§ FACTORS RELEVANT TO DETERMINATION OF APPLICATION FOR LICENCE
§ Mr. FortescueI beg to move Amendment No. 21, in page 13, line 5, leave out 'in particular' and insert 'only'.
§ Mr. SpeakerWith that we are taking the following Amendments: Amendment No. 22, in Clause 20, page 15, line 2, leave out 'expedient' and insert:
',or advisable on the ground of safety, efficacy or quality,'.Amendment No. 28, in Clause 24, page 19, line 16, leave out 'expedient' and insert:',or advisable on the ground of safety, efficacy or quality,'.Amendment No. 46, in Clause 34, page 29, line 21, leave out 'expedient' and insert:', or advisable on the ground of safety'.
§ Mr. FortescueWe now come back to the topic which we have already discussed this evening, namely, the importance of the three qualifications of safety, efficacy, and quality of drugs. The first Amendment stands on its own, but the other three go together and are relevant to the same point.
In committee, we moved an almost identical Amendment to persuade the Minister that it would be proper for him to omit the provision that the licensing authority should have regard in particular to the safety, efficacy and quality of drugs in granting a licence, and should have regard only to those qualities.
1434 The Minister resisted the Amendment, but he yielded a little at the end, because he thought that the licensing authority should in no way be limited in its consideration of applications by being able to refer only to those three qualities. After some persuasive speeches he came to the following conclusion:
I have listened to what both hon. Gentlemen have said and I think that we might look at this again. I am not going to say more than that. On one side I feel we must not constrain the authority too much;"—and that was the point he was making throughout—on the other side I feel that it is reasonable to say that without a clear prescription of its rules the authority might be prejudiced in its activities. We will see whether, somewhere between these two points of view, both of which are reasonable, we can achieve some degree of agreement.—[OFFICIAL REPORT, Standing Committee D, 28th March, 1968; c. 273–274.]We have waited in vain for that agreement to be reached and for what the hon. Gentleman accepted as the reasonableness of our case to be translated into an Amendment. Finally, in despair, we have put down this Amendment, to see whether we can persuade the Minister to take some action on his hon. Friend's undertaking. This Amendment is very much on the lines of an earlier one to the effect that we believe that safety, quality and efficacy are the only criteria for judging applications for licences, and not the criteria by which "in particular" they should be judged.9.30 p.m.
The other three Amendments seek to omit the word "expedient" and to insert other words. We pointed out gently in Committee that expediency is not a quality for which people are enthusiastic and that to accuse a Minister of expediency was not a compliment. We sought to have the word omitted altogether but the Minister said that the only criterion then left for the grant or refusal of licences in Clause 20, for decisions on variation or renewal of licences in Clause 24 and for decisions on clinical and field trial certificates in Clause 32 would be for the licensing authority to decide whether the issue or renewal was necessary. The words in the Bill are "necessary or expedient" and we sought to have the word "expedient" omitted so that the only criterion left would be necessity. The 1435 Minister said that this would make the whole thing inflexible:
If the reference to expediency were omitted, even in a case where the expert committee had advised refusal of a licence the Ministers, as licensing authority, would have to ask themselves, 'Do we therefore consider it necessary to refuse the licence, and has the expert committee established that there is no alternative?' The true position might well be that in a balance of considerations relating to safety, efficacy and quality,"—which is exactly what we are trying to say—the committee thought it inadvisible that the product should be marketed. It is exactly what it was set up to advise on, and what the licensing system is set up to support."— [OFFICIAL REPORT, Standing Committee D, 2nd April, 1968; c. 304.]Therefore, in our ever-reasonable frame of mind, and in an attempt to help him, in these Amendments, instead of simply omitting the word "expedient", we propose that it should be replaced with the phrase "or advisable on the ground of safety, efficacy or quality", which is precisely what the Minister said he would like to see in the Bill. This co-operation from our side in his drafting must be unparalleled. We have been trying to do what he wanted to do. We know that he has been very busy, and we have done it for him. We hope that he will accept the Amendments, because they are exactly from his own mouth in Committee.Amendment No. 46 would provide for the consideration of grounds of safety only in respect of clinical or field trial certificates, where there can be no question of quality or efficacy but only of safety, because the trial has not yet happened and it is not known what the efficacy or quality will be.
