MEDICINES BILL (Hansard, 30 July 1968)

HL Deb 30 July 1968 vol 296 cc263-300 263

§ 7.56 p.m.

§ LORD KENNET
My Lords, I beg to move that this Report be now received.

§ Moved, That the Report be now received.—(Lord Kennet.)

§ LORD KENNET
My Lords, I beg to move that consideration of Amendments Nos. 38 to 54 inclusive and Amendment No. 79 be postponed until to-morrow. I am moving this Motion to meet representations made by members of the Opposition Front Bench, and this proposal has been put to them through the usual channels. I realise it is unusual to postpone Amendments on Report stage, and I say, on behalf of my noble friend the Leader of the House, that this should not be regarded as a precedent, except where it has been ascertained, through the usual channels, that such a couse is likely to meet with the approval of the House. I should have thought it undesirable for any Government to move a Motion of this sort unless there was general agreement that it was for the convenience of the House as a whole, as I am sure it will be on this occasion.

§ Moved, That consideration of Amendments Nos. 38 to 54 inclusive and Amendment No. 79 be postponed until to-morrow.—(Lord Kennet.)

§ LORD SANDFORD
My Lords, I would confirm that, in the circumstances, this is a convenient arrangement. It is, 264 indeed, unusual to postpone Amendments on the Report stage, but it is also unusual, and I think unacceptable if the House is to fulfil its functions and work smoothly, for the Government to table Amendments which may be of substance without notice the night before they are to be dealt with on the Floor of the House, and on an occasion when the Bill is to go through all its remaining stages in one move. But having said that, from these Benches I certainly accept the Motion.

§ LORD SHACKLETON
My Lords, I must reply to the noble Lord. I think he must know—he has, I am sure, been long enough in this House—that frequently in the interval between the two stages of a Bill Amendments are put down. Sometimes this is done quite late, especially when they are put down, not particularly to please the Government, but to meet particular wishes. The Government agreed on this occasion that it was wrong to take these Amendments to-day, and we therefore responded. I hope that the arrangement that has now been proposed will be for the general convenience of the House, but I must make clear that it ought not to be assumed that in the process of putting down Amendments—and this is as much in the interests of the other side of the House, if ever they come into Government—one can always hope to give on every Amendment more than two or three days' notice.

§ Clause 5 [Supplementary provisions as to Commission and committees]:

§ LORD KENNET moved Amendment No. 1:

§ Page 5, line 9, leave out from ("function") to end of line 11 and insert ("for purposes connected with medicinal products or related matters, or. (c) terminate any function conferred on the Commission by or under this Act, or (d) vary any such function, so however as not to confer on the Commission any new function which could not be conferred on them in accordance with paragraph (b) of this subsection").

§ The noble Lord said: My Lords, on Committee stage the noble Lord, Lord Auckland, raised the question of the possible extra powers which might be given to the Medicines Commission, and at that stage I undertook, if he withdrew the Amendment he had down, to 265 see whether there were any objections to writing words into the Bill to make it perfectly clear that any additional functions given to the Commission must be related to the subject matter of the Bill and must not go outside it. The Amendment now before the House is in fulfilment of that pledge. My Lords, I beg to move.

§ LORD AUCKLAND
My Lords, I am grateful to the noble Lord, Lord Kennet, for having moved this Amendment, which is a great help to the Commission as a whole and which I am quite certain will quantify very effectively the work which we all hope they will successfully carry out.

§ Clause 7 [General provisions as to dealing with medicinal products]:

§ 8.2 p.m.

§ LORD KENNET moved Amendment No. 2:

§ Page 6, line 22, at end insert: ("() For the purposes of subsection (5) of this section a person shall be taken to be responsible for the composition of a medicinal product if (but only if) in the course of a business carried on by him—

(a) he procures the manufacture of the product to his order by another person, where the order specifies, or incorporates by reference to some other document, particulars of the composition of the product ordered, whether those particulars amount to a complete specification or not, or
(b) he manufactures the product otherwise than in pursuance of an order which fulfils the conditions specified in the preceding paragraph.")

§ The noble Lord said: My Lords, this Amendment clarifies the definition of responsibility for composition on which the requirement to hold a product licence depends by making it clear that this responsibility does not transfer to a manufacturer producing a product to the order of another simply because that other person's specification was incomplete. This point is of particular importance in the making up of a special order where a practitioner may have some latitude in formulation to the manufacturer. There is a consequential Amendment to Clause 128 which I shall move formally when we come to it. My Lords, I beg to move.

266

§ Clause 10 [Exemptions for pharmacists]:

§ LORD KENNET
My Lords, this Amendment fills a small gap in the licensing exemptions for pharmacists. I beg to move.

§ Amendment moved— Page 9, line 9, at end insert ("and those restrictions do not apply to anything which is done in a hospital or a health centre by or under the supervision of a pharmacist and consists of preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) of this section.").—(Lord Kennet.)

§ LORD SANDFORD
My Lords, this is a perfectly acceptable Amendment. It occurs to me as I read it, however, just to query whether the term "health centre" ought not to be included in Clause 127(3). That is a point I make in passing which the noble Lord might like to consider as we proceed.

§ Clause 13 [Exemptions for imports]:

§ LORD KENNET moved Amendment No. 4: Page 10, line 17, leave out ("his own personal use") and insert ("administration to himself or to any person or persons who are members of his household").

§ The noble Lord said: My Lords, this Amendment is designed to remove doubts which were raised in another place about the effect of the expression "for h s own personal use"; and to make it clear that the exemption from the need to hold a product licence for the purpose of importing a medicinal product does not cover importation by a farmer of a product intended for his own animals, or by a veterinarian for use in his professional practice. My Lords, I beg to move.

§ LORD SANDFORD
My Lords, we welcome the extension that this Amendment confers, but I am wondering whether the wording is still quite right. Under this new clause some particular tablet, say, could be administered to a person himself and could be available to, say, another member of his household—perhaps his cook—but only if it were administered by the head of the household. Is this exactly what is intended—the cook could have it but only if administered by the person who brought it in?

267

§ LORD KENNET
My Lords, this is a fine point of interpretation. If the noble Lord has a better wording, I think he should have put down an Amendment to my Amendment.

§ Clause 16 [Transitional exemptions]:

§ LORD KENNET moved Amendment No. 5: Page 11, line 21, after ("if") insert ("in the course of a business carried on by him, any medicinal products of that description were sold or supplied, or procured to he sold, supplied, manufactured or assembled, at any time before the first appointed day and").

§ The noble Lord said: My Lords, at Committee stage I undertook that if the noble Marquess, Lord Lothian, withdrew his Amendment on this point I would put down at Report a form of words which I hoped would meet his point about limiting the transitional exemption in Clause 16(2) to a product which the promoter himself had effectively on the market at the first appointed day and which is not a product which another manufacturer had on the market. My Lords, I beg to move.

§ LORD SANDFORD
My Lords, my noble friend Lord Lothian has asked me to express his thanks to the noble Lord for this Amendment, which does indeed meet his point.

§ Clause 21 [Procedure on reference to appropriate committee or Commission]:

§ LORD KENNET moved Amendments Nos. 6 to 15:

§ Page 16, line 8, leave out from ("report") to ("and") in line 9 and insert ("to the licensing authority their findings and advice and the reasons for their advice")

§ Page 16, line 18, at end insert ("and the reasons stated by the appropriate committee or the Commission for giving that advice")

§ Page 16, line 36, leave out from ("report") to ("and") in line 37 and insert ("to the licensing authority their findings and advice and the reasons for their advice")

§ Page 16, line 41, leave out ("conclusions") and insert ("advice")

§ Page 16, line 46, leave out ("conclusions") and insert ("advice")

§ Page 17, line 3, leave out ("conclusions as are") and insert ("advice as is")

§ Page 17, line 21, leave out ("conclusions") and insert ("advice")

268

§ Page 17, line 22, after ("committee") insert ("and the reasons stated by the Commission or the committee for giving that advice")

§ Page 17, line 25, at end insert ("and the reasons stated by the committee or the Commission for giving that advice")

§ Page 17, line 30, at end insert— ("(6A) Where under subsection (5) of this section the applicant avails himself of the opportunity of appearing before, and being heard by, a person appointed for the purpose by the licensing authority—

(a) the person so appointed shall not, except with the consent of the applicant, be an officer or servant of any of the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act;
(b) if the applicant so requests, the hearing shall be in public; and
(c) if the applicant so requests, the licensing authority shall furnish to him a copy of the report of the person so appointed.")

