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Dáil Éireann debate -
Wednesday, 15 Feb 2006

Vol. 614 No. 5

Irish Medicines Board (Miscellaneous Provisions) Bill 2005 [Seanad]: Report and Final Stages.

Amendment No. 2 is an alternative to amendment No. 1. It is proposed, therefore, to discuss amendments Nos. 1 and 2 together by agreement.

I move amendment No. 1:

In page 5, to delete lines 31 to 33 and substitute the following:

"(5) The Health Acts 1947 to 2005 and Part 5 may be cited together as the Health Acts 1947 to 2006 and shall be construed together as one.”.

I thank the Labour Party for its amendment. I appreciate the intention of the amendment. However, I am advised by the Office of the Parliamentary Counsel that it is not necessary to include a reference to the Health (Amendment) Act 2004, the Health Act 2004 and the Health (Amendment) Act 2005 in the citation. The Health (Amendment) Act 2004 was repealed in its entirety by the Health (Amendment) Act 2005. Therefore, I cannot accept the Labour Party amendment. A technical amendment is being proposed in regard to section 1(5) in respect of the citation of the health Acts. It was originally envisaged that this Bill would be enacted in 2005. The citation in regard to the health Acts was worded in such a way as to take account of the fact that the Health (Amendment) Act was also enacted in 2005. Because the Bill will be enacted in 2006 I am advised by the Office of the Parliamentary Counsel that the wording as it stands needs to be amended to take account of this. In addition the revised wording would ensure the citation is consistent with the other citations in the Bill.

Amendment agreed to.
Amendment No. 2 not moved.

I move amendment No. 3:

In page 6, between lines 10 and 11, to insert the following:

3.—The Minister may, upon the coming into effect of this section, having regard to -

(a) changes in the value of money generally in the State since the passing of this Act or the last previous exercise of the power under this section, and

(b) the need to ensure the continued effectiveness of the fines under this Act with respect to the enforcement of the provisions of this Act,

by order amend any section by substituting for the amount standing specified for a fine in those provisions for the time being, an amount that is greater than that amount.

I do not have the list of amendments but I presume the amendment deals with fines. There was much comment on this issue during Committee Stage debate. What we are talking about is indexing the fines. At the time the Minister stated a new Bill would be introduced, and it is with the Attorney General, on the issue of indexing fines. Has the Minister of State any further comment to make? I was hoping that the heads of the Bill would be ready.

On enforcement and breaking the law in regard to people's health, we have seen more than enough of that in recent years where because fines are not in keeping with the crimes committed people ignore the law. Enforcement is more effective if fines are kept up to date. Has the Minister of State anything more to say on that issue? When the matter was pushed on Committee Stage he said it was being discussed with the Attorney General.

I am supportive of the principle that fines should be kept up to date. However, this is a complex legal area and we do not wish to amend legislation in a piecemeal way. A fines Bill is being drafted in the Office of the Parliamentary Counsel. I am advised it is due for publication before the end of this session. I am further advised that the Bill provides for a system of updating the value of all existing fines which can be imposed in the District Court and maintaining the value of those fines in the future. Bearing this in mind it would not be in order to put an indexation provision in this Bill.

Will the Minister give the House an indication on the progress of the Bill? Are the heads of the Bill prepared? Is it still with the Attorney General? What is the present position with regard to the indexing of fines Bill?

The draft heads of the Bill are being prepared. I do not know the exact position but I will ascertain that information and get back to the Deputy.

Amendment, by leave, withdrawn.

I move amendment No. 4:

In page 6, line 34, after "section," to insert the following:

"and subject to such requirements as may be prescribed by the Minister making consequential provision for any one or more of the following:

(I) the certification or licensing of premises on which services are provided by a person referred to in subparagraphs (i) or (ii);

(II) inspection, quality assurance and enforcement issues in respect of such persons;

(III) co-operation between statutory bodies having functions in respect of such persons;

(IV) regulation of professional training and development of such persons;

(V) development of effective medicines management;

(VI) any other matter that appears to the Minister to be incidental or conducive to the proper functioning of the prescribing régime;".

I reintroduce this amendment on Report Stage arising out of my great concern about the lack of regulation of the pharmacy sector. It is an issue that has been raised by pharmacists and, in particular, by the society that has the duty to regulate, as far as it can, despite the total absence of proper statutory controls in terms of fitness to operate and fitness to practice. The Minister of State would have specialist knowledge in this area but it is extraordinary that animals are better protected under veterinary law against pharmacy malpractice than are humans. It seems negligent if the Minister of State does not accept this amendment which he refused to accept on Committee Stage but which I reintroduced to offer him the opportunity to deal with this issue. There have been long delays in regard to legislation that has been promised. The medical practitioners Bill has been promised for 13 years. We may have to wait as long for a pharmacy Bill, as two pharmacy Bills have been promised. There is a logjam when it comes to the production of legislation.

