The world of medical and pharmaceutical advertising is in the
throes of a colourful dispute which could result in the introduction of
even more stringent controls than currently exist and a system under
which transgressors could find themselves in jail without any chance of
appeal.
The drama started on 21 August when the Medicines Control Agency, the
executive agency of the Department of Health, issued a consultation
document (MLX 239) in which it proposed five amendments to existing
regulations controlling the advertising of medical products, enshrined
in various legislative documents.
One of these proposals is causing particular alarm in advertising
circles.
The government agency suggested it should be given the power ’backed by
criminal sanctions’ to pre-vet advertising and ’prevent the publishing
and republishing of advertising’ that does not comply with its own
regulations.
However, the industry’s various watchdog bodies almost unanimously
insist that this bid to increase the MCA’s powers and impose criminal
sanctions on those who do not abide by a new set of regulations is ’not
proportionate or justified’ in any shape or form.
Sara Price, head of public affairs at the Advertising Association,
comments: ’There is no published research we can find which suggests
current legislation is consistently misinterpreted or flouted. Given the
stringency of existing controls and the fact compliance rates are
extremely high, we do not believe fines or criminal sanctions are
warranted.’
The Broadcast Advertising Clearance Centre has responded to the MCA with
similar bemused outrage. Uisdean Maclean, director of the TV advertising
watchdog, says: ’We have questioned the need for another regulatory
authority in this area and are questioning the reasons why the MCA might
be doing this anyway.’
Both bodies, together with numerous other respondents to the
consultative document, claim the MCA needs to show clear evidence that
there is a need for such draconian measures.
Close scrutiny of the various reports logging advertising complaints
would suggest that there is not a huge problem under the existing
system.
There have been only two complaints about medical ads on TV registered
with the Independent Television Commission over the past 18 months, one
of which was on the grounds of supposed bad taste rather than
questionable claims. No radio ads have triggered complaints to the Radio
Authority in the past 12 months, while the print and cinema advertising
watchdog, the Advertising Standards Authority, reports that it has
received ’no complaints whatsoever in recent times’ against any major
pharmaceutical or medical advertiser. In addition, most parties are
alarmed that such a move to grant the MCA the power to pursue criminal
proceedings - crucially, without the right of appeal or any involvement
of the courts - would fundamentally disrupt the self-regulatory system
and amount to the introduction of statutory controls, anathema to the UK
advertising industry. The very fact that the MCA would be acting as both
executive and judiciary also flies in the face of the existing system in
which independent watchdogs monitor codes drawn up by the industry.
’My feeling is that there is a basic misunderstanding with the MCA about
the self-regulation system and its proven efficiency,’ Price says.
Other opponents of MLX 239 believe any extension of the MCA’s powers
would be an unnecessary duplication of the work of existing
authoritative bodies. Health product manufacturers already have a
labyrinthine set of controls governing what they can and cannot say in
any marketing communication.
If they want to go on TV, for example, they have to abide by the ITC
code and the BACC’s own guidelines, while they must also comply with the
independent code drawn up by the Proprietary Association of Great
Britain, the trade body for the manufacturers of over-the-counter
medicines, if they are members (and most major blue-chip pharmaceutical
advertisers are).
For press, they must also abide by the PAGB rules as well as the CAP
code, which incorporates a bewildering range of clauses outlawing, for
example, the use of health professionals and celebrities in ads for
medicines, and the use of fear or anxiety to persuade people to buy a
product.
Sheila Kelly, executive director of the PAGB, comments: ’There are
already a plethora of bodies with advertising control functions as well
as several pre-vetting bodies. The MCA’s proposals would be like
throwing a great big stone into a pond and would put into question the
role and very existence of these bodies.’
In addition to all these controls, there are, of course, existing MCA
licensing rules: all products have to be licensed by the MCA before any
medicinal or beneficial claims can be made in advertising work.
In a dramatic move, the PAGB took advice from a Queen’s Counsel, who
said the MCA’s pro-posal ’breaches the human rights of commercial
organisations’.
Kelly adds: ’There were so many opinions floating around that we got a
heavyweight legal opinion. It looks like the MCA has rushed this
consultation document out and it is a very bad piece of drafting.’
The MCA has asked all interested parties to respond to MLX 239 by 10
October. Those organisations, which include most PAGB members and their
MPs as well as the various industry bodies, have received a letter
thanking them and have been told the matter is now ’under
consideration’. It will soon go before the Department of Health which
will decide how to proceed, but it’s thought the industry will hear the
outcome of the consultations in the first quarter of 1998.
Whether the MCA’s suggestions will be waved through is impossible to
predict, but opponents believe the sheer weight of opinion against any
extension of its powers should guarantee the status quo remains. They
hope their cry of ’If it ain’t broke don’t fix it’ will be heard.
The MCA’s response, however, is ominous. ’We remain convinced there is a
need for the strengthening and clarification of our powers,’ says a
spokeswoman.