Léim ar aghaidh chuig an bpríomhábhar

Seanad Éireann díospóireacht -
Wednesday, 30 Nov 2005

Vol. 182 No. 1

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


Amendments Nos. 1 to 3, inclusive, are related and may be discussed together by agreement. Is that agreed? Agreed

Government amendment No. 1:
In page 5, before section 1, to insert the following new section:
"1.—(1) This Act may be cited as the Irish Medicines Board (Miscellaneous Provisions) Act 2005.
(2) The Misuse of Drugs Acts 1977 and 1984 andPart 2 may be cited together as the Misuse of Drugs Acts 1977 to 2005 and shall be construed together as one.
(3) The Irish Medicines Board Act 1995 andPart 3 may be cited together as the Irish Medicines Board Acts 1995 and 2005 and shall be construed together as one.
(4) The Control of Clinical Trials Acts 1987 and 1990 andPart 4 may be cited together as the Control of Clinical Trials Acts 1987 to 2005 and shall be construed together as one.
(5) The Health Acts 1947 to 2005 andPart 5 shall be construed together as one Act and the collective citation the ‘Health Acts 1947 to 2005’ shall include Part 5.
(6) This Act shall come into operation on such day or days as the Minister for Health and Children may appoint by order or orders either generally or with reference to any particular purpose or provision and different days may be so appointed for different purposes or provisions.".

Amendment No. 1 seeks to delete section 1 of the Bill and replace it with a new section, which gathers together all the citations and commencement provisions. These amendments were originally suggested by the Labour Party but have been slightly amended based on advice received from the Office of the Parliamentary Counsel. I, therefore, cannot accept amendment No. 2. I thank Senators for their contributions. As a result of amendment No. 1, citations in sections 7, 19 and 24 have been deleted.

Amendment No. 3 provides for the insertion of a new section to provide a standard provision regarding enactment. This is a technical amendment. The new section arises as a result of grouping all the citations in one section.

This Bill is one of the most badly constructed pieces of legislation I have seen in my political career. I have no argument with any issues it contains. The Short Title of this Bill is the Irish Medicines Board (Miscellaneous Provisions) Bill and it incorporates amendments to the Irish Medicines Board Act, the Control of Clinical Trials Acts, the Misuse of Drugs Acts and the Health Acts. A generation of lawyers will be kept occupied tracking down amendments to the Health Acts alluded to in a Bill that will not refer to that fact in its Short Title. I would like to claim credit for this insight but it came from a lawyer friend who does such work for the Labour Party.

The Government amendment is better than the Labour Party amendment and is necessary. However, I dispute the manner in which the Bill has been introduced although it does not affect this particular amendment. I am very concerned about making amendments to four different Bills. The amendments to the Health Acts concern the provision of health services and have nothing to do with the Irish Medicines Board. This House ought to assert that the short titles of Bills should contain material relevant to what reasonable people would assume to be their content, as opposed to the Department of Health and Children's practice of tacking on every additional piece it can think of to a Bill. It is poor legislative practice that will make more money for more lawyers and will probably expose the Department to increased litigation in the future.

A good symptom of the peculiar way the Department conducts much of its business, which culminated in the financial disaster relating to nursing homes last year, is the fact that it puts legislation together in this way. This Bill is a mishmash and should have been called the Health (Miscellaneous Provisions) Bill. I agree with the Bill's content, although I have queries regarding nurse prescriptions and professional liability. These issues should have been addressed in separate Bills.

Amendment agreed to.
Section 1 deleted.
Amendment No. 2 not moved.
Government amendment No. 3:
In page 5, before section 2 but in Part 1, to insert the following new section:
"2.—A reference in this Act to any enactment shall be construed as a reference to the enactment as amended, adapted or extended by or under any other enactment including this Act.".
Amendment agreed to.

Amendments Nos. 4 to 7, inclusive, and Nos. 9, 38, 47, 48, 50, 51 and 64 are related and may be discussed together by agreement.

That is a lot of amendments to take together. Amendment No. 38 is one page long. I am not trying to be unhelpful but one might like to ask questions about some of these amendments. Organisational convenience may have to be subordinated because it is the privilege of the House to refuse to agree to group amendments. However, I do not wish to do that.

Amendment No. 38 is the main amendment and the others are related or are consequential.

Perhaps the Minister of State would be kind enough to talk about amendment No. 38. I am not trying to speak for Senator Browne either.

There are many typographical errors in the Bill which would back up the claim by Senator Ryan about it being a bit rushed and badly thought-out. What are the implications of typographical errors? I have never seen a Bill with so many missing full stops, inverted commas, etc. Are there any implications apart from grammar? Perhaps the Minister of State will expand on amendment No. 38.

Many of the amendments are consequential on other amendments. When legislation is amended, full stops and commas are required with the addition of extra text.

It is unusual to see so many typographical errors. One normally sees one or two in a Bill.

One finds that with every Bill.

Not to the same extent.

Does the House agree to grouping these amendments? Agreed.

Government amendment No. 4:
In page 6, line 3, to delete "profession;"; and substitute "profession;',".

Amendments are being made to the Irish Medicines Board Act, the Misuse of Drugs Acts and the Health Act 1970 to allow regulations to be made for nurse prescribing. 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 the procedures to be complied with in the issue of such prescriptions will be set out in regulations under the Irish Medicine Board Act and in accordance with the standards and requirements of An Bord Altranais.

