Irish Medicines Board (Miscellaneous Provisions) Bill 2005 [Seanad]: Second Stage.

Minister of State at the Department of Health and Children (Mr. B. Lenihan)

I move: "That the Bill be now read a Second Time."

I am very pleased to introduce Second Stage of the Irish Medicines Board (Miscellaneous Provisions) Bill 2005. This Bill has already completed all Stages in the Seanad where a number of amendments to the Bill as initiated were accepted.

In general terms, the Bill allows for the transfer of certain functions regarding controlled drugs from my Department to the Irish Medicines Board and for the improved operation and enforcement activities of the Irish Medicines Board in respect of medicines and the control of clinical trials. It amends the Irish Medicines Board Act 1995 regarding medicinal products, cosmetic products, veterinary medicinal products, drug precursors and medical devices. It allows for the making of regulations for nurse prescribing and for information to be provided by the retail, restaurant and catering sectors on meat sold or served to consumers where this is not already a requirement. It enables officers of Customs and Excise to exercise surveillance of medicinal products at ports, airports and land frontiers. It clarifies the legal position on eligibility for dental, aural and ophthalmic services and extends eligibility for dental, aural and ophthalmic examinations to all children.

This Bill encompasses a number of different areas and many aspects of it are technical in nature. I will attempt to steer Deputies through its main provisions as clearly as I can. The Bill provides for the Irish Medicines Board to act as the licensing authority for controlled drugs under the Misuse of Drugs Acts. The designation of the Irish Medicines Board for this purpose is consistent with my Department's strategy whereby executive functions that are not directly related to the mission or objective of the Department should be devolved to an appropriate executive agency. This Bill formalises the arrangements that have been put in place whereby staff at the Irish Medicines Board carry out this work, and it amends the Irish Medicines Board Act to transfer legal competence to the board to carry out licensing and inspectorial functions under the Misuse of Drugs Acts.

The Bill also updates and consolidates the functions carried out by the Irish Medicines Board to conform to European Community legislation on medicinal products, veterinary medicinal products and medical devices. The authority to enforce legislation relating to medicinal products is set out in a number of different regulations. The introduction of new provisions under the Irish Medicines Board Act 1995 will ensure that the enforcement provisions for all of the regulations will be contained in a single Act.

On clinical trials, the Bill allows for appropriate provisions to be included in the Control of Clinical Trials Act 1987 to enable the requirements of the Act to be supervised and enforced.

Part 1 of the Bill deals with the preliminary matters, including the standard citation and construction sections. Part 2 amends the Misuse of Drugs Act 1977, Part 3 amends the Irish Medicines Board Act 1995, Part 4 amends the Control of Clinical Trials Act 1987, Part 5 amends the Health Acts 1947 to 2005, and Part 6 deals with consequential amendments to regulations made under section 32 of the Irish Medicines Board Act 1995 or referred to in section 34(4) of that Act.

On Part 2, section 3 defines certain expressions that are used in the Bill. Section 4 amends section 5 of the Misuse of Drugs Act and allows regulations to be made to permit registered nurses or classes of registered nurses to prescribe certain controlled drugs in specified circumstances. There are a number of amendments throughout the Bill which provide for an enabling provision for nurse prescribing and I will go into these in greater detail later.

Section 5 extends the powers available in the Misuse of Drugs Act to prohibit bodies corporate involved in the practice of community pharmacy and their officials from having controlled drugs following a conviction for an offence under the Misuse of Drugs Acts or the Customs Act. These powers are available in respect of practitioners and pharmacists convicted of such an offence.

A new section is being inserted to amend section 8(7) of the Misuse of Drugs Act 1977, as amended. Section 8 provides that the Minister may issue a special direction against a practitioner. This new section provides that where the Minister has issued a special direction against a nurse, he or she should send a copy of the report to An Bord Altranais. This is a consequential amendment to the enabling provision for nurse prescribing.

With regard to section 7, section 14 of the Misuse of Drugs Act 1977 allows the Minister to grant licences or issue permits or authorisations for any of the purposes of that Act, or to attach or vary conditions to such licences, permits or authorisations and to revoke any such licence, permit or authorisation. It provides for the making of regulations requiring the payment of prescribed fees in respect of the granting or issuing of such licences, permits or authorisations. Section 7 of the Bill amends section 14 to transfer these functions, which were previously carried out by my Department, to the IMB. This section also provides that licences, permits and authorisations issued prior to the commencement of this section continue to be valid when the amendments being made by this Bill come into effect.

Section 8 amends section 17 of the Misuse of Drugs Act to confine the prohibition in regard to poppies to the cultivation of poppies for the purpose of producing opium. It in effect tidies up a situation where technically the range of poppies covered by the current definition includes many poppies grown for decorative or ornamental purposes.

Section 9 amends section 24 of the Misuse of Drugs Act to enable the IMB to authorise officers to carry out inspections under the Act and allows the Pharmaceutical Society of Ireland to authorise officers to inspect pharmacy shops. The term "practitioner" is included in this section to ensure that registered practitioners — medical and dental — fall within the remit of this section so that records held by them with regard to their prescription, possession and use of controlled drugs can be subject to inspection should the need arise. Section 9 also provides that the appropriate warrants of authorisation are issued by the Minister, the IMB or the Pharmaceutical Society of Ireland to authorised persons carrying out inspections and that appropriate transitional arrangements for those persons with existing certificates of authorisation are in place.

Part 3 of the Bill contains all the amendments that are being made to the Irish Medicines Board Act 1995. Sections 10, 11 and 12 of the Bill update the functions carried out by the IMB to conform to European Community legislation in regard to medicinal products, veterinary medicinal products and medical devices. The principal functions of the IMB are being extended to include its designation as competent authority for the purposes of EU directives relating to medical devices, cosmetic products and precursor drugs and in respect of clinical trials for medicinal products for human use. The IMB is also being designated as the competent authority for EU Directive 2004/23/EC which sets standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells for human applications. The scope of the directive does not apply to blood and blood products, organs or in vitro research.

In addition, provision has been made within section 11 of the Bill for the IMB to issue various export certificates in respect of medicinal products, veterinary medicinal products, cosmetic products and medical devices as are required by manufacturers exporting such products to other countries. The IMB in discharging these functions is also required to have regard to the provisions of any national legislation that would be applicable to such products.

Section 13 provides that the chairperson of the advisory committee for medical devices be an ex officio member of the board of the IMB. There is a similar provision in the Irish Medicines Board Act for the chairpersons of the advisory committee on human medicines and the advisory committee on veterinary medicines. Section 14 expands section 9 of the Irish Medicines Board Act to ensure that no refusal of a licence, authorisation or certificate in respect of medicinal products, on the grounds of safety, quality or efficacy, may be made unless the appropriate advisory committee has been consulted. Section 15 amends section 13 of the Irish Medicines Board Act to make better and more appropriate provision for the IMB to charge fees in regard to its activities.

Section 16 amends section 32 of the Irish Medicines Board Act. It provides a clarification that sale and supply will not include administration and at the same time introduces a provision whereby regulations may be made to control administration if required. It provides for the specific control of prescription medicinal products and for non-prescription medicinal products in pharmacies and, in the case of some products, for their availability in non-pharmacy outlets. This section enables the making of regulations relating to medical devices and in respect of the implementation of EU directives relating to medicinal products, medical devices and cosmetic products. It takes account of the Supreme Court decision in the Vincent Browne v. Attorney General and others case where, in the context of the creation of indictable offences, the Supreme Court expressed a view about how we should implement EU legislation. The provisions in the Bill ensure that breaches of any regulations made to give effect to acts of the institutions of the European Community relating to medicinal products for human use, cosmetic products or medical devices may be prosecuted on indictment, where appropriate.

