CAMPAIGN REPORT ON HEALTHCARE: The red-tape row. Of course, agencies must be sensitive when it comes to ads for medicines, but should people end up in jail if they get it wrong? By Belinda Archer

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 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.