Amendments Nos. 4 and 5 are technical amendments. Amendment No. 6 amends the definition of "practitioner" in the Misuse of Drugs Act 1977 to include a registered nurse. It also defines a "registered nurse" as a person registered with An Bord Altranais. This is required for the introduction of nurse prescribing as provided for in amendments Nos. 7, 9 and 64 as well as in part of amendment No. 38.

As regards amendment No. 7, a new section is being inserted to amend section 5 of the Misuse of Drugs Act 1977. This will allow regulations to be made to permit registered nurses or classes of registered nurses to prescribe certain controlled drugs. A new subsection 1A is being inserted which stipulates that the Minister shall only make regulations in respect of nurses where he or she is satisfied that it is safe to do so following consideration of the type of controlled drug concerned.

Subsection (c) excludes a nurse from the provision of section 5(2)(a) which allows a registered medical practitioner, a registered dentist and a veterinary surgeon to prescribe, administer, manufacture, compound or supply a controlled drug. A new subsection is being inserted so that regulations can be made in order that it is not unlawful under the Misuse of Drugs Act for nurses, subject to section 13 of the Misuse of Drugs Act, to prescribe, administer, manufacture, compound or supply a controlled drug. These subsections facilitate the making of regulations for nurse prescribing for certain controlled drugs in specified circumstances.

As regards amendment No. 9, a new section is being inserted to amend section 8(7) of the Misuse of Drugs Acts 1977, as amended by section 3 of the Misuse of Drugs Act 1984. 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.

As regards amendment No. 38, the amendment inserted between lines 29 and 30 inserts two new paragraphs (l) and (m) which deal with different issues. The main purpose of paragraph (l) is to provide power to the Minister to make regulations, which would provide for nurse prescribing in certain circumstances as would be set out in the regulations. In the context of this provision, it also became necessary to set out in the Bill all those who would be entitled to issue prescriptions for prescription-only medicines under any regulations that would be made.

Subparagraph (i) of the new paragraph (l) is intended to continue the traditional position in relation to practitioners’ ability to prescribe medicinal products within the scope of their professional practice. Subparagraph (ii) establishes the entitlement of nurses to issue a prescription in respect of medicinal products as may be specified by regulations. Provision is made so that the authority to issue prescriptions could be made available to nurses generally or to nurses of a particular class having regard to the particular education and training of the class of nurse concerned. It is also provided that the issuing of prescriptions by nurses shall be subject to such conditions, if any, as may be set out in the regulations.

Subparagraph (iii) provides for the supply of medicinal products in certain emergency circumstances in accordance with provisions that would be set out in regulations. This also preserves the limited authority available to pharmacists to supply certain medicinal products in certain emergency situations and the availability of certain medicinal products for use by emergency medical technicians, that is, ambulance personnel.

Paragraph (m) has, as it main purpose, the prescription and non-prescription control of medicinal products as classified by the Irish Medicines Board acting in its capacity as the competent authority for the granting of marketing authorisation in respect of medicinal products placed on the market in this country. Products which are not to be subject to prescription control may also be controlled by being made available only in pharmacies and, as appropriate, in other outlets according to the classifications in that respect to be assigned by the board.

This arrangement will enable regulations to be made to give direct effect to the various classifications that are currently being assigned by the Irish Medicines Board in the grant of the relevant marketing authorisations. This proposed control in respect of non-prescription products is a national control and is intended to rationalise the current three-tiered system that has, to date, operated in respect of medicinal products. The three tiers are those specified in the Irish Medicines Board product authorisations, the prescription and control of supply regulations and in the poisons regulations. As part of this rationalisation process, it is intended to remove medicinal products for human use from the scope of the poisons regulations.

Amendment No. 47 proposes the insertion of two new subsections (11) and (12) into section 32 of the Irish Medicines Board Act. Subsection (11) refers to the proposed regulation-making powers under the new subsection (2)(1) which relates to the control of medicinal products on prescription and the issue of prescriptions. This new subsection sets out in greater detail the criteria to be taken into account in the introduction of the prohibitions and exceptions that may be made in regard to the issue of prescriptions and the supply of medicinal products on foot of such prescriptions, including those medicinal products that may be supplied on the prescription of nurses or certain classes of nurses.

Subsection (12) refers to the proposed regulation making powers under the new subsection (2)(m)(ii) which relate to those non-prescription medicinal products that may be sold otherwise than in pharmacies. This subsection sets out in greater detail the criteria which would be applicable to such products in terms of their nature, purpose and safety.

Amendment No. 48 is a technical amendment as a result of the earlier insertion of new subsections (11) and (12). Amendment No. 50 is a technical drafting amendment arising from amendment No. 51. Amendment No. 51 inserts a new subsection which defines "relevant profession" for the purposes of subsection 2(k) which enables regulations to be made in regard to who may administer medicinal products and subsection 2(1) which relates to the control of medicinal products on prescription. This is a generic description, which is intended to cover registered medical practitioners, and registered dentists who heretofore had a traditional entitlement to administer to patients under their care all classes of medicinal products which they considered necessary for the treatment of their patients.

