HC Deb 20 June 1968 vol 766 cc1382-90



  1. (1) Notwithstanding anything in sections 7 to 41 of this Act, in relation to anything done before such day (subsequent to the first appointed day) as the Ministers may by order appoint for the purposes of this subsection (in this section referred to as ' the special appointed day ') those sections shall have effect as if in them—
    1. (a) every reference to exportation (in whatever form the reference occurs) were omitted;
    2. 1383
    3. (b) any reference to the sale or supply of a medicinal product did not include sale or supply which involves, or is for the purposes of, exporting the product; and
    4. (c)any reference to offering a medicinal product for sale did not include an offer for sale where the prospective sale would involve, or would be for the purposes of, exporting the product.
  2. (2)The Ministers shall not make an order under the preceding subsection unless it appears to them to be necessary or expedient to do so for the purpose of giving effect to an agreement to which the United Kingdom or Her Majesty's Government in the United Kingdom is a party or will be a party on the day appointed by the order.
  3. (3)The following provisions of this section shall have effect where an order is made under subsection (1) of this section; and for the purposes of those provisions the relevant transitional condition? shall be taken to be fulfilled by a person in relation to medicinal products of any description if, in the course of a business carried on by him,—
    1. (a) substantial quantities of medicinal products of that description (that is to say, quantities exceeding those required for distribution as samples) were exported or procured to be exported during the period of twenty-four months ending immediately before the special appointed day, and
    2. (b)during the whole of that period further substantial quantities of medicinal products of that description were available, or could within a reasonable time have been made available, to be so exported or procured to be exported if required.
  4. (4) Unless the order expressly excludes the operation of this subsection,—
    1. (a) subject to any order made by virtue of paragraph (b) of this subsection, section 7(2) of this Act shall not have effect in relation to a person in respect of his exporting on or after the special appointed day, or procuring the exportation on or after that day of, medicinal products of any description in relation to which he fulfils the relevant transitional conditions;
    2. (b) section 17 of this Act shall have effect in relation to paragraph (a) of this subsection as it has effect in relation to the subsections of section 16 of this Act mentioned in that section.
  5. (5) Where a product licence which is in force on the special appointed day authorizes the holder of the licence to sell medicinal products of any description, or to procure the sale, or procure the manufacture or assembly for sale, of medicinal products of any description, that licence shall have effect on and after that day as if—
    1. (a) it also authorised him to export medicinal products of that description, or (as the case may be) to procure the exportation, or procure the manufacture or assembly for exportation, of medicinal products of that description, and
    2. (b) it authorised him to do so subject to the like provisions as (apart from subsections (3) to (7) of section 41 of this Act) 1384 are specified in the licence in relation to selling or (as the case may be) procuring the sale, or procuring the manufacture or assembly for sale, of such products:
      • Provided that, if the operation of subsection (4) of this section is not excluded by the order, a product licence shall not have effect as mentioned in this subsection in relation to medicinal products of any description so long as paragraph (a) of that subsection has effect in relation to the holder of the licence in respect of his exporting, or procuring the exportation of, medicinal products of that description.
  6. (6) Where on an application for a product licence made before such date as may be appointed by the order for the purposes of this subsection, which states that it is an application made by virtue of this subsection, it is proved to the reasonable satisfaction of the licensing authority that the applicant fulfilled or will fulfil the relevant transitional conditions in relation to one or more descriptions of medicinal products, then (subject to the next following subsection) he shall be entitled to the grant of a product licence granted so as—
    1. (a) to be limited to exportation, or procuring exportation, of medicinal products, and
    2. (b) not to extend to medicinal products of any description other than those in respect of which it is so proved that the applicant fulfilled or will fulfil those conditions, and
    3. (c) not to extend to medicinal products of any description in respect of which, at the time when the licence is granted, a product licence is already held by the applicant.
  7. (7) If a person would, on making an application under subsection (6) of this section, be entitled to the grant of a product licence under that subsection in respect of medicinal products of a particular description, and he would at the same time, on making an application as mentioned in section 25(1) of this Act, be entitled to the grant of a licence of right in respect of medicinal products of the same description, he may apply to the licensing authority for a single product licence for both purposes, and he shall be entitled to the grant of a product licence having the same effect as the two licences, if granted separately, would together have had.
  8. (8) Subsection (6) of section 26 of this Act shall have effect for the purposes of subsections (6) and (7) of this section as it has effect for the purposes of that section.
  9. (9) An order made under subsection (1) of this section may contain such provisions relating to proceedings on an application made under subsection (6) or subsection (7) of this section (whether by way of applying with modifications any of the provisions of section27 of this Act or otherwise) as the Ministers may consider appropriate.
  10. (10) No order shall be made under this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.—Mr. K. Robinson.]

