Dáil Éireann debate -
Wednesday, 5 Jul 1995

Vol. 455 No. 5

Irish Medicines Board Bill, 1995: Second Stage.

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

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

The essential purpose of this Bill is to provide for the establishment of a new statutory body to be known as the Irish Medicines Board. The 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 the field of medicines control, not least the establishment of the European Agency for Evaluation of Medicinal Products, it is appropriate that the role of the NDAB should be reviewed and that appropriate structures which take account of these changing circumstances should be put in place.

Heretofore 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. Similarly, under the Control of Clinical Trials Acts, 1987 to 1990, permissions to conduct clinical trials are granted by the Minister on the advice of the NDAB.

For some time it has been accepted that this involvement of two separate bodies in the process of licensing was unnecessary and administratively cumbersome and 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.

The recent report of the Expert Group on the Blood Transfusion Service Board endorsed that proposal to transfer the licensing function to the NDAB arguing that the present arrangement is cumbersome and unsatisfactory. However, in order to transfer the licensing function of the Minister to the NDAB, it will be necessary radically to restructure that organisation so as to equip it to take on these additional responsibilities and to make the change from being an advisory body to being a licensing authority.

Having considered how best to achieve this transfer of functions from the Minister, the Government has decided that the most appropriate way of doing so is to have a new national medicines licensing authority, established on a statutory basis, which will replace the National Drugs Advisory Board, take over its existing functions and also take over the licensing function of the Minister.

The Bill before the House, therefore, provides for the establishment of the Irish Medicines Board, which will become the licensing authority for both human and veterinary medicines and will also be given the responsibility for granting permissions to conduct clinical trials.

The new board will be more compact and different in character from the NDAB. The current board has a membership of 18 persons representing a wide range of expertise relating to medicines. Its members also sit on a number of specialist committees of the board, dealing with issues such as the evaluation of human medicines, the evaluation of veterinary medicines and clinical trials.

It is proposed that the board will be primarily management in character. Consequently, a smaller size is appropriate and the Bill provides for a membership of nine.

At the same time, it is necessary that the new board should have available to it a range of expertise such as is 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 as currently represented on the National Drugs Advisory Board. The committees will also be authorised to establish such expert advisory subcommittees as they need to assist them in their work.

The new board will carry out the current functions of the NDAB but will have the additional responsibility of being the licensing authority for human medicines. As I mentioned earlier, the NDAB already fulfils this responsibility for veterinary medicines. The board will also take over responsibility for the granting of permissions to conduct clinical trials and will generally assume the responsibilities currently exercised by the Minister under the Control of Clinical Trials Acts, 1987-90.

Following the recent review of the Blood Transfusion Service Board, it is desirable that an independent expert body should be available to inspect and report upon the processing of blood and blood products. It is considered that the medicines board would be the most appropriate body to undertake such a role.

For this reason, the new board will be given a specific responsibility in the 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.

The board will also become the competent authority in the State in relation to our obligations regarding 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 expected that the board, along with similar agencies in other countries, will be commissioned by the European agency to carry out assessments of applications for European licences.

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 new board on no less favourable terms than those they enjoyed whilst in the employ of the NDAB.

While at first sight the Bill is not a particularly short one, Deputies will appreciate that most of its provisions are the standard ones which arise when a statutory body is being established. For that reason, I will not dwell on these, but I would like to refer to some important provisions concerning the financing of the board.

It is intended that the board will be self-financing and this is reflected in sections 13 and 14. Under section 13, the Minister may make regulations for the payment of fees to the board in respect of licences. It is intended that fees will be set at a level necessary to meet the costs of operation and this is reflected in the provision of subsection (4). Section 14 permits the board to charge for any service which it may provide other than licensing and thus will enable it to sell other services to the extent that this may be feasible.

Nonetheless, it is appropriate that provision should be made for the payment of grants out of the Exchequer should the need arise, particularly during the transition period, and this is dealt with in section 15.

The Bill has been welcomed by the pharmaceutical industry who recognise the need to update our regulatory system. The proposed approach will streamline the licensing system and bring a new management-oriented emphasis to the overall board while retaining the essential technical expertise in the form of the advisory committees. I am sure it will have widespread support among Deputies and I commend it to the House.

Mrs. Geoghegan-Quinn

Cuirim fáilte roimh an Bille seo. Tuigim an réasún atá ag baint leis. Tuigim freisin go bhfuil roinnt mhaith oibre déanta air le trí bliana go leith anuas ó tógadh an cinneadh don chéad uair an cineál seo reachtaíochta a chur ar fáil. Chomh fada agus a bhaineann sé le Fianna Fáil beimid ag tacú leis an Bhille. Ar ndóigh beimid ag cur leasuithe chun cinn ar Chéim an Choiste agus tá mé cinnte go mbeidh an tAire nó an tAire Stáit sásta breathnú orthu ag an am.

We have come a long way from the day when pharmaceutical companies could market in Ireland without let or hindrance drugs of dubious quality, efficacy and safety. The history of drug licensing in Ireland reached a low in the early 1960s when one company which supplied drugs to health authorities was required by a Minister of Health to withdraw its products because the potency of the drugs was suspect.

As a result of that unfortunate situation, which may have contributed to the deaths of a number of Irish people, the Government established the National Drugs Advisory Board. The board was established in 1966 to ensure the safety, quality and efficacy of all drugs on the market. In its almost 30 years of existence, the board has served a useful purpose and I would like to place on record my own appreciation and that of my party to all the staff who worked in the National Drugs Advisory Board for their dedication and commitment at a time when they were under enormous pressure.

However, the length of time taken by the NDAB to process applications for both new and renewal licences for medicinal products has been a matter of concern for some years. The problems have arisen with the substantial extension of the NDAB's functions over the last two decades. When it started out in 1966, the board's job was just to disseminate information regarding drugs and to advise the Minister for Health on drug safety measures.

In 1974, a statutory scheme for the licensing of drugs was introduced. This scheme was extended to blood products in 1983 and to veterinary products in 1985 and all of this work was given to the NDAB.

The extension of the board's functions without a significant increase in resources has contributed to the length of time taken to process applications for licences. There is currently a backlog of about 1,250 new applications for authorisations for products and about 275 renewals that are still held up at the NDAB.

It is unusual to take a number of years to process applications for new licences under the present system. There have also been significant delays in processing applications for renewals of product authorisations for blood products. This happened in the case of Anti-D immunoglobulin which is at the centre of the present hepatitis C controversy.

The report of the Expert Group on the Blood Transfusion Service Board records that a product authorisation for anti-D was applied for in December 1982, but was not issued until October 1986, almost four years later. The report also shows that the National Drugs Advisory Board lacked the powers to speed up the licensing process and there was an excessive level of bureaucracy involving the NDAB, the Blood Transfusion Service Board and the Department of Health's public health division. The expert group noted that the BTSB's anti-D was effectively without a valid product authorisation for a number of years and that the authorisation for such an important product was issued eventually on a retrospective basis because of the crisis in the licensing system.

