This section relates to the transfer of functions to the board. I acknowledge this is a very complex area, and one would need to be an expert on pharmacology and medicine to understand the huge number of regulations, so we have to be led and accept the Minister's assurances on many things.
I read an article which appeared in the Irish Medical Times of 15 September 1995 which stated that more than half of Irish doctors do not know the requirements for reporting adverse drug reactions. A survey carried out with the health research board surveyed 400 doctors, of whom 50 per cent did not know that the National Drugs Advisory Board rules require doctors to report all adverse drug reactions regardless of the kind of drug involved or the severity of the reaction. Those doctors believed they only needed to report adverse drug reactions involving new drugs or serious drug reactions involving drugs that had been on the market for many years.
Having looked at a news report on one of the satellite channels which stated that in America there is statistically quite a high admission rate to hospitals as a result of over prescribing or incorrect prescribing by GPs, I put down a question to the Minister for Health some weeks ago as to whether there was any evidence of this or research carried out into it here. There is a vast range of new products coming on the market and it is very difficult to keep up to date. I asked the Minister whether we had any evidence to indicate any admissions to our hospitals as a result of adverse drug reactions or over-or mis-prescribing. Unfortunately, the Minister had no information to give me on it.
I had reason to put my hands on a book called Irish Medical Law in the last couple of days in relation to a totally different matter which I wish to bring to the Minister’s attention. I presume he will not discuss this area in detail because there are no amendments down and I will not delay this meeting on the very complex issue of clinical trials and the vast range of regulations and rules that relate to it. The book acknowledges there is ample protection for the conduct of clinical trials, but the Minister might consider what it has to say in the context of this legislation on Report Stage, or perhaps any other legislation he may be planning. It says in respect of the Control of Clinical Trials Act, 1987, which is referred to in the schedule:
A potentially controversial section provides a complete exception for clinical trials where the substance or preparation is to be administered to medical, dental, or pharmacy undergraduate students. The students in question are defined as persons undergoing a course of training leading to a qualification which will entitle such a person to be registered as a registered medical practitioner or a registered dentist or as a registered pharmaceutical chemist. The substance or preparation must be administered as part of such a course of training. It is surprising to say the least that this exemption applies irrespective of the nature of the substance or preparation. It is also surprising that legislation does not accord undergraduates students protection, but this comment should not be taken to suggest that there is evidence that any abuse of this section exists. It might be more acceptable if the section was confined to doctors, dentists and chemists, who, having qualified, might be expected to be better aware of the nature and effects of such trials and to only certain substances or preparations. The authors consider whether in fact such an exception meets the requirements of Article 40 of the Constitution but this has not yet been decided.
Some years ago quite a number of students in Dublin, not necessarily medical students, were paid to undergo clinical trials. It was very much in the media. I fully recognise there is adequate protection in the conduct of such trials, but there appears to be one notable exception — there is no protection for medical, dental or pharmacy students. It appears that they could at some stage be treated as unprotected guinea pigs. The authors have said there is no evidence of any abuse of this section, but I would like to know if the Minister has any indication whether any clinical trials have taken place using medical students for the conduct of clinical trials and if so, is he concerned in respect of the absolute total exemption in the 1987 legislation as amended in 1990?