Amendment No. 64 provides for the amendment of section 59(2) of the Health Act 1970 to allow for prescriptions written by nurses to be reimbursable under the drug treatment schemes. Eligibility for free medical services and drugs under the Health Act 1970 is provided for under sections 58 and 59(1) for fully eligible persons, that is, those in the GMS scheme; and under section 59(2) and (3) for limited eligibility persons under the drugs payment scheme and the long-term illness scheme. It is necessary to amend section 59(2) in regard to the drugs payments scheme. The existing subsection (2) provides for reimbursement of expenditure on drugs, medicines and medical and surgical appliances by limited eligibility persons, above the defined monthly threshold for the DPS, on the prescription of a registered medical practitioner. The proposed amendment would permit the reimbursement to a contracted pharmacist of the prescription of a registered nurse within the parameters to be defined for such prescribing.

This is ridiculous. There is no other word to describe it. Nobody in this House knows what the Minister of State has just said and I am no less intelligent than anybody else in this House, nor am I less intelligent than the people who drafted these amendments or the Minister. I do not claim to be brighter than any of them but I have never in my life been in a situation like this before. I have dealt with complicated company law — and I am not a lawyer — and I have not had this problem. The correct thing to do if they are going to rewrite it like this is to withdraw the Bill, add in all these amendments and reintroduce it.

Hear, hear.

This House has never held up legislation and it is extremely efficient at processing it. We do not cause delays. We wait and we ask. Most of the time in this House we are either waiting for the Dáil to finish legislation or for the Government to be ready to move with it. We do not hold up legislation either by inertia or deliberate intent and none of us is an innocent in politics. This is a good legislative House.

I do not have a script from the Minister of State and I can only remember so much of what he said. This is a profound change, one to which I do not have any principled objection. The Minister of State referred to subsection (i) of new paragraph (3) of an amendment. This is entirely wrong. If I had any sense I would just leave but I am not going to.

I have a number of questions. I am not even in a position to state to which amendments they refer because I do not know. The fundamental change to the legislation is both necessary and correct but it must be clear where the professional liability will lie if a nurse prescribes erroneously. Some people suggest to me, including people very close to me, whose existence I do not have to advert to every time I speak here, that the professional liability will still lie with the medical practitioner and that in the event of a prescribing error it is not clear that a nurse would be professionally liable but that it may well be the doctor under whose supervision the nurse is working.

That question must be answered with absolute clarity, otherwise the Minister is heading for another big row with the medical organisations, one in which the medical organisations will have right on their side. The legislation must contain clarity on where professional liability begins and ends in terms of culpability for negligence. It appears that professionals are to be liable for the errors of others. We cannot leave this matter unclear and I have seen nothing in the amendments to provide clearly for it. The matter may be addressed but the more I have read of the amendments, the more my mind boggled.

Assuming we are only talking about nurses, I question why we have to introduce into our legislation terminology that is hopelessly dated. The Minister of State said that giving people the power to prescribe somehow involves giving them the power to compound and manufacture. I do not know if it does because I am totally confused. The Minister of State mentioned words like "compound" and "manufacture". I put it to him in his professional capacity that a reference to pharmacists compounding prescriptions is little more than a leftover from the way they used to do business. Pharmacists have a hugely important role as the interface in this transaction and as a second safety check but I am not sure they do much compounding any more, if at all. They do an extremely important professional job in terms of making sure that what the public gets is what has been prescribed and deal with ambiguities, uncertainties or even mistakes by those prescribing.

It is not clear how pharmacists will know what different grades of nurse are allowed to prescribe. The Minister of State said that certain nurses will be allowed to write prescriptions for certain substances but how will an individual pharmacist know whether Nurse Ryan is a psychiatric nurse or a palliative care nurse? We must know where that information will show up in a way that is clear. My spouse is a psychiatrist and when she writes prescriptions she regularly gets telephone calls from pharmacies to confirm the prescription because she is not a GP. This situation will now be multiplied.

I would like to know if the Department of Health and Children has thought out the process by which we can ensure a failsafe proof that prescriptions for palliative medicine in particular, which can have appeals to people other than those who need it, are valid. Increasingly, we have a corporatist pharmacy industry in which there is not an individual local pharmacy but a number of pharmacists employed by what is, effectively, in some cases nearly a multinational at this stage. Substances should be available to people that can help them palliatively, including some of the more controversial substances. If there is medical evidence that either heroin or cannabis is helpful to people who are sick I cannot accept there is any reason not to provide it for them. We must ensure that the chain of authorisation is clear. It may be my fuzzy head or advanced years but I choose to say it is the Minister of State's fault for producing amendments like this without back-up documentation. I do not know that these matters are dealt with in the proposed amendments. That is my first round.

I share Senator Ryan's view. I am very uncomfortable with this. I have never seen anything like it before in the three years I have been in the Seanad. I am also concerned the Minister of State may have a conflict of interests in his role as a former pharmacist. It is regrettable the Ministers of State, Deputies Seán Power or Brian Lenihan——

There is no need for that.

I am being fair to him. It is regrettable that neither Deputy Seán Power nor Deputy Brian Lenihan, who are also Ministers of State in the Department, was sent here today because it puts the Minister of State, Deputy Tim O'Malley, in a very awkward position dealing with this area as a member of the pharmacy profession. I do not make any apology for saying that. I say it out of respect for the Minister of State.

I fully agree with Senator Ryan. What we should do at this stage is withdraw the Government amendment until Report Stage and debate it on a different day. It is next to impossible to take in all the information that has been thrown at us in the space of a few minutes.

