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Date: Mon, 12 Oct 1998 12:29:17 -0400
To: "abrecher@arxc.com" <abrecher@arxc.com>
From: John Hammell <jham@iahf.com>
Subject: MCC is Running Amok Against Vitamins...Transcript of a Meeting
  from HELL in S.Africa-
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I think to add to what Dr. Makhambeni said, we do acknowledge this problem
in administrative processes. We have not looked at any form of
administration that will
apply to SAMMDRA. Hence, we have requested a financial and organizational
analysis. That will inform us of some of the processes that must be taken.
But as of now,
it is not quoted. This investigation, which is more in depth will establish
what to do. We have not as yet passed any coding system. The current coding
system applies.
The general coding system that applies to any other medicines in the
country. That is what we use in government for purposes of tendering. But
for the purposes of the
Medicines Control Council, we have not made any consideration with respect
to coding.

ANDREW MC DONNALD

Do the codes stay the way they are ?

MRS. MTSOSO

Well, it is a matter that will have to consult on.

DR. MAKHAMBENI

Thank you The gentleman in the front here

UNKNOWN QUESTIONER

(QUESTION NOT HEARD ON TAPE)

DR. MAKHAMBENI

If someone here says, the law is the law, I think we have clearly said that
we would like to engage in constructive discussions with all role-players.
To discuss ways
forward. We have also said certain things that have been discussed are such
that at this point of time, are regulated by Act 101. Some things, we
cannot do outside the
law. Now, if you could just restate the question .

PETER SWAN

(QUESTION NOT HEARD ON TAPE)

PROFESSOR EAGLES (PHARMACY COUNCIL)

I think I will lead that as the Pharmacy Council. Basically we approached
all stakeholders to help us define the Act. I do not see this particular
approach from being any
different. I think it doesn't matter who we talk to, at the end we are
going to make the decisions, based on fact, and what is good for you, and
the regulatory system, as
we see it.

ANTHONY REES

How dictatorial !!!

PROFESSOR EAGLES

I think we are really committed to negotiation. That kind of remark is not
actually called for !!! We are actually saying to you, let's together work
out our destinies. So,
there will be no problem with talking to lawyers about anything. I think it
is a kind of open process.

DR. MAKHAMBENI

Thank you Professor Eagles Dr. Rees

DR. HELEN REES

I think .. I am trying to listen very hard to the problems that people
have put forward. I do accept the you are quite right, that our creativity
is going to only come
from one place in this process. That is why we are sitting here today, to
try hear exactly what the problems are. Now, we agree with you that we have
problems in this
transitional period. We absolutely agree with you. That is why we sought
opinion, and to be quite truthful, it has not helped us at all. I think
this is what you are discussing.
Um in the light of that, if you in consultation with your lawyers can come
up with creative suggestions that could solve the problem, we would welcome
that.
Considering that, we also have to consult with our lawyers. If we could
find a way out within the law to address the problem at the moment, we
would welcome it , and
that is exactly why we are listening to your suggestions. So, my answer to
your question is, if you come up with anything creative and everyone is
convinced is within the
law, and help us get over this bridge, we would welcome you. You had
another question. What was the question again ?

HILLARY SHANNON

It is regarding the embargoing of products. If the motivation is really for
the protection of the public and that those very products are going to be
able to be registered
under the new Act unchanged. My question is. If they are not registered,
why can we not in the interim look over that. The analogy I use is, just
before the official end of
apartheid and before it was abolished, one overlooked petty apartheid. Much
was overlooked at that stage. Why can't we do that now ?

