E-DRUG: Controlling advertising (2)
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Candy,
I wish I had a week to write a full response to your questions including
references and explain the context and reasons for my answers.
If South Africa is serious about doing something to protect your population
from misleading promotion then MaLAM / Healthy Scepticism would be delighted
to assist.
It is important to understand that because pharmaceutical companies are
rewarded in proportion to sales regardless of impact on health it is
unreasonable to expect them to be able to produce information which is not
misleading. It is NOT something the companies have control over. It is a
system problem.
Unfortunately it is difficult to measure companies contribution towards
health care outcomes so that we can pay them accordingly. ( The nearest
that I know of are the "capped maximum annual contracts" used by PHARMAC
when they can in New Zealand. Under that system I have heard of drug reps
persuading doctors who where overusing a drug to reduce their use of a drug
which had exceeded the agreed sales volume. The reps motivate is to to
maximise profits for the company but in that case lower use was good for
patients also. The trick is to estimate the optimal volume for your country
and then to get the company to accept a contract with maximum payment only
if the target is reached but not exceeded. )
Now your questions:
Question 1
Should drug promotion be the subject of legal restrictions or be left to
industry self-regulatory mechanisms?
Self regualtion has a small place as part of a hierachy of many different
mechanisms of increasing strength. It can help if you are willing and able
to make it work by threatening strong sanctions if it does not work. Eg
there was dramatic improvement in the UK after an individual medical
director was threaten with jail.
Please read Ayres I, Braithwaite J. Responsive regulation: transcending the
deregulation debate. New York: Oxford University Press, 1992
Ian and John explain how talking softy can work well if backed up with a big
stick when needed. They recommend that all regulatory systems should
include the option of removing the persistent offender from the market.
Please note that this is accepted for health professionals ie I accept that
if I break the rules I can be deregistered. This system has many
advantages including increasing profits for those companies who have the
best products and the most honest promotion by protecting them from unfair
competition.
Question 2
South Africa's Bill of Rights makes a vigorous stand on the autonomy of
individuals. Accordingly, should South Africa follow the US model and
provide for direct-to-consumer advertising of prescription-only
medicine, or only educational programmes that inform consumers about the
availability of treatment without mentioning specific prescription
drugs?
Unless you can prove that promotion to health professionals is reliable in
your country then you should not put consumers at risk.
Question 3
The Internet provides some interesting challenges, especially as it
crosses national borders with impunity. While some progress has been
made towards "harmonisation" of drug regulatory systems, there are still
differences between countries. In the light of this, can national legal
mechanisms still work effectively, or should this area be governed by
international agreements?
International government/agreements are needed. However I am not aware of
any reason why you could not use sanctions such as adverse publicity plus
rewards such as good publicity from an NGO contracted for the purpose to
influence what companies put on their websites regardless of the location of
the site. However your influence with depend on how important your country
is to that company unless you can achieve an international sanction or
reward eg international publicity.
Question 4
Should national or international legal mechanisms make specific mention
of the Internet and other electronic media, or should they be included
in broad definitions of "promotional material"?
It is a good idea to avoid specific language that would not include some new
media not yet invented.
Question 5
What sanctions could an international legal mechanism apply?
The more different sanctions and rewards the better. I guess the key issue is
extradition treaties so that you can jail senior staff of foreign companies
that harm your citizens.
Question 6
Which international structure could police such agreements?
I guess the people who currently work on war crimes would be appropriate.
The amount of harm involved can be similar at times.
Question 7
Most current legal and self-regulatory codes operate on the basis of
three main ingredients - the reason for the advertisement (promotion of
sale), the origin of the advertisement (the manufacturer), and the
contents of the advertisement (match with the evidence submitted for
registration of the product). However, it is clear that the reason for a
particular web site might not be obvious or its origin made explicit. In
terms of current guidelines therefore, would the following be
acceptable:* a web site which provides the package inserts (registered
product information) for a large number of prescription only products
from different manufacturers
No because registered product information is often unreliable.
* a web site which provides the national
Essential Drugs List (by generic name), together with the relevant
standardised treatment guidelines (algorithms)
Yes if the information is of good quality and unbiased.
* a web site which provides the material included in the national
Medicines Formulary (including prescription only medicines)
Yes if the information is of good quality and unbiased.
* an electronic journal aimed at health professionals that contains
drug company advertisements for prescription only medicines that is
available unrestricted on the web?
No because both the ads will be misleading and funding via advertising is
not good for journals. Patients will get better results paying for medical
education via their taxes rather than via higher drug prices.
If they are acceptable, what loopholes might this reveal in the current
approach?
I do not understand this question.
regards,
Peter
Dr Peter Mansfield
GP
Director, MaLAM (Medical Lobby for Appropriate Marketing)
MaLAM aims to protect compassionate scientific health care from marketing
practices that may be detrimental to health.
peter.mansfield@flinders.edu.au
www.camtech.net.au/malam
PO Box 172 Daw Pk SA 5041 Australia
ph/fax +61 8 8374 2245
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