I move that the Bill be read a Second Time. This is a measure with close and important bearing on public helth, and I think it will be generally agreed to be a very necessary measure, and, in fact, may be looked upon as a matter of urgency. Its object is to secure proper supervision over substances whose technical purity and potency have to be determined by experiment rather than by chemical examination. The Pharmacopoeia provides an authoritative source of information for all chemists in connection with chemical prescriptions, but the examination of the therapeutic substances dealt with in this Bill involves complicated processes which can only be undertaken by a bacteriologist, physiologist or experienced pharmacologist.
The public and the medical practitioners are alike dependent on the State to ensure the trustworthiness of these articles when offered for sale.
The constant progress made by science and medical research in recent years has led to the introduction of many important substances derived from animal sources for the prevention, diagnosis and treatment of disease. These preparations have displaced many of the older drugs of vegetable origin, which were officially controlled by the Pharmacopoeia as to the method of preparation, standard and dosage. The control of biological products—sera, vaccines and analogous products—is of far greater importance than that of the Galenic preparations. This is recognised in Great Britain, France, Germany and other European countries, as well as in the United States of America, where the manufacture and importation of such therapeutic substances are under State control. The statutory provisions in these countries apply to certain therapeutic substances, the purity and potency of which cannot be adequately tested by chemical means, viz., vaccines, sera, toxins, anti-toxins, antigens, insulin, salvarsan and pituitrin. In that connection the Acts may be applied to other substances by regulation subsequently. For example, in Britain "catgut" has already been added to these substances. Licences are issued to manufacturers of these products and authority is given for the suspension and revocation of such licences, and the importation of the substances is prohibited unless they comply with prescribed standards.
With the exception of vaccine lymph and stock vaccines, the manufacture of these substances in this country is not extensive. The production of vaccine lymph is adequately supervised by the Department of Local Government and Public Health. Stock vaccines are prepared in Dublin on a small scale only, and there have been no complaints as to their quality.
The bulk of therapeutic substances is, however, manufactured outside this country. In connection with substances manufactured abroad and imported here, the chief safeguard we possess at the moment is the very natural and understandable desire of the manufacturer to see that his products maintain a good reputation and that accidents do not occur following their administration. Examination of the facts will show that this safeguard is insufficient. The main countries of origin of these imports are Great Britain, the United States, France and Denmark. In the British Rules (Statutory Rules and Orders, Part V., 21) it is implied that the restrictions in force in England would not be relaxed on products for export to this country as long as there are no adequate regulations in force here. But as the tests may be carried out by the manufacturing firm (Statutory Rules and Orders 6 (1) (b)), it is obvious that we are largely dependent on the honour of the licensee, as the Licensing Authority is under no obligation to test samples of batches for export, and might not do so unless complaints arose. As regards the other countries mentioned, so far as has been ascertained, similar arrangements are in force. The products mentioned, and with which we are concerned in this Bill, might be objectionable or dangerous on a number of grounds: in the first place if the products were relatively unstable and there were danger from dissociation, as with organic derivatives of arsenic, "606" and similar preparations, and diphtheria-prophylactic.
Deaths after the administration of salvarsan have been remarkably few in this country, and apparently the manufacturers are very particular in its manufacture to avoid undue toxicity, but accidents have occurred elsewhere from the administration of this drug and from diphtheria antitoxin.
Now another reason why the products mentioned might be objectionable or dangerous, is if there were risks to patients owing to the presence of living micro-organisms in the preparations.
Complaints of sepsis following injections are very infrequently made, and the presence of small amounts of antiseptics apparently suffices to kill off, or inhibit the growth of any stray micro-organism escaping sterilisation during the process of manufacture, or gaining entrance at the time of filling the containers.
And again, the medical profession might feel that the products coming into the Saorstát were of very variable, or uniformly low, potency.
