Vol. 357 No. 3
asked the Minister for Health if he received a request for consultation and discussion on the question of controls for drug testing from any firms in this field in Ireland; and, if so, if he will be arranging to have consultations and discussions on this subject with the firms concerned.
13.
asked the Minister for Health the number of firms in Ireland engaged in drug testing; the safety standards at present applicable; and if he will make a statement on the matter.
I propose to take Questions Nos. 12 and 13 together.
I have not received a specific request from any firm for consultation or discussion on the question of controls for clinical trials of drugs but I did in fact receive detailed and specific observations from a particular firm in relation to the nature of the controls which might be imposed and I am considering those views.
I have had detailed consultations with the National Drugs Advisory Board, who are the expert advisory body in such matters, about the Bill I propose to introduce to control clinical trials. The NDAB are in close contact with the organisation of the activities of companies who conduct clinical trials, through the administration of a voluntary arrangement for the clearance of submissions for trials through the board. The proposed Bill will put this voluntary system on a statutory basis and will apply to existing as well as new drugs.
The number of firms engaged in clinical trials of drugs in Ireland in 1984 was 51. The safety standards applicable to the conduct of trials by these companies are set out in detail in guidelines issued by the NDAB and these refer also to the question of informed consent of participants in such trials and the approval of ethical committees. Standards of good laboratory and clinical practice are also set out in the guidelines.
Would the Minister not agree that it is little short of a scandal that there are 51 firms in this country engaged in testing drugs on people in the absence of any legal guidelines, especially since many of these firms are testing drugs produced in the US where for years the strictest controls by way of legislation have been imposed on such firms? Is this not a matter of urgency especially in the light of the tragic loss of life of a young man in Dublin not long ago?
I assure the Deputy that many months prior to that tragic death, as a result of reading an article in In Dublin magazine, I initiated a full scale review in the Department. As a result the heads of a Bill to deal with this area will be before the Government on Thursday next. The reason for the delay is the complexity of the legislation in respect of which I have had to consult in detail with the NDAB, who are the general experts in such matters. I have received a number of other representations also. I agree with the Deputy that the matter is one of serious concern and I assure him that there will be no delay on my part in endeavouring to have the Bill published and enacted.
What type of procedure is applied to the policing of the implementation of the voluntary guidelines? Is the Minister satisfied that in all cases these guidelines are being complied with?
As the Deputy is aware, guidelines are laid down by the NDAB. In general I would hold the view that they are being observed but I do not have any statutory control regarding the arrangements for the clearance of submissions to the board in respect of such trials. Neither do the NDAB have any statutory authority in this area. There are a number of very serious issues involved but these are being dealt with in the Bill. I might add that in Europe generally the number of pieces of statutory legislation in this area is minimal, that there is virtually no control, and this includes the UK.
What about the US?
There are rigorous controls in America, strange as it may seem, but in terms of European legislation we have had to start from scratch. Obviously, the Bill will be important in so far as the pharmaceutical and chemical industry is connected. I am satisfied that it will not lessen in any way the general role of such companies, but safety standards, consent standards and supervision are essential and will be provided for in the Bill. The 51 companies engaging in clinical trials will have to comply with those standards.
The Minister will have received representations from me on this subject arising from the tragic death of a Dublin man while undergoing tests at one of these clinics. The Minister tells us the heads of the Bill are ready but may we take it that the legislation will be passed before the summer recess, having regard to the urgency of the matter?
The draft heads of the Bill and the general scheme involved are being circulated to the Government this week. They are on the agenda for Thursday's meeting. I anticipate that by mid-May the white print of the Bill will be available for publication, but I doubt if the legislation will be enacted before the summer recess.
Is the Bill to be based on the guidelines set down by the NDAB?
It is not in order to go into the details of the Bill or even its general content.
In part the Bill will incorporate a number of those guidelines but there is no parallel legislation to work from.
I am concerned at the Minister's statement that there is no policing of the manner in which the guidelines are implemented or otherwise. Can he give us an assurance that one of his top priorities will be to investigate to what extent the guidelines are being adhered to? Perhaps departmental inspectors or some other persons might be designated to make themselves available to advise people who are being encouraged to participate in these clinical trials so as to ensure that there is no risk to life.
Has the Deputy a question?
I assure the Deputy that I have received a number of representations on this matter. In addition, I have met some of the interested parties but I have not yet met any of the drug companies. I consider it appropriate to have a Government decision first and then to consult with the companies when the legislation has been published. Regarding the incident referred to by Deputy Taylor, an incident which obviously concerns Deputy De Rossa also, I have had deep internal investigations undertaken but have found that I have no statutory control in this area.