§ The noble Lord said: My Lords, Amendments Nos. 6 to 17 all hang together, and I will, with the leave of the House, move Amendments Nos. 6 to 15 en bloc; and I would ask the House to consider now Amendments 16 and 17 and Amendments to Clause 22, Clause 27 and to Schedule 2, which I shall move formally when we come to them. On our Second Reading the noble Lord, Lord Shawcross, suggested ways of improving the procedure under Clause 21 relating to the grant and refusal, and so on, of licences. He criticised in particular the fact that the procedure took place and decisions might be made behind closed doors and that reasons might not be given. I am sure he was not suggesting that what we had provided in the Bill was an arbitrary procedure. In fact, as I said on Second Reading, we had given careful consideration to all this and had incorporated suggestions made by the Council on Tribunals. But the Government have no wish to keep a possible aggrieved applicant or licence holder in ignorance of matters that affect his fate, so we have again reviewed the procedure for representations and have concluded that there are some respects in which the Bill can be improved.

§ These Amendments accordingly propose the following changes, which I will explain as succinctly as I can to the House. First, the appropriate committee or the Commission will now give advice, or findings and advice, throughout, instead of advice at one stage and findings and conclusions at other stages. Together 269 with the advice, or findings and advice, they will give the reasons, and the licensing authority must notify these to the applicant or licence holder at all stages where he has the opportunity to request a hearing or to make representations. Secondly, the person appointed by the licensing authority—that is, the Minister—to hold a hearing is not to be an employee of the Health or Agriculture Departments unless the applicant agrees. The hearing by that person is to be in public if the applicant so requests, and a copy of that person's report is to be furnished to the applicant if he requests it. Corresponding changes are made in other places in the Bill where the same points are relevant.

§ My right honourable friend the Minister does not think that hearings should automatically be in public, or that the report of the person appointed should be published in the Press, because they may well be concerned with matters which the applicant or licence holder regards as confidential. For instance, it is obvious that he might not want his competitors to know of his plans to market a new product. The important point is that the aggrieved party himself should always be fully informed of the relevant matters. My Lords, I beg to move.

THE DEPUTY SPEAKER
My Lords, if it is for your Lordships' convenience I will put the Amendments to Clause 21 en bloc. Otherwise, I will put them singly.

§ LORD SANDFORD
My Lords, these Amendments are indeed to be welcomed, particularly Amendment No. 15. If I may follow the noble Lord, Lord Kennet, into Clauses 22 and 27, Amendments Nos. 16 and 17 are also in our view of considerable importance to this Bill.

§ Clause 22 [Procedure in other cases]:

§ LORD KENNET
My Lords, I beg to move Amendment No. 16.

§ Amendment moved—

§ Page 18, line 5, at end insert— ("() Subsection (6A) of section 21 of this Act shall have effect in relation to a person appointed under subsection (3) of this section as it has effect in relation to a person appointed under subsection (5) of that section.").—(Lord Kennet.)

270

§ Clause 27 [Proceedings on application for licence of right]:

§ LORD KENNET
My Lords, I beg to move amendment No. 17.

§ Amendment moved—

§ Page 24, line 19, at end insert— ("() Subsection (6A) of section 21 of this Act shall have effect in relation to a person appointed under subsection (3) of this section as it has effect in relation to a person appointed under subsection (5) of that section.").—(Lord Kennet.)

§ Clause 31 [Clinical trials]:

§ 8.12 p.m.

§ BARONESS SEROTA moved Amendments Nos. 18, 19 and 20:

§ Page 27, line 2, at beginning insert— ("() In this Act 'clinical trial" means an investigation or series of investigations consisting of the administration or one or more medicinal products of a particular description—

(a) by, or under the direction of, a doctor or dentist to one or more patients of his, or
(b) by, or under the direction of, two or more doctors or dentists, each product being administered by, or under the direction of, one or other of those doctors or dentists to one or more patients of his,

where (in any such case) there is evidence that medicinal products of that description have effects which may be beneficial to the patient or patients in question and the administration of the product or products is for the purpose of ascertaining whether, or to what extent, the product has, or the products have, those or any other effects, whether beneficial or harmful")

§ Page 27, line 37, leave out subsection (4) and insert— ("() Subject to the next following subsection, the restrictions imposed by the preceding provisions of this section do not apply to a doctor or dentist in respect of his selling or supplying, or procuring the sale or supply of, a medicinal product, or procuring the manufacture or assembly of a medicinal product specially prepared to his order, or specially importing a medicinal product, where in any such case) he is, or acts at the request of, the doctor or dentist by whom, or under whose direction, the product is to be administered. () The exemptions conferred by the last preceding subsection do not apply in a cast where the clinical trial in question is to be carried out under arrangements made by, or at the request of, a third party (that is to say, a person who is not the doctor or dentist, or one of the doctors or dentists, by whom, or under whose direction, one or more medicinal products are to be administered in that trial)")

§ Page 29, line 3, leave out from ("dentist") to end of line 12 and insert ("(or, if there is to be more than one, any of the doctors or dentists) by whom, or under whose direction, 271 any medicinal product is to be administered, or the patient or patients to whom any medicinal product is to be administered")

§ The noble Baroness said: My Lords, Amendments 18, 19 and 20 have been put down following further consideration of the new clause which the House added to the Bill when in Committee. It is felt that the exemption for practitioners in subsection (4) could give rise to misunderstanding. That is because the reference to the doctor or dentist "under whose direction a trial is carried out" might be taken to refer to a professionally qualified employee of the manufacturer and not, as was intended, only to the doctor or dentist conducting a trial with his own patients. To clarify this point, the definition of "clinical trial" has been recast and a distinction has been made between trials arranged by or conducted at the request of a promoter, and those undertaken by doctors or dentists on their own initiative and exemptions for practitioners are limited to trials in the latter category. Amendment No. 18 also makes it clear that the expression "clinical trial" includes a series of investigations carried out by a number of practitioners. I hope these Amendments will commend themselves to the House. I beg to move.

§ LORD SANDFORD
My Lords, I am afraid the welcome for these Amendments now has to be tempered with a mild protest—not as vigorous a protest as we have made about the other Amendments. This clause and the succeeding Clauses 32, 33, 34 and 35 appeared, all forming one clause occupying one and a quarter pages, when the Bill was introduced into this House on July 4, and they now form five clauses and occupy eight pages. These are all Government Amendments, and the Government are still finding it necessary, at this late stage, to amend these clauses. It does not give us a chance to consult all the interests who are concerned, and I know quite a number of them are not entirely happy with these Amendments. However, I am not prepared to take the protest any further than that.

THE DEPUTY SPEAKER
My Lords, if it will meet the wishes of your Lordships I will put these three Amendments en bloc.

272

§ Clause 35 [Supplementary provisions as to clinical trials and medicinal tests on animals]:

§ BARONESS SEROTA moved Amendments Nos. 21, 22 and 23: Page 34, line 1, leave out from beginning to ("apply") in line 2 and insert ("Neither the restrictions imposed by section 7 of this Act nor those imposed by section 31(1) of this Act") Page 34, line 4, leave out from ("and") to ("apply") in line 5 and insert ("neither the restrictions imposed by section 7 of this Act nor those imposed by section 320) of this Act") Page 34, line 7, leave out ("test") and insert ("medicinal tests on animals")

§ The noble Baroness said: My Lords, here again the House may wish to take Amendments Nos. 21, 22 and 23 together. I hope the noble Lord, Lord Sandford, will not protest again, because we feel that there is a need here to fill a gap that has been noticed in the Bill. It is the view of the Government that in legislation of this kind we must exercise the utmost care and, even in the later stages, we must make quite certain that legislation of this kind, which has such importance for every human being in the country, is as good as we can possibly make it. I therefore make no apology whatsoever to the House for the fact that the Government have put down further Amendments when they have seen the need. I beg to move.