Meanwhile there is a real concern and risk that a scandal will hit the headlines because of rogue pharmacists. Pharmacists are no different from anybody else. There are good and bad pharmacists. To protect the public good there must be a proper regulatory framework. When we were petitioned, as Members of this House, by pharmacists who are extremely concerned about the current position we were told that two or three pharmacists per year should be struck off and that there may be up to 30 pharmacists who should not be practising. A pharmacy owner has been brought to court because he has been operating a pharmacy for three weeks without a pharmacist and medications were given out.

An interesting court case is proceeding in regard to a journalist who went out to see exactly how thorough are standards when it comes to giving out medication. This is a matter that cannot be put on the long finger. We have enough scandals in the health service without permitting further delay, which will lead to issues of pharmacy malpractice. Everybody who knows anything about this area agrees there is a real risk that needs immediate attention.

The chief pharmacist position in the Department is vacant. When I raised this matter on Committee Stage it took a long time for the Minister of State to tell me who is filling that post on a temporary basis. Certainly much greater attention should be given to the pharmacy area. There is no doubt that the pharmacist is a key player, particularly in primary care, in the delivery of health services at local and community level, quite apart from the role the pharmacist plays at hospital level or even in our prisons. It is unconscionable to continue with a situation where there are no protections and safeguards that people require and expect because we have a Government that is incapable of producing legislation.

We are still waiting for legislation on nursing home repayments. How many people will have died before that money is provided? In the meantime I suggest to the Minister of State that he accepts this amendment. I have no doubt he will have all sorts of cogent reasons that we should wait for the pharmacy Bill to be published, but frankly that is not good enough. I suggest to the Minister of State, who has specialist knowledge and has concerns in this area, that he has an opportunity to provide some safeguards, even by way of regulations under this Bill, by accepting the amendment.

If the Minister of State answers in the negative he needs to explain to the public how he can sustain the idea that we persist with the absence of a proper regulatory framework where people can and should be struck off as registered pharmacists. The authority that registers pharmacists does not have that power. One cannot be struck off the register. Do we simply wait for matters to become so acute that a criminal law must apply or do we ensure there are professional standards? This is no disrespect to the pharmacy profession generally, which is of the highest standard in the main. When one looks at the Shipman case in Britain where a pharmacist was examined and found wanting in terms of practice, one should learn from the experience, not just here but abroad. We are dealing with people's health and people's lives, and there is this extraordinary unacceptable anomaly where animals are protected and humans are not.

Deputy McManus made several comments on aspects of the practice of pharmacy in Ireland. The practice of pharmacy is governed by legislation dating from 1875 to 1962. The Minister for Health and Children is well aware that the current fitness to practice provisions in these Acts are inadequate to the modern practice of pharmacy. On foot of the recommendations of the pharmacy review group, Government approval was obtained in June 2005 to commence the process of drafting, as a priority, new pharmacy legislation to allow, among other things, the making of fitness to practice regulations for pharmacists. The purpose of these new provisions is to ensure the highest standards from pharmacists and to safeguard the safe and effective delivery of pharmaceutical services.

My Department is at an advanced stage in drawing up the heads and general scheme of the pharmacy No. 1 Bill. It is intended to take a memorandum to Government in the very near future seeking approval for the draft heads and general scheme and requesting that the legislation be referred to the Office of the Chief Parliamentary Counsel for formal drafting. It is expected that the Medical Practitioners Bill will be published later this year. I appreciate the points made by Deputy McManus but due process must be adhered to in striking off anyone, be he a pharmacist, doctor, veterinary surgeon or dental surgeon. There is need for this legislation. Both the Minister for Health and Children and I have said this in the Dáil and it will be achieved very quickly.

On the issue of the chief pharmacist, to which the Deputy alluded, the Department of Health and Children is being restructured arising from the implementation of the health reforms. The restructured Department will have provision for a chief pharmacist post. The precise duties and responsibilities of the post are under review vis-à-vis the role of the HSE in the delivery of health services. Ideally, this should be finalised before the job description is drawn up. In the meantime, the services of the former chief pharmacist, who retired in April 2005, continue to be available on a consultancy basis regarding particular issues. We are very lucky to have a former chief pharmacist with many years of expertise who is still providing that expertise to the Department. Another pharmacist employed by the Department is acting in the role of chief pharmacist at present. Therefore, the required specialist advice is available all the time to the officials and Ministers in the Department.

