Department — my officials are probably having heart attacks behind me — what we did in the Department of Enterprise, Trade and Employment where we put a group together to examine company law and report every other year stating the need to modernise in certain areas, to do the work and, therefore, make the legislation easy.

On regulation, when we get the nurses and midwives modern legislation in place — the relevant legislation is 20 years old — and the dentists legislation, it would be no harm to have a group representing the different regulatory bodies who would look at it from time to time so that we do not wait. In the case of the Medical Practitioners Act, the legislation dates from 1978. In this case, the Acts date from 1875 and 1962, which is crazy. The nurses legislation is 20 years old, which is not so bad, but still a great deal has changed. We must have a more frequent way of being able to change and modernise legislation, and that would be a good day's work.

The code of conduct must have the consent of the Minister. The Minister must have the view of the Competition Authority and, therefore, it would be open to the Minister to state that he or she would not consent if he or she felt what was being suggested was not reasonable.

For clarity and accuracy, I say to Senator Ryan that when the negotiations were under way, it was the legal representative of the IPU who brought to the attention of the negotiators their legal advice that stated that the wholesalers cannot negotiate with us because it affects them as a third party. It was not the Competition Authority who highlighted that we must stop here. It was the lawyers for the IPU. When the Attorney General and the HSE's lawyers got it — I remember getting the advice of the Attorney General — they all agreed that the IPU was correct. That is what happened.

That was because of previous activity by the Competition Authority vis-à-vis actors.

It relates to competition law and is about price fixing. Clearly, we can negotiate the contract, what is included in the contract, the level of service, etc. and then there must be an objective adjudication of the price. I believe the mechanism being put in place can resolve the issue. It is a matter of being pragmatic and sensible, but clearly we cannot be in breach of the law.

The intention obviously would be that the code would be examined by the Competition Authority. The views of the Competition Authority, if it has views, would be attached when the Minister was consenting or, obviously, not consenting. The only reason the Minister would not consent is if there were something in the Competition Authority's view which the Minister felt was reasonable and which would lead to a period of discussion, or whatever, with the society.

On the point I raised, the Minister is agreeing with me but yet failing to put it in stone.

One does not want to start writing in a review every three years.

Why not?

Look how long this has taken. It is not practical.

But that proves the point.

It is not practical to go through the mechanism of reviewing for the sake of it.

In the previous general election and Seanad election——

It is open to any Member of this House, including a Member of the Opposition, to table a Bill to amend any law if there is a deficiency in legislation. It rarely happens because generally legislation is made by Government for the good reason that it has available expertise and assistance and it has the majority to get legislation through. However, I do not want to be so prescriptive as to write into the Bill that every three years we will review this, that and the other merely for the sake of it, and have endless meetings of individuals and professionals going through a process that could be meaningless.

With respect to the Minister, following the previous general election, and no doubt the same will be the case following the next general election, there was a turnover of over one third of the Houses of the Oireachtas between Members retiring, Members who, unfortunately, will not get re-elected and new Members being elected. I speak not of a review every few years but that we agree to even one review. The Minister has admitted this is major legislation involving major changes.

Is Senator Browne speaking of a review of the code or a review of the Bill?

A review of the Bill and, I suppose, the code of conduct is linked into it.

The code could be reviewed every year. There is nothing in this Bill that prevents the society from changing or reviewing its code on an ongoing basis.

The point I make is that the Minister has admitted that it has taken many years for this Bill to come about in the first place, and no doubt her intentions are honourable in so far as she would, if she were re-elected and reappointed Minister for Health and Children, do as she stated. The danger is that she might not be reappointed as Minister and there could be a new Minister in place. In life, change is guaranteed. The danger is that a review could be lost in the process and not take place by 2012.

Senator Browne might be Minister for Health and Children.

I doubt it. There is an advantage in providing on Report Stage an option of reviewing the entire procedure approximately three years from the date of enactment of the Bill. As it is major legislation, we would do everyone a service.

I do not know how workable Senator Browne's proposal would be. From the Medical Council's point of view, every time there was a query over something, the 27 year old legislation concerned would be taken out and read, and one was working continually on the legislation in place. It would be almost negative to provide in the Bill for a review in three years' time because one would not have determined all the workings of the Bill in that period. I cannot see where it would be helpful.

