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Seanad Éireann debate -
Thursday, 23 Feb 2006

Vol. 182 No. 20

Irish Medicines Board (Miscellaneous Provisions) Bill 2005 [Seanad Bill amended by the Dáil]: Report and Final Stages.

This is a Seanad Bill which has been amended by the Dáil. In accordance with Standing Order 103, it is deemed to have passed its First, Second and Third Stages in the Seanad and is placed on the Order Paper for Report Stage. On the question "That the Bill be received for final consideration", the Minister may explain the purpose of the amendments made by the Dáil. This is looked upon as the report of the Dáil amendments to the Seanad. For the convenience of Senators, I have arranged for the printing and circulation of the amendments. The Minister will deal separately with the subject matter of each related group of amendments, and I have circulated the proposed groupings. A Senator may contribute once on each grouping. I remind Senators that the only matters which may be discussed are the amendments made by the Dáil.

The first group comprises amendments dealing with technical drafting. It consists of amendments Nos. 1 and 4 to 8, inclusive.

Question proposed: "That the Bill be received for final consideration."

Amendments Nos. 1 and 4 to 8, inclusive, are technical drafting amendments. An amendment was needed to the citation in section 1(5) to reflect that the Bill would now be enacted in 2006. Amendments Nos. 4 to 8, inclusive, were made to remove subparagraphs (s) and (t) of section 11 from the Bill. These subparagraphs are a duplication of two subparagraphs already in the Irish Medicines Board Act 1995 by virtue of two European Community regulations. Account was not taken of this in the drafting of the Bill, so it is necessary to correct the anomaly by way of technical amendments.

Are the amendments in the first grouping agreed? Agreed. The second grouping of amendments deals with the Animal Remedies Act 1993. It consists of amendments Nos. 2, 3, 14 and 15.

The objective of amendments Nos. 2, 3, 14 and 15, made to the Animal Remedies Act 1993, fall into two broad categories. The first is to ensure an adequate legal basis in the future for the collection of fees by the IMB arising from changes in EU legislation. The second objective is to use this opportunity to update and express in euro amounts the penalties provided for under the Act for breach of licensing and other requirements.

I draw Senators' attention to the fact that under the Animal Remedies Act 1993 and regulations made thereunder, the IMB acts as a licensing authority with respect to veterinary medicines, animal remedies 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.

A new framework EU legislation governing veterinary medicines — Directive 2004/28/EC — has come into force in this area. It has been transposed into national law by means of the Animal Remedies Regulations 2005. One of the changes brought about by the new EU legislation is a shift away from time-bound authorisations to open-ended authorisations. This change puts greater emphasis on ongoing supervision by licensing authorities and on reporting obligations applying to licence holders.

Up to now the emphasis has been on licences which were renewable after five years. The Animal Remedies Act 1993 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 that, in future, 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.

These amendments also clarify the IMB's inspection role with regard to manufacturing plants and that fees are collectable for this activity, as well as other services such as certification. With regard to the amendments to section 23, it is appropriate to bring penalties under the 1993 Act fully up to date and express them in euro amounts. I draw Senators' attention to changes in the penalties for summary offences. On the advice of the Parliamentary Counsel, 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. The amendments to section 1 introduce a citation regarding the Animal Remedies Act 1993.

I welcome the amendments but I make the point once again that I do not understand why fines are not index linked. I realise the Attorney General has difficulty with this matter but I suggest to the Minister of State that it be considered at Government level. It makes sense for fines to be index linked, as opposed to being a fixed amount, which goes out of date almost immediately.

Senator Browne is correct. It is always a mystery to me what cannot be done. Some extraordinary things are attempted and it is no surprise when the Supreme Court sometimes throws out such initiatives.

I will state again that we now have a completely new part of this Bill, Part 7. The Bill, entitled the Irish Medicines Board (Miscellaneous Provisions) Bill 2005, now involves amendments to the Misuse of Drugs Act, the Irish Medicines Board Act 1995, the Control of Clinical Trials Acts, the Health Acts, etc. When the Bill was introduced in the Seanad, I stated that it was being made into an extremely complicated piece of legislation. The contents are perfectly understandable. It appears to be the proclivity of the Department of Health and Children to make simple items more complicated.

Anybody now searching for the updated position on any parts of this Bill will need to employ a lawyer to figure it out, as it is now scattered. Why could this not have been done by a series of short Bills? For the future of our food industry and to move up the value added chain, to use an awful cliché, it is extremely important that the use of animal remedies should be properly regulated and that the appropriate fees should be charged.

