asked the Minister for Health whether his attention has been drawn to reports of ill effects recently caused to pregnant women and their unborn children by the taking of tranquilliser drugs containing substances such as thalidomide; whether he will outline the precautions taken in this country to prevent tranquilliser and other drugs being sold, with or without prescription, without adequate clinical trials to ensure their absolute safety; and whether in view of the large number of new drugs being put on the market by pharmaceutical manufacturers both in this country and elsewhere he intends to take any steps to increase in any way the present precautions against the use of unsafe drugs.
Ceisteanna—Questions. Oral Answers. - Sale of drugs.
13.
I have for some time been aware that thalidomide and preparations containing thalidomide have come under suspicion in connection with the incidence of certain types of neo-natal deformities. As a consequence of this suspicion, the supply of the substance and the preparations mentioned to the pharmaceutical trade and to doctors was discontinued by the manufacturers in December last and supplies in their hands were recalled shortly afterwards.
Clinical trials as a condition precedent to the use of any drug are not obligatory in this country; but in this respect we are not exceptional. Because the use of any drug is not confined to a particular country, the problem of requiring such trials is now recognised as one which can be most effectively dealt with by international co-operation. This matter was the subject of a resolution adopted by the 15th World Health Assembly last month. The resolution, which received the support of this country's delegation to the Assembly, 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 exchange of information on the safety and efficacy of pharmaceutical preparations; and in particular,
(c) of securing prompt transmission to national health authorities of 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, with particular reference to the solution of any problems arising in relation to the safety of drugs available for use in this country.
There can be no completely satisfactory solution of this difficult problem. The safety of any new drug cannot be established beyond reasonable doubt until it has been in widespread use over a very considerable period and the prohibition of the general use here of all such drugs until complete safety had been established by their prolonged use elsewhere would have the effect of depriving doctors and patients in this country for a considerable time of the benefits of many advances of science in this field. I can assure the Deputy, however, that I shall continue to keep the matter under constant review and that I shall take all reasonable steps open to me at any time, on the advice of Comhairle na Nimheanna, established under the Poisons Act, 1961, or otherwise, to safeguard the public interest.