E-drug: Direct-to-consumer ads and Internet
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Hi all,
Some of you may recall a questionnaire we put out to some lists about
issues relating to direct-to-consumer advertising on the Internet at the
end of 1999. The results and discussion from this are now available in
a publication from the Health Systems Trust:
How should South Africa deal with direct-to-consumer (DTC)
advertising within the context of globalisation and the Internet? Andy
Gray, Candy Day (May 2000)Some copies are available on request,
and the full text of the publication 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out-of-date legal and policy framework.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 natureAn 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 arenaIt 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.
Regards,
Candy Day
HealthLink (Programme of Health Systems Trust)
e-mail: candy@healthlink.org.za
http://www.hst.org.za
Tel: 27-31-3072954 Fax: 27-31-3040775
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