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Return-Path:
Errors-To: <>
Date: Mon, 12 Oct 1998 12:29:17 -0400
To: "" <>
From: John Hammell <>
Subject: MCC is Running Amok Against Vitamins...Transcript of a Meeting
  from HELL in S.Africa-
X-MIME-Autoconverted: from quoted-printable to 8bit by id CAA02688

IAHF List: Anthony Rees, a health freedom fighter from the South African
group PHARMAPACT has just transcribed the minutes of a meeting that just
took place which illustrates the gross scam being foisted off on dietary
supplement manufacturers and the consuming public there. A bill which turns
vitamins into "drugs" is being shoved down their throuts at very high
speed, and the MCC is raiding health food stores and threatening people
with arrest. Note the comments below of Hillary Shannon, and Anthony Rees
especially. I met them when I was in S.Africa. Hillary Shannon was driven
completely out of business when the MCC impounded her aromatherapy oils.
She lost her house, her car, and everything she owned trying to fight them.

Anthony Rees's questions graphically illustrate the gross lack of
transparency and honesty in the S.African proceedings, and two of his
questions which were evaded raises serious questions as the the legality of
what the MCC is doing, and this could be used against them in court. When I
was in S.Africa, I interviewed some health food store owners who
anticipated being driven completely out of business if this bill gets
passed. They gestured at their goods and told me that under their current
law, almost all of them are "illegal". PHARMAPACT has identified very clear
links between the pharmaceutical industry and the takeover campaign they
are currently facing. I strongly encourage all S.Africans to hold a massive
demonstration against this bill. They have one month to try to stop the
most undemocratic process imaginable. If you live in CAnada, or the states,
be glad, thats all I can say- because S.Africa is a total dictatorship when
it comes to the sale of natural pruducts, and the process they're using
there to try to burn them threatens to become what the rest of the world
will "harmonize" to. The transcript below is from


                            SO-CALLED BROAD-BASED REFERENCE GROUP


                                   MEDICINES CONTROL COUNCIL AND


                             HELD AT THE BOULEVARD PROTEA HOTEL, PRETORIA:
9/10/98: 2-4PM

(This document uniquely comes to you courtesy of PHARMAPACT, whose
Co-co-ordinator, Anthony Rees attended as observer to this
illegitimate forum with a mandate to defend PHARMAPACT'S position, if
necessary. As noted, this was the case and his performance in
this regard is exemplary.)


(Anthony had the foresight to audio-tape the proceedings and has rendered
an extremely valuable service by laboriously transcribing the proceedings
with the exclusion only of the usual introductory "the law is the law"
rhetoric, repeatedly heard ad nauseum. We take-up proceedings where the
information recorded
becomes a valuable actionable record.)


We have looked at amending the Medicines Control Act 101 of 1965. The
amendment of this act will come into being when we get the SAMMDRA Bill. The
SAMMDRA Bill requires that Complimentary Medicines require different
processes. We also have to deal with the current problems that we are faced
with. Our
recommendation is as follows: We must look at the Act as it exists, and
those of you who need to apply for registration of medicines, they need to
use the current Act,
and it's regulations. Most of you have raised concerns that the current
regulations, especially MBR1 do not apply. Our view is that we can not do
anything about that
because the current Act is an Act of parliament. We do however realize that
the current Act does allow for exemptions. Section 36 of the current Act
exemptions. However each product will have to be evaluated by Council,
based on how it is presented by whoever applies for application. Council
has it's own technical
committees who will deal with that application. I think that we are as
Council bound to comply with the existing law. This is the legal opinion we
got and we can not
move away from that.

I do realize that the MBR form provides for the registration of both human
and animal medicines and that 16 annexures should be filled in. This is
what the regulations
say. These are the forms you should use under the current Act. Hence we
say, please refer to these forms as they are legally standing and that is
what the law
advocates. The opinion we have is that everyone must comply with the
current law until there are amendments. The law will be there until there
is the establishment of
the new SAMMDRA Bill.