I fully agree with Deputy McManus on her point about the training of pharmacists and ensuring quality and continual professional education for all medical personnel. I thank her for her thinking on these matters. These matters, which are essential to the professionals concerned, could be considered more appropriately in the context of legislation relevant to the professions in question, such as pharmacy legislation, the Medical Practitioners Act and the Nurses Act. This Bill, which amends the Misuse of Drugs Act, is not the appropriate legislation for making such changes. I therefore cannot accept the Deputy's amendment, which I know is offered in good faith. As I stated, the Minister for Health and Children made a commitment to introduce legislation regarding fitness to practice.

That is absolutely disgraceful although the Minister of State is probably not the person responsible for making the decision. I recall that, on Committee Stage, we were told the job of chief pharmacist was being advertised. We are now being told the position is being reviewed and that there will be new terms of reference. The affair has gone into some kind of Neverland, which is an all-too-common feature of the arrangements between the HSE and the Department.

There are no safeguards in place at present. This Bill deals with the misuse of medicines and is called the Irish Medicines Board (Miscellaneous Provisions) Bill 2005. It is perfectly in order to include the provisions I advocate in this Bill. One can certainly deal with other issues relevant to the pharmacy No. 1 Bill, the Medical Practitioners Bill or any other legislation in the pipeline, but one should remember that the pipeline has a very narrow gauge and there is an awful lot of stuff choking up the flow.

We are waiting for a lot of legislation and the weasel words referring to "the near future" and "the short term" are meaningless. Before the aforementioned legislation is introduced, the Minister is responsible to protect patients from malpractice. We have seen the lack of protection that obtained in the medical profession. Horrific practices were carried out because there were improper oversight and protections. We know what needs to be done in this regard and we can do it now — it is a matter of choice.

I hope the decision that has been taken does not come back to haunt the Minister of State, but I fear it might. It is a disgrace that an amendment such as mine, which could be accepted, is not being accepted and that the Minister of State is choosing an option that may be as long as a piece of string — we just do not know because no commitment from the Minister, Deputy Harney, on legislation has been met except the one that the HSE would be delivered on 1 January 2005. That, in itself, involved the wrong decision. It was made too quickly and now we see matters of life and death being addressed too slowly.

I do not accept the amendment.

Amendment, by leave, withdrawn.

Amendments Nos. 5, 6 and 7 are related and may be taken together.

I find it difficult to understand why they are to be taken together because they more or less cover different issues. One concerns pharmacists, another paramedical staff and another the role of the chief executive officer.

Does the Deputy want to take them separately?

It would be easier if we took them separately. We would probably deal with them faster.

I move amendment No. 5:

In page 6, after line 40, to insert the following:

"(iii) registered pharmacists, who are members of the Pharmaceutical Society of Ireland,".

When did the Minster say the chief pharmacist retired from the Department of Health and Children?

He retired in April 2005.

He has been acting in a consultancy capacity since then.

Am I incorrect in believing there was a recent announcement by the Department that a new chief pharmacist was employed? Has another pharmacist been taken on or has he or she been employed specifically as chief pharmacist?

There may have been a recent announcement but I do not know from where it emanated. There has not been a recent announcement by the Department of Health and Children.

There is still no chief pharmacist.

That is correct.

Amendment No. 5 seeks that registered pharmacists be members of the Pharmaceutical Society of Ireland and that that body should adopt a role akin to that of the Medical Council to ensure there are standards. This leads very much to what Deputy McManus was talking about. We are not comfortable with the legislation pertaining to the health services.

It is funny that when the Minister of State referred to the fines Bill, he stated he did not want to introduce piecemeal legislation in regard to fines. We are only on amendment No. 5 but we are already being told a new pharmacy Bill and fines Bill are needed to address the issues raised. This is the ultimate in piecemeal legislation because we are told that many of the concerns we raise require new legislation and that we must wait for it to be enacted before the arrangement is 100% kosher and before we can all sleep comfortably in our beds at night. This is a strange way to do business. Does the Minister of State not agree that the pharmacy No. 1 Bill should be taken in tandem with the Bill before the House? It appears we are giving a considerable degree power to the profession and that perhaps we should strengthen the legislative role to protect patients. Protecting the public is what we are about. I have more to say on the matter. I will not press amendment No. 5, but I would like the Minister of State to take my argument on board in the context of this vital legislation.

I will take what the Deputy has said on board.

Amendment, by leave, withdrawn.

