Skip to main content
Normal View

Seanad Éireann debate -
Wednesday, 25 Oct 1995

Vol. 144 No. 17

Irish Medicines Board Bill, 1995: Second Stage.

Question proposed: "That the Bill be now read a Second Time."

I am pleased to come before the Seanad today to present the Irish Medicines Board Bill, 1995. The essential purpose of the Bill is to provide for the establishment of a new statutory body to be known as the Irish Medicines Board. This new board will replace the National Drugs Advisory Board, which was established in 1966 and which, over the years, has given considerable service to the State in ensuring the safety and quality of medicines supplied in this country.

However, with recent developments in relation to the control and regulation of medicines, not least the establishment of the European Agency for Evaluation of Medicinal Products, it is appropriate that we should review our own regulatory structures and procedures and adapt these to reflect these changing circumstances. Up to now, the Minister for Health has acted as the licensing authority for medicinal products. However, all applications for such licences, commonly known as product authorisations, were assessed on behalf of the Minister by the NDAB so as to establish the safety, quality and efficacy of the products. Licences were only issued by the Minister on the advice of the NDAB. Similarly, under the Control of Clinical Trials Acts, 1987 to 1990, permissions to conduct clinical trials are granted by the Minister, also on the advice of the NDAB.

For some time now it has been accepted that this involvement of two separate bodies in the process of licensing was both unnecessary and administratively cumbersome. Indeed, since 1991 it has been Government policy that the licensing functions of the Minister should be transferred to the NDAB. However, in order to successfully transfer the licensing function of the Minister to the NDAB it will be necessary to radically restructure that organisation so as to equip it to take on these additional responsibilities and to make the fundamental change from being an advisory body to being the licensing authority.

Having considered how best to achieve this transfer of functions from the Minister, I have decided that the most appropriate way of doing so is to establish, on a statutory basis, a new national medicines licensing authority which will replace the National Drugs Advisory Board. It will at the same time take over the existing functions of the NDAB and will also assume the licensing function at present exercised by the Minister. The Bill before the House, therefore, provides for the establishment of the Irish Medicines Board. This board will become the licensing authority for both human and veterinary medicines and will also be given the responsibility for the granting of permissions to conduct clinical trials.

The new board will be more compact and different in character from the NDAB. It is proposed that the board will comprise some nine members and that it should be primarily management in character. At the same time, it will obviously be necessary that the board should have available to it the range of expertise contained within the current membership of the NDAB. For this purpose the Bill provides for the establishment of two expert advisory committees, to be known as the Advisory Committee on Human Medicines and the Advisory Committee on Veterinary Medicines. These advisory committees will be made up of a broad range of experts drawn from the medical, pharmaceutical and veterinary professions such as are currently represented on the National Drugs Advisory Board. The committees will also be authorised to establish such expert advisory sub-committees as they may require to assist them in their work.

The functions of the new board shall be broadly those currently exercised by the NDAB but with the additional responsibility of being the licensing authority for human medicines. The NDAB is currently the licensing authority for veterinary medicines. The board will also take over responsibility for the granting of permissions to conduct clinical trials and generally assume the responsibilities currently exercised by the Minister under the Control of Clinical Trials Acts, 1987-1990.

At the same time, the new board will be given a specific responsibility in relation to inspection of the collection, screening, processing and quality control facilities and procedures in respect of human blood, blood components, blood products and plasma derivatives with a view to ensuring the safety of such products. Senators will be aware that the recent report of the expert group on the Blood Transfusion Service Board recommended that the implementation of the Government's proposal to transfer the licensing of medicines to the NDAB should be proceeded with. I am obviously anxious to give early effect to the recommendations contained in that report. Indeed, this is one of the reasons I am anxious that this legislation should be enacted without delay.

The board will also become the competent authority in the State for our obligations in relation to the licensing and control of medicines which arise as a consequence of our membership of the European Union. The new board will also work closely with the newly established European Agency for the Evaluation of Medicinal Products and will have responsibility for the supervision of any medicines on sale in the State which are licensed by the European Agency. It is also to be hoped that the board will be in a position to provide services as rapporteurs to the agency for the assessment of applications for European licences.

Quite apart from establishing the new board and setting out its functions, the Bill, of necessity, provides the legal basis for the transfer of all the functions, responsibilities, assets and liabilities of the National Drugs Advisory Board and, in particular, for the transfer of the staff of the NDAB to the employ of the new board on terms no less favourable than those they enjoyed while in the employ of the NDAB. The Bill also includes a number of standard provisions relating to State-sponsored bodies.

The original Government decision in 1991 provided that the board should become self-financing at the earliest possible date. It is certainly my wish and that of the Government that this will still be an objective for the board; the Bill, as presented, seeks to place such an obligation on the board.

Finally, the Bill provides the statutory basis for the regulation of medicine. The specific details of the licensing scheme will be spelled out in regulations to be made under the Bill. In this respect, I wish to draw the attention of Senators to a number of commitments in relation to the regulations which I gave to the Dáil and which I reiterate here. In particular, I undertook to examine the possibility of providing some form of appeals mechanism in the regulations. This was in response to representations made to me by the pharmaceutical industry and concerns expressed by a number of Deputies in the course of the debates in the Dáil.

It is intended that the regulations should provide a statutory basis for the supply of medicines on the so-called "named patient" basis. Heretofore this has operated on a voluntary basis, but it has been recognised for some time that the named patient supply of medicines should be put on a clearly defined statutory basis. The regulations will seek to address this issue.

The enactment of this Bill will provide the framework for the future control and regulation of medicines in Ireland and I am happy to commend it to the Seanad.

I welcome the Minister to the House. It is important that we know the content of the regulations before we deal with Committee Stage of the Bill because the contents of those regulations could decide whether we propose amendments to the Bill on Committee Stage.

I welcome this legislation to the House. Things have changed since the time when pharmaceutical companies could market their drugs in Ireland without hindrance. These drugs were sometimes of dubious quality. That changed in 1966 when the Government established the National Drugs Advisory Board whose function was to ensure the safety and quality of all drugs on the Irish market. I thank the National Drugs Advisory Board for its dedication to the work it has carried out over the last 30 years. However, the board has run into difficulty. There is now a very long delay in the processing of applications for both new and renewed licences for medicinal products, which has been a matter of great concern in recent years. These problems have arisen as a result of the extra functions given to the National Drugs Advisory Board.

In 1974 a statutory scheme was introduced for the licensing of drugs. This scheme was extended to blood products in 1983 and to veterinary products in 1985. All this extra work was given to the National Drugs Advisory Board but resources were not increased significantly and this has contributed to the backlog. There are now, I understand, more than 1,000 applications awaiting authorisation.

The Bill before the House — the Irish Medicines Board Bill, 1995 — broadly speaking, has the support of Fianna Fáil. We must be conscious at this time of the importance of the pharmaceutical industry to this country. We must also be conscious of a situation where there is an understanding between the board and the pharmaceutical industry.

The main purpose of the Bill is to establish a new medicines board that will take over the authority from the Minister to license medicines, both human and veterinary. It will also be given the responsibility for the granting of permissions to conduct clinical trials. It is proposed that we delegate power to this board to carry out a statutory function. It is of vital importance that this new board be accountable and responsible and that the highest standards are maintained by the board in the powers that are delegated to it. We do not want a repeat of the blood bank scandal. That was an enormous setback to the regulation of blood products in this country and is something of which the enormity has not been debated and certainly not in this House. I understand that over 1,000 women have been affected by the negligence of a State agency in this case. It seems quite inappropriate that this matter has not been debated at length in both Houses of the Oireachtas.

The Bill will tighten the supervision and inspection of, and the reporting on, the processing of blood and blood products and this is to be welcomed. I believe the introduction of this Bill was precipitated by the Hederman-O'Brien report, which highlighted in its review of the Blood Transfusion Service Board the need to examine the role of the National Drugs Advisory Board in supervising the licensing of blood products. The facts are that inefficiencies have taken place and a major backlog has been allowed to build up. Many new drugs have not been introduced because of bureaucratic administrative difficulties on the existing board. It is quite clear that there was a major breakdown in the preferred activity of the Blood Transfusion Service Board, the National Drugs Advisory Board and, indeed, the Department of Health and its public health division, in particular, as it applied itself to the product authorisation for the anti-D product, which was applied for in December 1982 and not issued until October 1986.

