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Thursday, 26 Jan 2006

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

I welcome the Minister of State at the Department of Health and Children, Deputy Tim O'Malley, and his officials. With the agreement of members, I propose that the meeting should end no later than 1.30 p.m. Is that agreed? Agreed.


I move amendment No. 1:

In page 5, lines 30 to 32, to delete subsection (5) and substitute the following:

"(5) The Health Acts 1947 to 2001, the Health (Amendment) Act 2004, the Health Act 2004, the Health (Amendment) Act 2005 and Part 5 may be cited together as the Health Acts 1947 to 2006 and shall be construed together as one.”.

My legal advice is that the amendment which seeks to include a reference to the Health (Amendment) Act should have been included previously. I ask the Minister of State to accept it.

I thank Deputy McManus for tabling the proposed amendment. I advise her that the Health (Amendment) Act 2004 was repealed in its entirety by Schedule 4, Part 1, to the Health Act 2004. Therefore, my legal advice is that it is not necessary to make any further amendments to the citation.

Amendment, by leave, withdrawn.

Amendments Nos. 2, 3, 23 and 24 are related. They may be discussed together.

I move amendment No. 2:

In page 5, between lines 32 and 33, to insert the following subsection:

"(6) The Animal Remedies Act 1993 and Part 7 may be cited together as the Animal Remedies Acts 1993 and 2006.”.

The amendments have two main objectives, the first of which is to ensure an adequate legal basis for the collection by the Irish Medicines Board, IMB, of various fees arising from changes in EU legislation. The second is simply to use this opportunity to update and express in euro the penalties provided for under the Animal Remedies Act 1993 for breach of licensing and other requirements.

By way of background, I draw attention to the fact that under the Animal Remedies Act 1993 and regulations made thereunder, the IMB acts as licensing authority in respect of veterinary medicines, including all animal medicines, and the manufacturing plants in which such products are made. Section 29 of the 1993 Act provides the basis for the collection of fees for these services which are fixed by the Minister for Agriculture and Food with the consent of the Minister for Finance. New framework EU legislation governing veterinary medicines — Directive 2004/28 of the European Parliament and Council — has come into force in this area and has been transposed into national law by means of the Animal Remedies Regulations 2005, SI No. 734 of 2005.

One of the changes brought about by the new EU legislation is a shift away from time-bound to open-ended authorisations. This change puts greater emphasis on ongoing supervision by licensing authorities and reporting obligations applying to licence holders. To date, the emphasis has been on licences renewable after five years.

As I stated, the Animal Remedies Act provides an adequate legal basis for the charging of fees by the IMB in respect of these services. However, in view of the change in emphasis to open-ended authorisations, it is of critical importance to ensure the legal basis for fees charged by the IMB, both for human and veterinary medicines, is extended to cover the changed demands placed on the board by the new EU regulatory framework. Accordingly, the amendments to sections 8 and 29 make specific provision for annual fees in respect of open-ended licences. They also clarify the IMB's inspection role in regard to manufacturing plants and that fees are collectable for this activity, as well as for other services such as certification, etc.

With regard to the amendments to section 23, it is appropriate to bring the penalties under the 1993 Act fully up to date and express them in euro. I draw the committee's attention to the changes for summary offences where, on the advice of the Parliamentary Counsel's office, the maximum penalty which can be imposed in the District Court is being increased to €5,000 in line with the current norm.

Overall, the amendments are both prudent and appropriate for a measure which relates to the statutory activities of the IMB.

That sounds perfectly reasonable to me. However, I make the point that the amendments have only been received by members this morning. I telephoned the Bills Office yesterday afternoon because I was mystified as to what was going on with regard to the Financial Resolution being brought before the House. I received the amendments by e-mail. I cannot understand this as the Dáil has not sat for a long time. It is not as if there has been pressure of work. I cannot understand how it is we only receive Government amendments on the morning we are to debate Committee Stage of a Bill. We need to get legal advice on what we do too. It is not adequate to be in this bind. What the Minister of State said sounds reasonable, as I am sure it is. While this is not a contentious issue, it is not the way to scrutinise legislation.

I take the Deputy's point and will talk to the officials to see whether we can improve the situation.

We did not receive the amendments until this morning. There are 12 people involved but they did not give them to us until this morning.

Amendment agreed to.

I move amendment No. 3:

In page 5, subsection (6), line 33, after "Act" to insert "(other than Part 7)”.

Amendment agreed to.
Section 1, as amended, agreed to.
Section 2 agreed to.