§ Mr. Dudley SmithThe case put forward by my hon. Friend the Member for Liverpool, Garston (Mr. Fortescue) is beyond dispute, making all other considerations in the Clause appear completely irrelevant. It is imperative that the licensing authority is absolutely sure of its terms of reference, and these should be completely and closely defined.
In debating the last Amendment, my hon. Friend the Member for Derbyshire, West (Mr. Scott-Hopkins) referred to the activities of pirate drug companies, which are bringing in a tremendous amount of 1436 undercover material and putting it on the market for general sale. There is great need for the licensing authority to clamp down on these activities. I hope that, once established under the Bill, the authority will run these pirate drug companies out of business.
It is important, therefore, that we get the authority's terms of reference absolutely right, which brings us to the three key words; safety, quality and efficacy. These are the bye words to the whole of the Bill and they have been often repeated in Committee and in the House. They are the three words governing the activities of the reputable pharmaceutical companies, which represent the vast majority of this industry. There are, however, some disreputable elements and it is against them that this legislation is aimed. It is in the Ministers interest to ensure that the Bill will work efficiently and give the right sort of backing to the Commission and those it chooses to carry out this task. His acceptance of the Amendment would enable him to ensure that the Commission does its work properly.
§ Mr. K. RobinsonI always enjoy listening to the hon. Member for Liverpool, Garston (Mr. Fortescue) moving Amendments with what appears at first sight to be impeccable logic. He is a skilled verbal prestidigitator. What he did on this occasion—not for the first time in the proceedings on the Bill—is to take an objection which I had made to a previous Amendment, frame a new Amendment to take that into account and overlook the fact that it might not have been the only objection that I had to the earlier Amendment.
The purpose of this series of Amendments is, broadly, to make safety, efficacy and quality the only criteria for the grant or refusal of a licence in certain circumstances. The first Amendment would make them the only factors to be taken into account in considering a product licence application. The second would make them the only relevant factors for refusing to grant a licence. The third and fourth would make them the only factors for a refusal to renew a licence or decision to issue a new licence or clinical or field trial certificate instead of renewing the existing one.
1437 The first Amendment is subject to the same technical objection as one of identical effect moved by the hon. Member for Somerset, North (Mr. Dean) in Committee in that it is inconsistent with Clause 19(2), which requires further matters to be taken into account in relation to imported products. The provisions to which the second and third Amendments relate are concerned not only with product licences but also with manufacturers' and wholesale dealers' licences. As such licences are likely to cover a large number of descriptions of medicinal products, there would be doubt as to precisely to what the criteria of safety, efficacy and quality were intended to relate.
In Committee my hon. Friend the Parliamentary Secretary gave an example of a consideration other than safety, efficacy and quality that might be taken into account. It was that the licensing authority might have ascertained that something in the application for a product licence was false in a material particular. There is no reason why the licensing authority should be barred from taking such a consideration into account. On the question of renewals, it might be that the characteristics of the product no longer corresponded to those at the time of the original granting of the licence, and it would be desirable to issue a new licence instead of renewing the old one, or alternatively of refusing to renew.
In so far as the Amendment relating to refusal or renewal would cover manufacturers' licences, the matters mentioned in Clause 19(4) on which the original licence was based might well have changed in a material way that would have given ground for varying or even revoking the licence. It would be onerous to show in all cases that safety, efficacy or quality was involved and also inconsistent with the provisions of Clause 28 which did not stipulate this.
These are not necessarily technical points. I can see no reason why the licensing authority should be forbidden to take such factors into account unless at the same time it can be demonstrated that safety, efficacy and quality are also involved, and this would involve the expert committee. Of course the principal factors are undoubtedly these three, but it is being far too rigid to insist 1438 that only these factors should be relevant.
