Select Committee on Social Affairs debate -
Wednesday, 4 Oct 1995

SECTION 4.

Minister of State at the Department of Health (Mr. O'Shea)

I move amendment No. 1:

In page 5, subsection (1) (1), line 42, to delete "any such inspection" and substitute "the administration of such a service".

The purpose of this amendment is to clarify the role the board will have on advising the Minister in the matter of blood and blood related products. As originally presented, the provision could have been construed as only requiring the board to advise the Minister about matters arising out of any inspections that the Minister might have referred to the board. Obviously, the Minister would wish for the board to be in a position to advise him on blood and blood products generally and not merely matters arising out of inspections. The amendment of the text of section (4) (1) (1) is desirable so as to remove any doubt or legislative restriction on the board as to its role and responsibility in providing advice to the Minister in this area.

Amendment agreed to.

Question proposed: "That section 4, as amended, stand part of the Bill."

Mr. Hughes

In the private session, reference was made to veterinary drugs. I raised the question of vaccines on Second Stage and it was also referred to in the private session. Who is responsible for evaluating and testing vaccines? As a lay person, I could not distinguish a vaccine from a drug but is there a lacuna there?

Mr. O'Shea

The human vaccines are in a different category to the veterinary ones. I am not in possession of the full information on that subject but I can get it for the Deputy during the course of the debate.

Mr. Flood

Does this section set out in a more comprehensive way to empower the Minister to a much greater degree with regard to the handling, collection, management and storage of blood products? I have the Blood Transfusion Service Board in mind. Is this the area about which we are speaking and is the purpose of the Minister's amendment to deal with that serious issue?

Mr. O'Shea

The context here is on external or independent monitoring of the activities of the blood service. The wording in the Bill could have given the impression that we were restricting the ways in which the Minister could intervene solely to matters arising from inspections. Obviously, the Minister would want to play a more active role in the independent monitoring of the service.

Mr. Flood

I thank the Minister for that explanation. A crisis arose in the Blood Transfusion Service Board, especially with regard to storage etc., during recent months. We have heard of situations in other countries where, regrettably, contaminated blood has been used — it has been used here also — and of the implications of that for patients, the worry and concern they suffered, not to mention their medical setbacks.

I want to be sure that this section will empower the Minister, through the board, to a greater degree to stop the type of scandal that arose in this service recently. The BTSB provided a good service to this country but ran into the most appalling difficulties, even down to the basic issue of storage of blood products which, even to a lay person, seemed to leave much to be desired. The Minister is telling us that with this amendment, he is making absolutely certain that he will have greater strength through the board to step into such situations and deal with them and if that is the case, I welcome it.

Mr. O'Shea

This amendment gives the Minister the power not alone to step in but enables him to conduct independent monitoring on an ongoing basis. It will have a twofold effect; it provides for the independent monitoring and — this was indicative in what Deputy Flood said — it will help rebuild public confidence in the service.

Dr. Moffatt

Assurances need to be sought from the Minister on the functions of the board on named patient arrangements. These operate under article 5 of the Medical Preparations Regulations, 1984. This system has operated informally under the NADB. The expert group on the Blood Transfusion Service Board recommended that the named patient system be put on a more formal basis. Will the Minister comment on that?

Can the Minister specify if the new board has power to take into account the assessment made by other regulatory bodies, mainly in the EU? This mutual recognition would reduce the time taken to process applications for new and existing products and authorisations. This power was also recommended by the expert group on the BTSB.

Will the new board be independent of the Exchequer's financial constraints? It has been alleged in the past that the Department of Health did not favour the introduction of certain new products that would be very expensive to our health system and, naturally, a cost on the Exchequer. Will the new board have responsibility for the issuing of certificates of free sale? This certificate is necessary to allow export of materials by pharmaceutical firms to certain countries and it is unclear in the Bill if the medicines board will issue them.

We have dealt with the blood section. This is a completely new departure for the board. In other countries, a separate board deals with blood, blood products, components etc. and the collection of same. Can the Minister tell us if he will set adequate resources aside to deal with this, not only in personnel but especially in the area of collection of blood? It has been said that the current set-up in regard to the collecting of blood, especially in rural areas and some of the bigger towns, is not acceptable. It is not acceptable to collect blood in a dance hall, school, hotel, etc. We should move forward and get a state of the art mobile unit that would meet the best standards. Naturally, this would put a cost on the Exchequer but the idea must be examined.

