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

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

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

I am pleased to introduce the Second Stage of the Irish Medicines Board (Miscellaneous Provisions) Bill 2005 to the Seanad. In general terms, the Bill allows for the transfer of certain functions in respect of controlled drugs from the Department of Health and Children to the Irish Medicines Board for the improved operation of the board with regard to medicines and the control of clinical trials and amends the Irish Medicines Board Act 1995 with regard to medicinal products, cosmetic products, veterinary medicinal products, drug precursors and medical devices. Many aspects of the Bill are technical in nature and I will attempt to steer the Members through its main provisions in as clear a manner as possible.

The Bill provides for the Irish Medicines Board to act as the Irish competent authority for controlled drug licensing under the Misuse of Drugs Acts 1977 to 1984. The designation of the board as the competent authority is consistent with departmental strategy whereby executive functions which are not directly related to the mission or objective of the Department should be devolved to an appropriate executive agency. The Bill formalises the arrangements which have been put in place whereby staff at the board carry out this work and amends the Irish Medicines Board Act in order to transfer legal competence to the board to carry out licensing and inspectorial functions under the misuse of drugs legislation.

As far as clinical trials are concerned, the Bill also updates and consolidates the functions carried out by the board to conform to European Union legislation with regard to medicinal products, veterinary medicinal products and medical devices. The authority to enforce legislation relating to medicinal products is currently set out in a number of different regulations. The introduction of new provisions under the Irish Medicines Board Act 1995 and the Control of Clinical Trials Act 1987 will ensure that the authority for all of the regulations will be contained in the Act itself in a single piece of legislation. With regard to 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; 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; and Part 5 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.

Section 3 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 or customs legislation. At present, these powers are available in respect of practitioners and pharmacists convicted of such an offence.

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 to attach or vary conditions to such licences, permits or authorisations and to revoke any such licence, permit or authorisation. It also 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 4 of the Bill amends section 14 to transfer these functions, which were previously carried out by my Department, to the Irish Medicines Board. It also provides that licences, permits and authorisations issued prior to the commencement of this section continue to be valid.

Section 6 amends section 24 of the Misuse of Drugs Act 1977 to enable the IMB to authorise officers to carry out inspections under the Act and allows authorised officers of the Pharmaceutical Society of Ireland to inspect pharmacy shops. The term "practitioner" is also 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 6 also provides that the appropriate warrants of authorisation, issued by the Minister, the IMB or the PSI, are provided 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 8 and 9 of the Bill update the functions carried out by the IMB to conform to European Community legislation in regard to the various matters within the scope of the Bill. 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. Section 9 includes provision for the IMB to issue various export certificates in respect of the products and devices mentioned, as required by manufacturers exporting products to other countries. The IMB is required to have regard to any national legislation giving effect to such provisions.

Section 11 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 legislation for the chairpersons of the advisory committees on human medicines and the veterinary medicines. Section 12 expands section 9 of the existing IMB Act to ensure that no refusal of a licence, authorisation or certificate on the grounds of safety, quality or efficacy can be made unless the appropriate advisory committee has been consulted.

Section 13 is amended to make better and more appropriate provision for the IMB to charge fees regarding its activities. Section 14 of the Bill amends section 32 of the existing IMB Act. It provides a clarification that sale and supply will not include administration and introduces a provision whereby regulations may be made to control administration if required. This section also enables the making of regulations in respect of the implementation of EU directives on medicinal products, medical devices and cosmetic products.

Section 15 inserts new sections, 32A to 32F, into the IMB Act in order 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. 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 that it is sufficient prima facie evidence in a court.

Section 32E sets out the penalties for offences created by this Bill and allows the IMB, where it has seized stocks under the legislation, to seek orders from the courts to 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 IMB Act up to two years after the date of the offence rather than the normal six months. These sections provide for better regulation in respect of medicinal products and ensures that the penalties available for breaches of the regulations are the same for all regulations relating to medicinal products.

Part 4 amends the Control of Clinical Trials Act 1987. Section 21 provides that the Act will not apply to clinical trials that are controlled under the European Community regulations of 2004 that deal with clinical trials and medicinal products for human use. Section 22 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 provides that summary proceedings may be brought by the IMB.

