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Direct-to-consumer advertising of drugs on the Internet
Candy Day
2000-06-28
How should South Africa deal with direct-to-consumer (DTC) advertising within
the context of globalisation and the Internet?
A publication addressing this issue is available from the HST web site at
http://www.hst.org.za/hlink/dca.htm in portable document format (PDF)
It has been really interesting to note some of the international debate that is
ongoing with relation to the complex issues of the Internet regulation, freedom,
privacy, protection of consumers, e-commerce and taxation issues, legal issues.
As and when these global issues are addressed, this will have some impact on
the specific issue of drug use/information. However policy will still need to
address those aspects that require different treatment because health/drug
products and information are not the same as other consumer products.
In addition, a global framework is going to take time to develop, and regulatory
authorities need to put appropriate measures in place very quickly to avoid drug
control systems being completely undermined by the disparity between what is
technologically possible and the out-of-date legal and policy framework.
An extract of the suggested positions South Africa should take on six continua of
drug advertising regulation is included below:
Continuum 1
The extremes of the first continuum are industry self-regulation and regulatory
intervention. As can be expected, industry guidelines promote self-regulation.
WHO are somewhere in the middle, while SA and the US are in favour of more
regulatory intervention.
Also plotted on each continuum are the positions of the Australian lobby group-
MaLAM (Medical Lobby for Appropriate Marketing) as expected they are strongly
in favour of strict regulatory control.
SA needs to move to a position that is largely interventionist in nature, positioned
somewhat between that of the current MCC and the extreme represented by
MaLAM - Australian experience has shown that self-regulation mostly one
industry complaining about another rather than health workers/public complaining
about contraventions. Current abuse of loopholes provided by new technology
(Internet) indicates that industry self-regulation is unlikely to be effective as
a sole mechanism.
Continuum 2
On a global - national continuum, positions reflected the type of organisation
rather than a policy stance
It is suggested that a national focus be maintained, but with mention of
information which enters South Africa from across its borders. In other words,
positioned on the global side of the current MCC/FDA position. Currently there
are no appropriate international structures to deal with the cross-border flows,
therefore the national regulatory authority must continue to play the leading role,
while acknowledging factors beyond its borders.
Continuum 3
Most current processes are reactive in nature
An assessment of the Australian PMA Code (reactive) found that it was limited
by a number of factors:
* any action was retrospective (be that monitoring or sanctions for contravention),
allowing the damage to be done
* any fines levied were insignificant compared to the promotional budgets of the
companies concerned
It is suggested that a pre-emptive component be considered, moving towards the
position suggested by MaLAM, and away from the reactive mechanisms of the
WHO/MCC/PMA/IFPMA. Some form of co-regulatory framework should be
developed. To have every bit of web information vetted prior to publication is
impossible, but registration and prior approval of type and organisation of the
content, together with proactive monitoring would help
Continuum 4
A single catch-all definition of advertising is difficult- it can’t provide enough
specificity to deal with the differences between advertising media, and practical
realities of regulating this arena
It is suggested that new technologies should be mentioned, but enough leeway
be left to allow for the guidelines to be immediately applicable to whatever media
is developed in future. In this regard, the views of the PMA/IFPMA should be
followed
Continuum 5
Currently only WHO is attempting to cover non-industry providers of information.
Regulatory and self-regulatory systems are aimed purely at industry.
It is suggested that an attempt be made to widen the scope of the regulations to
cover the activities of all providers of information, rather than to restrict it to
only manufacturers. This should follow the suggestions of MaLAM, and be somewhat
broader than the current WHO position
Continuum 6
The position advocated by MaLAM to restrict all forms of drug advertising is
somewhat extreme and probably would needlesly restrict the activities of drug
information providers.
However, it is suggested that current restrictions against DTC advertising (for
prescription meds) be maintained, as is the case in the current MCC regulations.
Information providers who can provide substantiated, independent, contextualised
treatment information can be a valuable asset, and should not be blocked.
A policy such as has been outlined in the pointers above will be consistent with
the objectives of the National Drug Policy, coherent in that it will remain focussed
on rational drug use, and place health before commercial considerations. It would
be comprehensive in that it would attempt to regulate a variety of activities,
whether overtly undertaken by drug manufacturers or by organisations that are
ostensibly independent. It would not however restrict the dissemination of
unbiased, accurate, independent drug information. The greatest challenges lie in
making such a system, with a degree of pre-emptive approval, financially viable.
In this regard we would echo the suggestions of the Australians and Health
Action International, for a co-regulatory system with industry. This should be
funded by a dedicated levy on pharmaceutical manufacturers, and involve
empowering an independent third party in this country. In time this role can be
played by an autonomous Drug Regulatory Authority, perhaps with non-
governmental organisation aid. (While previous fiscal policy did not allow for
earmarked taxes, this position seems to have been abandoned in the design of
the Skills Development Levy Act.)
However, no system will succeed unless alternative sources of independent drug
information are made readily available. In this regard, a nationally-funded centre
is needed in South Africa. Current systems should be built upon and weaned, where
necessary, from direct drug company support. This is an appropriate role for the
national Department of Health and should be pursued during the current funding
cycle of the South African Drug Action Programme.
The way forward
The passage of medicines legislation in South Africa has not been an easy one.
The Medicines Amendment Act of 1997 remains stalled by a manufacturer
initiated court order. The premature promulgation of the 1998 SAMMDRA Act has
been reversed by the High Court. Therefore opportunities do still exist to influence
the content of the drug regulatory environment. It is thus suggested that this
policy analysis can form the starting point of a dialogue about an effective
regulatory system for drug advertising in a globalised, connected world.
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