The report of the Expert Group on the Blood Transfusion Service Board of January 1995 states:

We believe that the practice of authorising PAs retrospectively is undesirable, especially when long delays arise, as in the case of Anti-D. The Department has informed us that procedures have now been improved to ensure prompt processing of renewal applications so that the need for retrospection will not arise in the future.

The new Bill is welcome as it should alleviate many of these problems. However, I have a number of concerns about it.

The proposed legislation follows a study and recommendations by the expert group on the BTSB. However, when Deputy O'Hanlon was Minister for Health in 1991, concerns were expressed by him and by the Department in relation to the NDAB. At that time, if memory serves me right, the Government made a decision to change the NDAB and to give it the type of independence now being given under this Bill.

One of the recommendations of the expert group was that the NDAB should take account of the assessments on products performed by regulatory agencies in other countries. At present, the detailed nature of applications is one of the factors in the huge delays at the NDAB. Applicants are required to submit extensive information on the product. The board then undertakes medical and pharmaceutical assessments through two specialist committees, the Committee on Evaluation and Toxicity and the Committee on Drug Usage and Adverse Reaction. They make their recommendations to the board which assesses the information before a recommendation can be made to the Minister for the granting of a product authorisation.

The expert group said it would reduce the time taken to process applications for new and existing product authorisations if the board took account of the assessments performed by regulatory agencies in other countries. The NDAB could then raise any supplementary issues it might wish to examine. It said this would reduce the unnecessary duplication of assessments, while retaining the right and responsibility of the board to raise specific issues it considered relevant.

The Minister does not appear to have taken this on board. While new advisory committees will be appointed, will they be able to use assessments by other regulatory agencies? It does not appear that they will be able to do so. Will the Minister consider including this provision for the use of assessments by regulatory agencies in other countries on Committee Stage?

There is considerable and extensive co-operation between the authorities here and those in the United Kingdom on many issues. This should also extend to co-operation between the British Medicines Control Agency and the new Irish Medicines Board.

The Bill does not make clear if the named patient arrangements will continue. This process operates under Article 5 of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984. It provides an exemption from product authorisation requirements for the importation or sale of a medical preparation by or to a registered medical practitioner for the treatment of a particular patient. The named patient system has been operated informally by the NDAB.

The usual purpose of the named patient scheme is to help treat patients for whom authorised, commercially available, medical preparations would not offer a satisfactory treatment or in cases of new experimental drugs. However, the system was used to introduce the replacement Anti-D product after the Blood Transfusion Service Board withdrew its product at the start of the Hepatitis C controversy. The expert group on the Blood Transfusion Service Board said it did not believe the replacement Anti-D product came within the remit of the named patient system, as it is a widely used product.

The expert group recommended that product authorisations should be processed speedily. That is provided for in this Bill. We welcome such an inclusion. The group also recommended that the named patient system should be put on a formal basis, but this does not appear to be included in the Bill. Perhaps the Minister could clarify this. It is important that the system be put on a formal footing and to make the regulations for the operation of the system more explicit as, at present, doctors and dentists are not obliged to notify the NDAB that they are importing a medicinal product. This would make the circumstances in which products may be issued on that basis clear and unambiguous. As the regulations stand and with the precedent of using the replacement Anti-D product on a named patient basis, there is a great danger that the system might be used for some type of clinical trial.

The expert group emphasised that the establishment of the new European Medicines Evaluation Agency would be of assistance to the NDAB in expediting applications. Has the Minister taken this into account in the legislation? What impact will the European dimension have on the staffing of the new Medicines Board? Will it free up staff at the board and will it speed up the process? Will the European input lead to excessive bureaucracy, which many people believe it leads to in other areas?

This brings me to the implications of the Bill for the management and staff of the new Medicines Board. A new staffing structure will be necessary. At present, the NDAB appears to have great difficulty in carrying out its functions in a satisfactory way as the structure, role and modus operandi of the board has not basically changed since the NDAB's establishment in 1966. The problems will now be greater as a result of these additional powers.

Perhaps the Minister could give details of the staffing plans and the current backlog at the NDAB. I would also like him to give a commitment here today that the changes will only be introduced after extensive consultations with staff interests. Details also need to be given of the plans for strengthening management structures at the new board, the plans for dealing with the backlogs and for the planned increases, if any, in the number of professionals at the Medicines Board. The professionals, along with other members and categories of staff, will be under immense pressure with the new regime proposed. It is important for the Minister to clearly spell out what changes will be made, how they will be implemented and how a consultation process, if it has not already begun, will be operated by the Department of Health.

Can the Minister give an estimate of the additional cost of the changes which will be necessary because of the new legislation? For example, are there plans for increases in fees? There is a proposal to make the applicants for licences liable for all costs of the Medicines Board. The power to charge fees under the terms of the Bill is unlimited. No matter what the activity is, the fees can be increased to cover the costs, according to the proposed legislation. If there are to be changes and increased resources for the Medicines Board, does this mean that licence fees will rocket?

Surely the Exchequer should make some contribution in this regard? Section 15 states "The Minister may, in each financial year, after consultation with the Board in relation to its proposed work programme and expenditure for that year, make grants of such amount as may be sanctioned by the Minister for Finance" available to the Medicines Board. However, this needs to be teased out further to ensure that the cost of the operation of the board, particularly in areas which are outside its normal remit, is included.

Healthcare, veterinary, pharmaceutical and medicine sectors are major contributors to employment here. Today the Minister for Enterprise and Employment announced the expansion of an existing pharmaceutical company and welcomed the establishment of a new company. During the past number of years members of successive Governments have repeatedly travelled abroad to entice companies involved in the pharmaceutical industry around the world to set up companies here. Such companies will be interested in this legislation. If they are asked to provide all the funding for the new restructured medicines board, that might make them less enthusiastic about Ireland as an alternative and attractive industrial location. The Minister would not like that to happen as a result of the enactment of this Bill. It might be more acceptable to make the sectors liable for the costs related to the registration of medicines, but not for unrelated activities of the board.

It is unclear as to whether the medicines board will be able to build up financial resources. Will the board get an annual grant from the Exchequer to expand its accommodation facilities since the present premises of the National Drugs Advisory Board require upgrading. Perhaps the Minister plans to move the board to a new location. Will such accommodation costs be paid for directly by the Exchequer by way of a grant from the Minister's Department or will the board be expected to meet such costs by way of fees?

The Bill lacks clarity regarding the Minister's accountability for the new medicines board. Under the present system there is no doubt about the Minister's role. The National Drugs Advisory Board advises him on precautions or restrictions subject to which drugs may be marketed or continued in use, the board reports to the Minister on general matters relating to drugs, it advises him on licensing, manufacture, importation, distribution and sale of drugs, on the standards of drug manufacturing practices and on the certification for the export of drugs. Under the new Bill it is unclear where the buck stops. The Minister appoints the board, but following that there appears to be no direct relationship. As stated in the Bill, the board will file an annual report, but the Minister will not be responsible for the operations or policy of the medicines board. That needs to be clarified. Is the medicines board to be completely autonomous or will the Minister for Health have an input through the appointment to the board of, say, an official from the Department of Health who would directly represent the Minister on the board?