Section 23 inserts a new section into the Control of Clinical Trials Act to improve enforcement and supervision powers for clinical trials falling under this legislation. This includes 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, 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 required only where a private dwelling is concerned. However, the section also provides that warrants will not be required for part of a private dwelling used for professional practice.

In Part 5, sections 25 to 35, inclusive, make consequential amendments to the various regulations in force under the Irish Medicines Board Act 1995, to which I referred in the sections concerned. Those amendments, which relate to enforcement, arise from the insertion of the new sections into the Irish Medicines Board Act.

The remainder of the Bill consists of the interpretation sections, which are sections 2, 8, 15 and 20, and those dealing with citation and constructions, sections 7, 19 and 24. Those are standard legislative provisions. A detailed explanatory and financial memorandum was published and circulated with the Bill. The Minister estimates that no significant financial implications arise from those amendments and that the work entailed in these changes is, in the main, already performed by the Irish Medicines Board.

The Government intends to introduce several amendments on Committee Stage in this House, the first being an enabling provision for nurse prescribing. The Minister proposes a provision in the Bill which will allow us to introduce nurse prescribing on a statutory basis. It is not intended that all nurses will prescribe all drugs. Rather, it is intended to permit the introduction of a scheme for prescription for medicinal products, or certain classes of medicinal products, or certain controlled drugs, for example, in palliative care situations, to be issued in prescribed circumstances by certain registered nurses. The various circumstances and procedures to be complied with in the issue of such prescriptions will be set out in regulations under the legislation, and in accordance with the standards and requirements prescribed by An Bord Altranais.

Regarding meat-labelling, the Government proposes an amendment to the Health Act 1947. The amendment will allow for the extension of the beef-labelling requirements that currently exist at retail level to include a requirement for information on the country of origin of beef at the point of final consumption in the restaurant and catering sectors. The proposed amendment also includes a provision to enable us to make 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. However, EU approval will be required, and there is no precedent for this provision in EU member states. The Government also proposes an increase in the maximum fines for breaches of regulations on meat-labelling.

It is also intended to include an amendment to the Health Act 1947 to increase the maximum fines for breaches of the regulations on meat-labelling. The designation of the Irish Medicines Board as a competent authority regarding human cells and tissues will be addressed. An amendment to the Irish Medicines Board Act 1995 is proposed to designate the board as the competent authority, as required by 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 or blood products, organs or in vitro research.

A further Government amendment will provide that Customs and Excise officers at points of importation and exportation will be authorised officers under the Irish Medicines Board Acts for the purposes of carrying out inspections pursuant thereto. An amendment is proposed to provide 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.

It is proposed to give 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. The Supreme Court has decided, in the case of Vincent Browne v. the Attorney General and others, that indictable offences created by EU legislation must be clearly and explicitly set out in primary legislation. Amendments are being proposed that will take the decision into account, meeting the standard set down by it and ensuring that breaches of any regulations made to give effect to Acts of the institutions of the European Communities relating to medicinal products for human use may also be prosecuted on indictment.

Section 66 of the Health Act 1970 made provision for dental, ophthalmic and aural health examinations for children. Under section 66, those examinations are confined to children of five years and under or children who attend national primary schools. The Minister intends to propose an amendment to provide for all children, regardless of where they are educated, to be eligible for dental, ophthalmic and aural health examinations, and for follow-up treatment.

As part of the ongoing review of eligibility to health services, officials at the Department of Health and Children have identified an issue with regard to section 67 of the Health Act 1970. This section 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 limiting the application of the section to medical card holders. Provision of these services has been limited to medical card holders since that time.

The Department sought the advice of the Attorney General on this matter. His advice was that section 67 the Health Act 1970 should be amended to provide legal clarity with regard to the issue of eligibility to dental, ophthalmic and aural services. An amendment will be proposed to provide such legal clarity. A more detailed analysis and description of the various amendments will be provided on Committee Stage.

It is the belief of the Minister that this Bill will succeed in consolidating and creating a stronger framework in which the Irish Medicines Board can carry out its business in relation to controlled drugs, medicinal products, cosmetic products, drug precursors, medical devices and clinical trials. The legislation, together with the amendments to be proposed on Committee Stage, will support the development of a more efficient, effective and patient-controlled health service. I commend the Bill to the House and I look forward to the ensuing debate thereon.

