MEDICINES BILL (Hansard, 15 July 1971)

§ THE MINISTER OF STATE, DEPARTMENT on HEALTH AND SOCIAL SECURITY (LORD ABERDARE)
My Lords, this Bill seeks to make a minor alteration in the provisions about fees to be charged for licensing under the Medicines Act 1968. The alteration is necessary because doubts have arisen as to the legal effect of the original provision and no policy considerations are involved. The Medicines Act 1968 makes provision for the licensing of manufacturers and wholesalers of medicinal products as well as for the issue of licences relating to medicinal products themselves. The Act contains transitional provisions as to products already effectively on the market and manufacturers and wholesale dealers carrying on business immediately before the first appointed day. For these, no licences are required during the transitional period and thereafter they are entitled to licences as of right. The criterion for the issue of these licences is simply that the licensing authority is satisfied that the products were effectively on the market or that manufacturers and wholesale dealers were carrying on business immediately before the first appointed day. On the other hand, licences for products marketed for the first time after the first appointed day may be issued only after consideration of the safety, efficacy and quality of these products; and licences for manufacturers and wholesale dealers commencing business after that date may be issued only after consideration of the adequacy of their equipment and facilities.
It was quite clearly the intention, when the Act was originally presented to Parliament, that fees should be charged in respect of the issue of both full licences and licences of right. In the provisions as to regulations about such fees (Section 128(3)) the draftsman used the word"power ". In the light of certain court rulings, it now seems doubtful whether power"as used in this context comprehends also the duty of issuing licences of right. As I have said, the only criterion for the issue of licences of right is that the transitional provisions in the Act are satisfied, and it may therefore be argued that the issue of a licence of right is a duty which the licensing authority 572 is required to discharge rather than a function which it is empowered to exercise. Since the number of new products likely to be introduced to the market and the number of new manufacturers and wholesale dealers beginning licensable business for the first time is small in relation to the number of existing products and dealers, it follows that if we were prevented from collecting fees in respect of licences of right, which, for the first five years at least, will be the greater proportion of licences issued, the whole burden of fees would have to fall on new licences.
The objective of the Bill is to deal with this situation by repealing the section about which doubts have been expressed and replacing it by an entirely new provision. This provision refers expressly to the issue of licences, certificates and directions, instead of using the more general phraseology previously employed. At the same time the opportunity has been taken to set out explicitly the precise ambit of the regulations which may be made under the provision. These provisions, which are contained in Clause 1(1)(b), are intended to make it clear that it is possible to include in the regulations provision for the payment of fees by instalments and for their refund in certain circumstances. If payment by instalments is to be permitted, it is a necessary corollary that the regulations may authorise the suspension of any licence in respect of which the instalments are in arrears.
The remaining provisions of the Bill are of a formal nature and necessary in order to apply various provisions of the principal Act. As a result of them, the Health and Agriculture Ministers will be required, before making any fees regulations, to consult bodies representative of the interests concerned, and the regulations themselves will require the concurrence of the Treasury and be subject to Parliamentary approval under the Negative Resolution procedure. The first appointed day for the purposes of the licensing scheme under the Act is to be September 1, 1971, and it is very desirable that this Bill should go through as quickly as possible so that the appropriate regulations may be made at the earliest possible date. I therefore should like the House to give the Bill a Second Reading, 573 and beg to move that the Bill be now read a second time.

§ LORD BURNTWOOD
My Lords, before I come to my few observations on this small but significant Bill, I should perhaps declare a personal interest in this matter, as I act as consultant to a company which might be involved. I am not unfamiliar with the principal Act, the Medicines Act 1968, and I was surprised when I heard that there was any question as to the liability of those who apply for transitional licences. I have indicated to the noble Lord that I should be interested to know what are the rulings of the courts which have led to doubts being raised. The noble Lord said that these had arisen because of some uncertainty as to the use of the word"power"as opposed to the word"duty ". I hope he can give us a little more information in this regard. Secondly, I apprehend from his remarks that the provision which he is now moving covers both products and manufacturers' transitional licences. Perhaps he would clarify that point. I would say that my noble friends do not propose to oppose this Bill, which is relatively significant and logical.

§ LORD ABERDARE
My Lords. I am grateful to the noble Lord. I think that this is the first time that we have heard him speak from the Opposition Front Bench, though he did so in another place, and may I say what a pleasure it is to see him there. The noble Lord very kindly gave me notice of his first question and I am glad that he did so, because it is a highly technical, legal subject and neither he nor I are lawyers; but I have been into it and find it an interesting subject. The courts have been obliged from time to time to distinguish between the words"powers"and"duties ". There was a case in Australia, Patch v. Ebbage, in which Mr. Justice Stanley said: As at present advised, I incline to the view that a duty is an express or implied obligation to do something; and a power is at least a capacity conferred by the Act to do something for the purpose of fulfilling a duty under the Act. There was another case, Regina v. Waterfield in 1963, which was heard in 574 the High Court here. The court was concerned with the question of whether an assault on a police constable was an assault in the execution of his duty. The assault consisted in driving a car from a stationary position at the constable, who was standing in its path with raised hand. Mr. Justice Ashworth said: The argument involves considerable difficulties. In the first place its validity depends on the construction of the section which would enable the constable not merely to require a moving vehicle to stop, but to require a stationary vehicle not to move. The court finds it unnecessary to reach a conclusion on that because, in the second place, it is to be observed that the section is merely giving a power as opposed to laying down a duty. There has been no ruling in the courts on the use of the word"power"in Section 128(3), and there has been no occasion for there to be one, because the provisions have not yet come into effect; as I said, they come into effect on September 1. However, the Act itself distinguishes in other provisions between the exercise of a power as distinct from the performance of a duty. Thus in Sections 3(2), 67(3) and 108(4) the distinction is drawn; in Sections 28(3) and (5) and 39(2) there are references to powers conferred; and in Sections 1(2), 2(1), 3(2) and 6(2) the functions of various bodies are referred to. This leads us to the conclusion that the word"power"in Section 128(3) must be construed with some exactitude, particularly as it is a provision which presents a liability to be imposed.
Licences of right are provided for by Sections 25 to 27 of the Act, and, since these provisions refer to entitlement to the grant of a licence, it would appear that in granting such an application the licensing authority would be performing a duty rather than exercising a power. Accordingly, it is necessary to replace Section 128(3), which contains no reference to the performance of a duty, by a new provision that will relate to all applications made under the Act. I hope that that is some explanation of the reason why there is a difficulty. The answer to the other question which the noble Lord asked is: Yes, it applies to the granting of all licences, both product licences and wholesalers' and manufacturers' licences.

§ LORD BURNTWOOD
My Lords, I think the House is indebted to the noble 575 Lord for his explanation of the fascinating duties and responsibilities of police constables.