The expert group has noted that the Blood Transfusion Service Board Anti-D was effectively without a valid product authorisation for a number of years and that the authorisation for such an important product was eventually issued on a retrospective basis because of the crisis in the licensing system. This type of activity cannot be allowed to continue and there is an onus on the Minister and the Government to ensure, in the provisions of this Bill and in the Minister's Department, that we do not have a repetition of what has happened over recent times, particularly as regards the anti-D situation.

A number of studies have been conducted since the early 1990s regarding the matter and expert groups have made recommendations. One of the areas which is not clear to me and does not seem to be contained in the Bill is that the named patients arrangements will continue. The Minister made mention of it at the end of his speech. I understand that this process operates under Article 5 of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984, and these provide for an exemption from product authorisation requirements for the importation or sale of a medical preparation for or to a registered practitioner for the treatment of a particular patient. This named patient system has been operated informally by the National Drugs Advisory Board. I would like the Minister to comment on that in his reply and to see if this system will be allowed to continue. I appreciate that the Minister has made some comment on this matter, but we would like something definite as regards the regulations.

We also had the situation where a replacement for the anti-D product was imported under the named patient category. The expert group did not seem to be happy with that and it did not believe that it was appropriate that the replacement of the anti-D product came within the remit of the named patient system. I would like the Minister to refer to this matter in his reply.

There is worry that the named patients system is open to some abuse and that certain products could be imported for chemical trials. We would all like to have the matter fully regulated so that the system would not have any loopholes. I welcome the provisions of the Bill under which product authorisation will be carried out speedily. Will the Minister set a time limit for the giving of this authorisation?

I wish to ask the Minister questions about the staffing arrangements and funding of the new board. It appears from the Bill that the board will have unlimited power to charge fees and I wonder if this is good. There is also a proposal to make the applicants for licences liable for all the costs of the board. The power under the Bill to charge fees is unlimited no matter what the activity. My reading of the Bill is that fees may be increased to cover the cost; the Minister may have something to say about this. Is there not a danger that licence fees may go through the roof to maintain funding for the board?

Does the Minister envisage the Department of Finance or the Department of Health making any contribution to the funding of the board? Surely funding of the blood transfusion service and public health should be the responsibility of the Exchequer and should not be funded by extra fees imposed on drug companies.

The pharmaceutical industry is of major importance to the country. It is a big employer in my county, where over 500 people are employed by the Elan Corporation. We do not want this Bill to work in any way against the continuation of existing pharmaceutical companies or the setting up of new ones. This is a growth industry: the IDA and Ministers are trying to attract foreign companies to set up in Ireland. We should not bring forward provisions which will hamstring or inhibit the possibility of this continuing.

The Bill is unclear about where responsibility ends. The existing situation is that the National Drugs Advisory Board advises the Minister for Health on all matters pertinent to drugs. The Minister will appoint the members of the board but, following that, it seems that there will be no direct relationship between him and the board. I question this. In recent times a Minister said he was not competent to give information about the National Roads Authority concerning road developments which were being undertaken. Are we now to have a situation where the Minister will not be answerable to the Oireachtas for the Irish Medicines Board? This would be inappropriate. The buck stops with the Minister and the Government and I would like the Minister to clarify this matter.

To whom will the chief executive officer of the board be responsible? Will the chief executive officer and the board of directors be obliged to attend committees of the House where they can be questioned about the day to day operations of the board? It is important, considering what has happened in the past, that the board is accountable, that its activities are transparent and that it is open to questioning and investigation by Members of both Houses of the Oireachtas. The Minister is the person responsible at the end of the day.

Is it the intention of the board to consult with the pharmaceutical, health care and medical industries? These industries have an enormous amount of information, knowledge and expertise in this area. There should certainly be co-operation between the pharmaceutical industry and the board because both are working towards the same end. The pharmaceutical industry exists to make money but it must also take responsibility for the products it brings forward. It must prove that these products are safe; otherwise there is the prospect of litigation. The Minister should inform us of the procedures he envisages for such co-operation.

Will there be indemnity for people working for the Irish Medicines Board? Who will be responsible in the event of litigation by somebody who may be injured by a drug approved by the board?

Another area of concern is the publication of the annual report. The present situation as regards the National Drugs Advisory Board is most unsatisfactory. I believe a report has not been published in the past five years. This cannot be allowed under the new system and board. The Bill provides that the Irish Medicines Board must file an annual report within six months of the year end. However, there is a loophole in that it does not state when the Minister must publish the report. This is not acceptable. The Minister should amend the Bill so that the report is brought forward as quickly as possible and laid before the Houses of the Oireachtas within a specified time.

I am also concerned about the opportunity for an appeals system against the refusal to grant a licence, which the Minister mentioned in his speech. There should be some recourse to appeal. Has the Minister considered the matter? Is he prepared to amend the legislation to accommodate such an appeals procedure?

Recently the contraceptive pill made news headlines. Canadian studies point out that side effects can occur as a result of taking certain brands of the contraceptive pill. Is the Minister satisfied that the health of Irish women is protected in this situation? Does this Bill reassure women that their health is not in danger?

By and large, Fianna Fáil supports the Bill, which is important in the context of public health. It is welcome and it addresses a situation which has become controversial and which, to some extent, has lost the support of Members of the Houses of the Oireachtas and the public. We all accept that we need an independent competent authority to deal with these matters. I believe the Irish Medicines Board is an appropriate vehicle but it must have the confidence of the public and the professions.

I raised a number of matters and I hope the Minister will respond. If they are not clarified we may table amendments on Committee Stage. We welcome the Bill which is overdue and, as I said, addresses a controversial and serious situation that has arisen. I hope the apparent difference between us and the Minister can be resolved on Committee Stage and that the new Irish Medicines Board will carry out its functions in a proper manner in the interests of public health and the safety of our citizens.

I welcome the opportunity to speak on this Bill. I am delighted on behalf of my party to support it. The Bill, while somewhat technical in nature, proposes to replace the National Drugs Advisory Board with a new body to be known as the Irish Medicines Board.

The National Drugs Advisory Board was established in 1966 and it is only right that we acknowledge the excellent work it has carried out since then. The primary role of the National Drugs Advisory Board was advising the Minister for Health on all matters relating to the safety of medicines. The Minister was the licensing authority, but all applications for licences were subject to scientific assessment by the National Drugs Advisory Board. It was on the advice of that body that the Minister issued licences.

It has been recognised for some time that the involvement of two separate organisations in the licensing process was probably not the most effective or efficient way of dealing with such matters. It is not surprising that since 1991 it has been the policy of successive Governments that the licensing function should be carried out by one agency. I am pleased the Minister has now grasped the nettle and has brought forward this Bill.

This legislation is timely for a number of reasons. Senators will be aware that the Report of the Expert Group on the Blood Transfusion Service Board recommended that the licensing of medicines should be devolved from the Minister to the National Drugs Advisory Board or, as is now proposed, to its successor, the Irish Medicines Board. I would like to read from that report.

From our investigation of Anti-D, we offer the following conclusions and recommendations relating to the NDAB:

—There is an urgent need to strengthen the Board and management of the NDAB so that it can discharge its functions in relation to medicinal products, including blood products, with sufficient speed and efficiency.

—We recommend that the NDAB should become the licensing authority for all medicinal products for human consumption. The present arrangement whereby the Minister for Health issues licences on the advice of the NDAB is cumbersome and unsatisfactory.

If only to implement these recommendations, then the legislation before the House is timely.

Developments are also taking place at European level in relation to the regulation and control of medicines. Perhaps the most important of these is the establishment of the European Agency for the Evaluation of Medicines. It is important that we in Ireland, while keeping abreast of these developments, put in place structures which will equip us to deal with the challenges and opportunities these developments present. I hope the new board will build on the expertise and the reputation which the National Drugs Advisory Board enjoys among its European counterparts. It is crucial that the new board is properly constructed and equipped to play its full role in the new European regulatory environment.

I am pleased the new board will be more compact than its predecessor and, in particular, that greater emphasis will be placed on the management of its character and orientation. This is important for the success of the new board. At the same time I recognise that it must have the same range of expertise and advice that was available to the National Drugs Advisory Board. However, the Minister's proposal as set out in the Bill to establish an advisory committee will ensure that the range of expertise required will be available to the board.