Section 16 provides an enabling provision for nurse prescribing, which was introduced on Committee Stage in the Seanad. It is an important amendment. The intention is to introduce prescriptive authority for nurses in circumstances where it is safe to do so, to give greater accessibility and convenience for patients and to help community services and acute services. The Department will conduct consultation with all stakeholders on the implementation of this provision before regulations are drawn up. This will assist us to ensure that the necessary safeguards and controls are put in place. An Bord Altranais will play an important role in setting the educational and clinical standards to be required of nurses who will be permitted to prescribe.

Section 17 inserts new sections, 32A to 32F, into the Irish Medicines Board Act to improve enforcement powers with regard to medicinal products, cosmetic products and medical devices. Section 32A defines the expressions used in the new sections. Section 32B provides for the appointment of authorised officers and sets out the various powers available to them for carrying out inspections in regard to the products and devices. These include additional powers to authorised officers to enable appropriate inspections to be carried out, including the effective supervision of the activities of those persons selling medicinal products by mail order, including the Internet. Section 32C provides for the taking and handling of samples of these products and devices. Section 32D provides for the certificate stating the results of any test, examination or analysis carried out on a sample to be accepted as prima facie evidence in court.

Section 32E sets out the penalties for offences created by this Bill and allows the IMB, where it has seized stocks under the Act, to seek orders from the courts to appropriately dispose of these stocks and where appropriate to recover the costs incurred from the offending company. Section 32F provides that summary proceedings for an offence can be instituted under the Irish Medicines Board Act up to two years after the date of the offence. These sections provide for better regulation in respect of medicinal products and ensure that the penalties available for breaches of the regulations are the same for all regulations relating to medicinal products.

Part 4 of the Bill amends the Control of Clinical Trials Act 1987. Section 22 provides that the Act will not apply to clinical trials that are controlled under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004. Section 23 permits proceedings for an offence under the Control of Clinical Trials Act to be instituted up to two years after the date of the offence and invests capacity in the IMB to bring summary proceedings for an offence under the Act. Section 24 inserts a new section into the Control of Clinical Trials Act to provide appropriate enforcement and supervision powers in regard to clinical trials falling under those Acts. These also include powers to inspect records held by practitioners in respect of clinical trials.

With regard to clinical trials it is likely that most if not all of these records would be held for use in the course of a practitioner's professional practice and that if a warrant had to be obtained for each occasion an inspection was required it would render the supervision of clinical trials impractical if not impossible. Therefore, warrants from the District Court are only required where a private dwelling is concerned. However, the section also provides that warrants will not be required for that part of a private dwelling that is used for a professional practice.

Part 5 of the Bill relates to amendments of the Health Acts 1947 to 2005. Section 25 amends the Health Act 1947, as amended, to enable the making of regulations to extend the EU-based beef labelling laws that exist at retail level to include a requirement here for information on the country of origin of beef at the point of final consumption in the restaurant and catering sectors. This section also proposes an amendment to the Health Act 1947 to increase the maximum fines for breaches of regulations under section 54 of that Act, including those relating to meat labelling. Section 25 includes provision to enable the making of regulations to extend the requirements on labelling for poultry meat, pigmeat and sheepmeat to provide full country of origin information on all such meat at retail and catering level. EU approval will be required before such regulations may be given effect.

Section 26 allows for prescriptions written by nurses to be reimbursable under the drug payment schemes. Sections 27 and 29 amend the Health Act 1970 and the Health (Amendment) Act 1994 to provide that all primary school or home taught children are eligible for dental, ophthalmic and aural health examinations. Under current legislation, these examinations are confined to children of five years and under and children who attend national schools, and do not include children who are attending private primary schools or who are home taught. This provision addresses that anomaly.

Section 28 relates to eligibility for dental, ophthalmic and aural services. As part of the ongoing review of eligibility to health services, my officials identified an issue with regard to the current section 67 of the Health Act 1970 which provides for eligibility for dental, ophthalmic and aural services. At the time this section of the Act was commenced, in 1972, a statutory instrument was adopted by the Oireachtas which limited the application of section 67 to medical card holders and provision of these services has been limited to medical card holders since that time.

My Department sought the advice of the Attorney General on this matter. His advice was that section 67 of the Health Act 1970 should be amended to provide legal clarity to the issue of eligibility to dental, ophthalmic and aural services. Section 28 provides such legal clarity.

In Part 6, sections 30 to 40, inclusive, make consequential amendments to the various regulations in force under the Irish Medicines Board Act 1995 and which are referred to in the sections concerned. These amendments, which relate to enforcement, arise out of the insertion of the new sections 32A to 32F, into the Irish Medicines Board Act, where the corresponding enforcement provisions are now being inserted.

It is my belief that this Bill will succeed in consolidating and creating a stronger framework in which the IMB can carry out its business relating to medicinal products, medical devices and clinical trials. In future this will include controlled drugs, cosmetic products, drug precursors and human tissues and cells. It will also support the development of a more efficient, effective and patient-centred health service.

I hereby commend the Irish Medicines Board (Miscellaneous Provisions) Bill 2005 to the House. I look forward to the ensuing debate and any comments arising from it.

Dr. Twomey

I extend a happy Christmas to the Acting Chairman, the Ministers of State present and all the staff and Members of the Houses of the Oireachtas.

This is interesting legislation and much debate will surround it as it proceeds on Committee and Remaining Stages. Many important points in the debate will not be raised by us in the House but they may crop up when people read about this legislation in the media. People will then make comments on it and express their concerns. There are many good points in the legislation and it functions well in tidying up. It covers new ideas coming into the health services, such as nurses prescribing medication and the current and future role of pharmacists in the community. Although there is much to commend in the legislation, there are many factors in it that we have not considered fully. We will probably consider them fully during the course of debating the Bill over the next few months.

The central point of any health service legislation in this House is patient safety. It is a core point in this Bill. In drawing up legislation such as this we must look at how it affects the professionals who provide patient care. The legislation will bring some new practices with regard to how some professionals will work within our health services. If the legislation is not properly enacted, it could have detrimental consequences for some professionals and their patients. In particular, the nursing profession should pay much attention to what this legislation will bring about. Section 16 is a clear indicator of this.

Hundreds of nurses could see their careers destroyed if the regulations in the legislation are not put into practice properly or if proper safeguards are not put in place when the Bill is going through. For example, palliative care nurses in the community work regularly with controlled drugs and in conjunction with local general practitioners. Both, in some respects, are a quality check on each other. The palliative care nurse is a quality check on the GP and vice versa. These people play a significant role in the community, which must be protected. We must be careful going forward, particularly in considering the use of controlled drugs. It is a major point that cannot be emphasised enough.

The Minister of State wishes to extend the prescription of all medications to nurses, but we must be careful about the issue of controlled drugs. This will become the vital issue in this legislation, both for patients and nurses involved. I am surprised there is not more detail around this matter when we are discussing the legislation. To state that regulations will follow on such a significant topic is wrong. It demonstrates an inherent weakness in the beginning of discussions on the legislation.

It is a failure on the part of the Minister of State that more has not been put forward on how the issues of prescribing medication outside the medical profession are being thought of. There is some prescription of medication outside the medical profession, as pharmacists do it and nurses have an increased role in how they dispense medication. However, this legislation changes the issue, and it allows pharmacists and nurses to be the primary prescribers. There should be much more in the primary legislation to point this out, and I am surprised the Minister of State has not done so.

I will list issues that have cropped up in the media recently that will alert the Minister of State that we are not talking about giving out Smarties and that the issues are important. A recent Irish Medical Council report from the fitness to practice committee examined doctors who fail in the duty to protect patients and prescribe properly. The report showed that doctors were struck off for taking controlled drugs themselves, selling controlled drugs to addicts and providing controlled drugs for sexual favours. The numbers of these offences are extremely small, as the legislation covering the Irish Medical Council and how doctors operate is reasonably robust. The council takes these concerns quite seriously and acts strongly on any complaint made about doctors abusing their privileged position in handling controlled drugs.