Brought up, and read the First time.

The Minister of Health (Mr. Kenneth Robinson)

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

The new Clause relates to the postponement of restrictions in relation to exports. On 21st March, in Standing Committee, the hon. Member for Surbiton (Mr. Fisher) moved a series of Amendments designed to exclude from the ambit of the licensing provisions of Part II of the Bill the activities mentioned in Clause 7 in relation to the exportation of any medicinal product.

The hon. Member urged, in support of the Amendments, that the valuable export business of the United Kingdom in pharmaceutical products might be lost if exporters had in this country alone to go through a licensing procedure which their competitors in other countries did not have to face.

Moreover, it was urged that in many cases the circumstances in which the products would be used in overseas countries were very different from the conditions in the United Kingdom and that, consequently, an assessment of safety and efficacy appropriate to United Kingdom conditions was not necessarily valid in relation to the country to which the product was to be exported.

In particular, it might be entirely acceptable for a product to be marketed overseas where its properties and hazards were acceptable to the practioners and to the authorities in the countries concerned, but where the Clause 4 committee or the Medicines Commission itself would not recommend a licence for marketing in the United Kingdom.

In general, we agree with this, but we are very conscious that discussions are now proceeding in the Assembly of the World Health Organisation with the objective of ensuring that the quality of exported pharmaceuticals is at least as high as is required for products to be marketed in the country of origin. This is a matter of importance to underdeveloped countries and others who have not the resources to test on a wide scale for quality when the goods have arrived in their country. We have felt, and we understand that the industry accepts, that if the United Kingdom is a party to an international agreement such as I have described to which other important pharmaceutical manufacturing countries are also party, the licensing authority in this country must be in a position to ensure that the obligations are fulfilled. This would be done by a reactivation of the licensing requirement.

We undertook in Standing Committee to move Amendments postponing the licensing obligation, together with machinery for reactivating it later. Under pressure from the hon. Member for Farnham (Mr. Maurice Macmillan) and his colleagues I outlined, on 4th April in the Standing Committee, two alternative methods of securing this objective. I indicated which of them I thought I would prefer, and the Clause under discussion now follows the lines of that method. The substance of the Clause has been discussed with representatives of the pharmaceutical industry and others, and I hope that now they have been able to examine the text of the actual Amendment they will feel that it fulfils the purposes that were outlined in the Standing Committee and on which I think there was a very large measure of agreement.

I will very briefly refer to the contents of the Clause, which is inevitably long and somewhat complicated. Subsection (1) postpones the provision in Part II of the Bill requiring a product licence to be held for export products, by omitting, pending reactivation by an Order subject to affirmative Resolution, every explicit reference in Clauses 7 to 41 inclusive to exports and exportation, and provides that all references in these Clauses to sale or supply are to be treated as not including sale or supply involving or for the purpose of exportation. The omissions that I have just described cover also Clause 31 relating to clinical and field trials.

Subsection (2) provides that a reactivation Order is to be made only for giving effect to an international agreement to which the United Kingdom is a party. The rest of the Clause deals with the inevitable transitional matters that would arise when the Order is made reactivating the licensing obligation. They are roughly parallel with the transitional provisions that are included in Part II of the Bill for introducing licensing of medicinal products for marketing at home. The Amendments to Clauses 7 and 8, Nos. 8, 9 and 10, are all consequential to this new Clause.

I would like to bring the attention of the House to important related matters. The first concerns certificates under Clause 31 of the Bill in relation to exportation for the purpose of clinical or field trials. The new Clause postpones the operation of Clause 31 in relation to exportation for clinical and field trials in just the same way as for licences for marketing by exportation.

During our discussions in Standing Committee the hon. Member for Surbiton asked, in c. 395, that we should be cautious about imposing controls on the exportation of material for clinical or field trials overseas because such a restriction had led to complications in the United States, and it was by no means clear that the Clause 4 committees or the Medicines Commission in the United Kingdom were in a good position to pass judgment on proposals to conduct trials, for example, in tropical countries where conditions might be very different, or that controls of this kind of clinical trials in other countries were of real value.

We have thought a great deal about this view, and we have come to the conclusion that it has force. When considering a marketing submission, the Safety of Drugs Committee had always been willing to consider on its merits data relating to clinical trials conducted in other countries, and I have no doubt that the licensing authority and the expert committee will do the same when licensing comes into operation. But there is not the same reason to screen proposals to conduct the clinical and field trials themselves when they take place overseas. Accordingly, provided that it is clear that such exportation would be for genuine clinical or field trials, I think that we need not provide for a certificate for this purpose or for reactivating the licensing provisions for this purpose.