If Members table parliamentary questions to the Minister regarding a problem that arises in the board, will they receive the standard reply which has been given in respect of newly established agencies, that the Minister no longer has responsibility for the day to day operations of a particular agency, that he decides on and will answer questions on policies, but will not be prepared to answer any on the operation of the agency? We have learned a tough lesson from what happened in the Blood Transfusion Service Board recently. I do not support the transfer of such a degree of accountability. It would be incumbent — and if it is not specifically stated in the Bill, it should be written into it — that the Minister will have to answer for the board to the House.

It should be possible to call the chief executive or director of the board before the Select Committee on Social Affairs, the Committee of Public Accounts or another committee of the House perhaps on an annual basis to account for his or her stewardship. I have advocated that in and out of Government. Sometimes Ministers must be answerable to the House for public officials who are responsible for the day to day operation of specific duties while those public officials are not answerable to anybody. In this era of openness, transparency and accountability such a provision should be incorporated in the Bill.

Who is legally accountable if something goes wrong? What will happen if a person sues over the use of a drug or a company takes an action over a delay in processing an application? Who provides legal indemnification? As I am sure the new medicines board will have very few assets, will responsibility in that regard lie with the Minister and the State? Will the Minister be responsible if a member of staff of the board takes an action? Those matters should be clarified and we need to tease them out on Committee Stage.

The public health division of the Department of Health has had a major input over the past 20 years into the licensing and product authorisation work of the National Drugs Advisory Board. What will its role be when the medicines board will be the competent authority? Will it be possible to use the expertise built up over a long number of years in the public health division of the Department under the new regime? There is no commitment in the Bill regarding the timescales for processing applications for licences and product authorisations. It is desirable that best practice procedures should apply to legislation. Will the Minister consider including in the Bill or in regulations the desired processing time for applications? That should be a key performance measure for any regulatory authority.

The Bill does not include any commitment to consult the industries that will deal with the medicines board. Those pharmaceutical, veterinary, healthcare and medical industries have a wealth of knowledge and expertise which they are willing to make available to the board. While appointments may be made to the board from the sectors, it is vital that an efficient communication forum should be established between the medicines board and the industry. A general forum should be considered for an exchange of views with the relevant industries on a regular basis together with a formal system for consultation or communication of critical policy issues.

The committees and boards to be appointed by the Minister should include representatives of the industries to ensure that processing of licence applications is not unnecessarily delayed. While the Bill provides that the board shall not refuse to grant a licence for a new pharmaceutical product without first consulting an advisory committee, the representation of the relevant industries on the committee is an essential requirement.

In the past one of the considerations in the issuing of licences was the cost of drugs. It is believed that concern regarding costs and the implications for the Exchequer appear to have resulted in the Department of Health delaying approval of drugs recommended by the advisory committee of the National Drugs Advisory Board in the past. Had the approval been given immediately, many patients may have benefited. Will such budgetary considerations continue under the new medicines board? Its work should be independent of budgetary constraints and Exchequer politics.

At present the reporting arrangements of the National Drugs Advisory Board are most unsatisfactory. The current advisory board has yet to publish its 1991 annual report. I know from my experience in Government that from time to time every Taoiseach warns Ministers regarding agencies under his or her control and the fact that the publication of many annual reports are delayed for various reasons. It would be useful if the Minister could indicate today or on Committee Stage when the annual reports for the last number of years will be made available. It is important that such reports should be published and that the business of the National Drugs Advisory Board should be dealt with to ensure that the medicines board, which will take over the assets, liabilities and functions of the board, should not be made responsible for the annual reports of the National Drugs Advisory Board awaiting publication. The backlog of four annual reports is a matter of concern. They should be published in a consolidated form as a matter of urgency.

The Bill provides for the new medicines board to file an annual report within six months of the year end, but a timeframe has not been set within which the Minister must publish the report. The Bill should be amended to provide that the Minister must lay the report before the Houses of the Oireachtas within a specified time after the end of the board's financial year.

Fianna Fáil supports the Bill. It is important in the context of public health and it is welcome as it has been overdue for some time. It is correct that the medicines board should be the competent authority and it should be independent in the performance of its duties, but a number of matters to which I referred need to be clarified. Amendments will probably be tabled to the Bill on Committee Stage before the new body is established. I would like the Minister to clarify those issues and I hope he will be generous in addressing the concerns that will be expressed by Opposition Members during the course of the debate.

Ms O'Donnell

The Progressive Democrats Party welcomes the introduction of the Bill. Committee Stage debates are usually of great benefit in that they allow time for people with the necessary expertise to communicate with Members. We do not have the requisite research facilities or professional knowledge to deal adequately with legislation such as this. The Opposition insisted that some time should lapse between the publication of the Bill and its introduction in the House so that experts in the field could communicate with Members and indeed the Minister. As Deputy Geoghegan-Quinn stated, it is important that strong links are established between the medicines board and the industry. The pharmaceutical industry is one of our most successful sectors. Goodwill between the board and the industry is worth fostering.

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. I share the concern that we must be sure about how far we delegate power. As we are establishing yet another statutory body, perhaps we should examine how systems of accountability and responsibility are maintained by boards following the delegation of powers to them. The blood bank scandal is a case in point. This Bill was possibly precipitated by the Hederman 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 the supervision and licensing of blood products.

The Minister spoke about a recent review of the Blood Transfusion Service Board. The word "review" is a euphemism to cover a multitude. The public and Members of this House were shocked by the recent events in the Blood Transfusion Service Board. Public confidence in it was diminished, but it is being won back by the way the Minister is dealing with compensation claims. The enormity of what happened has not been debated in the House. A total of 1,100 women, if not more, have been grievously wounded by the negligence of a State agency and, because of the enormity of the matter, the House has not debated it. However, we can move on and learn from mistakes and I welcome this Bill which will tighten the supervision and inspection of, and reporting on, the processing of blood and blood products. The board's lapse and inactivity on such matters resulted in the introduction of this Bill.

The licensing of drugs is not a matter generally debated in the House, but people in the industry are concerned about the efficiency of the existing board and its capacity to perform its duties. It has allowed a backlog to build up and many new drugs have not been introduced because of bureaucratic and administrative difficulties in the board. Many drugs introduced in other countries to deal with specific health problems are not available here. I understand that some of those products are available only on a named patient basis. Because the companies involved are market driven and interested only in making money, it is understandable that they are not interested in introducing a drug for which there would be a low demand. The Minister did not refer to this matter but it must be teased out on Committee Stage. Some important drugs that are necessary for specific and rare diseases, because of their cost, are not available here. In a market driven economy, the companies concerned do not feel obliged to introduce such drugs because of the low demand for them.

This is a particular concern in the context of so-called orphan drugs which are compounds developed for rare conditions. In a small market multinationals will not push their development. Legislation on such drugs was introduced in America a few years ago. The existing board was also slow to facilitate clinical trials of new agents. Multi-centre international trials are necessary to decide on the effectiveness of an agent. I welcome the establishment of the new board. A board comprising 18 members is unwieldy. One comprising eight or nine members, as recommended in this case, would carry out its work much more efficiently.