We are broadening this issue. The matter of controlled drugs in our society is discussed on a regular basis. The prescription rate for benzodiazepines, such as Xanax or Valium, is very large. The potential for abuse is also very large. These prescribed drugs are sold as illegal products in this country. For example, Valium is regularly sold to heroin addicts and people who take ecstasy as a means of helping them control the highs and lows of the drugs. There is a huge potential for abuse with these types of drugs in our community. If we are to open up the prescribing of these types of drugs to nurses and pharmacists and to open up their use in nursing homes, hospitals and the community, we need extremely robust legislation to prevent abuse and protect patients from misadventure.

The events surrounding Dr. Harold Shipman exposed this as an issue in society some years ago. Shipman used controlled medication, Cyclomorph, to murder a huge number of his own patients. It is possible that no amount of legislation would have protected those patients from the psychopathic behaviour of the individual, but it shows that we must be extremely diligent about the auditing and control of this type of medication. Shipman was ordering vast amounts of Cyclomorph from pharmacists and wholesalers. It was noted that he was taking into his possession a large amount of these drugs, and people wondered what happened to them. Nothing was done, however, until he was exposed as having murdered hundreds of people.

We must bear in mind that legislation on its own is not good enough to protect patients. It is important before this Bill is cleared to clarify what the Minister of State is intending with checks and balances being put into legislation to protect patients. The enforcement of legislation is important, and the point has been made repeatedly that it is much better to have primary legislation as the way to protect patients. Amendments to a Bill and ensuing regulations should not have to follow primary legislation, which should be the gold standard for the Members in this House. We should not begin with catch-all primary legislation to cover the Minister of State, only to issue regulations and amendments afterwards.

This has in some ways facilitated the major problem we have today. It is the type of action that will cost the Government €1 billion over the nursing home charges issue. In that case, amendments after the primary legislation created ambiguity with regard to legal issues. Although it was strenuously denied by the Ministers involved, there may have been reaction when primary legislation was going through relating to old age patients. We will never know for sure. This shows that primary legislation should be the main way for this House to act and not through amendments. We are told that much of this Bill will be followed by amendments and regulations later on.

It looks as if this legislation will go through next February. The Government does not talk about continual medical education and competence assurance for the people involved. This applies, for example, to general practitioners. I take part in continual medical education but competence assurance does not apply to general practice.

The continual medical education in which I participate happens at night and weekends. There is no time off to do it. It is voluntary. Since I qualified as a general practitioner I have been under no obligation to read a book, attend a lecture or pursue any form of continual medical education whatsoever, yet I am one of the primary prescribers in this country.

In respect of competence assurance I can be registered on the specialist register of the Medical Council as a specialist general practitioner. That too is voluntary. I do not have to be included on the register but can remain as a general doctor in the Medical Council.

The structure of continual education must be crystal clear, otherwise, nurses, pharmacists and other health professionals will run into problems, not deliberately but because they have not kept up to date with the training and issues surrounding prescription of drugs. That is extremely important.

The Minister of State said he will talk to the stakeholders about section 16. What consultation has there been to date with the stakeholders, of whom there are many? These include the Department of Health and Children, the Health Service Executive, administrators at community level, pharmacists, general practitioners, hospital consultants, nurses, the regulatory bodies and unions, the Irish Nurses Organisation and the Irish Medical Organisation, An Bord Altranais and the Medical Council. The Minister of State should tell us what discussion has taken place with those stakeholders who will in turn discuss with us aspects of this Bill which they fear or distrust, over the next eight weeks.

Has the Minister of State drawn up protocols for nurses prescribing and under what circumstances they may do this? If there is to be limited prescribing there must be protocols. In Monaghan hospital that unfortunate man, Mr. Walsh, died because people did not follow the protocols. There was much discussion about what the consultants in Monaghan hospital should have done but the protocols were not followed. There will be another inquiry into that episode.

The protocols stated that if surgery could not take place in Monaghan hospital the patient was to be transferred to Cavan hospital, regardless of whether there was a bed there or whether someone would take him in. The protocol was flawed because the consultants in Cavan hospital could not accept patients with serious illnesses. The protocol failed Mr. Walsh.

We must be careful about how we draw up the protocols that are necessary. We should issue them now to the stakeholders to show them what we are discussing. The legislation might be fine but the thinking behind it and the work that needs to be done to make it stand up does not seem to be coming through.

Are there any plans to set up an organisation similar to the National Institute in Clinical Excellence, NICE, in the United Kingdom? Officials in the Department of Health and Children will be familiar with NICE. It is a controversial organisation because in some respects it limits the medication patients can take. If we extend the roles of different people and the scope for prescribing, it will no longer suffice to use the regulations covering members of the Royal College of Surgeons, the Royal College of Physicians or the Irish College of General Practitioners. If nurses and pharmacists are to have a broader role in prescribing we need a national organisation of clinical excellence to guide people in this area.

The Irish Medicines Board cannot do this because its role is specific. We need to go further than that. Has the Minister of State studied the situation in the United Kingdom, following the Harold Shipman case? The authorities there were concerned about how regulations for drugs and prescription were applied. I believe that nurse prescribing in the United Kingdom does not cover controlled drugs because of the limitations and controls on how this might work. I look forward to hearing the Minister of State's comments on that when he has the opportunity to reply.

Much of this prescribing will happen in the controlled environment of either a nursing home or a district or acute or psychiatric hospital. Have formulae been drawn up within those hospitals on how nurses prescribe? Have discussions taken place with the Medical Council and An Bord Altranais to cover the professional level of this activity? The Minister of State will need to talk to the INO especially and to the IMO about this. Nurses must be protected.

These regulations can be introduced but in a few years people will be a bit casual, the legislation will be forgotten, the training gets slack, then young nurses who are overworked and under pressure will find themselves in the courts for the reasons that doctors sometimes end up there, for misadventure, negligence or whatever. We must be robust about the regulations and highlight them to ensure no young nurse gets into trouble because we think this practice will make life a bit easier in hospitals. It is important to discuss these matters with patient advocacy groups. I presume the Attorney General will also have his say on this development.

A recent report from the Irish Society for Quality and Safety in Health Care should jolt the Minister for Health and Children and the Department out of complacency on these issues. According to that report half of all patients received their medication with no explanation of its side effects. Several patients probably got medication before anyone checked whether it was the correct patient. There may even be cases where the wrong medication is given.

The question often arises in respect of private nursing homes and other similar institutions whether the person distributing the medication in the evening is the appropriate person to do so. Several reports show that the working of the drug trolley on which medication is stored can be haphazard, a problem the former health boards have exposed. I would not like to see a situation develop in which prescription of serious medication becomes casual.

Hospitals are extremely pressurised environments. Recently I sat beside the bed of a family member and watched the nurses and other staff working around me. Ten years ago I worked in hospitals but the environment is more pressurised now than the one in which I worked. Student nurses now spend most of their time in university and do not have the same on-the-ground training that many of the older staff nurses experienced. One learns a great deal from experience rather than books. If we are not careful about how people dispense medication we could run into problems.

There are many reports in medical literature of patients dying from being prescribed the wrong medication. It is difficult to prove but it happens. In the United States the numbers run into thousands. In extending the range of people who can dispense medication, especially controlled drugs, we will encounter serious problems if we are not careful. This must be taken on board and it will be watched closely on Committee Stage.

Many organisations such as the INO, the IMO, the Pharmaceutical Society of Ireland and patients groups will study the legislation and will be getting in touch with Members in the new year. It is imperative the Tánaiste and Minister for Health and Children publishes her proposals on the Bill well before Committee Stage is taken. It is too dangerous to be given these the night before Committee Stage sometime in February. Members will only be fumbling in the dark, trying to work out what the Tánaiste means and its implications.

