MEDICINES BILL (Hansard, 25 June 1971)

§ The Under-Secretary of State for Health and Social Security (Mr. Michael Alison)

I beg to move, That the Bill be now read a Second time.

This is a short Bill which makes a very small change in the provisions about fees for licences under the Medicines Act, 1968. There is no point of policy or substance involved. The need for the Bill arises from the fact that doubts have arisen about the legal effect of the original provisions.

The main doubt with which the Bill seeks to deal relates to the power to charge fees in respect of one particular class of licence for which the Act makes provision. These licences, referred to in the Act as "licences of right", arise from the transitional provisions under which medicinal products already on the market on the first appointed day can qualify initially for licences without undergoing the scrutiny as to safety, quality and efficacy to which new products will be subjected.

There seems to have been no doubt in anybody's mind when the Bill which became the 1968 Act was going through Parliament that licences of this description would give rise to fees in the same way as other licences. The doubt arises because in Section 128(3) the draftsman has used the word "power" and it is a matter of uncertainty, in the light of certain rulings by the courts, whether a reference to a power in this sort of context can be construed as a reference to a duty. The issue of a "licence of right" is a duty in the sense that if an applicant can show that the conditions set forward in the Act apply in his case the authority is obliged to issue the licence.

As I have said, there does not seem to have been any doubt at the time that fees were to be charged in respect of "licences of right" as well as other licences. If fees cannot be charged in respect of this type of licence, it would still be possible to collect substantial sums by way of fees in respect of other types 1774 of licences, but at least for the first five years of the licences scheme the result would be highly inequitable and inconvenient in practice. The bulk of the licences issued would be licences of right and the fees would fall upon those firms who had occasion during that period to apply for ordinary licences because they were launching new products.

This Bill deals with the situation by repealing the doubtful subsection to which I have referred and replacing it by the new provision contained in Clause 1 of this Bill which refers expressly to licences, certificates and directions instead of using the general term "power" which has led to the difficulty.

The opportunity has also been taken to include some other provisions which make explicit the ambit of the regulations which can be made under the power. These provisions, which are contained in Clause 1(1)(b), will avoid any doubt whether it would be possible to include in the regulations provision for fees to be paid by instalments and for fees once paid to be refunded in prescribed circumstances. As a necessary implication of payment by instalments, the regulations can authorise the suspension of a licence which has been issued if the instalments fall into arrear.

The other provisions of the Bill are of a formal nature and are necessary in order to apply various provisions of the principal Act. As a result of them, the Health and Agriculture Ministers will, before making the fees regulations, be required to consult bodies representative of the interests concerned, and the regulations themselves will require the concurrence of the Treasury and be subject to enforcement under the negative procedure.

The House will not expect me now to go into any detail on questions which will arise in the course of such consultations. Some proposals were put forward before the organisations concerned in April, and since then a good many representations have been received by the Departments concerned. All the points raised are being carefully considered, and I believe that we shall shortly be in a position to put forward revised proposals which will be more acceptable both as to the total amount to be collected in fees and as to the incidence on particular categories.

1775 I trust the House will agree that the provisions in this short Bill are reasonable and necessary, and that it will be willing to grant it a Second Reading. The first appointed day under the Medicines Act is to be 1st September, 1971, and it is, therefore, desirable that this Bill should go through quickly.