I move amendment No. 4:

In page 6, before section 3, but in Part 1, to insert the following new section:

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

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

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

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

I support the principle that fines should be kept up to date. This, however, is a complex legal area and we do not wish to amend legislation in an ad hoc manner. The Government is considering introducing a fines Bill which may include a scheme for the general indexation of fines. Heads of a Bill are with the Office of the Attorney General. Bearing this in mind it would not be in order to include an indexation provision in this Bill.

Will the Minister of State indicate when the fines Bill will come before the House?

I cannot do so at the moment but will respond to the Deputy later.

I hope we will receive some information on the fines Bill prior to Report Stage of this Bill.

Amendment, by leave, withdrawn.
Section 3 agreed to.

Amendments Nos. 5 to 8, inclusive, are related and will be discussed together.

I move amendment No. 5:

In page 6, between lines 36 and 37, to insert the following:

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

I wish to speak to my amendment, amendment No. 7, which refers to protections and safeguards that need to be in place when controlled medication is being prescribed. It seems there is no statutory protection sufficient to ensure patients will be protected against pharmaceutical malpractice. We live in extraordinary times because animals are better protected than humans against malpractice in the distribution of medication. Much of the blame attaches to the Minister of State and his Department which has promised to introduce a pharmacy Bill for a long time. It is clear there are practices which put humans at risk. When a Bill is brought forward that will offer the possibility of providing safeguards, I urge the Minister of State to take the opportunity to provide them. He has not done so by way of a new pharmacy Bill. Unlike the Medical Council, the Pharmaceutical Society of Ireland cannot take action to penalise or strike pharmacists off the register. I understand there are several pharmacists who should not practice but do. I know of a pharmacy which operated for three weeks, although there was no pharmacist on the premises. The only penalty the owner incurred was a fine of €200 in the courts. This is a serious issue, about which the Minister of State probably knows much more than I do but I know enough to know this cannot continue without a major scandal occurring. It is only a matter of time before it happens.

The Minister of State is taking a long time to deal with a matter that requires urgency. I ask that he incorporate this limited amendment into the Bill.

I support Deputy McManus. She has probably met representatives of the Pharmaceutical Society of Ireland, as I have recently. It was shocking to hear what they had to say. I am sure representatives of the society have also met the Minister for Health and Children and perhaps the Minister of State who knows that the case is shocking.

A pharmacy Bill has been promised since the time Brendan Corish was in office but nothing has appeared. Meanwhile, there is potential for serious malpractice, as the Pharmaceutical Society of Ireland has told us. Who will take the rap? Deputy McManus cited a number of examples. A further example furnished by the society is that of someone operating as a pharmacist who clearly is an alcoholic and addicted to various drugs. Some of the drugs this person handles must be dispensed very carefully. If the dosage is wrong, it can affect a person's life, yet there is no protection against such malpractice. Recently nine pharmacies dealing with animal medicines were taken to task. If pharmacists are prosecuted in respect of animal medication, why have there been no prosecutions in respect of human medication? While I believe in proper animal husbandry, I regard human health as far more important, yet it is not protected.

The Minister of State needs to get his skates on and introduce a pharmacy Bill as soon as possible. In the meantime he should provide the protection offered by the amendment. He is in a better position than most to know that there is a serious problem.

I appreciate the point made by Deputies McManus and Gormley. They are correct in saying I am well aware of the issues raised. The Minister for Health and Children has given an undertaking on the fitness to practice Bill which she hopes to bring to the Government soon. It will be dealt with. I thank the Deputies for their contributions and do not dispute what they say.

Is the Minister of State accepting the amendment?

No. I am referring to the fitness to practice Bill for pharmacists.

We are debating an amendment. Is the Minister of State accepting it?

No. I answered a direct question on what was happening with the fitness to practice Bill for pharmacists.

In the meantime there is no protection. This is an opportunity——

I was responding specifically to the question about the pharmacy Bill. The amendment refers to the issue of prescriptions in respect of controlled drugs under the Misuse of Drugs Act and to paramedical staff working as emergency medical technicians in the ambulance service. My Department has carefully examined the issue of prescribing by other health care professionals. However, it is considered that, apart from nurses and existing prescribers, the necessary regulatory regime on fitness to practice is not in place to permit the extension of prescribing for controlled or other drugs and medicines. My Department is drafting legislation to provide for an updated fitness to practice regime. Given the importance of the pharmacist's role in the protection of public health, any developments in this area need to be considered carefully. The Government has accepted the recommendation of the pharmaceutical review group that there should be no beneficial ownership or business interests between dispensing and prescribing but the proposed amendment would contradict this.