The pharmaceutical industry is a major sector of the economy. Not only do we have many major international companies operating here, but there is also a considerable indigenous pharmaceutical industry. It is important that the agencies of Government work in tandem with the industry to ensure that there is no unnecessary bureaucracy in the regulatory controls. I am sure the establishment of one agency with overall responsibility for the licensing of medicines will provide a more effective licensing system and as such will be welcomed by the pharmaceutical industry.

It is important that we ensure the highest possible level of protection for the consumer. This can only be done by ensuring that the medicines we licence and make available are of the highest order as regards their safety, quality and efficacy. The Irish Medicines Board will have an important role to play in this respect. I believe it will achieve this high objective. For that reason, I am pleased to support the Bill.

Although the Ethics in Public Office Act will not be implemented until the beginning of next year, I want to point out that I also have an interest in this Bill as a medical practitioner, a patient, as someone who has run clinical trials, who has given the pharmaceutical industry advice and hopes to do so again in the future, who has been on some of these boards, who has given advice to the National Drugs Advisory Board and as a member of the public.

For me this is one of the most important Bills to come before the House. I am delighted the Minister brought it forward so swiftly. Mrs. Hederman-O'Brien and her colleagues must be complimented on the report they produced on the Blood Transfusion Service Board; it was instrumental in bringing this Bill forward with such rapidity.

The objectives of the Bill are welcome, particularly from the point of view that it appears to reduce bureaucratic duplication between the Department of Health and the Minister and the board itself, which always seemed to be a problem with the old National Drugs Advisory Board.

I must be one of the few Members of the House who has been involved with the National Drugs Advisory Board. While it did a great deal of very worthwhile work in the early part of its career, towards the end it was quite obvious that because of the lack of resources or staff, it was becoming absolutely overwhelmed by the amount of work it had to do. The serious delays were a major difficulty for many people within the medical and pharmaceutical industries, some of which have already been alluded to.

One of the many problems was the fact that named patient regulations were grossly abused because there was such a delay in trying to bring in some drugs as it took so long for the board to assess them. I am sure it was not their fault, but there were terrible delays. It is important to remember that some new drugs may be very beneficial to patients and, especially if they are only needed on a small scale, doctors will be very anxious to have them as rapidly as possible.

Senator Finneran spoke about fees. It is important to remember that in a small country such as this, if the fees are very high for some drugs which may only be of use to a very small number of patients, it may not be worthwhile for the pharmaceutical company to apply for a licence to market the drug here. I hope that the Minister will bear that in mind.

The Minister said that the named patient regulations will be looked at. I think that this will be done under the Medical Preparations (Licensing, Sale and Advertising) Regulations, 1994. However, as Senator Finneran said, I hope that we will be told how soon these regulations will be changed. I do not think that we are the only country which has been in a position to abuse the named patient regulations. During the blood transfusion debacle last year when Win RHo was brought in here on a named patient basis, I was told that the drug was widely used in North America and on the Continent. However, I discovered after some investigation — in fact I was told by the FDA — that it was only being used on a named patient basis in some states in the US and in some countries on the Continent. It is very serious to allow these regulations to be used for a large number of patients and I hope that the Irish Medicines Board will look at it very carefully. Senator Finneran is wise to ask the Minister to let us know when this new regulation regarding named patients is being brought in.

The Bill covers medical and veterinary drugs. We are inclined to think that all of these will be prescribed by a doctor, but there is a great increase in the number of over the counter products which can be bought. Unless the person concerned reads the documentation given out with the drug very carefully, they may get little or no advice — although some pharmacists are very careful to advise patients about any problems with drugs. We must remember this when we are increasing the number of drugs which can be bought over the counter. I am glad that cosmetic products have also been included.

I am not clear if homeopathic products are included. Are they included under the Council Directive of January 1965, which I believe provides the definition of medical product in this Bill? If they are included, what is the definition of homeopathic product? This is a very important because an increasing number of nature products are being produced as well as homeopathic products. In some cases they have had very serious adverse effects on those who have taken them, particularly if they were taken in amounts in excess of what one would normally recommend.

This Bill results largely from the report by Mrs. Hederman-O'Brien, which did not show the National Drugs Advisory Board and the Blood Transfusion Service Board in a very good light. I am glad that the Minister has acted so rapidly. It was a revelation to me that there were such incredible delays between when a licence was requested and when one was eventually given. The Win RHo product was imported here for emergency use in February and, even with a great deal of urging — they must have known the sense of urgency regarding this product — it was not licensed by the board until the end of June. That was a very long delay for a product about which there was a great deal of public worry.

The first Clinical Trials Bill had to be introduced in 1987 because of the death of a young man on a clinical trial. The subsequent Bill in 1990 had to be introduced because of worries about immunity, which I will come to later.

This Bill is very important for the licensing of drugs in this country to ensure that they are efficacious, safe and so on and for their continued monitoring. It is important to remember that the monitoring is as important as the initial licensing of the drug in terms of assessing the side effects found on an international basis.

I wish to discuss Ireland's relationship with the new European drug regulation system. We have an enviable reputation in assessing medical products and carrying out clinical trials and are asked to do an enormous number of them by pharmaceutical companies. I was one of those who hoped that the proposed European medical evaluation agency would be established in Ireland. The Department of Health did lobby for it but I told it to make the bid as vigorous as possible as it would have been splendid to get it. We did not get it, but that does not mean we will not be in a position to do a great deal of the work which will come from the agency.

All drugs to be sold within the European Union will have to be sent to this new agency which will be based in London. It will put together dossiers of work on each drug which will be farmed out to various agencies within the European Union. We are in a splendid position to bid for an enormous number of those dossiers on all biotechnological products. The committee which will be distributing these dossiers is the committee on proprietary medical products. The financial rewards for just looking at these dossiers will be worth about £50,000 per assessment in the number of people they will employ on a technical and professional basis. We see in the newspapers today that the services area of the economy has been the best at increasing employment in this country. It is important to ensure that this Bill is so watertight that the agency will wish to have as many of its evaluations as possible done here. We already have an extraordinarily high reputation for carrying out clinical trials. The fact that we speak English is also a great advantage.

Other Senators pointed out how important the pharmaceutical industry is in this country and how successful we have been in attracting many pharmaceutical companies to set up in this country, mainly because of the very good employees they can get in this field. I hope that everything possible is done to facilitate the medical, pharmaceutical and veterinary professions in this country to gain as many of these dossiers and evaluate as many drugs as possible.

The situation which pertained in the old board regarding the under-reporting of adverse reactions to drugs is also very important. Approximately eight million prescriptions are issued every year by the general medical services. It has been recognised that there has been gross under-reporting of adverse reactions to drugs. Approximately one to 2,000 reactions are reported each year. My profession is worse than the pharmaceutical profession as regards reporting them. This situation must be rectified. Perhaps the under resourcing of the last board was an important factor and, if that is the case, the new board should be made aware that this is a priority as far as the Department of Health is concerned. Adverse reactions must be reported.

Section 4 gives the new board a remit as regards the safety, quality and efficiency of all medical products in use. Many people feel we have not been vigilant enough under the current system for testing products and assuring their ongoing safety. I urge the Minister to ensure that the board makes this a priority.

Last week the committee on safety of medicines in Great Britain issued a warning to one million women that the contraceptive pill they were taking might not be as safe as had been previously claimed. It was suggested that the pills under the brand names Femodene, Femodene ED, Minulet, Triodene, TriMinulet, Marvelon and Mencilon, which contain the new progestagen, gestodene, were more likely to cause blood clotting problems than other pills. These pills had initially been considered safer than other contraceptive pills because they were low oestrogen dosage pills — oestrogen was implicated in the original pills in the 1960s which caused blood clotting problems. I did part of my MD thesis on the blood clotting problems associated with those contraceptive pills, although they were then known as period regulating pills because contraceptives were not allowed into the country. Although these pills were totally unsuitable for older women with large families, because they were more likely to have blood clotting problems, they were still the only form of contraception available. Many of these women felt it was wiser to take them rather than risking another pregnancy.

The committee on safety of medicines in Great Britain issued the warning last week, but it was greatly criticised for doing so. The World Health Organisation, which is organising this major trial, was said to be furious. The trial is incomplete. Dr. Anne Szarewski, a leading expert on family planning in Great Britain, said the Government's action was "irresponsible and premature". Perhaps it was, but I wonder if the fact that members of the committee on safety of medicines could be sued by anyone who got blood clots while on these pills influenced the issuing of this warning. The committee is currently being sued by Femodene Action and this happened before the World Health Organisation's document got into the public domain. This may be a serious problem here.

