I am pleased to come before the Seanad today to present the Irish Medicines Board Bill, 1995. The essential purpose of the Bill is to provide for the establishment of a new statutory body to be known as the Irish Medicines Board. This new board will replace the National Drugs Advisory Board, which was established in 1966 and which, over the years, has given considerable service to the State in ensuring the safety and quality of medicines supplied in this country.
However, with recent developments in relation to the control and regulation of medicines, not least the establishment of the European Agency for Evaluation of Medicinal Products, it is appropriate that we should review our own regulatory structures and procedures and adapt these to reflect these changing circumstances. Up to now, the Minister for Health has acted as the licensing authority for medicinal products. However, all applications for such licences, commonly known as product authorisations, were assessed on behalf of the Minister by the NDAB so as to establish the safety, quality and efficacy of the products. Licences were only issued by the Minister on the advice of the NDAB. Similarly, under the Control of Clinical Trials Acts, 1987 to 1990, permissions to conduct clinical trials are granted by the Minister, also on the advice of the NDAB.
For some time now it has been accepted that this involvement of two separate bodies in the process of licensing was both unnecessary and administratively cumbersome. Indeed, since 1991 it has been Government policy that the licensing functions of the Minister should be transferred to the NDAB. However, in order to successfully transfer the licensing function of the Minister to the NDAB it will be necessary to radically restructure that organisation so as to equip it to take on these additional responsibilities and to make the fundamental change from being an advisory body to being the licensing authority.
Having considered how best to achieve this transfer of functions from the Minister, I have decided that the most appropriate way of doing so is to establish, on a statutory basis, a new national medicines licensing authority which will replace the National Drugs Advisory Board. It will at the same time take over the existing functions of the NDAB and will also assume the licensing function at present exercised by the Minister. The Bill before the House, therefore, provides for the establishment of the Irish Medicines Board. This board will become the licensing authority for both human and veterinary medicines and will also be given the responsibility for the granting of permissions to conduct clinical trials.
The new board will be more compact and different in character from the NDAB. It is proposed that the board will comprise some nine members and that it should be primarily management in character. At the same time, it will obviously be necessary that the board should have available to it the range of expertise contained within the current membership of the NDAB. For this purpose the Bill provides for the establishment of two expert advisory committees, to be known as the Advisory Committee on Human Medicines and the Advisory Committee on Veterinary Medicines. These advisory committees will be made up of a broad range of experts drawn from the medical, pharmaceutical and veterinary professions such as are currently represented on the National Drugs Advisory Board. The committees will also be authorised to establish such expert advisory sub-committees as they may require to assist them in their work.
The functions of the new board shall be broadly those currently exercised by the NDAB but with the additional responsibility of being the licensing authority for human medicines. The NDAB is currently the licensing authority for veterinary medicines. The board will also take over responsibility for the granting of permissions to conduct clinical trials and generally assume the responsibilities currently exercised by the Minister under the Control of Clinical Trials Acts, 1987-1990.
At the same time, the new board will be given a specific responsibility in relation to inspection of the collection, screening, processing and quality control facilities and procedures in respect of human blood, blood components, blood products and plasma derivatives with a view to ensuring the safety of such products. Senators will be aware that the recent report of the expert group on the Blood Transfusion Service Board recommended that the implementation of the Government's proposal to transfer the licensing of medicines to the NDAB should be proceeded with. I am obviously anxious to give early effect to the recommendations contained in that report. Indeed, this is one of the reasons I am anxious that this legislation should be enacted without delay.
The board will also become the competent authority in the State for our obligations in relation to the licensing and control of medicines which arise as a consequence of our membership of the European Union. The new board will also work closely with the newly established European Agency for the Evaluation of Medicinal Products and will have responsibility for the supervision of any medicines on sale in the State which are licensed by the European Agency. It is also to be hoped that the board will be in a position to provide services as rapporteurs to the agency for the assessment of applications for European licences.
Quite apart from establishing the new board and setting out its functions, the Bill, of necessity, provides the legal basis for the transfer of all the functions, responsibilities, assets and liabilities of the National Drugs Advisory Board and, in particular, for the transfer of the staff of the NDAB to the employ of the new board on terms no less favourable than those they enjoyed while in the employ of the NDAB. The Bill also includes a number of standard provisions relating to State-sponsored bodies.
The original Government decision in 1991 provided that the board should become self-financing at the earliest possible date. It is certainly my wish and that of the Government that this will still be an objective for the board; the Bill, as presented, seeks to place such an obligation on the board.
Finally, the Bill provides the statutory basis for the regulation of medicine. The specific details of the licensing scheme will be spelled out in regulations to be made under the Bill. In this respect, I wish to draw the attention of Senators to a number of commitments in relation to the regulations which I gave to the Dáil and which I reiterate here. In particular, I undertook to examine the possibility of providing some form of appeals mechanism in the regulations. This was in response to representations made to me by the pharmaceutical industry and concerns expressed by a number of Deputies in the course of the debates in the Dáil.
It is intended that the regulations should provide a statutory basis for the supply of medicines on the so-called "named patient" basis. Heretofore this has operated on a voluntary basis, but it has been recognised for some time that the named patient supply of medicines should be put on a clearly defined statutory basis. The regulations will seek to address this issue.
The enactment of this Bill will provide the framework for the future control and regulation of medicines in Ireland and I am happy to commend it to the Seanad.