This has major implications and Senator Ryan alluded to some of them. The question that strikes me immediately is whether extra resources will be given to An Bord Altranais. I have limited dealings with the board on the issue of Irish nurses returning home after training or working abroad. It is under pressure dealing with those applications. It also has difficulty finding the resources to deal with the issue of recognising the qualifications of foreign nurses who wish to work here. This will put the board under extreme pressure. Nothing in the Bill provides it with extra funding or staffing. I wonder how well it will work out.

What are the implications for ambulance crews? Will people on ambulance crews and fire services have the power to prescribe drugs? I am aware that in Dublin the fire service works on a different system to the rest of the country. It is run like an ambulance service and has extra powers. What are the implications of amendment No. 38 for ambulance and fire services?

I urge the Minister of State in the interests of co-operation and fairness to park this series of amendments. Let us have time to digest and examine them and make sure we are proceeding in a correct manner instead of the farcical scenario of returning in a few months' time to put forward further amendments after realising we rushed this through. I urge the Minister of State to leave this amendment to Report Stage. Let us think about it for a week. Hopefully, it will work out fine.

Fine Gael has no objection to nurses having the power to write prescriptions. It makes sense. However, we must work out the details and make sure we are not taking an action that will backfire on us.

I thank Senators Ryan and Browne for their contributions. I am surprised by the comments made by Senator Browne on a conflict of interest arising because I am a pharmacist. I would like the Senator to spell out how it is a conflict of interest. I do not see any. On the contrary, the fact that I am a pharmacist helps me to understand it. Does it mean that a Minister who was a farmer could not take any matter pertaining to farming, or that if I were a businessman I would have to leave if a matter pertaining to business was before the Seanad?

It is unfair.

It is extremely tenuous and unfair and it is the first time it was put to me. If a conflict of interest arose I assure Senator Browne I would not be here. This is enabling legislation and as it progresses I can foresee objections from pharmacists. I cannot apologise for being a pharmacist. It is what I am.

I do not expect the Minister of State to apologise. The Department of Health and Children has three Ministers of State. It would have been preferable if the Minister of State with a pharmacy background did not take the Bill. I do not apologise for that.

Will Senator Browne qualify that statement and explain why he made that comment? I do not understand it. The other Ministers of State are unavailable and I see no conflict of interest. If Senator Browne pursues that line of thought he must explain where the conflict of interest lies.

I welcome the comments made by Senators Ryan and Browne on the Bill. It is somewhat confusing, particularly for those such as myself seeing the Bill for the first time. However, I am willing to take the word of the Minister of State and his officials that everything is in order and that the concerns raised by both Senators, particularly those raised by Senator Ryan, will be addressed by the Minister of State in his comments. It is unfair of Senator Browne to even suggest that the Minister of State has a conflict of interest in this Bill. In the interests of fair play I ask Senator Browne to withdraw the remark.

I do not want to do this, but I do not agree with Senator Browne. Apart from anything else, I am married to a medical practitioner and if the Minister of State has a conflict of interest, so do I. Deputy Micheál Martin was before the House putting through an education Bill and he is a teacher. I do not accept Senator Browne's point. If I felt the Minister of State was representing pharmacists I would be the first to tell him. I do not believe that. It does not mean I am in any way less displeased with how this Bill is being dealt with.

I will attempt to answer some of the questions. On the issue of accountability and clinical indemnity, it is important that these issues are addressed during consultation, and a great deal of consultation with professionals will take place to allay doctors' fears and ensure they are dealt with if unforeseen issues arise during implementation .

Senator Ryan asked whether doctors will be held accountable for the prescribing decisions of nurses and midwives. The answer is "No". Nurses and midwives are accountable for their own professional practice and competence. The authority to prescribe medication will require the individual practitioner to be responsible for the prescribing decision, which is the nurse in this case. An individual not involved in determining the medication treatment plan cannot be held accountable. Communication and collaboration among the health care team is essential in sharing the plan of care of patients and clients, particularly as it relates to medication management. On that point, Senator Ryan also asked about errors made in prescription by a nurse. It is the professional responsibility of the pharmacist to pick up errors made in prescriptions, regardless of who prescribed.

On the question of clinical indemnity, nurses working in hospitals or other agencies covered by the clinical indemnity scheme are insured to undertake any practice which is in accordance with the law and any stipulations by An Bord Altranais regarded as falling within its area of responsibility. The clinical indemnity scheme is based on the principle of enterprise liability. The employer is covered and assumes vicarious liability for the acts and omissions of employees. The clinical indemnity scheme covers public hospitals and other agencies funded by the Exchequer. It does not cover GP practices.

Senator Ryan also asked a question on identifying prescriptions. When the GMS started, numbered medical pads with the name of the doctor were introduced, and only prescriptions on those pads are accepted by pharmacists. Only doctors who are registered can prescribe. The same system will apply for nurses. I agree with Senator Ryan that it will be a technical matter to sort out the classes of nurses who will be allowed to prescribe. It will be done by regulation following consultation with An Bord Altranais and the nursing profession. It has been done in other countries. It will take a great deal of agreement and consultation but it can and will be done.

