Joint Committee on Statutory Instruments Eleventh Report



APPENDIX V

Memorandum by the Department of Health

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

The Committee has requested a memorandum on the following points:

1.  The new regulation 3A(2) inserted by regulation 3 into the Medicines (Advertising) Regulations 1994 creates a 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."

Explain, with an example of an advertisement of such a product -

  (1)  what sort of facts would have to be proved to make the advertisement "objective";

  (2)  what sort of facts would have to be proved to make the advertisement one which does not "exaggerate its properties";

  (3)  what (if anything) the requirement that the advertisement must "encourage the rational use" of the product adds to the two above requirements and the sort of facts which would have to be proved to satisfy it.

2. Given that the offences created by paragraph 7 of the new Schedule to the Monitoring of Advertising Regulations (S.I. 1994/1933) are triable either way, that is, summarily or on indictment, ought not the maximum fine on summary conviction (subparagraph (a)) to have been expressed as the statutory maximum rather than in terms of "level 5 on the standard scale"?

Question 1

  Generally, the Committee is asked to note that the new regulation 3A implements Article 2.3 of Directive 92/28/EEC on the advertising of medicinal products for human use, and that the Department has, with a view to ensuring the correct implementation of Community law, adopted the "copy out" approach.

1.  In the Department's view, in order for an advertisement to be "objective" it must, in the first place, be accurate and factually verifiable. For instance, an advertisement would not be "objective" if it promoted a product as a treatment for arthritis, when it merely provided relief of short term symptoms. An advertisement would also not be "objective" if it failed to refer to any significant limitations that were relevant to the claims made for the product. An example would be if an advertisement said that a product was a safe treatment for back pain but omitted to say that it was not suitable for use by the elderly. Every licensed medicinal product has a Summary of Product Characteristics approved by the licensing authority. This sets out information that is relevant to the product. The Health Ministers can assess the objectivity of an advertisement from this summary, and from other data held by them, such as the results of tests and trials on the product.

2.  In the Department's view, in order for an advertisement not to exaggerate the properties of a product, 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. For instance, an advertisement would exaggerate a product's properties if it suggested a 90% success rate, whereas tests and trials suggested only a 50% success rate, or if an advertisement claimed that a cancer treatment product prolonged life to a greater extent than another such product, when tests and trials showed that it was comparable to that other product.

3.  The requirement that an advertisement should encourage rational use is understood by the Department to mean encouraging appropriate and correct use of the product by the consumer. This requirement is, in the Directive, the overriding requirement, and so the reference to it in regulation 3A acts so as to qualify the requirements of objectivity and lack of exaggeration. That is, the advertisement must not present the product in a manner that lacks objectivity, or which exaggerates, such that there is a failure to encourage rational use. For instance, a claim that a steroid product had fewer side effects than other steroid products could lead to over use of the product without adequate monitoring, with consequent risk. On this basis, in the Department's view, the advertisement would exaggerate the product's properties such that there was a failure to encourage rational use, and the regulation would be breached. However, the regulation would not necessarily be breached if, for example, an advertisement exaggerated a product's properties, but the exaggeration did not result in such a failure; for instance, if an advertisement suggested a 52% recovery rate whereas tests and trials suggested only a 50% recovery rate.

Question 2

  The Department agrees that, given that the offences created by paragraph 7 of the new Schedule to the Monitoring of Advertising Regulations are triable either way, the maximum fine on summary conviction should be expressed as the statutory maximum. The Department apologises for this error, and undertakes to correct it as soon as possible. It is intended that the correction will come into force immediately after the amendment made by these Regulations.

23 February 1999


 
previous page contents

House of Lords home page Parliament home page House of Commons home page search page enquiries

© Parliamentary copyright 1999
Prepared 11 March 1999