Brian Lenihan Jnr (Dublin West, Fianna Fail)

I move: "That the Bill be now read a Second Time."

I am very pleased to introduce Second Stage of the Irish Medicines Board (Miscellaneous Provisions) Bill 2005. This Bill has already completed all Stages in the Seanad where a number of amendments to the Bill as initiated were accepted.

In general terms, the Bill allows for the transfer of certain functions regarding controlled drugs from my Department to the Irish Medicines Board and for the improved operation and enforcement activities of the Irish Medicines Board in respect of medicines and the control of clinical trials. It amends the Irish Medicines Board Act 1995 regarding medicinal products, cosmetic products, veterinary medicinal products, drug precursors and medical devices. It allows for the making of regulations for nurse prescribing and for information to be provided by the retail, restaurant and catering sectors on meat sold or served to consumers where this is not already a requirement. It enables officers of Customs and Excise to exercise surveillance of medicinal products at ports, airports and land frontiers. It clarifies the legal position on eligibility for dental, aural and ophthalmic services and extends eligibility for dental, aural and ophthalmic examinations to all children.

This Bill encompasses a number of different areas and many aspects of it are technical in nature. I will attempt to steer Deputies through its main provisions as clearly as I can. The Bill provides for the Irish Medicines Board to act as the licensing authority for controlled drugs under the Misuse of Drugs Acts. The designation of the Irish Medicines Board for this purpose is consistent with my Department's strategy whereby executive functions that are not directly related to the mission or objective of the Department should be devolved to an appropriate executive agency. This Bill formalises the arrangements that have been put in place whereby staff at the Irish Medicines Board carry out this work, and it amends the Irish Medicines Board Act to transfer legal competence to the board to carry out licensing and inspectorial functions under the Misuse of Drugs Acts.

The Bill also updates and consolidates the functions carried out by the Irish Medicines Board to conform to European Community legislation on medicinal products, veterinary medicinal products and medical devices. The authority to enforce legislation relating to medicinal products is set out in a number of different regulations. The introduction of new provisions under the Irish Medicines Board Act 1995 will ensure that the enforcement provisions for all of the regulations will be contained in a single Act.

On 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, including the standard citation and construction sections. 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, Part 5 amends the Health Acts 1947 to 2005, and Part 6 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.

On Part 2, section 3 defines certain expressions that are used in the Bill. Section 4 amends section 5 of the Misuse of Drugs Act and allows regulations to be made to permit registered nurses or classes of registered nurses to prescribe certain controlled drugs in specified circumstances. There are a number of amendments throughout the Bill which provide for an enabling provision for nurse prescribing and I will go into these in greater detail later.

Section 5 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 Acts or the Customs Act. These powers are available in respect of practitioners and pharmacists convicted of such an offence.

A new section is being inserted to amend section 8(7) of the Misuse of Drugs Act 1977, as amended. 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.

With regard to section 7, 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, or to attach or vary conditions to such licences, permits or authorisations and to revoke any such licence, permit or authorisation. It 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 7 of the Bill amends section 14 to transfer these functions, which were previously carried out by my Department, to the IMB. This section also provides that licences, permits and authorisations issued prior to the commencement of this section continue to be valid when the amendments being made by this Bill come into effect.

Section 8 amends section 17 of the Misuse of Drugs Act to confine the prohibition in regard to poppies to the cultivation of poppies for the purpose of producing opium. It in effect tidies up a situation where technically the range of poppies covered by the current definition includes many poppies grown for decorative or ornamental purposes.

Section 9 amends section 24 of the Misuse of Drugs Act to enable the IMB to authorise officers to carry out inspections under the Act and allows the Pharmaceutical Society of Ireland to authorise officers to inspect pharmacy shops. The term "practitioner" is 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 9 also provides that the appropriate warrants of authorisation are issued by the Minister, the IMB or the Pharmaceutical Society of Ireland 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 10, 11 and 12 of the Bill update the functions carried out by the IMB to conform to European Community legislation in regard to medicinal products, veterinary medicinal products and medical devices. 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. The IMB is also being designated as the competent authority for 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 and blood products, organs or in vitro research.

In addition, provision has been made within section 11 of the Bill for the IMB to issue various export certificates in respect of medicinal products, veterinary medicinal products, cosmetic products and medical devices as are required by manufacturers exporting such products to other countries. The IMB in discharging these functions is also required to have regard to the provisions of any national legislation that would be applicable to such products.

Section 13 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 Irish Medicines Board Act for the chairpersons of the advisory committee on human medicines and the advisory committee on veterinary medicines. Section 14 expands section 9 of the Irish Medicines Board Act to ensure that no refusal of a licence, authorisation or certificate in respect of medicinal products, on the grounds of safety, quality or efficacy, may be made unless the appropriate advisory committee has been consulted. Section 15 amends section 13 of the Irish Medicines Board Act to make better and more appropriate provision for the IMB to charge fees in regard to its activities.