Does the Minister wish to comment?

I made the point that we should not be wasting time and I do not want to keep repeating myself.

Question put and agreed to.
SECTION 13.

I move amendment No. 20:

In page 15, lines 27 to 32, to delete subsection (2) and substitute the following:

"(2) The Council shall publish each register within 12 months of the setting up of the register and thereafter at intervals of not more than 12 months.".

The Minister has addressed this in amendment No. 21. She must have decided to share my anxieties. There is a vast trade in illegally prescribed drugs and it is depressing to learn of the amount of legalised drugs traded between drug addicts — analgesics, various anziolectics, steroids and the like. My concern was putting too much information on the Internet. Security lapses occur all too easily and such substances could be found too easily if a person were a keyholder for a pharmacy, for example. There would be a security risk for the person involved and also a risk to the security of the drugs.

I note that the Minister has provided, in amendment 21, that the duty should not extend to the home addresses, telephone numbers and e-mail addresses, etc. I would be grateful if I knew she had asked the Garda Commissioner about this because he gave a speech the other day about draft advice on security in pharmacies because it is a significant problem. I do not know that people really need that information on the Internet. It can be published somewhere but one would like to know who was looking at the information.

Perhaps the Minister might consider my point about the Internet. It is that which concerns me because it provides easy access to anyone to get a fair bit of information about someone who is in a position in which he or she has the security of supplies and the security of himself or herself and his or her family, to consider.

I share Senator Henry's concerns on that and especially her last point. They are in a position where they are housing drugs and cash. We live in a security conscious era. Even from a lesser point of view, Senators Henry, Browne and I have been receiving mail over the past two weeks from a certain Irish lobby group regarding the Medical Practitioners Bill 2007. I am glad the mail is being sent to my business address because when I was on the Medical Council, that kind of correspondence was sent to my home, along with nasty telephone calls, and it was not nice. There was no risk to my life at the time but the life of a pharmacist could be put at risk in this instance.

I share the views expressed by the Senators. The amendment seeks to ensure that home and e-mail addresses and telephone numbers will not be included. That is important.

With regard to the Medical Council, I am apparently going to overrule the Constitution with the Medical Practitioners Bill, such is the power I am giving myself. I have seen some of the correspondence to which Senator Feeney referred and there is no doubt that in the modern era, even without the Internet, people can dispense products such as drugs which can be very dangerous if taken in the wrong circumstances. They are vulnerable and we must ensure that open and transparent processes are in place for the council while not going so far that we aid and abet people in activities which are not helpful. My amendment gives the society the power to protect the security and privacy of individuals when deciding what is to be disclosed.

Amendment, by leave, withdrawn.
Government amendment No. 21:
In page 15, between lines 32 and 33, to insert the following subsection:
"(3) The duties imposed bysubsections (1)(e) and (2) do not extend to the home addresses, telephone numbers and e-mail addresses of individuals and to such other similar information about them as the Council considers should, in the interests of the security and privacy of those individuals, not be disclosed.”.

I want to make a suggestion to the Minister on the potential threat to the safety of pharmacists where too much information is disclosed and on the related issue of Internet sales of drugs. We have given the Garda and the Minister the right to oblige all companies to retain their records of traffic for three years. Every piece of spam concerning the Internet sale of drugs that lands in my in-box is in the possession of the authorities. The tedious job that is now required is tracking the sources of spam and demanding that whoever is making the offers be prosecuted by the authorities of the country in which he or she resides. There is no simple solution other than to pursue those who offer me God knows what medications at bargain prices. Our authorities should demand that either the ISP being used to send the e-mail or the authorities of the relevant jurisdiction deal with the offers.

The ability to purchase cheap drugs of dangerously bad quality over the Internet is going to become a significant threat to public health. It is already a major issue in countries less enlightened than our own, where people must pay large sums for necessary drugs. The fact that we have a fairly sensible drug payment assistance scheme is probably a guarantee that we will not follow that route. People in other countries are not buying these drugs for reasons of addiction but because they cannot afford the drugs prescribed for them. More vigour is needed on the part of our authorities in terms of finding out where the offers of cheap drugs are being made.