Our understanding is that the fees applicable are written into the
regulations and that the fees will apply within the current law, within the
existing law. This must be done.
Only after we have a new law, will fees possibly be adjusted.

We do have a process which has been established where we have appointed a
committee the carry out a financial analysis for fees. This committee will
advise us on
what the appropriate levels of fees will be in the future. The current Act
and it's regulations apply.


Thank you Mrs. Mtsotso. I would like now to ask Mr. Andre Van Zyl to come
up and talk to you about embargoed goods and illegal substances. Mr. Van Zyl


Dr. Ntsaluba, ladies and gentlemen.. I was asked to brief the meeting on
some of the responsibilities of the MCC inspectorate and the seizure of
products. Now, as
you know the inspectorate report to the MCC and the Registrar of Medicines
of the Medicines Control Council. The inspectors are appointed by the
Director General of
Health for the proper enforcement of the Medicines Control Act. The Act
also defines a medicine and I think you all know the definition in the
current Act. I think you
also know what is the definition of the word "sell" in the definition of
the Act means. It is important to note that the definition of the word
"sell" in the Medicines Control
Act includes: offer, advertise, import, and keep.

The current legislation also prohibits the sale of medicines that are
subject to registration and are not registered. This also means that if one
applicant has applied for a
particular product, and that that product is registered or if there is an
application for that product, and if second applicant wants to manufacture
or import the same
product, the council do not regard that product to be the same.

The second applicant has to then apply for registration and wait for
registration before that product can be sold legally in South Africa. Any
person who contravenes the
provisions of the Medicines Control Act, shall be guilty of an offense in
term of the Act. I think it is vital to note that you must comply with the
current legislation
immediately until new legislation is in place. This is applicable to
locally manufactured and imported products. When it comes to the attention
of the Department of Health
or the inspectorate, that there are illegal medicines on the market, the
inspectors have to investigate because it is their responsibility.
Appropriate action has to be then
taken. We always try to apply the aldi ultrum partum rule by communicating
with the person, who we are in the opinion may be transgressing the Act.

When products are brought into the country they may be sampled, they may be
seized in terms of the Customs and Excise Act. The Customs Act also make
for the disposal of seized goods. When unregistered medicines are available
on the market, communication will be entered into with the importer or
manufacturer, and
criminal charges may be laid with the South African Police Services. They
may seize the products in terms of the Criminal Procedures Act. I trust
this clarifies the
seizure of illegal products.

Transfer interrupted!

Thank you very much Mr. Van Zyl. We are now going to come to the second
part, that is, questions. I just want to appeal to people to try refrain
from making speeches.
This is a specific time for question and answers. We have a panel of people
who are going to respond to your questions. Besides the people sitting at
this table, in addition
there will be Dr. Stoffberg, Mr. Michael O' Brien, Dr. Allan Tomlinson, and
Dr. Patricia Tsotsetsi.

Now, I think to make this quite manageable, I would ask someone to take a
pen and paper around so that we can take the names down of people asking
questions. I see
one hand up at the back already. (pointing to Hillary Shannon). I would
like each person who asks the questions to state their names, so we can
know who they are, and
then we can get a response.

The lady right at the back, there .


I am Hillary Shannon.


I think perhaps if you came to the front and gave your question over the
microphone, most people will hear. Please come forward.


Good afternoon everybody. My name is Hillary Shannon, and I work in the
field of vibrational healing. I had my goods seized by customs and kept
there for three years,
and have been though the whole process with the MCC. My question today is.
If we are going to have a secretariat, is it going to be formed in the same
way the CMC
was formed? Is it going to be democratically formed, or is it not? Is the
public going to be informed? Is the committee going to be comprised of
people who do not have
vested interests, who are intelligently informed, and I say this because in
the process I went through people judged me, people on the MCC made
comments. I have them
recorded. Most of them did not have a clue, of what I was doing. Bias came
through in the minutes. I need the assurance today that anyone on the new
secretariat are
put there by us and have no vested interests. (Clapping from audience)


Thank you very much for your question. Ummm.. Dr. Rees. Would you like
to respond to that question ? (Dr. Rees nods).


