Clause 28 (Hansard, 20 June 1968)

§ Mr. Snow
I beg to move Amendment No. 32, in page 24, line 1, leave out ' not been complied with ' and insert: 'to a material extent been contravened'.

§ Mr. Speaker
With this Amendment we can take Amendments Nos. 33, 34, 48 and 49.

§ Mr. Snow
In the Standing Committee on 4th April I accepted in principle, on 1446 behalf of my right hon. Friend, certain Amendments which had been put down by the hon. Member for Liverpool, Garston (Mr. Fortescue), and promised to put down Amendments at a later stage in conformity with the drafting requirements.
The first three Amendments introduce the concept of "to a material extent" into Clause 28(3)(b) and (c) and 28(4)(c). The two Amendments to Clause 35 amend Clause 35(2)(b) and (c) in a manner corresponding to the Amendments to Clause 28 to which I have referred. There is, incidentally, nothing in Clause 35 corresponding to Clause 28(4)(c).
The amended grounds for revocation will, therefore, be that any of the provisions of the product licence or certificate has to a material extent been contravened; that products fail to a material extent to correspond to the characteristics by reference to which the licence or certificate was granted; that any of the provisions of a manufacturer's or wholesaler's licence has to a material extent been contravened.
Our wording in Clause 28(3)(b) and Clause 35(2)(b) has not quite the same import as the Amendments put down in Committee by the hon. Member for Liverpool, Garston. His Amendments referred to non-compliance "with any material provision". We think that the relevant matter here should not be whether a particular licence provision is material but whether the non-compliance is a material matter. It could well be that a provision that in itself was important had been contravened in a technical way which was of no practical importance. In the case of a contravention of a less important provision, the importance of the non-compliance would be judged in relation to the importance of the provision.

§ Mr. Fortescue
All I have to say is, "Thank you very much; thank you very very much". I agree entirely that the Parliamentary Secretary's edition of my Amendment is a great improvement. It is obvious that what I meant was a material contravention rather than the contravention of a material provision. I welcome the Amendments.

§ Mr. Speaker
Amendments Nos. 35, 36 and 37 fall on new Clause 1. We come now to Amendment No. 38.

§ Mr. Maurice Macmillan
I rise to ask leave of the House to withdraw Amendment No. 38, which is concerned entirely with the provisions for clinical and field trials in terms of exports, in view of the promise which the Minister gave in the debate on new Clause 2 that he will bring in some such provision at a later stage. I beg to ask leave to withdraw the Amendment.

§ Mr. Speaker
We have dealt with Amendments Nos. 39, 40, 41, 42 and 43. We come now to Amendment No. 44.

§ Mr. Scott-Hopkins
I beg to move Amendment No. 44, in page 27, line 10, leave out from 'be' to 'advantageous' in line 11.
In moving the original new Clause, the right hon. Gentleman indicated that there will be a complete redraft of that part dealing with clinical and field trials. As a result, what I have to say now is not exactly relevant. If it is to be redrafted, there is not much point in trying to amend the existing wording. However, it would be useful if I tendered my advice to the Parliamentary Secretary that, in any redrafting, the words my be beneficial to, or otherwise advantageous in relation to, the animal or animals should be omitted.
The reason is simple. After such a field trial, it may be that the animal or animals concerned will have to be put to death so as to find whether the trial has been successful, whether an organ has been affected in this or that way, and whether the drug which has been administered has had the desired effect. It is difficult to stretch the English language to pretend that the word "beneficial" means killing the animal concerned. It is on that ground alone that I suggest that the words be omitted.
1448 The whole concept of dealing with animals in the course of field trials is not the same as when one considers dealing with human beings. There are many excellent and wide-ranging regulations about cruelty to animals, but that does not come into it in this context, and I do not want it suggested that any cruelty should or could be practised. That is covered by existing regulations.
At the end of field trials concerning animals, in many cases the animals will be slaughtered, and the use of the words to which I have referred is not only wrong but could inhibit a great many field trials which are vital if the development of veterinary drugs is to continue, both here and overseas. If the Parliamentary Secretary cannot accept my Amendment straight away, I hope that he will bear in mind what I have said in any redrafting of that part of the Bill dealing with field trials.

§ Mr. John Mackie
The words "beneficial to" are intended to indicate that the medicinal product itself may benefit the animal when administered to it. It has no bearing, for instance, on the possibility that the animal concerned may need to be slaughtered for the purposes of a post-mortem examination. This is not a direct effect of the drug itself on the animal.
The object of introducing the concept of benefit is to distinguish between a field trial and pure experimentation in a laboratory where the effects of the substance are not known. With the exception of a case where produce from an animal is to be used for human consumption—and our proposed Amendments will deal with this—we have no wish to control the administration of a drug in the process of development until experimental evidence is available as to its possible beneficial effect.
10.15 p.m.
It is at this stage that the requirement for a field trial certificate becomes relevant. The reference to advantageous in relation to, the animal or animals". is intended to cover administration of a medicinal product where the effect may be of advantage to an owner from the point of view of increasing productivity, etc., rather than directly to the animal—for example, preparations for de-horning cattle or something of that kind.
1449 As my right hon. Friend has said, and I would reinforce it, we are most grateful for the valuable comments about field trials made during the Committee stage. As a result, we are proposing to revise and expand the provisions relating to field trials on the lines mentioned by my right hon. Friend. These will also include a broader definition of field trial, appropriate measures for safeguarding the consumer of animal products, which is a very important point, and provision for a greater measure of flexibility.
I am sorry that it is not possible to go into the details of what we have in mind but I hope that in the light of this explanation and since I gather that the hon. Gentleman the Member for West Derbyshire (Mr. Scott-Hopkins) was not going to press his Amendment and was seeking rather to hear our ideas on future Amendments, that the Amendment will not be pressed.

§ Mr. Scott-Hopkins
I am, of course, grateful to the hon. Gentleman for saying what he is going to do and for taking the points we have made upstairs, but I must register my protest for he has had plenty of time. The way he comes to the House at the fifty-ninth minute of the eleventh hour and says he has not had time to finish his consultations and therefore will produce the Amendments in another place is treating the House with a great deal of contempt.
It is not only in relation to field trials that we are in this difficult position. We are passing a Bill which the hon. Gentleman admits is defective in respect of field trials and he has rightly mentioned the important aspect of residual effects and the necessity for new trial provisions to safeguard consumers of animal products. That is, of course, right and necessary. The existing provisions of field trials are too narrow, but we should have the Amendment to discuss here rather than when they come back to us from another place. Exactly the same comment applies to the Amendments which I gather are to be made to Clause 36 of animal feeding stuffs.

Mr. Deputy Speaker
The hon. Gentleman's indignation must not carry him out of order.

§ Mr. Scott-Hopkins
My feelings of indignation carried me a little beyond what is right and proper. I accept that the hon. 1450 Gentleman will do what he has said with regard to this Amendment and we will see in due course what comes back from another place. In view of what he has said, I beg leave to withdraw the Amendment.