More changes will be proposed to the Bill because a large number of issues surround it. There are, however, issues outside the legislation which the Department of Health and Children must address. An examination is needed of continual medical education, protocols and the establishment of a national institute of clinical excellence. How can we ensure nurses maintain their training, particularly if it is not being done now? Once a person qualifies as a general practitioner, there are no further checks on his or her prescribing habits. In the ten years since I qualified as a GP, treatment of basic conditions such as diabetes and blood pressure has changed dramatically. It is important to understand how reviews of people's training and competence are managed.

These will be the questions I will ask the Tánaiste and Minister for Health and Children on Committee Stage. I will also ask what plans are in place to ensure standards in prescribing do not drop so that doctors do not contribute to the deaths of their patients.

I am unsure of the Tánaiste's intentions regarding the EU directive on human organ tissues. The report of the inquiry into organ retention has not yet been published. When this issue broke in 1999, the Royal College of Pathologists drew up regulations on how to deal with the issues arising from organ retention. A similar set-up of protocols is needed in Ireland. If there is anything unusual or different in the Irish situation, it must be discussed on Committee Stage.

In vitro fertilisation treatment is not provided for in the Bill. Has any aspect of the report of the commission on assisted human reproduction being included in the Bill? There were issues around stem cell research and in vitro fertilisation, as well as the protocols for handling embryos and gametes. Has the Department of Health and Children examined the recommendations of the commission? Do any of these impinge on the legislation? The commission needs serious legislation as a follow-up on its recommendations. If any issues exist, we need to address them to avoid any problems in the future.

Ms McManus

The Irish Medicines Board is an important and powerful body within the health service and will increasingly become so as medicines become more available, effective and inevitably more expensive. The issue of patient safety is obviously central to the debate and to any changes we are making in the law.

It is worth noting the level of consumption of medications in Ireland is not inordinately high. Some members of the Joint Committee on Health and Children recently visited France to learn of its health service. It was interesting to see a high consumption of medications there. It is fair to assume this arose from the easy access to specialists. In turn, this leads to shopping around by patients until they find the doctor who will prescribe whatever they want. Two factors control the level of consumption of medications in Ireland. The first is the role of GP as gatekeeper. The second, unfortunately, is due to inequality with people unable to access primary or secondary health care owing to low incomes and the inadequacies of social protection.

The establishment of the Irish Medicines Board was the manifestation of a trend within the health service, accelerated in recent times, where institutions and agencies now operate large chunks of it. The largest organisation is the Health Service Executive which has the overall responsibility of managing the health service. The role of the Department of Health and Children, meanwhile, has been considerably circumscribed over time. This trend raises particular problems with accountability. Across the House, Members are concerned about the lack of accountability in the health service. There will always be an issue with any board operating in the health service that is not directly accountable to the House. The old question of quis custodiet ipsos custodes arises.

This Bill will not ensure there is adequate oversight for a body as powerful as the Irish Medicines Board. I raise this point not to be unfair to anyone but because two years ago a situation arose which to this day remains unanswered. The case relates to an eminent oncologist, Dr. John Crown. No one in the health service can say he is anything but a major specialist in his field, with a high reputation. However, his history with the Irish Medicines Board is most regrettable. I do not believe the questions he legitimately raised were dealt with in a proper or fair fashion.

Some three years ago, cancer patients were denied access to a potentially life-saving breast cancer drug at St. Vincent's Hospital for nine months in 2002 and 2003 as a result of a dispute at the hospital. The controversy first erupted in September 2002 when Dr. John Crown discovered St. Vincent's Private Hospital had erroneously billed private patients and their insurers to the tune of €1 million. Approximately 50 women with breast cancer had been participating in a major international clinical trail, spearheaded in Ireland, using a combination of promising high-powered drugs. As it was a trial, the drugs, Herceptin and Taxoterre, had been provided free of charge by the international pharmaceutical companies that manufactured the medication. This is the standard procedure followed for the use of drugs in clinical trials. St. Vincent's Hospital, however, had billed patients and their insurers for about €1 million.

When Dr. Crown discovered this, he reported it to the Irish Medicines Board. One would expect the matter to be investigated by the board and whoever was responsible would have been held to account, as it was fraudulent practice. Instead, the work of Dr. John Crown was interrupted for almost nine months and clinical trials did not proceed. In the view of Dr. Crown, lives were lost as a consequence, a direct result of decisions made by the Irish Medicines Board which is not accountable to the House.

This is a matter of concern which raises issues for the Government in respect of the need for legislation of protect whistleblowers. It has never been more important to protect whistleblowers in the health service. While I appreciate the legislation to establish the Health Service Executive made certain changes, the record shows that the Irish Medicines Board affair was disgraceful. Fortunately, the relevant clinical trials have been reinstituted but only after the individual concerned experienced considerable stress.

My colleague, Deputy Quinn, tabled a parliamentary question on 21 November 2002 asking the then Minister for Health and Children, Deputy Martin, about this issue. Essentially, the Minister's reply was a hand-washing exercise. Despite being the shareholder of the VHI, he did not consider it his role to intervene, even though the company was an aggrieved party in the sense that it was told to pay out money it did not have to pay. Eventually, the VHI was reimbursed by the hospital but if the hospital had not been found out, the practice would, I presume, have merrily continued until this day. This is a serious matter about which all of us should be concerned.

Deputy Twomey referred to the misuse of prescriptions and we are all probably aware of examples of doctors using their position to illegally prescribe drugs in return for favours. In addition, however, in the area of alternative therapies and complementary medicine there have been a number of grave examples of practitioners taking advantage of patients who are suffering, in some cases from a terminal illness, by taking money from them on completely fraudulent grounds and to the detriment of their health. We do not appear to have any real protection against such persons. While safeguards, in the form of the Medical Council, are in place to protect patients from medical practitioners, they do not apply to alternative practitioners. This is an important issue because interest in this area of health care, if it can be so described, is growing.

It is important to note that both the clinical trials I mentioned affected women. One related to women with breast cancer while the other involved female cancer patients who encountered difficulties accessing clinical trials in the Mater Hospital due to an issue which arose at the hospital's ethics committee, although it is still unclear whether the ethics committee took the decision. The fact that a decision made on ethical grounds — in reality on religious grounds — impacted on a woman's right to have the best possible care is a central issue. While I appreciate that European directives have yet again saved us from ourselves, this does not mean we can abdicate responsibility for ensuring that something which is legal here — contraception in this case — can never be used to prevent a woman accessing health care and the best treatment, whether by way of clinical trial or otherwise, as happened in the case in question, which was, fortunately, resolved.

The Bill covers more than the Irish Medicines Board. I share the justifiable unhappiness expressed in the Seanad by my colleague, Senator Ryan, about the form of the Bill. It is a compendium of this and that brought together under a Title which bears no relation to many of its sections. This approach creates a lack ofclarity. It is difficult for people referring back to consider that meat labelling or ophthalmic entitlements for children in home schooling belong in legislation entitled the Irish Medicines Board (Miscellaneous Provisions) Bill 2005. There is no relationship between these issues and the Title, and I am unhappy that compendium, portmanteau type Bills such as this come before the House from time to time. For the sake of clarity, people would be better served in future if a couple of small Bills were introduced and Deputies would not need to spend an excessive amount of time on them to justify ourselves.

Senator Ryan, who has been around these Houses for some time, described the legislation as "one of the most badly constructed pieces of legislation I have seen in my political career". His point was that as well as being a mix and match of items which needed to be dealt with, the Bill was then subjected to a series of major, complex amendments in the Seanad. This approach to legislation is not helpful in terms of ensuring clarity as the legislation proceeds and people start to get involved in the process. One must be aware that professional bodies are frequently not 100% familiar with the process in which the House engages, which is a little obscure, even to Members at times. Rather than making it difficult to submit amendments, we should try to facilitate those on the outside who try, sometimes helpfully, to make inputs into the work we do. From time to time, proposed amendments received from concerned individuals have arrived too late or have been found to be inappropriate simply because of a lack of information and knowledge. If procedures were clear and accessible, the legislation may have been improved.