Section 16 amends section 32 of the Irish Medicines Board Act. It provides a clarification that sale and supply will not include administration and at the same time introduces a provision whereby regulations may be made to control administration if required. It provides 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. This section enables the making of regulations relating to medical devices and in respect of the implementation of EU directives relating to medicinal products, medical devices and cosmetic products. It takes account of the Supreme Court decision in the Vincent Browne v. Attorney General and others case where, in the context of the creation of indictable offences, the Supreme Court expressed a view about how we should implement EU legislation. The provisions in the Bill ensure that breaches of any regulations made to give effect to acts of the institutions of the European Community relating to medicinal products for human use, cosmetic products or medical devices may be prosecuted on indictment, where appropriate.

Section 16 provides an enabling provision for nurse prescribing, which was introduced on Committee Stage in the Seanad. It is an important amendment. The intention is to introduce prescriptive authority for nurses in circumstances where it is safe to do so, to give greater accessibility and convenience for patients and to help community services and acute services. The Department will conduct consultation with all stakeholders on the implementation of this provision before regulations are drawn up. This will assist us to ensure that the necessary safeguards and controls are put in place. An Bord Altranais will play an important role in setting the educational and clinical standards to be required of nurses who will be permitted to prescribe.

Section 17 inserts new sections, 32A to 32F, into the Irish Medicines Board Act 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 for carrying out inspections in regard to the products and devices. These include 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. 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 carried out on a sample to be accepted as prima facie evidence in court.

Section 32E sets out the penalties for offences created by this Bill and allows the IMB, where it has seized stocks under the Act, to seek orders from the courts to appropriately 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 Irish Medicines Board Act up to two years after the date of the offence. These sections provide for better regulation in respect of medicinal products and ensure that the penalties available for breaches of the regulations are the same for all regulations relating to medicinal products.

Part 4 of the Bill amends the Control of Clinical Trials Act 1987. Section 22 provides that the Act will not apply to clinical trials that are controlled under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004. Section 23 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 invests capacity in the IMB to bring summary proceedings for an offence under the Act. Section 24 inserts a new section into the Control of Clinical Trials Act to provide appropriate enforcement and supervision powers in regard to clinical trials falling under those Acts. These also include 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 of these 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 only required where a private dwelling is concerned. However, the section also provides that warrants will not be required for that part of a private dwelling that is used for a professional practice.

Part 5 of the Bill relates to amendments of the Health Acts 1947 to 2005. Section 25 amends the Health Act 1947, as amended, to enable the making of regulations to extend the EU-based beef labelling laws that exist at retail level to include a requirement here for information on the country of origin of beef at the point of final consumption in the restaurant and catering sectors. This section also proposes an amendment to the Health Act 1947 to increase the maximum fines for breaches of regulations under section 54 of that Act, including those relating to meat labelling. Section 25 includes provision to enable the making of 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. EU approval will be required before such regulations may be given effect.

Section 26 allows for prescriptions written by nurses to be reimbursable under the drug payment schemes. Sections 27 and 29 amend the Health Act 1970 and the Health (Amendment) Act 1994 to provide that all primary school or home taught children are eligible for dental, ophthalmic and aural health examinations. Under current legislation, these examinations are confined to children of five years and under and children who attend national schools, and do not include children who are attending private primary schools or who are home taught. This provision addresses that anomaly.

Section 28 relates to eligibility for dental, ophthalmic and aural services. As part of the ongoing review of eligibility to health services, my officials identified an issue with regard to the current section 67 of the Health Act 1970 which 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 which limited the application of section 67 to medical card holders and provision of these services has been limited to medical card holders since that time.

My Department sought the advice of the Attorney General on this matter. His advice was that section 67 of the Health Act 1970 should be amended to provide legal clarity to the issue of eligibility to dental, ophthalmic and aural services. Section 28 provides such legal clarity.

In Part 6, sections 30 to 40, inclusive, make consequential amendments to the various regulations in force under the Irish Medicines Board Act 1995 and which are referred to in the sections concerned. These amendments, which relate to enforcement, arise out of the insertion of the new sections 32A to 32F, into the Irish Medicines Board Act, where the corresponding enforcement provisions are now being inserted.

It is my belief that this Bill will succeed in consolidating and creating a stronger framework in which the IMB can carry out its business relating to medicinal products, medical devices and clinical trials. In future this will include controlled drugs, cosmetic products, drug precursors and human tissues and cells. It will also support the development of a more efficient, effective and patient-centred health service.

I hereby commend the Irish Medicines Board (Miscellaneous Provisions) Bill 2005 to the House. I look forward to the ensuing debate and any comments arising from it.

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