§ Clause 49 [Special provisions in respect of exporting certain products]:

§ BARONESS SEROTA moved Amendment No. 24:

§ Page 53, line 4, at end insert— ("() In relation to any application for a licence of right which is made by virtue of section 25 of this Act as applied by subsection (5) of this section, the provisions of section 27 of this Act shall have effect subject to such modifications as may be specified by order made by the Ministers for the purposes of this subsection.")

§ The noble Baroness said: My Lords, this is a consequential "machinery" Amendment, if I may put it in that way, to Clause 49, which was inserted into the Bill at Committee stage. I beg to move.

§ LORD SANDFORD
My Lords, it is quite true that nothing very much is raised by this Amendment, but we have 273 not heard at any stage just exactly which products it is intended to cover by Clauses 48 and 49, or why it is necessary to have this provision. I wonder whether the noble Baroness can give us a short explanation of this before we pass it?

§ BARONESS SEROTA
My Lords, I will do my best to satisfy the noble Lord on this point. The new subsection which this Amendment adds to Clause 49 enables the Minister by Order to modify, in relation to the products with which Clause 49 is concerned—namely, those of the kind now subject to the Therapeutic Substances Act 1956 and the Diseases of Animals Act 1950—the procedure in Clause 27 normally applying to applications for licences of right. Account would have to be taken, for example, of the fact that normally a product covered by this clause qualifying for a licence of right would previously have been subject to licensing under the Therapeutic Substances Act or the Diseases of Animals Act. I hope that explanation helps the noble Lord, Lord Sandford.

§ Clause 65 [Compliance with standards specified in monographs in certain publications]:

§ LORD KENNET
My Lords, with the leave of the House I will move Amendments Nos. 25 to 29 inclusive, since they hang together. These five Amendments are concerned with the interpretation of monographs in official compendia. The first makes it clear that all relevant provisions of an edition of a compendium apply to the interpretation of a monograph in it. The other four Amendments enable the Medicines Commission to approve synonyms which are, for the purposes of Clause 65 of the Bill, to have the same validity as the name at the head of a monograph in the European Pharmacopoeia. Briefly, this is to ensure that recognised synonyms for the name of a substance are shown at the head of a monograph, for example aspirin and acetylsalicylic acid. I beg to move.

§ Amendments moved— Page 65, line 10, leave out from ("any") to ("and") in line 11 and insert ("general monograph or notice or any appendix, note 274 or other explanatory material which is contained in that edition and is applicable to that monograph"). Page 65, line 19, after first ("section") insert ("subsections (1) and (2) of this section shall have effect as if, after the words 'that name is' in each place where those words occur, there were inserted the words 'or is an approved synonym for'"). Page 65, line 21, after ("Pharmacopoeia") insert ("and after the words 'headed by that name', in each place where those words occur, there were inserted the words 'or by a name for which it is an approved synonym'"). Page 65, line 25, after ("name") insert ("or by a name for which it is an approved synonym"). Page 65, line 47, at end insert ("and a name shall be taken to be an approved synonym for a name at the head of a monograph in the European Pharmacopoeia if, by a notice so published and not withdrawn by any subsequent notice so published, it has been declared to be approved by the Medicines Commission as a synonym for that name").—(Lord Kennet.)

§ Clause 66 [Further powers to regulate dealings with medicinal products]:

§ LORD KENNET moved Amendment No. 30:

§ Page 66, line 7, at end insert— ("(aa) the amount of space to be provided in any premises for persons preparing or dispensing medicinal products, the separation of any such space from the remainder of the premises, and the facilities to be provided in any premises for such persons; (ab) the amount of space to be provided in any premises for the sale or supply of medicinal products; (ac) the accommodation (including the amount of space) to be provided in any premises for members of the public to whom medicinal products are sold or supplied or for whom medicinal products are being prepared or assembled; (ad) the amount of space to be provided in any premises for the storage of medicinal products.")

§ The noble Lord said: My Lords, the noble Lord, Lord Coleraine, ha s been courteous enough to let me know that he is in doubt about this Amendment. Therefore I will explain it at moderate length to see whether my explanations meet with the approval of the House.

§ This is really a drafting Amendment, that is to say, the effect which it was intended to achieve by the clause as drafted did not appear, after a second look, to be quite certain of being 275 achieved, and I am advised that the way to make it certain is to introduce this rather formidable looking Amendment. The point is that any requirements that it is desired to make as to construction, layout, equipment and the other matters referred to in Clause 66(2) can be prescribed only in so far as they can be related to one or more of the purposes in subsection (1); for instance, cleanliness, sanitation and so on, which are to be found in paragraph (g) of that subsection.

§ The point is that the second subsection is not tightly enough pegged to the first subsection to be quite certain that it will achieve its effect. So it seemed that, since all the purposes listed in subsection (1) did not cover all the points it would be important to cover in regulations relating to the suitability of pharmacy and storage premises, it would be a good thing to rectify that and ensure that they did. The purpose of this Amendment, then, is to include these purposes. I beg to move and I shall be happy to go further if what I have said so far is not enough or not clear enough.

§ 8.20 p.m.

§ LORD SANDFORD
My Lords, I am sure that my noble friend Lord Coleraine will want to probe further into this Amendment and into that explanation of it. But, speaking as a layman with no particular interest in this field, I must say that I am rather at a loss to see how this Amendment is going to work out in practice. It seems to involve a tremendous intrusion into the detailed operations of the retail outlets that are concerned here. How any outside body which is not involved in all the commercial operations concerned in the running of a retail outlet can say what space should be provided for this, that or the other thing, I am rather at a loss to see. I shall be interested to hear what further explanation the noble Lord, Lord Kennet, can give in respect of this Amendment. At the moment, I feel that we are left in a good deal of doubt and uncertainty.

§ LORD KENNET
My Lords, we should remember that we are talking here only about a regulation-making power, and that Section 126(6) lays on the Minister a statutory duty to consult with relevant organisations on making the regulations 276 which this clause entitles him to make. I should like to assure the House that he will indeed be doing that, as he is bound to in this case, and that if the retailers and distributors have any worries about what might be in the regulations they will have a full opportunity of putting them to him at that stage.
There is one possible worry which I would touch on now, and that is the question of the possible physical separation of the pharmacy part from the places where other goods—such as stationery or leather goods, books and so on—might be sold. It is quite clear from the drafting of the Amendment that none of the heads would enable regulations to be made to secure that, and it could not be done under the clause as amended.

§ LORD COLERAINE
Would the noble Lord repeat what could not be done?

§ LORD KENNET
My Lords, regulations could not be made which would have the effect of physically separating the part where drugs were sold in a mixed store from the part where other things, such as leather goods and books, were sold.