The Blood Transfusion Service Board deals mainly with the daily crisis management of running the blood transfusion service. In the context of the safety and confidence of blood products it is vital that the highest possible standards apply to the licensing, testing and the introduction of drugs into the State. Of course, similar high standards are necessary in the context of blood products.

Deputy Geoghegan-Quinn referred to a matter we raised recently with the Minister.

In regard to parliamentary questions, I might cite an example of the National Roads Authority established to deal with all national routes when from time to time I needed to ask questions about the progress of a given road within my constituency. Yet there is no method by which one can pose such a question here because the Minister has had no responsibility for our national routes since the establishment of the National Roads Authority. This has led to a democratic deficit. A statutory board such as that being established under this Bill, with very important delegated powers in terms of public health, should be accountable or answerable to this House in some fashion. Perhaps the Minister would examine that suggestion.

Looking back on the scandal surrounding the Blood Transfusion Service Board, it is most important that questions be asked in this House and, more importantly, adequately answered. That leads me to the danger of asking questions here in relation to such a possible disaster. I wonder, if Opposition spokespersons had been asking questions about allegations of bad management on the part of the Blood Transfusion Service Board at the time, would they have been accepted, adequately answered and would it have been possible for a committee of the House to investigate the matter. As it transpired, the disaster was discovered in another way. I doubt whether we would have been able to obtain replies which would have disclosed all that was revealed in the subsequent Hederman-O'Brien report. As we discovered recently, it appears the Government felt constrained in answering parliamentary questions which might have found fault with a third party.

Had Deputy Geoghegan-Quinn and/or I been asking questions about the Blood Transfusion Service Board at the time, I wonder if in answering such questions truthfully, the Government might have left itself open to a huge compensatory claim against it and/or the board. It leaves me wondering whether we would have got to the bottom of the matter in terms of accountability for the management of a most important public health facility. For that reason the Minister should consider just how far he wants to go in delegating these important powers to a new statutory body. For example, quite apart from presenting us with an annual report, perhaps he might devise some mechanism to ensure greater accountability to this House.

In the short interval since the publication of this Bill there have been some responses from the pharmaceutical industry or people who know a lot about it and those involved in veterinary medicine. Adequate time should be allowed before Committee Stage to enable such people contact Opposition Members to express their views.

An important point was raised by Deputy Geoghegan-Quinn about liability, about who would be held to be liable if and when things went wrong. I should like to know what would happen in such circumstances because, as we have witnessed on many occasions, there can be huge implications when something does go wrong. There is need for greater clarity with regard to legal responsibility and just how far the Minister's responsibility goes.

The Minister indicated that the Irish Medicines Board will be self-financing. This begs the question of just how self-financing will it be in practical terms. The self-financing requirement is laudable, but I wonder what will be the position if the board encounters difficulties in maintaining high standards while complying with this requirement.

I welcome the streamlining of the licensing system and the fewer number of board members, which should ensure their being workmanlike and professional. I hope Committee Stage will not be taken very soon. While I know the Minister is anxious to have the Bill pass all Stages, it would benefit from a reasonably thorough Committee Stage examination. I hope the Minister and his officials will be available to brief Opposition spokespersons on a whole range of issues, particularly those relating to blood products.

Kathleen Lynch

Last April the Minister for Health announced the establishment of a tribunal to settle compensation claims for women infected with hepatitis C through Anti D products. Since then there have been indications that hepatitis C infection extended beyond that group and may include people who received blood transfusions in the normal course of their medical treatment. It is clear that the whole matter of the safety of blood products is very much more complicated than had originally been thought. Indeed, we are still discovering more about the problem about to confront us.

When the Hederman-O'Brien report was published the Minister for Health gave a commitment that he would act on its recommendations as soon as possible. This Bill is part and parcel of that process. I hope we shall have an opportunity to formally thank the members of the Hederman-O'Brien committee. It was an eye-opening experience for any woman who found herself possibly infected by immunoglobulin. I had personal experience of that. I was very lucky and escaped, despite having been in the high-risk category. I am sure most women finding themselves in my circumstances would be eternally grateful to the Hederman-O'Brien committee, as I was and remain, and grateful to the Blood Transfusion Service Board, because our pregnancies up to that point had been rather perilous. Most women, if and when faced with the choice, would have opted for a healthy pregnancy. Therefore, I continue to be extremely grateful for the progress made in relation to Anti D and immunoglobulin. In that respect I think I speak for the majority of women in the rhesusnegative bracket since the late sixties/early seventies.

I am delighted the Minister has moved not only to replace the National Drugs Advisory Board but to streamline the supervisory procedures in regard to blood products and derivatives. It is only during the past couple of years that we have become aware of the problems of infection and contamination associated with blood products, as we have also become aware that medical advances carry inherent problems. the saying: "Not every cloud has a silver lining" is as true as the opposite, because, along with progress, we shall experience new problems with which we need to be able to cope. As medical science advances and the use of such products increases, we shall become even more aware of potential dangers. It is my belief that the provisions of this Bill anticipate many such problems by putting in place the necessary structures for early detection and by a recognition of the need to adjust to and deal with such contingencies.

Recent events surrounding the Blood Transfusion Service Board have highlighted the need for an independent body with the requisite expertise in the processing of blood and blood products, which role will be fulfilled by the Irish Medicines Board.

There will be teething problems, as is always the case when a new board is established. However, because of the expertise of those appointed to the board, any problems that might arise will be quickly addressed. The members of the board are experts in their own fields. A board such as this should have been in place a long time ago rather than having a political master being advised by experts and then making a decision on whether to issue a licence. Had that procedure been public knowledge, and the problems that were associated with it, most people would have found it extraordinary. I make that statement without any malicious intent.

The Minister has taken an opportunity to establish a comprehensive and accountable system for the licensing of medicines and the granting of permission to conduct clinical trials. He has ensured that the licensing and assessment functions, previously divided between the Minister and the NDAB, are brought together under one authority. That is a sensible suggestion which arose out of the Hederman-O'Brien report, although that is not referred to in the Bill. In years to come we will continue to be grateful to that committee and its investigation.

Pharmaceuticals are increasingly subject to European legislation and the new board will be well placed to ensure we comply with EU regulations in this area. I welcome the Minister's assurance that the board will co-operate closely with the new European agency for the evaluation of medicinal products. We must be able to act quickly and with knowledge in regard to new products and clinical testing and be in a position to link in with the research and development available in other countries. The board will play its role in that regard.

European and Irish markets are currently being deluged with a bewildering variety of pharmaceutical and generic products. The increase in supply, however, has not been matched by a similar increase in consumer information. Over the counter products are bought with little or no information being made available to the consumer as to their possible side effects and contraindications. Package inserts, demanded by law in most European jurisdictions, are often absent and the information available is often incomprehensible to the lay man or woman. That area must be addressed.