Mr. Feighan

I welcome the Minister of State to the House. This Bill is rather technical and was mainly drafted to bring our legislation on medicines and their control into line with that of the European Union. I welcome the Bill as it entails numerous proposals that will result in greater protection of the consumer. Over the years, the consumer has not always been to the forefront of legislation and it is therefore good to see legislation drafted to protect the consumer.

Section 3 reflects the changes that have taken place in the pharmacy sector over the years. These changes are sometimes regarded as progressive. Every small town and village used to have a pharmacy that was integral to the local community. One could walk into such pharmacies and seek advice, on a cut, for example. It seems one can no longer obtain such information, good or bad, from a pharmacist. Legislation introduced in this area has meant that voluntary advice is no longer offered. One must now go to a doctor and pay €40 or €50 for advice, after which one must visit the pharmacist. Although the legislation that has been introduced is to protect the consumer, we miss the opportunity to walk into a pharmacy and perhaps get a tablet for a certain ailment.

Local pharmacies were often owned by individuals or families. However, there has been an increase in the number of pharmacies that are part of chains owned by companies. Although this is also regarded as progress, we were much better off when pharmacists were running their own businesses. They would have been very aware of what was happening in their communities and would have been of service to them.

We now have chains of 15, 16 or 17 pharmacies, which are providing a competent service, but I cannot help but think that many of them are driven by financial concerns, as with most businesses. Many are only in the business to earn maximum profit. It would be nice if pharmacies were again run by individuals or families but this will not happen.

Section 3 extends the powers available to the Minister under the legislation to the groups or bodies corporate involved in the practice of community pharmacy. I welcome section 6, which amends section 24 of the Misuse of Drugs Act 1977, thus enabling the Irish Medicines Board to authorise officers to carry out inspections under the Act and the Pharmaceutical Society of Ireland to authorise officers to carry out inspections of pharmacy shops in respect of their handling of controlled drugs. I have always wondered what process was in place in this regard and I note the Minister has upgraded the inspection system.

It is comforting to know the Irish Medicines Board has the power to carry out inspections of pharmacy shops and to ensure they are handling drugs in accordance with the law. However, I am concerned about certain drugs and practitioners as they may not be covered by the Act. Will the Minister of State explain the law on inspections, including in respect of alternative health practitioners and the drugs they administer in their shops? Over the years, we and many retailers have noted the various weights and measures that applied in respect of inspections by the former health boards. Senator Quinn would know they had vast powers. A health inspector can close down a grocery shop, public house or restaurant immediately if he finds it necessary. I always wondered what powers are held by those who inspect pharmacies. Can they close them down immediately if they find improper practices?

Another issue, which is probably not related to the Bill, concerns the fact that there may be too much regulation. There are many alternative remedies or drugs in existence and, in this regard, a few constituents complained to me about the regulation of St. John's wort. I cannot understand why it is only available by prescription, nor can I understand why the Irish Pharmaceutical Union has had a say in ensuring that this be the case. Vast numbers of people drive to Northern Ireland or fly to Britain and obtain as many boxes of the drug as they want, in Boots, for example, yet access to this remedy appears to be over-regulated in Ireland. It is cheap and is as effective as conventional medicines. We are doing ourselves a great disservice by ensuring that it be prescription-only. We may be over-regulating the sector. It would be much easier if one could go into a chemist and pick remedies off the shelves without requiring a prescription. Will the Minister of State explain to me and my constituents the position in this regard?

Does the Irish Medicines Board or the Department of Health and Children have any powers to protect consumers in regard to traditional medicines? Can officers carry out inspections of the practices of practitioners of traditional medicine? Has the Minister any plans in this area?

Mr. B. Lenihan

Is the Senator referring toherbal remedies?

Mr. Feighan

Has the Minister any plans to carry out inspections in the alternative medicine sector?

