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Dáil Éireann debate -
Wednesday, 26 Oct 1932

Vol. 44 No. 4

Private Business. - Therapeutic Substances Bill—Second Stage.

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.

I am not going to take up the time of the House in criticising this measure. I am rising to say I am going to support the Second Reading, although at the same time, I have a few questions to ask. With regard to the appointment of the Advisory Committee, I am satisfied as to the personnel. When we come to look at the Schedule one finds that this Bill deals with vaccines, sera toxins, antitoxins and antigens. It deals also with substances used for the specific treatement of infective disease, and with preparations of the specific antidiabetic principle of the pancreas known as insulin and with pituitrin. Now there is nothing done in this country at the present time, at least in the Free State, so far as I know, except the preparation of toxin, and this is done cheaply in the laboratories of the Universities, and there is nothing to prohibit the future action of the laboratory worker in this respect. They are still to be allowed, without any licence, to make the toxin for their patients, or for doctors who require them for specific cases. On the other hand, if any of the laboratories in the Free State propose to go in for an extension of the extensive making of these they have to apply for a licence. Now, sir, there are two or three things that have puzzled me in regard to the matter. As I say, the Minister or Parliamentary Secretary cannot hope for a long time that any firms here will be going in for the extensive manufacture of any of these substances. Toxins may be undertaken to a greater extent than at present, but certainly as regards the making of the other bodies, there is not the least likelihood of their being undertaken here.

The main object of the Bill, however, is this: it is to prevent very poor toxin or a very low series of foreign products, which are not up to a certain standard, from being dumped into this country. I take it the Parliamentary Secretary will agree with me that that is the meaning of this Bill—to prevent the dumping of inferior articles from other countries here. Now what is puzzling me in connection with this is—he prohibits the manufacture of these therapeutic substances, not complying with the standard of strength and purity, from firms who have applied for licences, he then goes on to say that they will give a licence for the importation of these articles. I do not know to whom these licences will be given, whether the licence will be given to the ordinary chemists to import them, or whether it will be only given to some specific firm. But as I say, what is puzzling me then is, when I go on, it says there is to be a restriction on the import of therapeutic substances. Now, who is going to be the judge? On reading over the Bill I could see no provision made for a person who was going to test these substances and say they were up to the standard or not up to the standard. I think he has said in the statement that there is to be an inspector appointed. This inspector, I think, from what he said, is to be a consulting bacteriologist. I take it, therefore, this consulting bacteriologist is to be the authority who will decide as to whether these sera and therapeutic substances are of the proper standard or not. I would like to have him explain that a little more fully. I think he might also clear up another point I am doubtful about: vaccine lymphs have been made in the Free State for many years, and it is under a specific control at the present time. I want to know is there going to be any change made in the control or examination of the vaccine lymph that is provided throughout the country to the dispensary doctors who use it for vaccine purposes.

As I say, I think there are only two things done in this country, the making of vaccines on a very small scale and the production of the vaccine calf lymph that is sent through the country for vaccination purposes. I am supporting the measure because it endeavours to deal with the dumping in this country of therapeutic substances that are not of a proper standard. The Parliamentary Secretary in his statement mentioned the fact that a distinguished physician had stated that the products of one firm were good, the products of another were middling and the products of a third were useless. Any of us who are in practice knows that there are products sent out with certain names, that these are really inefficient and are not up to the standard that would be necessary. I am supporting the measure for the reason I have stated. As far as I can see there are very few changes that can be made in it. I should only like to know whether I am right in saying that a competent bacteriologist will be appointed who will decide whether the standard is of a proper type or not.