We must have scientific information available to us when we examine particular products. The products most widely used, however, are those that can be bought without a doctor's prescription. Consumers are often unaware of the side effects, which can be disastrous in some cases. Those side effects are becoming more evident. We must examine the problem of drug dependency in our society. People often want a quick fix and they take a tablet for every minor problem. We now have a population who will live well into their eighties and it is important that we develop a more holistic approach to our lives.

Medicines were developed to help us but we should not become dependent on them. We must develop a healthier attitude to medicine, its benefits and adverse side effects and that attitude should be developed from an early age. We must inform the public that the availability of drugs without a doctor's prescription does not necessarily mean those drugs are entirely safe or that they can be used at will. I hope this issue will be addressed by the new medicines board. The Bill provides for the Minister to make such regulations as he sees fit in the whole area of pharmaceutical supply and distribution and I urge him to address also the area of consumer information.

Dr. Moffatt

I am delighted to have an opportunity to contribute to the debate on this Bill. The Bill has been in the pipeline for some time. In 1991, the then Minister for Health, Deputy O'Hanlon, intended bringing forward such a Bill. It has been introduced with some haste but I nevertheless welcome it because it will be of benefit to patients, doctors, the pharmaceutical industry, members of the veterinary profession, those working in the horse racing area — in which Deputy McGahon has a great interest — and the medical devices sector.

I pay tribute to the National Drugs Advisory Board for its excellent work. It has an excellent reputation and, in that regard, I wish to mention Dr. Scott and Dr. Maura Burns in particular. It has been said that the NDAB was somewhat tardy in issuing licences but that was to our benefit on some occasions in that certain products which were injurious to both man and beast were not allowed into this country.

The task of assessing and licensing medicines has become more difficult in recent years due to expansion in this field. Many developments have taken place in biotechnology, immunology, genetic engineering and the general medical devices currently available. The new board will not only have to take on the task of the NDAB but it must also involve itself in the areas of blood components and products. That is a whole new area and I do not know whether the board will act as a monitoring agent or have a hands on effect. It is an area of which the previous board had no experience. In many other European countries this area is the responsibility of a specific board. The Minister should consider whether it is advisable to include it in the Bill, but if it is properly monitored I do not see any problems arising.

The new European Medicines Agency was recently established in London. There has been liaison with that agency in an effort to get the new agency here up and running. It was thought initially that the London agency would be of benefit to us in the long term but much of its work will be distributed among the sub-agencies in the various EU member states, including Ireland.

I note that, for the first time, the chairperson of the board will receive a salary. That is a welcome development. I believe the chairperson should be someone from the medical profession because 80 per cent of the board's work will involve dealing with medicines affecting people; the other 20 per cent will involve dealing with medicines setting up of committees is also welcome, but I hope they will not be too cumbersome. The composition of the board is not specified, but I would like to see a good mix between medics, veterinary surgeons, pharmacists and people involved in public health. The chief executive officer is mainly a manager, and that is as it should be. I am glad the workers on the old board will be transferred in toto to the new operation and will not suffer hardship.

The fees charged should equal the total expenditure of administering this Act. As the work of this agency will have more to do with the adverse effects of drugs on people and will also be dealing with blood and blood components, the pharmaceutical industry should not be expected to take on all the expenditure of running it. Having said that, our fees should not be exorbitant because we must try to entice pharmaceutical industries to Ireland.

It was said that the previous board was tardy. I hope we will not have the same problem with this board and that the number of advisory staff attached to it will not lead to procrastination in regard to licences. Is there an appeal mechanism which would allow an application to be examined in a different light if a licence is denied?

On the question of how the board will work, there is more emphasis on the monetary aspect than on quality control. That is another deficiency in the Bill. The board should be judged on how it is working as a quality control agency rather than just on how much money it will make for the national coffers. However, there is a possibility that this board could sell its expertise abroad. There are many third world countries that do not have the same expertise and they are anxious that certain drugs and pharmaceutical products should not enter their countries without due scrutiny. In that area the board might bring some money into the country. It is another aspect I would like the Minister to examine.

I welcome the Bill. However, I have some reservations about funding. I would also welcome it if the Minister were to examine the blood components aspect of it because the board has no previous experience in this area. It is a new departure and many more specialists, haematologists etc., will be needed. The old board was tardy about issuing licences because it did not have enough personnel and support. It would be a shame if the same thing happened to this board, particularly when it will be taking on a new area relating to blood and blood components.

Mrs. T. Ahearn

I welcome the opportunity to speak on this long overdue Bill and I am delighted it is supported on all sides of the House. Any Bill dealing with public health should be taken seriously and given careful consideration.

The Bill proposes to replace the National Drugs Advisory Board with a new body to be called the Irish Medicines Board. The National Drugs Advisory Board was set up in 1966, and it is fair to acknowledge its excellent work over the years. Perhaps it was slow at times, but when dealing with drugs and matters of national health it is safer to be prudent than to make hasty decisions and have regrets later. I congratulate the board on its work.

With the emergence of the European Agency for the Evaluation of Medical Products, we should keep abreast of changes on the European scene. The National Drugs Advisory Board acted in an advisory capacity but the power to issue licences lay with the Minister. This was the essence of bureaucracy. The work will be carried out more effectively and with greater speed by the new agency proposed in this Bill.

This new body will be very important because the quality and the safety of our medicines will depend on its evaluation and judgment, and I wish it well. I represent a constituency that has two very important chemical companies, Merck Sharp and Dohme and Clonmel Chemicals, without which many important drug products would not be available. On a recent visit to Merck Sharp and Dohme, I was astounded by the amount of money it is prepared to plough back into the production of new drugs and the assessment of its present products. It continually evaluates and assesses medical needs. The same is true of the local company, Clonmel Chemicals. We tend to look at companies like those on the basis of their economic value to the local community rather than the value of what they produce. From an economic point of view such companies are valuable, but one has to go inside their doors to realise the tremendous work they do in the area of health.

I acknowledge the work done by the two companies in my constituency. We could not provide the resources necessary for research without which many new health products would not be developed. The female Members of the House tend to speak on the safety of blood products because of the experience with Anti-D. As a result of either mismanagement, miscalculation or misfortune 1,037 women have been affected and will bear this tragedy for the rest of their lives. I have spoken to many of them through their effective organisation, Positive Action. In spite of their suffering, the future they face, the impact it has had on some of their marriages and children they have adopted a fair and realistic approach.

I congratulate the Minister for Health on the speed with which he set up the tribunal and hope the victims will be satisfied with the assessments made. It is a human tragedy with which they must live. We will also have to live with it as we bear ultimate responsibility for it. These women should be catered for in a caring and humane way. I congratulate the Minister on the priority he has afforded to these women and their families. I assure them that we do not see their tragedy ending with the agreements that emerge from the tribunal. They must continue to be our concern during their lifetime.

I hope the board will be successful. Boards that have a smaller membership are usually more effective than those with a larger one. Membership of the new board will be limited to nine members rather than 18. It is important that appointees serve the best interests of people and contribute positively to decisions made. The new board will be streamlined and this will help eliminate the present cumbersome system where the National Drugs Advisory Board was an advisory board to the Minister and the Minister had power to grant a licence.