I will refer to the legal liability of those who serve on the board and its subcommittees and those who give advice to the board. No matter how carefully drugs are assessed, it must be appreciated that licences will be issued on a limited amount of information. Animal toxicology and first stage trials are done, second stage trials are done on healthy volunteers and then clinical trials are done on patients. Most drugs are evaluated on approximately 2,000 people. This means that if a person has serious side reactions, even as serious as death which may only occur with a certain drug once in every 5,000 to 10,000 cases, it will not show up in the 2,000 patients. Nothing can be done about this and it does not mean that one is negligent as a result. Some adverse reactions, even serious ones, will not come to light until the drug is used in the wider community — for example, on older patients, debilitated patients or on patients who are taking other drugs at the same time. A serious criticism is often made that the majority of clinical trials are only done on healthy young males. How do these relate to women? Side effects will occur no matter how careful we are in assessing the drugs involved.

The Minister and all members of the medical profession know there is a climate of litigation at present. Companies, as well as individuals, threaten the relevant boards with litigation. The National Drugs Advisory Board was successfully sued by Scotia Pharmaceuticals. I do not remember the details of the case, but it was a technical matter involving relevant details from one product which were used in assessing another similar product.

While the board can be sued as a corporate body in a legal action, it does not have tangible assets. When we look at the experience of what happened in other jurisdictions it is likely that committee members and advisers who have assets could be sued by companies or individuals. The members of this board will be voluntary, apart from the chairman who will be paid. If it is established in the same way as the old National Drugs Advisory Board, medical practitioners, nurses and vets will be on it. The clinical work done by doctors is covered by the medical malpractice insurance agencies, but they have said they will not cover us for doing the work on these boards. I do not know if the Irish Nurses' Organisation, which has a large indemnity for its members of approximately £1 million, will cover its members on the board and I do not know what will happen as regards the veterinary practitioners. Many people say a good horse or dog is worth more than a human, so they might have the same trouble as well. This is an important situation which has not yet been considered.

Anyone the Minister asks to serve on these boards — we want the best people — must look at the fact that they could be sued for considerable amounts of money. The Minister has not indicated what he will do to provide for the legal costs of a defence for these people or how they will cope if awards are granted against members of the board, the committee or its advisers.

It has been implied that immunity is granted to people on these boards — for example, those on ethics committees — under the Control of Clinical Trials Act, 1990. However, this does not seem to be watertight. The majority of legal opinion believes that the granting of such immunity from prosecution is unconstitutional. Tomkin and Hanafin's book, Irish Medical Law states:

S. 5 of the 1990 Act provides an immunity in respect of actions (except in the case of wilful neglect or default) against the Minister for Health, the National Drugs Advisory Board, and its members acting as such, its officers or servants, and ethics committees or any member thereof. The immunity is for actions for damages ‘in respect of any injury to persons or property alleged to have been caused or contributed to by reason of or arising from the discharge of any of their functions imposed by the' 1987 and 1990 Acts. [These have now been incorporated into this Bill].

S. 5 (2) provides a similar indemnity in respect of claims against the National Drugs Advisory Board.

A question must be asked about the constitutionality of this section. It provides an immunity from suit on a subordinate body created by the Oireachtas, [as we are now doing] and, since the State itself is not constitutionally entitled to avail of immunity from suit since Byrne v. Ireland, it follows that any subordinate body might not be so entitled. This view would seem to be supported by Hogan & Whyte, who discuss immunities in the context of the inconsistency of the State's obligation under Article 40.3 to defend and vindicate the citizen's personal rights. “Hogan & Whyte” refers to The Irish Constitution by J.M Kelly.

Since the people the Minister asks to serve on this board will be totally exposed medically and legally, how does he propose to confer indemnity on the members of the board, its staff, committees, sub-committees and expert advisers? The foundation of the board, as well as its functioning, could be in jeopardy from its beginning if the Minister does not do this.

Senator Henry's speech will be a hard act to follow; it was educational in itself.

The Irish Medicines Board Bill, 1995, has been welcomed by all parties in the Oireachtas because people believe it is important to the health of the general public and is overdue. The pharmaceutical industry is one of our most successful sectors and it is important that strong links are established between that industry and the Irish Medicines Board.

This Bill gives us an opportunity to discuss many issues of major concern to people working in the health area. The purpose of the Bill is to provide for the establishment of a new statutory body to be known as the Irish Medicines Board. It will replace the National Drug Advisory Board, which was established in 1966, which has given considerable service to this State in ensuring the safety and quality of medicines.

There have been major developments in the field of medicine controls, not least the establishment of the European Agency for Evaluation of Medicinal Products. The role of the NDAB should be reviewed and appropriate structures which take account of these changes in circumstances should now be put in place. I believe this is what the Minister is doing in this Bill.

Up to now, the Minister has acted as the licensing authority for all medicinal products. However, all applications for such licences, commonly known as product authorisations, were assessed on behalf of the Minister by the NDAB so as to establish the safety, quality and efficiency of the product. Similarly, under the control of the Clinical Trials Acts, 1987 to 1990, permission to conduct clinical trials is granted by the Minister on the advice of the NDAB.

It has been accepted for some time that this involvement of two separate bodies in the process of licensing was unnecessary and maybe cumbersome administratively. Since 1991 it has been Government policy that the licensing function should be transferred to the NDAB. This is already the case in respect of veterinary medicines in that the NDAB is both the assessor and the licensing authority and it is not necessary to have a further stage in the process.

We have come a long way since the early sixties when companies were allowed to supply drugs to health authorities without full consideration being given to the potency of the drugs being supplied. Pharmaceutical companies should not be allowed to process or sell their drugs without competent tests or assessments being carried out on them. It is possible that deaths may have occurred in some cases a few years ago because some drugs were suspect. We must ensure this does not happen again.

The National Drugs Advisory Board, which was established in 1966 to ensure the safety and efficiency of all drugs on the Irish market, has been in existence for almost 30 years. This board has served a useful purpose and the people who work there are to be commended for their commitment. However, the extension of its functions over the last two decades has created problems for it. The extension of its functions without a significant increase in its resources may have contributed to the time it takes to process applications for licences. I understand there is currently a backlog of approximately 1,250 new applications for products and about 275 renewals. This seems unduly long. Hopefully, the new board will speed up the process when it comes on stream. Resources may be needed to allow this to happen and I hope the Government will seriously consider this situation.

The Bill provides for the establishment of the Irish Medicines Board which will become the licensing authority for both human and veterinary medicines. The current board has a membership of 18 while the new board provides for a membership of nine. Two committees will also be set up within this new board. I also welcome the establishment of the two advisory committees — the Advisory Committee on Human Medicines and the Advisory Committee on Veterinary Medicines. A broad range of experts should be drawn from all areas of medicine to advise the people concerned.

If we look at the human and veterinary medicines currently on the Irish market, we would have to express major concerns about the lack of assessment and trials being carried out. I refer specifically to Prozac. I do not want to create a scare, but many people using this drug over a number of years, especially women, have reacted badly to it. I would call it a suicide drug because of the reactions I have seen and the way in which people behave when they are on it. Not enough assessments and trials have been carried out on Prozac and the Minister should request the current board to seriously consider its full medicinal qualities. I am extremely concerned about it. A Channel 4 television programme on the use of Prozac referred to one American State as the Prozac State. The number of people who committed suicide because they used this drug was unbelievable. People on the drug have come to me for help. They are concerned and I can understand why.

Some sportsmen and women are using steroids and some of them have died due to an excess usage of these drugs. At times we wonder why they are so easily available when we consider the dangers they pose.

The expert group laid much emphasis on the establishment of the new European Medicines Evaluations Agency which would be of assistance to the NDAB in expediting applications. Has this been taken into account in the legislation? What effect will the European dimension have on the staffing of the new medicines board? Will it free up staff in the board and speed up the processes or could it lead to excessive administration, which many have seen happening in other areas where the European dimension has been involved? I seek clarification on this matter.

Sections 13, 14, 15 and 16 of the Bill deal with fees and charges. Will the licensing fees bring in enough money to make the board self-sufficient? Can the Minister outline what the cost to the Exchequer may be if not enough money comes in from the licence fees? I know the power to charge fees under the terms of the Bill is unlimited, but will the board have to increase its fees if it needs more resources? Will this mean that licensing fees will have to increase dramatically? Is there some way the Minister can indicate what the cost may be to the Department? Is there anything in the Bill which indicates costings in that sense?