DR. HELEN REES

Is there a creative solution. We are saying. If we can find one under the
present Act, we would welcome that because I think we feel very
sympathetic. I think the
problem that customs and the inspectorate are faced with is clearly, you
are standing there saying that you have ethical goods that are safe, and
effective and I want to
list them, and I think that they would pass with no problem. The problem
for the inspectorate is that that is not true. I think that you would agree
that it is not true for all
the products that are being brought in. And so, we can't leave that call to
an individual inspector to say - My call is that person X will have good
ethical products, but I am
going to embargo Y because I do not know that person and where the products
come from. It is an impossible call. This is where their hands are tied. I
think what we
keep coming back to is the frustration of this interim period. Indeed this
is what the Complimentary Medicines Committee have indicated. I know people
have had all sort
of frustrations with the process, but they have shared that and banged the
table and shouted at us on the MCC. We have understood it. That is why we
got the legal
team, and it has not helped with all honesty. So, indeed, what I am saying
to you, if you can find a way, by looking at the Act, and believe that
there is anything that will
allow us to go through this transitional period, we would welcome it. I
think our inspectorate are also frustrated because they have to do their
job. This is what they are
obligated to do. They have no leeway within the Act. We cannot at the
moment give them leeway. We will go back and talk about what you have said
but, please note
that we are saying - We note this - Come up with some ideas - and we will
go back and think about it again, and let us see if we can find a way out
of this mess.

DR. MAKHAMBENI

Thank you There are a lot of people who have been waiting to ask
questions for a long time. This gentleman in the front here. Followed by
the gentleman with the
blue shirt.

SINDEPHI SPOGTER

Thank you very Mr. Chairman, and the Medicines Control Council. My name is
Sindehpi William Spogter, cum Cina. I am a traditional healer. I am from
the I.C.C, in
short the Interim Coordinating Committee For Traditional Medical
Practitioners of South Africa. Just in brief, we were the first group in
1996, on the 27th of March who
submitted proposals for legislation of traditional healers in this country.
Under the Senate, we then got the key from the Minister of Health, she was
there, and we put our
point forward. That proposed legislation contains all the standards, code
of conduct, as well as medicines included. We are so disappointed today
that we are hearing
about the MCC and the SAMMDRA Bill where traditional medicines are defined.
Since 1996 the Department of health have known us and heard from us. The first
question is, we as the ICC want to contribute to the health care system of
this country. Why have we never been invited ? (clapping from audience) For
all these years
we have been fighting. We fought the apartheid regime. We were banned in
1913. Our grandfathers were labeled as witchdoctors under the persecution
of witchcraft.
Now we are in a new dispensation. Why were we not invited here ? .
Because, why we are saying this - you are talking about medicines. You are
talking about
listing. Do you know that we as traditional healers, we represent eighty
percent of the population of this country before they go to the western
doctors ? (audience claps)
Secondly, there are people out there who go out saying they represent
traditional healers. What are you saying about these people. We have never
hid ourselves as the
ICC. I feel very, very badly about this. I was not instructed by our
committee to come and partake in this meeting. I was instructed by people
to observe what is going on
here. We appeal to the Medicines Control Council to restructure yourselves.
The CMC structure applies as well !!!! Why ? Because we are represented
throughout this country. We will be getting our legislation because we need
an Act of parliament very soon. All the hearings you saw take place in this
country, were
initiated by us !! WHY DO YOU LEAVE ICC OUT ? Those are the questions I
would like you to answer. I appeal that in the future, that whatever you do
concerning
us, we need an INDABA, because we have been left out for a long, long time.
We have got stakeholders here who we are working with. The pharmaceutical
companies, we are working with them. Why do you leave traditional healers
out ? Thank you.

DR. MAKHAMBENI

I will ask Mrs. Mtsotso to answer your questions. The CMC must restructure
itself. When the SAMDRA Bill comes through, a new structure will be brought
about. I
just want Mrs. Mtsotso to respond in terms of what attempts have been made
to establish a forum for traditional healers.

