Joint Committee on Statutory Instruments Eleventh Report



MEDICINES (ADVERTISING AND MONITORING OF ADVERTISING) AMENDMENT REGULATIONS 1999 (S.I. 1999/267)

  7. The Committee draws the special attention of both Houses to these Regulations on the grounds that in one place they require the elucidation provided by the Department and in another place they are defectively drafted.

  8. The Regulations implement Council Directive 92/28/EEC on the advertising of medicinal products for human use. Regulation 3 inserts a new regulation 3A(2) into the Medicines (Advertising) Regulations 1994, creating a new criminal offence in the following terms:

    "No person shall issue an advertisement relating to a relevant medicinal product unless that advertisement encourages the rational use of that product by presenting it objectively and without exaggerating its properties."

The Committee asked the Department of Health three questions relating to this new offence. First, the Committee asked what sort of facts would have to be proved to make the advertisement "objective". The Department reply in the memorandum printed in Appendix V that the advertisement would have to be accurate and factually verifiable, and note that every licensed medicinal product is accompanied by a Summary of Product Characteristics which can be used by the Health Ministers (along with other data such as the results of tests and trials) to assess the objectivity of an advertisement. Second, the Committee asked what sort of facts would have to be proved to make the advertisement one which does not "exaggerate [the] properties" of the product. The Department reply that it must not, for example, suggest that there is a greater likelihood of recovery than is suggested by tests and trials carried out on the product. Third, the Committee asked what the requirement that the advertisement must "encourage the rational use" of the product adds to the provisions on objectivity and exaggeration. The Department explain that in the Directive this is the overriding requirement, and the reference to it in new paragraph 3A(2) is intended to qualify the other two requirements, so that to avoid committing an offence the product must be presented objectively and not in a manner which exaggerates its properties, such that there is a failure to encourage rational use. They give as an instance overuse of a steroid product due to a claim that it had fewer side effects than other such products. The Committee reports new regulation 3A(2) as requiring the elucidation provided.

  9. The Committee asked the Department, given that the offences created by paragraph 7 of the new Schedule to the Monitoring of Advertising Regulations 1994 (inserted by regulation 13) are triable either way, whether the maximum fine on summary conviction ought to have been expressed in terms of the statutory maximum rather than as "level 5 on the standard scale". The Department admit that the maximum fine on summary conviction should be expressed as the statutory maximum, and say that they intend to make a correction which will come into force immediately after the amendment made by these Regulations. The Committee reports regulation 13 for defective drafting, acknowledged by the Department.


 
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Prepared 11 March 1999