EXTENSION OF SECTION 7 TO CERTAIN SPECIAL CIRCUMSTANCES (Hansard, 18 October 1968)

§ Mr. K. Robinson
I beg to move, as an Amendment to the proposed Amendment, in line 2, after 'sells', insert 'supplies'.

§ Mr. Deputy Speaker (Mr. Sydney Irvine)
With this we are to take the following consequential Amendments to the Lords Amendment:
In line 8, after 'sells', insert 'supplies'.
In line 11, after 'sale', insert 'supply'.
In line 12, after 'selling', insert 'supplying'.
In line 15, leave out from first 'a' to 'unless' in line 16 and insert: 'transaction whereby a person, in the course of a business carried on by him, sells a substance or article by retail or supplies a substance or article in circumstances corresponding to retail sale'. In line 18, after 'sold', insert 'or supplied'.
In line 25, after 'sell', insert 'supply'.
In line 28, after 'sells', insert 'supplies'.
In line 28, after 'selling', insert 'supplying'.
In line 33, after 'sell', insert 'supply'.

§ Mr. Robinson
The purpose of new Clause G is to extend the requirement to hold a product licence in respect of a medicinal product to some substances 796 not at present covered by the Bill. Under the definition in Clause 117(1), it is possible for a substance or article to be something other than a medicinal product at its time of manufacture or import, but subsequently to become a medicinal product on being marketed wholly or mainly for medicinal purposes. For example, this might arise when an ordinary chemical substance which has many uses is packaged, labelled and sold with medicinal directions.
When the person who first markets such a product for medicinal purposes is its importer or the person responsible for composition, Clause 7 requires him to hold a product licence if he sells or supplies the product, but as it stands the Clause does not place a licensing obligation on other people selling or supplying. This is because where the person responsible for composition holds a licence, it would not be reasonable to place a licensing obligation on each successive dealer in the product as well.
But the consequence is that, as the Bill stands, if the first person to market the product for medicinal purposes is someone other than the importer or the person responsible for composition, no product licensing obligation arises. It is this loophole which new Clause G is intended to fill by providing that a product licence should be held and enabling the person concerned to apply for a product licence. 797 Subsection (2) is intended to put the retailer in the same position as the wholesaler where he is consciously setting out to sell the substance as a medicinal product.
There is, however, a defect in the new Clause as it was included in another place in that no mention is made of "supplying" otherwise than by way of sale. The absence of such a reference would mean that the loophole which I have mentioned would not be closed in such circumstances as where a single fee for treatment covered both professional advice and the supplying of medicine, or where artificial arrangements not amounting to sales were made between mushroom companies operating at "wholesale" or "retail" levels and the person who is really setting out to market the product. The 10 Government Amendments to the Lords Amendment are accordingly intended to improve the Lords Amendment by inserting appropriate references to supplying.

15	(2) Subsection (1) of this section shall not have effect in relation to a person selling a substance or article by retail in the course of a business carried on by him unless in the course of that business the substance or article has been assembled for the purpose of being sold by him.
20	(3) In any reference in this Part of this Act to the provisions of, or the restrictions imposed by, section 7 of this Act, the reference to that section shall be construed as including a reference to subsection (2) of that section as extended by the preceding subsections.
25	(4) Where in the course of a business carried on by him a person proposes to sell or export a substance or article for use as mentioned in subsection (1) of this section, where the substance or article will not constitute a medicinal product before he so sells or exports it and he will not be selling or exporting it in circumstances to which section 7(2) of this Act applies, he may, if he so desires, apply for a product licence in respect of that substance or article, and the licensing authority (subject to the provisions of sections 19 to 22 of this Act) may grant to him a product licence in respect of it, as if he were proposing to sell or export it in circumstances to which section 7(2) of this Act applies; and a product licence so granted may be renewed suspended, revoked or varied accordingly.
30
35
40	(5) In subsection (2) of this section the reference to assembling a substance or article in the course of a business carried on by a person is a reference to doing in the course of that business anything which (in accordance with section 118(1) of this Act) would constitute assembling it if it had been a medicinal product when sold or supplied to him."