I think clearly, that the speaker is reflecting something you feel very
strongly about, and I think we have picked this up in Council.


This acting by the MCC has destroyed me. I have lost my house, my car,
everything in this three years of struggle with the MCC.


Ummm. I think we are all trying to note the difficulties against the
background. Now, in terms of your specific question, I just want to
separate two things for
the moment. The first is the Secretariat. The second is the committees that
will be formed. The Secretariat are the employed staff of the proposed new
who will be providing all the technical and administrative support required
to process application. What we have said is that those people will be
employed by the
SAMMDRA and we will look for their skills in the particular range or areas.

We are not going to look only at people who have a history of orthodox
medicine to run the secretariat. We are going to try find people who are
empathetic, and have
some sort of insight into the various disciplines. We accept that there
might very well be a need for anyone of those people to have training. I
think we must all accept
that. Someone might be very knowledgeable about homeopathy, but have little
knowledge about other areas. Clearly if one wants to work in a secretariat,
you are going
to need a breadth of experience that will probably come with time.

But clearly, those people will apply for jobs, and will be appointed on
that basis. I am going to come back to the vested interest question again.
The appointment of the
committees.. The Minister Of Health will have the power to appoint the
chairperson of the overall SAMDRA committee and the vice chairperson.
Including the
chair-people of the committees below that. Thereafter, the board will
appoint the members of the committees, and those names of applicants will
be shared with the
Minister. But, I think we should be very clear that the appointments
according to the legislation will be made by the board. Now you are clearly that you
want that process to be transparent as possible. Clearly this is something
people are raising here. The committee would want that as well. But, I
think at the end of the
day, they will have the legal responsibility to appoint. They will not
appoint in a vacuum. I think that the reason there are these types of
consultation is because we can
get a real and honest sense of who the constituencies are that need to be
consulted. But, at the end of the day, what is going to be looked for, are
people who are
experts, that are representative across the board, that have a constituency
that supports them, and that have no vested interests. I want to stress
that the vested interest
question not only applies to people on the expert committees, but also to
people working in the secretariat. Vested interests will have to be
declared, and that if there is a
vested interest, you will be precluded either from the secretariat or from
those committees. Any subsequent conflict of interest must be declared.
That is how the
appointments will be conducted, and I think what you are appealing for is
very honest consultation that will inform the board on that appointment.

I think that certainly, the spirit, and nature of the complimentary
medicines constituency will make that an absolute necessity. But, the
ultimate responsibility will be the
legal responsibility of the board.


Thank you Dr. Rees. This gentle man in the front (pointing to Anthony Rees


Ladies and gentlemen. I am Anthony Rees, co-co-ordinator for PHARMAPACT and
member of the International Advocates For Health Freedom. My question is to
Rees. I have two questions for you. I want you to either answer my
questions by a simple yes or no. Have you had any training in
administrative sciences ? (No
response for Dr. Rees) I need an answer Ma'm, please .. Are you familiar
with your mandate ?


I cannot answer those questions.


So, you can not answer these two very simple questions, therefore I bring
to your attention affidavits here and a PHARMAPACT writ of summons to the
Protector, with whom we have an open investigation file against you and
your colleagues in the MCC. As manditarius you are a public functionary and
have not lived up
to your function in terms of Just Administrative Action as entrenched in
the Constitution of South Africa. It is clearly documented and noted that
in each level of the
Department of Health and the MCC, the officials have failed to render the
services required by mandate in serving PHARMAPACT information in terms of
our rights. Thereby we are in opinion and hope the court's opinion, that
you are guilty of fraud and corruption according to the law. Pharmapact are
going to have to be
taken seriously in the future as we are not going to take this tyranny any
longer. (No comment from the committee)


We do not make comment upon any allegations against individuals. On those
grounds I am not going to ask Dr. Rees to respond. I do not think that this
is relevant right
now. (Audience Claps for Dr. Makhambeni and Hillary Shannon calls for

Hillary come forward, come forward..