I move amendment No. 6:

In page 6, after line 40, to insert the following:

"(iii) paramedical staff—

(I) who are in the employ of the State, either directly or indirectly through the Health Services Executive or a Local Authority, and

(II) whose position could be described as one that would require the ability to prescribe medicinal products from time to time, and

(III) who have undergone such training as may be deemed necessary by the Minister from time to time,".

Amendment No. 6 relates to paramedical staff. Does the legislation relate to the paramedical staff being trained in this country at present?

I wish to respond to the issues raised by Deputy Twomey about the practice of pharmacy. The Department of Health and Children has examined carefully the issue of prescribing. I assume he is referring to other professions, such as nursing. It is considered that apart from in the cases of nurses and existing prescribers, the necessary regulatory regime, with adequate fitness to practice provisions, is not in place at present to permit the extension of prescribing to registered pharmacists for controlled drugs or other drugs and medicines. The Department is drafting legislation to provide for updated fitness to practice provisions in this area. Given the importance of pharmacists in the protection of public health, any developments in this area need to be considered carefully. The Government has accepted the pharmacy review group's recommendation that no beneficial ownership or business interest of any kind should be shared by those dispensing and prescribing. The proposed amendment would contradict this.

I do not recall whether Deputy Twomey spoke on Committee Stage about the ownership of pharmacies, which is an issue of major concern to doctors and pharmacists. Many people are unhappy about some unfortunate things which are taking place in the marketplace. I am aware that the Department is considering this ethical issue. The ownership of pharmacies was not a matter of such concern in the past when there was a clear demarcation between the medical and pharmaceutical professions. That demarcation now appears to be blurred in some instances. This entire area needs to be examined carefully. The new Bill is necessary for that reason. The Department needs to consider this matter closely.

Regulations which were introduced last year under the Irish Medicines Board Act 1995 have provided the necessary authority for the various grades of paramedics to obtain and administer the various categories of medicinal products in accordance with clinical practice guidelines or on the instructions of a registered medical practitioner. If such personnel are to be in a position to administer any controlled drug, they need to have appropriate authority under the Misuse of Drugs Acts to possess such drugs lawfully. It is intended to grant group authority to such personnel under section 14 of the Misuse of Drugs Act 1977 to allow for this. Therefore, the amendment proposed by Deputy Twomey in respect of such drugs is unnecessary.

It is considered too early to introduce such authority in the case of medical personnel other than emergency medical technicians. It is important that appropriate structures and controls are put in place for each of the relevant health or social care professions before authority can be given in respect of the issue of prescriptions, especially where controlled drugs are concerned. I am aware that the President recently signed into law the Health and Social Care Professionals Act 2005 which provides for the registration of fitness to practice structures for certain health and social care professionals. As such structures are not yet in place, however, it would be premature to consider giving prescribing authority to those health care professions at this stage.

Can the Minister of State explain further the issue of group authority? Will group authority be vested in the Health Service Executive or in the local hospital in which paramedical staff are employed? Who will have the group authority that will allow paramedical staff to prescribe and dispense medication?

I understand it will be vested in the employer, which will normally be the HSE.

It will not be vested in the individual hospitals.

I would like the Minister of State to clear up another matter. He said that the Government has accepted the pharmacy review group's recommendation about the beneficial interests of those dispensing and prescribing. Does the Minister of State not find it strange that the Government has missed the boat in this regard?

Last year, the Tánaiste opened a clinic in which there is an obvious combination of those dispensing and prescribing. The ownership of the building in question is vested in a single group. Groups of doctors, pharmacists or businessmen are planning to establish many more centres containing both pharmacies and general practitioners' clinics. Pharmacists are being invited to become involved in such clinics. I use the term "invited" in a loose sense because pharmacists are asked to pay €1.2 million for their invitations.

Does the Minister of State agree that the Government has missed the boat by accepting the pharmacy review group's recommendation? By the time the necessary legislation has been passed, it will be almost irrelevant and impossible to implement because the primary care scene will have changed dramatically in the manner I have outlined.

One can never pre-empt what may happen in the future. The Deputy has correctly stated that many changes, which would have been questioned by the relevant professions several years ago and might not have happened, are taking place at present. It is a grey area. Every Deputy is aware that this is a company law issue. This complex matter is being examined by the Department of Health and Children. I assure Deputy Twomey that the decisions being taken may have consequences for those involved in the developments to which he referred if wrongdoing can be proved.