Compounding is a term used. Senator Ryan is correct to state that pharmacists do little compounding, but it was done up to a few years ago and pharmacists are still competent to do it. EU regulations have changed it and a problem now exists with pharmacists using broken packs. It is extremely difficult for pharmacists to compound extemporaneously. It is still done in hospitals and in the community but not as much as before.

If it is still done I agree it should be included. Does the Minister of State agree that if this were done properly we could have had a far more enlightened and informed debate? I have no issue with what the Minister of State proposes. Changing a practice that has been done here and in most other countries for an extremely long time must be done in a comprehensible manner. If ever there is an argument for two Houses of the Oireachtas, this is it. As this Bill emerges from this House a proper debate will take place in the other House but that is no consolation to those of us addled by this procedure.

Last summer I had the pleasure of visiting what I claim to be the oldest pharmacy in Europe, located in Dubrovnik. It looked quite different to the Minister of State's former place of work.

I reserve the right to examine this amendment and consider further amendments on Report Stage. I must read the Minister of State's detailed explanation of this group of amendments, particularly amendment No. 38.

This Bill expands the number of people that can write prescriptions. This has the potential to lead to increased business for pharmacists. We see major commercialisation of pharmacies, with health centres built around the country, complete with in-house pharmacies. There are more and more commercial features. I will withdraw my comment and I did not intend to be personally unfair to the Minister of State.

To ensure we debate this Bill correctly, I ask the Minister of State to withdraw this amendment and table it on Report Stage. By that time we will have had the opportunity to digest and debate it.

I accept Senator Browne's apology.

I did not apologise.

I agree with some of the comments on the commercialisation of pharmacies and share some of Senator Browne's reservations on the globalisation of my profession. I do not always get my way.

Much legislation is being brought together to allow nurses to prescribe and for the use of drugs by ambulance technicians. Much existing legislation is being amalgamated and we should proceed with the legislation before us. As Senator Ryan stated, this Bill must be passed by the Dáil, at which point amendments can be made.

An Bord Altranais has completed a major review of prescribing and has set up an implementation project. There will be no significant funding issues and work has already been done on the educational requirements and standards for nurses to prescribe. Ambulance technicians are employees of the service providers involved and are not covered by this legislation. This legislation provides that they can use the drugs but they cannot prescribe them.

They will administer drugs.

They will administer drugs, as happens in other EU countries. In the heel of the hunt it is best for the patient as the drugs are administered quicker than if one had to wait for doctors to administer them.

Perhaps I am the one with the conflict of interest. What about nurses not employed in the State sector? Erroneous prescription of drugs and adverse side effects are two reasons doctors or their professional indemnity insurers have had to pay substantial sums of money. If these mistakes are made by nurses not employed by the State and if they are to be covered by professional indemnity insurance, nurses will pay insurance policies comparable to those of the most expensive sections of the medical profession until the matter was resolved recently. I wonder what happens in other countries. Perhaps those people do not sue but one will never stop Irish people from suing.

Nurses would not be able to prescribe drugs unless registered with An Bord Altranais. Professional liability will lie with the nurse if he or she does something incorrect. The counterbalance is the pharmacist, who has responsibility for the prescription being correctly written. Liability resides with the pharmacist if a prescription that is incorrectly written is dispensed. It is envisaged that a small number of nurses will prescribe when regulations come into effect. Much discussion will take place with the nursing profession.

Regarding Senator Ryan's point on liability, these regulations will not happen unless the nursing profession and An Bord Altranais are on board. It would be foolish to allow legislation to be passed if it were against the wishes of the professional body.

I do not wish to delay the House. I believe I am doing fairly well, considering the state of matters.

I agree.

It has been suggested that in many areas of delegated responsibilities, where the senior medical person is no longer the person who is professionally liable, there is widespread reluctance to use the delegated authority. People are aware they are open to major legal consequences. We must reassure professionals that as long as they act in an appropriate fashion, taking what peers determine to be appropriate levels of care, they will not be subject to legal actions which they cannot sustain. This is true of all professionals and everybody is responsible for doing a job competently and to an acceptable standard.

Regarding the other Bill I have debated with the Minister of State, concerning sub-professions within medicine and social care, people in those professions should also meet a certain standard. When people meet that certain standard they should not have to worry about the possibility of being sued for doing their job in a way everyone regards as competent but which sometimes results in unfortunate consequences. This applies to consultants as well as nurses.

I would have wished we could have debated this in a different manner as it requires further discussion.

Senator Ryan's point is valid. In the United Kingdom, many general practitioners in the national health service write a considerable number of prescriptions, thereby freeing doctors to do more necessary work. This system has worked despite fears that major problems would arise. I understand the problems to which Senator Ryan alludes but legitimate fears about delegation of responsibility and opening up professions can often be overcome. Proper consultation and working as a team are essential.

