Memorandum by the Department
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:
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
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
(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"?
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
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.
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