Attendance list:
O Shisana - Department of Health
JHO Pretorius - Department of Health
OMB Pharasi - Department of Health
J Schlebusch - Department of Health: Medicines Administration
T van de Venter - Department of Health: Directorate Food Control
A Booysen - Department of Health
PR Makhambene - Chairperson: Complementary Medicines Committee of the MCC
P Folb - Chairperson: Medicines Control Council
L du Toit - Department of Health: Medicines Administration
K Omar - Department of Health: Medicines Administration
A van Zyl - D epartment of Health: Medicines Administration
J Gouws - Department of Health: Medicines Administration
P Kreft - International Consultant (Director Bioforce S.A (PTY) Ltd.)
D Lilley - SACMA (South African Complimentry Medicines committee)
PP Wertheim Aymes - Pharma Natura
R Doms - Pharma Natura
E Stoffberg - Health Products Association (Natura)
BJ Turner - Health Products Association (Pharma Natura)
L Brom - Homeopathic Association of South Africa
JP Prinsloo - SA Naturapaths and Herbalists Association
S Thomson - PHARMAPACT (Gaia Research Institute)
MJ Ford - Homeopathic Association of South Africa
M O' Brien - Chiropractor's, Homeopaths and Allied Health Professions Interim Council
WA Tomlinson - Chiropractor's Homeopaths and Allied Health P ofessions Interim Council + Sportron Director + HPA Executive Member
T Tsotetsi - South African Homeopathic Association
R Cooppan - Chiropractor's Homeopaths and Allied Health Professions Interim Council (Natura / Sportron)
B Wilkinson - Gauteng representative of COCHASA
P Swan - COCHASA/Ayuverda Board (Dept's Spelling)
V Lohman - Pharmacare / South African Druggists
A Vienings - Medicines Control Consultants (HPA)
R Stewart - Pharmacare Ltd
(Note: bracketed notes, green writting and underlined text by PHARMAPACT. Ed.)
Dr Shisana: Opened the meeting and welcomed everybody present. Everybody was thanked for their participation and the hope expressed that the problematic issue could be resolved satisfactorily. Each organisation was given time to present their case.
Mr Doms: The company complained to the Department with regard to the upholding of the law. The public are being put at risk. Proof was presented that the MCA had issued warnings on two deaths and nine serious toxicities that have occurred with the use of herbal products (internationally). By allowing the illegal importation of these products, the Department is also supporting unfair trade practices.
Mr O'Brien: The definition of a medicine is too wide and is today not what was intended by the legislature in 1965. The Council proposes the following:
*The Department should redefine a medicine;
*The Complimentary Medicines Committee should be revived;
*This committee should be representative of experts in the different fields and should function with a certain measure of autonomy;
*The 'proposed' listing procedure should be implemented as soon as possible.
Mr Stewart: It is noted with concern that the 'traditional healers' are not being represented.
Dr Shisana: This forum does not include all the role players, but the meeting is only with people who had lodged complaints with the Department. (PHARMAPACT was not invited but gatecrashed).
Mr Turner: A technical committee has been established to develop a software program for the registration of herbals. The TGA Listing System has already been presented to Prof Folb and Prof Schlebusch: The HPA further feels that the MCC should be more accessible to Industry and also that the law should be uniformly applied.
Mr Thomson: PHARMAPACT is a newly formed group that stands-up for pro-active health products and strategies and their goal is to pressurise the MCC into change. Their anger is not directed at the DG or the Minister, but at the MCC and its 'incompetent secretariat'. They feel that the act is being used to protect the medical and pharmaceutical professions and industries. They promote the use of safe herbal products and feel that the MCC should not interfere with these if documented proof of safety exists. The MCC should also not interfere with groups that pose no threat to the public health. Court cases like that against Medical Supplies International are a waste of the taxpayer's money that should have been used in the promotion of health. There are also a number of complaints about the secretariat and Council relating to the non co-operation of both bodies.
Dr Shisana: It must be pointed out that the MCC is regarded as one of the ten 'best'(?) regulatory authorities in the world. The MCC are furthermore only implementing the law passed by Parliament. If a serious problem exists with a particular person, a complaint can be lodged with the DG or Minister.