I am also concerned about ministerial responsibility and ministerial accountability. The present system seems fine but under the new system what happens after the board is appointed? It is stated we will receive a report from the board each year, but who will be ultimately responsible? Will the Minister have people appointed to the board? What happens if Senators raise questions in the House about problems which may exist with the board? The Minister is finally responsible, as is clear from what happened in the case of the Blood Transfusion Service Board, but what is the answer if things go wrong?

The Bill has been welcomed by the pharmaceutical industry, people working in the health services and all political parties in the House. I have no doubt it will have widespread support among Senators and I commend it to the House. There will be much more to be said when we come to the next Stage.

I also welcome the legislation and join with other Members in expressing appreciation to Dr. Miriam Hederman-O'Brien and the expert group on the Blood Transfusion Service Board who presented the report. It is timely to bear in mind that it is as a result of a tragedy — the contamination of a blood product — and the effect it has had on 1,000 women that we are now dealing with this Bill.

As the Minister and other Senators were speaking I was looking at the report of the expert group because if we introduce legislation we should ensure we improve on what existed before. It appears the old board did not work tremendously differently from what is proposed in the legislation. The major difference is that under the old system, to quote the report:

The Minister for Health, through the Department of Health's Public Health Division, issues the licence or authorisation in each case on the advice of the National Drugs Advisory Board. In practice, officers of the Department of Health issue licences and authorisations on behalf of the Minister on the basis of advice given by the NDAB.

There is a suggestion in the Minister's speech and the legislation that he is introducing a major change to what went before. The impression is given that the Minister went through applications and decided who would get licences; that may have been what was in the previous legislation, but it is not what happened. The report states that on the recommendation of the board, the Minister granted a licence, as it was his authority.

The presumption is that if we transfer that responsibility to a new drugs board we will make a dramatic change from the previous procedure and prevent the recent tragedy from happening again. I am not sure that will happen. I know it is a recommendation of the expert group, but it may not be a solution to further tragedies and problems in relation to blood products or medicines.

The report deals specifically with the crisis in the BTSB and its main point is that while the board did not do its work properly, it was totally overloaded and could not cope with its work and additional responsibilities it was given. The report states:

We were told that over the years the backlog of new applications for first Product Authorisations awaiting examinations by the NDAB continued to grow. To this backlog were added applications for the renewal of existing authorisations which were then expiring at the end of their five-year periods of validity. We understand that due to this backlog of applications in the NDAB, new applications for first PAs were given priority by the NDAB, which in turn delayed the issue of PA renewals.

As Senator Finneran and others have said, blood product, including anti-D, was one of those given a retrospective PA. I hope we are not carried away in the belief that simply having the board issue the licence will solve the problem, because it appears to be greater than that A number of matters have to be addressed, not least the staffing level in the board.

As to how the board works, I welcome the Minister's statement that:

in order to successfully transfer the licensing function of the Minister to the NDAB [or the new board] it will be necessary to radically restructure that organisation so as to equip it to take on these additional responsibilities and to make the fundamental change from being an advisory body to being the licensing authority.

I hope he means by this that the board will be given the necessary resources to do the expanded job it is being given.

An objective of the board is that it will be self-financing. That has been the thrust of much legislation through the years and it is an objective rather than an absolute, but I am slightly worried about it. If it is to be self-financing, is it possible its work might be compromised if it has to seek funding for its costs and cost structure? Due to lack of finance it might be compromised in terms of funding from outside agencies.

The expert group stated that the functions of the board and of the chief executive should be clearly outlined and defined, and that is done in the legislation. The functions of the new board are listed in section 4, but they are slightly disappointing in comparison with the functions of the old board, although it had its shortcomings. The report stated the first function of the NDAB was:

to organise and administer a service for obtaining and assessing information as regards the safety of new and reformulated drugs and, in particular, their toxicity and other adverse affects[.]

This may not mean anything as the functions are probably not listed in the Bill in order of priority, but the first function of the new board, in section 4 (1) (a), is:

the licensing of the manufacture, preparation, importation, distribution and sale of medicinal products[.]

It is only in section 4 (1) (f) it is stated the board has the function:

to establish and administer a service for obtaining and assessing information as regards the safety, quality and efficacy of medicinal products[.]

That should have been first on the list and the last function listed should have been the issuing of a licence. We are replacing a board which was found to be deficient, but its first function as outlined in the report is a more important function.

Senator Finneran and Senator Henry mentioned section 4 (1) (g), which lists as a function:

to establish and administer a service for obtaining and assessing reports on any adverse effects of medicinal products in use in the State[.]

There is a huge degree of concern regarding the contraceptive pills listed in the national media as being dangerous. I ask the Minister if he can give Senators information on the functions of the new board in section 4 (1) (a) and (g), the first of which was also a function of the previous board. Has any ongoing testing or research been done since the newspapers highlighted that some contraceptive pills are dangerous? I realise it is only a short time since then, but if any other drug was flagged as a cause for thrombosis, we would see an effective and efficient recall of the drug until it was tested. At present there is a "suck it and see" attitude — women have gone to GPs who have said they do not think that is the effect of the named contraceptive; if the women want to change it the doctors will facilitate them but they do not see an absolute necessity for doing so. Thrombosis is a serious condition and this is not an appropriate response if it may be a side effect to a medicine. I endorse the comments of other Members.

Section 4 (1) (1) deals with another function of the board, which is to "establish and administer a service for the inspection of any service for the collection, screening, processing and quality control facilities" of the Blood Transfusion Service Board. I welcome this aspect.

In common with Senator Henry, although I approach it from a different angle, I am a little concerned about the transfer of the function from the Minister to the board if a product is found to be unsafe. The legislation states that any cases before a tribunal or legal cases pending against the old board will be transferred to the new board. What will be the effect on further litigation when the new board is established? Is the Minister responsible for answering legal cases?

Senator Henry's point related to covering practitioners who may join the board. Who will be responsible for actions which may be taken in the future against the new board? Since the new board will be the licensing authority and the Minister was previously the licensing authority, will the Minister be liable to legal action? I am a little worried that the devolution of power will involve the transfer of a heavier responsibility. I ask the Minister to reassure me that the new board will be able to fulfil any obligations it may face in the future in terms of compensation.

Regarding the functions of the board, section 8 states: "The Board shall hold such and as many meetings as may be necessary for the performance of its functions". I may have overlooked it, but the section does not stipulate the minimum number of meetings the board should hold. The board is being told to do its job effectively and efficiently and I understand the rationale behind that move. However, for example, when the Civil Legal Aid Board was being established, the legislation specified the number of meetings which should be held in the year. This Bill leaves the position open. If the board is good, it will do its job efficiently and hold regular meetings. However, if that is not the case, the Bill does not state that it must meet at specific intervals. The board may feel it fulfils the performance of its function by meeting once a year and I am concerned about this aspect.

Regarding the overload, the report of the expert group states:

It would reduce the time taken to process applications for new and existing PAs if the NDAB [the new board] took account of the assessments performed by regulatory agencies in other countries and raised any supplementary issues it might wish to examine. This would help to reduce unnecessary duplication of assessments while retaining the right and responsibility of the NDAB to raise specific issues it considered relevant.

The group is clearly stating there is no need to reinvent the wheel. We must ensure the highest standards but there is no need for duplication. The Minister must ensure that does not happen.

Section 10(8) states: "The Chief Executive shall devote the whole of his or her time to his or her duties as Chief Executive and shall not hold any other office or position without the consent of the Board." This is an extremely good provision and I welcome it.

I mentioned that the board is to be self financing. In relation to charges for services, section 14 (2) states: "The determination of the amounts of charges by the Board for advisory services shall be subject to the approval of the Minister." However, subsection (3) states:

Charges, prices and payments under subsection (1) in respect of functions performed, services provided, activities carried on or things sold, shall not, save with the approval of the Minister, be less than the cost of the performance of the function, the provision of the service, the carrying on of the activity or the production and development of the thing, as the case may be.

The board is being given licensing authority, which is a strong power, and being told that its function and responsibility is to ensure that products receiving a licence are safe, etc. However, the Bill also states the charges, which is a much less weighty issue in terms of the board's responsibility, shall be subject to the approval of the Minister.