Section 9 updates Irish legislation to conform to European Union legislation, thus making the Irish Medicines Board the competent authority for the purposes of EU directives relating to medical devices. I welcome this. The Irish Medicines Board is being appointed to exercise powers under section 14 of the Misuse of Drugs Act in regard to the granting of licences and other authorities in respect of the manufacture, possession, supply, import and export of controlled drugs. I also welcome this but wonder if alternative medicines are covered under the board's power to grant licences.

Section 12 states that the board will not refuse to grant a licence or authorisation in respect of the manufacture or wholesale of medicinal products on grounds of safety, quality or efficacy unless the advice of the appropriate advisory committee has been considered. Will the Minister of State outline who is on these advisory committees? How many committees are there and who appoints the members? Are they political appointments or are they appointed by the board?

Section 13 is one of the shortest sections and seeks to make better and more appropriate provision for the Irish Medicines Board to charge fees for its activities. How much will these fees be? Will the fees fund the board? I am concerned when I see fees mentioned in case they might be another stealth tax but I am sure that is not the case here.

I am pleased that the Government proposes an amendment to the Health Act 1947, as amended, regarding meat labelling. The amendment will allow for the extension of the beef labelling requirements that currently exist at retail level to include a requirement for information on the country of origin of beef at the point of final consumption in the restaurant and catering sector. This will be a relief to my constituency colleague, Deputy Naughten, who has lobbied strongly on this issue. It is also intended to extend the requirements for the labelling of poultry meat, pigmeat and sheepmeat to provide full country of origin information. The amendment to the Health Act will also increase the maximum fines for breaches of regulations on meat labelling. How much will the fines be?

The Minister said he intends to introduce amendments to the Bill to allow certain nurses and midwives to prescribe certain drugs. Such a measure is long overdue. There is a manpower crisis in hospitals and in general practice and it appears to have worsened as a result of the Government cap on recruitment to the health service, about which we hear a great deal. There are many well trained nurses who would have no problem prescribing certain drugs. Such a change would allow doctors to concentrate on more important functions. It would be a better use of human resources, particularly in view of the manpower crisis in the hospitals.

With regard to the Government's commitment to the Hanly report, does the Minister propose to amend the Bill to allow paramedics administer certain drugs? If the Government is committed to its proposals regarding accident and emergency departments and ambulance services, this legislation should cover paramedics and allow them to administer certain drugs. Will such regulations be enacted?

Section 15 makes much better provision for the enforcement and supervision of regulations made under the Irish Medicines Board Act 1995. Much has happened in the intervening ten years. The section will allow officers to carry out inspections and to take samples of medicinal products and medical devices. It is good that the IMB will have such powers. Sometimes we do not like too much power to be vested in one body but it is good that this body will have the power to protect consumers.

Under Part 4, EU legislation supersedes Irish legislation with regard to clinical trials. EU legislation came into force in May 2004 on clinical trials on medicinal products for human use. The EU regulations replace certain sections of the Control of Clinical Trials Act 1987.

I welcome the Bill and look forward to receiving answers to the questions I raised.

Ms Feeney

I welcome the Bill. It is a technical Bill to clear up various conflicts between existing Acts and to accord recognition to EU regulations. I agree with Senator Feighan that it might appear, at times, that we are over-regulated. I certainly feel that way occasionally, particularly with regard to local pharmacies.

Not long after I was elected to this House, I put on record the great role of the local pharmacy in giving people advice. One could go to the pharmacist without consulting a doctor and be assured that one was getting good advice and being properly looked after. However, with the new regulations the pharmacist, although highly qualified and competent, no longer feels comfortable about giving such advice.

Consider the situation regarding St. John's wort. Approximately 18 months ago all Members were lobbied strongly about this product. I live in Sligo and people there can drive 30 miles to the Border and buy it over the counter in a health food shop. It is cheap and convenient but here the product can only be sold under licence.

On the Order of Business recently I raised the problem of paracetamol. The rules on the sale of paracetamol have been tightened a great deal in that one can only buy one packet containing 12 capsules in a retail outlet. One will not be allowed to purchase a second packet. I have no difficulty with that. Unfortunately, however, I encountered two serious cases of self harm by overdosing on paracetamol. The consequences of overdosing with something that is as readily available as paracetamol are terrible for the person's liver. The damage is done in the space of a few hours. However, people are not sufficiently educated to realise that such damage can be done.