MRS. MTSOSO

Thank you chair. I will try address you with respect to the processes which
are not addressed here. I think you are aware of the National Drug policy.
One of the
components of our new drug policy, is to have a National Reference Center
For Traditional Medicines. I think that that forum in particular will
address traditional
medicines of plant origin. With respect to that, a process was initiated by
the Department of Health and Stuart Thomson of PHARMAPACT came to one of our
meetings. With respect to how that was organized, we invited a number of
stakeholders at the first meeting to look specifically on how we can begin
to have that
reference center established. We looked at several areas. I will just
mention some of them. One was to look at traditional medicines, and
especially of plant origin can be
considered in terms of usage. The second one, was how we are going to look
at Intellectual Property Rights. And how they would apply. The third thing
was looking at
how to bring in several resources in the country and establish a central
data base of all work that has been done by several institutions. These are
botanists,
pharmacologists, and traditional healers. I want to say that it is very
difficult for the Department. We have tried to draw in as many stakeholders
as possible to share
ideas. The National Reference Center has not yet been establish. We are
still looking at several measures. We are still collecting information. We
have also gone further
to look at how standards will be set, in terms of code of conduct,
medicines, etc.. Specifically the standard of traditional medicines of
plant origin. What was considered
was, the center become established as a resource center for products. It
will not only be an institution for a few stakeholders. We are looking on
how to draw in the
resources are need in this country. One last thing, is we are looking on
how to protect our environment so that plant can not just be used anyhow.
Environmental
role-players will also advise us on how to protect the environment. So, we
have drawn in as many people that we could get hold of, especially
traditional healers. A group
has gone out to find out who the several role-players are. It is difficult
to know. We acknowledge that fact. We have not looked at regulatory aspects
with respect to that
process. We have just looked at how research can be conducted and how to
pool resources.

SINDEPI SPOGTER

Just a second, you are talking about a Bill that is coming up.

MRS. MTSOTSO

With respect to my response to were not talking about you in the
Bill.??????????????????????

SINDEPI SPOGTER

No, no, this is a question which worries me !!!!

MRS. MTSOSO

Is this a second question ?

SINDEPI SPOGTER

Yeah, just a follow-up question. We have got a problem that we are
provincially governed. There are a lot of people as far as Komatiepoort
that we are visiting. From
four corners of this country. Now, most of these people know nothing about
this Bill or anything that is happening. Now, my question is - We also, as
health providers.
Only certain people elected by those of the previous regime are represented
on the bodies here, without our knowledge. What is going on here ? These
are not our
elected representatives. (No comment from the committee)

DR. MAKHAMBENI

As I said earlier on. People, who have burning questions come out and
direct them to us or the Precious Mtsotso, who will respond to them.

DR. NTSALUBA (DIRECTOR-GENERAL OF HEALTH)

Can we just say, in addition to what Precious was saying, I need to respond
to the gentleman. I think we are looking at two processes. We are looking
at the SAMDRA
Bill and are looking at another process which is related to the general
practice of Traditional Healers, which is a bigger problem. I have heard
you talking about the
process, which we initiated in the Senate. But, that process deals largely
with the regulatory framework for the practice of traditional healers. Now,
you also know that
the report from the Senate at the end of that process was discussed by both
the Senate and the National Assembly Portfolio Committee For Health. The
two of them
have set a process further, which has been communicated by Dr. Twebu to
representatives of traditional healers. That process is ongoing. So, in as
far as that process is
concerned, there is ongoing consultation. Let me just draw that distinction
so that we do not start confusing the issues and processes that relate to
the processes in the
SAMMDRA Bill. Because as much as there are elements that cut across both,
there are significant differences in the two processes, and what the two
processes will
achieve.

DR. MAKHAMBENI

Thank you Dr. Ntsaluba

JONATHAN WOLF (YOUR LIFE)

Good afternoon Ladies and Gentleman. My name is Jonathan Wolf. While I
understand the law is the law, and nobody can do anything about the law. It
is the MCC
secretariat and inspectorate who apply the law. Now, my understanding is
that.. I know people in this room will stand with me on this . The MCC
applies the law
more strictly to some companies and less strictly to other companies.
(clapping from audience) I would like to know why people in this room are
still trading ? Why is it
that products are still sitting on shelves ? Why is it that certain people
like Denise Maidment and myself have criminal charges laid against us this
week, while the rest of
us don't ? Since the law is the law, should the law not apply to everyone
here ? I want to know why ?

ANTHONY REES

Either take us all out, or leave us alone !!

