Seanad debates

Tuesday, 22 November 2005

Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Second Stage.

 

4:00 pm

Photo of Brian Lenihan JnrBrian Lenihan Jnr (Dublin West, Fianna Fail)

I thank Senators for an interesting and substantive debate. I acknowledge their contributions and will address as many of the issues raised as I can. Senator Feighan asked about the powers of inspectors of pharmacy shops. Under the Irish Medicines Board Act 1995 and the Poisons Act 1961, these inspectors are employed by the Pharmaceutical Society of Ireland and are entitled to take prosecutions in its name. They do not currently have the power to close a pharmacy in the course of their inspections.

The Minister is in the course of preparing regulations for the purpose of implementing a recent EU directive on traditional herbal medicinal products. Enforcement in this area will be possible when those regulations are made and we will have an opportunity to debate this subject when they are drawn up. I was not clear whether Senator Feighan was raising a doubt about whether there should be regulation in this area but such regulation is imminent on foot of the EU directive.

Senator Feighan also raised the question of St. John's wort and the fact that, depending on one's location on this island, one will or will not encounter restrictions on its purchase. Many of us participated in that debate some years ago and, like the Senator, I was on the side of those who wanted greater liberalisation in this area. The problem throughout the health and medicinal sector is that of clinical and scientific independence. If the Oireachtas provides legislation for a medicines board, we are, perforce, obliged to accept its recommendations. We cannot substitute our view of what is good science and medicine for that of the board, even when, on occasion, the latter offends our common sense. That is the problem we face. The board took a view on this issue and the classification was assigned by it on the basis of its concerns about safety.

Senator Feighan also raised a question about the advisory committees set out under section 13. There are currently three independent advisory committees which provide scientific advice to the board as necessary. Members of these committees are appointed by the Minister on the basis of their expertise. The members of the advisory committee on veterinary medicinal products are appointed by the Minister on the recommendation of the Minister for Agriculture and Food.

In regard to offences for breaches of the meat regulations, it is intended that penalties in respect of meat labelling will be raised from the existing figure of £1,000 to a more effective penalty of €5,000. Queries were raised about the fees charged by the medicines board. In general, the policy is that the board should self-finance its activities. It is always expected that the fees will be set to reflect that arrangement.

In regard to the granting of licences for drugs other than controlled drugs, the licences referred to in the Bill related in the main to controlled drugs included in the UN treaties and not to other products. Senator Feighan also referred to paramedical qualifications. The Health and Social Care Professionals Bill 2004 is before the Dail and was dealt with at length in this House.

Senator Feeney raised the perils posed to human health, particularly the liver, by paracetamol. The Minister will ask the Irish Medicines Board to consider whether improved labelling can be used in that respect.

Senator Quinn raised the matter of generic drugs. I will reiterate a point of my reply to Senator Feighan, namely, that we are at a difficult intersection between law and our expertise and the expertise and clinical independence of people who make decisions in this matter. There is no doubt that Senator Quinn's case is powerful and there could be a substantial saving to the Exchequer were we to decide what drugs could be prescribed.

However, we cannot decide this but we can work on the problem. A great deal of information on it is in the public domain and a considerable amount of work has been done by the Department in the context of trying to improve clinical practice. If Senator Quinn has a proposal to make, the Minister will be receptive to examining it with great care and consideration. I have dealt with most of the issues raised by Senators and I thank them for their contributions.

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