R v Licensing Authority Established under Medicines Act 1968, ex parte Smith Kline & French Laboratories Ltd

JurisdictionEngland & Wales
JudgeLord Bridge of Harwich,Lord Templeman,Lord Ackner,Lord Oliver of Aylmerton,Lord Lowry
Judgment Date09 February 1989
Judgment citation (vLex)[1989] UKHL J0209-3
Date09 February 1989
CourtHouse of Lords

[1989] UKHL J0209-3

House of Lords

Lord Bridge of Harwich

Lord Templeman

Lord Ackner

Lord Oliver of Aylmerton

Lord Lowry

Regina
and
The Licensing Authority
(Respondents)
Ex Parte Smith Kline and French Laboratories Limited
(Appellants)
Lord Bridge of Harwich

My Lords,

1

I have had the advantage of reading in draft the speech of my noble and learned friend, Lord Templeman. I agree with it and, for the reasons he gives, I would dismiss the appeal

Lord Templeman

My Lords,

2

On 9 March 1972, the appellants, Smith Kline & French Laboratories Ltd., filed a complete specification for the grant, subsequently made, of an United Kingdom patent for the compound known as cimetidine, a medicinal product. That patent and allied patents conferred on the appellants an effective monopoly of the production, sale and importation of cimetidine for the period of 16 years expiring on 9 March 1988. Cimetidine is a most valuable drug which heals duodenal and gastric ulcers and treats and cures several other gastro-intestinal tract disorders. Cimetidine was first marketed by the appellants in the United Kingdom in November 1976 under the trade mark and brand name of Tagamet. The four year delay between the filing of the patent specification and the first marketing of Tagamet was largely due to the research and development, detailed and expensive, which were required to prove, pursuant to the Medicines Act 1968, that cimetidine was safe and effective and that Tagamet, a brand of cimetidine, would be produced of a consistently high quality.

3

By section 7(2) of the Act of 1968, no person shall in the course of a business, sell, manufacture or import any medicinal product except in accordance with a product licence granted by the appropriate licensing authority, in this case the Minister of Health. By section 18 of the Act:

"(1) Any application for the grant of a licence … shall be made to the licensing authority and shall be made in such form and manner, and shall contain, or be accompanied by, such information, documents, samples and other material, as may be prescribed."

4

By section 19(1), in dealing with an application for a product licence, the licensing authority shall in particular take into consideration —

  • "( a) the safety of medicinal products of each description to which the application relates;

  • ( b) the efficacy of medicinal products of each such description for the purposes for which the products are proposed to be administered; and

  • ( c) the quality of medicinal products of each such description, according to the specification and the method or proposed method of manufacture of the products, and the provisions proposed for securing that the products as sold or supplied will be of that quality."

5

By section 20(1) of the Act of 1968, as amended by reg. 4(3) of the Medicines ( Medicines Act 1968 Amendment) Regulations 1977 ( S.I. 1977 No. 1050), on any application to the licensing authority for a licence, the licensing authority —

(3) The licensing authority shall not refuse to grant such a licence on any grounds relating to the safety, quality or efficacy of medicinal products of any description, except after consultation with the appropriate committee or, if for the time being there is no such committee, with the Commission."

  • "( a) may grant a licence containing such provisions as they consider appropriate, or

  • ( b) if, having regard to the provisions of this Act and any Community obligation, they consider it necessary or. expedient to do so, may refuse to grant a licence.

6

The Commission mentioned in section 20(3) is the Medicines Commission established by the Minister pursuant to section 2 of the Act of 1968 and comprising experts in the fields of medicine and pharmacy. The appropriate committee mentioned in section 20(3) is a committee established by the Minister under section 4 of the Act to deal with any particular kind of medicinal product and charged under section 4(3), with —

  • "(a) giving advice with respect to safety, quality or efficacy, or with respect to all or any two of those matters;

  • (b) promoting the collection and investigation of information relating to adverse reactions, for the purpose of enabling such advice to be given."