Another important change in the Bill which has no connection with the Irish Medicines Board is the extension to nurses of the capacity to prescribe. This measure has been sought by the Irish Medical Organisation for some time and the practice is common in other countries. Although it is a positive step forward, it is not good enough to state that the entire matter will be governed by regulation at some point in the future. We do not know who will prescribe, when they will prescribe or how they will do it. This is shoddy, poor practice, particularly given the significance of the change.

While I hope this change will be for the better, the best safeguard against the system not working in such a difficult area is good preparation and working out beforehand how a change will operate in the complex, high pressure context of the health service. This is a political decision as much as anything else and I am critical of the Minister in this regard. She makes a grand announcement, as she is perfectly entitled to do, but fails to deliver on the actual form of the change, that is, in terms of protocols, liability and all the other issues raised in this debate. Instead, the change will be made by some regulation to be published at some point in the future. People cannot feel secure that best practice will prevail because issues arise in terms of training and the context in which this change is being made. Anybody looking at our hospital service knows just how difficult it is to provide the best kind of care.

Only yesterday, there was a distressing court case concerning Tallaght Hospital. It was a terrible case for the woman involved. As far as one can gather, it would seem a serious mistake was made because the provision did not exist within the hospital, in terms of its physical capacity, to deliver full information for that patient when it was needed. I am not making excuses but obviously somebody is responsible. Doctors and nurses make errors like the rest of us. There is always a danger that we expect doctors never to make mistakes. Having read what was said in the court, however, it seems there were issues about the fact that our health service does not have the capacity to provide for doctors and nurses to work at their very best. We must be conscious of that.

The idea of ensuring that there is a capacity for nurses to prescribe makes sense as regards repeat prescriptions, palliative care and nursing home care. Presumably it also makes sense within the hospital context. It would be helpful, however, if we could tease out what we are talking about in a much more detailed and thoughtful way instead of something simply being presented to us without that kind of reflection.

We have seen criticism in the area of psychiatric care. On a number of occasions the Inspector of Mental Hospitals has made the point in his reviews that there is excessive prescription of medication for psychiatric patients. Such patients are extremely vulnerable, so one can imagine circumstances where the use of drugs is not justified but is being applied. We need to be careful about that because there is a requirement for transparency. There have been many problems concerning mental health legislation and the failure of systems to protect patients. The hard facts exist, however, and we know from the inspector's reports that, time and again, he has complained about the excessive prescription of drugs.

Another issue that I hope comes within the remit of the Irish Medicines Board is that of drug shortages. From time to time, pharmacists and doctors complain that prescribed drugs are not available. A woman came to me who was quite disturbed because she availed of a product called B12 which she needed to have monthly by injection, I think, although I am not a medical person. She received one injection and was told that from then on the product would not available for some time, and when it became available again it would not be on the General Medical Service. I tabled a parliamentary question on the matter but the answer I received was not terribly reassuring. It stated:

The vitamin B12 product concerned was removed from the common list of reimbursable drugs and medicines when the manufacturer advised my Department that due to problems in the manufacturing process, it had become temporarily unavailable both in Ireland and the UK. As soon as the manufacturers inform my Department that the problems have been resolved, the product will be restored to the common list.

That is just one example of what I am talking about. In attempting to discover what is going on with regard to these shortages, the phrase "due to problems in the manufacturing process" tends to crop up. The suspicion is that as companies produce newer drugs which are more expensive, but do exactly the same thing as the older, less expensive drugs, they construct manufacturing problems as an excuse to retrain doctors to prescribe more expensive drugs. This may be happening in the area of contraception, for example, and if that is so, it must be ended. We already have a large drugs bill and, in addition, there are all the arguments about generic drugs and banned drugs. If it is the case that drugs are being taken out of the system to introduce a newer drug which is the same and no better except in making more profits for pharmaceutical companies, that must be addressed. I presume the appropriate body to do that is the Irish Medicines Board.

From time to time, patients visit the pharmacist but cannot obtain what they have been prescribed. I know the Progressive Democrats are the great proponents of the free market, but if we do not have freely available on the market drugs that we need, it is up to the Government to sort that out. We should not be subject to the whims of drug companies that are trying to expand their profits.

I was reading an article in the IPU Review, a journal with which I am sure the Minister of State is familiar. The author of the piece, Mr. Jack Shanahan, referred to the continual shortages of a range of medicines. His particular concern was about palliative care medications, which were not available on the GMS. I hope that issue will be addressed. Mr. Shanahan said he would complain to the chief State pharmacist only that we do not have one anymore. I was not aware of that, so perhaps the Minister of State will respond to that point.

Mr. Shanahan wrote:

Palliative care is one of the great services of modern medicine. It allows a team to facilitate dying with dignity and comfort . . . Bureaucracy is important and allows for the safe provision of drugs. When it starts to impede the delivery of an important service then the rules need to be revisited. Not only would a rule change make a more effective service, it would also be more efficient and less expensive. My suggestions are simple. Drugs used in palliative care should have GMS codes. Drugs used in palliative care should be readily available in all pharmacies in the same way as the bulk of the medicines that we buy.

Until I read that article I was not aware that there was an issue concerning palliative care drugs. Surely we need to deal with this matter. If we cannot look after people dying in a humane manner with the best possible treatment, then there is something amiss in the health service.

I was interested in Deputy Twomey's references to pharmacists. My understanding was that this legislation related to extending the power of nurses to prescribe. Significant changes are already occurring in Britain where, from next spring, qualified nurses and pharmacists will be able to prescribe any licensed medicine for any medical condition with the exception of controlled drugs. Obviously, there is another structure in Britain where general practice operates rather differently than it does here, but it seems to be a major shift. If the Minister has such a proposal in mind, then we need to know about it.

According to Ms Ginette Howell, the head of pharmacy in Britain, this is a major step forward in providing care that is more responsive to the needs of patients and the public. It is ground-breaking for the pharmaceutical profession. As independent prescribers, Ms Howell said pharmacists will fully use their expertise in medicines, in partnership with patients and other members of the health care team. It is a major change in the role of pharmacists and it might be useful to extract the Minister's view.

The Minister made an announcement a few weeks ago regarding nurses prescribing. That was in response to a review of nurses and midwives in the prescribing and administration of medicinal products, which was jointly carried out by An Bord Altranais and the National Council for the Professional Development of Nursing and Midwifery. I support the idea and if nurses are given that extra authority, pharmacists will naturally enough seek a similar dispensation. It is difficult to see how one can leave them out of such changes. I would be very interested to explore the matter further since I am sure that there is a down side to that change of which we need to be conscious, as well as the possibility of an up side.

We cannot underestimate the abuse of prescribing powers. There have been very high profile cases such as that of Dr. Shipman, but also quite regular cases subject to Medical Council investigation whereby doctors have abused their power to prescribe drugs illegally. Even where treatments are perfectly legal, some medications can be extremely potent. I am very much struck by the fact that, in all communities, young men in particular have died because of illegal drug overdoses. I am also conscious of the fact that some have died from methadone. That drug is legal, and yet they are able to secure enough of it, or mix it with illegal substances, that they lose their lives.

I welcome the fact that children in all primary schools will receive entitlements under this Bill. It is extremely welcome, since that anomaly existed for too long.

My last point concerns HIQA, which I understand will have a role in assessing medicines and medical technology. I know that it has been learning from such bodies as the National Institute for Clinical Excellence, NICE, in Britain. However, it would be very useful if we had the HIQA legislation to see where exactly the two roles are defined — that of the IMB and that of HIQA. It was grossly deficient of the Department and the Minister to set up the HSE 12 months ago without establishing the protective counterbalance of HIQA at the same time. That was the concept behind the reforms, but all that we got was the HSE. We still do not have HIQA on a statutory footing and that is a real problem when it comes to ensuring best practice.

Ms C. Murphy

I wish to share time with Deputies Boyle and Ó Caoláin.

Acting Chairman (Mr. Kirk)

Is that agreed? Agreed.