I share Deputy O'Donnell's concern about devolving power to a board. I, too, have had the experience of tabling questions to a Minister only to receive the reply that the Minister has no function in the matter. This hinders the input we can make as elected representatives. It is easier to contact a Minister's office than it is to find out who makes the decision on some of these boards.

Our experience of the National Roads Council in south Tipperary is that it is impossible to meet with it. Irrespective of what party is in Government Ministers will receive deputations and visit constituencies. Last week I tabled a question on grants to the hotel industry and was told that, as a new authority had been established, the Minister had no function in the matter and was unable to provide the information. Boards are given important powers and responsibilities. They should be open and provide information to public representatives.

The Bill, which I welcome, has received all party support. I am sure the Minister will consider any amendments that may be proposed. I hope there will be no undue delay and that the staff will not be disadvantaged by establishment of the view board. I look forward to the board helping to provide a good, effective health service.

Mr. Hughes

I accept the remarks made by Deputies Quill, O'Donnell and Ahearn that the establishment of a new board can have the effect of preventing Members obtaining information. However, it is not unknown and it is becoming increasingly more common in the House for Members to be prevented from receiving information on matters that come within the ambit of the Minister. I asked the Minister for Finance for information on the amount of tax outstanding by publicans who use the tax clearance certificate procedure. There are not that many publicans in the country and the information should be available. I received a reply indicating that resources and the amount of time involved in compiling a reply did not warrant giving the information. I received a similar reply when I asked about the ownership of fishery rights in Mayo.

The NDAB, Bord Fáilte and the IDA are most forthcoming in facilitating me with information and at times they push me to propose improvements to legislation. I fully endorse the genuine concerns expressed regarding the establishment of another vehicle which could at times be used by Ministers and Ministers of State to only give information on policy and not on day to day functions. I welcome the opportunity to contribute to this debate and the recognition of the need to upgrade the NDAB from a statutory and regulatory point of view. It is good that Ireland espouses the highest standards for the administration and manufacture of medicines and their supply to the consumer. We compete for mobile international investment in the pharmaceutical industry worldwide. The industries already here and those which will be attracted want proper statutory provision and formal recognition given to the national licensing authority. The highest possible standards are demanded of this industry so that it can develop with the confidence that slipshod standards are unacceptable.

The pharmaceutical industry is a valuable employer. It has particular concentrations in Cork, the midlands, Dublin, Limerick and, I am pleased to say, my town of Westport where Allergan Pharmaceuticals employs almost 700 people. Of the product manufactured in Ireland, 54 per cent is exported to European countries, 20 per cent to North America, 16 per cent to southeast Asia and 7 per cent to east European countries. It makes a major contribution to our export earnings and it is at the cutting edge of knowledge. It has a higher level of investment in research as a percentage of turnover than almost any other industry and it must make ongoing investment in plant and machinery to keep up with worldwide competition. Many pharmaceutical companies manufacturing in Ireland, which are in the main United States companies, also have sister companies located in Europe and elsewhere. Low cost manufacturing nations and emerging new markets which have opened up their frontiers to multinationals, such as China, are competing for this investment. Any legislative or regulatory framework which adds to confidence in the level of high standards in the industry must be welcomed.

However, there must be a parallel commitment to ensure that any gap in resources or manpower is tackled.

The Bill's explanatory memorandum refers to the transfer of authority from the Minister to the Irish Medicines Board, the authority which licenses human medicines. The NDAB was responsible not only for human medicines but also veterinary medicines. One of the four committees under the old board dealt with veterinary medicines, while the others dealt with clinical trials, pharmacology and toxicology. Does section 4 (d) confer the powers to deal with veterinary drugs? Perhaps the Minister could clarify this point in his reply. If it does include veterinary drugs, what is the position with regard to veterinary vaccines, which I understand do not fall within the ambit of the NDAB? Who is responsible for their testing and regulation? I ask the Minister to clarify this point also.

A huge range of drugs and medicinal products are on the market. Some of these are long established but, under European legislation, they must all be subject to authorisation and licensing if they are to remain on the market. As other Deputies mentioned, there is a serious backlog of licensing, particularly with regard to veterinary products. In May 1995, 1,790 veterinary applications were received, of which 589 were dealt with and authorisations issued; 302 were withdrawn by companies because they did not meet initial criteria, while 78 were refused authorisations. A total of 824 were referred for further assessment to committee No. 3, which deals with toxicology, and 789 were referred to committee No. 1, which deals with pharmacology and 750 applications are awaiting authorisation. I do not have the figures for human medicines but I accept those of Deputy Geoghegan-Quinn who referred to in excess of 1,000 applications awaiting authorisation. I assume, therefore, that approximately 250 applications are awaiting authorisation on the human side, while there are 750 applications on the veterinary side.

The Minister has been asked for clarification in this regard.

It is true some products, which require authorisation but which have not yet been considered, continue to be sold on the market. It is important that all applications are dealt with quickly. Old product on the market can show problems, which did not appear previously, when it is has been retested or subjected to new criteria.

The expert group on the Blood Transfusion Service Board indicated that the extension on an informal basis of additional functions to the board led to an increased delay in product authortisation. Under the Bill, the inspection of the collection, processing and distribution of blood, blood components and products and plasma derivatives, together with the extension of functions, will add to the workload of the new Irish Medicines Board.

There has not been a corresponding commitment to provide additional resources or staff. I understand there are approximately 50 highly skilled employees, between professional and clerical staff, working under the old board. They have a grave responsibility in terms of the licensing of human medicines and they must receive additional resources. If a member of the existing professional staff takes leave of absence he must be replaced and the time required to train additional staff is at least one year, given the sophistication and expertise required in this field. Since we operate in a market of free movement of people and goods, procedures must be introduced to avail of the expertise and assessments carried out by other regulatory bodies in other European countries. My colleague, Deputy Geoghegan-Quinn, referred to this aspect in detail. I understand a pharmaceutical company can now get a CE marking for new product. This is the European quality standard and allows the introduction of that product to other European countries rapidly and without the former lengthy delays. This marking is of a much higher standard than the ISO 9000 or ISO 9002.

As this only applies to new product, and one must recognise that not many new products come on the market, the biggest problem relates to existing products which must be reauthorised at five year intervals. Many companies some of which produce up to 1,000 separate products require individual authorisations from each licensing authority. Despite the fact that licensing should only take into account the propriety of the product from the point of view of its effects on human beings, there is a suspicion in the pharmaceutical industry that some countries, such as France, are delaying authorisation and creating difficulties for the placement of Irish manufactured product if an industry in France could suffer economically from its introduction.

If that is correct, I ask the Minister to investigate any such complaints at European level. He will appreciate that pharmaceutical companies may be slow to make such complaints, given that they operate in a very open and mobile market. However, that complaint has been made to me and the Minister should take it on board. I can understand another country operating procedures, such as those laid down in the Bill, to protect an existing industry which may be subject to Irish competition. However, one must recognise that the Irish competition is often owned by a US pharmaceutical company which uses Ireland as a base to penetrate the European market.