Perhaps we should consider putting a clear warning on packets of paracetamol stating that it can kill. If the liver is damaged badly enough, a person can die from liver failure. The two cases I encountered during the summer ended very tragically. One of the people involved did not realise they would cause as much damage. This is an issue worth examining.

Like Senator Feighan, I have selected a few issues from the Bill which interest me. Section 2 in Part 2 extends ministerial powers with regard to companies owning pharmacies. They are extended to cover the officers of the company. This is most important because the new trend in this country is that we no longer have local, family run pharmacies. Fortunately, or unfortunately, competition is everything and the bigger pharmacies and chain pharmacies are taking over.

Section 4 permits the Irish Medicines Board to issue licences and permits. This function was previously carried out by the Minister. I welcome such moves whereby responsibilities are removed from the Department and stronger powers are given to the Irish Medicines Board.

Section 5 changes the rules on the cultivation of the poppy. I smiled when I read that section over the weekend because there was much debate in this Chamber last week on the so-called poppy and the thought occurred to me that regardless of from where one is coming, all our views on the poppy are changing.

Section 9 updates the functions carried out under the Irish Medicines Board Act 1995 and allows them conform to European Union legislation. I suppose eventually every area will come under EU legislation but the section is welcome because we should have a common trend across the European market.

Section 14 amends the Irish Medicines Board Act 1995 in such a way that it removes any confusion between the sale and supply of medicinal products and their administration. The Bill clarifies the position and ensures that regulations may be made to control administration if required. Section 15 proposes to tighten up the enforcement and supervision of regulations under the Act, which is necessary. The timing is right and I welcome the section.

Part 4 makes certain technical changes to the Control of Clinical Trials Act 1987. I was pleased to hear the Minister of State say it would also cover nurse prescribing. I am an advocate of nurse prescribing. As a former member of An Bord Altranais I am aware that eight to ten years ago, the board called for such a measure. It has been a long road for the board but I welcome mention of it here today.

Nurse education is ever-changing. Our nurses are now educated with a four year primary degree that is very scientific and medically based. I welcome this change, which I note is in the area of palliative care. Other areas might also be examined. I am aware that consultant rheumatologists would welcome their nurse practitioners being able to inject patients and even prescribe. Rheumatology nurses give injections to patients, which is unusual for them, but that was covered under previous legislation and is welcome also. As a former member I believe nurse prescribing will be welcomed by the Medical Council; I do not believe medics will have any difficulty with it. As Senator Feighan pointed out, it will help alleviate some of their heavy workload.

The introduction of the Bill is welcome. It is short in nature and technical in content but it is necessary. Apart from it being technical it is important legislation and I look forward to the Committee Stage debate and whatever amendments may be tabled.

Mr. Quinn

I welcome the Minister of State to the House and the Bill. The Minister of State said the Bill is largely technical and I accept that is the case. I want to use the occasion to make the case for adding another function to the role of the Irish Medicines Board, one I am sure it can discharge as effectively and efficiently as it has done for many years, along with all its other functions. The matter I want to raise concerns the drugs doctors prescribe for their patients, which represent a major and growing cost to our overall health services. I am concerned to ensure we get the best possible value for that spending but that does not appear to be the case.

I speak from a grocery background. A revolution took place on the shelves of grocery stores and supermarkets throughout Europe about 20 years ago with the arrival of what we call generic products, which were often practically identical to the highly branded product. They were often made by the same companies that made the top brands on the grocery shelves but they were sold at a much lower price and a battle ensued between the generic and the branded product. The revolution that occurred on the grocery shelves quickly moved on to the chemist shops and the pharmaceutical area but it has not been availed of correctly.

When a doctor seeks to prescribe for a patient, he or she often has a choice between a branded drug and a generic one, although that choice does not exist in all cases. The important point is that in most cases the only significant difference between the two drugs is the cost. Invariably, the branded drug costs much more than the generic one, and sometimes considerably more. That difference is paid ultimately by the taxpayer and the amount goes into the coffers of the big drug companies.

