ENFORCEMENT IN ENGLAND AND WALES (Hansard, 18 October 1968)

§ Mr. Deputy Speaker
I think that it would be appropriate if we were to deal with Lords Amendments Nos. 105–116, Nos. 118–120 and No. 166.

§ Mr. K. Robinson
I beg to move, That this House doth agree with the Lords in the said Amendment.
This group of Amendments arises out of an undertaking that I gave both in Standing Committee and on Report to examine the enforcement role given in Clause 100 to the Pharmaceutical Society and to consider whether and to what extent food and drugs authorities should be brought into these enforcement functions. It also rectifies certain omissions which have been brought to light in Clause 100, as it then was, and covers the enforcement of the additional paragraphs added to Clause 59(1) by Amendment No. 90.
As the Bill left this House it placed the duty of enforcing Clause 59(1)(a) to (f) and Clauses 45, 46 and 47 on the Pharmaceutical Society, because the provisions of these Clauses and the requirements of the regulations to be made under them seemed broadly analogous to or, at any rate, no more than an extension of the kind of provisions that the Society has enforced for many years fairly, responsibly and effectively.
The main grounds of the criticism have been, first, that the Society has only about 15 qualified inspectors, which was thought to be a small number compared with the number of retail outlets for general sale list medicines, which some people think might be up to 150,000.
Secondly, as pharmacists are in competition with ordinary shop and health 811 food stores and are alleged to be unsympathetic to the techniques and activities of herbalists, it would be wrong for the Society, as the professional body of the pharmacists, to have this enforcement function, however meticulous and objective it may try to be. The critics suggested that local authorities, or food and drugs authorities instead, might do this, notwithstanding that the functions would be novel for them. Pronouncements by the Council of the Pharmaceutical Society that drugs ought only to be sold to the public by retail pharmacists have also been quoted, and followed by the suggestion that it would be difficult for the Society's officers to avoid bias.
1.30 p.m.
I think that none of those arguments is conclusive. Whatever the council of the society may say, the authorised officers could only enforce the provisions in the regulations or in Clauses 46 and 47, and these could not include a restriction of the sale of drugs to pharmacies. In addition to the 15 inspectors which it has with pharmaceutical qualifications, the society employs other experienced persons in connection with its inspection duties, where professional qualifications are unnecessary. Nevertheless, it must be admitted that the number is small in relation to the number of potential retail outlets.
Herbalism is an earlier form of pharmacy, and pharmacists are instructed in the techniques used even though they may think that many of the herbal remedies are now obsolete. Functions in regard to herbalists would be new for either local authorities or food and drugs authorities, and it is questionable how much detailed knowledge the officers of such authorities would have about herbalism. Subsections (4) and (5)(a) of Clause 100 are also somewhat defective in not providing for enforcement of the functions in question in places other than premises and in vehicles, ships, and so on, and, as they stand, could be inappropriate to the new paragraphs in Clause 59(1) introduced by Amendment No. 90.
The most important factor pointing to the desirability of a provision along the lines of the Amendment is the difficulty of foretelling at the present time the range of variations in the requirements to be 812 made in the regulations under Clauses 46 and 59 in relation to different persons and places, for example, pharmacies, ordinary shops and premises, vehicles and ships. In each case the appropriate enforcement authority could vary according to whether the products are on the general sale list, are human or veterinary medicines, herbal remedies, or, at some time in the future, medical or veterinary devices. In some cases the Pharmaceutical Society will undoubtedly be appropriate, in others the local authority or the food and drugs authority.
Looking only at the enabling powers, which is all we can do at present, I do not think we can be precise enough to be sure of getting the most appropriate allocation of functions. It will be much easier to decide on the appropriate enforcement authority when the regulations in question are known, and consultations take place about their enforcement.
In Section 87(3) of the Food and Drugs Act 1955, and the corresponding Scottish Act, there have for many years been powers which enable regulations to specify the relevant enforcement authorities for particular regulations, and this has proved a practical way of handling a situation in which it is difficult to foretell precisely where the enforcement functions should lie.
The effect of Amendments Nos. 105, 106, 107 and 109 therefore is to delete the present subsections (4) and (5)(a) of Clause 100 and the reference to Clauses 46 and 47 in subsection (5)(b), and to enable Ministers to make regulations specifying the appropriate enforcement authorities for specified regulations under Clause 59 and for the provisions of Clauses 46 and 47. The enforcement body has to be chosen from the Pharmaceutical Society, the food and drugs authorities, and, in the case of Clause 59, the local or public health authorities, the Ministers also having concurrent enforcement powers, or the regulations can leave the particular enforcement functions solely with the appropriate Minister.
Amendments Nos. 102 and 108 deal with a somewhat different aspect. They relate to the enforcement of prohibition orders on grounds of safety. Safety considerations might demand the utmost speed in enforcing the prohibition of sales from retail outlets. The food and drugs authorities, who are already mentioned in 813 this provision in connection with the composition of medicines, could be a most valuable means, alongside the Pharmaceutical Society and the Ministers, of securing it. Accordingly these Amendments transfer the reference to Clause 55(1)(a) from Clause 100(5)(c) under which the duty of enforcement rests with the Pharmaceutcial Society, and includes it in Clause 100(2)(a) with the provisions relating to the composition of medicinal products, so that the appropriate Ministers will be able to make arrangements with, or give directions to, either the food and drugs authorities or the Pharmaceutcial Society, or, in all probability, both, in respect of the enforcement of such orders.
The "enforcement regulations" provided for in the new subsections (4) and (4)(A) and the new subsection after (5) will be made in England and Wales by the Health and Agriculture Ministers jointly. Their making must be preceded by the usual consultations. Corresponding amendments to Clauses 101 and 102 make corresponding provision for Scotland and Northern Ireland.