Like Deputy Sir James Craig, I think the Bill has the approval of the profession and it should have. Nevertheless, I think some serious difficulties may arise when it comes to the matter of administration. The import licence to be obtained under Section 9 to my mind will impose restrictions that will affect the well-being of patients, which after all, should be our first and ultimate consideration in a Bill of this kind. It seems that Section 9 restricts the importation of medicines to the manufacturers of these medicines, and that they will have to pay for a licence to import these medicines. I can quite understand that there will be Continental and other manufacturers doing such little trade in this country in medicines of a specific character that they will not think it worth while to take out a licence, in fact that they will refuse to take out a licence. Moreover, this is a small country, and our laws are not so well known outside the country. Continental manufacturers have very little knowledge of Ireland, and do not or would not think it worth while to take out a licence to import particular products. Some of the products are of very great importance, and I was going to suggest to the Minister that he would allow manufacturers of high repute to import into this country certain preparations of a well known therapeutical character, and also that he would allow a medical practitioner to get these medicines from an unlicensed manufacturer, say by wire. If you go through the whole procedure and the delays incidental to it, while the medicine is coming or while you get a proper permit to import the medicine, your patient may be dead.

I am glad to see that the Bill provides for some important restrictions in connection with proprietary medicines. The use of proprietary medicines in this country has been grossly abused. We know sometimes that they contain very simple medicines under very high-sounding names, and there was no indication given, up to the introduction of this Bill, of what they contain. It is the layman who has such implicit faith in these proprietary medicines. Even commonplace medicines like Epsom Salts when put under a Latin name sound very impressive. They are undoubtedly useful for certain purposes, but they are not a cure-all. We know that it is a common practice to compound two or three of these medicines, call them some beautiful name and advertise them extensively. It is the unfortunate consumer who has to pay for the advertising. It is the unfortunate consumer who is called upon to pay half-a-crown or more for medicines which he could get in a chemist's shop for a couple of pence. Of course it may be said that the consumer is foolish to pay such a price, but when he sees an account of an old man of 70 or 80 years of age who, after taking a course of this medicine, will not go to the trouble of opening a gate, but who will take an eight-barred gate at full run, he will cheerfully pay his half-a-crown and perhaps his second half-a-crown. He is undoubtedly impressed by the advertisement. I see the difficulty of dealing with that, but perhaps under the Profiteering Bill something might be done to deal with the case of persons who are charged 2/6 for medicines which can be bought for a couple of pence. Some people of course, will insist on doctoring themselves. Goldsmith is supposed to have had a medical degree, but I think it was Doctor Johnson who advised him to prescribe only for his enemies. I think the Bill has many excellent features, but I should be glad if the Parliamentary Secretary would give further consideration to the points raised by Deputy Sir James Craig and to those I have just mentioned.

On the point with regard to import licences, I am not quite clear as to how a medical practitioner who wants to get a vaccine made for an individual patient of his, can, as many practitioners do at present, send out of the country to get that vaccine made. Has that person to apply for an import licence to import the vaccine that he is getting made in particular instances? It seems to me that if an import licence is required in such cases the difficulties in the matter about which Deputy Doctor Hennessy spoke are going to be enormous. The matter Deputy Sir James Craig raised with regard to the carrying out of tests prompts me to ask a question which may not be perhaps entirely in order, but which in my personal opinion is very relevant in this Bill. Deputies may recollect that on certain occasions I stated it was the intention of the late Ministry to establish a State Pathological Laboratory, and in respect of the building and equipment of it, a considerable amount of money was available from an outside source. I should like to ask the Minister, in connection with the work which he anticipates will be carried out under this Bill, whether any consideration has been given to the establishment of a State Pathological Laboratory. The position was that we were supposed to go ahead with that. A Director was advertised for when further discussions with the University were opened. You practically have the position that in a large sphere of public health work, very necessary public health work and very necessary public health development, the Universities claimed to bottleneck that development. I think the question arises on this particular Bill as to what exactly is going to be done on the matter of setting up a State laboratory or some laboratory under public control, or whether all this work which has developed in this piece-meal way, so vitally affecting public health, is going to continue to filter in that piece-meal way into the Universities, with the cramping effect on the development of necessary public works and the volume of public works that that undoubtedly has when the administration of that work is in the hands of persons not subject to public authority.