Regulations introduced last year under the Irish Medicines Board Act 1995 have provided the necessary authority for the various grades of paramedic to obtain and administer various categories of medicinal products. The authority to administer is either in accordance with clinical practice guidelines or based on a registered medical practitioner's instructions. In order for such personnel to be in a position to administer controlled drugs, it is necessary that they also have appropriate authority under the Misuse of Drugs Acts to lawfully possess such drugs. To allow for this it is intended to grant group authority under section 14 of the Misuse of Drugs Act 1977 in respect of these personnel. On these bases, the proposed amendment is unnecessary.

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

I fully agree with the principle of training, ensuring quality and continuing professional education for medical personnel and thank Deputies for their thoughts in this respect. However, these matters which are essential to the professional bodies concerned could be more appropriately considered in the context of Acts relevant to these professionals such as the Medical Practitioners Act, the Nurses Act, the Veterinary Practitioners Act, etc. This Bill which amends the Misuse of Drugs Act is not the appropriate legislation to make such changes. Therefore, I cannot accept the amendments.

I intend to reintroduce my amendment on Report Stage. Let me ask about the post of chief pharmacist which is vacant. What is the story about that post?

I am not aware if it has been advertised. The former chief pharmacist, Mr. Tom McGuinn, is acting in a consulting and advisory capacity to the Department.

When will the post be filled?

I do not know the exact date but I can find out for the Deputy.

Will the Minister of State not ask his consultant beside him?

I do not think it is a matter for Mr. McGuinn.

No, but he might know. Does anybody know?

Mr. McGuinn must be an extraordinary man considering that there are five pharmacists working for the Department of Health in Northern Ireland.

I do not know the exact numbers.

Does the Minister of State agree we should have more than one pharmacist in the Department of Health and Children?

There are many people around the Minister of State. Does any of them know when the post is likely to be filled?

My understanding is that a pharmacist, Ms Noreen Quinn, is filling the position on an acting basis. We are reviewing the position raised by Deputies McManus and Twomey in respect of the post of chief pharmacist and whether there should be one, two or three pharmacists in the Department.

Is the Minister of State saying he does not know how many pharmacists he will have?

As the matter is under discussion, I cannot answer the question.

Therefore, the Minister of State does not know how many pharmacists will be appointed or when. He said the former chief pharmacist was filling the post. Now he is saying somebody else is filling it.

No. I said the former chief pharmacist was acting in an advisory capacity to the Department.

Yes, but who is filling the post at the moment?

Another pharmacist, Ms Noreen Quinn, is filling the position on a temporary basis. My understanding is she has been working with the Department for several years.

Let me make a practical suggestion. As Deputy Gormley said, we met the representatives of the Pharmaceutical Society of Ireland and they were not aware somebody else was filling the post. I suggest Ms Quinn should contact the society and listen to its concerns. It might be useful.

I am sure there is an ongoing dialogue between the Pharmaceutical Society of Ireland and the Department of Health and Children.

I am just making a practical suggestion because the society's representatives are not aware Ms Quinn is filling the post.

Amendment, by leave, withdrawn.
Amendments Nos. 6 to 8, inclusive, not moved.
Section 4 agreed to.
Amendment No. 9 not moved.
Section 5 agreed to.
Sections 6 to 10, inclusive, agreed to.

Amendments Nos. 10 to 14, inclusive, form a composite proposal and may be discussed together.

I move amendment No. 10:

In page 13, to delete lines 28 to 46.

The purpose of these technical amendments is to remove from the Bill subparagraphs (s) and (t) of section 11. The subparagraphs duplicate two subparagraphs already included in the Irish Medicines Board Act 1995 by virtue of two European Community regulations. In drafting the Bill account was not taken of this. Therefore, it is necessary to correct the anomaly by way of the amendment.

What is amendment No. 11 about and what does it deal with?

It deals with in vitro medical devices.

What are they?

I am sure that, as a doctor, the Deputy is aware of the difference between in vivo and in vitro.

It deals with in vitro diagnostic medical devices.

Was there an error in drafting?

Two subparagraphs were inserted which resulted in duplication. It is only a technical amendment.

Amendment agreed to.

I move amendment No. 11:

In page 13, line 47, to delete "(u)” and substitute “(s)”.

Amendment agreed to.

I move amendment No. 12:

In page 13, line 50, to delete "(v)” and substitute “(t)”.

Amendment agreed to.

I move amendment No. 13:

In page 14, line 6, to delete "(w)” and substitute “(u)”.

Amendment agreed to.

I move amendment No. 14:

In page 14, line 9, to delete "(x)” and substitute “(v)”.

Amendment agreed to.
Section 11, as amended, agreed to.
Sections 12 and 13 agreed to.

