Thursday, 8 December 2005
Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Report and Final Stages.
I move amendment No. 1:
In page 6, between lines 6 and 7, to insert the following:
"2.—The Minister may, upon the coming into effect of this section, having regard to—
(a) changes in the value of money generally in the State since the passing of this Act or the last previous exercise of the power under this section, and
(b) the need to ensure the continued effectiveness of the fines under this Act with respect to the enforcement of the provisions of that Act,
by order amend any section by substituting for the amount standing specified for a fine in those provisions for the time being, an amount that is greater than that amount.".
I wish the Minister of State at the Department of Health and Children, Deputy Brian Lenihan, the best of luck in his new additional ministerial responsibilities.
The Tánaiste and Minister for Health and Children agrees in principle with the purpose of the amendment that fines must be kept up to date. However, this is a complex area with substantial legal implications. The Tánaiste and Minister for Health and Children does not wish to amend legislation in this area on a piecemeal basis. The Government is considering introducing a fines Bill, which may include a scheme for the general indexation of fines. As heads of such a Bill are with the Attorney General's office, it would be inappropriate to put an indexation provision in the Irish Medicines Board (Miscellaneous Provisions) Bill 2005.
I move amendment No. 2:
In page 6, between lines 36 and 37, to insert the following:
"(iii) registered pharmacists, who are members of the Pharmaceutical Society of Ireland,".
On Committee Stage on Tuesday, Senator Minihan informed the House that pharmacists in the North will shortly be allowed to prescribe certain drugs over the counter. This amendment recognises such a provision and empowers the Irish Medicines Board to extend the option of writing prescriptions to pharmacists and other paramedical staff, either those employed by the State or the Health Service Executive.
For example, the Dublin Fire Brigade comes under the remit of the local Health Service Executive area, which is different from the rest of the country. The sudden cardiac death report will be published presently. It will have implications for many local authorities where some fire officers will be pushing to have defibrillators on board fire engines for their own safety and that of accident victims.
I am not suggesting that pharmacists and paramedics should immediately have the option to write prescriptions. However, such a scenario is inevitable. It will be impossible to patrol it if pharmacists on one side of the Border can write prescriptions, while those a few miles on the other side cannot. The provision must be inserted into the Bill now rather than at a later date. This will allow the board to include pharmacists and other paramedics at a future date.
I second the amendment.
Amendment No. 2 must be considered under the canopy of the Good Friday Agreement which states that, where possible, legislation must be introduced which is consistent between both parts of the island. As Senator Browne pointed out, it will soon be possible for pharmacists to prescribe certain drugs in Northern Ireland. We do not want this provision to be introduced with immediate effect in the South, as it must be properly established. However, I hope the Minister of State will consider accepting the amendment.
Will the Minister of State clarify the situation regarding trained paramedics and ambulance staff? After an ambulance has been called to a suspected heart attack, the earlier the thrombolytic therapy is instituted, the better. I understood the administration of certain drugs was possible in the pre-hospital services, namely, the ambulance service. However, I have received conflicting reports as to whether this is happening. Such a service would be provided for by amendment No. 3. Has it already been introduced as a ministerial regulation?
Amendment No. 2 relates to the prescription of controlled drugs by registered pharmacists, while amendment No. 3 relates to prescription by paramedical staff. The Department has examined the issue of prescribing by other health care professionals. However, it is considered that apart from nurses and existing prescribers, the necessary regime of regulation with adequate fitness to practise is not in place 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 in the area of pharmacy. Given the importance of the pharmacist in the protection of public health, any developments in this area would need to be considered carefully. Essentially, however, the position is that the Department is reviewing arrangements on fitness to practise for pharmacy. If this review results in legislation, the issue raised by Senators Browne and Bradford in the amendment on registered pharmacists could be considered in that context.
On amendment No. 3 and the query raised by Senator Henry, emergency medical technicians have an authority to administer controlled drugs acting in accordance with the directions of practitioners. It is on this basis that such personnel administer controlled drugs. In order for such personnel to be in a position to administer any controlled drugs, it is necessary that they also have an appropriate authority under the Misuse of Drugs Acts to lawfully possess such drugs. 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 understand this will by done by statutory instrument. On that basis, the amendment proposed by the Senator in respect of the prescribing of drugs by paramedical staff is unnecessary.
In the case of medical personnel other than emergency medical technicians, in other words, paramedical personnel generally, it is considered too early to introduce such an authority. It is important that appropriate structures and controls are in place for each of the relevant health and social care professions before an authority in respect of the issue of prescriptions, especially for controlled drugs, could be given. The President has recently signed into law the Health and Social Care Professionals Act 2005, which provides for the 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 give prescribing authority to the health care professionals in question at this stage.