§ LORD COLERAINE
My Lords, I am most grateful for the explanation which the noble Lord has given of this Amendment, and for the way in which he has sought to meet the misgivings which I put to him about it. I am not completely happy about his explanation, though it goes a considerable way to meet my point of view. The noble Lord knows, I think, that I have an especial interest in the Medicines Bill, and in this clause in particular, inasmuch as I am a director of a multiple chemist company; and when I saw this Amendment I viewed it with a good deal of concern.
Of course, I freely admit, as anyone must admit, that the Minister has a right, and indeed a duty, to see that pharmacies are adequate in space and in every other respect. But it seems to me that under this Amendment the Minister is taking powers far wider than he needs. The noble Lord says that the Minister has not sufficient powers under subsection (2) as drafted. I should have thought he had; but I must defer to the noble Lord's judgment. But I still think the powers he is now taking under this clause are a little too great. For example, the 277 Minister has the power not only to ensure that the premises on which medicines are prepared, dispensed and sold, are adequate, but also, as I understand the Amendment, to lay down quite arbitrary percentages of the space which in any store might be devoted to pharmacy. To take an extreme example, a Minister might say of a big Boot's store that one floor, or half-a-floor or a quarter of a floor—a purely arbitrary figure—must be given over to the pharmacy. And I do not think it is a sufficient answer to say that the Minister would never propose anything so absurd as that. I think the Minister should not, if it can be avoided, take powers which might be exercised in an absurd way, and I should have thought it would have been possible for him to withdraw this Amendment and put forward a more modest one in its place.
There is a particular point which the noble Lord, Lord Kennet, raised about the question of "the separation of any such space from the remainder of the premises", and I was very grateful to him for his assurance that this could not mean, in fact, that a pharmacy could be cut off from the rest of a retail store. I think that assurance meets one of the most serious misgivings I had about the Amendment, because it seemed on the face of it that this particular proposal about physical separation might be a rather roundabout way of circumventing the judgment not only of this House but of the two lower courts in the case of Dickson v. The Pharmaceutical Society, with which the Minister is of course entirely familiar. I am most grateful to him for the assurance that in fact these regulations not only would not be used but could not be used to divide a big retail store, so that the pharmacy was on one side and the rest of the store on the other. I am most grateful to him for this assurance, but I would ask him whether he would agree to look at this Amendment again and see whether he could not put in some limiting clause which would give to the Minister the power which he needs without giving him those powers which are unnecessary.

§ LORD DRUMALBYN
My Lords, may I ask the noble Lord one question? I understood him to say that this Amendment and this clause related 278 only to pharmacies. The rubric of the clause, however, is "Dealings with medicinal products", and I am concerned to know whether these rather detailed provisions also relate to the sale of "general list" products under Clauses 51 and 53. It would seem that these provisions are exceedingly detailed in relation to the sale of "general list" products in premises other than pharmacies, and I wonder whether the nobly Lord could give us a little more information about this.
The point is, of course, that it will be very difficult to lay down regulations which could apply equally to pharmacies and to the sale of medicinal products in premises other than pharmacies. They would be of two quite different kinds, yet there is no provision that I can see in the clause which says that different provision may be made for different circumstances, or words to that elect. I may be wrong about this, but on the face of the clause it seems that it covers "general list" products as well. I do not know whether the noble Lord is awaiting further information on this, or whether he is able to give an answer to it now.

§ LORD KENNET
My Lords, I speak again, only with the leave of the House—I am afraid this is the third time I have spoken on this Amendment: it is getting a little out of hand. I will try to avoid speaking so often again in future if noble Lords will co-operate with me by not asking so many questions. The noble Lord, Lord Coleraine, raised a particular point about carving up the floor space in stores into one-third pharmacy and two-thirds the rest, and said that that would be an absurd thing to do. I agree with him: it would be an absurd thing to do. And why on earth should any Minister do it?
This leads me to a general point which it might not be disadvantageous to make. I appreciate that the distributors of drugs, be they pharmacists or general stores, are coming up against the normal facts of statutory control, to a large extent for the first time. Something of the same sort applies to the pharmaceutical industry. So it may not be as familiar to them as it is to other sectors of the economy in the populus that although Ministers often take powers which could be exercised in the most absurd and tyrannical way, in 279 fact of course, they never are, and that it is quite possible to live with this. For instance, it occurs to me, as an experience of my own, that the Ministry of Housing and Local Government is entitled, I believe, to dissolve the Greater London Council and put it into commission under his own direct rule. The fact that he has this power does not, I think greatly inhibit the Greater London Council, or indeed any other local authority from carrying on its day-to-day affairs. There is an analogy here. One can quite safely give a sane Minister—and most of them are sane—under regular day-to-day Parliamentary control, power that one profoundly hopes he will never use. This is one such power.
As to the question about covering only pharmacies the answer is, No: the powers do, of course, apply to stores which sell "general list" products as well as to pharmacies. They are designed to enable regulations to be made to ensure that that part of the store in which drugs are sold is worthy of the special product which is being sold there. I would, if I may, just repeat what I said: that there is plenty of room and time to thrash this out in detail with the interests concerned when the regulations in question are being drawn up.

§ LORD DRUMALBYN
My Lords, may I, with the leave of the House, ask the noble Lord whether it is possible to make different provisions for different circumstances—because this is generally said in an Act of Parliament where this is required, and it is not said in this one.

§ LORD KENNET
My Lords, it is possible. I am sorry; I should have mentioned that it is possible, and the provision to enable this to take place is to be found at Clause 126(5).

§ LORD DRUMALBYN
My Lords, I am much obliged.

§ Clause 69 [General provisions]:

§ LORD KENNET moved Amendment No. 31: Page 68, line 37, after ("each") insert (",or in Scotland, one or more,")

§ The noble Lord said: My Lords, in Scotland there are partnerships between 280 a pharmacist and somebody else who is not a pharmacist who carry on a business without being a firm. The purpose of this Amendment is to allow these persons who are not corporate persons but are yet in a business partnership to become persons lawfully conducting a resale pharmacy business within the terms of the Bill. This Amendment is necessary for Scotland because in England there are no such partnerships. If one of the partners is not a pharmacist in England, the partnership is always a firm, already a legal person. I beg to move.

§ Clause 70 [Business carried on by individual pharmacist or by partners]:

§ LORD KENNET
My Lords, Amendment No. 32 is consequential upon the last Amendment. I beg to move.

§ Amendment moved—

§ Page 70, line 26, at end insert— ("In the application of this subsection to Scotland, for paragraph (a) there shall be substituted the following paragraph— (a) in paragraph (a) of that subsection, for the words "the person carrying on the business" there were substituted the words "one or more of the partners who are pharmacists ", and").—(Lord Kennet.)

§ Clause 73 [Power to extend or modify conditions]:

§ LORD KENNET moved Amendment No. 33: Page 72, line 40, leave out from ("order") to end of line 8 on page 73 and insert ("add to, revoke or vary any of the provisions of sections 70 to 72 of this Act, so as either—

(a) to modify, or provide new conditions in substitution for, the conditions referred to in any of the paragraphs of section 69(1) of this Act, or
(b) for the purposes of any of those paragraphs, to provide alternative conditions compliance with which is to have the like effect as compliance with the conditions referred to in that paragraph.

() Any provision made by an order in accordance with subsection (1) of this section may be made either generally or in relation to any particular circumstances specified in the order. () Any order made under this section may direct that subsection (1) or subsection (2) of section 69 of this Act shall have effect subject to such exceptions or modifications 281 as appear to the Health Ministers to be necessary or expedient in consequence of the provision made by the order in accordance with subsection (1) of this section. () Where an order under this section is for the time being in force, any reference to section 69 of this Act in any other enactment as amended by this Act shall be construed as a reference to that section as modified by the order.")

§ The noble Lord said: My Lords, this Amendment provides for greater flexibility by making it possible to amend the conditions for persons lawfully conducting a retail pharmacy business by substituting new conditions for those in Clauses 70, 71 or 72. As the clauses are at present drafted, alternative conditions can be introduced, but those specified in Clauses 70, 71 and 72 would have to remain in force subject only to power of amendment which is limited to modification and the prescribing of exceptions. The purpose of this Amendment is to allow the earlier ones to be entirely withdrawn when they give way to new ones. I beg to move.

§ Clause 90 [Provisions as to medicated animal feeding stuffs]:

§ LORD KENNET
My Lords, this is machinery. I beg to move Amendment No. 34.

§ Amendment moved— Page 86, line 37, leave out from ("section") to end of line 40 and insert ("no account shall be taken—

(a) of any mark which, in pursuance of the Fertilisers and Feeding Stuffs Act 1926, is made on a container or package, if the animal feeding stuff contained in it is of a kind specified in the first column of Part II of Schedule 1 to that Act, or
(b) of any statement which, in pursuance of that Act, is made in, a leaflet supplied, or intended to be supplied, with any animal feeding stuff of a kind so specified").(Lord Kennet.)

