TRANSCRIPTION OF A MEETING OF THE

SO-CALLED BROAD-BASED REFERENCE GROUP

OF THE

COMPLEMENTARY MEDICINES COMMITTEE

OF THE

MEDICINES CONTROL COUNCIL AND THE DIRECTOR-GENERAL OF THE DEPT. OF HEALTH

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.)

PLEASE NOTE THAT WE WILL BE POSTING A SUBSTANTIAL REPORT ON THIS MEETING. WATCH THIS SITE FOR MORE DETAILS…..

(Anthony had the foresight to audio-tape the proceedings and has rendered an extremely valuable service by laboriously transcribing the proceedings word-for-word, 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.)

MRS. PRECIOUS MTSOTSO (REGISTRAR OF MEDICINES : MCC)

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 allows 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.

DR MAKHAMBENI (CHAIRMAN, CMC)

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…

MR. VAN ZYL (DEPUTY DIRECTOR, MCC INSPECTORATE)

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 audi ulteram partem 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 provision 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.

DR MAKHAMBENI

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 ….

HILLARY SHANNON (PHARMAPACT MEMBER / MANUFACTURER)

I am Hillary Shannon.

DR MAKHAMBENI

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

HILLARY SHANNON

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)

DR MAKHAMBENI

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

DR HELEN REES

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

HILLARY SHANNON

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.

DR HELEN REES (CHAIRPERSON : 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 SAMMDRA 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 saying……….is 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.

DR MAKHAMBENI

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

ANTHONY REES (PHARMAPACT)

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 Dr. 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 ?

DR HELEN REES

I cannot answer those questions.

ANTHONY REES

So, you cannot answer these two very simple questions, therefore I bring to your attention affidavits here and a PHARMAPACT writ of summons to the Public 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 defending 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)

DR. MAKHAMBENI

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 attention)

Hillary come forward, come forward…..

HILLARY SHANNON

Dr. Makhambeni, Dr. Rees, I have said what I have been through. I really feel …. I 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.

DR. MAKHAMBENI

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 Complimentary 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 crisis 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 cannot see how PHARMAPACT can blame other people.

ANTHONY REES

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

DR. MAKHAMBENI

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 are 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.

ANTHONY REES

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

DR. MAKHAMBENI

You may.

ANTHONY REES

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.

DR. MAKHAMBENI

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.

HILLARY SHANNON

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 audience)

DR. MAKHAMBENI

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)

ROSETTA SUTTNER (HOMEOLINK HOMOEOPATHIC COMPANY)

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.

DR. MAKHAMBENI

Mrs. Mtsoso, will you please respond to that.

MRS. MTSOSO

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.

DR. MAKHAMBENI

Thank you madam… lady.

ROSETTA SUTTNER

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

MRS. MTSOSO

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.

DR. MAKHAMBENI

Denise, then the gentleman.

DENISE MAIDMENT (C.E.O SOLGAR S.A)

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 that 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)

DR. MAKHAMBENI

 

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

DENISE MAIDMENT

Sorry about that !

MRS. MTSOSO

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

ANTHONY REES

It has already been broken !

MRS. MTSOSO

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 process 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.

DR. MAKHAMBENI

Thank you, that gentleman ……….. Please come forward

PETER SWAN (CHINESE HERBAL IMPORTER)

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 ? (Clapping from audience)

DR. MAKHAMBENI

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

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 consider…..it.

DR. MAKHAMBENI

Thank you Precious, the lady there….

DORICE SHER (PHARMACIST / AROMATHERAPY OIL MANUFACTURER)

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 almost pharmaceutically registered? How accommodating is it going to be? Is it going to be pharmaceutically orientated?

DR. MAKHAMBENI

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 ……

ANDREW MAC DONNALD (MEDICAL AID COMPANY)

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 requirement ………

DR. MAKHAMBENI

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…..

MRS. MTSOSO

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.

SINDEPHI SPOGTER

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

MRS. MTSOTSO

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

SINDEPHI SPOGTER

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

MRS. MTSOSO

Is this a second question ?

SINDEPHI 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 we know you are not going to be 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 won't 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 it’s 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.


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