I move: "That the Bill be now read a Second Time."
I am pleased to bring this Bill before the House on behalf of the Minister for Health. The Bill was fully debated and passed by Seanad Éireann where it received wide support and was welcomed by all parties. The purpose of this Bill is twofold. First, it is to amend the Control of Clinical Trials Act, 1987, to deal with difficulties which have arisen in the operation of that Act, particularly in so far as it relates to the responsibilities imposed on ethics committees by the Act. Secondly, the Bill seeks to provide certain legal immunities for the National Drugs Advisory Board in relation to the functions imposed on them under Article 4 of the National Drugs Advisory Board (Establishment) Order, 1966.
The Bill is necessary in order to overcome obstacles which have adversely affected the effective operation of the 1987 Act as a whole and which threatens to seriously limit clinical research in this country. Because of the difficulties being experienced, the Minister for Health established a working party, which was representative of the pharmaceutical industry, clinicians and the Department of Health, to review the workings of the Act and in particular to see how the obstacles being experienced might best be overcome.
The recommendations of the working group have been taken fully into account in the preparation of the Bill now before the House.
Particular difficulties have arisen for ethics committees from the obligations imposed on them by section 10 of the Act which obliges the committees to satisfy themselves in relation to the adequacy of the financial arrangements made to compensate those who may suffer injury or loss as a result of participating in a clinical trial. Legal advice obtained by a number of hospital based ethics committees has highlighted the potential open-endedness of section 10 and suggests that the burden placed on ethics committee members in assessing the adequacy of compensation arrangements leaves such members open to being sued for negligence. Most hospital based committees have accordingly either stepped down or are only giving consideration to trials on products which have licences and which are in current use, with the result that hospital based trials on new products have virtually ceased.
I am therefore proposing the removal of this particular obligation from ethics committees by amending section 10 of the Act as provided for in section 3 of the Bill. The amendment will require that a person shall not either arrange for the conducting of a clinical trial nor conduct a clinical trial unless that person has first established to the satisfaction of the Minister for Health the adequacy of the arrangements for security to compensate persons who may suffer injury or loss as a result of their participation in a clinical trial. The amendment will, while removing the difficulties experienced by ethics committees, at the same time ensure that there will be adequate security to provide any compensation to participants that may become necessary.
While dealing with the particular problems of ethics committees I have taken the opportunity to further amend the Act to deal with two other minor matters which require further definition or clarification.
Section 6 (2) (a) (ii) provides for an exemption from the definition of a clinical trial and thereby from the controls set out in the Act of a trial where the principal purpose is the welfare of the patient.
In the light of the operation of this subsection, it has transpired that, as worded, there is scope for a fairly broad interpretation of what is intended. Clinicians involved in clinical research sought clarification on the intention of the section and so I propose in section 2 of the Bill to amend section 6 of the Act so as to state clearly the aim of the section and specifically to exclude trials where the intention is to prevent disease in, or to save the life, to restore the health, alleviate the condition or to relieve the suffering of the patient. The amendment, which will set out clearly and unambiguosly the intention of section 6, was prepared in full consultation with parties involved in this area of research. It will also provide a useful tie in and ensure consistency with the provision of section 9 (7) of the Act which provides safeguards for patients who are participants in clinical trials.
I also propose by section 4 of this Bill to amend section 13 of the Act which deals with offences and provides for defences in relation thereto. There is a need to provide appropriate defences for unincorporated bodies such as ethics committees and the purpose of the proposed amendment is to bring this about.
It is necessary to provide certain legal immunities for those parties involved in administering the Act, in particular the ethics committees in relation to their functions under the Act. I am also proposing an immunity for the Minister for Health in relation to the Act and I am taking the opportunity to deal with the liability of the National Drugs Advisory Board under this Act and in relation to their functions under Article 4 of the National Drugs Advisory Board (Establishment) Order, 1966, and for committees established under Article 18 of the same order. The provision of such immunity is a well established feature of legislation and there are many precedents for it.
The members of the National Drugs Advisory Board, who are appointed by the Minister for Health, are leading specialists in the fields of medicine, pharmacology, toxicology and other related disciplines and provide their services free of charge. Over the years concern has been expressed by members of the National Drugs Advisory Board with regard to possible legal liabilities which may fall upon them as a consequence of their membership of the board and they have sought an appropriate indemnity. The matter was referred to the Attorney General for advice. The Attorney recommended the provision of an immunity as set out in section 5 of the Bill. Similar immunity has been granted to other State boards, including EOLAS, formerly the Institute for Industrial Research and Standards, and the National Health and Safety Authority set up last year by the Minister for Labour. In order to ensure the continued participation of specialists of the highest standing as members of the board and their specialist committees and thereby maintain their internationally recognised status the Government consider that it will be necessary to provide an immunity along the lines which I now propose. The Attorney General considers the proposed Bill to be an appropriate vehicle in which to provide this immunity.
The Control of Clinical Trials Act, 1987, was a prototype piece of technical and complex legislation. In such circumstances initial teething problems were always a possibility. At the same time the Government were committed to keeping the operation of the Act under review and to deal with any difficulties that arose.
The amendments now proposed will overcome the difficulties being experienced and thus restore Ireland's position as a favourable location for clinical research, thereby ensuring the objectives of the Act to facilitate research and to protect participants in clinical trials are fully realised.
I commend the Bill to the House and look forward to this Second Stage debate on this very important legislation.