One cannot say that the development of such facilities is wrong if the practices of pharmacy and medicine are kept separate. That is the approach that has always been taken. One would have to prove that the doctors or pharmacists in question have a financial interest in the prescribing of medicines for financial gain. Like most people involved in the medical profession, I have strong views on the ethics of this issue. The views of Deputy Twomey and I might not be shared by all of this country's doctors and pharmacists, unfortunately.

I remind the Minister of State that money talks in matters of this nature. The centre opened by the Tánaiste last year is owned by a single company. It has a commercial interest in the pharmacy downstairs and it is leasing the rooms upstairs to general practitioners for low rents. I accept that the company does not instruct the doctors to churn out a certain number of prescriptions every day.

The Minister of State referred to company law and the need to bear legal issues in mind, but we should also consider the principle of allowing this combination of professionals to work so closely together, which is something that is taking place as we speak. The business in question, which does not relate to the primary care strategy, is organised on a purely commercial basis between dispensers and prescribers.

The entire scene is changing as we speak and will have altered significantly within five years. Groups are coming together every day to develop such clinics as I have mentioned. It will be too late to do anything about it in two years' time. The Minister of State has said that the Department of Health and Children is reviewing this matter, but that is even worse because people investing huge sums of money are not unsure how their commercial arrangements will be affected by what the Department will come up with in 12 months' or two years' time. This matter needs to be cleared up quickly. We cannot afford to wait for further legislation. The Government needs to issue a clear direction in this regard.

In response to the Deputy's question——

Perhaps we should conclude our consideration of this amendment.

Amendment, by leave, withdrawn.

I move amendment No. 7:

In page 7, between lines 2 and 3, to insert the following:

"(b) in subsection (1), by inserting the following new paragraph (g):

"(g) to make it the responsibility of the Chief Executive Officer of the hospital to which a staff member referred to in paragraph (f) is attached, to ensure that that staff member has received the requisite training and education to allow him or her to fulfil his or her duties in accordance with the terms of this Act,”,”.

I have proposed this amendment in the interests of accountability. Are the HSE or the hospitals accountable for paramedics? One of the biggest problems with accountability in the health services is that there are no clear lines of demarcation. The responsibility is all very nebulous. If one has the persistence to keep asking who is responsible in a hospital and to keep following the links in the chain, one might still never find out who is responsible for issues. There must be clear lines of accountability.

The HSA has queried whether practices in our accident and emergency departments in our hospitals could contribute to patient illnesses and whether the HSE could be exposed to significant litigation. The report of the Neary inquiry will be published soon and it will show terrible practices in our hospitals which have affected patient care. We had a Private Members' debate here led by Fine Gael two weeks ago on the social services inspectorate. The whole basis of that is to protect patients. The audit of our hospitals shows that our hospitals are unhygienic and are not safe places for patients in too many cases. All of this comes down to who is responsible. If legislation is to be put through the House, we should put responsibility on people throughout the health service.

The Deputy is referring to standards of practice in all of the professions involved in the medical area and I agree with him. Responsibility for best practice lies with the various professions. With regard to the Neary case in Drogheda, one could query that many things happened, but I do not want to talk about any case in particular. Where bad practice evolved, be it in medicine or pharmacy, one could say that it was the professionals themselves who were involved. It could also be construed that other professionals knew what was going on, but did not come forward and inform those in charge. There is a responsibility on all professional bodies to ensure best practice. That is why, in bringing forward two pharmacy Bills, we want to get things right. Finding where the responsibility lies is a very complex area.

This is an important point. We talk about giving nurses additional permission to prescribe. Doctors already have this, but many consultants in our hospitals work almost as independent contractors. There is an unmerciful amount of freedom. At question time in this House before Christmas, the Tánaiste stated quite categorically that she was completely against whistleblower's legislation. What led to the Neary inquiry was the failure to communicate what was happening because people were afraid of what might happen to them. There must be a carrot and stick approach to this and that is why we support whistleblower's legislation in the first place. This is the stick approach which makes people responsible. There were doctors, nurses, midwives and administrative staff working in this hospital. The Minister of State has just said that if they know something, they should do something about it. They are not protected if they do something about it because we have no whistleblower's legislation. We must make people responsible. If an inordinate number of elderly patients, for instance, die on a ward where certain staff members are on duty, sometimes there is a tendency not to comment on it.

The Neary case is not the first and will not be the last disaster in our health services, but unless we have some mechanism to make people responsible, or at least give them the protection of whisteblower's legislation, we will have this sort of thing. There is no protection for the patient unless we do something like this. I would just like to know why the Minister of State cannot do it.

