E-DRUG: Controlling advertising
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Dear E-druggers
Since the advent of the democratic government in 1994, South Africa has
undertaken a fundamental review of its health system, including all
relevant legislation. Accordingly, the Medicines Act of 1965 is in the
process of being reworked. Although the new Act provides for a legal
means to control the promotion of drugs, the details still have to be
provided in the form of Regulations.
HealthLink is a project of the Health Systems Trust, a leading
non-governmental organisation in this field in South Africa. The core
aim of the project is to meet the communication and information needs of
health workers and planners. One avenue that is used is the Internet. In
developing our services in this area, we have become aware of the lack
of effective mechanisms in current legislation. We therefore invite
comment on the following issues, in order to inform our submissions to
the legal drafting process. We would welcome comment on the questions
raised from all interested E-Druggers, and undertake to post a summary
of input to the list once it is received and collated.
Question 1
Should drug promotion be the subject of legal restrictions or be left to
industry self-regulatory mechanisms?
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?
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?
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"?
Question 5
What sanctions could an international legal mechanism apply?
Question 6
Which international structure could police such agreements?
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
* a web site which provides the national
Essential Drugs List (by generic name), together with the relevant
standardised treatment guidelines (algorithms)
* a web site which provides the material included in the national
Medicines Formulary (including prescription only medicines)
* an electronic journal aimed at health professionals that contains
drug company advertisements for prescription only medicines that is
available unrestricted on the web?
If they are acceptable, what loopholes might this reveal in the current
approach?
--
Candy Day (HealthLink, Health Systems Trust)
candy@healthlink.org.za
Andy Gray (Drug Management, ISDS, Health Systems Trust)
andy@healthlink.org.za
\\\ Candy Day, candy@healthlink.org.za
/// HealthLink, http://www.healthlink.org.za a program of
\\\ Health Systems Trust http://www.hst.org.za
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