I think that most of the points raised in connection with this matter could be discussed, perhaps more appropriately, at a later stage. If any improvement can be made or if any valuable suggestions come from any of the Deputies interested in this Bill, I shall be very happy to give them careful examination, and if they appear to be calculated to improve the Bill, they will certainly be incorporated in it. Deputy Sir James Craig appears to have some uneasiness about the relationship already existing between the medical practitioner and the bacteriologist who manufactures his vaccines in particular cases. It is not intended that this Bill should operate to interfere with the practice already established in this country where, for a particular case, the medical attendant wants to have a special vaccine made and he sends along the stuff to the bacteriologist here in the city for the purpose of having his specific vaccine made for a specific case. It is not intended to interfere with that practice, and it does not appear to me to be necessary that there should be any interference in that matter.

The suggestion was made that in some cases orders were sent out of the country to make these vaccines. One vaccine was made, say, in Britain. I did not raise that point, however. It was raised, I think, by Deputy Mulcahy.

I quite recognise that there will be no interference with the making of vaccines here now as in the past; but Deputy Mulcahy has raised another case—that of vaccines which have to be made in another country. Is that going to be interfered with?

As I understand the Bill, that practice of having vaccines manufactured outside the country can only be continued under an import licence. It appears to me, on that particular heading, that there ought not to be much need to have vaccines manufactured outside this country. The various other matters, the sera, the antitoxins, and the other matters which form the main subject matter of this Bill, are not manufactured in this country, and, under existing circumstances, cannot be manufactured in this country. There is no reason apparent to me, however, why vaccines should not be manufactured here or why, in the circumstances that Deputy Mulcahy has in mind, any hardship should be imposed on anybody by having these vaccines, in cases of urgency anyhow, manufactured in this country. If a medical practitioner has not sufficient confidence in the manufacturers of vaccines in this country and wishes to have them made outside the country, it can be done within the machinery of this Bill, but will entail some little delay.

The question has been raised, by Deputy Sir James Craig, I think, as to on whose advice licences will come to be issued. As I indicated in the course of my introductory remarks, the licences will be issued on the advice of a bacteriologist of standing, appointed by the Minister for the purpose. There will be no interference, of course, with the existing arrangements so far as the preparation of vaccine lymph is concerned, and it is possible that the duties imposed by this Bill will be allocated to the bacteriologist already employed in the production of calf lymph. Anyhow, that is a matter of detail, and whoever is the person who will advise the Minister on the matter of the issue of licences obviously will have to be a bacteriologist of considerable standing in his profession.

I do not know whether or not I have touched on all the points that were raised. I think I have covered most of the ground. However, if there is any point on which Deputies require further information, we can deal with any matter I may have overlooked.

The possibility of a State laboratory is rather outside the purview of this Bill. However, I may say that I am personally interested in the matter and intend examining the position at the earliest possible opportunity. Beyond that, however, I cannot go. The work, however, under this Bill will be comparatively small. The well-known manufacturers of the sera and vaccines, and the other matters mentioned here, already come under a licence of the Ministers of Health of their own country, and the inquiries to be made before we will allow them to export to this country will be largely a matter of form. I do not anticipate that the bacteriological work will be very heavy under this Bill.

You will not shut the door against British imports?

I do not think we will develop the war atmosphere in connection with this Bill, but I think that if any of the subnstances coming under this Bill are manufactured in England and are likely to prolong the life of our citizens we are not likely to bar them out.

On a point of explanation, I wish to say that I do not at all accept Deputy Mulcahy's representations of the University attitude on the question of a State laboratory. I think it will be found that all that they claimed was that due regard should be paid to the work they have done and to the work which they are still doing.

I should gladly wish not to misrepresent the Universities and I hope I have not misrepresented them. I would ask the Minister, in regard to getting vaccines outside the country, whether he would look into that matter. I have no very technical information about it, but I do know that there has been a considerable volume of that type of import in operation. I do not know whether it is necessary or not. If it is not necessary, it would be most desirable that the work should be done here; but if any part of it is necessary, I feel that greater facilities than are provided under Section 9 would have to be provided if very great inconvenience was not going to be caused.

I will look into the point raised by Deputy Mulcahy. If he has any specific information I would be glad to have it for the purpose of guidance.

Question put and agreed to. Bill read a Second Time. Committee Stage fixed for Wednesday, 2nd November.