I want to be clear that I am not trying to undermine the business model of the giant drug companies. That model is based on the idea that they recoup the vast costs of research and development from what they charge for those drugs that make it to the market for the length of time they continue to enjoy patent protection. I have no problem with that and what I am suggesting is not a threat to that way of doing business. Generics come into the picture when the patent protection expires, which to the best of my knowledge is after 16 years. They do not have to carry the burden of recouping the research costs and therefore the prices they are sold at can often be much closer to the cost of producing the drugs, which invariably is much lower.

That whole process can be seen as a classic example of the patenting process working very well. In other words, the original inventor's costs are covered and he or she makes a profit in the short term while the public benefits from the advances in the long term. Understandably, the large drug companies do not like to see their revenues cut off in that way. Ideally, they would like to continue receiving premium prices for what they produce, and to continue that indefinitely. They have a number of techniques to ensure that happens, one of which is to continue making small and largely insignificant changes to the drugs they produce, which allows them to claim that the tweaked drug is new and improved. Much of the time it is sheer marketing bluff.

Another technique they use is to expose medical practitioners to a blitz of publicity, pushing their wares. All doctors — Senator Henry will be in the Chamber later — speak of the pressure they come under from the big drug companies pushing them to use their products. That pressure is all one-sided. There is no corresponding marketing from the producers of generic drugs because their cost structure does not allow for large spending on marketing. The inevitable result is that we, the members of the public, end up paying far more for many drugs than we should pay to get the medical result we want. The individual patient is not directly involved in the process. Naturally, the patient leaves it to the doctor to prescribe what is best and often does not pay directly for what is prescribed. In most cases it is the taxpayer who ends up paying the bill.

It appears obvious that if we strive to improve our health service we should try to ensure that the money we spend on it is well spent. This is a clear example of throwing considerable amounts of money down the drain year after year, and those amounts are getting bigger all the time.

We cannot force doctors to prescribe one kind of drug over another. The freedom to choose a particular drug appears to be regarded as an important issue of clinical independence. That might explain the reason the Minister for Health and Children and the chief executive of the Heath Service Executive restrict themselves to exhortations to doctors to use generic drugs more frequently. What I propose is a modest measure to back up these exhortations, which do not seem to be having much effect. The Irish Medicines Board should maintain a register of those drugs for which there is a generic equivalent, and it should be published on the Internet for the benefit of the medical profession and pharmacists. Such a register would be considered a statement by an authoritative and respected body that there is no significant therapeutic difference between these drugs, other than price. It would place the truth about the drugs that doctors choose in the public domain, and as such, would be a small but useful counterweight to the marketing efforts of the major drug companies as they seek to preserve their revenues. Doctors, moreover, would have a readily available reference to consult in ascertaining whether a generic equivalent for a particular drug is available.

Such a register could be set up and maintained at a tiny cost relative to the significant amounts that might be saved if the prescribing practices of doctors are changed. I accept we cannot do this by compulsion. This does not mean, however, that we should not take every possible step to set out the facts of the matter and put them before the medical profession. I ask the Minister of State to consider this proposal. If necessary, I will put it forward in the form of a Committee Stage amendment.

It is interesting that the issue of subsidiarity constantly arises in the context of the EU. It encompasses the notion of bringing decision-making as close as possible to the citizen. Both Senators Feighan and Feeney observed that a person can buy St. John's wort off the shelf in the North but that strict conditions apply to its sale on this side of the Border. That is what subsidiarity is about, namely, the freedom for this State to take such decisions. There will always be differences in practice across the Border.

I did not expect the provisions on meat labelling to be included in this legislation and I congratulate the Minister on this welcome measure. This is a topic that is strongly debated in the United States of America, where retailers are battling against the obligation to disclose the country of origin, whether Canada, Mexico, Chile or elsewhere.

The Minister has acknowledged that this measure presents some difficulty in the context of our EU membership. The EU is quite restrictive in terms of the ability to specify an individual country within the Union and we may well encounter some difficulty in this regard. Even if the Minister does not manage to achieve what has been set out on this issue in legislative terms, the solution is for the matter to be determined by the marketplace. The market will decide the respective fortunes of those restaurants and hotels that advertise their willingness to disclose the source of the meat products they serve, whether chicken from Thailand or pork from Poland, and those that do not.