Prof. Folb : *It is noted that a problem exists with the definition of a medicine. The MCC cannot change the law, but can only do what is required in terms of Act 101. Any weakness in the law should be argued at the right level and the law changed accordingly if needed. However it should be noted that our definition is in line with 38 other countries, including those with regulatory systems we aspire to.
*'Traditional African medicines' should be included in all deliberations.
* The MCC is restrained by the needs of the SA administrative law, but its decisions should be fair and uphold the constitutional law. The MCC is bound by its mandate which relates only to safety, efficacy and quality of 'medicines'.
Dr vd Venter: His directorate shares the concern for the safety of herbal products. They feel there should be more control over herbs. They agree that the need for updated regulations in this regard exists and is currently in process. Herbs which may not be sold as foods will be listed as such.
Peter Kreft: The basis of departure could be the guidelines for assessment of homeopathic products drawn up by Council in 1991 which was based on WHO recommendations. Although the public should have a free choice, they should at the same time be protected from unsafe products. Experience has shown us that the greatest problem exists with safety including GMP, identification of herbs, impurities, concentration of herbs.
Ms Wilkinson: There seems to have been a change in policy from the MCC in the control of herbal preparations. Over the last few weeks a great increase in the seizure of unregistered products have occurred.
Dr Shisana: The problem is what to do in the meantime before these products are registered. The MCC has always been implementing the law? There has been no change in policy and the MCC cannot be penalised for being more efficient.
Prof Schlebusch: There has been no change in policy. It must again be explained that all medicines were called up by means of their pharmacological classifications. Certain specific groups, including 'herbals were again called up to eliminate any possible confusion'. The MCC must react to illegal activities? And unfortunately, with the opening up of SA, the 'illegal activities' have increased considerably.
Ms Viennings: They understand the call-ups and agree that these products should be controlled. They find it 'disturbing that members of the 'secretariat' seems to be giving advice on an ad hoc basis regarding the registrability of these agents'.
Dr Shisana: The MCC canot be discriminatory in its applications of the law. It is not only unfair business practise, but also unsafe to the public. The only way the Act can be changed is by a parliamentary committee taking hearings on the proposed changes.
Dr. Tsotetsi: The MCC need to look at fair competition. Applicants that have only now entered the play field should be allowed to pay the 'same monies' and submit the 'same data' as was done in '1965'. (86)
Dr.Tomlinson: It is generally agreed that control is needed but that the appropriateness of the mechanism of call-up procedures are questioned.
Prof. Schlebusch: It is very clear from both the Act and the courts that 'the law'? should be enforced. Excessive claims are being made by applicants for 'so-called' food supplements.
Dr.Shisana: The law stands and must be applied.
Peter Kreft: The 'cost of registering' a product as medicine should be an issue for discussion. Furthermore, the opinion exists overseas that since 1994 anything goes in SA and that no control is needed.
Mr Aymes: As the law is still in place, we have to conform to it. The proposals regarding the listing system should be implemented as soon as possible.
Dr Stewart: There is concern about the time involved before the listing system will be functional.
Dr Brom: They are in favour of the public interest. There should be transparency on the MCC side and experts in their specific field should be consulted.
Mr Doms: Act 101 can be rated as one of the best Acts in the world. It is very clear on the safety, efficacy, quality and manufacture of 'medicines'. The Department has an obligation to uphold the law. There are 41 articles available on side-effects that have occurred with the use of herbals. A mechanism within the Act should rather be considered (Section 36) which will allow persons to continue selling safe efficacious products of a high quality.
Dr Stoffberg: They support responsible control for these products with an appropriate registration system.
Prof. Folb: In summarising the meeting the following points were made:
* Most of what have been requested are achievable and reasonable.
* The Complimentary Medicines Committee of the MCC must be activated in the coming weeks and must include experts from Industry.
* Processes must include experts on 'food'.
* A system of liaison between industry, MCC and the Department must be developed. This could be as regular workshops, open forum etc.
The ideas of the listing system need to receive careful attention from the committee.
Other ways of handling these products should be investigated.
* The people have the power to change the law. A special parliamentary committee should be asked to examine suggestions.
(See PHARMAPACT's 15 November minutes to the Public Protector for a more balanced record. Ed.)