The sale of drugs by mail order is prohibited in Ireland. The issue arises with regard to procuring products over the Internet from sites outside the country. The Irish Medicines Board has reported to agencies and authorities in other countries and some sites have been closed down. The board has considerable powers, in so far as modern communications networks allow power in any single jurisdiction, and can communicate with enforcement agencies in other places with a view to having them take action on sites which sell in Ireland.

Controlling the Internet is a global challenge. People in certain places in the world do not care who locates there. The challenge arises not only in respect of medicine and drug sales but also in several other areas. I commend, for example, the wonderful work that has been done by enforcement agencies on child protection issues. It is encouraging that authorities in Europe and the United States have worked together to bring successful prosecutions, but we have a long way to go to ensure the Internet is used in a positive manner.

Amendment agreed to.
Section 13, as amended, agreed to.
SECTION 14.

I move amendment No. 22:

In page 16, subsection (2)(a)(ii), line 26, after “state” to insert “or in the State”.

I tabled this amendment because it appeared that if a person from outside the State was convicted in another State of an offence, the nature of which in the opinion of the council had a bearing on the person's fitness to practice, he or she would not be allowed to practice. However, it appears that a person is not excluded if he or she commits a crime in this State.

The issue raised by the Senator is addressed by section 14(1)(d), which is all-encompassing. The paragraph states: “satisfies the Council that the person is fit to be a registered pharmacist.”

As long as it is all right.

Amendment, by leave, withdrawn.
Question proposed: "That section 14 stand part of the Bill."

I may have worded incorrectly a question I asked yesterday on existing pharmacists who lack the requisite qualifications. Section 14 requires that a pharmacist hold a qualification appropriate for his or her practice. I may have inadvertently claimed that hospital pharmacists are not qualified, which I certainly did not mean to imply, and I apologise for that mistake. I was trying to point out that the hospital and retail pharmacy sectors may employ people who have practised for many years and possess good records but who may hold different qualifications from modern pharmacists. How will such people be dealt with under the legislation? I presume they will be allowed to continue practising for as long as they wish. In her conclusion to yesterday's debate, the Minister acknowledged their role in the pharmaceutical trade.

One of the conditions set out in section 14 is that a person must satisfy the council that he or she is fit to be a registered pharmacist. That condition is additional to the requirements on qualifications. Does the council have to observe the tenets of the Equal Status Act 2000 in its determination of whether a person is fit to practise? I am simply trying to understand the meaning of this provision. The Irish Blood Transfusion Service will not accept blood donations from gay men simply because of their sexual orientation, which is of considerable annoyance to many gay men who know they are in perfect health. What is to prevent the council from deciding that having gay men working as pharmacists is too great a risk to take? Does the Equal Status Act apply?

Of course it does.

Does it?

I am sorry. I did not understand the point the Deputy was making. Clearly, the role of the society is to make sure the person who registers has the qualifications to practise pharmacy but their sexual orientation, marital status or political or religious beliefs are irrelevant. The Equal Status Act 2000 applies across the board in this State and one cannot be discriminated against.

The Senator raised a valid issue relating to blood, which Senator Norris asked me to examine two weeks ago. I have not had an opportunity to discuss this with the Blood Transfusion Service Board. The quality of the blood is paramount, as was highlighted by members of the hemochromatosis group. I recently met four sufferers, even though it is a very rare disease. They receive the highest quality blood and that is not accepted. Recently, I appointed a member of the voluntary group that represents them on the BTSB. She has come together with a group of patients who have a blood-related issue and given that the service is about blood, I appointed this lady to see if she could use her powers of persuasion on the board. This is a not a matter for the Minister because the board is an independent body and it is appropriate that its members make decisions based on expertise. However, the quality of the blood is paramount and I intend to examine this issue in consultation with my Department and the BTSB. Senator Norris attended a function recently during when he announced that of the 100 people present, 15 were gay. I was told by somebody in attendance that everybody was looking at each other.

He does worse.

On the law of averages, some pharmacists are gay but their sexual orientation does not matter. If they are able to do the job, the only concern is their qualifications.

As it should be.

Their sexual orientation cannot be an issue. They would have a great case if it was.

Under the section, the linguistic competence of nationals of other states is mentioned. Who will decide whether they are competent because there is no question of an examination being undertaken?

The society decides.