Who will pay these fees? If it is the farming organisations, directly or indirectly, the Minister of State can expect yet another row because they seem to have a profound hostility to anything that costs them money, as distinct from what costs the rest of us money to help them out of a difficult spot.

I thank the Senators for their contributions. I am restricted to the subject matter before us but will deal with the matter raised by Senator Browne. Most Members of both Houses support the principle that fines be kept up to date and it is an issue that has been discussed on many occasions in both Houses. However, it is a complex legal area and we do not wish to amend the legislation in a piecemeal manner.

As the Senator will be aware a fines Bill is being drafted in the Parliamentary Counsel's office and I am advised that it is due for publication before the end of this Dáil session. I am also told that the Bill provides for a system of updating the value of all existing fines which can be imposed in the District Court, and maintaining the value of those fines in the future. Low inflation such as we have at present ensures fines remain relevant for longer periods.

On the matter raised by Senator Ryan, the objective of the amendments to the Animal Remedies Act 1993 falls into two broad categories. On the question of fees the intention is for the industry to pay them directly to the IMB.

That is just as well.

It should be self-financing. The food industry is very conscious of the importance of there being as much transparency as possible. A number of measures in the Bill are taken in the interests of the consumer.

Are the amendments in group 2 agreed? Agreed. Group 3 relates to licences granted by the Irish Medicines Board and consists of amendments Nos. 9 and 10.

These amendments delete the references to the amendment of licences and authorisations from section 9(9) of the Irish Medicines Board Act 1995. Section 9(9) obliged the board to notify the appropriate advisory committee whenever the board 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 would effectively render the purpose of the notification and scrutiny process ineffective. In these circumstances the amendments were made so as to discontinue the need to notify amendments, which will enable the advisory committee to concentrate on the more significant issues which arise with the granting, suspension, renewal or revocation of licences or other authorisations.

Are the amendments in group 3 agreed? Agreed. Group 4 relates to amendments of certificates for test results and consists of amendments Nos. 11 and 12.

These are technical amendments which make it clear that a certificate issued under section 20 of the Bill is issued under the power of the Irish Medicines Board Act 1995, as amended by this Bill.

Are the amendments agreed? Agreed. Group 5 concerns meat labelling and consists of amendment No. 13.

This is also a technical amendment to give a clear definition of the term "retail, restaurant and catering sectors" as used in section 25 of the Bill. This section replaces the current 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 to all consumers 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 178/2002, which lays down the general principles and requirements of food law. In this way the term encompasses all food service outlets that are subject to that law.

I welcome the amendment but question how enforceable the labelling provision will be. It is a massive problem because we have no idea where food is produced. Food is being brought into the country and relabelled as Irish produce when it is not, and it presents a major challenge for everybody involved in the food industry. I was surprised to learn lately that even sugar from the Carlow factory, down the road from the Minister of State's constituency, was once labelled as produced in Carlow but has now been relabelled as produced in Europe, which means a choice of 25 countries for anybody wishing to move the factory out of Carlow. It is a grey area that we will not solve today. Consumers are not being told the truth about the origin of products.

I agree fully with Senator Browne. There is a lack of will to enforce in this country and I believe it will manifest itself in this case. I am not a scaremongerer about health issues but there must be absolute certainty about the origins of chicken or other meat derived from birds. There are idiots, and I use the word deliberately, who think it is smart to circumvent the regulations but they will actually succeed in bringing down the industry. The beef industry took years to recover from the idiots who used growth hormones and those who played games with BSE, and the same thing will happen again. I appeal to the Department and the Minister to ensure that rules about labelling of origin are enforced and verified by the relevant bodies, or it will be pointless.

This amendment excels in gobbledygook that will keep lawyers occupied forever. It is not the fault of the Minister or the Department but something must be done. It reads "persons operating ... within the meaning of Article 3 of the European Parliament and Council Regulation EC 178/2002 of 28 January 2002". That is bad enough but superscript 13 is appended to it, which is given below as "OJ L31,1.2 2002, p.1". I really understand every single bit of that. I am not blaming or attacking anybody but if we do not come up with a way of incorporating European legislation into our own, how can any middle-ranking public servant enforce something, if that is the legal reference to which he or she has to refer? I have no objection to the amendment but this is certainly not the way to make people aware of what is happening.

I completely agree on the sourcing of food. Greed and quick profits are central concerns of producers in terms of feeding their livestock but, because food is needed to sustain life, it must be nutritious and of a high standard irrespective of its origins. We have done our job by introducing legislation and, when the Bill was before the Dáil, the Members of that House found it necessary to include further amendments. The value of this Legislature will be illustrated if this legislation serves its purpose.