Amendment agreed to.
Government amendment No. 5:
In page 6, line 8, to delete "1995;" and substitute "1995,".
Amendment agreed to.
Government amendment No. 6:
In page 6, between lines 8 and 9, to insert the following:
"(c) in the definition of ‘practitioner’, by substituting , ‘a registered veterinary surgeon and a registered nurse’ for ‘and a registered veterinary surgeon’, and
(d) by inserting the following after the definition of ‘registered medical practitioner’:
‘"registered nurse" means a person whose name is entered in the register of nurses maintained by An Bord Altranais under section 27 of the Nurses Act 1985;'.".
Amendment agreed to.
Section 2, as amended, agreed to.
Government amendment No. 7:
In page 6, before section 3, to insert the following new section:
"3.—(1) Section 5 of the Misuse of Drugs Act 1977 is amended—
(a) in subsection (1), by substituting the following for paragraph (f):
‘(f) subject to subsection (1A) of this section, regulating the issue by—
(i) registered medical practitioners, registered dentists or registered veterinary surgeons, or
(ii) registered nurses, or registered nurses belonging to a class of registered nurses,
of prescriptions for controlled drugs and the supply of controlled drugs on prescription,',
(b) by inserting the following after subsection (1):
‘(1A) The Minister shall only exercise the power to make regulations under subsection (1)(f) of this section in the case of registered nurses, or registered nurses belonging to a class of registered nurses, if the Minister, after having had regard to the nature and purpose of the controlled drug concerned (including any deleterious effects which may arise from the misuse thereof), is satisfied that it is reasonably safe to permit the issue by registered nurses, or registered nurses belonging to a class of registered nurses, of prescriptions for that drug.’,
(c) in subsection (2), in paragraph (a), by inserting ‘(other than a registered nurse)’ after ‘practitioner’, and
(d) by inserting the following after subsection (2):
‘(3) Subject to section 13 of this Act, the Minister may exercise the Minister's power to make regulations under this section so as to secure that it is not unlawful under this Act for a practitioner who is a registered nurse, or a practitioner who is a registered nurse belonging to a class of registered nurses, for the purpose of the practitioner's profession as a registered nurse, to prescribe, administer, manufacture, compound or supply a controlled drug if the Minister, after having had regard to the nature and purpose of the controlled drug (including any deleterious effects which may arise from the misuse thereof), is satisfied that it is reasonably safe to permit the practitioner, for the purpose of the practitioner's profession as a registered nurse, to prescribe, administer, manufacture, compound or supply that controlled drug.'.".
Amendment agreed to.

I move amendment No. 8:

In page 6, to delete lines 31 to 33, and substitute the following:

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

This amendment refers to accountability because there seems to be no accountability at the head of the organisation. Fine Gael is concerned that the circumstances raised by Senator Ryan could arise, whereby an individual nurse could be held personally liable. That might cause problems down the line, especially where a person is working for a major GP service. Fine Gael wishes the chief executive of the organisation to accept responsibility and liability. What are the implications if a nurse was sued for millions of euro and did not have the money to pay the litigant?

The wording in the Bill is standard when dealing with offences relating to body corporates. The wording would also cover the chief executive officer, but to limit responsibility to the CEO alone is considered too narrow an approach. For example, managers, who may not be CEOs, may be responsible for a pharmacy and therefore, must also remain liable if convicted of an offence in connection with controlled drugs. For this reason, I cannot accept the amendment.

Amendment, by leave, withdrawn.
Question proposed: "That section 3 stand part of the Bill."

On section 3, the word "secretary" is wide open to interpretation, unless the Minister of State can quote company or other legislation to the contrary. The word had a definite meaning at one point in time but it is strange to include it in this Bill. I have always objected to the use of the word when it arises in these types of circumstances because it is a term from another era.

All I can say is that this wording is the recommendation of the Parliamentary Counsel and is the way the issue has been dealt with to date. Whether one likes it or not is another issue. The Bill refers to "any director, manager, secretary or other official of a person referred to in paragraph (a)” and secretary is included to cover everyone.

Question put and agreed to.
Government amendment No. 9:
In page 6, before section 4, to insert the following new section:
"4.—Section 8(7) of the Misuse of Drugs Act 1977 (as amended by section 3 of the Misuse of Drugs Act 1984) is amended—
(a) in paragraph (c), by substituting ‘Council, ‘for ‘Council.’, and
(b) by inserting the following after paragraph (c):
‘(d) in case the practitioner concerned is a registered nurse, to An Bord Altranais,’.”.
Amendment agreed to.

Amendments Nos. 10 to 13, inclusive, are related and may be discussed together by agreement.

I move amendment No. 10:

In page 7, line 16, to delete "accordingly."." and substitute "accordingly."

This amendment corrects a typographical error.

The licences referred to in this section are those issued by the Irish Medicines Board, in connection with the operation of the various licensing schemes under the UN Conventions on Narcotic Drugs and Psychotropic Substances. These licences, permits, authorisations and so forth are issued to manufacturers, suppliers and wholesalers of controlled drugs. On occasion they are also issued, for the purposes of research, to universities.

Senator Browne's amendments relate to nurse-prescribing but I have made provision in the Government amendments to enable this. With regard to paramedical staff, an advanced paramedic training programme commenced this year and ensures that ambulance personnel can administer an additional 19 medications, including, for example, cardiac medicines. A statutory basis has been provided for this scheme and, therefore, I cannot accept these amendments.

The main point of amendments Nos. 11 to 13, inclusive, is to ensure that nurses undergo training. While a nurse may be registered, medicine is constantly evolving and new drug treatments come on stream regularly. In that context, it is important that nurses be required to undergo additional training on a regular basis to update their skills. That is the simple point Fine Gael is making with these amendments.

It is a sine qua non that nurses, doctors, pharmacists and others involved in this area would undertake continuous education courses. No profession would claim that once individuals are qualified, they do not need postgraduate education. An Bord Altranais ensures that continuous education takes place among nurses. That would be happening automatically, in effect.

