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:
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
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
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
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.