MHRA to extend pre-vetting of advertisements
MHRA is to keep its combined regulatory and monitoring roles |
No advertisements for newly licensed medicines are to be allowed unless the Medicines and Healthcare products Regulatory Agency has approved them.
This extension to the pre-vetting procedures was announced by the Department
of Health last week in its response (PDF 180K) to the House of Commons’ Health
Committee report
on the influence of the pharmaceutical industry (PJ,
9 April, p410). The change reflects the Government’s acceptance
of a recommendation that all promotional material for new products be
pre-vetted. It is expected to apply to about 20 products a year.
In the past financial year, the MHRA vetted advertisements for 30 products
under an existing scheme, which applies to newly licensed products subject
to intensive monitoring, products reclassified from POM to P and products
where earlier promotion has breached advertising regulations.
The Government has also agreed with the Health Committee that a safer
way of introducing new medicines needs to be found.
It said that a ministerial strategy group was looking at regulatory issues
and would consider whether there could be better controls when new medicines
come into clinical use and better ways of seeking safety data to avoid
sudden scares.
Generally, the Government response indicates that it is satisfied with
the workings of the relationships between the pharmaceutical industry,
prescribers, patients, the NHS and medicines regulation. It rejects a
recommendation that post-marketing surveillance and drug safety monitoring
systems should operate independently of regulation by the MHRA because
this would impede the continuous examination of the risk/benefit balance
throughout a product’s life-cycle.
The Association of the British Pharmaceutical Industry said that it was
important that pre-vetting of advertising should not delay the availability
of innovative new medicines for patients.
“The welfare of patients has to be at the centre of actions of
both Government and industry with regard to the Committee’s recommendations,” said
Richard Barker, ABPI director-general. “We recognise that action
has to be taken in some areas and endorse the majority of the Government’s
proposals, but it is essential that they are implemented in such a way
that they do not delay or, worse still, deny patients’ access to
the benefits of modern, innovative medicines.”
Rob Darracott, director of corporate and strategic development at the
Royal Pharmaceutical Society, said that the Society would have liked
to see more explicit acceptance by the Government of the involvement
of pharmacists in local drug and therapeutics committees, as the Health
Committee had suggested. But he welcomed the Government’s rejection
of an idea that regulatory bodies should hold registers of their members’ interests. |
The
Pharmaceutical Journal
Acrobat
Reader