I move amendment No. 3:
In page 6, between lines 36 and 37, to insert the following:
"(iii) paramedical staff, who—
(a) are in the employ of the State, either directly or indirectly through the Health Services Executive or a Local Authority, and
(b) whose position could be described as one that would require the ability to prescribe medicinal products from time to time, and
(c) who have undergone such training as may be deemed necessary by the Minister from time to time,".
I move amendment No. 4:
In page 29, between lines 42 and 43, to insert the following:
"18.—(1) It shall be an offence—
(a) for any person or body corporate to send or cause to be sent by use of the postal service, any medicinal product, where the sale of such a medicinal product is concerned, or where there is financial reward for the person or body corporate body so sending the medicinal product,
(b) for any person to order or take delivery, within this jurisdiction, of a medicinal product referred to in subsection (1).
(2) Where a person is guilty of an offence under subsection (1)(a), he shall be liable to a fine of up to €3,000, or up to twelve months in prison, or both.
(3) Where a person is guilty of an offence under subsection (1)(b), he shall be liable to a fine of up to €1,000, or up to three months in prison, or both."
As this amendment addresses the complicated and awkward area of importation of drugs from what is effectively an illegal source, I have discussed the matter with the Fine Gael Party legal adviser. While the obvious solution is to fine the person who sends the medicinal product by post, it is next to impossible to apprehend a person in the Bahamas who has sent a package to Ireland which contains cheap Viagra or another drug ordered on the Internet.
A second option is to fine the person who receives the package. It may be considered unfair to fine a person who has legally purchased and imported drugs via the Internet using a credit card. There is, however, an onus on the State to protect the health of its citizens, many of whom purchase bogus drugs of dubious quality. The system of fines proposed in the amendment would, I hope, deter people from purchasing drugs from outside the State via the Internet. Fines would be imposed only where it is proven that drugs intercepted on arrival in the State should not have been imported. The proposed recipients would be penalised in the interests of their personal health. While they might not thank the State initially, perhaps they will be grateful over time, particularly if it transpires that their health would have suffered had they taken the so-called drugs they ordered.
I appreciate this is a difficult matter as the obvious approach would be to fine the person sending the drugs. Given that this is not practical, it may be preferable to fine those who order them as a means of deterring those who seek to order medicinal products on-line. As the Minister of State, Deputy Tim O'Malley, noted, many companies sending spam have criminal connections and the sale of drugs by mail order is often a form of money laundering. The purpose of the motion is not to make a draconian change in the law but to protect the interests of citizens.
I second the amendment.
As Senator Browne stated, this is a difficult area. The Minister of State, Deputy Brian Lenihan, will share the concerns expressed by his colleague, Deputy Tim O'Malley, who is a pharmacist by profession, about the quality and type of drugs increasingly being purchased by mail order over the Internet. It is worrying that people may procure drugs without cognisance being taken of which other pharmaceutical products they may be taking. Senator Browne's amendment, which would at least fire a shot across the bow of such persons, could prove helpful in this regard.
The provision relates to the selling of medicinal products by mail order, in particular via the Internet, as outlined by Senators Browne and Henry. I welcome the amendment because the thinking behind it is correct. Nevertheless, provisions are already in force under the Medicinal Products (Prescription and Control of Supply) Regulations 2004, which define the term "supply by mail order" as "supply made, after solicitation of custom by the supplier, or by another person in the chain of supply whether inside or outside of the State, without the supplier and the customer being simultaneously present and using a means of communication at a distance, whether written or electronic, to convey the custom solicitation and the order for supply." On the basis of this definition, the sale and supply of prescription-only medicines is already prohibited under the 2003 regulations.
The provision operates effectively in so far as mail order sellers in this jurisdiction are concerned because such persons commit a criminal offence once they engage in this type of activity. I welcome the fact that Senator Browne has highlighted this issue because we are dependent on the controls in force in other jurisdictions to restrict the making available of prescription medicines in their own jurisdictions and in respect of the supply of such products to purchasers in this country.
The Irish Medicines Board, in conjunction with officers of the Customs and Excise, is active in this area. The extension of the enforcement authorities which will be made available under the Bill to customs officers will be of great assistance in detecting the passage of such drugs through ports of entry in the State. Under the Bill, powers are also being given to all authorised officers, including officers of the Customs and Excise, to obtain information from various sources, including the various Internet service providers, to enable them to enforce compliance with our laws in this matter where there are reasonable grounds for believing that such prescription medicines are being transmitted in the post.