No applicant or licence holder has any need to fear arbitrary refusals to grant a licence. The factors to be taken into account must not be extraneous to the general purposes of the Bill and in cases of refusal for the granting of a licence otherwise than in accordance with the application the applicant or licence holder has the right of representations under the Bill.
We looked at this matter again, as my hon. Friend the Parliamentary Secretary undertook that we should, but without commitment. We still think the Bill is satisfactory in its present wording and I must ask the House to reject these Amendments.
§ Mr. FortescueI speak again by leave of the House. I regret that the right hon. Gentleman regarded me as a prestidigitator, but if I am it must be catching. The right hon. Gentleman has repaid me in his own coin, because, when he was explaining to the House why the insertion of the words
advisable on grounds of safety, efficacy or qualityhe omitted to say that these words are alternative to the word "necessary".If the Clause is not amended in the way we seek to amend it, the licensing authority could renew or refuse a licence if it thought it necessary or advisable to do so. We would retain the word "necessary". It would be perfectly proper for the licensing authority to say that a licence should be granted because in its view it was right for it to be granted, but to refuse a licence because it considered it was expedient to refuse it would be in the realms of the critical. We should like the licensing authority to have some terms of reference for its reference to expediency. What better terms could there be than the three qualities written into the Bill?
If the grant or refusal of a licence is to depend on necessity or advisability on grounds of safety, efficacy or quality, the authority would be on firm ground, but since the criterion is the ground of expediency the sands begin to shift. I am sorry to have to advise my hon. Friends to vote in favour of these Amendments.
§ Question put, That the Amendment be made:—
1440§ The House divided: Ayes 97, Noes 127.
1441| Division No. 228.] | AYES | [9.44 p.m. |
| Atkins, Humphrey (M't'n & M'd'n) | Foster, Sir John | Page, Graham (Crosby) |
| Biffen, John | Gibson-Watt, David | Page, John (Harrow, W.) |
| Biggs-Davison, John | Gilmour, Ian (Norfolk, C.) | Pink, R. Bonner |
| Black, Sir Cyril | Grant-Ferris, R. | Powell, Rt. Hn. J. Enoch |
| Blaker, Peter | Gresham Cooke, R. | Pym, Francis |
| Boardman, Tom (Leicester, S.W.) | Grieve, Percy | Ramsden, Rt. Hn. James |
| Body, Richard | Griffiths, Eidon (Bury St. Edmunds) | Rawlinson, Rt. Hn. Sir Peter |
| Braine, Bernard | Hall, John (Wycombe) | Renton, Rt. Hn. Sir David |
| Brown, Sir Edward (Bath) | Hall-Davis, A. G. F. | Rhys Williams, Sir Brandon |
| Bruce-Gardyne, J. | Hawkins, Paul | Ridsdale, Julian |
| Buck, Antony (Colchester) | Hirst, Geoffrey | Rossi, Hugh (Hornsey) |
| Bullus, Sir Eric | Hogg, Rt. Hn. Quintin | Russell, Sir Ronald |
| Burden, F. A. | Holland, Philip | Scott, Nicholas |
| Campbell, B. (Oldham, W.) | Hunt, John | Scott-Hopkins, James |
| Chichester-Clark, R. | Iremonger, T. L. | Shaw, Michael (Sc'b'gh & Whitby) |
| Clegg, Walter | Johnson Smith, G. (E. Grinstead) | Silvester, Frederick |
| Cordle, John | Johnston, Russell (Inverness) | Sinclair, Sir George |
| Corfield, F. V. | Kaberry, Sir Donald | Smith, Dudley (W'wick & L'mington) |
| Costain, A. P. | Kershaw, Anthony | Speed, Keith |
| Cradclock, Sir Beresford (Spelthorne) | Kirk, Peter | Turton, Rt. Hn. R. H. |
| Crouch, David | Lane, David | Wainwright, Richard (Colne Valley) |
