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Dáil Éireann debate -
Wednesday, 18 Nov 1959

Vol. 178 No. 1

Ceisteanna—Questions. Oral Answers. - Medicinal Preparations.

11.

asked the Minister for Health whether, in view of the considerable extension in the range of home-manufactured medicinal preparations to be made available, he will state what steps he has taken by means of the establishment of some form of bureau of standards machinery or otherwise to provide accurate information for those members of the medical profession who wish to have a competent analysis for comparison purposes and for purposes of therapeutic assessment of the composition and purity of home-manufactured medicinal products which they must in the future order in place of similar imported preparations.

Standard formulae are laid down in the British Pharmacopoeia and the British Pharmaceutical Codex for medical preparations. These formulae apply in this country and it is an offence to sell a medical preparation listed in the Pharmacopoeia or the Codex which does not comply with the formula prescribed for it. Furthermore, the ingredients must be listed on any preparation (or its container) where it is sold by retail.

Any member of the public, including a member of the medical profession, who is prepared to pay the prescribed fee may submit a medical preparation to a Public Analyst for analysis. It is assumed, however, that members of the medical profession have been accustomed to accept without question the quality of preparations manufactured outside the country, and as I have pointed out above, the same standards apply to home-manufactured preparations. It would appear invidious, therefore, to imply, by instituting special machinery for testing their products, that Irish manufacturers are inferior to their competitors abroad in meeting these standards.

Is it not a fact that there is a Committee of Standards in Great Britain which is an independent watchdog and whose function it is to assess the quality and the contents of the preparations produced from the different drugs? We have no such independent machinery here for examination of these drugs.

I cannot answer that question for the Deputy.

Is it not of vital importance that there should be some body other than the drug houses themselves to whom the public and the medical profession can apply and in whom should be vested the responsibility of maintaining the quality and therapeutic standards of these drugs? Leaving the medical profession out of it altogether, this is in the interests of the patients.

The Deputy is, of course, aware that samples are taken from time to time and submitted for analysis. These samples are taken in the ordinary way by the Department which looks after these matters.

In view of the considerable extension of the products to be made available on the home market, will there be any extension of the facilities to provide for the examination of these drugs? Is there no independent body to be established by the Department?

I do not know why the Deputy should ask for an extended system of examination. We are merely replacing drugs imported up to this by drugs manufactured at home. If we have faith in our own manufacturers to do the thing as well as the foreigner, there should be no necessity for an extension.

Were not the imported drugs subject to the repeated supervision of the Committee of Standards in Great Britain? We were not dependent solely upon the word of the manufacturers as we will be from now on if we do not set up such a commission here.

Could the Minister say whether there was any necessity for the increase of almost 50 per cent in the whole line of pharmaceutical goods as from yesterday?

That is a separate question.

That is the question that is never answered.

12.

asked the Minister for Health whether, following the recent restriction imposed on imported medicinal preparations, it is intended that, through the operation of the authorised drugs list compiled by his Department for the use of medical officers in local authority hospitals and institutions and in the public health and dispensary services, doctors must prescribe the home-manufactured medicinal preparations even where the medical officer concerned may conscientiously believe that the imported product is of greater therapeutic value to his patient.

I am not aware of any recent restriction on the importation of medicinal preparations.

The duty recently imposed by the Government covers only certain medicinal tablets and ready mixed materials for such tablets.

Tablets of Irish manufacture, where available, have been used for some years in the health services under the control of my Department. The imposition of the duty has not, therefore, brought about any significant change in the former position.

Where applications have been received for the use, in special circumstances, of alternative brands of tablets manufactured elsewhere, such applications have been specially considered in my Department and, where reasonable grounds have been shown, the applications have been approved.

Is it a fact that there is to be a much greater extended list of drugs which must be substituted, if Government policy is to be respected, for the imported article and, consequently, will not the members of the medical profession concerned be forced, whether they accept, agree or believe in the therapeutical value of these drugs, to accept the home-produced medical preparations without having had any of the investigations which I suggested in the previous question they should have?

As a member of the medical profession, Deputy Dr. Ryan should know that this is a matter of serious importance for the sick people of this country.

I have called Question No. 13.

13.

asked the Minister for Health whether a chemist who offers a cheaper home-produced medical preparation of identical B.P. constituents as an alternative to a more costly imported preparation medically prescribed is liable to prosecution under any Statute.

Barbiturates, cortisone and A.C.T.H., and certain preparations for the oral treatment of diabetes may normally be sold by retail only on prescription and I am advised that it would be an offence for a pharmaceutical chemist to dispense a prescription for one of these drugs except in accordance with its terms. Otherwise, it appears that to make an offer such as is referred to in the question or to implement such an offer would not be an offence under any statute.

Could I ask the Minister whether any attempt has been made to obtain the approval of the medical profession for the changes which are implicit in the recent importation Order?

I presume that the Minister for Health consulted the medical profession. The Deputy and I know that he is not always in agreement with the medical profession.

I would be the last to suggest that the Minister for Health should be bound by any recommendation made by the medical profession but both of us would agree that some representatives of the medical profession should be consulted. I am concerned not with the medical profession but with the sick people. They are going to be made the victims. They are being made the scapegoats.

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