MRS. MTSOSO

It is a difficult question, but I would like to answer. Mmmm.. What has
been brought to our attention , and I think this is what I communicated
yesterday to Denise,
in terms of the law, when inspectors are informed that there are illegal
products they do apply the law within the framework of their mandate. And,
if by any chance that
any member of the public has that knowledge, that gets communicated to us
and we do send inspectors. I have made it very clear that we are aware of
products that are
being sold and are not registered. We say that is information that must be
brought to us so that the inspectorate can enforce the law. I think in
terms of that - I think it is
very difficult - you request of us to ignore the law and not enforce it. We
have a responsibility. A responsibility to protect the public. I think our
difficulty is that we can
not assume that any product that is in the market by word of mouth is safe,
and is of quality. We can not assume that. We have a process to ensure
that. It is only our
mandate and we have to act within that mandate. Now, if there is a product
that is available illegally, the law will be enforced. There are people who
have applied to the
requirements of that law, and as long as we have that, the law will apply.

DR. MAKHAMBENI

Thank you, that gentleman there ..

ALEX NIVEN (VETENARY SURGEON : USES HEALTH PRODUCTS ON ANIMALS)

Mr. Chairman, I thought I was never going to meet you. My name is Alex
Niven. I recently passed my fifty-first birthday and think my hand has been
up so long that my
sixtieth birthday is quickly approaching. I must confess of my virginity
here. This is the first opportunity I have had to attend one of these
meetings, and I find it absolutely
fascinating. It's a real melting pot. However, I would like to bring up a
problem which has not been voiced so far yet Mr. Chairman. We appointed an
elected
government to help our country. We have a massive problem of unemployment
in this country, and if you look at the figures exposed yesterday,
unemployment is
increasing at a terrible rate. Now, we have a listing process which has
been ongoing for almost two years, and with a little bit of effort and
common sense, could be
implemented very quickly. The Rand exchange rate is not alarming, it is
wonderful. Because we have an enormous opportunity for export potential
here. My question is
quite simple - How quickly can we get this listing process implemented so
that we can export new medicines and existing medicines to save the
population from the dire
mess that it is in ? (Audience claps)

DR. MAKHAMBENI

Thank you, I am going to leave that question for Dr. Rees to answer.

RICHARD MATHIAS (OWNER : HEALTH FOOD STORE)

My name is Richard Mathias, and I was appointed among some other people to
an interim solution committee at the last BBRG meeting. It is here that I
stand on the
same subject, and I appeal to all of you honorable people for a moratorium
right now, before any of these suggestions of a new law be put into force.
On the subject of
being legal or illegal, I have the following possible solution to part of
what you are saying. We had, in 1985, registrations, which turned out to
not be registrations for a fee
of R25.00. Those fees made certain products safe. (people laugh) Those
products are now, when somebody else wants to market them, suddenly unsafe.
I can't
understand this at all. So, it goes back to a question of safety, Helen.
Those products were safe in 1985. A thousand i.u of Vitamin E was safe in
the 1985 registration,
and now someone else brings in 1000 i.u Vitamin E, and it is not safe. Now,
I must also mention what could be a starting point for you and your idea of
getting some form
of cohesion between us. It would, if you lifted those gates, where
everybody can market the same way a 1000 i.u of Vitamin E and 1000 mg of
Vitamin C which is illegal
at the moment, then you will get some respect from the people you are
talking to and the people you want to talk to. (Audience claps) I have
another question which I
want to ask you. ecause a fee of R2000.00 is being mentioned now in 1998 to
register the same products. Yesterday I saw some of the people here,
including the
Registrar and they asked the question about - how are the R25' ers going to
fair as far as upgrading is concerned? She said there will be no fee. (Boo
from the
audience) So, the R 25 'ers are still in business, and I now start talking
as a businessman. Two things have happened, first of all, the Supreme Court
of South Africa,
some months ago said that all the products are illicit and illegal. We have
been talking about legalities today. I do know one thing, that when a
subject is declared illegal, it
cannot be re-dressed up and upgraded to become legal. It is illegal and it
has to be deemed legal again before it can be re-dressed up. That is a
point I want everyone to
bear in mind in this room because it might come back in your face. The last
thing is that - yes it is a question - as a businessman, what are we going
to expect, and I ask
you again, to pay when the new law comes into force? Because, if I had to
put down R 2000.00 today, and I suddenly see the new Bill saying R 80.00,
then I am a very
bad businessman. So, in the meantime, I must stand back and not register.
But, in the meantime I am going to be illegal, and I am going to be
reported to the Narcotics
Bureau. And, maybe I will be put in jail. I can't reconcile this. In
humanity terms. I go back to the days of apartheid, where people were
moving over. Even then,
during the interim period when blacks were not allowed on busses, people
got on busses and it was just accepted. I call this moratorium again. Laws
were set aside, and
I suggest that the moratorium does the same thing here. (Claps from
audience) Thank you ..