| Dean, Paul (Somerset, N.) | Lewis, Kenneth (Rutland) | Walker, Peter (Worcester) |
| Deedes, Rt. Hn. W. F. (Ashford) | Lubbock, Eric | Ward, Dame Irene |
| Doddt-Parker, Douglas | MacArthur, Ian | Webster, David |
| Doughty, Charles | McMaster, Stanley | Whitelaw, Rt. Hn. William |
| Drayson, G. B. | Macmlllan, Maurice (Farnham) | Williams, Donald (Dudley) |
| Elliot, Capt. Walter (Carshalton) | Maude, Angus | Wilson, Geoffrey (Truro) |
| Elliott, R. W. (N'c'tle-upon-Tyne, N.) | Maxwell-Hyslop, R. J. | Winstanley, Dr. M. P. |
| Emery, Peter | Miscampbell, Norman | Worstey, Marcus |
| Errington, Sir Eric | More, Jasper | |
| Farr, John | Morrison, Charles (Devizes) | TELLERS FOR THE AYES: |
| Fisher, Nigel | Murton, Oscar | Mr. Anthony Royle and |
| Fletcher-Cooke, Charles | Nabarro, Sir Gerald | Mr. Hector Monro. |
| Fortescue, Tim | Onslow, Cranley | |
| NOES | ||
| Anderson, Donald | Hilton, W. S. | Morgan, Elystan (Cardiganshire) |
| Armstrong, Ernest | Hobden, Dennis (Brighton, K'town) | Murray, Albert |
| Atkinson, Norman (Tottenham) | Homer, John | Ogden, Eric |
| Barnes, Michael | Howarth, Harry (Wellingborough) | O'Malley, Brian |
| Beaney, Alan | Hoy, James | Oram, Albert E. |
| Bidwell, Sydney | Huckfield, Lesile | Oswald, Thomas |
| Blackburn, F. | Hunter, Adam | Owen, Will (Morpeth) |
| Blenkinsop, Arthur | Irvine, Sir Arthur (Edge Hill) | Page, Derek (King's Lynn) |
| Booth, Albert | Jackson, Peter M. (High Peak) | Palmer, Arthur |
| Boston, Terence | Johnson, Carol (Lewisham, S.) | Park, Trevor |
| Braddock, Mrs. E. M. | Jones, Rt. Hn. Sir Elwyn (W. Ham, S.) | Peart, Rt. Hn. Fred |
| Butler, Mrs. Joyce (Wood Green) | Jones, J. Idwal (Wrexham) | Perry, Ernest G. (Battersea, S.) |
| Coleman, Donald | Judd, Frank | Perry, George H. (Nottingham, S.) |
| Concannon, J. D. | Kelley, Richard | Prentice, Rt. Hn. R. E. |
| Corbet, Mrs. Freda | Kerr, Mrs. Anne (R'ter & Chatham) | Price, Thomas (Westhoughton) |
| Crawshaw, Richard | Kerr, Russell (Feltham) | Price, William (Rugby) |
| Cronin, John | Lawson, George | Reynolds, Rt. Hn. G. W. |
| Crossman, Rt. Hn. Richard | Ledger, Ron | Rhodes, Geoffrey |
| Davidson, Arthur (Accrington) | Lestor Miss Joan | Richard, Ivor |
| Davies, Ednyfed Hudson (Conway) | Lewis, Arthur (W.Ham, N.) | Roberts, Gwilym (Bedfordshire, S.) |
| Dell, Edmund | Luard Evan | Robinson, Rt. Hn. Kenneth (St.P'c'as) |
| Dickens, James | Lyon, Alexander W. (York) | Robinson, W. O. J. (Walth'stow, E.) |
| Dobson, Ray | Lyons, Edward (Bradford, E.) | Roebuck, Roy |
| Driberg, Tom | McBride, Neil | Rogers, George (Kensington, N.) |
| Dunwoody, Dr. John (F'th & C'b'e) | McBride, Neil | Rogers, George (Kensington, N.) |
| Eadie, Alex | MacColl, James | Ross, Rt. Hn. William |
| Ellis, John | McKay, Mrs. Margaret | Rowlands, E. (Gardiff, N.) |
| Ennals David | Mackenzie, Gregor (Rutherglen) | Shaw, Arnold (llford, S.) |
| Ennals, David | Mackie, John | Short, Mrs. Renée (W'hanoton, N. E.) |
| Fletcher, Raymond (Ilkeston) | Mackie, John | |
| Fletcher, Ted (Darlington) | McMillan, Tom (Glasgow, C.) | Silkin, Rt. Hn. John (Deptford) |
| Forrester, John | MacPherson, Malcolm | Silverman, Julius |
| Fowler, Gerry | Marquand, David | Skeffington, Arthur |
| Fraser, John (Norwood) | Mason, Rt. Hn. Roy | Slater, Joseph |
| Courlay, Harry | Mendelson, J. J. | Small, William |
| Gregory, Arnold | Mikardo, Ian | Snow Julian |
| Grey, Charles (Durham) | Millan, Bruce | Swingler, Stephen |
| Griffiths, Rt. Hn. James (Llanelly) | Miller, Dr. M. S. | Thomas, Rt. Hn. George |
| Hamilton, William (Fife, W.) | Milne, Edward (Blyth) | Tinn, James |