Linguistic competence is an increasing problem in our health service. For example, the linguistic ability of many nurses is not quite what it should be. I was asked by a nursing home, which had a problem recruiting staff from the Philippines, if I could try to point out to the recruits that they would be dealing with people with Alzheimer's. However, Poles who spoke no English had grave trouble communicating with patients who had serious trouble understanding anything. While the society will make decisions in this regard, will it be given guidance? Filling drug prescriptions and explaining how they should be taken is a serious business. This is again a public safety issue.

Under the section, a citizen of the State or another EU member state does not have to satisfy the linguistic test. Only non-EEA citizens will have to satisfy the council they have the linguistic competence. Does that mean, for example, somebody from Nigeria who speaks reasonably good English would have to undertake a linguistic test while somebody from Hungary, which is an accession state, would not? Is there a provision to preclude a citizen of Hungary, for example, who has the relevant qualifications and experience from working as a pharmacist in this State?

Senator Browne referred to the qualifications issue. Anyone who is registered under the current legislation can continue to practise and I am advised there is no issue regarding their qualifications.

The society, not the Minister, will decide the linguistic competency of an individual. I am sure the society will learn from the experience of other organisations such as An Bord Altranais and so on. International standards apply and our standard is higher than in many other countries.

Citizens of EU member states and EEA countries who are pharmacists must register and they will have a period within which they must fulfil the language competency. Citizens of non-EEA countries will only be registered when they fulfil both the language and qualifications requirements. That will be a matter for the society. I have not discussed this issue with the society but I presume it will inform itself regarding what happens in other organisations such as An Bord Altranais.

Senator Henry made a valid point about how distressing it is to try to establish what is wrong with a loved one when they have lost the power of speech following a stroke and so on. A number of years ago I visited a patient in a Dublin hospital and a Chinese woman was also a patient on the ward. Nobody spoke Chinese and she was clearly very distressed. It was an awful experience to observe this, although the nurses were very helpful and doctors were called but it was impossible. Aside from the need for health care professionals to be competent in English, given that the State is reliant on foreign nurses, more and more patients are from outside the State and some of them cannot communicate in English. This is a major issue and we are trying to be as practical as possible. The HSE provides translation services in certain situations, which is important.

With regard to the dispensing of drugs, I am always amazed pharmacists can read a doctor's prescription. I have not had a clue how to read any prescription I have ever seen. I suspect training will have to be provided to pharmacists on how to read a doctor's handwriting.

The prescriptions should be typed.

The Senator makes a good point.

Question put and agreed to.
Section 15 agreed to.
SECTION 16.

Amendments Nos. 23 and 24 are related and both may be discussed together by agreement.

Government amendment No. 23:
In page 18, lines 21 to 25, to delete subsection (5) and substitute the following:
"(5) The third of those requirements is that the person—
(a) holds a diploma, certificate or other evidence of formal qualification as a pharmacist granted by a competent authority of a third country, and the diploma, certificate or other evidence has been recognised by a relevant state for the purpose of being a pharmacist in that state, and
(b) has experience, of at least three years, of practising as a pharmacist in that state certified in accordance with Article 3.3 of the Professional Qualifications Directive.”.

The amendment will further clarify the qualifications required. The section sets out the conditions which must be met to allow a person's qualifications be considered appropriate for practising pharmacy in the State. It deals with Irish, EU, EEA and non-EU qualifications. It gives the council the power to satisfy itself as to the appropriateness of any qualification and, if deemed necessary, to require the person to sit an examination or undergo such training as it may specify. These provisions do not interfere with the right of Irish and EU-EEA citizens to have their qualifications recognised under EU directives on qualifications and the free movement of professionals.

I referred to a little bugbear of mine on Second Stage. If EU directives are referred to in a section, they should be listed on the same page in the legislation. They are a major part of the legislative process and they should not be hidden in enabling legislation unless that is made clear. It is a minor issue, which could be addressed through a proper search.

I am glad the Minister has clarified who is entitled to work as a pharmacist in the State. However, many of us asked on Second Stage why there is no sign of a reciprocation in this regard by other states. The IPU told me a person who had qualified in the North could open a pharmacy in Dundalk but a person operating a pharmacy in Dundalk could not open one in Newry. Are other countries holding things up or is there an unwillingness on the part of the Commission to require countries to implement the directive?

