asked the Minister for Health what controls exist to ensure that drugs on sale to the public are effective for their stated purposes.
Ceisteanna—Questions. Oral Answers. - Drug Control.
16.
The Medical Preparations (Advertisement and Sale) Regulations, 1958, provide that medical preparations may not be publicly advertised in a manner that might lead to their use in the diagnosis, prevention or treatment of a wide variety of human ailments scheduled in the regulations, for example, cancer, tuberculosis, diabetes etc.
One of the functions of the National Drugs Advisory Board, which was established in 1966, is to obtain and assess information as regards the safety of new and reformulated drugs and, in particular, their toxicity and other adverse effects. Under the scheme operated by the board persons marketing drugs in this country submit relevant information regarding the product to the board. In considering such submissions the board take into account the efficacy of the particular product for the purpose for which it is intended to be used, as stated by the manufacturer.
The board also operate a service for obtaining and assessing reports on the adverse effects of drugs already in use and on the basis of such reports may request information from the persons responsible for marketing particular products, which would be assessed by the board in the same way as in the case of a new drug.
Could I ask the Minister if there is provision whereby a penalty may be imposed on a manufacturer who sells a drug which, though quite safe, is not effective for the purpose for which it is alleged to be effective?
Of course, it depends on whether it comes within the category of drugs that are examined by the National Drugs Advisory Board. There are many what are known as non-ethical preparations which are claimed by the manufacturers to have therapeutic properties which it would be difficult to substantiate because they are of a harmless nature and not looked at by the board.
Would the Minister consider that in the interest of protecting the consumer it might be desirable to extend the legislation in order to ensure that the consumers do not spend money on a drug which is not effective for the purpose for which it is supposed to be effective?
I would not propose to extend legislation at the moment. There are a great many drugs and medicines on supply in which people have great confidence. The element of confidence very often enters into the matter.