Dr. Makhambeni, Dr. Rees, I have said what I have been through. I really
feel . In am a member of PHARMAPACT. It was the only organization from
which I got
clarity and help in the struggle I had. I feel that Anthony Rees would not
have got up here and stood up today if we had a forum of real democracy in
the past where he
could say what is really needed to be said.


I will respond to that. On the 1st of November two years ago 1996 ..
we had a meeting held by the Director General. At that meeting we took a
look at the
problem of how do we register complimentary medicines. Various stakeholders
attended that meeting. At that meeting it was decided to resurrect the
Medicines Committee, which had previously became dysfunctional. From that
meeting a workshop was called. All the role-players were asked to be
present, so that we
could look at the way forward. That meeting was held at the end of
November. At that meeting people were then elected to a smaller group that
met on the sixth of
December, where a Complimentary Medicines Committee was chosen. Now, that
committee was an interim committee to try and deal with the situation, the
situation. It was also made quite clear that the committee had to act under
Act 101. That is the legal position. We also suggested that another group
be established called
the Broad Based Reference Group. These two groups would work parallel to
address issues around complimentary medicines. That was decided because, as
I said, the
Complimentary Medicines had to function within the Act. I actually remember
the Director General (referring the Olive Shisana) saying that the
establishment of the
other group is to lobby, and ask for changes to legislation so that at the
end of the day, we can have new legislation to address the problems. At
that very first meeting, on
the 1st of November, PHARMAPACT was represented. And if subsequently
PHARMAPACT have not participated in all the follow up meetings up until
now, I can-ot
see how PHARMAPACT can blame other people.


PHARMAPACT protested from the first day about vested interests and nothing
was ever done. (Audience clap) Nothing, Admit it !


Now, the question of vested interests was raised and I would say at the
subsequent meeting when PHARMAPACT did not attend. From then on PHARMAPACT
decide to be outside of the process. If people are outside the process, I
do not see how they can come back after two years and say they a
protesting, because vested
interests are being addressed as you have heard. I also mention that the
Complimentary Medicines Committee of the time, the interim committee, is
culminating into a
new act. We are going to address those very issues that are a sore point. I
want to say that the work that has been done by the CMC was done by
dedicated individuals,
all for the safety and good of the public. People have had different
opinions and perceptions about what has happened. At the end of the day,
when the new
SAMMDRA Bill comes into being , only then will the people realize the
amount of work that has gone into the Listing Procedure. This will give us
what we accept and
will show us the integrity of those who have allowed this process to be
done. So, I just want to say that during these two years, we have had lots
of meetings, we have
had contact with the Director General. We are grateful for the kind of
support that we have had, because it has been a very difficult time. At one
stage in Council .
When this question came up about the Parliamentary hearings that people
said they were not represented. It was brought back to the Medicines
Control Council. The
Medicines Control Council again sent out invitations for people to come on
board. The Cape Lobby group attended such a meeting , PHARMAPACT again did not
respond. So,. Ahh. I hear people say that they were not represented, but
how do you represent people who stay out of the process ? That is a
question that we must
be all aware of. As much as Mr Anthony Rees, Hillary Shannon and other
people claim that they have not been a part of the process. The process
has been going
on any they have been aware of the process. They have not taken advantage
of being a part of the process.


Sir, may I respond to that in a few sentences.


You may.


Sir, the reason we have not been a part of the process from the beginning
was because the position was that the CMC, in our legal opinion was
illegal, purely because of
financial interests concerned, there was no public notice and that the
proceedings were not democratic. Therefore we stayed out the process
voluntarily because we
would not get ourselves involved with a committee which we believe has
been, and is illegal.


