Brian Lenihan Jnr (Dublin West, Fianna Fail)

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

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

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

Part 1 of the Bill deals with the preliminary matters; Part 2 amends the Misuse of Drugs Act 1977; Part 3 amends the Irish Medicines Board Act 1995; Part 4 amends the Control of Clinical Trials Act 1987; and Part 5 deals with consequential amendments to regulations made under section 32 of the Irish Medicines Board Act 1995 or referred to in section 34(4) of that Act.

Section 3 extends the powers available in the Misuse of Drugs Act to prohibit bodies corporate involved in the practice of community pharmacy, and their officials, from having controlled drugs following a conviction for an offence under the misuse of drugs or customs legislation. At present, these powers are available in respect of practitioners and pharmacists convicted of such an offence.

Section 14 of the Misuse of Drugs Act 1977 allows the Minister to grant licences or issue permits or authorisations for any of the purposes of that Act to attach or vary conditions to such licences, permits or authorisations and to revoke any such licence, permit or authorisation. It also provides for the making of regulations requiring the payment of prescribed fees in respect of the granting or issuing of such licences, permits or authorisations. Section 4 of the Bill amends section 14 to transfer these functions, which were previously carried out by my Department, to the Irish Medicines Board. It also provides that licences, permits and authorisations issued prior to the commencement of this section continue to be valid.

Section 6 amends section 24 of the Misuse of Drugs Act 1977 to enable the IMB to authorise officers to carry out inspections under the Act and allows authorised officers of the Pharmaceutical Society of Ireland to inspect pharmacy shops. The term "practitioner" is also included in this section to ensure that registered practitioners, medical and dental, fall within the remit of this section so that records held by them with regard to their prescription, possession and use of controlled drugs can be subject to inspection should the need arise. Section 6 also provides that the appropriate warrants of authorisation, issued by the Minister, the IMB or the PSI, are provided to authorised persons carrying out inspections and that appropriate transitional arrangements for those persons with existing certificates of authorisation are in place.

Part 3 of the Bill contains all the amendments that are being made to the Irish Medicines Board Act 1995. Sections 8 and 9 of the Bill update the functions carried out by the IMB to conform to European Community legislation in regard to the various matters within the scope of the Bill. The principal functions of the IMB are being extended to include its designation as competent authority for the purposes of EU directives relating to medical devices, cosmetic products and precursor drugs and in respect of clinical trials for medicinal products for human use. Section 9 includes provision for the IMB to issue various export certificates in respect of the products and devices mentioned, as required by manufacturers exporting products to other countries. The IMB is required to have regard to any national legislation giving effect to such provisions.

Section 11 provides that the chairperson of the advisory committee for medical devices be an ex officio member of the board of the IMB. There is a similar provision in the legislation for the chairpersons of the advisory committees on human medicines and the veterinary medicines. Section 12 expands section 9 of the existing IMB Act to ensure that no refusal of a licence, authorisation or certificate on the grounds of safety, quality or efficacy can be made unless the appropriate advisory committee has been consulted.

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

Section 15 inserts new sections, 32A to 32F, into the IMB Act in order to improve enforcement powers with regard to medicinal products, cosmetic products and medical devices. Section 32A defines the expressions used in the new sections. Section 32B provides for the appointment of authorised officers and sets out the various powers available to them. Section 32C provides for the taking and handling of samples of these products and devices. Section 32D provides for the certificate stating the results of any test, examination or analysis that it is sufficient prima facie evidence in a court.

Section 32E sets out the penalties for offences created by this Bill and allows the IMB, where it has seized stocks under the legislation, to seek orders from the courts to dispose of these stocks and, where appropriate, to recover the costs incurred from the offending company. Section 32F provides that summary proceedings for an offence can be instituted under the IMB Act up to two years after the date of the offence rather than the normal six months. These sections provide for better regulation in respect of medicinal products and ensures that the penalties available for breaches of the regulations are the same for all regulations relating to medicinal products.

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

Section 23 inserts a new section into the Control of Clinical Trials Act to improve enforcement and supervision powers for clinical trials falling under this legislation. This includes powers to inspect records held by practitioners in respect of clinical trials. With regard to clinical trials it is likely that most, if not all, records would be held for use in the course of a practitioner's professional practice and that if a warrant had to be obtained for each occasion an inspection was required it would render the supervision of clinical trials impractical if not impossible. Therefore, warrants from the District Court are required only where a private dwelling is concerned. However, the section also provides that warrants will not be required for part of a private dwelling used for professional practice.

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

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

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

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

It is also intended to include an amendment to the Health Act 1947 to increase the maximum fines for breaches of the regulations on meat-labelling. The designation of the Irish Medicines Board as a competent authority regarding human cells and tissues will be addressed. An amendment to the Irish Medicines Board Act 1995 is proposed to designate the board as the competent authority, as required by EU Directive 2004/23/EC, which sets standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells for human applications. The scope of the directive does not apply to blood or blood products, organs or in vitro research.

A further Government amendment will provide that Customs and Excise officers at points of importation and exportation will be authorised officers under the Irish Medicines Board Acts for the purposes of carrying out inspections pursuant thereto. An amendment is proposed to provide for the specific control of prescription medicinal products and for non-prescription medicinal products in pharmacies and, in the case of some products, for their availability in non-pharmacy outlets.

It is proposed to give additional powers to authorised officers to enable appropriate inspections to be carried out, including the effective supervision of the activities of those persons selling medicinal products by mail order, including the Internet. The Supreme Court has decided, in the case of Vincent Browne v. the Attorney General and others, that indictable offences created by EU legislation must be clearly and explicitly set out in primary legislation. Amendments are being proposed that will take the decision into account, meeting the standard set down by it and ensuring that breaches of any regulations made to give effect to Acts of the institutions of the European Communities relating to medicinal products for human use may also be prosecuted on indictment.

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

As part of the ongoing review of eligibility to health services, officials at the Department of Health and Children have identified an issue with regard to section 67 of the Health Act 1970. This section provides for eligibility for dental, ophthalmic and aural services. At the time this section of the Act was commenced, in 1972, a statutory instrument was adopted by the Oireachtas limiting the application of the section to medical card holders. Provision of these services has been limited to medical card holders since that time.

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

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