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.