E-drug: Comments to Mr Bada Pharasi
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Dear Mr. Pharasi,
I believe that the South African Medicines Regulatory System Review report
and
proposals for reform should be supported in principle. I am however in
disagreement with certain recommendations that appear to be in flagrant
violation
of South African law. In particular the recommendation that the present
Medicines
Control Council (MCC) should cease to exist. I am surprised that the review
committee couched the recommendation in such strong terms and totally
ignored
the existing requirements of our law. Albeit that may not (and hopefully
this is the
case) have been their intention, the statement was taken up literally by
the press
and the impressions initially created by politicians that the MCC had been
disbanded. This detracts from the positive value of the report.
Any expert committee putting forward suggestions that are going to affect
the daily lives of all the citizens of the country should be sensitive to
the
environment that we live in. They should not propose (albeit possibly
innocently)
a state of civil disobedience in the country by ignoring basic conditions
of the law.
Long after they (the experts) have left, we have to pick up the pieces and
carry
on our daily lives in a responsible way. Let us build on what we have and
be
weary of quick sure and wrong answers to very complex questions. South
Africa
is struggling to curb crime in its emerging new society. We should not
create the
impressions that civil disobedience will be tolerated nor allow people to
undermine what we have built up so far. It damages the very essence of our
society. Experienced people know all to well that developing countries have
frail
systems that need nurturing and support and will capitalize on its
infirmity to the
detriment of all of us. An outright attack on good order however deficient
cannot
be tolerated until a new one has been put in place. Let us work towards
creating
such a system.
The Minister of Health needs to be commended on recognizing this flaw and
acting appropriately by not dissolving the MCC immediately and recommending
that they work together for the good of all of us. There is so much to be
done!
If the review committee membership had included the appointment of a local
legal
expert I am confident that the report's credibility would have been
enhanced.
Perhaps we should bear this in mind in future?
The message to Mr Pharasi and the people selected who have to implement the
recommendations is that we do have South African citizens that can
positively
contribute and assist him in devising a system of drug registration and
control
that will be suitable for South African if not African conditions. I have
mentioned
repeatedly on national and international public platforms that we need to
find
African solutions to African problems and be careful not to import
ready-made
fixes that ignore our rich multi- cultural heritage. I believe this is
possible if we try
to find the common good. Let us use our limited valuable resources in the
interests of all our peoples.
You are requesting comments on the structure, as we now have to work on the
details of implementation. Before we do that a number of issues mentioned
in the
report need to be clarified. We must outline the background, principle
issues and
objectives very carefully before we tackle procedural matters.
My questions to you are:
1. Please explain your understanding of the split between policy and
technical
matters;
2. What are the expected benefits to the public of the proposed new system;
3. What is the existing MCC's opinion and have they put forward any
recommendations;
4. On what authority was the review committee granted the right to extend
its
mandate beyond what the Minister proposed;
5. What part of the report, if any does the Minister reject;
I wish you well in the great task ahead and good luck!
Best wishes,
Rene Doms
rene@pharma.co.za
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