Amendment put and declared lost.

I move amendment No. 11:

In page 7, between lines 16 and 17, to insert the following:

"(4) The Minister may grant limited licences, permits or authorisations, to a registered nurse, who has undergone such training as is specified from time to time by the Minister, to prescribe certain specified medication.".

Amendment put and declared lost.

I move amendment No. 12:

In page 7, between lines 16 and 17, to insert the following:

"(4) The Minister may grant limited licences, permits or authorisations, to certain paramedical staff, who have undergone such training as is specified from time to time by the Minister, to prescribe certain specified medication.".

Amendment put and declared lost.

I move amendment No. 13:

In page 7, between lines 16 and 17, to insert the following:

"(4) It shall be the responsibility of the Chief Executive Officer of the hospital to which a staff member is attached, to ensure that that staff member has received the requisite training and education, to allow him or her to fulfil his or her duties in accordance with the terms of this Act.".

Amendment put and declared lost.
Question proposed: "That section 4 stand part of the Bill."

I was not in the House for the Second Stage debate but I read the Minister of State's contributions carefully, both his introduction of the Bill and his reply to the debate. I ask him to explain the practical implications of section 4. As I understand it, the aim of the section is to transfer what were the functions of the Minister to the Irish Medicines Board, which seems like an eminently sensible thing to do. However, does the section mean that, for example, a decision to allow cannabis or heroin to be prescribed for people who are ill, will be entirely a matter for the Irish Medicines Board or will the Minister still have a reserve function in that regard? I have struggled with various elements of the legislation so I now ask the Minister of State to prove that he has done the necessary research.

Section 4 amends section 14 of the Misuse of Drugs Act 1977 to allow for the activities of the Irish Medicines Board to include the granting of licences, permits or authorisations under the Misuse of Drugs Act. To date, this activity was carried out by the Department of Health and Children and is now being transferred to the IMB, which will be responsible for the management and supervision of the various licensing schemes.

To answer the Senator's question about allowing cannabis or heroin to be prescribed, under controlled conditions, by medical practitioners to terminally-ill patients, the Minister would have the authority to do so.

Would that power still rest with the Minister or the Irish Medicines Board?

The consent of the Minister would be required.

If that is the case, what difference will it make? It is always better for these decisions to be made by people who are somewhat detached from the maelstrom of politics. I accept that the medical jury is out on this issue but if there emerges significant medical evidence that heroin has palliative benefits or that cannabis is a suitable prescription for people with multiple sclerosis will there be a political row or will the competent professional body be allowed to decide? Might the Minister veto the Irish Medicines Board if it deems it necessary and appropriate that the two substances should be made available under controlled conditions?

This is another example of the Government moving accountability away from the Department of Health and Children to an independent body. I have no objection in this case but there seems to be a trend for this Government to continually take powers away from the Department. The downside to this is a lack of accountability. In future if people ask the Tánaiste and Minister for Health and Children about prescription drugs they will be told to ask the Irish Medicines Board. When the Bill is debated in the Dáil another section should be inserted to allow for accountability to the Dáil because otherwise, like in other areas, there will be none.

The Irish Medicines Board would make a recommendation to the Minister and the Minister would accept or reject it. It would not involve a political row because the Minister of the day would be foolish to ignore the recommendations of the board. The products must be licensed to be manufactured and used properly. The Irish Medicines Board has the expertise and is there to advise the Minister, who will make the final decision. I cannot envisage the Minister of the day making a decision against the wishes of the board.

I never claim to understand the logic by which Ministers make decisions. Many forces may be at work. I am trying to find out what difference this will make in practice. Is there to be a transfer of personnel from the Department of Health and Children to the Irish Medicines Board or are we simply legislating for the de facto situation that the board already makes recommendations to the Minister?

Senator Ryan's point is valid and it strikes me as similar to the Health Insurance Authority, set up to advise the Minister but whose advice on risk equalisation the present Minister has rejected.

The Minister of State did not answer my question on accountability. I become more confused every day as to the exact role of the Department of Health and Children. A huge amount of power has been devolved from the Department. We welcomed the formation of the Health Service Executive on this side of the House but are now beginning to change our minds because of the lack of accountability. It is anti-democratic because people cannot get answers to questions. Are we creating a similar situation with the Irish Medicines Board?

I do not have the regulation on the powers of the Irish Medicines Board but they have existed from the time of the National Drugs Advisory Board. There has been no addition to or diminution in those powers. Senator Browne is incorrect to say that this further diminishes the powers of the Department. The Department of Health and Children makes decisions for the Government on policy.

They are the words in the explanatory memorandum.

It is the responsibility of the Irish Medicines Board to advise the Minister on technical matters such as the usage and licensing of drugs, particularly the ones Senator Ryan mentioned. It already does that for all drugs to ensure legislation in Ireland is up to date, so there is no change. Many people try to circumvent legislation with counterfeit drugs and Members will be aware of a case in the past few days, about which I will not comment. The Irish Medicines Board must be vigilant of change and update the Minister accordingly.

There is an ongoing worldwide debate on the therapeutic effects of heroin and cannabis in limited situations.

I am still not clear. As Senator Browne said the explanatory memorandum states, the section enables "the Irish Medicines Board to issue licences, permits and authorisations in respect of controlled drugs for various purposes including manufacture and supply, import and export". If that is the case then the Minister has no function. If the Minister has a function then the board is not enabled to do that task.