To be frank, the answer is yes. Many EU countries use qualifications as a barrier to entry. That is why we have not achieved to create the single market. There is a derogation. It is a matter for member states to decide but that others do not do it is not a reason we should not. What motivates me mostly is the position of Irish people who graduated abroad. Under Irish law, one cannot distinguish between EU citizens. This is to help them. There was a time when the number of places in pharmacy was very restricted. Thankfully, we have moved from a figure of 70 to 160. Despite this, many more wish to become pharmacists. We will, however, have an adequate supply from the indigenous population. Other EU countries have not followed suit. As in the case of the smoking ban, it is no harm to be the trailblazer occasionally in matters which are good and worthwhile. The three year post-qualification requirement, before one can open a pharmacy, is reasonable. Many believed it was unreasonable but it is reasonable that one cannot open a pharmacy on the day one completes one's education. The requirement that one should have three years' experience is a good one.

Amendment agreed to.
Amendment No. 24 not moved.
Section 16, as amended, agreed to.
Section 17 agreed to.
SECTION 18.

I move amendment No. 25:

In page 21, between lines 16 and 17, to insert the following subsection:

"(2) The Minister shall, prior to making any such regulations, consult with the Irish Pharmaceutical Union and with the Society, and with any other person or body the Minister considers, in his or her discretion, it would be desirable to consult in advance of making any regulations under this section.".

Out of the blue in the middle of legislation dealing with the profession, with outside assistance, regulating itself, section 18 states: "The Minister may, for the proposes of the health, safety and convenience of the public, make regulations about all or any of the following matters in respect of retail pharmacy businesses". Nobody would dispute the significance of this but there is no reference to the pharmaceutical society. The Minister will say there is no intention of producing regulations without consultation and I believe her because she is a reasonable woman most of the time. However, the amendment reads: "The Minister shall, prior to making any such regulations, consult with the Irish Pharmaceutical Union and with the Society, and with any other person or body the Minister considers, in his or her discretion, it would be desirable to consult in advance of making any regulations under this section". It seems rather bald to suddenly decide the Minister will do all this in isolation. There should be a formal consultation process.

I agree there should be consultation and give an undertaking that there will be. However, one should not prescribe that there should be consultation by way of legislation. That is overly prescriptive and unnecessary. I have probably met representatives of the pharmacy profession more often than any other group in the past two and a half years and I am always happy to do so because I have been well informed by the union and the society and it is my intention to consult both. I had this debate yesterday in regard to the Medical Practitioners Bill. The psychiatric training committee was mentioned and Deputies said they had never heard of it. It is the training body for psychiatrists. I was giving myself a transitional power because there was talk of a merger of the committee and the college in order that we would not have had to change the legislation when the body went out of existence and merged with another. I am not suggesting the IPU will go out of existence but it could well decide to become known by another name. One is overly prescriptive when one writes such provisions into legislation. It is my intention and, no doubt, that of my officials to consult widely before regulations are introduced. We need to consult because we do not have expertise.

I take it from the format of section 18 that enforcement of the regulations will be a matter for the Minister exclusively, not the pharmaceutical society.

I will not enforce the regulations. They will be enforced by the society. I do not yet have an enforcement wing at my disposal in my Department.

Amendment, by leave, withdrawn.
Question proposed: "That section 18 stand part of the Bill."

I do not see where it is stated in the section that the society will enforce the regulations but I take the Minister's word in that regard. I find it peculiar that a body would be required to enforce regulations which it did not draft.

The Minister informed us that half the people on blood pressure tablets should not be taking them and that half the people who were not on them, should be. She has spoken at length about the overuse of antibiotics, particularly at a time when she is in trouble over MRSA.

I would have liked to have brought Senator Browne to Scandinavia last week. If I had thought of it, I would have.

He would have been a lovely companion.

It would have been money well spent by the Government.

The Minister told me she would bring me to the Progressive Democrats party conference in Wexford too but she did not. I have received all these invitations after the event.

The Minister has talked a lot about the overuse of antibiotics, rightly so. I agree with her on the rise in the incidence of MRSA. However, I do not see any action being taken by her to combat it.

Acting Chairman

Is this relevant to section 18?

