Ceisteanna — Questions. Oral Answers. - Sale of Drugs.


Mr. Leonard

asked the Minister for Health if his attention has been drawn to an article on the control of the sale of drugs in Bangladesh as published in the December 1982 issue of the Trócaire bulletin One World; and if he has satisfied himself that in this country we are not also being made the victims of the large drug combines.

I have seen the article referred to by the Deputy. I am satisfied with the adequacy of the controls on the safety, quality and efficacy of drugs marketed in this country.

Under the European Communities (Proprietary Medicinal Products) Regulations, 1975, a proprietary medicine may be placed on the market here only on the authorisation of the Minister for Health, following the advice of the National Drugs Advisory Board who carry out a detailed assessment of the application. By agreement with the industry, non-proprietary medicines are similarly cleared by the board before they are placed on the market. The board operate arrangements also for the post-marketing surveillance of medicines.

To supplement these controls certain safeguards are provided for in the Medical Preparations (Licensing of Manufacture) Regulations, 1974, the Medical Preparations (Licensing of Manufacture) Regulations, 1975 and the Medical Preparations (Wholesale Licences) Regulations, 1974 which govern the adequacy of arrangements for the manufacture and wholesale distribution of medicines generally in this country.

Mr. Leonard

Does the Minister make use of the World Health Organisation who advise on drugs? To use their own words, some of those drugs are either harmful, useless, or simply a duplication of a drug available more cheaply elsewhere? Would the Minister also agree that the present price of drugs is crippling the health services and that both quality and price should be looked into? Is he satisfied that the home drug manufacturers are getting a fair crack of the whip? I sent a submission to him some time ago raising this matter, following a discussion with the health board. Drug manufacturers here claim that they are being left in the cold, with international combines getting the pickings.

The WHO, in response to claims of multinational drug companies flooding developing countries with products which are often irrelevant to their needs, drew up a list of 200 basic drug substances recommended as the only essentials for the health care of the vast majority of the world's population. That list consisted of essential drugs with proven efficacy and safety in relation to common and important symptoms and diseases.

I share the concern of the Deputy, but am not quite sure what we can do in that regard. We have a very large number of drug companies employing about 60,000. If the Deputy has any further information following on the Trócaire publication and the One World publication, I would be only too glad to take up the matter with my own Department and the WHO.

Did the Minister say that the same stringent regulations apply in the case of non-proprietary medical preparations?

By agreement with the industry, non-proprietary medicines are similarly cleared by the board before they are placed on the market. That is the assurance I have and I hope it applies.