My only problem with ministerial responsibility is the fact that Ministers want the glory. When the day arrives when a new road or motorway is not opened or announced by a Minister and both are done by the National Roads Authority I will accept there is no ministerial responsibility for building a road. What frustrates the Oireachtas is that Ministers want to be seen to make the announcement of good news but when life gets complicated they say it is not the Minister's responsibility. It either is or is not the Minister's responsibility.

I believe that decisions such as this are best taken by a group of competent people. I happened to agree with the Irish Medicines Board on St. John's wort but I must listen to other wise and experienced voices. I am satisfied St. John's wort is potentially dangerous and without regulation would do harm.

Wearing a different hat and declaring an interest, I teach people who work in the manufacture of pharmaceutical products. Does the Department currently, and will the Irish Medicines Board in future, provide licence approval for the export of pharmaceuticals out of the country? What work can the Department or the IMB do to deal with the significant Internet trade in what are effectively prescription drugs? I have no idea what harm is being done to people by drugs that have come through no quality assurance scheme. I am not trying to lead the Minister of State astray, but these are valid issues under section 4.

As far as I am aware, licences for the export of drugs will only be issued if they are being manufactured for export to other countries. Obviously manufacturers will be aware of the different regulations.

The point the Senator made about the Internet is a valid one. I share his concern on the matter. I have had a few meetings with all the different agencies involved. It is not just a problem in Ireland. It is a worldwide phenomenon which is causing serious problems.

The Senator is correct that we have no idea of the damage it is causing. Terrorists are involved and the Internet is also being used to launder money. What people think they are getting on the Internet may be totally different from what they get.

I had a meeting with the Irish Medicines Board, the Irish Patients Association, the Revenue Commissioners, the Garda and all the interested agencies. The Irish Patients Association, in agreement with the Irish Medicines Board, got a small grant recently to research further the matter and advise the Government on it. It is a serious problem which is getting worse. There are significant safety implications for vulnerable people such as psychiatric patients who may start to get medicines on the Internet which would not be prescribed for them or may already be prescribed by their psychiatrist. They may add to it with impunity without the intervention of other doctors. We are examining this area and I would be obliged if the Senator would make suggestions on the matter at any time. The Irish Patients Association, representing consumers, is very interested in this issue. I had several discussions with Mr. Stephen McMahon on the matter.

I would like to see a study on the market for Internet drugs in different countries, depending on the generosity of their public health service, in other words, in countries where people do not have heavy prescription charges, such as ourselves, for example. The drugs refund scheme is extraordinarily good for middle class families, in particular, but it hits people on a lower income. In countries where there are comparatively low pharmaceutical product prices, like France, people are in danger of killing themselves with the levels of pharmaceutical consumption. Is there any evidence that where people have access to comparatively cheap prescription medicine through their public health services there is a decline in the demand for Internet drugs and, by contrast, does one find a significant demand in a country like the United States which probably has the cruelest health service in the world?

I am unashamedly making a political argument for the idea of a publicly-provided, free at point of use health service. I would ask the Minister of State not to go the route of trying to blame the Internet service providers. This would be shooting the messenger because one does not like the message. It is reasonable in the case of the exploitation of children. It is a sufficiently grave matter involving so much human hurt. Whatever people do with Internet drugs, they are, by and large, doing it to themselves. This is a different level of hurt from the person who is exploiting children in order to sell their images on the Internet. I do not think we should go the route of trying to clamp down on ISPs. We must ensure that people have access to medication at a reasonable price, otherwise we are leaving them wide open to this problem.

Not only do we not have the information the Senator seeks, it is extremely difficult to get it because many of these companies are illegal and can move quickly from their country of origin. One may think one is sourcing a drug on the Internet from America, but it could come from anywhere in the world. We have had discussions on this matter. However, it is extremely difficult to get any handle on the quantities involved because one is basically dealing with an illegal activity.

Is there any evidence in this country of increasing numbers of people showing signs of being harmed because of this activity? I would not care so much if it was just placebos that were involved. I would not care if people just got an overdose of chalk from the tablets but I would be concerned if there were half attempts at making the active agent, containing God knows how many impurities in perhaps multiple doses. What is happening is ridiculous, because on any given night one could sort out one's love life, pharmaceutical needs and everything else on the Internet for allegedly no cost. Paradise is just round the corner.

I presume the Senator is speaking hypothetically.

Of course. My life is already sorted out.

The Irish Medicines Board is aware of the problem and there have been some arrests. There is good co-operation between the Irish Medicines Board and the Revenue Commissioners in regard to seizing drugs coming into the country and so on, but it is extremely difficult. If the Senator is interested, I would be pleased if he joined the working group because we need all the expertise available.

The story of my life is talking myself into work.

Question put and declared carried.
Question proposed: "That section 5 stand part of the Bill."

Did the form of the legislation cause problems? I have no problem with the amendment. Did the previous prohibition on the production of poppies inhibit people from celebrating great days in November? Is it something we included as a matter of good sense? The amendment proposes that we no longer prohibit the production of poppies unless it is for the production of opium. It used to be a blanket prohibition on the production of poppies.

No difficulties have been encountered in this area. It is inappropriate that the current prohibition should continue to apply.

Question put and agreed to.
Progress reported; Committee to sit again.