asked the Minister for Health the protection enjoyed by the Irish community with regard to medicines to ensure that they are safe; and if he considers that new legislation may be required.
Ceisteanna—Questions. Oral Answers. - Safety of Medicines.
13.
The National Drugs Advisory Board, with the co-operation of the pharmaceutical industry, operate an effective scheme for assessing the safety of new and reformulated drugs before they are put on the market in this country. The board also monitor reports on adverse effects of drugs already in use.
However, although these arrangements are operating satisfactorily, it is recognised that they should have statutory backing and it is proposed to provide for this in comprehensive legislation controlling the safety, quality and efficacy of medical preparations. In the meantime, regulations for the licensing of pharmaceutical manufacturers and wholesalers, which are being made under existing powers in the Health Acts, are at an advanced stage of preparation. In addition, regulations for the licensing of the marketing of individual pharmaceutical products are being drafted under the European Communities Act, 1972, as our EEC obligations require us to have a legally based product licence scheme before 30th June, 1974.
Has the Parliamentary Secretary seen any reports to the effect that certain medicines and drugs have been withdrawn in other countries which are being distributed here? If any country withdraws drugs of which they might have some small suspicion, would the Parliamentary Secretary not agree they should be withdrawn here as well?
I agree wholeheartedly with the Deputy but I am confident that the National Drugs Advisory Board, in consultation with the manufacturers and the Department of Health, are doing a worthwhile job.