It is because the section refers to the disposal of medicinal products and the manner in which such products must be sold or supplied. Is there scope in the section to include guidelines on the appropriate use of antibiotics which the Minister has said on numerous occasions are overprescribed and overused and a factor in the rise in the incidence of MRSA?

I raised this issue on Second Stage. I refer to subsection (1)(k) on physical characteristics. A pharmacist must make arrangements in order that he or she can talk to patients in private, if necessary. This could be very onerous on those who run small pharmacies. I hope there will not be retrospective retribution against those who do not have a special section in which to people in private. In general, pharmacists do the very best they can to talk to people in private. I would not like to see those who run small shops and perhaps have inadequate facilities getting into trouble under this subsection.

I spoke about this matter on Second Stage. I had hoped those with pharmacies would not be penalised, unless they undertook refurbishment works or created space. Many family pharmacists work from small premises and give advice in private in a corner. I would be reassured if the Minister said they would not be compelled to implement the provisions of this subsection if they did not have the required space.

Senator Browne raised the issue of MRSA but we are not including provisions in that regard. As he knows, this is about empowering a regulatory body to regulate a profession.

In response to Senator Ryan, in section 19——

Senator Henry has pointed this out to me. I apologise.

The regulations made by the Minister will be enforced by the society under section 19. Clearly, it is not the intention to close down anyone's business. I am the last person who would wish to so do as I am a strong believer in supporting those who take risks and open businesses. There will be transitional arrangements and there will be widespread consultations before regulations are made regarding private space. I believe that during the Second Stage debate, I mentioned the pharmacy my parents used while I was growing up. It was a very small establishment in which one handed in one's prescription, did one's shopping and returned to collect the medicine because the pharmacy could not accommodate more than three or four patients at any one time. The man in question provided a great service. I believe I noted that his County Galway roots were the main reason my parents went to him. It is as good a reason as any other, as he was qualified and so on.

Many excellent pharmacists practice in relatively small premises and one must be pragmatic and sensible. Consequently there will be widespread consultation and no one will be closed down. A distinction must be made between what exists at present and what will be required in future. The phrase, "grandfathering", is often used in legislation. While I am unsure exactly how this will pan out, there will be much consultation and, hopefully, agreement in respect of this matter.

Will this measure be phased in?

Yes. There will be one set of circumstances for new pharmacists and presumably there will be time for others to meet the requirements. It may be that in some locations this will be extremely difficult. One must be pragmatic and sensible in the manner in which one seeks to apply this provision.

I did not receive a proper reply to my question. In the case of a pharmacy being aware of a doctor's over-prescription of antibiotics, is the onus on the pharmacists to inform on the doctor? Am I correct to assume there is no link between pharmacists and the Medical Council, which regulates doctors? Whenever the issue of MRSA is raised in this House, the abuse of antibiotics is discussed. However, I do not discern any joined-up thinking in this regard. It is more than likely that a pharmacist would spot over-prescription of antibiotics sooner than anyone else by virtue of observing the number of patients coming from a particular doctor. What should a pharmacist do in such a scenario? Should a report be made to the Pharmaceutical Society of Ireland or is a mechanism in place to make a direct report to the Medical Council, which governs the general practitioners concerned?

The Senator's point is interesting. The Pharmaceutical Society of Ireland will regulate pharmacists rather than doctors. Consequently, there would be no point in reporting the activities of a doctor to the society. It would be an appropriate matter for the Medical Council and any citizen, pharmacists included, is free to make a complaint. There will be stronger powers in this regard under the new legislation.

I refer to the question of conflicts of interest that I dealt with earlier. I forgot to make the point that the legislation will require anyone who is aware of economic or financial arrangements that are not in line with market trends to report it.

To whom?

It should be reported to the society in the case of a pharmacist. The requirement under the law as amended will be that those who are aware of such financial arrangements will have a duty to report them. It is important that this will not be simply voluntary; one will have a duty to do so in order that it can be investigated.

Doctors and pharmacists must work more closely together and the issue of MRSA and over-prescription is simply one such area. It will take considerable time to change the culture, habit and practice of patients in the first instance, as well as doctors and others. The public awareness campaign that began recently will include training, seminars and information for general practitioners and patients. It will take some time for it to sink in that looking for antibiotics for virtually all ailments is not a good thing. In fact it is both a bad and dangerous practice.