The Tánaiste has given a commitment to the House that the pharmacy legislation will be brought before the House. With regard to new prescribing procedures for nurses, a consultation process is in place at the moment and the educational requirements for nurses and midwives will be raised for discussion. It is anticipated that An Bord Altranais will create the structures needed to initiate effectively and examine the outcomes of a competency framework for prescribers under the new legislation allowing nurses to prescribe. Prescriptive authority for nurses and midwives will not be operative until regulations are made by the Minister. It is intended to do this following a consultation process.

The specific educational requirements to permit nurses to prescribe within their scope of practice will be drawn up by An Bord Altranais and incorporated in revised rules, which will also require the approval of the Minister. The intention to introduce an enabling provision for nurses to prescribe is to improve services to patients. These changes are all about providing safe and convenient access to medication by patients in both acute and community settings. That practice is already happening in other jurisdictions and I see no reason for it not to happen satisfactorily here.

I am particularly concerned about the wording in some sections of the legislation on the intent regarding midwives. The Minister of State referred to nurses and midwives prescribing, yet section 26 and other sections do not refer to midwives and refer only to nurses. We need absolute clarity that we are legally providing for nurses and midwives prescribing.

The Minister of State has already spoken twice. It would be helpful if all Members obeyed the Standing Order on Report Stage, otherwise we are effectively on Committee Stage of this Bill. It is listed as being on Report Stage. If the Minister of State wants to make a brief comment, I will allow him this time.

All midwives are nurses anyway. They are, therefore, automatically qualified under the word "nurse".

Therefore, where it does not appear, we must assume that it is there.

Is there a difficulty with making the CEO of a hospital accountable for the actions of the staff? Is there a difficulty with accepting my amendment or is it just that the Minister of State does not want to accept it?

I have no difficulty with it, but at the moment, all the hospital consultants are independent contractors to the HSE.

Amendment put.
The Dáil divided: Tá, 60; Níl, 63.

  • Allen, Bernard.
  • Boyle, Dan.
  • Breen, Pat.
  • Broughan, Thomas P.
  • Bruton, Richard.
  • Burton, Joan.
  • Connaughton, Paul.
  • Connolly, Paudge.
  • Costello, Joe.
  • Cowley, Jerry.
  • Crowe, Seán.
  • Cuffe, Ciarán.
  • Deasy, John.
  • Durkan, Bernard J.
  • English, Damien.
  • Enright, Olwyn.
  • Ferris, Martin.
  • Gilmore, Eamon.
  • Gormley, John.
  • Gregory, Tony.
  • Hayes, Tom.
  • Healy, Seamus.
  • Higgins, Joe.
  • Higgins, Michael D.
  • Hogan, Phil.
  • Howlin, Brendan.
  • Kenny, Enda.
  • Lynch, Kathleen.
  • McCormack, Padraic.
  • McEntee, Shane.
  • McGinley, Dinny.
  • McGrath, Paul.
  • McHugh, Paddy.
  • McManus, Liz.
  • Morgan, Arthur.
  • Moynihan-Cronin, Breeda.
  • Murphy, Catherine.
  • Murphy, Gerard.
  • Naughten, Denis.
  • Neville, Dan.
  • Ó Caoláin, Caoimhghín.
  • Ó Snodaigh, Aengus.
  • O’Dowd, Fergus.
  • O’Keeffe, Jim.
  • O’Sullivan, Jan.
  • Pattison, Seamus.
  • Penrose, Willie.
  • Perry, John.
  • Rabbitte, Pat.
  • Ring, Michael.
  • Ryan, Eamon.
  • Ryan, Seán.
  • Sargent, Trevor.
  • Sherlock, Joe.
  • Shortall, Róisín.
  • Stagg, Emmet.
  • Stanton, David.
  • Twomey, Liam.
  • Upton, Mary.
  • Wall, Jack.