That is anybody's' democratic right. The fact that you made the decision
not to be a part of this process, is your right. I don't think we have a
problem with that. Hillary I
am going to take your question and I am going to give other people the
chances to ask. Please let it be a question and not a quote.


I am sorry to take up your time, but I believe that this is important to
everyone sitting here. My question is that we were told we would be looked
after and that the
problem of vested interests was being addressed for two years. My question
to people here, is if Dr. Shisana said that she was handling the vested
interests, but did not
pass on the documents for President Mandella to sign, are we really going
to be looked after, and can we trust people who say they are looking after
us? (Clap for


We cannot respond to allegations. Sorry, I do not want to take that any
further. Thank you .. (Dr. Makhambeni gestures for Rosetta Suttner to
come forward to ask
her question)


Good afternoon, my name is Rosetta Suttner. I just want to get
clarification of the registration of medicines under the current Act and
the SAMMDRA Bill. After
speaking to Mrs. Mtsoso who kindly addressed a meeting with us, I want to
have clarification that the full MBR1 has to be filled in, with application
for exemption with
annexures which the Complimentary Medicines field can not adhere to. The
fee for that would be R 2000.00 per product. Under the SAMMDRA Bill, should
we get our
registrations under the current Bill, would our registrations be still
recognized under SAMMDRA. I feel the fee of R 80.00 that was discussed is
not a fee that is feasible.


Mrs. Mtsoso, will you please respond to that.


Thank you Mr. chair. I have clearly expressed that from the opinions that
we have received that the current Act and the current regulations apply.
What applies in the
regulations is that the MBR4(?) for human medicines has 16 annexures, and
for veterinary medicines 17 annexures. With respect to that, if in the
paradigm of
Complimentary Medicines people state that the current MBR1 is for
allopathic medicine and does not apply, that must be brought to the
Council. There is no provision
that says you can not fill in the annexures. But, the provision that we
have under the Act is exemption, should you so require. That is all I can
say. This is the current
position with regard to the registration process.


Thank you madam lady.


Sorry, you did not answer the question of new fees.


With relation to the fees, the fees are prescribed also in the regulations.
The fees that are prescribed apply. So we can not change them. We have a
team who will
analyze the appropriate fees in the SAMDRA Bill. That will determine, for
different types of applications, retention fees, for different types of
registration, the
appropriate levels of fees. I can not sit here and give you a thumb-suck
figure. I can not do that. We need a proper analysis that will establish
the fees for different types
of products and different types of applications.


Denise, then the gentleman.


Sorry, I have a very loud voice. I take note of what Mrs. Precious Mtsoto
is saying regarding the present Act being in existence and if we have what
are deemed to be
illegal products, we have to register them with full MBR1 at R 2000.00 as
it stands. The first speaker this afternoon said that the anticipation is
that the SAMMDRA Bill
will go through Parliament and go through both houses by the twelfth of
November. What is the motivation to force people to fill in the full MBR1
when most people wait
for two to three years for a substance, when the new SAMMDRA Bill will take
care of this anyway. Secondly there were provisions made for exclusions in
1985 during
the call-up. People in 1985 submitted a few pages of MBR1 and nothing else
was done for twelve years in further evaluation. I believe that they have
been recently been
asked to complete their MBR1, but for twelve years they were considered
legal and nothing was done about these. My question is, surely a precedent
was set in 1985
which allowed those products to stay on the market until today without the
full MBR1's being completed. We accept that SAMDRA will take care of us and
government have noted our frustrations as an industry, and that they
recognize the frustrations and work towards the imbalances that have been
created. Surely we can
apply for some sort of situation that will allow us to carry on trading
(clap from audience) We want to carry on trading until such time as the
SAMDRA Bill comes
through. We cooperated as an industry in full force. We spent many, many
man hours of time and effort, finances, to offer you an appropriate
regulatory system. We did
your work for you. Please allow us a little bit of leeway and dispensation
of reconciliation, if this is too much to ask for. (audience claps)



That was a question and an appeal. Precious, can you respond to that ?