DR. MAKHAMBENI

I am now going to ask Dr. Rees to give her closing comments so we can
address some of those questions that have been asked.

DR. HELEN REES

I think before my closing thoughts, and not necessarily closing solutions,
they are closing thoughts. I am going to talk about some things that
Anthony Rees mentioned,
which was asking me about my mandate. My mandate, when I was asked to take
on this position was in fact to assist and oversee the transformation of
the Authority
from where we were to where we want to be. I think that I will continue to
take that mandate extremely seriously. That is why I sat and listened to
what people have
had to say here today. I am not saying that to just fool anyone in this
room, because it is clear that there is a constituency in this room that is
a problem to the MCC. I am
just going to summarize what I think we, as the MCC are going to have to
take away and think about again. We need to make some suggestions to
yourselves, so we can
go away and consider this. It seems to me that there are certain themes
that have come up repeatedly, as you have talked. One is a sense of the
process and playing
fields have never been fair. From some perspectives, there might have been
vested interests and that may have biased things in one direction or
another. Now, as I am a
new person to this forum, and that I am relatively new to the position, I
must listen to that and ensure that we sit with all the stakeholders. We
must look at if the playing
fields have not been fair in any manner, become fair. I think this is the
first thing. Indeed one of our intentions is to start to look at the vested
interests and codes of
conduct in the existing Council and it's committees. We are going to draft
that for ourselves and have it ready before the new legislation. I think
that is one big message I
propose. OK, we will come back to that. The second thing that is mentioned
is this interim period and as I say that the CMC has thrust that view on us
I know it is
leveled at us that we are saying one thing now and something else later and
that we are not consistent. It is R 2000.00 now and question mark in the
future. One thing
that I would be very happy to do now, is entertain any suggestions that you
may come up with. We are going to go back to our lawyers again now in the
light of what you
have said, and say to them again - Is there anything we can do. We have
felt your needs. Your needs have got to me. I am sure I will go back with
my colleagues and
say - It there anything that we can do ?. I think we all need to find a way
so we can start the listing procedure as soon as possible. I think that
will begin to address some
of the frustrations that we face today. I think that you should realize
that the secretariat and the inspectorate are faced with the confines of
the law which they must
work under. They are public servants and are bound by law. They are not
picking and choosing in terms of what they do. They are not choosing. They
report to us on
everything they have done. The only way to change that is to find some way
in the interim to go forward. A moratorium has been suggested. At the
moment we are
bound by the law. Let's see whether there is any solution. Let's try. I
think that this is an industry that has the potential to create small
businesses and we must note that.
We must note that, and we have noted that. The other comments I would like
to make finally is, the comment of questions of democracy, and voices not
being heard. We
are going to create a system that is as transparent as possible. I think
the existing Council is beginning to understand more and more about your
frustrations, and I
personally would like to thank some of you for being extremely loud, and
not being silenced. So, no matter what the mixed feeling are, I am glad you
have spoken your
frustration. I think what has to be accepted is that there will be a
legislative framework that will bind all. In the formulation of regulations
we need to get as much input
from yourselves as possible. And in the way we enact the Bill, we need to
ensure it is fair and open to all. I think that at most people will agree
that at the end of the day,
we cannot have a large constituency making decisions themselves on
everything. The process is going to fair. At that end, I would encourage
you to "A" give us written
inputs around the Bill and these developments, and "B" to make your
submissions to parliament, in either writing or personally at the
Parliamentary Portfolio Committee
for Health. I think that we have hear all the frustrations and in the
future, whenever we have to go ahead and attend these kind of meetings. I
regard this as part of my
mandate. We wont always agree, but I think healthy discussion is healthy.
We will go back and look at a way to address these frustration.

