asked the Minister for Health whether his attention has been drawn to recent statements advocating the setting-up of an authority in this country to test the safety of imported drugs; and whether he will take steps to set up such an authority.
Ceisteanna—Questions. Oral Answers. - Testing of Drugs.
15.
I have seen a recent press report to the effect that the Irish Medical Association are anxious to see an Institute of Biological Assay set up here for the purpose of testing drugs. It was also reported that a spokesman of the Association pointed out that there was no independent authority here to test drugs, and that clinical trials were left to the individual doctor, a respect in which, I may say, we are not unique.
"Biological assay" means the determination of the potency of a substance by biological methods instead of by physical means; the word "biological" implies the use of living organisms, such as animals or bacteria, as test subjects. I take it that the Association, if correctly reported, has it in mind that all imported drugs of which the safety has not been established should be tested in this manner here.
The establishment of an Institute of Biological Assay would require resources such as are at the disposal of highly developed industrial countries with large populations and considerable wealth but are not available to us. Further, biological assay would not necessarily give a complete assurance of safety as untoward complications or side-effects might not manifest themselves until a drug had been in use for a considerable period.
The problem is of such complexity and requires such resources that the 15th World Health Assembly last May felt that it could be most effectively dealt with by international co-operation. The Assembly, by resolution, decided to arrange for the study of the scientific aspects of the clinical and pharmacological evaluation of pharmaceutical preparations, and also the study of the feasibility or otherwise on the part of the World Health Organisation:—
(a) of establishing minimum basic requirements and recommending standard methods for the clinical and pharmacological evaluation of pharmaceutical preparations;
(b) of securing regular exchanges of information on the safety and efficacy of pharmaceutical preparations; and in particular,
(c) of securing prompt transmission to national health authorities on new information on serious side-effects of pharmaceutical preparations.
Any general policy evolved by the World Health Organisation in the matter will, of course, receive my careful consideration.
Subsequently, as a result of the thalidomide tragedy, legislation was enacted in the United States of America which will give the Food and Drug Administration new powers of factory inspection and quality control; in particular, detailed records, which will be available to the Administration, must be kept of clinical trials, and these trials may not be carried out except in accordance with prescribed conditions.
Early this month, a committee set up in Great Britain under the chairmanship of Lord Cohen of Birkenhead to consider the matter advised that experimental laboratory testing of new drugs before they are used in clinical trials should continue to be the responsibility of the individual pharmaceutical manufacturer and they rejected, as being neither desirable nor practicable, the idea that the responsibility for testing new drugs should be transferred to a central authority. In a further recommendation, the committee stated that they believed that one of the many safeguards which may be needed is that there should be an expert body to review the evidence and offer advice on the toxicity of new drugs, whether made in Great Britain or abroad, before they are used in clinical trials. This is a matter on which the committee will report further when they have formulated detailed advice on the terms of reference and composition of this expert body.
It will be noted that the legislation in the USA and the recommendations so far in Great Britain make no mention of Institutions of Biological Assay.
The bulk of the drugs used here are imported and it may be that in our circumstances and with our limited resources we must depend to a great extent on the controls exercised in the countries of origin. As I have stated in reply to previous questions, however, I shall continue to keep this matter under constant review and I shall take all reasonable steps which are open to me at all time to safeguard the public interest.
Having regard to the Minister's reference to the World Health Organisation and, indeed, his reference to the Irish Medical Association, does he not appreciate that this step was also advocated by representatives of the Irish Drug Association and the Pharmaceutical Society of Ireland, and would he not be disposed to taking advice from such bodies in so far as Ireland is concerned without waiting for world-wide decisions?
I am not so certain that either of those bodies would be competent to advise on this matter.
Or the doctors either.
Another declaration of war? Two new fronts?
The Deputy may not be aware that we have Comhairle na Nimheanna upon which those bodies are represented.
I understand that the President of the Pharmaceutical Society of Ireland is a highly esteemed person. He is well known to the Minister.
Is the Minister aware that there is a drug on the market at the moment which, when taken, creates a most irritating itch which cannot be got rid of? This is no joke. I am aware of a person who got this drug for a cold. He has been going to doctors and hospitals for the past three months because he took this drug for a cold. I shall give the Minister particulars later.
It is a separate matter.
It has a bearing on drugs which react in ways that are not intended.
It is a different matter altogether.
I wonder is the drug responsible for the number of supplementaries from which we are suffering at the moment?
You are all very skittish since you came from the Árd Fheis.
We have good reason.
It was a wonderful success.
You heard some wonderful revelations there.
Order!