I could accept the inclusion of this aspect if subsection (3) did not specify that the board cannot charge less for the service. This should not be provided at a nominal cost which would place a burden on the Exchequer and I accept that point. However, it is counterproductive to allow the board to be free to perform its functions and issue licences, but then specify that the Minister will oversee matters of cost. The Minister either stays in or out and there is no need for the charges provision.

Section 16 states: "The Board may accept gifts of money, land or other property, upon such trusts or conditions, if any, as may be specified by the donor". I do not understand this measure. Does it mean that if somebody makes a bequest to help the board continue its work it may accept it if it is not in conflict with what it is doing? The Minister is nodding, so I understand the position.

In common with previous pieces of legislation, the Bill stipulates that accounts should be provided within a specified period. This is welcome. I gleaned these points from a summary examination of the Bill. This is welcome legislation if it achieves its objective. For example, a similar case arose with regard to the Office of the Attorney General and we received a report yesterday on the ongoing review. Unless the legislation equips the new board to deal with its workload effectively and efficiently, it will fail.

Regarding the expansion of the functions of the old board, it was the licensing authority for veterinary medicines. Perhaps that authority should be removed from the new board as its other functions in relation to human medicines and blood products are of far greater importance. Perhaps another body should deal with the veterinary products. The new board should not be overburdened with both functions. Perhaps a separate veterinary medicines licensing board should be established and human medicines dealt with separately.

Senator Henry raised the issue of homeopathic drugs. They are popular, but I am not sure whether specific checks on them are carried out. Another aspect occurred to me during the Minister's speech. When the board is up and running, working well and acting as a model of how boards should work, is it the intention to sell that expertise to developing or Third World countries which are often exploited in many ways in terms of pharmaceutical and other products?

I welcome the Bill but we should remember that it came about as a result of a crisis. The board had become ineffective in carrying out its important duties but that problem was not tackled. I welcome the Bill if it achieves its objectives. The Minister said a radically restructured organisation will be put in place to equip it to take on the additional responsibilities and to make the fundamental change from being an advisory body to being a licensing body. This may require substantial additional finance, but unless we ensure the new board has the resources it requires to carry out its job properly, we may be faced with a report from another expert group examining a human tragedy. I hope that will never occur again.

My party welcomes this Bill. I compliment the Minister for introducing it so quickly in response to the recommendations of the expert group on the Blood Transfusion Service Board. The recent tragic events for women who have become infected with hepatitis C through the anti-D vaccine has been the greatest scandal in the history of the Department of Health and the bodies under its aegis. It has made us all aware that, while there are great benefits from advances in human science, there can also be a downside which was not anticipated. Dr. Miriam Hederman-O'Brien's report on the Blood Transfusion Service Board was damning. One of the recommendations of that report was the setting up a new body and I compliment the Minister on moving so quickly on the matter.

The Irish Medicines Board will replace the National Drugs Advisory Board which has been in existence for almost 30 years. It was originally set up to ensure the safety and efficacy of all drugs available in Ireland, but over the years its powers increased. In 1974 the statutory scheme for the licensing of drugs was introduced and this was extended to cover blood products and veterinary products. The functions and duties of the board have increased without a parallel increase in the facilities available to it. This has been the reason for the delays in licensing new products and renewing licences which have led to an outcry on the part of those using the board. The matter needed to be addressed and, hopefully, the new medicines board will be a more efficient and effective organisation because I presume it will have increased facilities.

The report of the expert group on the Blood Transfusion Service Board made us aware of some of the dangers inherent in medical advances, particularly in relation to blood and blood products. It is to be welcomed that the new board will have such a large remit in this regard.

We do not often have the opportunity to talk about drugs in this sense in this House. We constantly call for debates on illegal drugs. Regrettably, society now demands and believes there is a pill for every ill. There is a lack of awareness, education and information on the drugs which are available. A prescription from the doctor legitimises drug taking. We do not seem to concentrate on education and awareness.

With regard to the recent concern about the contraceptive pill and possible associated dangers, the experts researching the matter believed there was an increase in the risk of thrombosis from 1 in 10,000 to 2 in 10,000. Although the risk had effectively doubled it was still a very small number. For many women the dangers of pregnancy are greater than the dangers of taking the contraceptive pill. Many women may be scared of hormone replacement therapy. Nobody talks about the dangers of smoking and its enormous consequences for women's health, particularly in this country but scare tactics are used when dealing with the pill or HRT products which can benefit many women. We should have reasoned and responsible debate on all such issues rather than frightening many people, often unnecessarily.

Health matters can be of great concern and people can be frightened if they do not have all the information. There is an onus on Members when dealing with such issues to do so in a responsible manner. Where dangers to health are posed by drugs, they should be taken off the market. However, when there are outcries about what might be dangerous, we should be careful. We should not tell women to stop taking the pill when the consequences for them could be greater than the effects of taking the pill.

I am also concerned about liability or responsibility. In relation to the hepatitis C problem responsibility has been accepted by the Department of Health, and the Minister is dealing with the issue by compensating the women involved. However, I would be concerned if the responsibility for this new board was taken away from the Minister. The National Drugs Advisory Board made recommendations to the Minister but the new board will be the licensing authority. In the light of recent events I am concerned as to where the ultimate liability will rest.

Another matter of concern on which many of us have been lobbied is that the running costs of the board will have to be generated by levying fees. Large multinational companies can afford larger fees. However, there are also small Irish based pharmaceutical companies and I would not like to see their potential for development and employment hindered by the Bill's provisions on fees. The level of fees charged to these companies should involve a realistic appraisal of the size of a company, its turnover and the number it employs.

The National Drugs Advisory Board seemed to lag behind in the production of its annual reports — its last report was published in 1991. Annual reports which are published so late are almost irrelevant. The new board should not just have a duty to file a report but the Minister should have to publish it and lay it before the Houses of the Oireachtas. While the public may not be aware of the concern they should have about this subject it is of great importance. It is a sector which can greatly affect people's lives. It will be the licensing authority for drugs and medicines and will also be in charge of blood and blood products. When something goes wrong in this area we have seen the devastating effects it can have on people's lives.

We should be concerned about this sector and the report should be brought before the Oireachtas annually; it should be produced before a specified date at the end of each year. There is no point telling us what happened in the Blood Transfusion Service Board five or six years ago; we want to know what is happening now. I welcome what the Minister and the Department are doing in relation to the Blood Transfusion Service Board and the action taken as a result of the Hederman-O'Brien report.

The procedure for licensing these drugs has been established in other European countries. Will we accept that drugs have passed through the advisory boards or medicine boards, or their equivalent, in other European countries? Is this good enough for us or will we have to thoroughly investigate them again? These are issues which would have a bearing on the running costs of the boards, and, in turn, would have an effect on the fees we are going to charge pharmaceutical companies. If these agencies, including ours, conform with the guidelines of EU legislation, that would be acceptable to us.

I welcome the Bill and the speed with which the Minister has responded to the Hederman-O'Brien report. I also welcome the fact that procedures will be more streamlined, that it will be a management board and that it will have two expert committees to advise it, one on medicines and one on veterinary products. However, I would like to see some form of reporting system which would enable both Houses to keep an eye on what is happening. I hope we will never again have anything like the horrific hepatitis C scandal.

I welcome the Bill. It is a necessary, efficient, housekeeping operation. The Minister is tidying up the situation and making it more efficient, which everybody welcomes. He expresses the hope that the board will become self-financing. How will this finance be generated? Will subventions be made by the drug companies? If so, will it be open to abuse? Will it come from the veterinary professional organisations and medical groups?

The Minister also referred to the Control of Clinical Trials Acts, which went through the House, if I recall correctly, in the wake of a tragic case where a young man died while undergoing a drug trial. At that stage we were trying to regulate the situation to ensure that no further tragic accidents occurred. Also at that time, a lively group, centred on the old Sir Patrick Dun's Hospital, appeared to be about to launch a kind of world programme. I understand this venture either failed or has dwindled away, which is regrettable because I was invited to be a member of its advisory ethical committee and I was looking forward to having my say on the matter. However, following the difficulties which the group got into, I was never contacted by it again.

There are two sections to the Bill covering veterinary medicine and human medicine. Many lay people believe there is a kind of crossover here, especially because of the increased use of antibiotic drugs in veterinary medicine. There are concerns among the public that this crossover effect can be damaging. For example, if cattle and sheep are saturated with drugs and if we eat too much of this meat we will develop a resistance to these very useful drugs. I presume that this matter will also be monitored by this new agency.