The legislation will significantly strengthen the enforcement side. The Department is satisfied that a penal provision governing the matter is already in place. In these circumstances, it is not necessary to include a provision such as that proposed by the Senator in the Bill. Nevertheless, I welcome the thinking behind the proposal because it is very much in line with the policies being pursued on this issue by the Department and the Irish Medicines Board. I assure the Senator that both bodies are well aware of the matter and anxious to address it.
I move amendment No. 5:
In page 36, line 4, after "charge" to insert ", including dental health,".
The inclusion in the legislation of provision for free dental care for children in primary school is interesting. I am aware that amendments Nos. 6 and 7 have been ruled out of order, but with your permission, a Chathaoirligh, I might cover that topic now, if possible, because they are linked in my view.
The amendment seeks to insert the words "including dental health" because primary school children require proper dental health facilities. I was surprised by this section as I was not aware that dental health came within the remit of the Bill. I will leave it at that and will speak later on amendments Nos. 6 and 7 that were ruled out of order.
The importance of dental health came late to us in the health service. We should try to promote anything that protects the health of schoolchildren and dental health is an important part of that. That is why I support the amendment. Children may require orthodontic treatment after they leave primary school, which makes it important to accept this amendment. I am sure the Minister of State's heart will be behind it, but the issue is one of cost. Given that we are in such good funds, as we were told in yesterday's Budget Statement, surely the Minister of State will be able to include this provision.
This is an interesting amendment which I will have to address. Senators Browne and Bradford are seeking to amend section 66(2) of the Health Act 1970. That section is the provision which covers making available without charge a health examination and treatment service for pupils attending a national school. It is being amended within this Bill to cover all primary schools, hence Senator Browne has seized his legislative opportunity to clarify that dental health is encompassed by section 66(2) of the 1970 Act. Of course, however, the practice concerning the provision of health examinations of pupils attending primary schools has always encompassed the concept of a dental examination. Therefore, the Department takes the view that the relevant subsection has always covered dental health and that the concept of health is broad enough to include dental health.
Senator Henry makes the point that we have been slow in recognising dental health, but if one examines the section, the concept of health itself encompasses dental health for the purposes of that particular subsection. It cannot be qualified in this way in legislation, otherwise other forms of health care would be required to be included in the section as well.
As the Minister of State has correctly pointed out, it is happening anyway and children in primary schools are being examined for dental health purposes. My amendment sought to include such a provision in the Bill once and for all. The term "health examination" is very vague — it could mean taking blood pressure, as well as aural, oral or optical tests. Since it is happening anyway, it would not make any difference if it were to be included. It would just clarify the situation, removing any ambiguity concerning dental care for children.
I wish to thank the Minister of State, his officials and all Members for their contribution to this important legislation. It is a landmark Bill in terms of what it proposes to do. I welcome the fact that a number of my former nursing colleagues will, in certain circumstances and categories, be able to prescribe. I take on board the concerns that have been expressed about the IPU. I have expressed those concerns myself, but I am assured by what the Minister of State had to say in that regard. I believe that in the fullness of time this matter will be addressed.
I thank you, a Chathaoirligh, and everyone else concerned, especially the Minister of State.
I congratulate the Minister of State and his officials. I am particularly glad to see Mr. Tom McGinn here today because he and I go back a long way in the health sector.
It might be a good idea to reconsider our views of visits to GPs, so that such visits that do not result in a prescription for antibiotics would not be classified as failures. We are talking all the time about MRSA, but we are not making the dangers involved in the abuse and overuse of antibiotics clear enough to the general public. The Minister of State might consider using this opportunity to bring that matter to public attention. When I discussed this Bill with some members of the public I was asked, "Why shouldn't nurses prescribe you four, five or six antibiotic tablets? Wouldn't that be grand?" That gives an appalling notion of how people think antibiotics should be prescribed.
The provisions of the Bill will be useful for people in palliative care who, for example, will not have to wait for morphine or pethadine to be prescribed because nurses will know what they can do for those patients. That is worthwhile.
I was interested in the Minister of State's explanation regarding paramedical staff who have been trained for pre-hospital care. I hope that action is taken in this area by way of regulation as soon as possible. A pilot study in Donegal involved GPs giving thrombolitic therapy as early as possible and they had much better rates of recovery from heart attacks than in cases where it was not possible to give such medication immediately.