§ LORD SANDFORD
My Lords, I wonder whether the noble Lord could explain whether this Amendment is a result of consultations that the Ministry are already having in connection with the revision of the Fertilisers and Feeding Stuffs Act 1926, or whether it is an Amendment that arises out of some consideration of this Bill alone.

§ LORD KENNET
My Lords, I regret that at this particular moment of time I 282 am not able to say whether it is the result of consultations.

§ LORD SANDFORD
My Lords., perhaps I could enlarge a little on the reason why I asked that question. It appears that some earlier clauses in the Bill to deal with medicated feeding stuffs for animals have been introduced without consultation with some of the interests concerned. I know that a revision of the Fertilisers and Feeding Stuffs Act is in progress, and if the noble Lord was able to say that these changes are as a result of that consultation some of our anxieties would be set at rest.

§ LORD KENNET
No, my Lords; the Amendment arises out of considerations from this Bill alone.

§ Clause 102 [Supplementary provisions]:

§ LORD KENNET
My Lords this Amendment, No. 35, also is machinery. I beg to move.

§ Amendment moved— Page 99, line 35, after ("compendium") insert ("or a list of names").—(Lord Kennet.)

§ LORD KENNET moved Amendment No. 36: After Clause 102, insert the following new clause

§ Construction of references to specified publications

§ "—(1) In this section 'specified publication' means any of the following, that is to say—

(a) the European Pharmacopoeia;
(b) the British Pharmacopoeia;
(c) the British Pharmaceutical Codex;
(d) the British Veterinary Codex;
(e) the British National Formulary;
(f) the Dental Practitioners' Formulary;
(g) any compendium prepared under subsection (3) and published under subsection (6) of section 99 of this Act; and
(h) any list of names prepared and published under section 100 of this Act.

§ (2) Where any licence granted or certificate issued under Part II of this Act refers to a specified publication, but not to a particular edition of that publication, then, for the purpose of determining whether anything done, at a time when the licence or certificate is in force, is done in accordance with the licence or certificate, the reference shall, unless the 283 licence or certificate otherwise expressly provides, be construed as a reference to the current edition of that publication as in force at that time.

§ (3) Where under any enactment other than this Act (whether passed before or after the passing of this Act) there is power to make any regulations, rules, order, list or other instrument which is to have effect by virtue of, or for the purposes of, that enactment, and an instrument made in the exercise of that power—

(a) could be made so as to refer to the current edition of a specified publication as in force at the time when the instrument is made, but
(b) could not, apart from this subsection, be made so as to refer to the current edition of a specified publication as in force at a subsequent time,

the power to make the instrument may (unless, in the case of an enactment passed after this Act, the enactment otherwise expressly provides) be exercised so as to refer to the current edition of a specified publication as in force at such time (whether before, or after the time when the instrument is made) as may be specified in, or determined in accordance with, the instrument.

§ (4) Where any such power as is mentioned in subsection (3) of this section (in this subsection referred to as the primary power') includes power to vary instruments made in the exercise of the primary power, subsection (3) of this section shall have effect in relation to any exercise of the power to vary any such instrument (whether the instrument was made before, or is made after, the passing of this Act) as it has effect in relation to any exercise of the primary power.

§ (5) In this section any reference to the current edition of a specified publication as in force at a particular time is a reference to the edition of that publication in force at that time together with any amendments, additions and deletions made to it up to that time; and any reference to making an instrument in the exercise of a power conferred by an enactment shall be construed as including a reference to issuing or approving such an instrument."

§ The noble Lord said: My Lords, this new clause is to enable references in statutory instruments to the current editions of the British Pharmacopoeia and other publications specified in subsection (1) to be construed as references to the additions current at the time of the Act or matter in question unless the instruments expressly state otherwise. The Amendment is necessary in order to meet a point made in 1964 by the House of Commons Select Committee on Statutory Instruments, which said that such an interpretation would require to be specifically authorised by Statute: that is, they were against Ministers up-dating Orders to meet succeeding editions of publications 284 unless the Statute governing the Orders expressly gave them power to do so. This the Amendment does. A similar provision is also made by this Amendment for licences and certificates issued under the Bill. I beg to move.

§ Clause 104 [Application of Act to certain other substances which are not medicinal products]:

§ LORD SANDFORD moved Amendment No. 37: Page 100, line 33, at end insert ("but excluding those substances specified in the Pesticides Safety Precautions Scheme.")

§ The noble Lord said: My Lords, I beg leave to move the Amendment standing in the name of my noble friend Lord Nugent of Guildford. Clause 104 gives the Minister power by order to make regulations applying the Act to certain other substances which are not medicinal products. The effect of this Amendment would be to exclude from this application the substances coming within the scope of the Pesticides Safety Precautions Scheme. As the House will know, this is a voluntary scheme set up by Government Departments and the industry to ensure that all pesticides in commercial and domestic use are safe. The scheme is, I am advised, working satisfactorily, and the Government have announced their intention of introducing legislation in the near future to give statutory form to the present voluntary scheme. It would therefore seem to be unnecessary and possibly leading to confusion for the Minister to take power in this Bill to bring these substances within its scope.

§ I should add that the Association of British Manufacturers of Agricultural Chemicals are disquieted at the prospect of their products being brought within the scope of the Medicines Bill, which is primarily concerned with a different kind of substance. If the Minister made an order applying the provisions of this Bill under Clause 104 to some pesticides there would be an immediate implication that the existing voluntary scheme was inadequate for the whole range of pesticides that are not included in the order. At the same time there would be confusion as to which substances were covered by the order under the Medicines Bill and which were covered under 285 the voluntary scheme. In these circumstances the effective life of the voluntary scheme would soon come to an end. Obviously there would be little point in the agricultural chemical manufacturers going to the good deal of trouble they have to go to, and the expense, to support the operation of the scheme if the value of its recommendations and approval had been so severely shaken. I suggest that the right course is to leave out from this Medicines Bill the substances coming under the voluntary pesticides scheme, in the knowledge that the scheme is working satisfactorily and that in the near future it is going to be made statutory in new legislation which will cover the whole range of those substances and not just a few of them. This Amendment seeks to do just that. I beg to move.

§ LORD KENNET
My Lords, at first sight there is a great deal in what the noble Lord says about this matter. It would have the merit of simplicity and a clean break between one sort of substance and another, and between one Act controlling one sort and one Act controlling the other sort in the future. But there are certain reasons for having the partial control over this group of substances written into the Bill, which I shall lay before the House. The substances dealt with in the voluntary Pesticides Safety Precautions Scheme are described in it by a broad general definition, and this the Government agree is satisfactory for the voluntary scheme, but it would not be appropriate as a demarcation line for the purpose of this Bill, as it is too vague. As was explained in another place on an identical Amendment, on Report, if we were to use the relevant clause of the Bill—it is Clause 104(1)(b)—to apply any provisions of the Bill to pesticides, we should do so only for a very limited number of products. They would be the sort at present dealt with under the Veterinary Products Safety Precautions Scheme. But it would not be possible to do this if the noble Lord's Amendment were accepted, since the broad definition of "pesticides" in the Pesticides Scheme is wide enough to cover such products, and they would be excluded from the scope of Clause 104(1)(b).
In any case this proposed exclusion is not necessary. The Government readily 286 agree that this Bill is not the place to control the pesticides (including the herbicides, insecticides and so on) in general which are at present dealt with under the voluntary Pesticides Safety Precautions Scheme. It is intended that the Pesticides Scheme should continue as it is until such time as it might be replaced by a Statute specifically for pesticides.
Under the Medicines Bill certain products such as sheep dips and warble fly dressings which could be thought of as pesticides but which are at present considered under the Veterinary Products Safety Precautions Scheme will be covered by the definition of "medicinal product" in Clause 127. It really is a complicated net of provisions we have here. There are also some substances at present considered under the Veterinary Scheme which are not covered by the definition of "medicinal products" because they are not administered to the animals themselves. It might be desirable to bring these within the ambit of this Bill if the factors referred to in Clause 104(1)(b) applied to them. As "pesticides" they fall at the margin between the Veterinary and Pesticides Schemes. These substances world be those with which animals would almost certainly come into contact—for instance in a poultry house or a dairy. An example would be a product for destroying red mite in poultry where the application of the substance is not to the birds at all but to the walls of the poultry house.
In these circumstances the product licence, for instance, would be concerned only with the product sold and manufactured for the specific purpose concerned. As I have said, products of this sort are at present controlled under the voluntary Veterinary Products Safety Precautions Scheme and it is only products of these kinds which the Government might control under this clause. The Government would not seek to control the others, and might not even control these under the Medicines Bill. But it is convenient for these products to be considered by the committee of experts concerned with the Veterinary Products Safety Precautions Scheme, and it would be for similar reasons that it might also be found appropriate to deal with such products under Clause 104(1)(b) of this scheme.
287 Moreover, in an order made under this clause only those provisions of the Bill specified would apply to the substances concerned, and those provisions might be modified. How far the various provisions of the Bill might apply and to what extent they might need modification would have to be considered by the Minister making the order in relation to the particular substance or substances concerned on that occasion. Lastly, of course, there are important safeguards; before any order is made there would have to be consultation with interested organisations and there would be the added safeguard of Affirmative Resolution procedure in both Houses of Parliament under Clause 104(1)(b). I hope with that complicated explanation that we shall not fall between any of the three stools concerned, and with the explanation and reminder of the safeguards I have given, the noble Lord will think it safe to withdraw the Amendment.

