The Parliamentary Secretary to the Minister for Local Government and Public Health is in charge of this Bill, and I formally give him leave to attend and be heard during its different stages in this House.
Public Business. - Therapeutic Substances Bill, 1932—Second Stage.
Cathaoirleach
Question proposed: "That the Bill be now read a Second Time."
This Bill is of a very technical nature and I do not propose to go into an explanatory statement in any great detail. Its object is to secure proper supervision of substances whose technical purity and potency have to be determined by experiment rather than by chemical examination. The information in the Pharmacopoeia is available to chemists in connection with chemical prescriptions, but the examination of the therapeutic substances particularly referred to in this Bill is a complicated process and can only be undertaken or carried out by a bacteriologist or a physiologist and, in that way, the public and the medical profession are depending on the State to take such steps as will ensure that these substances, when offered for sale in this country, will have reached a certain standard of purity and potency. Medical research and medical science have made considerable progress in recent times and, as a direct result of that progress in medical science, many important substances derived from animal sources have been introduced for the prevention, treatment and diagnosis of discases. To a considerable extent, these substances have replaced in treatment and diagnosis some of the older drugs of vegetable origin. The control of the biological products, such as sera, vaccines and other products, is really of greater importance to the community than the control of the ordinary chemical preparations. In most European countries at the present time the manufacture and importation of these substances are under State control.
With the exception of vaccine lymph and stock vaccines, the substances covered in this Bill are not manufactured in this country. The production of vaccine lymph is already adequately supervised by the Department of Local Government and Public Health, but, as I have said, the bulk of the therapeutic substances with which we are concerned now are manufactured outside this country and, by the very nature of the complicated process of their manufacture, must continue to be manufactured outside this country. I think it would be obvious, even to the lay mind, that there are certain dangers to the community arising out of the existing position, arising out of the fact that such substances of doubtful origin, and even of doubtful purity, can be dumped into this country and used in the treatment of certain diseases. Apart from that, many of these substances are relatively unstable and if they have been manufactured a considerable time before use, dissociation may have taken place with very serious consequences to the patient to whom they might come to be administered. We have consulted very eminent physicians and eminent men in the medical profession in relation to these matters and there appears to be no difference of opinion that the potency of several of these substances varies to a very extraordinary extent, and it has, indeed, been stated by a physician of eminence in the City of Dublin that some of these substances that are being used for specific diseases have, for all practical purposes, no curative powers at all by reason of their low potency.
It is intended under the Bill to issue licences to duly authorised persons for the manufacture or importation of these substances and the issue of research licences to persons using the substances for research purposes will, of course, involve the inspection of the establishment concerned and laboratory examination of samples of the products to ensure the observation of safe methods of manufacture and to ascertain their freedom from contamination, etc. For the purpose of advising the Minister from time to time as to the issue of licences to manufacturers of these substances, the Minister will have the expert advice of a consulting bacteriologist, and, on the advice of that consulting bacteriologist, licences will be issued or refused to manufacturers. During the discussion in the Dáil on this Bill, representations were made to me regarding the possible difficulties that might be placed in the way of a medical practitioner who required such substances in a case of urgency, and who, perhaps, might find that a person to whom an importer's licence had been issued had not any of the material in stock. Amendments were inserted dealing with that point in order to enable the Minister in cases of emergency to issue a permit to a medical practitioner to import any of the substances to which the Bill might have application, if the Minister was satisfied that the case was sufficiently urgent or that it was advisable to issue such permit. I think that covers the main features of the Bill.
I have great pleasure in supporting the Second Reading of this Bill. It is a very important and very necessary Bill. It is only right that these substances which are of vital importance to the community should be of a particular standard and that is the aim and object of the Bill. The Bill is framed largely on the English Act, but circumstances in Ireland and in England are somewhat different. In England, they manufacture these substances, but this country is too small and we do not manufacture them, but it is quite possible, and I have two cases in mind at the moment, that it might be very important for a medical practitioner, in case of sudden or urgent necessity, to get the substances he wishes without going to the trouble or delay of putting the application to the Minister. Such a case may not occur for years and it may occur to-morrow. It may occur on a Saturday when it will not be possible to get at the Minister and the delay until Monday of two days, or a delay of even twelve hours, might mean the difference between life and death.
I strongly urge the advisability of giving power to medical practitioners to get these substances. I remember when we had rabies ten or twelve years ago anti-rabies serum had to be obtained. Another instance was a case of botulism which we had no serum for treating. These were very urgent cases, because a difference of a few hours might have meant a difference between life and death. The serums were obtained by telegraph within twelve hours. The same thing might occur in some other diseases because these cases occur like a bolt from the blue. It will not injure but rather will improve the Bill to have such a provision in it for dealing with such cases. It would be only in a case of great emergency the question would arise, but it might be a safeguard that a person who would want these substances must give particulars to the Minister within a specified time thereafter.
I should like to point to Section 11 of the Bill, to which I have no doubt the Parliamentary Secretary has referred. Cases of emergency are not met, seeing that you have to get the permit of the Minister. It is not in a case where you would not have time to get a permit of the Minister, that this becomes important. I suggest to the Parliamentary Secretary that he should accept an amendment which, I am sure, Senator Bigger will undertake to move on the next stage.
The only point that calls for further discussion is that raised by Senator Bigger and by Senator Brown. The amendment which was produced in the Dáil, dealing with this particular difficulty, was drafted after consultation with members of the medical profession. I think Senator Bigger will agree that, generally speaking, the substances under discussion are used in the treatment of chronic cases rather than acute cases. I can quite conceive the possibility of such substances being required urgently, in very exceptional circumstances, in acute cases such as the Senator cited. I think some further consideration might be given to the point he has made. I do not think, under the amendment, there would be very much delay. Those who have given special consideration to the matter under discussion agree that if we make it too loose it is going to defeat its object. While it would be necessary, as the Bill stands, for a medical practitioner to apply for the Minister's permission to import such substances, the delay in securing permission, in the circumstances outlined by Senator Bigger, would certainly be very short. However, I am quite prepared to look into the point again, and perhaps we would be able further to amend it, without making it unduly lax.
I should like to assure the Parliamentary Secretary that I do not wish to make the Bill in any way lax in its operations. I followed the discussion in the Dáil and I thought the point raised by Deputy Hennessy was rather not to hamper the profession too much. He had not in mind the cases I mentioned. Similar cases might occur.
I suggest that this is a case where the Senator and the Parliamentary Secretary——
Cathaoirleach
The debate has been closed by the Parliamentary Secretary, and I merely allowed Senator Bigger to explain.
Question put and agreed to.
Committee Stage ordered for Wednesday, 30th November.