I have not yet put down an Amendment because it would affect the wording of Clause 31 and I have not yet been able to complete the review of Clause 31 which I undertook to do for quite other purposes in the Standing Committee. We have made considerable progress, however, but it seems likely that there will have to be some radical redrafting, and I propose to arrange for the necessary Amendments to be moved in another place. They will incorporate the relaxation to which I have referred in relation to export for clinical and field trial. I hope, therefore, that hon. Members opposite will bear this in mind when we come to a number of Amendments which they have put down on Clause 31, I think in most cases to remind me of my promise to review that Clause.

The second matter to which I want to refer relates to the licensing for exportation of a limited range of products the manufacture for sale of which is at present subject to licensing under Part I of the Therapeutic Substances Act, 1956, and Part II of the Diseases of Animals Act, 1950. They are all substances the purity and potency of which cannot be adequately tested by chemical means, and include all vaccines, antitoxins and sera, whether for human or animal use, and a number of other substances covered by the Schedules to those Acts. Both Acts provide that the manufacture for sale shall not take place except in accordance with a licence issued in the first case by the Health Ministers and in the second by the Agriculture Ministers. This restriction applies now equally to manufacture for sale in the United Kingdom and for sale by exportation.

Some of these vaccines require the most stringent controls—for example, polio vaccine and foot-and-mouth vaccine—and all these substances involve safeguards in manufacture which can only be applied at the place of manufacture. The country receiving them may be quite unable to apply all the tests necessary to the finished product to assure itself about the products. Therefore, we think that these produots must remain subject to licensing when the Bill comes into operation.

Accordingly, it will be necessary to arrange for an Amendment to be moved in another place to exclude them from the postponement provisions of the new Clause. The point has been brought to the notice of representatives of the industry, and my understanding is that the need for an exception for these classes of products is fully recognised.

Mr. James Scott-Hopkins (Derbyshire, West)

On the agricultural side, I assume that the right hon. Gentleman is referring to live and not dead vaccines in this context.

Mr. Robinson

I will check that, but I think that that is the case. These are the vaccines scheduled in the Diseases of Animals Act in the case of agricultural substances. It is my understanding that the need for an exception for these classes of products is recognised by the industry. As I have already said, licensing applies now, so that there is no question of introducing a new impediment to the export of British Pharmaceuticals.

If the House agrees to the new Clause, I also intend to consider between now and the appropriate stage in another place, the consequences of the new Clause in relation to Clause 36, which deals with medicated animal feeding-stuffs. Here again, I have not put down an Amendment because we are reviewing a number of points in connection with Clause 36, and it would be more appropriate to deal with the consequences of this new Clause when that review is completed. I will undertake to arrange for any necessary Amendments to be moved in another place.

This has been a long explanation, but it is probably the most important point discussed between the two sides in Committee, and I thought that the House would like a detailed explanation of what inevitably is a long and complicated Clause.

Mr. Speaker

As I mentioned earlier, we are taking with this group of Amendments new Clause 4. It has occurred to me that I would be prepared to allow a Division on new Clause 4 if it were asked for.

7.15 p.m.

Mr. Maurice Macmillan (Farnham)

In view of how far the Minister has gone, it would be churlish of me to wish that he had put his new Clause on the Amendment Paper earlier. As he suggested, it accounts for the appearance on the Paper of a number of Amendments, one or two of which are marked to be called, which the new Clause and his explanation now make unnecessary.

Before he began his explanation, the only point that I had in mind was to ask him to clarify the position as regards clinical and field trials. I am, therefore, grateful for his assurance that this point also will be met in subsequent Amendments in another place.

We on this side of the House accept the limitations imposed by the Therapeutic Substances Act and the Diseases of Animals Act and, since no new licensing provision is required, we would not quarrel with what the right hon. Gentleman has said.

It only remains for me to thank him for meeting so fully the points which he raised in Committee and to welcome the new Clause and the consequential Amendments.

Mr. Scott-Hopkins

There is only one point which I wish to raise, and it concerns the animal feeding stuffs Clause and the Amendment which the Minister says that he will bring forward. I assume that he is talking in the context of the export of animal feeding stuffs—or is he talking about the revision of the whole of that Clause? Will the Amendment that he is to bring forward later be concerned purely with the export of animal feeding stuffs, or will it cover the whole subject of animal feeding stuffs?

Mr. K. Robinson

No. We are considering a number of Amendments on other points, besides the export points.

Question put and agreed to.

Clause read a Second time and added to the Bill.

Mr. Speaker

We come now to new Clause 2, with which I propose that we take Government Amendments Nos. 16, 17, 63, 64, 65 and 105.

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