GENERAL PROVISIONS AS TO DEALING WITH MEDICINAL PRODUCTS (Hansard, 18 October 1968)

§ Mr. K. Robinson
I beg to move, That this House doth agree with the Lords in the said Amendment.

§ Mr. Speaker
I suggest that it will be convenient if we also take Lords Amendments 18, 20, 21, plus the Amendment thereto, 22, plus Amendments, 23, 24, plus Amendments, 25 to 54, 57 to 62, 65 to 71, 76 to 79, 133, 146, 148, 149, 151, 152, and 169 to 175. It looks a formidable list but the grouping makes sense.

§ Mr. Robinson
May I thank the hon. Member for Somerset, North (Mr. Dean) for his kind remarks and good wishes. It is perhaps unusual that a translation of this kind takes place with delay action, but at least it gives me time to see through the final stages of this Bill, for which, complex though it is, I have developed a somewhat perverse affection.
Amendments 2 and 18 prepare the way for the new Clauses A to E which replace Clause 31, covering clinical and field trials, which was in the Bill as passed by this House. The replacement gives rise to these numerous consequential Amendments, and I am grateful to you Mr. Speaker and the House, for agreeing to discuss them together. The five new Clauses concerned with clinical trials and medicinal tests on animals were drafted in the light of some of the criticisms and suggestions made in Committee by hon. Members opposite.
My hon. Friend said then that Clause 31 and the succeeding Clauses would be considered further in the light of those criticisms. One criticism was that Clause 31 did not sufficiently distinguish between the different factors which affect the use of drugs in men and in animals. As to drugs for humans, control is first imposed under Part II, when a new drug is to be used in a clinical trial, that is therapeutically, in circumstances where there is a doctor-patient relationship.
The field trial was envisaged as the equivalent therapeutic control trial of animals. Under Clause 31, control was also first imposed at this stage. However, even at the pre-clinical stage, animal tests can give rise to hazards to human or animal health, for example from undesirable residues in animal products sold for human consumption.
New Clause D in particular is designed to deal with this by controlling the sale of animal products for human consumption. We came to the conclusion that further safeguarding provisions would be appropriate, and in the new Clauses control is not limited to those tests on animals which have a therapeutic purpose. The expression "medicinal tests on animals" has been substituted for the expression "field trials" throughout, since the latter expression was felt to be too narrow in its connotation to cover the extended kinds of tests with which these new Clauses are concerned.
775 A further objection to Clause 31 was that in limiting the requirement to hold a certificate simply to the importer of the drugs or the person "responsible for its composition" it imposed too narrow a control and could have allowed an entrepreneur, or a manufacturer acting through a third party, to escape the need for a certificate. The new Clauses stop up this loophole.
We have found it necessary to table four further Amendments to this group of Lords Amendments. The first two, which are new Clauses B and C, are to bring certain provisions relating to medicinal tests on animals into line with the corresponding provisions in Amendment 20 relating to clinical trials on humans. These provisions were amended to their present wording in the final stage in the House of Lords and it was not then possible to move consequential parallel Amendments in relation to medicinal tests in animals.
The other two Amendments to Amendment No. 24 are consequential on an Amendment introduced at the last stage in another place. This added to new Clause A a new subsection (6) modifying the exemption in subsection (5), and the other exemptions in what were originally subsections (6) and (7) were renumbered (7) and (8). The references in subsections (8)(a) and (10) of new Clause E to these exemptions consequently need to refer to all four subsections.
As my hon. Friend the Parliamentary Secretary said in Committee, Clause 31 and the following Clauses were breaking new ground and we therefore welcomed the constructive spirit in which the suggestions made in Committee were put forward. I think that the outcome has been to add appreciably to the number of Clauses in the Bill and to involve a fearsome collection of consequential Amendments, but I think that the House will agree that the total result is a real improvement.

§ Mr. James Scott-Hopkins (Derbyshire, West)
It would be ungracious of me if I did not thank the Minister of Health and join my hon. Friend the Member for Somerset, North (Mr. Dean) in congratulating him on his new position. The right hon. Gentleman has done a mammoth 776 task in bringing these new Amendments before the House, and I thank him for doing so. They very closely follow the points we made with such force in Committee. There were real difficulties as the Clause stood originally. These Amendments and the new Clause in place of Clause 31 add substantially to the benefit which will accrue from the Bill. I have had consultations with many interests since the Amendments were put forward. I have found very little criticism of them. These Amendments fulfil the purpose which the right hon. Gentleman claims for them and meet most of the objections we raised at earlier stages.

§ Mr. K. Robinson
I beg to move, That this House doth agree with the Lords in the said Amendment.

§ Mr. Speaker
I suggest that with this Amendment we discuss also Lords Amendment No. 154.

§ Mr. K. Robinson
The purpose of the Amendment is to clarify the definition of responsibility for composition on which, apart from imported products, the requirement to hold a product licence depends, in particular by making it clear that such responsibility does not transfer to the manufacturer producing a product to the order of another simply because that other person's specification is incomplete. This point is of particular importance in the making up of a special order where a practitioner may leave some latitude in formulations to the manufacturer. The Amendment to Clause 118 is consequential.