I held discussions last week in Scandinavia and it has never been the experience there that people sought antibiotics in the manner in which people in Ireland do. This is the main reason they have such a terrific record and they do not understand how Ireland has arrived at the point it has reached. Some people to whom I spoke suggested that it will probably take a long time to change practices in Ireland. This issue pertains to education and awareness. While calling it a module might sound over-prescriptive, this issue should be included in the training and education of doctors, particularly those who will work in general practice. Doctors have a major role in helping to inform patients, as do pharmacists.

Acting Chairman

I call Senator Browne. Members have almost exhausted this issue.

This is a significant point. Patients find it quite intimidating to query a decision by a doctor. In general they are glad to receive advice from doctors and tend to assume that the latter are acting in their best interests. I refer to patients with the courage to question such matters and bring them to the attention of a pharmacist who then brings them to the attention of the Pharmaceutical Society of Ireland. It appears that such an action will come to a complete dead end and no joined-up thinking is discernible. What should the society do in such a case? It has no jurisdiction over GPs but a complaint has been received regarding the misuse of drugs. There should be some mechanism in place whereby the Pharmaceutical Society of Ireland can pass on such concerns to the Medical Council. This issue must be raised.

The Minister's suggestions regarding education of the medical profession, patients and pharmacists must be followed in this instance. There is no standard dictating that one definitely prescribes penicillin in one instance and a different antibiotic in another. Pharmacists cannot state that a medical practitioner is doing something appalling by taking a particular course of action, or something good by taking another. It would take gross abuse of the use of antibiotics before any pharmacist would consider making a report. The route suggested by the Minister is the only one to take. There must be education for the profession and the public and we will continue from there. I agree with the Minister that this will take ages.

Question put and agreed to.
Section 19 agreed to.
SECTION 20.
Question proposed: "That section 20 stand part of the Bill."

As is traditional, I wish to record my dislike of the phrase, "as soon as is practicable". I do not simply refer to this example, as this issue arises continually. Members should have reached the point whereby they can specify what constitutes a reasonable timeframe in which such matters should happen. While I hope it will not be an issue in this instance, I am not keen on this let-out phrase.

Question put and agreed to.
Sections 21 to 23, inclusive, agreed to.
Amendment No. 26 not moved.
Section 24 agreed to.
Amendment No. 27 not moved.
NEW SECTIONS.

Acting Chairman

Amendments Nos. 28 and 37 are related and both may be discussed together by agreement.

I move amendment No. 28:

In page 23, before section 25, but in Part 5, to insert the following new section:

25.—It shall be an offence for any person knowingly or recklessly to make any declaration or disclosure to the Society which is false, misleading or incomplete.".

This amendment is an attempt by the Labour Party to make it an offence for anyone who knowingly or recklessly makes any declaration or disclosure to the society that is false, misleading or incomplete. This is to deter malicious complaints. It ought to be clear that someone who knowingly makes a false declaration is committing an offence.

I will take advice on this amendment. I have made provision that the preliminary disciplinary proceedings committee can require a complainant to supply information by way of an affidavit. This is a good idea, if it believes it to be necessary rather than spending a lot of time on an issue that may not stand up or may be vexatious. Consequently, giving the committee the power to do this is appropriate. Somebody could genuine believe he or she has cause for complaint. I would like to take advice on the particular word used in the amendment. The same applies to medical practitioners and any professional body. Every profession takes complaints seriously. While we want people to complain when there is cause for complaint and to properly investigate those complaints we do not want people trying to destroy somebody's reputation, profession and livelihood by making vexatious or unwarranted complaints. It is a difficult issue.

If one wants to have an open and transparent mechanism by which complaints made are properly investigated by the regulatory body one cannot be too restrictive. Through preliminary proceedings, the health committee and mediation we have provided a range of mechanisms other than a full fitness to practice investigation which will deal with more serious issues.

When the Medical Practitioners Bill was discussed yesterday, the question was asked whether one could make a complaint if one did not like the doctor next door or had a problem with his or her planning permission or house. Those complaints cannot be dealt with by a regulatory body which will only deal with professional conduct.

Amendment, by leave, withdrawn.
Progress reported; Committee to sit again.
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