Amendments No. 15 and 16 are related and may be discussed together.

I move amendment No. 15:

In page 14, paragraph (a), line 42, to delete “subsection (8)” and substitute “subsections (8) and (9)”.

This amendment deletes references to the amendment of licences and authorisations from section 9(9) of the Irish Medicines Board Act 1995. The provisions of section 9(9) of the Act oblige the board to notify the appropriate advisory committee whenever it grants, suspends, renews, revokes or amends an authorisation in respect of a medicinal product. In view of the fact that over 11,000 such amendments are made annually, the implications of requiring such notifications would be significant for both the board and the advisory committee and effectively render the notification and scrutiny process ineffective. In the circumstances it is proposed that the need to notify amendments be discontinued to enable the advisory committees to concentrate on the more significant issues that arise where the granting, suspension, renewal or revocation of licences or other authorisations are concerned.

Amendment agreed to.

I move amendment No. 16:

In page 15, between lines 13 and 14, to insert the following:

"(9) Whenever the Board grants, suspends, renews or revokes a licence or other authorisation in respect of a medicinal product, it shall notify the appropriate committee of such grant, suspension, renewal or revocation.".

Amendment agreed to.
Section 14, as amended, agreed to.
Sections 15 to 17, inclusive, agreed to.

I move amendment No. 17:

In page 29, before section 18, to insert the following new section:

"18.—(1) It shall be an offence—

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

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

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

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

I do not know if this is being corrected, but it concerns such issues as medicines being sold over the Internet and sent through the post.

Has it been amended?

Is it covered in the legislation? Some medications are being sold over the Internet and may even be entering the country from outside jurisdictions.

This provision relates to the selling of medicinal products by mail order, in particular via the Internet. I should explain that provisions are already in force under the Medicinal Products (Prescription and Control of Supply) Regulations 2003 which define 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 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 order for supply. On the basis of this definition, the sale and supply of prescription-only medicines is prohibited under the 2003 regulations. While the prohibition operates effectively in so far as mail order sellers in this jurisdiction are concerned, we are dependent on the controls in force in other countries to restrict the making available of prescription medicines in their jurisdictions and, in respect of supplies of such products, to purchasers in this country. The Irish Medicines Board, in conjunction with officers of Customs and Excise, is very active in the area and the extension of the enforcement provisions available under this Bill to such officers will be of great assistance in detecting the passage of such drugs through our ports of entry.

Under the Bill, powers are also being given to all authorised officers, including officers of 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 to believe such prescription medicines are being transmitted in the post. With all these provisions in place, it is not necessary for a provision such as that proposed to be included in the Bill. I nevertheless welcome the thinking behind the proposal which supports in general terms the policies being pursued by my Department and the Irish Medicines Board in these matters.

This issue has been discussed by the Irish Patients' Association, under the chairmanship of Mr. Stephen McMahon, while the Department of Health and Children recently commissioned a report from DCU which has now been published and is in the public arena. There is ongoing dialogue about the Internet. We are not happy, since the Government can do everything within its power, but it is, unfortunately, an extremely difficult international problem. One is dealing with people with a vested interest in contravening all international legislation. It is, therefore, a difficult area. If the Deputy has any suggestions to make in this regard, I would be delighted to discuss them with him at any time. The matter is causing major problems for governments worldwide.

I will withdraw the amendment if it is covered by other legislation.

Amendment, by leave, withdrawn.
Sections 18 to 24, inclusive, agreed to.

I move amendment No. 18:

In page 35, between lines 35 and 36, to insert the following:

""persons operating in the retail, restaurant or catering sectors" includes food business operators within the meaning of Article 3 of the European Parliament and Council Regulation (EC) No. 178/2002 of 28 January 200213;".

13 OJ L31, 1.2.2002, p. 1.

This is a technical amendment to provide a clear definition for the term "retail, restaurant and catering sectors" as used in section 25 of the Bill which replaces section 54 of the Health Act 1947. The new section allows for the making of regulations to extend the current EU labelling laws on meat to require country of origin information to be provided for all consumers here at the point of choice. Such regulations will be enforced by the Food Safety Authority which already enforces extensive EU food legislation in these sectors. We have been advised that to ensure uniformity the retail, restaurant and catering sectors should be defined as including food business operators referred to in EU Regulation No. 178/2002 which lays down the general principles and requirements of food law. This way, the term encompasses all food service outlets subject to that law.

Amendment agreed to.
Section 25, as amended, agreed to.
Section 26 agreed to.

I move amendment No. 19:

In page 36, line 4, after "examination" to insert ", including dental health examination,".