It seems the regulatory impact of which Senator Feeney spoke presents problems. Given that dangers arise every time we pass legislation without taking into account its costs and other consequences, some type of regulatory impact analysis should be done on a case-by-case basis.

Senator Feeney mentioned the restrictions in regard to the sale of paracetamol. The introduction of scanning has facilitated the management of such restrictions. For example, adherence to the legislation prohibiting the sale of alcohol until 12.30 p.m. on Sundays was simple because the scanning system could be programmed so that the bar codes on any alcohol products could not be processed before that time. A similar system can deal with those instances where a person attempts to buy multiple packets of a particular drug in respect of which quantity restrictions apply. Technology can achieve a great deal in this respect. On the other hand, however, a person who wants to cheat can easily visit several different supermarkets or chemists.

I welcome the Bill and thank the Minister of State for his efforts in this regard. It is interesting that he has added some extra elements we did not expect to see. The legislation deserves support.

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

I thank Senators for an interesting and substantive debate. I acknowledge their contributions and will address as many of the issues raised as I can. Senator Feighan asked about the powers of inspectors of pharmacy shops. Under the Irish Medicines Board Act 1995 and the Poisons Act 1961, these inspectors are employed by the Pharmaceutical Society of Ireland and are entitled to take prosecutions in its name. They do not currently have the power to close a pharmacy in the course of their inspections.

The Minister is in the course of preparing regulations for the purpose of implementing a recent EU directive on traditional herbal medicinal products. Enforcement in this area will be possible when those regulations are made and we will have an opportunity to debate this subject when they are drawn up. I was not clear whether Senator Feighan was raising a doubt about whether there should be regulation in this area but such regulation is imminent on foot of the EU directive.

Senator Feighan also raised the question of St. John's wort and the fact that, depending on one's location on this island, one will or will not encounter restrictions on its purchase. Many of us participated in that debate some years ago and, like the Senator, I was on the side of those who wanted greater liberalisation in this area. The problem throughout the health and medicinal sector is that of clinical and scientific independence. If the Oireachtas provides legislation for a medicines board, we are, perforce, obliged to accept its recommendations. We cannot substitute our view of what is good science and medicine for that of the board, even when, on occasion, the latter offends our common sense. That is the problem we face. The board took a view on this issue and the classification was assigned by it on the basis of its concerns about safety.

Senator Feighan also raised a question about the advisory committees set out under section 13. There are currently three independent advisory committees which provide scientific advice to the board as necessary. Members of these committees are appointed by the Minister on the basis of their expertise. The members of the advisory committee on veterinary medicinal products are appointed by the Minister on the recommendation of the Minister for Agriculture and Food.

In regard to offences for breaches of the meat regulations, it is intended that penalties in respect of meat labelling will be raised from the existing figure of £1,000 to a more effective penalty of €5,000. Queries were raised about the fees charged by the medicines board. In general, the policy is that the board should self-finance its activities. It is always expected that the fees will be set to reflect that arrangement.

In regard to the granting of licences for drugs other than controlled drugs, the licences referred to in the Bill related in the main to controlled drugs included in the UN treaties and not to other products. Senator Feighan also referred to paramedical qualifications. The Health and Social Care Professionals Bill 2004 is before the Dail and was dealt with at length in this House.

Senator Feeney raised the perils posed to human health, particularly the liver, by paracetamol. The Minister will ask the Irish Medicines Board to consider whether improved labelling can be used in that respect.

Senator Quinn raised the matter of generic drugs. I will reiterate a point of my reply to Senator Feighan, namely, that we are at a difficult intersection between law and our expertise and the expertise and clinical independence of people who make decisions in this matter. There is no doubt that Senator Quinn's case is powerful and there could be a substantial saving to the Exchequer were we to decide what drugs could be prescribed.

However, we cannot decide this but we can work on the problem. A great deal of information on it is in the public domain and a considerable amount of work has been done by the Department in the context of trying to improve clinical practice. If Senator Quinn has a proposal to make, the Minister will be receptive to examining it with great care and consideration. I have dealt with most of the issues raised by Senators and I thank them for their contributions.

Question put and agreed to.

Seanad Éireann debate -
Tuesday, 22 Nov 2005