  • Ahern, Noel.
  • Andrews, Barry.
  • Ardagh, Seán.
  • Brady, Johnny.
  • Brady, Martin.
  • Browne, John.
  • Callanan, Joe.
  • Callely, Ivor.
  • Carey, Pat.
  • Carty, John.
  • Cassidy, Donie.
  • Coughlan, Mary.
  • Cowen, Brian.
  • Cregan, John.
  • Cullen, Martin.
  • Curran, John.
  • de Valera, Síle.
  • Dempsey, Noel.
  • Dempsey, Tony.
  • Dennehy, John.
  • Devins, Jimmy.
  • Fahey, Frank.
  • Finneran, Michael.
  • Fitzpatrick, Dermot.
  • Grealish, Noel.
  • Hanafin, Mary.
  • Haughey, Seán.
  • Hoctor, Máire.
  • Jacob, Joe.
  • Kelleher, Billy.
  • Kelly, Peter.
  • Kirk, Seamus.
  • Kitt, Tom.
  • Lenihan, Brian.
  • Lenihan, Conor.
  • McEllistrim, Thomas.
  • Martin, Micheál.
  • Moloney, John.
  • Moynihan, Donal.
  • Moynihan, Michael.
  • Mulcahy, Michael.
  • Nolan, M.J.
  • Ó Cuív, Éamon.
  • Ó Fearghaíl, Seán.
  • O’Connor, Charlie.
  • O’Donnell, Liz.
  • O’Donovan, Denis.
  • O’Flynn, Noel.
  • O’Keeffe, Batt.
  • O’Malley, Fiona.
  • O’Malley, Tim.
  • Parlon, Tom.
  • Power, Peter.
  • Power, Seán.
  • Sexton, Mae.
  • Smith, Brendan.
  • Smith, Michael.
  • Treacy, Noel.
  • Wallace, Mary.
  • Walsh, Joe.
  • Wilkinson, Ollie.
  • Woods, Michael.
  • Wright, G.V.
Tellers: Tá, Deputies Neville and Stagg; Níl, Deputies Kitt and Kelleher.
Amendment declared lost.

I move amendment No. 8:

In page 8, to delete lines 6 to 8 and substitute the following:

"(b) in the case of a body corporate, the Chief Executive Officer of that body.”.”.

This amendment follows on from amendment No. 7 in the sense that it places responsibility back onto the chief executive of the body with regard to accountability. Since the Minister opposed the previous amendment, I assume he will do the same with this one.

The wording provided in the Bill is standard for dealing with offences related to body corporates. As it stands, the wording also covers the activities of a CEO. To limit responsibility to the CEO alone is considered too narrow an approach. For example, managers who may not be the CEO may be responsible for a pharmacy and therefore must also remain liable if convicted of an offence related to controlled drugs. For this reason I cannot accept this amendment.

Does the Health Act 2004 not provide some format whereby the chief executive can delegate responsibility to people under his management in either a hospital or the HSE?

A CEO delegates authority all the time in management, but when it comes to legislation and who is to take responsibility if something goes wrong, the legislation deems this should be the CEO. Somebody must accept the responsibility as it cannot be delegated down the line all the time.

Therefore, the CEO is responsible.

Amendment, by leave, withdrawn.

I move amendment No. 9:

In page 29, between lines 42 and 43, to insert the following:

"18.—(1) It shall be an offence—

(a) for any person or body corporate to send or cause to be sent by use of the ordinary postal service, any medicinal product, where the sale of such a medicinal product is concerned, or where there is financial reward for the person or body corporate so sending the medicinal product, or

(b) for any person to order or take delivery, within this jurisdiction, of a medicinal product referred to in this subsection.

(2) Where a person is guilty of an offence under subsection (1)(a), he shall be liable to a fine of up to €3,000, or up to twelve months in prison, or both.

(3) Where a person is guilty of an offence under subsection (1)(b), he shall be liable to a fine of up to €1,000, or up to three months in prison, or both.”

We discussed this amendment extensively on Committee Stage. It focuses on pharmaceutical products being sent in the post from other jurisdictions. This would take into account people buying drugs abroad or on the Internet. The Minister of State made a contribution at that time and he may have more to add.

Since Committee Stage there have been discussions between the Irish Patients Association and the Department on this issue. The matter is being discussed in the European Parliament and the World Health Organisation, WHO, and the talks are ongoing. Not alone is this a national problem, it is a large international problem. We are endeavouring to co-operate with all stakeholders and agencies involved internationally to get to grips with the matter. It is a problem which is causing trouble for vulnerable people.

Much is being done already in the area through the Irish Medicines Board, the Revenue Commissioners, Customs and Excise and An Post. It is an issue which involves criminals, terrorists and people involved for monetary purposes. The matter is of great concern to the Department of Health and Children and in similar departments throughout the world.

Amendment, by leave, withdrawn.

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

I move amendment No. 10:

In page 30, lines 7 and 8, to delete "ACTS 1995 AND 2006" and substitute the following:


Amendments Nos. 10 and 11 are technical amendments making it clear that the certificate issued under section 20 of the Bill is issued under the power of the Irish Medicines Board Act 1995 as amended by this Bill.

Amendment agreed to.

I move amendment No. 11:

In page 30, lines 12 and 13, to delete all words from and including "Irish” in line 12 down to and including “2006” in line 13 and substitute the following:

"Irish Medicines Board Act 1995 (as amended by section 17 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006)”.

Amendment agreed to.