I wish the Minister of State well with the Bill and hope it will be enacted as soon as possible. He should try to launch a publicity campaign about antibiotics, which are serious drugs and should not be taken in a haphazard manner. In addition, ambulance paramedics, who are now highly trained, should have the right to administer thrombolitic drugs in particular.
I thank Senators, the Minister of State and his officials for facilitating the passage of the Bill through the House. I must record my deep unhappiness about the Bill in general, however. When the Bill was first presented I thought it was quite a simple and uncomplicated measure, but it has turned out to be somewhat different than planned. I am not happy with the Government's approach to introducing large numbers of amendments after a Bill is published. It is not the way to do business. The Minister of State's senior colleague at the Department of Justice, Equality and Law Reform, Deputy McDowell, seems to specialise in it. I have been told that it is done regularly in that Department, but it is not a good way of dealing with legislation. It will leave us wide open to criticism in future. I understand the need to introduce amendments after a Bill is published, but there is a limit to that procedure.
Members of the Opposition should be given full briefing notes, especially when an amendment is one page long, yet we got nothing on it. I do not know if they consider me a genius or a fool, but I hope it is the former.
I wish I had the ability to listen to a Minister reading out a one-page answer about a Government amendment and take it all in, but I cannot. The lack of briefing notes means that I am failing in my job on behalf of the electorate.
I compliment Senator Minihan who informed us on Tuesday that pharmacists in the North are able to prescribe. That information was not given to us beforehand, although it changes the nature of the Bill somewhat. I have a suspicion that the Bill is already out of date. I also suspect that by the time it goes through the Dáil in the new year, we will see major amendments tabled to it again. Consequently, the legislation will be back before this House.
The Bill is an important one, however, and there are some tricky aspects to it. For example, the sale of drugs on the Internet is an awkward matter to which there is no easy solution. The Minister of State might take on board some of our amendments in order to tighten up on that area. He should also consider including in the Bill a provision for dental care for post-primary students. There is a degree of ambiguity regarding children between the ages of 12 and 17 or 18 in the case of orthodontics in particular. That is normally when children get braces, and many parents find themselves either unable to make an appointment with an orthodontist or having to pay massive sums running to thousands of euro for their teenage child to have them fitted. There may be scope in this Bill to introduce an amendment to extend coverage from primary to post-primary level. That might overcome that issue, as recommended by the relevant sub-committee of the Committee on Health and Children, which dealt with orthodontics. It would make Government policy consistent.
I spoke on only one aspect of this Bill on Committee Stage, namely, pharmacists, which was taken up again today. I reiterate that the Bill is lacking in that regard. In an era of cross-Border co-operation, particularly regarding the Border counties themselves, having two different regimes for prescribing medicines is difficult. It will be difficult from the perspective of medical records, and we will have no access to the records of a person availing of a pharmacist's prescription in Northern Ireland or the Border counties who is subsequently admitted to hospital in the Republic. I fully understand that there are professional and business interests associated with a pharmacist having the power to prescribe.
At no stage did I ever suggest that there be a general prescription. However, in co-operation between GPs, patients and pharmacists, we could remove a burden from the health system through allowing, with the proper protocols and procedures in place, pharmacists to prescribe, particularly in the case of repeat prescriptions. I had hoped that the Bill might introduce provisions to enable the Minister at some stage to make regulations to give effect to pharmacists prescribing when the time is right and when the right protocols are in place. I regret that this Bill has not addressed that issue.
Outside that, the Bill is necessary, and I welcome it. I thank the Minister of State and his officials for their work.
I thank Senators Glynn, Minihan, Henry and Browne for their assistance with this legislation. I very much agree with what Senator Henry said about the dangers of prescribing and the public's assumption that a visit to a doctor necessarily entails the acquisition of a controlled drug or any other strong substance. That need not necessarily be the case. A doctor's first function is to diagnose, and there are many remedies for different complaints that do not require the consumption of a drug.
That is a timely warning. Whether we like it or not, it is very visible in the Estimates of expenditure for the Department of Health and Children that there is a great deal of consumption when it comes to controlled pharmaceutical drugs in our country and culture, and we must make the necessary legal arrangements for them. I accept Senator Browne's criticism on the chin that the Minister and I have been slow to introduce these amendments. However, they are important and improve the legislation by introducing some degree of flexibility regarding the prescribing of drugs, something touched on in the amendments tabled by Senators today.
The Bill is valuable legislation and will strengthen our powers of regulation in this area. I thank the Senators for a very interesting debate and for the quality of the contributions they made to it. I wish Senators a very happy Christmas and a peaceful new year. Is this the last session?