§ Mr. Fortescue
We warmly welcome the Amendments, especially Amendment No. 109 which is the key one to the point we made in Committee.
The Minister has recited nearly all our objections in Committee and we are grateful to him for doing so. There is, however, one which he did not recite, or did not emphasise, namely, our objection to the duty laid on the Pharmaceutical Society in the Bill as it was first drafted so that the Society was responsible to nobody, and its inspectors who were responsible to nobody except the Society itself, were given not only the power, but the duty, to inspect shops which had nothing to do with Pharmaceuticals at all except in the widest sense, which sold only products on the general sale list, and which could not regard themselves as pharmacies. That was our objection. The Bill seemed to be giving a professional society more power than it was proper and right to give it.
The regulations proposed in Amendment No. 109 will leave the matter flexible, as the Minister said, and we have no objection to that. We see that this must be so, but again I urge the powers that be to do all they can to see that when the regulations are made they do 814 not allow, much less empower, the society's inspectors to enter premises on which, in our minds, and I think, in most people's minds, they have no right to be.

§ Mr. Dean
I should like to emphasise, as we did when discussing these points earlier, that we imply no criticism of the Pharmaceutical Society in what we have said. We feel that the Minister has largely met the point, that it would in some cases be put in a very difficult position where it might be regarded, and indeed would be, as an interested party.
I am glad that the Minister is providing for this flexibility. It is impossible to foresee at this stage just who the most appropriate enforcement authority should be. During the earlier part of the Minister's explanation I felt that he was suggesting that the food and drugs authorities would not be appropriate, but I am sure it will be borne in mind, when the regulations are eventually formulated, preceded by consultations, that there are many new aspects to this matter. Somebody has to learn new aspects which will be involved in the regulations, and I do not think it necessarily follows that the food and drugs authorities will be less able to do this and be less appropriate bodies than the society. We very much welcome the additional element of flexibility which has now been introduced.

§ Dr. M. P. Winstanley (Cheadle)
We are galloping through the Amendments at such a rate that I thought I had better get a word in before we dealt with them all.
I rise, first, to compliment, as others have done, the Minister on his new appointment, and to express my personal profound regret that I shall not again see him in the position which he has occupied with such great distinction for a long time.
I think that the Minister has handled this difficult subject extremely intelligently. There is a certain ambivalence in the attitude of the public to how much restriction there should be, and how much freedom. He has maintained a flexible attitude which will be found of great value in years to come. We are here dealing with a matter in which many changes will take place. I am glad that he has dealt with the matter in this flexible way. It will not create too rigid a system and will leave room 815 for the kind of changes that some hon. Members on both sides feel may be necessary as time goes on.

§ Mr. K. Robinson
With the leave of the House—I am very grateful for what the hon. Member for Liverpool, Garston (Mr. Fortescue) has said. The hon. Member for Somerset, North (Mr. Dean) may have misunderstood me. I indicated that the food and drugs authorities might be inappropriate for the inspection of herbalists' premises. I can assure the House that it is not our intention to make Regulations which would make the Pharmaceutical Society the inspecting authority of premises other than pharmacies, but because of the need for flexibility I am afraid that the House must accept this as an assurance of the Government's intention rather than its being written specifically into the Bill.