While this legislation is straightforward, the day to day workings of the board and its relationship with other European agencies and manufacturing concerns is complex. As legislators, the most important thing we can do is ensure the new agency can adequately operate without being stretched in terms of manpower or resources and that previous practices are improved to worldwide acceptable standards. To use an analogy, we will end up with the same tuppence ha'penny worth if this Bill does nothing more than dismantle an old car and put back the old engine and expect it to run twice as fast.

The extension of functions under the Bill was referred to and there was a particular reference to blood. The expert report on the Blood Transfusion Service Board referred to the fact that the extension of functions on an informal basis over the years created a backlog in product application. In the Irish Medical News of 26 June 1995, Dr. John Kelly, the newly appointed chief executive of the National Drugs Advisory Board commenting on the legislation for the Irish Medicines Board said it will mean a significant increase in the level of responsibility for the board, and that if it goes according to the Minister's intentions it will involve them in quite a lot of work.

In an article on evaluating ongoing safety of medicines and assessing how a drug performs, in the Irish Medical Times of 16 June 1995, Dr. John Kelly stated:

According to the Board's most recently published statistics — for 1990 — GPs accounted for about 36 per cent and consultants and NCHDs for about 15 per cent of all adverse reactions reports.

As part of increasing the reporting of adverse reactions, the Board may consider a specially designed information pack and changes to alter the so-called "yellow card" system by which doctors and other health professionals report adverse reactions to the Board.

When doctors see something that may be an adverse reaction, the question we have to ask is, "Do they recognise it as an adverse reaction, do they document it, and do they report it?" he said.

Dr. Kelly said that the Board itself must increase its own level of exposure among the profession. He suggested that the Board publish a newsletter to alert doctors to potential safety and efficacy concerns that arise over medicines.

According to the Board's most recent annual report — for the year 1990 — delays in new product authorisations were running at an average of 25 months.

That is in excess of two years whereas the European average is one year. I support Deputy Geoghegan-Quinn's remarks on that and I suspect the reason there have been no reports since then is that the existing professional staff are stretched dealing with product authorisation and do not have the time to produce annual reports. Annual reports are important. Dr. Kelly also stated that more than 1,000 products were awaiting licensing renewal at the end of 1990. He said he hoped the board and its proposed successor — the National Medicines Agency — would be able to expand computer information systems to curb delays in product authorisations and renewals and to eliminate from delay calculations those delays caused by drug companies.

The National Drugs Advisory Board has 1,000 applications awaiting, new products are slowly coming onstream and existing products will require renewal in due course. A single application can run to thousands of pages and the National Drugs Advisory Board has up to 8,000 files on hand at any time, we need computerisation and computer literate personnel to fast track these applications. When will further resources be made available for this work? Otherwise, to use an analogy it is simply putting an old engine in a car and expecting it to run twice as fast. We would be only fooling ourselves. I know the Minister will respond to the concerns raised.

Mr. Boylan

I wish to share my time with Deputy McGahon.

An Leas-Cheann Comhairle

Is that agreed? Agreed.

Mr. Boylan

I welcome this very important Bill. As legislators we have a duty to protect the public from unscrupulous drug manufacturers. That may sound harsh but I have no doubt that a load of rubbish is being pushed on an unsuspecting public through advertising on television and in glossy magazines. There are claims of cures for every ache imaginable and that certain remedies will prevent grey hair. In that regard I am glad my colleague Deputy McGahon has not been fooled. In any reasonably sized supermarket, large shelf area is taken up with remedies and an unsuspecting public is prepared to buy these products and possibly get hooked on them. I wonder what tests have been carried on these products. It is noticeable that the name of the product is in banner headlines but that the print listing the ingredients is so small it cannot be read. We have a duty to ensure that the claims in advertisements can be upheld. The amount spent on advertising and promotion indicates that there is a consumer for the product but the consumer needs to be protected. There are good drugs and well known remedies for the common cold can be found in any kitchen cupboard.

It is necessary to draw attention to the issue of blood products. Women who went into hospital for a blood transfusion have been affected by contaminated blood products. They placed their faith in the doctor and the hospital but were given contaminated blood products and now their lives are in turmoil and they must be compensated. The people who allowed contaminated blood to pass through the system must be held responsible. I understand also that the storage conditions for blood were very unsuitable.

Veterinary medicine is a wide field. The modern farmer with his green certificate in farming, has syringes and veterinary medicine on hand. However, how long should an animal be retained on the farm after being treated by the farmer? Is this monitored? It will be maintained that farmers are careful, by and large most are but there are still cases where ruthless people are prepared to use the deadly drug angel dust and put lives at risk. Recently we saw the efforts that some people went to to prevent departmental officials removing samples from a factory. People will tell me that everything is under control but that is not the case. Ruthless people will exploit the situation and veterinary medicine is wide open to exploitation. The veterinary surgeon may recommend a certain dosage but some farmers will double the dose in the belief that it will speed up the cure but that may do more harm. Matters must be regulated. We must ensure that animals are not sent to the factory after treatment until it is safe to do so and that there is a system in the factory to double check that.

I do not want to cast aspersions on the outgoing board because I have no doubt it did its best but a number of failures in the system have come to light. If the new board is not able to correct that and prevent it from being repeated it too will have failed. The public must be confident that the product they buy will live up to its claim, nothing more, nothing less. If we can do that we will have achieved success. I wish the Minister every success in ensuring that will happen.

Mr. McGahon

I know more about the racing Bill than this Bill, as Deputy Moffatt is aware. I welcome the Bill if for no other reason than by amalgamating the two boards it will remove a tier of bureaucracy from a country which is awash with it.

This board which will replace the National Drugs Advisory Board will become the licensing authority for both human and veterinary medicines. This is a practical common sense approach. It is proposed to reduce the membership of the board from 18 to nine. I hope we practise what we preached in Opposition and will not make any political appointments to the board. The members should be well versed in the pharmaceutical and veterinary professions and should be selected purely on the basis of their professional qualifications.

I agree with Deputy Boylan that there is a shady trade, so to speak, in the pharmaceutical industry. The Border is being used by those involved in the lucrative trade of smuggling from Holland and other European countries. In this context I would highlight the flood of ecstasy tablets into the country and the growing addiction of young people to this terrible drug. I hope the new board will have a policing function which includes the strict monitoring of sales outlets and liaison with the customs authority in policing the Border.

The board will take over responsibility for granting permission to conduct clinical trials. I must confess that I am very ignorant of what happens in these trials and I ask the Minister to outline what they entail. I assume they are guinea pig experiments on animals and I would like to know if humans take part in them, whether they are paid, where they take place, how they are supervised and the criteria used for selecting participants. These matters are kept under wraps and the public has a right to know about them.

The board will be responsible for administering the blood transfusion service. It is desirable that a specialist body should monitor the processing of blood and blood products. Given the recent tragic cases involving hepatitis and the tragedy which befell many people as a result of slipshod practices, this matter must be a priority for the board.