Ms C. Murphy

Many aspects of the Bill appear technical in nature and certain changes seem aimed at overcoming some unintended consequence of previous legislation. A very obvious example is on the first page of the explanatory memorandum, which mentions limiting the prohibition on the cultivation of poppies to those intended for the production of opium. There may be several badly tended gardens about which people feel a little more comfortable, given that they were probably acting illegally by not weeding out the poppies.

The Bill's primary focus is that the Irish Medicines Board acts as the competent authority for the licensing of controlled drugs. I share concerns regarding the fact that there are many extra elements; seeking entitlements under legislation becomes quite difficult when that happens. I share the concern that it may not be good practice. I have no issue with the Irish Medicines Board being the competent authority. The number of drugs available grows daily, and it is quite difficult to anticipate new advances in medicines and devices so it is very important that there is a hands-on approach in that respect. Obviously, the primary task must be to protect human health. By regulating, one can help do that — I consciously use the word "help" rather than "fully achieve".

There are one or two areas of concern to me that are not regulated by this legislation. It is very difficult to see how one might overcome them, other than through public education, and cost may also be relevant. Those two areas are travel and the Internet. I know countless people who go on holiday and buy products or ask others going on holiday to bring them back three or four inhalers or whatever. I suspect that bags coming back from holidays are full of such things. They are not controlled by prescription and they are significantly cheaper. Spain, which is in the EU, is a case in point, since one can buy such medicines there. There is hardly a household in Ireland where one member does not have asthma. The availability of those fairly popularly used drugs in an EU country is an example of what is taking place. The checks and balances that should be in place to control use and ensure that people are monitored and so on are sometimes avoided because people are self-medicating and self-prescribing. That is an area of concern.

The second issue is the Internet. Unless one has a fantastic firewall on one's computer, as in the Dáil but not in the home or some other settings, one daily receives spam with offers of drugs at a reduced price. I certainly know people who have availed of that and even complained when their purchases were confiscated. There is no doubt that people are using that as a means of reducing their medical bills. They are certainly self-medicating.

This Bill will not deal with individuals purchasing and having such medication delivered. Instead, it deals with those who are licensed, with sanctions against those who misuse their licence by importing. There is clearly an issue of price and differences in regime across Europe, even though we are all governed by the same EU legislation, regarding what is prescribed. The area must be considered carefully since some of the drugs are used daily. The checks and balances are not there to deal with that.

I met representatives of the Irish Pharmaceutical Union, which held a briefing day six or eight weeks ago. I addressed the issue of price and was surprised to hear them say that many prices were predetermined since one signs up to a pricing mechanism depending on one's economy. I would not have thought that there would be great price differences between European countries, particularly in the 15 older member states, but that is clearly the case. I fully understand and support a difference in cost structure for anti-retroviral drugs, which are being made available to very poor countries that have a serious AIDS problem. However, the situation is very different where one is dealing with commonly used drugs in the EU.

There is a problem with public information that must be tackled but the appropriateness of the level of prescribing of some drugs and their prices must be examined. There is no doubt that people are voting with their feet on this issue but that is a dangerous way to proceed.

The Irish Medicines Board has specific functions but one area that has been talked about is animal health, which I understand, given that we are examining the food chain. The farming organisations, for example, have probably made a stronger case in regard to people ignoring symptoms and the need for veterinary care where there may be bad work practices or insufficient funding. It is interesting that there is such a focus from an animal perspective but not from a human perspective.

Regarding the mark-up, it would be useful to get some information on that. I will request that from the Department of Health and Children.

The principle of nurses being allowed to fill out prescriptions is a welcome move but it must be done in a very careful way. In that regard I take on board some of the points made by previous speakers. I am aware pharmacists are making the same argument in terms of a potential extension to their area.

The area of alternative medicine must be regulated. While there are many good moves taking place on that side, there is a lack of regulation. Like most Members, I got an e-mail from a mother whose son died having taken some magic mushrooms. She was very distraught. That shows that this is an area that must be strictly regulated.

As this is my first Christmas as a Member of this House, I take this opportunity of wishing the Members and staff a happy Christmas. There is a particular reason I take pleasure in doing that. I want to record my appreciation for the helpfulness and professionalism of the staff since coming into this House and the friendliness of Members across the political spectrum.

Mr. Boyle

I am afraid I will have to revert to bah humbug mode, although I echo the sentiments expressed by Deputy Murphy.

The Bill, being a miscellaneous provisions Bill, misses several opportunities in terms of the need to examine and reform the Irish Medicines Board. This body is in its first incarnation and while it does much useful work, it has been involved in what was often needless controversy. Part of that has come about as a result of the legislation that governs it and because of the constitution of the board that is meant to oversee its activities. It is a board that represents particular vested interests in the production and distribution of medicines in our society but a board with a better balance, under better legislation, is something for which this House should strive. We should be discussing a new, all-embracing Irish Medicines Board Bill rather than making matters more difficult by broadening the remit of the current board without ensuring it can operate effectively.

The most obvious controversy the board has been involved in is the area of complementary and alternative medicine, particularly its decision on the use of St. John's Wort. That remains a dichotomy because this substance has been banned by the Irish Medicines Board yet it is freely available in the northern part of this island. If we do not have consistency on an all-island basis, never mind the way such medicines are treated in a European sense, we are not doing a good job of representing the interests of our people.

One of the main functions of the Irish Medicines Board should not necessarily be the overseeing of the safety and efficacy of medicines, which is an important role, but making valued comment about the use of medicine in Irish society. We are a heavily over-subscribed society in terms of medicine, particularly in the use of antibiotics, and the question must be asked in the ongoing debate on our health service the reason, despite this over-prescription of medicines, there is such a prevalence of viral conditions. For instance, the existence of MRSA in our hospitals cannot be a coincidence in that these phenomenon go side by side. I would like to see more openness and honesty from a State agency that is meant to be performing that role. My party and I believe it is not performing that role effectively.

That said, the provisions in the Bill will make life harder rather than easier for the Irish Medicines Board. There is an obvious need to extend its remit in terms of medical devices but I question whether extending it to include veterinary medicines and, more particularly, cosmetics is something we should bestow on a board that is meant to be examining medicine in terms of the health needs of our citizens. Cosmetics is an area about which most people are not very concerned. There are safety issues that should be addressed and others that should have been dealt with in the past by the then Institute of Industrial Research and Standards and its follow-up organisation Forfás. They have to do with the chemical make-up of available products. The role of an Irish medicines board is obscured if one of the areas it is meant to be dealing with is cosmetics. That is leaving aside the ethical considerations of cosmetics, where many of those products are tested on animals.

There is another more open debate in regard to the testing of medicines on animals but when we get into the regulation of cosmetics and materials that have been produced by that method, we are entering dodgy ethical waters that will compromise the work of the Irish Medicines Board.

The main selling point of the Bill has been the additional power of nurses to dispense medicines in most circumstances. That is a welcome measure about which I have not come across dissent. My mother was a nurse for 40 years and it always was a source of frustration to her that she did not have that ability, particularly at a time when she would have gone through an education system in which women were not encouraged to become doctors, and nurses like her working on hospital floors had far more experience and ability to ascertain a diagnosis than many of the interns and junior doctors with whom they were dealing. This new power could be a help in terms of many of the problems we face, including unnecessary delays which often lead to tragedies in our health service. I hope it will be used and will have good effect.

Another area I have a concern about is the powers being vested in the Pharmaceutical Society of Ireland, which is a non-statutory, independent body. To have powers conferred on an agency which is not directly responsible or accountable to the State is something with which I am uncomfortable. Why does the Minister and the Department believe such expertise is not being provided by the State? I would have thought it would be an important part of the regulatory function for the State to have such a competence and be engaged in such work. That is aside from the various components of pharmaceuticals, from those who manufacture the goods to those who are eventually responsible for dispensing and selling them. Unfortunately, we must deal with the fact the pharmaceutical industry is represented by too many vested interests. The Minister of State has had personal experience of dealing with the industry. It is unfortunate that this Bill is being taken without a proper look at new pharmacy legislation. Difficulties arise with the medicines that are manufactured, the ways in which people can access them and the people who are responsible for making them available. Too often, this process is administered in a cartel-like fashion whereby people are not properly informed or unable to make full use of available medicines.