§ LORD SANDFORD
My Lords, I think the House will agree that there is scope for confusion here. It is a matter of opinion as to where it is convenient to draw the margin, and it is, I would confirm, the substances that can be equally considered as pesticides or as belonging in the veterinary world which cause the trouble. I do not believe that my noble friend would want me to press this Amendment. I think he will be satisfied by having drawn attention to the difficulties and possible confusions that exist; and having had that explanation from the noble Lord I beg leave to withdraw the Amendment.

§ Amendment, by leave, withdrawn.

§ BARONESS SEROTA moved Amendment No. 55: After Clause 114 insert the following new clause:

§ Liability to forfeiture under Customs and Excise Act 1952

§ (".—(1) For the purposes of section 44 of the Customs and Excise Act 1952 (forfeiture of goods improperly imported) any imported goods shall be deemed to be imported contrary to a restriction for the time being in force with respect to them under this Act if—

(a) they are goods falling within a class specified in an order made by the Ministers for the purposes of this subsection, and
(b) they are imported in such circumstances as are specified in that order.

288

§ (2) For the purposes of section 56 of the Customs and Excise Act 1952 (offences in relation to exportation of prohibited or restricted goods) any goods shall be deemed to be exported contrary to a restriction for the time being in force with respect to them under this Act if—

(a) they are goods falling within a class specified in an order made by the Ministers for the purposes of this subsection, and
(b) they are exported in such circumstances as are specified in that order.

§ (3) Any class of goods specified in an order under subsection (1) or subsection (2) of this section shall be so specified as to consist exclusively of goods appearing to the Ministers to be goods which are, or normally are, medicinal products or are, or normally are. animal feeding stuffs in which medicinal products have been incorporated.")

§ The noble Baroness said: My Lords, the purpose of this new clause is to deal with three problems which arise in connection with enforcement at the port of import and export of the provisions of this Bill. The first of these is that under the Customs and Excise Act the Customs officers' power of seizure can be exercised only when the goods in question are prohibited or restricted imports or exports as the case may be. In many places in the Medicines Bill, however, the prohibition is against a "person" who imports or exports. Apart from the technical problem of applying the Customs and Excise Act to such cases particular difficulty arises where goods arrive at the port and no one can be immediately identified as the person importing or exporting them.

§ The second problem arises from the nature of the definition of "medicinal product" which is included in this Bill. This, quite rightly in my view and I hope in the view of the House, is not related directly to the nature or characteristics of the substance itself but to the purpose for which a preparation has been wholly or mainly manufactured or marketed. Such a definition raises practical difficulties for the Customs officers, and so we think that the enforcement at the port would be more effective if directed to a limited range of medicinal products and medicated animal feeding stuffs where it is of particular importance rather than dissipated over the whole field.

§ This, however, raises the third problem, namely, that it is not satisfactory for a public authority with a general enforcement duty to exercise this selectivity 289 in the light of purely administrative choice. From this it follows that if we are to ask the Board of Customs and Excise to enforce import and export provisions in the Bill selectively, a statutory foundation for such selectivity is necessary. This new clause, which is the subject of Amendment No. 55, accordingly provides for an order to be made specifying goods in respect of the import or export of which Customs would have a duty of enforcement, and makes it clear that such goods, when imported or exported in specified circumstances are to be in the category of prohibited imports or exports and, therefore, subject to Customs powers as to forfeiture. The products which will be included in the order will be those which give rise to special danger, such as therapeutic substances and products like veterinary antibiotics, which present the greatest temptation to evasion of the prohibition. Existing general prohibitions in the Bill on importation and exportation will of course remain, and will be enforceable by Ministers either directly or, in the case of imports, through the possession offences provided for in Clause 45(2) and 67(3).

§ These arrangements in no way affect the requirement under Clause 7(2) that before an imported product is marketed in the country there must be a product licence. This requirement is additional to the product licence requirement in respect to importation itself, though the same licence would generally serve both purposes, and will be enforced in the same way as similar provisions applicable to the marketing of products produced in this country.

§ The Amendment to Clause 126—namely, Amendment No. 62—is a consequential provision making orders under this new clause subject to the annulment procedure. I hope that with that explanation the Amendment and new clause will be acceptable to the House. I beg to move.

§ LORD SANDFORD
My Lords, the House will be grateful to the noble Baroness, Lady Serota, for that explanation of this clause, and how it operates. Perhaps I was not listening carefully enough, but I did not quite understand from her explanation why this arises at this late stage. Is it as a result of representations, or was it delayed because of 290 the need to consult? Have there been consultations? Secondly, am I right in thinking that when these goods appear at the ports they are liable to forfeiture, and that forfeiture is not subject to any sort of court proceedings?

§ BARONESS SEROTA
My Lords, on the first point, this has been a matter which my right honourable friend has been discussing with Customs and Excise authorities. It is, I am sure the House will agree, something that needed to be dealt with with some care and in some detail. With regard to the second point, I am afraid I cannot answer the noble Lord off the cuff, but I will write to him and give him the answer to his question.

§ BARONESS SEROTA moved Amendment No. 56: After Clause 114 insert the following new clause:

§ Special enforcement and sampling provisions relating to animal feeding stuffs

§ ".—(1) For the purposes of the application of the provisions of sections 111, 112 and 114 of this Act in relation to animal feeding; stuffs, regulations made by the Agriculture Ministers may provide that any of those provision; specified in the regulations shall have effect subject to such modifications as may he so specified.

§ (2) Regulations made by the Agriculture Ministers—

(a) may make provision as to the manner in which samples may be taken by virtue of the provisons of section 111 of this Act as modified by any regulations made under the proceeding subsection, as to the manner in which samples may be set aside, or substances or articles may be treated as simples, by virtue of the provisions of section 112 of this Act as so modified, or as to the manner in which samples may be submitted for analysis by virtue of the provisions of section 114 of this Act as so modified, and
(b) in relation to samples so taken, set aside or submitted for analysis, or substances or articles so treated as samples, may make provision (either in substitution for, or by way of modification of or addition to, any of the provisions of Schedule 3 to this Act) as to the manner in which such samples, substances and articles are to be dealt with.

§ (3) In relation to the incorporation in animal feeding stuffs of substances or articles of any description or class specified in an order made under this section by the Agriculture Ministers, so much of any licence granted or animal test certificate issued under Part II of this Act as imposes any restriction or requirement by reference to the quantity to be incorporated, or the proportion in which ally substance or article may be incorporated, in any particular case if the discrepancy does not 291 exceed such limit as may be specified by the order in relation to substances or articles of that description or class.