DR. MAKHAMBENI

Thank you Dr. Rees .. There was a question which was unanswered. I will
ask that we address thet after the proceedings. I will now ask Dr. Ntsaluba
to give
his closing comments.

DR. NTSALUBA

First of all, let me completely identify myself with the comments made by
Helen. Just to reassure you, the Department will start to attend to the
problems that have been
raised. One thing that has been reassuring at the beginning of this
meeting, is that this is not something that I am too familiar with. What is
reassuring to me is the
consistency between what I have heard here and the briefing I had before
the meeting. I have noted the main areas of concern. I think that is
reassuring, as it makes me
feel more in a position of comfort. I think it is more difficulty to deal
with issues when there are contradictory messages. I want to thank you for
raising you concerns and
raising them sharply. You have raised them quite clearly, and honestly. I
think you have raised them with a passion of what you feel about these
issues. The two things
that I wish to appeal to you to assist us .. I think, as Helen does, that
we all make assumptions. That is not only for us in the Department of
Health, but in any work
environment. Those assumptions are often made on the integrity of the
people that we work with. Now, if for whatever reason there are legitimate
grounds to question
the integrity of the people we work with, then I think those problems need
to be raised factually, so practical steps can then be taken. If for
example there is a view that
the current secretariat of the MCC, whether the registration side, or the
inspectorate side, is applying different standards to different
individuals, I think that these must be
raised and we can deal with the substance of the problem. We have come from
the position where we have entrusted a group of individuals, with a
responsibility, to the
best of our understanding that they are discharging their duty in a manner
which is responsible. Quite clearly, we are not with them all the time,
therefore if there are
issues that are of concern to you, they must be raised. The second issue
that I would like you not to make a big issue of is Let me say
something crude.
Currently we have a criminal justice system that all of us question about
its success. Now, we know that as a matter of fact, that not everyone who
has committed a
crime is known to us, or everyone. The fact that some people are known and
some people are unknown should not be an indication to turn a blind eye on
those who you
may know are committing crimes. It is for us as a nation and as a country
to begin to join hands and identify those who are committing crimes we
don't know. This is the
only way we are going to build our country. Any other route, no matter how
emotionally appealing it is, it disastrous. I think we must stand up and
hold sacred our
constitutional dispensation. We refer to our constitution with pride at
some times, but at other times we try to undermine the very, fundamental
building blocks of our
constitution. I think we must be clear about that. We must make up our mind
what to do and make our choices initially. Once we have made that choice,
we must
sometimes accept the pain that comes with the choices we have made.
Finally, let me thank you and say to you that I will from now on be working
close to you and the
Council. If there is anything at the Department that we can do to expedite
the process to the solutions of the problems. I see no danger whatsoever,
and I see no problem
with the legal opinion that the MCC and the Department received. If anybody
has a different legal opinion, and that it can stand the test of time,
let's share that opinion.
We are going to be doing a lot of work. We have a series of meeting with
Helen, where we are looking at Act 101 as well as the regulations. We did
go through the
process at looking how to expedite the process through the present
regulation. We came to the conclusion that we can not. That was based on
strong legal advice that
we got. If there is anyone who can produce a standing legal view, that
would stand, then we would be prepared to look at that. We have looked at
pushing the
SAMMDRA Bill during this year because it all rests on the issue of
registering complimentary medicines. This forced us to make an appeal to
the portfolio committee of
health in addition to the other three Bills to consider putting this Bill
before parliament. Precisely because of the sense of urgency that we
clearly got against us. I would
really like to say, let's join hands and try to deal with these issues.
There are problems. There are difficult problems. We can only solve them
and put in place a
sustainable process if we work together. Again, I appeal that we are in the
process of reconstitution the MRA. You do not reconstitute something unless
there may have
been certain deficiencies there. We know that there are also many positive
things with will come out of the new Medicines Regulatory Authority. Let us
look at the
deficiencies, look at the good points, look at the good international
practices, and move forward. In the process of doing that, it will not help
us if we carry the garbage of
the past into the new. We all need to accept that we all need to build
something new, and make constructive input. Thanks again very much .

MEETING CLOSES.