Deputy Catherine Murphy spoke about people's ability to buy many medicines that are unlicensed over the Internet. Like every other Member of his House and, I suspect, anyone with a computer, I regularly receive spam e-mail encouraging me to improve my manhood or womanhood. Senders of such e-mail clearly use a scattergun approach. However, more serious spam e-mail, which encourages people to acquire products such as steroids, is sent. I have yet to hear the Government give a coherent response about how we can prevent people gaining access to drugs which can harm them and society, aside from giving the Customs and Excise more powers.

The Irish Medicines Board should become a more all-embracing organisation that represents consumer interests more than vested interests. The Government's arguments regarding the Irish Medicines Board are fundamentally flawed. The Government believes the board must be almost entirely led by experts, which is a "nanny knows best" approach to medicine. The public should have an input and be involved in the decisions made about the products that will be made available to it and how. I am not confident that the Irish Medicines Board is doing this job effectively. The fact that we have not taken the opportunity to introduce the reforms that would make the Irish Medicines Board the organisation it needs to be — an organisation in which the public can have confidence — is a missed opportunity.

Caoimhghín Ó Caoláin

Was I correct in noting the Minister of State furiously writing when Deputy McManus highlighted the unfilled position of chief State pharmacist? Is the Minister of State considering filling this position in the future?

Mr. T. O’Malley

Deputy Ó Caoláin will be the first to know about it.

Caoimhghín Ó Caoláin

We will see. While Sinn Féin will not oppose this Bill, the way in which it has been presented by the Government is most unsatisfactory. It is complex legislation which amends four separate Acts of the Oireachtas and a considerable number of regulations. With limited time and resources, it is impossible for a small Opposition party to deal comprehensively with all aspects of such a Bill. The difficulty is compounded by the introduction of significant amendments in the Seanad.

I cast no aspersions on those within the Department of Health and Children who work on legislation but the question arises as to whether they are adequately resourced and equipped to support the legislative role of the Tánaiste and Minister for Health and Children and her Department. On the Order of Business, I raised the Government's failure to produce a Bill to provide for repayments to those on whom nursing home charges were illegally imposed. The Tánaiste and Minister for Health and Children again referred to the extreme complexity of the legislation and has apparently pushed back the date of publication well into 2006. The Bill in question was promised for September 2005. It was to be published before the beginning of the forthcoming session at the end of January 2006.

It is more than a year since the Tánaiste and Minister for Health and Children undertook to repay those who were illegally charged and to provide for this repayment in legislation. If I recall correctly, these people were led to believe that everything would be in place by April 2005. It will clearly be beyond April 2006 before we have a legislative basis for repayments. These issues are connected, although we are not addressing the repayment of illegal nursing home charges today. It is unacceptable.

Something has clearly gone awry to result in the continued backlog and ensuing rush to introduce legislation. It is very difficult for everyone to deal with everything this entails. It is even more alarming in light of the nursing home scandal itself in which flawed legislation was allowed to stand and was not rectified. As a result, massive costs will be incurred by the State.

The Irish Medicines Board (Miscellaneous Provisions) Bill 2005 has undergone a metamorphosis in the Seanad and is now a different creature to that initiated in June 2005. Section 26, as inserted by amendment in the Seanad, is now the most significant section of the Bill. This section was not part of the original Bill but is the section that will be repeatedly referred to in future. It is the important and long-overdue provision to allow certain nurses to prescribe medicines. I welcome this provision.

It is vital that nurses have these powers and responsibilities. The fact that nurses have not been allowed to prescribe drugs has been a considerable disadvantage in our health service. However, I am very concerned by the wording of section 26. As I understand it, the section does not include midwives, although the Minister of State will correct me if I am mistaken. We need clarification regarding the categories of nurses who will be given these new responsibilities. The anomaly thrown up by the exclusion of midwives, if this is the case, must be rectified.

The review of nurses and midwives in the prescribing and administration of medicinal products was published in June 2005 and made a number of recommendations. The review recommended that "an explicit legislative basis be provided for the supply and administration of medicinal products using medication protocols by nurses and midwives in hospital and community settings". This recommendation is very clear and includes midwives. The report was the result of very intensive research and wide consultation. The report's third recommendation was that:

Nurses and midwives should be enabled to supply and administer over-the-counter medications to patients and clients in accordance with their competence and within their scope of practice and supported by medication protocols where appropriate.

The review's fourth recommendation was that:

Prescriptive authority should be extended to nurses and midwives, subject to regulations under the relevant legislation by the Minister for Health and Children and regulation by An Bord Altranais.

The review's fifth recommendation was that:

An Bord Altranais and the National Council for the Professional Development of Nursing and Midwifery should establish a Project Implementation Team to work in consultation with key stakeholders to facilitate the implementation of these recommendations and actions.

Will the Minister of State indicate the extent to which these recommendations are being implemented by this Bill, if further legislation is required and what other steps need to taken to implement the report's recommendations fully?

We have been awaiting the nurses Bill for years. It is long overdue and I would have thought that such a Bill would have been the appropriate vehicle for providing for nurse prescriptions.

The primary consideration in this must be the safety of patients. We must ensure that those with responsibility for prescribing are subject to the most stringent controls and act responsibly at all times. We must also ensure that medicines policy is implemented and that medicines are used in the best interests of the overall health service. I have raised the issue of the exorbitant cost of medicines on many occasions, the profiteering of pharmaceutical companies and the need for preference to be given to generic drugs. The State could make significant savings and divert much funding currently spent on overpriced medicines. The pharmaceutical industry is very profitable and is one of the key sectors of the economy here. However, there are also many vested interests in this area, including the pharmaceutical companies and even pharmacists and GPs. These groups are very interested in the State's policies on medicines, but our consideration must be public health above all.

I have dealt with only a couple of key aspects that arise out of this Bill. It is very complex legislation covering a plethora of areas and I hope we have a chance to return to these areas at later stages of the Bill. I welcome the Bill and I wish it a fair wind, as I do to the Minister of State, Deputy O'Malley, as he leaves the House.

Mr. N. O’Keeffe

I will make a few points on a very important section of the Bill for the Irish food industry, namely, section 25, which deals with food labelling and the country of origin. It is not a function of the Irish Medicines Board or any health organisation to have anything to do with food labelling or the country of origin. That should be a matter for separate food legislation. For some time, Irish producers have been clamouring for country of origin labels. This section represents a compromise, which is not good enough. The restaurants will have to identify the country of origin of beef, but that regulation should also apply to the retailer. Irish housewives and small retailers are struggling with rogue importations into the country. A country that exports 90% of its agricultural produce imports agricultural produce only because it is cheap and inferior and because it can be regurgitated and sold, making massive profits for many in the food industry.

In the past 12 months, we have witnessed the rise of avian flu in Asia. While we think we are exempt from that here, we should examine the migratory patterns of these birds around the world. In 12 months, they may have circled the globe due to changes in the weather conditions and will arrive in Ireland, giving us the same problems that they caused in Asia. A number of deaths from this virus have taken place in Asia and even in the Ukraine and other parts of central Europe, often due to poor health regulations in those countries.

The Irish Medicines Board regulates the farming community in a rigid way, making observations and representations. The board questions the different medicines used by farmers on their livestock. Irish farmers are probably the most regulated in Europe, if not in the world today, which makes it very difficult for them to operate. At the same time, we get imports from South America, from the Far East and from other countries where there are little or no controls. I have seen that for myself and it is a fact. It is important for the protection of the Irish housewife and the Irish retailer that the country of origin label is supplied to the retailer and the manufacturer, so that the consumer knows the country of origin and the place of manufacture. There are 30 supermarkets in this country selling meat at knock-down prices where the housewife does not know the country of origin for the produce, be it from the Far East, South America or wherever. The price at which they are being sold indicates that they are not of a quality or standard that is in keeping with good food practice.