Sorry about that !


It is quite interesting that I spoke to Denise yesterday. I told her that
we are bound by law. She said " Break it!"


It has already been broken !


Can I just say that it is true that the SAMDRA Act will come into being as
to soon as it has been agreed to by Parliament in November. I think that
what you should also
realize is that there is also a bridging process, and that we have to
develop regulations. The reason we are seated here today is that the
regulations that we have today do
not provide for Complimentary Medicines. The regulations we have, refer to
MBR1 and the MBR1 forms. Those regulations need to be changed. We do have a
on how to change. Even if the Act comes into being in November, we still
have to change regulations. So. It doesn't mean that in November when the
Act comes into
being that those regulations cease to exist. We need a mechanism that will
make that Act implementable. We need regulations. This is why we need
public input.
Because they get published and we get comments, and then we get
promulgation. That process must still come into being. So, unfortunately,
that appeal should take note
of that process, which is still going to have to happen.


Thank you, that gentleman .. Please come forward


My name is Peter Swan. My feeling is that the only way we are going to get
through this whole thing is to be creative. We have to use creativity and I
feel that what has
been offered to us is not particularly creative, although I do very much
appreciate the Department and the MCC coming here today. I have questions.
Firstly, why cannot
the regulations be amended within Act 101 ? Why not ? Secondly, would the
Department and the MCC be prepared to engage in transparent, democratic,
and creative
deliberation with our attorneys to find a way through this ? (Clasping from


Who will respond to that one, Mrs. Mtsoso ..


Well, I have already indicated that the process of amendment for
regulations exists. You are welcome, but if we had to start now, we need
ninety days in which to
respond to you. So, if we start now, we will have already got the SAMDRA
Bill which would be enacted. In that case we would have to chose whether we
still apply the
regulations based in the old Act, or the new Act. So, I see the SAMDRA
process as a opportunity to correct all problems that you have raised and
to address concerns
that you have brought forward. I see that as an opportunity, and maybe we
must embrace that. Perhaps to have the existing problems, we have laws
which are binding
us. Perhaps, let's look at the best possible route that can be made. I
think this is what we have presented to you. Maybe we should


Thank you Precious, the lady there.


My name is Doryce Sher. Following on from what Denise said, I believe that
the original intentions of the Act as you have already described, was to
protect the public,
and you say you are acting within the regulations as they stand at the
moment. But, in all fairness, I do not believe that the products that you
are dealing with are a
danger to the public in the manner in which they are being portrayed,
because when SAMMDRA comes in those products that will be sold will be
registered or regulated
without change. It is not the danger, which I believe is your problem. I
most certainly do believe that. I believe, and say this in all honesty as a
pharmacist. I believe there
are many registered medicines out there, being schedule one's and two's
that are extremely dangerous to our public. They are causing drug
addictions, which are far
more dangerous than any herbals, or things that are not registered at the
moment. (claps from audience) My question is, is the Act and it's
regulations a way to make life
difficult for us or is it really to protect the public? The second question
that I have is that when SAMMDRA does come in and complimentary medicines
are regulated
under their own way, how accommodating is that going to be to your small
player out there? Is it going to be suited to companies that are presently
pharmaceutically registered? How accommodating is it going to be? Is it
going to be pharmaceutically orientated?


If I may respond to that. A law is a law, is a law. The law will apply to
everybody. So, the law is not going to favor big pharmaceutical companies,
and not favor smaller
ones That gentleman over there


My name is Andrew Mac Donald. Most of my questions have already been
settled. We have products that we want to sell. I take it that NAPPI coding
will be a


We are talking here about the registration of medicines, and Council's and
SAMMDRA's job will be to make sure that medicines that are registered are
safe, of good
quality, and be efficacious. Now, that is where the responsibility of the
Council lies. When it comes to other things, such as what you have
mentioned , they may fall
under the Act. I would like to ask Precious Mtsotso whether I am correct,
because I do not know if Council takes note of things like that..