Mr. O'Shea

I will deal first with the use of self assessment by regulatory agencies in other countries. Where an applicant so chooses, he may request that an application for a product authorisation be examined under the new European decentralisation procedure under which a regulatory authority assessing an application for a product authorisation must have regard to the first and original application in a member state. This decentralised procedure operates on a voluntary basis but from 1998 where an applicant wishes to avail of the procedure, member states will be obliged to have regard to the original assessment. Any disputes under the procedure will be referred for arbitration to the committee for proprietary medicinal products, CPMP.

In view of the requirements of the decentralised procedure to which this country is a party, it is not necessary to provide specifically in the Bill for the board to have regard to assessment carried out in other member states. At all times the board must be satisfied that any medicinal product which is to be granted an authorisation meets the requirements of safety, quality and efficacy and it would renege on its duties if it were to abdicate its responsibility by relying solely on the assessment in of other countries. It would have to be satisfied with the standards of assessment in such other countries and while most other countries would have very high standards, there have been allegations of widespread corruption involving the regulatory authority in at least one member state.

In relation to the named patent medicines — this was a recommendation in the Hederman-O'Brien report — it is intended to formalise the arrangements for the supply of named patent medicines. However, this will be done in regulations to be made under section 31, which will replace the Medical Preparations Licensing, Advertising and Sale Regulations, 1984-94. This legislation comes into play in the enhanced monitoring role provided for the Minister, which is an additional role.

The Deputy asked a number of questions relating to the blood transfusion service and those questions would be proper to the BTSB. The new board will issue services of free sale. However, some countries only accept them if they have been issued by the relevant Government Department. In such cases, the Department will continue to issue them as well.

The matter of independence was also raised by Deputy Moffatt. I do not accept the suggestion that the Department of Health has at any time held up the licensing of a drug to save money for the Exchequer through not providing the money to pay for it. The board will be fully independent in determining if and when it is appropriate to licence a drug, so I can assure the Deputy that independence will operate in that area. It has not been the case, to my knowledge that at any time the Department for financial reasons has held back on the licensing of any drug.

Mr. Hughes

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?

Mr. O'Shea

I thank the Deputy for raising the issue and I will investigate it. If an area requires attention it will be addressed. The board will have to concern itself with what adverse side effects may accrue from any particular drug. The dissemination of that information is important. If difficulties such as this arise on the scale indicated by the article in the Irish Medical Times to which the Deputy referred then in-service training for people advancing in their profession would be important. The side effects of drugs on particular categories of individuals must be of concern to us all. To some extent, the Deputy’s first point would be outside of the scope of the Bill but I will examine it. If the problem could be addressed in the Bill I would not be reluctant to do so.

Mr. Hughes

I thank the Minister for his reply. There will be a transfer of functions from the old body to this new one. We have spoken about the lack of resources and it would appear that this is the root cause of the delay in issuing authorisations. This is surprising as it is a self-financing agency and will continue to be such. The applicants seeking drug approval will have to pay the appropriate rate for the time and expertise involved.

The main purpose of this board, apart from drawing up regulations, will be to ensure products for sale on the Irish market are safe for the consumer, that their quality is checked to ensure they are safe for human consumption. The GPs are at the coal-face of medicine and 50 per cent of those surveyed were not aware of their responsibility to report adverse drug reactions. There appears to be a lack of communication or management. We hope that will be improved and new techniques will be introduced whereby GPs and other professionals will be able to use channels of communication to report all adverse drug reactions. The new drugs advisory body will have this additional information and will be able to react to it with additional tests, for example.

Despite my best efforts, I can get no information as to the extent of adverse reactions to drugs for sale in this country. We must be conscious that drugs are available not only through GPs but on supermarket shelves. An increasing range of medicinal products is becoming available and one has to be guided by the advices printed on the packages.

Mr. O'Shea

We are absolutely ad idem in terms of the best possible standards being applied at all levels throughout the pharmaceutical industry and as that applies to patients. I will take on board the Deputy’s points in consideration of the legislation and in setting up the board.

With regard to adequate publicising of the adverse effects that may accrue from certain drugs, I see the pharmaceutical companies having a responsibility in terms of the licensing process. We must insist on the highest possible standards so nothing slips through the net. We all have a duty to ensure that any weakness in the system is dealt with. I take the Deputy's points and I undertake to investigate them. The bottom line assurance is that the new board will be about quality and best practice.

Dr. Moffatt

Will the board take on duties with regard to homeopathic and alternative medicines?

Mr. O'Shea

This is an area that is developing. I see no difficulty in examining a medication that may be outside the normal pharmaceutical lines if a particular treatment is seen to have merit and if a company believes it is commercially viable for them. Homeopathic medicines are classified as medicines in the 1994 regulations and come within their scope. This will only arise if a company feels there is a commercial line to be followed.

Question put and agreed to.