Annex B
THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY
AGENCY (MHRA) BREACH OF ADVERTISING REGULATIONS
The MHRA website states:
The MHRA website states: (still referring to
its former name, the MCA):
"5.6 Breach of Advertising
Regulations
Where the assessment of advertising
material identified under paragraphs 2, 3 or 4 above indicates
a potential breach of the Advertising Regulations, the person
responsible for the advertisement will be advised that the MCA
considers that the advertisement is potentially in breach of the
Advertising Regulations.
Although the Regulations clearly set
out the powers available to the MCA, the Agency is not intending
to extend its role. It is expected that, in the majority of cases,
companies will work with the MCA to issue acceptable advertising
without the need to resort to the formal procedures laid down
under the Schedule to the Monitoring Regulations. However, once
the formal procedures have been invoked they will continue until
the matter is resolved.
In the small minority of cases where
we are unable to reach a satisfactory result by negotiation the
advertiser may be issued with a notice under paragraph 3 of the
Schedule to the Monitoring Regulations advising him that:
the MCA is "minded to" determine
that the advertisement, if published, would be in breach of the
Advertising Regulations and the reasons why they are minded to
make such a determination; if such a determination is made, that
person may be required to refrain from publishing that advertisement
by a notice served under paragraph 5 of the Schedule; and the
person on whom the notice is served has 21 days from the date
of the notice in which to make written representations that the
proposed determination should not be made.
The notice may require that person
to refrain from publishing the advertisement until the notice
has been withdrawn by Health Ministers. In deciding whether to
include such a requirement, the MCA will take into account all
the interests involved and, in particular, the public interest.
If the advertiser agrees that the advertising
material may be in breach and agrees to amend the material before
issue, or withdraw material already in issue, any revised material
should be submitted for assessment before it is issued.
If the advertiser considers that the
advertising is not in breach of the Advertising Regulations, he
may submit a written representation that the proposed determination
should not be made. The representation will be passed to an Independent
Review Panel for advice before a final decision is made by the
Licensing Authority. Full details of the operation of the Review
Panel are available from the MCA.
5.7 Issue of decisions and determinations
If an advertiser has provided written
representations in response to a notice under paragraph 3 of the
Schedule to the Monitoring Regulations, the advertisements in
question will be reconsidered in the light of that representation.
The MCA will refer the advertisement and written representation
to an Independent Review Panel for advice before making a final
determination. If, following consideration of that advice, the
MCA decides that the advertisement would not be in breach of the
Regulations, a notice under paragraph 4 of the Schedule will be
issued informing the advertiser of that decision and withdrawing
the notice served under paragraph 3.
Alternatively, the MCA may, in the
light of advice received from the Independent Review Panel, make
a determination that the advertisement, if published, would be
in breach of the Advertising Regulations. In this case, a notice
under paragraph 5 of the Schedule will be issued stating the reasons
for the determination, withdrawing the notice served under paragraph
3 and which may require the advertiser to refrain from publishing
the advertisement.
Where the publication of an advertisement
has been prohibited under paragraph 5, and that advertisement
has previously been published, the person may be required to publish
the reasons for the determination (as notified to him by the notice
under paragraph 5a in full or in part) and a corrective statement
within a specified time and in an appropriate form (paragraph
6 of the Schedule refers).
Once the Licensing Authority's final
decision has been given, any further disagreement must be settled
in the Courts. A company which is unhappy about the decision will
continue to have the opportunity to request a judicial review
of the Authority's executive decision.
Paragraph 7 of the Schedule creates
offences where the addressees of notices under paragraphs 1, 3
or 5 of the Schedule fail to comply with the requirements imposed.
Paragraph 8 makes it an offence for a person to fail to comply
with any requirement imposed on him under paragraph 6 of the Schedule.
The provisions of the Monitoring Regulations make it an offence
to fail to comply with the MCA's determination of the matter and
the MCA will consider enforcement action where any breach of the
Regulations has taken place and where the legislation makes that
breach a criminal offence. In addition, the MCA is entitled to
seek an injunction in the courts as part of its investigation
of a complaint or of its own motion."
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