I hope the Bill will accelerate the proper acceptance, after some investigation, of new drugs, or of drugs that are not currently available in this country. This is particularly important in the area of frontier medicine, especially when we are dealing with AIDS. People look for drugs that are on the frontiers of medicine but which may not be available because the necessary trials have not been completed.

If people are in a terminable condition, they may wish to grasp whatever straws are available and they may, at their own risk, take some of these preparations. I know one must be careful in this area, but it is important that people be given access to whatever opportunities are available, especially at their own wish, and that they should be able to make use of these drugs.

I say this with some feeling because a number of years ago I was contacted by Mr. Jim Foster, whom I had met at a human rights conference ten years previously, and who had become the City Health Supervisor of San Francisco, which was dealing with its AIDS situation. He was prepared to make available to the country a stock of aerosolised pentamidine worth $500,000 which, at that stage at any rate, was regarded as being useful as an early intervention in the infection. I do not know if this was subsequently proved to be the case, but it was strongly felt in American medical circles that taking aerosolised pentamidine before the onset of pneumocystis carinii could inhibit the development of that disease.

Drugs worth $500,000, which would have been welcomed by a number of AIDS patients were offered, but the country was unable to accept what was a very generous gift because of various difficulties relating to the question of clinical trials and so on. It ran into an enormous amount of bureaucratic problems.

I hope that in this area of medicine, the establishment of the Irish Medicines Board will speed up the process where patients who are seriously ill, who have made a choice and wish to avail of frontier medicine, will be assisted so to do.

I thank all the Senators who took part in the debate. I welcome the cross party support for the legislation. The debate was wide ranging and constructive. There is one issue to which I should refer at some length because it was raised by a number of Senators. I agree with the view expressed by Senator Honan regarding the safety of certain oral contraceptives. This area has attracted considerable media attention following the statement last week by the UK's committee on safety of medicines. It is important that the possible risks associated with any pharmaceutical preparation are made clear to those for whom it has been prescribed. However, it is also important that these risks be interpreted in a balanced manner and that new scientific evidence is fully assessed and validated.

Senators will be aware that all pharmaceutical products marketed in Ireland must be licensed. This has been the essence of our debate this evening. Licences are issued on foot of scientific assessments of their safety, quality and efficacy which are carried out by the National Drugs Advisory Board. This is the position as of now. The board ensures that doctors are made aware of risk factors and it also monitors reports of adverse reactions.

It has long been known that certain oral contraceptives involve a slight risk of thromboembolism. The NDAB has always ensured that doctors are aware of this risk and that the risk may be greater in some patients with predisposing factors. The prescribing data and the package leaflets contain details of these possible risks and of the appropriate precautions to be taken in prescribing these products.

The letter issued by the UK's committee on safety of medicines advised restrictions on the use of so-called third generation oral contraceptives because of a suggested increased risk of thromboembolism compared with other oral contraceptives. The National Drugs Advisory Board has advised me that this recommendation was based on the results of scientific studies which have not yet been completely reviewed and validated. The results of the studies were made available on 18 October to the Committee for Proprietary Medicinal Products in the European Union, of which the NDAB is a member. This committee has decided to evaluate the data as a matter of urgency and is convening a meeting for that purpose. The NDAB will contribute to this and will follow it with the appropriate action if required.

The most important message that should go out this evening is that the risks concerned are very small. The NDAB has advised me that it is not even clear as yet that the risk is any greater than with earlier, less advanced oral contraceptives when the patients concerned are strictly comparable. As suggested, increased risk would still be small in absolute terms and smaller than the overall risks associated with pregnancy. I am satisfied that the approach being taken by the NDAB in this matter is an appropriate and responsible one. Any patient who has specific concerns about her treatment should consult her doctor. The NDAB will participate in the evaluation of the new evidence and will issue further information or advice as necessary. I have dealt with this matter in some detail because of the concerns that have been expressed recently.

Senator Finneran asked for more detailed information about the regulations. The regulations will be similar to existing regulations under the 1947 Health Act with amendments to apply to appeals — an issue that came up in the Dáil and which I agreed to address under the regulations — and to put the named patient system on a formalised basis. There will also be amendments in relation to fees. The regulations will go through the democratic process and will be laid before both Houses of the Oireachtas. If Deputies, Senators or political parties are not happy with them they can use the democratic process to make their concerns known. The spirit in which this legislation is presented is constructive and open to ideas and suggestions from Deputies and Senators.

It has been said that extra functions were given to the NDAB while there was no corresponding significant increase in resources. The staffing levels in the NDAB show that in 1982, 22 people were employed there and by 1994 the number had increased to 59. Extra duties and functions were certainly given to the board but there was a corresponding increase in staffing levels. More importantly, however, consultants are looking at the NDAB at present with a view to recommending changes in structures and resources to enable the new board to fulfil its functions. It is important on the changeover — and this relates to a number of points made by Senator McGennis — that the emphasis is on management and streamlining at board level. Allied to that, the technical staff of the new board will carry out a great deal of work on behalf of the board. There is provision under the Bill for the use of the two advisory committees and for the establishment of special sub-committees if that type of advice is necessary in particular circumstances.

A number of Senators raised the matter of fees. The fees can only be set by the Minister for Health with the approval of the Minister for Finance. Concern was expressed that if the fees reached too high a level they could have a depressing effect on our pharmaceutical industry. Effectively, the fees we are discussing in this context apply to products for the Irish market. It was decided by the previous Government — a decision that was endorsed by the present Government — that the board should be self-financing. The matter of fees would relate to a specific or particular product. There is also the matter of charges. Senator Henry dealt at length with this and I concur with the thrust of her argument. Obviously charges for work carried out on behalf of the European agency would be important in the overall financing of the new board. With regard to ministerial approval for fees, it is normal practice that the approval of the particular Minister — in this case the Minister for Health — and the Minister for Finance is necessary.

I accept the arguments advanced by Senator Henry with regard to the named patient scheme and the fact that aspects of the situation were unsatisfactory. Senator Norris, without referring directly to named patients, also dealt with this area. At present a doctor can prescribe a particular drug for a patient if there is no other alternative and his or her professional judgment is that the pharmaceutical preparation could have a good effect on the patient. However, the recommendation of the Hederman-O'Brien report that this be put on a statutory basis by way of regulation will be carried out. I accept the thrust of the arguments put forward in this regard by Senator Henry and Senator Finneran.

Senator Finneran was concerned about the responsibility of the board and its accountability. The annual report will be laid before the Houses of the Oireachtas. It is important to stress that the board will be appointed by the Minister and can be replaced by the Minister. The board's report must be presented to the Minister within six months of the end of the financial year. The report, in the normal course of events, would soon be laid before both Houses of the Oireachtas. However, I must sound a note of caution in this context. A report might contain sensitive material and the Minister of the day might be advised that the report in its entirety at that particular time should not be laid before the Houses of the Oireachtas for legal reasons. That sort of thing can arise and it is very difficult to legislate for it. It is a reasonable time scale. I accept the Senator's criticism in relation to the reports of the National Drugs Advisory Board not being available, but my advice is that they will be available very shortly so the six months time scale is reasonable. In regard to accountability to the Oireachtas, the Minister of the day, I have no doubt, would present those reports rapidly and the Government Whip would decide whether it would be necessary to make time available to discuss them. It is always open to Members who are part of groups to use Private Members' time or other parliamentary devices to pursue any area about which they are concerned.

Senator Finneran asked to whom the chief executive officer would be responsible. The chief executive officer would be responsible to the board. The issue of immunity was raised by a number of Senators. The immunity enjoyed at present by the National Drugs Advisory Board as set out in the Control of Clinical Trials and Drug Acts, 1990, will also apply to the new board. There are another couple of points which I should clarify here because Senators have raised them.

The carry over of immunities as provided for in section 34 covers all of the functions of the Irish Medical Board and is not limited to the functions of the National Drugs Advisory Board. This is achieved by the deletion of the words "under article 4 of the National Drugs Advisory Board establishment order, 1966". The section will now refer to the discharge of any of the board's functions. Senator Henry referred to clinical trials. All committees, including the clinical trials committee, will be covered under section 5 (2) as amended. These committees will be established under section 9 of the Bill and, in addition, responsibility for clinical trials is specified as a function of the board in section 4.