Section 27 deals with the Health Act 1970, whereby the Health Service Executive makes available without charge a health examination. I wish to insert into the legislation a dental examination for primary schoolchildren and dental care as part of the examinations provided in primary schools. I would also like to ask the Minister of State whether any problems have been encountered regarding the provision of services under this section of the Act.

The amendment asks that section 66(2) of the Health Act 1970 be amended to include the words "including dental health". Dental health is included in the context of the current legislation. Section 66 of the Health Act 1970 covers making available without charge a health examination and treatment service for pupils attending a national school. This is being amended in the Bill to cover all primary schools. The definition already includes dental health examinations.

Is the Minister aware of any problems having been encountered by schools in fulfilling their obligations under the Act? I have had contact with several schools. This goes back to pre-school examinations provided by the State which are considered free. For instance, development checks on children are now running approximately nine months behind schedule. A child who is supposed to undergo regular check-ups by the public health doctor at 14 months is sometimes over two years old before he or she is examined. Are there problems in primary schools?

The effect of the amendment would be to extend the provision of the health examination and treatment service to all children attending primary school or those who are home taught. Under the current legislation, these services are restricted to children attending national primary schools or schools which had applied for and were granted an order under subsection (3). I understand the point the Deputy is making.

We should tighten this aspect because the service is not being provided in the manner we would expect. We should make it clear in legislation what they should be getting.

Problems can be encountered in recruiting dentists and so on. That is one factor that leads to the problem outlined by the Deputy. I do not dispute what he is saying but it may be a problem of recruitment because as with many aspects of the health service, many dentists opt for private practice.

I will not push the issue because this is not the forum in which to do so. I took the opportunity to raise it as we were inserting into legislation a legal right for children in primary schools. As the Minister of State and I know, the service is not available in many parts of the country in the way we expect it to be. We should make it clear in the legislation what people are entitled to and perhaps place an obligation on the State to get its act together and provide enough dentists because this has been an ongoing problem for a number of years. I will retable amendment No. 20 on Report Stage.

Amendment, by leave, withdrawn.

Amendments Nos. 20 and 21 in Deputy Twomey's name and amendment No. 22 in the name of Deputy McManus have been disallowed because they would have the potential to impose or increase a charge upon the Revenue. All three amendments seek to expand the scope of the health examination and treatment service for children.

Amendments Nos. 20 to 22, inclusive, not moved.
Section 27 agreed to.
Sections 28 to 40, inclusive, agreed to.

I move amendment No. 23:

In page 37, after line 31, to insert the following new section:



41.—(1) The Animal Remedies Act 1993 is amended—

(a) in section 8(1)—

(i) in paragraph (a)(iii), by inserting “and any building or structure containing such” after “animal remedies”, and

(ii) in paragraph (b)(iii)(I) and (II), by inserting “or certificates” after “authorisations”,

(b) in section 23—

(i) in subsection (1)—

(I) in paragraph (a), by substituting “€5,000” for “£1,000”, and

(II) in paragraph (b), by substituting—

(A) in subparagraph (i), "€150,000" for "£100,000", and

(B) in subparagraph (ii), "€350,000" for "£250,000",


(ii) in subsection (2)—

(I) in paragraph (a), by substituting “€5,000” for “£1,000”, and

(II) in paragraph (b), by substituting—

(A) in subparagraph (i), "€50,000" for "£25,000", and

(B) in subparagraph (ii), "€100,000" for "£50,000",


(c) in section 29—

(i) by substituting for subsection (1) the following:

"(1) There shall be paid—

(a) on an application for the grant of a licence the issue of an authorisation or a certificate or the provision of a service under regulations made under section 8 or a renewal or amendment of any of them, such fee (if any),

(b) in respect of a licence, authorisation or certificate under regulations made under section 8 which is in force for a definite or indefinite period of more than 12 months, such annual fee (if any), and

(c) in respect of any fee or levy to which regulations made under section 8(2)(b)(vii) relate, such fee or levy.”,

(ii) in subsection (2), by substituting "licences, authorisations, certificates or services" for "licences or authorisations", and

(iii) in subsection (3)(b)(i), by substituting “authorisations or certificates” for “authorisations”.

(2) Subsection (1)(b) does not have effect as respects offences committed before the passing of this Act.”.

Amendment agreed to.

I move amendment No. 24.

In page 5, line 15, after "ACT" to insert "AND TO AMEND THE ANIMAL REMEDIES ACT 1993".

Amendment agreed to.
Title, as amended, agreed to.
Bill reported with amendments.

I thank the Minister of State and his officials for attending. I also thank members of the committee for their constructive contributions to the debate on the Bill and for facilitating its consideration.