§ (4) In section 113(2)(b) of this Act the referance to section 111 of this Act shall be construed as including a reference to the provisions of that section as modified by any regulations made under this section.

§ (5) The powers conferred by subsection (2) of this section shall be exercisable in addition to any power exercisable by virtue of paragraph 27 of Schedule 3 to this Act."

§ The noble Baroness said: My Lords, I think this new clause, which is the subject of Amendment No. 56, is fairly straightforward, and it is unlikely that the House would wish me to go into a great deal of detail about it. The Government promised during the Committee stage in another place to put down an Amendment which would make it possible to deal with special problems associated with sampling of medicated animal feeding stuffs. This clause does that by enabling the agricultural Ministers to make appropriate regulations, modifying the normal provisions in the Bill, and also to make orders as to tolerances and limits of variations similar to those applying to feeding stuffs under the Fertilisers and Feeding Stuffs Act 1926. It has been thought desirable to be able to modify in this way because of some of the modifications required will be rather complex and technical in nature and it may also be necessary to change them from time to time. A later Amendment on the Marshalled List, namely. Amendment No. 63 is consequential to the Amendment I am now moving, and I hope the House will allow me to move it formally. I beg to move.

§ BARONESS SEROTA
My Lords, this Amendment rectifies the omission in Clause 119. I beg to move.

§ Amendment moved— Page 116, line 27, after second ("the") insert ("name or").—(Baroness Serota.)

§ 8.56 p.m.

§ BARONESS SEROTA
My Lords, Amendments Nos. 58, 59, 60 and 61 are four Amendments which have been put down to strengthen this clause by adding a presumption about medicinal products, namely, medicated animal feeding stuffs, found in mobile shops. 292 They also extend to manufacturers and wholesalers the existing presumption in Clause 123 as to possession for sale or supply, which is at present limited to retailers. The clause also substitutes a more appropriate provision to deal with possession of leaflets of the package insert type which is supplied with medicinal products, and not by themselves. I beg to move.

§ Amendments moved—

§ Page 119, line 9, at beginning insert: ("(1) For the purposes of any proceedings under this Act for an offence consisting of—

(a) offering any animal feeding stuff for sale in contravention of section 40(1) of this Act, or
(b) offering a medicinal product for sale by retail in contravention of section 52 or section 53 of this Act, or
(c) offering a medicinal product for sale in contravention of section 63(b) of this Act,

where it is proved that the animal feeding stuff or medicinal product in question was found on a vehicle from which animal feeding stuffs or medicinal products are sold, it shall be presumed, unless the contrary is proved, that the person in charge of the vehicle offered that animal feeding stuff or medicinal product for sale and, in a case falling within paragraph (b) of this subsection, that he offered it for sale by retail").

§ Page 119, line 10, leave out from second ("of") to ("it") in line 16 and insert ("so much of any provision to which this subsection applies as relates to a person's having any medicinal product or animal feeding stuff in his possession for the purpose of sale or supply, where it is proved that the medicinal product or animal feeding stuff in question was found on premises at which the person charged with the offence carries on a business consisting of or including the sale or supply of medicinal products or of animal feeding stuffs in which medicinal products have been incorporated").

§ Page 119, line 17, leave out ("substance or article") and insert ("medicinal product or animal feeding stuff").

§ Page 119, line 18, at end insert— ("() Subsection (2) of this section applies to the following provisions of this Act, that is to say, section 63(b), subsections (3) and (5) of section 85, subsection (2) of section 87 and subsection (3) of section 88, to any of those provisions as applied by subsection (1) of section 90, and to subsection (2) of section 90 except in so far as it relates to leaflets. () For the purposes of any proceedings under this Act for an offence consisting of a contravention of subsection (2) or subsection 3 of section 86 of this Act, or of so much of subsection (2) of section 90 of this Act as relates to leaflets, where it is proved that the leaflet in question was found on 293 premises at which the person charged with the offence carries on a business consisting of or including the sale or supply of medicinal products or of animal feeding stuffs in which medicinal products have been incorporated, it shall be presumed, unless the contrary is proved, that he had the leaflet in his pos-session—

(a) where the offence charged relates to section 86 of this Act, for the purpose of supplying it with a medicinal product, or
(b) where the offence charged relates to section 90 of this Act, for the purpose of supplying it with animal feeding stuff in which a medicinal product has been incorporated").

§ LORD SANDFORD
My Lords, these Amendments come late in the day, but I agree that they are sensible and necessary in order to strengthen this clause and make it effective.

§ BARONESS SEROTA moved Amendment No. 62: Page 121, line 7, after ("105") insert ("(Special enforcement and sampling provisions relating to animal feeding stuffs) (3)").

§ The noble Baroness said: My Lords, this is a consequential Amendment to Amendment No. 55, which I mentioned earlier. I beg to move.

§ BARONESS SEROTA moved Amendment No. 63: Page 121, line 7, after ("105") insert ("(Liability to forfeiture under Customs and Excise Act 1952)").

§ The noble Baroness said: My Lords, this is a further consequential Amendment. This time it is to Amendment No. 56. I beg to move.

§ LORD AUCKLAND moved Amendment No. 64:

§ Page 123, line 17, at end insert— ("()cosmetics or toilet preparations which exert an action on or modify local physiological functions so as to prevent reduce or correct minor undesirable surfaces conditions blemishes or defects of the skin nails hair or teeth (but not intended to be swallowed) and are so sold;").

§ The noble Lord said: My Lords, Clause 127 deals with the meaning and definition of medicinal products. The purpose of my Amendment is to exclude cosmetics and toilet preparations, as listed in the Amendment. There are a number of products such as after shave 294 lotion and skin cream, and so on, which are not medicinal products in the therapeutic sense of the word. As the Bill is at present drafted, it would appear that these products could be within the ambit of the Bill. This would put an enormous onus on establishments which sell these products and on manufacturers who presumably would require a licence for them. These products are sold in a number of places in addition to chemists' shops; that is to say, in supermarkets, village stores, village post offices, and so on. They are products which are used by people of all ages and are safe.

§ I know it is argued that certain hormone creams which have been advertised in certain journals can, if used indiscriminately, do damage. This Amendment does not exclude such items, but there are more and more of these products now on the market. Most of them are branded goods made by reputable companies. Last year the whole market accounted for £118 million of sales—that is the average per year—and there is also an enormous export potential. If there were any doubt as to the safety of these products, this would not take place. Therefore, the real purpose of this Amendment is not to wreck the Bill or to try to exclude anything which is not perfectly safe and which cannot be proved to be so. I hope the Government will agree that the products named in the Amendment can safely be excluded from the rightly stringent licensing terms brought in by this Bill. My Lords, I beg to move.

§ BARONESS SEROTA
My Lords, may I assure the noble Lord right away that my right honourable friend the Minister of Health has a good deal of sympathy with the case which the noble Lord has just put forward, and also with some of the representations which have been made on behalf of the toilet preparation manufacturers. We appreciate their concern that controls under the Bill Should not needlessly be applied to toilet preparations. There are, however, substantial difficulties in trying to deal with this particular problem in the way in which the noble Lord, Lord Auckland, suggests in his Amendment. In particular it proposes to exclude from the definition of "medicinal product", and consequently from the Bill, a class of preparations defined in an unsatisfactory way, that is to 295 say by their "action"—which is imprecisely qualified—rather than by the medicinal purpose for which they are manufactured or marketed.
Moreover, the effects of the "action" are qualified by ambiguous words such as "minor", and "undesirable". The definition in the Bill is in terms of the medicinal purpose for which a product is wholly or mainly manufactured or marketed, and not in terms of its physical characteristics or actual or potential properties or action. If a product fell within the ambit of this exclusion, then, no matter what far-reaching and unjustified medicinal claims were made for it, it would be outside the scope of the Bill. Therefore, I cannot recommend the House to accept the noble Lord's Amendment.
I would draw his attention to Clause 127(5)(c) of the Bill, which was included to enable the Ministers by order to exclude substances or articles and classes of substances from the definition of "medicinal product", where they fall within the definition but it is agreed that the medicines control under the Bill need not apply. This is intended to deal with borderline preparations, not only for toilet use, but for dietary use, and for use as disinfectants, and purposes of that kind where similar borderline cases occur. My right honourable friend the Minister asks me to assure the noble Lord that it will be open to the toilet preparations industry, after the Bill is passed, to take up with the Department defined classes of toilet preparations that they think should be excluded in this way. We feel that this is a better way of tackling the problem than by trying to amend the basic definition of "medicinal product". I hope that, with that assurance, the noble Lord will withdraw his Amendment. It is possible for these matters of concern to be discussed with the appropriate interests.

