Frank Feighan (Fine Gael)

Has the Minister any plans to carry out inspections in the alternative medicine sector?

Section 9 updates Irish legislation to conform to European Union legislation, thus making the Irish Medicines Board the competent authority for the purposes of EU directives relating to medical devices. I welcome this. The Irish Medicines Board is being appointed to exercise powers under section 14 of the Misuse of Drugs Act in regard to the granting of licences and other authorities in respect of the manufacture, possession, supply, import and export of controlled drugs. I also welcome this but wonder if alternative medicines are covered under the board's power to grant licences.

Section 12 states that the board will not refuse to grant a licence or authorisation in respect of the manufacture or wholesale of medicinal products on grounds of safety, quality or efficacy unless the advice of the appropriate advisory committee has been considered. Will the Minister of State outline who is on these advisory committees? How many committees are there and who appoints the members? Are they political appointments or are they appointed by the board?

Section 13 is one of the shortest sections and seeks to make better and more appropriate provision for the Irish Medicines Board to charge fees for its activities. How much will these fees be? Will the fees fund the board? I am concerned when I see fees mentioned in case they might be another stealth tax but I am sure that is not the case here.

I am pleased that the Government proposes an amendment to the Health Act 1947, as amended, regarding meat labelling. 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 sector. This will be a relief to my constituency colleague, Deputy Naughten, who has lobbied strongly on this issue. It is also intended to extend the requirements for the labelling of poultry meat, pigmeat and sheepmeat to provide full country of origin information. The amendment to the Health Act will also increase the maximum fines for breaches of regulations on meat labelling. How much will the fines be?

The Minister said he intends to introduce amendments to the Bill to allow certain nurses and midwives to prescribe certain drugs. Such a measure is long overdue. There is a manpower crisis in hospitals and in general practice and it appears to have worsened as a result of the Government cap on recruitment to the health service, about which we hear a great deal. There are many well trained nurses who would have no problem prescribing certain drugs. Such a change would allow doctors to concentrate on more important functions. It would be a better use of human resources, particularly in view of the manpower crisis in the hospitals.

With regard to the Government's commitment to the Hanly report, does the Minister propose to amend the Bill to allow paramedics administer certain drugs? If the Government is committed to its proposals regarding accident and emergency departments and ambulance services, this legislation should cover paramedics and allow them to administer certain drugs. Will such regulations be enacted?

Section 15 makes much better provision for the enforcement and supervision of regulations made under the Irish Medicines Board Act 1995. Much has happened in the intervening ten years. The section will allow officers to carry out inspections and to take samples of medicinal products and medical devices. It is good that the IMB will have such powers. Sometimes we do not like too much power to be vested in one body but it is good that this body will have the power to protect consumers.

Under Part 4, EU legislation supersedes Irish legislation with regard to clinical trials. EU legislation came into force in May 2004 on clinical trials on medicinal products for human use. The EU regulations replace certain sections of the Control of Clinical Trials Act 1987.

I welcome the Bill and look forward to receiving answers to the questions I raised.