Here, obviously, the manufacturer has a great opportunity of making profit by reducing the strength of his preparations so that more will be required, or a firm may not have the requisite plant or the technical advice requisite to enable them to produce preparations of high potency. It is in this type of case one hears most complaints. Thus medical practitioners say that one firm's diphtheria-antitoxin is no use, that another person's salvarsan is the best, that so-and-so's vaccines are worthless. Statements of this nature are often unreliable, because they are founded on an insufficient number of observations, or perhaps they have been prompted by the suggestions of the salesman, or the literature with which we are inundated. At the same time statements of this kind are made so frequently that there would appear to be some real foundation for the suspicion that the products under discussion vary as regards their potency. A Dublin physician of experience has stated that the scarlet fever antiserum of one firm was good, of another fair, and that of a third firm worthless. This physician would have a sufficient number of cases under his observation regularly to enable him to form a reliable opinion on this subject.
Imported substances from Great Britain are manufactured by firms of repute and are under the same supervision as those for sale in Great Britain and Northern Ireland, and, so far as has been ascertained, the same applies to the other importing countries. There is, however, a definite risk from agencies established by unscrupulous manufacturers for the sale of inferior biological products, which would not alone be worthless as remedial agents, but might prove a positive danger owing to the presence of living micro-organisms. A grave responsibility rests on the State to ensure the purity and potency of these substances and the risks arising from lack of control are very serious.
At present the Department is in the position of trying to discountenance unreliable agencies, although, in fact, there is no statutory power to support their attempt. The issue of licences to duly authorised persons for the manufacture or importation of therapeutic substances and the issue of research licences to persons using the substances for research purposes will involve inspection of the establishments concerned and laboratory examination of samples of the products to ensure the observance of safe methods of manufacture, to ascertain freedom from contamination, and to determine the potency of products for which standards or tests have been established.
The cost of administering the Act will not be heavy.
It is intended to refer applications for import licences to a consulting bacteriologist who will be in a position without further formality to advise in the great bulk of the applications, especially those of the English firms who have been already granted a manufacturer's licence. Applications for manufacturer's licence in this country will be comparatively few and easily dealt with. The consulting bacteriologist will also act as inspecting officer in co-operation with the medical inspectors of the Department.
The licences granted to establishments do not imply an endorsement of the claims made by the manufacturers for their respective preparations. The granting of a licence means that inspection of the establishment concerned and laboratory examinations of samples of its products are made to ensure the observance of State methods of manufacture, to ascertain freedom from contamination, and to determine the potency, or safety, or both, of the various products for which potency standards or tests have been established.
The Bill contains twenty-one sections and a schedule of the substances to which the Act will apply. For the purpose of advising and assisting the Minister in the making of orders and regulations there will be established an Advisory Committee representative of the Department of Local Government and Public Health, the Department of Agriculture, the Universities and Medical Schools, Medical Registration Councils, the Irish Medical Association, the Veterinary Council, the Pharmaceutical Society and the Institute of Chemists. The Bill will apply to therapeutic, including prophylactic and diagnostic, substances for the use and the treatment of human or animal diseases. The Minister is empowered to make regulations as to standards and in relation to any matter or thing that may be prescribed under the Act. He is empowered by Order to add other therapeutic substances to those set out in the Schedule as coming under the provisions of the Act. The power to issue licences for the manufacture or importation of therapeutic substances is supplemented by prohibition of the manufacture or import of such substances without such licences and the restriction on the import of therapeutic substances through the Customs and by post is provided for accordingly. Fees to be fixed by the Minister with the consent of the Minister for Finance will be payable in respect of licences, and offences under the Act (to be ascertained by inspection and other examination) will involve the revocation or possibly the suspension of licences. The sale of proprietary medicines consisting of or containing therapeutic substances may be prohibited in the absence of proper descriptions appearing on the labels, including any necessary information as to the date of manufacture, etc., of the substance.
It is anticipated that the passage of this Bill will prove of great national value in the protection and assistance both of the public and the medical profession.