This is a very important section of the Bill. I have been arguing about it in my party. The Minister of State, Deputy Power, will be well aware of the difficulties because he comes from a rural constituency in south Kildare, where farmers are having difficulties competing with cheap imports.

It is important that we put a food authority in place that will cover all activities in the food sector. We have the IDA international food aid, Enterprise Ireland, the Department of Agriculture and Food, Teagasc and FÁS. In effect, we have a multiplicity of agencies dealing with the food industry, but they all have only a certain role to play. Ireland needs a food authority. We export between €6 billion and €10 billion worth of food. If agreement is reached at the latest WTO negotiations, it could be a disaster for Ireland, although many are hoping for agreement. It could result in further cheap imports coming here. The imports that come into this country are not quality imports. They are being imported by people who want to exploit the food industry, exploit the housewife and the retail sector. That is why I want the country of origin and the place of manufacture on all foods. A half-baked measure on legislation is not good enough for me. The major components of the Irish food industry are milk, beef, pigmeat and poultry meat. The latter two are causing the problem as they are the most exposed and exploited by imports. These industries give substantial employment at manufacturing level and at farm level, because they are intensive operations. The poultry and pigmeat industries have been in the news in recent weeks due to the nitrates directive. People realise their importance in rural areas because of the employment they provide. However, we will destroy them further if we do not introduce some kind of control for imports.

We are only looking for equal status with imports. We do not have that at the moment. In fairness to the officials from the Irish Medicines Board and from the Department of Health and Children, this is a not a function of theirs. It is a function of the Department of Agriculture and Food and the Department of Enterprise and Employment. However, the Irish Medicines Board and the Department of Health and Children are being saddled with this as a half-baked compromise that will not answer the problems I have outlined. The contradiction in the over-regulation of Irish farming is that the products coming into this country do not have the same standards. Why impose those standards on the farmers of rural Ireland when they do not have the same standard in Brazil or in the Far East? I do not want to hear the Minister of State or his officials tell me that the standards in those countries are as high as they are here. They are not.

I am making an appeal for a national food authority. I hope the Government bites the bullet on that, puts all the different agencies under one umbrella and that, once and for all, we can see the country of origin attached to all food imports, whether Irish, British, Danish, German, Jamaican or whatever. The Irish housewife should know what she is buying and retailers should know what they are selling. Many Irish food companies with major turnovers and which are quoted on the Stock Exchange exploit the people with imports by linking them to Irish standards because Irish food is wholesome, good and is liked.

Most Irish food is organic because of the climate. This is a grass-based country. Beef and sheepmeat are organic, as is milk. The climate allows for that. I know the Ceann Comhairle's heart is in the food industry. He comes from a good indigenous county which he has represented for a long time. He has always shared his views on the food industry with me. Deputy Twomey also comes from a west Cork family which was involved in the food industry as a farming family. We understand that. I appeal for change in the interests of Irish producers and, moreover, of Irish housewives.

Minister of State at the Department of Health and Children (Mr. S. Power)

It has been an interesting debate. I thank all the Members for their contributions. The debate has been substantive and it is difficult to deal with all the issues raised. Nonetheless, I will attempt to respond to some of them. Members will have further opportunities to contribute when the Bill is debated on Committee Stage early next year.

I thank Deputies for their comments on the introduction of an enabling provision for nurse prescribing. I assure them that the intention 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. Prescribing by nurses will be limited by regulation and will be targeted to ensure greater accessibility to medication for patients where it will help community and acute services and where it is safe to do so. Nurses and midwives are in a well regulated profession which is an essential requirement for the changes being introduced.

The Department of Health and Children will conduct consultations with all stakeholders on the implementation of this issue before regulations are drawn up. It is not intended that all nurses will prescribe all drugs. The regulations to be drawn up will be further supported by the standards and requirements of An Bord Altranais. The Irish health care system is changing rapidly and we need to support this with proper legislation and regulation. The Irish Medicines Board Act 1995 is the legislation under which medicinal products are controlled in this country. Accordingly, this Bill, which amends the 1995 Act, is the appropriate route for introducing provisions in respect of medicinal products which will enable nurses to prescribe them as appropriate.

An Bord Altranais and the National Council for the Professional Development of Nursing and Midwifery recently published a review of nurses and midwives in the prescribing and administration of medicinal products, which was launched by the Tánaiste and Minister for Health and Children last October. This included a literature review, an examination of international experience and a needs assessment survey. It also included a collaborative project involving a small number of pilot sites. It recommended that prescriptive authority should be extended to nurses and midwives, subject to regulations. A competency framework and education requirement for nurses to prescribe was developed as part of this review which will provide a useful foundation for further developments.

As regards costs, the available evidence is that nurses and midwives are cautious prescribers. In addition, it will be possible to restrict by regulation the range and categories of medication that a nurse or midwife may be permitted to prescribe. I have listened carefully to a number of the points made by Deputies on the inclusion of an authority in the Bill to allow pharmacists and others to prescribe medicinal products. I assure the Deputies that the Department has examined carefully the issue of prescribing by other health care professions. It is considered, however, that apart from nurses and existing prescribers, the necessary regulatory regime, with adequate fitness to practise norms, is not in a position at present to permit the extension of prescribing to registered pharmacists for controlled or other drugs and medicines.

The Department is drafting legislation to provide updated fitness to practise regulations in this area. Given the importance of the pharmacist's role in the protection of public health, this area will have to be reviewed carefully. In the case of medical personnel other than emergency medical technicians, it is considered too early to introduce such an authority. It is important that appropriate structures and controls should be in place for each of the relevant health and social care professions before an authority in respect of the issue of prescriptions, particularly where controlled drugs are concerned, could be given.

The President has recently signed into law the Health and Social Care Professionals Act which provides registration and fitness to practise structures for certain health and social care professionals. However, these structures are not yet in place and it would be premature to consider giving prescribing authority to those health care professionals at this stage. A significant development has been the recent introduction of the advanced paramedic training programme and the creation of a register of appropriately trained emergency medical technicians. This register is divided into three parts, depending on the level of training as it pertains to the emergency medical technician, paramedic and advanced paramedic grades. These personnel have undergone specific training to enable them to administer a range of medications safely in accordance with strict protocols under the direction of a registered medical practitioner, depending on the drugs involved.

The regulations introduced under the Irish Medicines Board Act 1995 in August this year have provided the necessary authority for the various grades of paramedics to obtain and administer the various categories of medicinal products concerned on this basis. The circumstances are set out in the Schedules and are appropriate to each division. The authority to administer these is in accordance with clinical practice guidelines or in line with the instructions of a registered medical practitioner. Morphine injection, which is listed in the Schedule, will only be administered by an emergency medical technician, paramedic or advanced paramedic on the instruction of a registered medical practitioner. For such personnel to be in a position to administer any controlled drugs, it is necessary that they have appropriate authority under the Misuse of Drugs Act to possess such drugs lawfully. It is intended to grant a group authority under section 14 of the Misuse of Drugs Act 1977 in respect of these personnel to allow for this.

I thank Members for their thoughtful contributions to the debate. I look forward to Committee Stage, which will allow Members to make changes as they see fit and to discuss the Bill further. Ultimately, I hope we will produce legislation in this regard that will be to the benefit of us all. I thank Members again and look forward to the careful analysis of the Bill to be undertaken on Committee Stage in the near future.

Question put and agreed to.

Dáil Éireann debate - Thursday, 15 Dec 2005

Irish Medicines Board (Miscellaneous Provisions) Bill 2005 [Seanad]: Second Stage.

Dáil Éireann debate -
Thursday, 15 Dec 2005