§ LORD SANDFORD
My Lords, with the leave of the House, and before we leave Clause 127, may I ask the noble Lord, Lord Kennet, whether he is in a position to answer the small query which I raised when we were on Clause 10, about whether health centres should go in here in subsection (3) or (4)? It is not a matter of great consequence. If 296 the noble Lord has not the answer, I will leave it for the moment.

§ LORD AUCKLAND
My Lords, I am grateful to the noble Baroness for her full explanation of why the Government are not prepared to accept the Amendment as drafted. I am prepared to admit that perhaps the Amendment is rather wide, and it is somewhat technical. The latter part of the noble Baroness's assurance that her right honourable friend will be willing to take part in consultations with the Toilet Manufacturers' Federation is very welcome. I would ask the noble Baroness to ask her right honourable friend to use as much discretion as possible. She will agree—and this is in many ways a feminine Amendment, rather than a masculine one—that these products are very widely used. They are very different from many of the products covered by the Bill. I beg leave to withdraw the Amendment.

§ 9.8 p.m.

§ LORD KENNET
My Lords, before the House gives the noble Lord leave to withdraw his Amendment, the noble Lord, Lord Sandford, a moment ago mentioned health centres. I am not quite sure that I have his question. Was it about the definition of a health centre?

§ LORD SANDFORD
No. Again with the leave of the House, I mentioned when we were dealing with Clause 10 that if it was right at that point to make a reference to a health centre, it seemed right to make a reference to a health centre in paragraph (a) of Clause 127(3), in order to round it off.

§ LORD KENNET
My Lords, may I say that I mistook the noble Lord's point. If he thinks it would be right to mention it there, he should really have put down an Amendment to do so.

§ Amendment, by leave, withdrawn.

§ BARONESS SEROTA moved Amendment No. 65: After Clause 127, insert the following new clause:

§ Meaning of "wholesale dealing", "retail sale" and related expressions

§ ".—(1) In this Act any reference to selling anything by way of wholesale dealing is a reference to selling it to a person as being a person who buys it for one or more of the 297 purposes specified in subsection (2) of this section, except that it does not include any such sale by the person who manufactured it.

§ (2) The purposes referred to in the preceding subsection, in relation to a person to whom anything is sold, are the purposes of—

(a) selling or supplying it, or
(b) administering it or causing it to be administered to one or more human beings,

in the course of a business carried on by that person.

§ (3) In this Act any reference to selling by retail, or to retail sale, is a reference to selling a substance or article to a person as being a person who buys it otherwise than for a purpose specified in subsection (2) of this section.

§ (4) In this Act any reference to supplying anything in circumstances corresponding to retail sale is a reference to supplying it, otherwise than by way of sale, to a person as being a person who receives it for a purpose other than that of—

(a) selling or supplying it, or
(b) administering it or causing it to be administered to one or more human beings,

in the course of a business carried on by that person.

§ (5) For the purposes of this section the provision of services by or on behalf of the Minister of Health, the Secretary of State or the Ministry of Health and Social Services for Northern Ireland under the National Health Service Act 1946, the National Health Service (Scotland) Act 1947 or the Health Services Acts (Northern Ireland) 1948 to 1967 shall be treated as the carrying on of a business by that Minister, the Secretary of State or that Ministry, as the case may be."

§ The noble Baroness said: My Lords. I hope that when I have moved this new clause, the noble Lord, Lord Sandford, does not once more say "late again". All I can say is, "better late than never", because it is felt that the definitions of "wholesale" and "retail" in Clause 128(3) of the Bill as drafted are defective, in not covering the sale to a person who purchases a medicinal product with the object of supplying it to someone else. The new clause remedies this defect. I am sure the noble Lord, Lord Sandford, would not wish the Government to fail in their duty of submitting Amendments even at this late stage, if they feel that the Bill is still defective in spite of the consideration given to it. I beg to move.

§ LORD SANDFORD
My Lords, we can both welcome and protest at the same time, which is what I do now.

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§ Clause 128 [General interpretation provisions]:

§ BARONESS SEROTA
My Lords, I beg to move Amendment No. 66.

§ Amendment moved— Page 126, line 11, at end insert ("or some other inert substance").—(Baroness Serota.)

§ BARONESS SEROTA
My Lords, I beg to move Amendment No. 67.

§ Amendment moved— Page 128, line 39, leave out subsection (3).—(Baroness Serota.)

§ BARONESS SEROTA
My Lords, I beg to move Amendment No. 68.

§ Amendment moved— Page 129, line 22, leave out subsection (6).—(Baroness Serota.)

§ Schedule 2 [Suspension, revocation or variation of licence]:

§ LORD KENNET
My Lords, Amendments Nos. 69 to 78, which are all to Schedule 2, arise from the run of Amendments which we adopted earlier, Nos. 6 to 17. I beg to move them all en bloc.

§ Amendments moved—

§ Page 133, line 39, leave out from ("report") to ("and") in line 40 and insert ("to the licensing authority their findings and advice and the reasons for their advice")

§ Page 134, line 5, at end insert ("and the reasons stated by the appropriate committee or the Commission for giving that advice")

§ Page 134, line 23, leave out from ("report") to ("and") in line 24 and insert ("to the licensing authority their findings and advice and the reasons for their advice")

§ Page 134, line 28, leave out ("conclusions") and insert ("advice")

§ Page 134, line 33, leave out ("conclusions") and insert ("advice")

§ Page 134, line 35, leave out ("conclusions as are") and insert ("advice as is")

§ Page 135, line 4, leave out ("conclusions") and insert ("advice")

§ Page 135, line 5, after ("committee") insert ("and the reasons stated by the Commission or the committee for giving that advice")

§ Page 135, line 8, at end insert ("and the reasons stated by the committee or the Commission for giving that advice")

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§ Page 136, line 26, at end insert—

§ ("Provisions as to hearings

§ Subsection (6A) of section 21 of this Act shall have effect in relation to a person appointed by the licensing authority under paragraph 6 or paragraph 9 of this Schedule as it has effect in relation to a person appointed under subsection (5) of that section, as if in the said subsection (6A) any reference to the applicant were a reference to the holder of the licence").—(Lord Kennet.)

§ Schedule 3 [Sampling]:

§ BARONESS SEROTA moved Amendment No. 80:

§ Page 139, line 15, leave out from ("Schedule") to ("and") in line 17 and insert— ("(a) if they relate exclusively to the examination or analysis of veterinary drugs and are made by an enforcement authority in England and Wales other than the Minister of Agriculture, Fisheries and Food, shall be arrangements approved by that Minister; (b) if in any other case they are made by an enforcement authority in England and Wales other than the Minister of Health, shall be arrangements approved by the Minister of Health; (c) if they are made by an enforcement authority in Scotland other than the Secretary of State, shall be arrangements approved by the Secretary of State")

§ The noble Baroness said: My Lords, Amendment No. 80 amends paragraph 17 of Schedule 3, which requires the approval of "the appropriate Minister" to any arrangements made by an enforcement 300 authority for examination or analysis by someone other than a public analyst. The expression "the appropriate Minister" is, however, not defined. The purpose of this Amendment is to spell out which Minister's approval is required. I beg to move.