I should bring another aspect to this to the attention of the Seanad. Notwithstanding the immunities provided, it is always open to any person or company to seek to take action in the courts and it will be ultimately a matter for the courts to interpret and rule upon the immunities provided in a particular case. In the event of any awards being made against the board, the question of whether the costs would be borne by the Minister is a matter that would be decided in the overall context of the financing of the board at that time. However, section 15 would allow the Minister to make a grant to the board.

The matter of time limit was raised by Senator Finneran. We will be bound by the EU directive in relation to time limit which is 210 days, but this is on a "stop the clock" basis so if, as the processing is progressing, extra information is required, it is open to the board to stop the clock at that point. The 210 days recommences when that information has been provided.

Senator Finneran raised the matter of co-operation with industry. I totally accept the need for co-operation, but no matter what legislation is in place, goodwill is very important and I have little doubt that the board will be, as the National Drugs Advisory Bord was, open to full consultation with the industry and will treat all matters with due confidentiality. Not alone do I agree with co-operation with industry in principle, but I believe it is very desirable in the context of the new board.

Senator Henry raised the matter of named patients and the delay in getting a licence, with which I dealt earlier. She also raised the matter of the fee for items which have small usage, which is a very important point. There is a provision at present which states that 5 per cent of the standard fee can be applied in such cases and I have little doubt that that will continue in the new situation.

Homeopathic medicines are included in the 1993 EU directive enacted by the 1994 amendment to the licensing regulations. The Win RHo Anti-D product was also mentioned by Senator Henry. The product was brought in on an emergency basis and licensed as a matter of urgency. Any delay which occurred was the result of delays in obtaining information from the company. It would have been improper to licence until the National Drugs Advisory Board and the Minister were satisfied that all safety aspects were covered.

Section 5 deals with monitoring after licence. The board will have the same responsibility as the National Drugs Advisory Board to monitor for adverse reactions on an ongoing basis. I referred to the assessment of EU dossiers earlier and we are ad idem on that. It is very important in the context of the prestige of the board and its staff and so on that the board becomes involved in this area and receives an ample supply of dossiers. The income accruing would not be unwelcome either. It is very important that we are at the coalface in all those areas.

Senator Henry dealt with reaction reporting. There is no doubt that any adverse reactions should be reported. There is an obligation on the licence holder, as a condition of their licence, to report any adverse reactions to the board. I would obviously be concerned about any failure to report such reactions and I reiterate the responsibility of the pharmaceutical companies in that regard. There is a grave obligation and responsibility on pharmaceutical companies to report to the Medicines Board any adverse reactions to their products. The thrust of what the Senator is saying is very important but it is part of the licensing process. The board will be very vigilant and will deal urgently with any such information as it becomes available.

We dealt with the oral contraceptive issue earlier but again there is a need for balance in all these areas and there can be scaremongering. I am not suggesting that that happened in this Chamber; it did not, but it is always a danger. Equity applies in both directions. There is a grave responsibility on companies who market licensed products to immediately and fully make the Irish Medicines Board or the National Drugs Advisory Board aware of those difficulties.

Immunity from prosecution for the board, its staff and members of committees, is provided for in the Control of Clinical Trials and Drugs Acts, 1990. The immunities will apply to the new board for all its functions. Any legal action is likely to be against the board in its corporate entity and not against individuals. Whether such immunities are constitutional is ultimately a matter for the courts. Frankly, I cannot see what more we can do in the Bill to provide this immunity and protection. At some future date the courts may make a particular decision but, in the context of all the legal advice available to us now, it is the firm intention that there would be full and comprehensive immunity for the board, its staff and committees. At the end of the day, the courts interpret the Constitution.

Senator Maloney spoke about the drug Prozac. My information is that there have been many confusing and misleading reports in relation to Prozac. Prozac is an antidepressant drug and is only available to people on prescription. People on this drug are monitored by their doctors. Equally, like all drugs, it is subject to ongoing monitoring by the board. I will discuss the issue with the Senator after this debate. If there is information that should be provided to the board, I will be happy to see that is done.

Senator McGennis asked how different things will be under the new set up when the Minister will no longer be licensing pharmaceutical products. The Bill does not merely transfer the power of licensing to the new board. The new board and how it will operate will be radically different to the National Drugs Advisory Board. Consultants are to advise us, as I reported earlier, on the changes and structures necessary to provide an effective and efficient licensing system and the resources necessary for this. The whole thrust is about removing what is identified in the Hederman-O'Brien report and also by a Government decision in 1991 as a cumbersome process. As Senator Henry stated in her contribution, if there are particular products and everything points to them being of real benefit to patients, the sooner we can make those available to patients the better, with the caveat at all times regarding safety. The essential point is to have streamlined, more effective and efficient measures.

Senator McGennis asked whether or not, if the board is to be self-financing, this could lead to the board being compromised. I do not see how that could apply against a set of fees which will have to be approved by both the Minister for Finance and the Minister for Health. The bottom line is that the board be self-financing. Like Senator Henry, I share the hope that worthwhile and substantial incomes will accrue from the European agency, but I do not frankly see how self-financing could in any way compromise the board.

The functions of the board was another area that Senator McGennis alluded to in her contribution. She made a point regarding how the various functions are listed and the order in which they are listed. Each of those functions is equally important and, essentially, it does not matter in what sequence they are listed. Their importance does not relate to where they appear on a list; it relates to their necessity and the board will so treat them.

Adverse reactions to drugs was raised by Senator McGennis. I have already alluded to that in my reply to Senator Henry. Senator McGennis was also concerned about the fact that the legislation was not specific about the minimum number of meetings the board should hold in the course of a year. Quite frankly, I cannot see that it is prudent to put any such limit into legislation. At the end of the day, the Minister has the final sanction relating to the most important issue — whether the board is doing the job properly or not. He or she can disband the board in the future. The important issue is the quality of the meetings and how the board carries out its duties to make sure that we have an efficient and modern assessment and licensing system for pharmaceutical products.

Recognition of the product authorisations from other regulatory agencies was another point raised by Senator McGennis. There is provision under EU regulations for mutual recognition of licences by other authorities. This will be mandatory from 1998 onwards. Senator McGennis also spoke about the ministerial approval of charges. The board will carry out its statutory functions and the Minister, as is standard practice — I dealt with this point earlier — will be the person who, at the end of the day, will clear the actual level of fees.

Veterinary medicines and the fact that they are provided for under this legislation was also raised by Senator McGennis. The licensing of veterinary medicines being dealt with by the same authority as deals with human medicines is usual practice. It is the normal practice throughout Europe and in the European Medicines Agency. Senator McGennis also spoke about the selling of expertise to other countries. In principle, it is desirable that expertise can be made available to developing countries and countries which have a real need to develop their health services to a modern standard. I have no difficulty regarding that and it is something that will emerge in practice.

Senator Honan spoke of the annual report. I have already dealt with that. Within six months of the end of the previous financial year, the report must be given to the Minister and, all things being equal, I would see that being rapidly available to the Houses of the Oireachtas. There is also the business of recognition of product authorisations from other states. I have already mentioned that being mandatory from 1998, but the final caveat is that the responsibility for safety is paramount. There is some evidence of corruption in this area in at least one member state of the EU, so we have to be careful how we proceed. That particular issue is a sensitive one but, for all that, it is also a fundamental and important one.

Senator Norris spoke in general terms about the named patients system and he also mentioned the cross over between veterinary medicines as residues in food products into the human food chain. The Minister for Agriculture, Food and Forestry will address this through the various means available to him and I am sure it will be dealt with by the new board.

I hope I have dealt comprehensively with the main points which were raised. If there are other areas about which Senators have concerns, they can talk to me about them or write to me. There is nothing confrontational or adversarial about how the Bill is being presented. It is important that we get it right and the package we are presenting is as far as we can go at this point. The Bill contains wide ranging provisions which enable the Minister to give other functions to the board by regulation as the need arises. The regulations which give concern to Senators, specifically those which are the subject of concerns expressed by Senator Finneran, are in line with the Health Act, 1947, along with the three areas I mentioned. I commend the Bill.

Question put and agreed to.

When is it proposed to take Committee Stage?

This day week, subject to the agreement of the Whips.

Committee Stage ordered for Wednesday, 1 November 1995.
Sitting suspended at 5.20 p.m. and resumed at 6 p.m.
Top
Share