I support the Bill which has been given a general welcome by the Opposition parties and the pharmaceutical industry. It makes sense to establish a medicines board to bring us into line with the advancements in this area in Europe.

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

Ar an gcéad dul síos, ba mhaith liom buíochas a ghabháil leis na Teachtaí go léir a ghlac páirt sa díospóireacht seo. Cé go ndealraíonn sé nach bhfuil an Bille seo róchasta ná as an gcoitiantacht, mar sin féin tá sé thar a bheith tábhachtach go mbeadh díospóireacht sa Teach seo a dhéanfadh scrúdú mion air. Rud a chuireann áthas orm go bhfuil na Teachtaí uilig d'aon ghuth go bhfuil an Bille ag teastáil agus tá sé sin le feiceáil lasmuigh den Teach freisin. Le linn na díospóireachta tháinig mé ar phointí tábhachtacha agus déanfaidh mé scrúdú ar na pointí sin idir seo agus an chéad chéim eile den Bhille nuair a théann sé faoi bhráid an Choiste.

I thank the Deputies who contributed to the debate. This may appear to be a relatively straightforward and routine Bill but it is important to give it due consideration in the House. The debate was focused and constructive and many important points were made. This Bill has been brought forward to deal with the issue of human and animal medicines, clinical trials etc. It is our best shot, so to speak, and if Opposition Deputies put down Committee Stage amendments which improve it I will be willing to accept them. I will consider in detail the points made between now and Committee Stage.

Many of the points made by Deputy Geoghegan-Quinn related to the future operation of the Irish Medicines Board, for example, its staffing, professional requirements and its relationship with the European agency. I wish to stress that the Bill essentially provides a legal framework for the restructuring of the National Drugs Advisory Board and is, therefore, only part of the picture. Obviously it is of great importance that the organisation, systems and structures within the NDAB are updated in preparation for the transition to the new board. This work is in progress and the board has appointed management consultants to assist in determining the most appropriate organisation, procedures and staffing to meet the future needs of the Irish Medicines Board.

Its terms of reference are to recommend appropriate organisation, management, staffing and internal reporting structures for the proposed Irish Medicines Board; to recommend systems for ensuring that applications are dealt with effectively within the prescribed time limits; to consider the implications for the board of the likely evolution of the centralised EU system for registration of medicines; to recommend options for a fee structure designed to ensure that the activities of the board are self-financing, that a regular income is achieved and that adequate and effective accounting systems are in place. This work will be completed shortly and, together with the Bill, will ensure that the new board is ready and able to deal effectively with the complex and every changing demands associated with ensuring the quality and safety of medicines.

Deputy Geoghegan-Quinn raised some concerns about the provisions of the Bill which relate to the self-financing nature of the board. It is important to note that it has been the specific intention from the outset that this should be the case. The original Government decision that a new board should be established was made in 1991 by the then Fianna Fáil-Progressive Democrats Government. That decision specified that the board should be self-financing. This was also accepted by the Government in agreeing the Bill. It is important to note that the licence fees approximate to the costs. It is also important to note that the pharmaceutical industry is on record as stating its willingness to bear additional costs, if this is necessary, to streamline the licensing system. As Deputy Geoghegan-Quinn pointed out, the transitional costs may require special consideration. This is one of the reasons we have included section 15 which allows for Exchequer funding.

A number of Deputies have raised the question of the accountability of the board and the Minister. As with any State board, the Minister will have the ultimate responsibility and will be answerable to the House for the board's performance. He will exercise this responsibility in the same was as every Minister does in relation to the boards under his or her jurisdiction — for example, through board appointments and the reporting arrangements set out in the Bill.

Deputies will note that a number of paragraphs of section 4, specifically paragraphs (h), (j), (k), (m) and (n) set out these reporting arrangements. They will also note the provisions on financial accountability set out in section 18 and the formal reporting requirements set out in section 19.

I understand and share the concerns of Deputies regarding the supply of medicines on a named patient basis. However, work is already in hand in the Department of Health to draft amendments to the Medical Preparations (Licensing, Sale and Advertising) Regulations, 1994, which will put the supply of the named patient medicines on a more formalised basis. It is intended that these amendments will be made when the regulations are being revised, as will be necessary following the establishment of the new board.

Deputy Geoghegan-Quinn mentioned there was an impression that the Department of Health had on occasion delayed the approval of a drug which had been recommended by the board due to the financial implications for the Department's expenditure on drugs. While the Deputy did not say she herself believed this to be the case, it would be unfair to the Department if I did not respond to this suggestion. I am assured by the Department that such a decision has never been taken; indeed, the reverse is the case. The Department has, on occasion, facilitated and paid for the supply of new and, as yet, unlicensed drugs through the GMS scheme on the named patient basis.

I acknowledge there have been delays in the publication of the annual reports of the National Drugs Advisory Board and that such delays are unacceptable. I understand the publication of the outstanding reports is imminent but I will examine the position further and clarify it on Committee Stage. I draw the attention of the House to section 19. As soon as may be after the end of each financial year, but not later than six months thereafter, the board shall make a report to the Minister on its activities during that year and the Minister shall cause copies of the report to be laid before each House of the Oireachtas. The position is improving in regard to the National Drugs Advisory Board and I will have more detailed information on Committee Stage.

The matter of backlogs in the National Drugs Advisory Board was also raised. Major progress has been made in dealing with the backlog of renewals. Additional staff were recruited on a temporary basis and new procedures put in place to deal with the backlog, which has been greatly reduced. We must continue to reduce the backlog even further. The establishment of the new board is part of the process in creating a more efficient licensing system.

Deputy Geoghegan-Quinn raised the matter of reliance on other regulatory agencies. While it might seem desirable to have regard to the licensing assessments of other regulatory authorities, the board must satisfy itself on the safety, quality and efficacy of medicines. Anything less would be unacceptable to the Irish consumer. Nonetheless, under new European procedures, it will be possible from 1998, under a decentralised system, to have greater regard to licences that come from other member states. This should speed up the licensing process.

A number of Deputies made suggestions about the composition of the board. The membership of the National Drugs Advisory Board, because of its advisory role, comprised a wide range of technical experts. As the new board will be primarily management in character, its membership should be more compact and reflect the managerial responsibilities while also including some persons of acknowledged expertise in the area of drug regulation and usage. The role of the members of the board will be to set clear aims and objectives and to monitor progress towards the achievement of these targets, including the quality objectives that must form part of these targets. More specifically, it will have responsibility to ensure that adequate procedures are in place for the assessment of applications for licences, permissions for inspections, information giving, record keeping and other functions of the board. While responsible in corporate law for its actions, it will discharge its functions in a supervisory fashion. Many other points have been raised, but in the time available I will be unable to deal with them. I thank all Deputies who contributed to this debate and assure them that all the points made will be fully examined between now and Committee Stage. The Government will not be found wanting where amendments emerge that would improve the legislation.

Question put and agreed to.