Mark,
You raise a very interesting issue. I have tried to investigate the data and
the publications around this topic.
Firstly the WHO report is an old report of a joint WHO/IFPMA workshop that
does not contain very good data.
Secondly there is a confusion of terms being used. Some people talk of
"fake" drugs which include counterfeit which are drugs that contain no
active ingredients but are usually packaged very well and are nearly always
expensive brand name products that are still patent protected. There are
also sub standard drugs which contain active ingredients but do not meet
pharmocopeal standards. These are usually generic drugs made by small scale
local or regional manufacturers who often lack quality control capabilities.
These are very different situations and the response to the two situations
needs to be different. The brand name true counterfeits are criminal
enterprises and need international police responses. The substandard
prparations need a different response in which the production or QC problem
is identified and remedies proposed.
I have been told that the larger multinational drug companies do have data
on their products but do not publicise the incidents for obvoius commercial
reasons.
A lot of statements get made about 30 or 40 or 60 percent of drugs in Africa
are counterfeit! I do not know what justification there is for these
statements. When I have investigated where countries have done quality
testing these statistics have not been confirmed. When I was in Eritrea in
January this year I reviewed the quality control test reports on 10
different drugs sent to a University reference laboratory in another African
country and all 10 simples were within BP or USP standards.
So my conclusion is that there could be a problem particularly in the
private sector but the evidence is not available. We need to find a way for
samples to be taken on a regular basis, to be tested in a reputeable
reference laboratory and then the results need to be publicised. This should
be both the negative and positive results! Finally there would need to be a
response when counterfeit drugs are discovered.
The reason for this concern is the lack of regard for the regulatory
authorities in developing countries who often do not have the capacity to
police the national drug market. When countries allow drugs to be produced
for export which do not have to meet national quality standards it is very
difficult for regulatory bodies to deal with unscrupulous agents.
I would be very interested to hear of properly conducted surveys with
confirmatory laboratory testing.
This is an intesting topic!
Richard Laing
Associate Professor of International Public Health
Boston University School of Public Health
53 Bay State Rd,
Boston MA 02215
Tel 617-353-6630
Fax 617-353-6330
-----
Comments from the E-drug moderator:
The 'fake", inflated figure that over 50% of drugs in Africa would be
counterfeited (read: substandard or counterfeited) probably is
misquoted from a study done in Nigeria among illegal drug sellers
in the streets of Lagos. The study was published in Nigeria, but I can
only give the reference at the end of November (as I am currently in
South Africa). Maybe someone else knows it?
The 'official' figure of the April 1992 WHO/IFPMA counterfeit meeting
was 5-6% This was based on undisclosed industry sources, and probably
related to studies on counterfeits in general. WHO has neither confirmed
nor challenged this figure of 5-6%
Industry is probably keeping many 'real' counterfeits secret. It could
be argued from an ethical point of view that:
- industry should report ALL counterfeit findings to the national
Drug Regulatory Authority, on a confidential basis, and that
- Drug Regulatory Authorities (or Industry) should issue public warnings
on counterfeits which are dangerous for the public (for example, because
they do contain a completely different active ingredient, or sub-
therapeutic dosages in case of antibiotics.
Wilbert Bannenberg, E-drug moderator
email: 73377.3055@compuserve.com