I thank Senators for their contributions. This new section will initially allow for the making of national regulations that will expand the beef labelling currently required under EU legislation to include the provision of information on the country of origin of beef to the consumer at his or her point of choice. That should be welcomed by consumers and the food industry because it means, for example, that a person ordering beef in a restaurant will be able to learn where the meat comes from by reading the menu.

The amendment will also allow for the subsequent extension of the requirement to provide country of origin information on other meats, such as poultry, pork and mutton. It is anticipated that this initiative will commence at retail level and progress in due course to the restaurant and catering sectors. However, this is not a straightforward matter but will involve considerable complexity, as well as approval at EU level. The latter may be difficult to secure because the requirements on country of origin labelling of these meats at EU level are different from and less comprehensive than those for beef and there is no precedent for this provision in any other member state.

Are the amendments in the fifth grouping agreed to? Agreed.

Question put and agreed to.
Question proposed: "That the Bill do now pass."

Although no Member would object to any single provision in this legislation, because it includes amendments on a range of unrelated areas, it is an objectionable Bill. How, for example, are amendments to the provision for medical examinations for school children related to the Irish Medicines Board (Miscellaneous Provisions) Bill 2005? I do not know whether the Oireachtas, the Government or the Attorney General is responsible but it is a dreadful way to do business and a guarantee for future trouble and confusion. Middle ranking civil servants will be blamed for mistakes that could equally be made by eminent barristers. How will one know, other than through a careful search, that the health Acts have been amended by this Bill?

I share Senator Ryan's view of this Bill. When it was first introduced, I asked for a briefing on it and was told that it was quite simple and contained few major provisions apart from expanding the categories of people who can write prescriptions to include nurses. That was an important selling point in what appeared to be welcome legislation but matters transpired very differently and the Bill now covers a wide array of areas, from free dental care and school-age children to food labelling.

I am not happy with my own performance on this Bill, which was affected by my bafflement with it. When the legislation was last before the Seanad, I predicted that it would return here because it would be subjected to numerous amendments in the Dáil and was proven right.

One can either agree with Senator Glynn's opinion that the Bill reveals the importance of a second House or regard the legislation as bad and flawed in the first place — I opt for the latter. We have been totally bamboozled by some of the amendments and I was delighted to realise that even people with superior intellects, such as Senator Ryan, did not have a clue about some of the references made by the Minister of State today.

The Senator is too hard on himself.

He is being hard on me. I do not like to be labelled an intellectual.

Some of the amendments were merely comical and I would hate to debate the merits of this Bill on "Prime Time." In my three and a half years in this House, it is the first occasion on which I have been unhappy about my own knowledge of a Bill after completing my consideration of it. I was in disagreement with a number of amendments because of my confusion.

I ask the Minister of State that, in future, we are given briefing material before debating complicated legislation, which did not happen in this instance. Would he understand the amendments before us today if he was not briefed? I am sure that he did not even understand the script he read. It is unfair on the Opposition because it prevents us from doing our jobs as parliamentarians.

I am struck by a number of typographical errors in the Bill, which suggest rushed and bad legislation. I am not happy with some of the amendments made in the Dáil but take them at face value and in the hope that the Government and its civil servants have introduced them in good faith.

A major issue, the barcoding of prescriptions, has been overlooked. This was raised last week in a court case concerning Ms Naomi McElroy of the Sunday Mirror.

I remind Senator Browne that we can only discuss the contents of the Bill. That issue will have to be addressed on another day.

The Bill deals with giving people the option of writing prescriptions and the aforementioned court case highlighted the farcical nature of the current situation. Currently, anyone can get a prescription from a pharmacy by having a letterhead printed. In England they are barcoded.

That is not relevant at this stage.

It is a matter we should have considered and it is regrettable it is not in the Bill. Prescriptions should be barcoded in the interests of patients and the public. I am unhappy with the Bill but I hope it is not as bad as it seems.

My views have not changed merely because I am sitting on this side of the fence. These amendments are of a technical nature and, when discussing such legislation, we tend to use phrases and language which we do not use on a daily basis. People can have difficulties in understanding this parliamentary speak.

Regardless of the legislation we introduce, I would like to think that officials are available to brief Members because the greater the scrutiny we can give, the better the end product. There was no intention on the Government's part to conceal any part of the Bill. Ultimately, the changes were introduced for the good of the consumer.

Question put and agreed to.

When is it proposed to sit again?

At 2.30 p.m. next Wednesday, 1 March.