7

On 1 January 1973, the United Kingdom became a Member of the European Community and pursuant to the European Communities Act 1972, became subject to Community law. Article 100 of the European Community Treaty provides that the Council of the Community shall:

"… issue directives for the approximation of such provisions laid down by law, regulation or administrative action in Member States as directly affect the establishment or functioning of the common market."

8

On 26 January 1965, the Council promulgated Council Directive (65/65/E.E.C.) on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary and medicinal products (the "1965 Directive"). The provisions of the 1965 Directive, as amended and amplified from time to time by subsequent Directives, became binding on the United Kingdom and must be performed and observed by the licensing authority. The 1965 Directive recited, inter alia, that:

"… the primary purpose of any rules concerning the production and distribution of proprietary medicinal products must be to safeguard public health:

… however, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community;

… trade in proprietary medicinal products within the Community is hindered by disparities between certain national provisions, in particular between provisions relating to medicinal products …; and … such disparities directly affect the establishment and functioning of the common market:

… such hindrances must accordingly be removed; and … this entails approximation of the relevant provisions; …"

Article 3 of the Directive directed that:

"No proprietary medicinal product may be placed on the market in a Member State unless an authorisation has been issued by the competent authority of that Member State."

9

In the United Kingdom, the authorisation issued by the competent authority consists of a product licence granted by the licensing authority pursuant to its powers under the Medicines Act of 1968.

10

Article 4 of the 1965 Directive, required an application for a product licence to be accompanied by certain specified particulars and documents which were detailed under 11 numbered paragraphs, including the following:

"1. Name or corporate name and permanent address of the person responsible for placing the proprietary product on the market and, where applicable, of the manufacturer.

2. Name of the proprietary product ….

3. Qualitative and quantitative particulars of all the constituents of the proprietary product in usual terminology . . .

4. Brief description of the method of preparation.

5. Therapeutic indications, contra-indications and side-effects.

6. Posology, pharmaceutical form, method and route of administration and expected shelf life if less than three years.

7. Control methods employed by the manufacturer (analysis and assay of the constituents and of the finished product, special tests, e.g. sterility tests, tests for the presence of pyrogenic substances, the presence of heavy metals, stability tests, biological and toxicity tests).

8. Results of:

— physico-chemical, biological or microbiological tests;

— pharmacological and toxicological tests;

— clinical trials.

However:

(a) a list of published references relating to the pharmacological tests, toxicological tests and clinical trials may be substituted for the relevant test results in the case of:

(i) a proprietary product with an established use, which has been adequately tested on human beings so that its effects, including side-effects, are already known and are included in the published references;

(ii) a new proprietary product, in which the combination of active constituents is identical with that of a known proprietary product with an established use;

(iii) a new proprietary product consisting solely of known constituents that have been used in combination in comparable proportions in adequately tested medicinal products with an established use;"

11

Thus in the case of an application for a new proprietary product "identical" with that of a known proprietary product with an established use, or in the case of a new proprietary product consisting of known constituents that had been used in "comparable proportions," in medicinal products with an established use which had already been adequately tested, the applicant was not compelled to carry out time consuming and expensive tests and trials provided there was evidence in published references that tests on and trials of the "identical" or "comparable" product had been carried out with satisfactory results. It was for the licensing authority to determine whether two products were or were not "identical" or "comparable" for the purposes of paragraph 8 applying any criteria laid down by the council.

12

By Directive (75/318/E.E.C.), dated 20 May 1975, the council laid down uniform rules applicable to tests and trials, the compilation of dossiers and the examination of applications for product licences in every Member State and specified the data to be provided under paragraph 8 of article 4 of the 1965 Directive. The declared objects of the Directive were to protect public health and to prevent obstruction to the free movement of medicinal products within the Community by different standards and evaluations in different Member States. By Directive (75/319/E.E.C.), also dated 20 May 1975, further rules were laid down in order to reduce or eliminate disparities between the practices of different Member States and in order to facilitate the movement of proprietary medicinal products.

13

The appellants...

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