THERAPEUTIC SUBSTANCES BILL. [H.L.] (Hansard, 10 March 1925)

§ THE MARQUESS OF SALISBURY
My Lords, this is a Bill with which your Lordships are already familiar, because it passed through your Lordships' House last Session very much in its present form. It was not successful, however, in passing through the other place. Certain amendments have been made in it since it was first introduced, but they are amendments inserted by your Lordships' House itself during its passage last year. A very few words will be necessary for me to explain to your Lordships the effect of the Bill. The principle of the measure is the same as that of a great many other measures. It is designed to protect those who buy therapeutic substances from being misled as to their character. If it be necessary that such provisions should be inserted in laws governing the sale of ordinary commodities, it is specially necessary in respect of these particular commodities, because upon the proper standard and strength of these therapeutic substances depends the health of the persons who use them. Indeed, even the medical profession itself is unable to be rightly advised as to what is being prescribed unless there is some standard regarding these therapeutic substances upon which reliance can be placed.
In some cases, of course, the mischief of uncertainty goes still further, because certain of them are highly poisonous in their nature unless they are taken in very carefully guarded strengths. In cases of that kind, if there is uncertainty, very formidable consequences indeed may follow. I do not suppose that there is anything of which it is more obvious that the standard ought to be fixed by law than these therapeutic substances. They include a number of different things. There are sera and vaccines and there are also special preparations like salvarsan which, 441 as your Lordships know, is a very important drug. The substances of which I have spoken cannot be tested by chemical analysis, but have to be tested biologically, and consequently require to be submitted to very competent persons. Legislation in respect of these matters is here merely following the example of very many other countries. Such control is provided in Norway, Sweden, France, Germany, Italy and Spain. In the United States the manufacture is subject to the most rigid inspection. In Denmark they go still further, and no such medicines are allowed to be prepared except at State institutions, so that your Lordships will see that there is abundant precedent in the legislation of other countries to justify our action.
To give examples I take, first, salvarsan. One of the constituent elements of salvarsan is arsenic, I am afraid I am no chemist and have very little claim to be considered even passably scientific, but I understand that it is impossible to detect the amount of arsenic in salvarsan except by a biological test. If you turn to other drugs there is the pituitary extract, a very important glandular extract, and so uncertain is the present figure that I almost hesitate to give it. The present standard may actually vary in the proportion of one to eighty without any legislative control. I cannot doubt that your Lordships will be convinced that in these matters some kind of standard is necessary, and in consequence some kind of control of that standard is required. Although there is nothing so variable as I have described in the case of sera and vaccines, it is nevertheless very clear that unless you know to some extent the strength of the sera and vaccines which are being prescribed even the doctors may be misled as to what they ought to do.
Now I come to the Bill itself. The proposed procedure is that these therapeutic substances shall be the subject of licences to the persons who are entitled to prepare them and to the places in which they are allowed to be prepared. These licences are to be protected with conditions which, in turn, are to be laid down in Regulations, and these Regulations are to be laid before Parliament. The authority whose business it is to make the Regulations will be, according to the proposals of the Bill, a Joint Committee 442 consisting of the Minister of Health, the Secretary for Scotland and the Minister for Home Affairs in Northern Ireland, the reason being that, the Bill has operation in those three parts of the United Kingdom and accordingly a responsible Minister of Health must in each case take, his share in the administration. There is precedent for allowing a Ministerial authority to have jurisdiction of this kind. I need not add that it is not suggested that the Minister himself should act, but that a representative of the Minister of Health in England and of the corresponding Ministers in Scotland and Northern Ireland should carry out the necessary work of administration. There is also to be an Advisory Committee to help this authority. This Committee is to be composed of representatives of the three Departments which I have mentioned, and also of a representative of the Medical Research Council, a representative of the General Medical Council and a representative of the Pharmaceutical Society. Your Lordships will see that great care is taken that proper scientific advice of the most responsible kind is at the command of these Ministerial authorities whose business it will be to administer this Bill if it becomes law.
I have merely to add that the therapeutic substances which have to be dealt with are included in the Schedule of the Bill and that there is power to increase the category of substances by Ministerial act. There are subsidiary Regulations in addition. The therapeutic substances which come in from abroad have to be subjected, very properly, to exactly the same tests as those which are produced in this country. I have to add that an exception is to be made in respect of certain examples of these therapeutic substances which are introduced into this country or made in this country, not for the direct purpose of medical use, but for the purpose of research. They must be allowed to be varied in strength and not be held to an exact standard of strength. But even here there is to be protection by means of special licences,—that is to say, all the persons who are allowed to be connected with this research work are to receive special licences.
There is, I think, only one other matter which I need mention. This subject of 443 therapeutic substances has been before the appropriate authority of the League of Nations, and this authority has come to the decision to move the various Governments to protect the standard of purity of therapeutic substances. The result will be that if other countries adopt these protections—and I have pointed out to your Lordships that many of them have done so already—then these substances, when produced in England, will, unless they are similarly protected, be excluded from those foreign countries. That is the inevitable result of international action. That would be very unfortunate by itself, although not a matter of first importance, because what we produce is very good, and there is no reason why it should not have proper sale abroad like anything else. For these reasons I have the honour to move the Second Heading of this Bill and I hope that it will have an easy passage. Of course, if your Lordships should desire to make any amendment, I should be most ready to consider it on behalf of the Government.

§ VISCOUNT HALDANE
My Lords, as to the principle of this Bill that is right, and it was the principle of the Bill which was introduced by the late Government; but there is just one question which I should like to put to the noble Marquess and which I think would have applied to the Bill which we introduced. It relates to subsection (2) of Clause 3. Under that subsection any man of science who wishes to make a research has to obtain a special licence, and when I look at the Schedule, particularly at the first class of substances in the Schedule, there are several things which a man of science may very well naturally want, and want at short notice. I have come a good deal in contact with men of science and I know there is one thing they will not do, and that is apply for licences. It is not in accordance with their practice to conduct correspondence with Government Departments. They dislike doing so very much.
I am concerned lest subsection (2) of Clause 3 of the Bill may interfere with a great deal of very valuable research, and I would suggest to the noble Marquess that that can probably be got over by special instructions given to the Department that when any well-known investigator, 444 who is recognised to be a proper person to receive permission to import small substances, asks permission, he should not be required to go through formalities, but it should be at once recognised that his position entitles him to get in small substances. If you do not give exceptional treatment to people of that kind you will stop a great deal of scientific work. I am not speaking out of my imagination, but from what I have been told by people engaged in the business of research.

§ THE MARQUESS OF SALISBURY
My Lords, I need not say that I will most carefully consider the suggestion made to me by the noble and learned Viscount and see whether any amendment is required in the Bill to carry out what he wishes. Whether we ought to insert such an amendment and whether it is possible to do so I cannot say without inquiry, but the authority of the noble Viscount on the subject is very great and I will give it my most earnest consideration.