E-drug: Re: Novartis advert (6)
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Hi all
In responding to the advertising issue, Neil Soderlund requested input on
the legal issues (at least those applicable in South Africa):
Although I am not sure of the letter of the law in South Africa,
this would seem to confound its general intention. Any other
comments on the legality of such advertising in South Africa or
elsewhere would be appreciated.
The situation in terms of the Regulations to the Medicines and
Related Substances Control Act, No 101 of 1965 is quite clear -
medicines may only be advertised to those who are in a position to
use the information so imparted to make a choice to use/prescribe or
purchase the item. So, those mediicnes which are scheduled for
over-the-counter sale can be advertised in any medium (the definition
of advertise is broad, encompassing any means by which the
information is brought to the notice of the target). Those medicines
which are restricted to prescription use may only be advertised in
media which are normally available to pharmacists, medical
practitioners and dentists (and veterinarians where applicable).
However, the price of a prescription medicine may be advertised to
the public. In addition, the advert may make no claims beyond those
which have been substantiated in the application for registration of
the medicine.
However, Neil raises a quite different issue with the following
statement:
I would imagine if 10% of your covered population suddenly starts
demanding the latest miracle cure, this tends to concentrate the mind.
Imagine the effect on an Essential Drugs Programme or a Rational
Prescribing Campaign of consumer-directed advertising in support of
the "latest miracle drug"? The high percentage spend on medicines in
the private sector insured population (about 30% of total costs) in
South Africa is already testimony to the power of that market. We
have seen some efforts in the private sector to introduce limited
lists and so-called "formularies", often based on price rather than
evidence. Nonetheless, this advert raises quite another issue - how
succesful will legislation like that in SA be in the Internet age?
If manufacturers choose to place product information on a company
website, can that be proscribed by national law? In South Africa we
already have a website which houses all the package inserts of
registered products - can that be construed as "bringing to the
notice" of the public, information about prescription-only medicines?
Andy Gray
Co-ordinator: Drug Management
Initiative for Sub-District Support
Health Systems Trust
andy@healthlink.org.za
PO Box 70451, Overport, 4067
Tel: 27-31-2044358 Fax: 27-31-2044792
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