| Harper, Joseph | Mitchell, R. C. (S'th'pton, Test) | Tuck, Raphael |
| Harrison, Walter (Wakefield) | Molloy, William | Urwin, T. W. |
| Hart, Rt. Hn. Judith | Moonman, Eric | Varley, Eric G. |
| Walden, Brian (All Saints) | Wells, William (Wasall, N.) | TELLERS FOR THE NOES: |
| Walker, Harold (Doncaster) | Wilson, William (Coventry, S.) | Mr. Ioan L. Evans and |
| Watkins, David (Consett) | Winnick, David | Mr. Alan Fitch. |
§ Mr. SpeakerWe now come to a Government starred Amendment, Amendment No. 112.
§ Mr. K. RobinsonI beg to move Amendment No. 112 in page 13, leave out lines 17 to 20 and insert:
(2) In taking into consideration the efficacy for a particular purpose of medicinal products of a description to which such an application relates, the licensing authority shall leave out of account any question whether medicinal products of another description would or might be equally or more efficacious for that purpose:Provided that nothing in this subsection shall be construed as requiring the licensing authority, in considering the safety of medicinal products of a particular description, in relation to a purpose for which they are proposed to be administered, to leave out of account any question whether medicinal products of another description, being equally or more efficacious for that purpose, would or might be safer in relation to that purpose.Even if you had not introduced the Amendment as you did, Mr. Speaker, I was going to say that, having made an oblique reference to a starred Amendment in the names of hon. Members opposite, I intended anyway to apologise to the House for this solitary Government starred Amendment.No doubt hon. Members opposite look at lines 17 to 20 with a certain amount of retrospective glee, since they were inserted when we were caught napping at the very beginning of one sitting at 10.30 in the morning. In the debate on their Amendment at the previous sitting on 28th March, I assured the Committee, as I had previously assured the House on Second Reading, that it was not intended that comparative efficacy by itself should determine the decision whether to grant or refuse a licence. Nevertheless, efficacy must be taken into account in relation to toxicity, and the Amendment which was then under discussion and was subsequently carried would preclude taking account of comparative efficacy even where this was relevant to the safety of the product under consideration.
The Amendment carries out the intention as I described it on Second Reading and safeguards the point about comparative efficacy in relation to safety which was the main ground of our opposition to the Amendment in Committee. 1442 I think that the Amendment carries out my undertaking, and I move it despite the fact that I felt that we should have been entitled perhaps simply to remove the words inserted in Committee.
§ Mr. Maurice MacmillanI must admit that I see with a certain sadness the removal of the words which sneaked in at 10.30 one morning, but I thank the Minister for substantially meeting the point which they tried to make. The Minister's wording leaves out any question of relative efficacy but brings back the question of relative safety and makes it quite clear that where one drug is clearly safer than another, the fact that the other is equally efficacious does not force the Commission to license it. We have no quarrel with that.
I am grateful to the Minister for rewording the provision and carrying out his undertaking, even if we see our words disappear with a certain amount of sorrow.
§ Amendment agreed to.