I move amendment No. 12:

In page 36, line 10, after "examination" to insert ", including dental health examination,".

This is an issue we considered on Committee Stage with regard to examinations. I wished to include dental health examinations. Amendments Nos. 13 and 14 are related to this and they take into account dental service providers at primary and secondary level. The Minister of State had stated this would not happen and I tabled this amendment to see if there has been any development. Deputy Ó Caoláin may make a point regarding midwives. I will wait to hear what he says on the matter and I may add a point later.

The commentary I made earlier referred to section 26, and I do not know if I will be allowed address that. I am accepting the Minister of State's clarification.

I wish to address amendments Nos. 13 and 14 as well as amendment No. 12, although they are not grouped. We must recognise that these seek to expand the free examinations available to children. In that regard they are eminently sensible and welcome. I regard this as a very important issue. In this case, amendment No. 12 would bring in dental health examination. This must be seen within the area of health promotion and what preventative measures can be introduced to avoid difficulties presenting in years ahead. All this must be seen as an important and, sadly, long-neglected issue within the health services.

Both health promotion and primary care should be the foundation stones of our health services. All too often we look at the area of health in a myopic way, and what we are considering most of the time is ill health. To have a full and rounded appreciation of the focus of the Department of Health and Children, one must see the areas of health promotion and primary care as critical and as foundation stones. The proposition contained in amendment No. 12 and the subsequent proposals in amendments Nos. 13 and 14 are eminently sensible. I join Deputy Twomey in commending them to the Minister of State and I hope he will accede to all three.

Amendment No. 12 seeks that section 66(2) of the Health Act 1970 be amended to include the words "including dental health". Dental health is included within the context of the current legislation. Section 66 of the Health Act 1970 covers the making available without charge of a health examination and treatment service for pupils attending a national school. This is being amended within the Bill to cover all primary schools. The definition already includes dental health examinations.

Sections 27 and 29 amend the Health Act 1970 and the Health (Amendment) Act 1994 to provide for all primary schools or home taught children to be eligible for dental, ophthalmic and aural health examinations. Under the current legislation, these examinations are confined to children of five years old or younger or children who attend national primary schools. It does not include children attending private primary schools or being taught at home. This provision addresses this anomaly and it is estimated that it will extend eligibility to an additional 5,000 children in the six to 12 years old age bracket. Therefore I cannot accede to amendment No. 12.

I did not mean to contradict Deputy Ó Caoláin but when he mentioned an issue concerning midwives, I wished to add to it. Does the legislation cover midwives who work at home in the community and who are not connected with a hospital? These midwives would deal with antenatal care in the home.

On amendment No. 12, there is a serious problem with regard to dental examinations which the Minister of State has indicated may be covered under current legislation. Significant problems exist with regard to children's dental health being properly looked after, even in primary schools. Children are having teeth extracted because there are not enough dentists to provide care for fillings. Children who should be getting orthodontic and other remedial work done are having teeth extracted because there are not enough dentists in the system.

The idea behind this legislation including a dental health examination is to show that it is a priority for legislators, and we do not wish to see children having teeth extracted unless it is necessary. It is to show that we do not wish to see children go through unnecessary pain or that we are delaying an appropriate treatment for them. When caries are neglected in one tooth, they can affect a tooth nearby. A child could then lose more teeth because of a delay in treatment. That is the reason this amendment has been tabled. It should be made clear in the legislation that we are considering the issue progressively. Even though the Minister of State has indicated such care is included by definition, I wish to press the amendment.

I do not have much to add to what has already been said. The amendment would be superfluous.

Is the amendment being pressed?

I will withdraw this amendment as the next two are tied to it and I will press those.

The next two amendments will be out of order.

Amendment put and declared lost.

Amendments Nos. 13 and 14 are out of order.

Amendments Nos. 13 and 14 not moved.
Bill, as amended, received for final consideration.
Question proposed: "That the Bill do now pass."

I thank Deputies for their consideration of and input into this technical and complex Bill. It provides for important and urgent improvements in a number of areas. I sincerely thank all Deputies for their thoughtful contributions throughout the process, which has been an interesting and challenging one. The Bill succeeds in creating and consolidating a stronger structure in which the Irish Medicines Board can carry out its business in regard to medicinal products, medical devices and clinical trials and which in the future will include controlled drugs, cosmetic products, drug precursors and human tissues and cells. This Bill also supports the development of a more efficient, effective and patient-centred health service.

Question put and agreed to.

The Bill, which is considered by virtue of Article 20.2 of the Constitution as a Bill initiated in the Seanad, will now be sent to the Seanad.