South Africa has missed a golden opportunity to lead the world with its restructuring of the Body that registers medicines, from one dealing only with conventional medicines, to one dealing with all manner of products that make medical claims, or purport to be medicines. 

This is providing a difficult task world wide, as the boundary between foods for survival and foods used as medicines has become ever more blurred. Doctors prescribe cranberries to heal bladder infections in their early stages. But we can’t define cranberries as medicines. Vit C is concentrated in factories into massive dose tablets, but it’s chemically the same as the substance we eat in oranges. Is it a medicine or a food? 

To ensure that all medicines, complementary medicines such as vitamins, herbs, homeopathic, ayurvedic and Chinese medicines and traditional African medicines, manufactured for sale to the public, could be checked for safety quality and in some cases efficacy, a new Authority, The South African Health Products Authority, ( SAHPRA) is to be formed. It will comprise full time employees who evaluate medicines, medical devices and products purporting to be medicines, for safety quality and efficacy. It will monitor advertising and work together with the Director General for health, to ensure that facilities producing these products employ good manufacturing practises.  

In view of the current Medicine Control Council failing to register 98% of the medicines submitted for registration in the last year and in the light of the country’s HIV pandemic, its TB crisis and the recent court case over the Minister’s sanctioning of Dr Rath’s vitamin products purporting to cure AIDS,  this is an urgent priority for the Department of Health. Recent experiences with wrongly labelled HIV medication and with combination generic TB medicines, have been stark reminders of the need for a strong regulator to protect the public. 

But the Authority that will be ushered in by a law already approved by the Portfolio Committee of Health, will not provide the protection we need. It will be managed by a CEO appointed by and accountable only to the Minister. Though a juristic person it will have no Council, no Board and no Executive Committee that runs it together with the CEO. The CEO will appoint full time committees to do what he/she decides. There is no guidance in the legislation about qualifications, transparency, or how to co ordinate the various sections. All is left to trial and error. Licensing of facilities will be done by the DG on behalf of the Minister, but all the work on safety, quality and efficacy will be managed by the CEO. Hence the CEO and the Minister have virtually unfettered power over a multi billion rand industry and the Authority will lack transparency and accountability. 

The SAHPRA will have a hugely complicated task involving advanced science, massive finances and management of many divisions, including the new ones of herbal medicines, homeopathic and complementary medicines, African traditional medicines and medical devices. Treasury made the same request as opposition members and members of the public for a Board , criticising the lack transparency and accountability of the proposed Authority.

The argument was advanced that if the CEO is incompetent she/he must be fired by the Minister. But the CEO will be doing the bidding of the Minister and is unlikely to be sacked unless the Minister is crossed. 

This is additionally worrying because the onus will be on the company manufacturing a medicine or product to apply to have it registered. Someone producing a magic potion for sale is not going to want the expense and the trouble of having it registered. This places the onus on stores selling medicines or products intended for use as medicines, to ensure that they are registered, or on inspectors, to check that products purporting to be medicines are registered. 

If a particular class of medicines is called up by the CEO , then people who make it will be obliged to send it for registration, but it’s up to the CEO to decide what classes of medicine and what products to call up. Only then do the provisions apply for advertising and licensing of the premises to ensure that they are sterile and safe.  

The Law also gives the CEO vast powers to exclude anything on any grounds. With our experience of some of the Minister’s headstrong and alternative approaches in the past, there is a real concern that the door is open for further untoward events to occur. Anything could be slipped past monitoring. Each division could be very much a law unto itself with little co-operation between disciplines and no overview by one group of another. When the time comes to include traditional African medicines, the controls introduced could be meaningless. 

Also problematic is the Bill’s requirement that only foodstuffs and cosmetics that have scheduled substances will be called up for registration. Scheduling relates to who can sell various medicines, not safety, quality or efficacy of a medicine and the CEO alone will decide what to schedule and what not to. Add to this the fact that there are no definitions in the law for the newly registerable products, (this is left to regulations), and the matter becomes even more subjective and arbitrary. 

In spite of the Bill’s failings the Health Committee introduced important changes to this piece of legislation, which would otherwise have proved unworkable. We insisted that there should be no financial conflict of interest for the CEO who heads the Authority, or for people on the Appeal Committee, a body to which people can appeal a decision of the CEO if he/she refuses to register their medicine.   

We also removed provisions that enabled the Minister or a panel to decide on the basis of public interest, whether a certified medicine should indeed be registered. The Minister will now have to use her influence over the Essential Drugs List and over government tenders to develop a South African medicine industry and to support specially disadvantaged groups. The private sector will be free to manufacture and supply state of the art medicines, provided they are shown to be safe, of good quality and effective and provided the CEO runs an efficient Authority. Initially this bill lacked appropriate provisions for medical devices. We also changed that. We showed how much impact the legislature can have when it is free to do so and doesn’t have to rubber stamp the Executive. The split in the ANC gave us this freedom which was a pleasant change.  

But both the old ANC and the new favour a regulating Authority that gives vast discretionary powers to Ministers. Hence the public will have to be trained to look after their own interests. The Authority will have a web site that lists all substances that should be registered. These should have a registration number on the pack. If a listed product has no registration number, it should be reported, not bought.

If something makes a medical claim and is not called up for registration, it should be exposed. Reputable dealers will be the safest bet for medicine purchases and problems with the Authority should not be tolerated. Sadly, poor and ignorant members of the public will be most subject to exploitation.

It will be the role of alert individuals and an active industry, together with parliamentarians, to keep this Authority on its toes. Competitors must be our watch dogs.

The Bill will be adopted on Tuesday 23^rd Sept.

Dr Ruth Rabinowitz M.P(MB BCh)
IFP Health spokesperson

JHB:Tel: 011 802 1826
       Fax: 011 804 4221

C.T: Tel: 021 403 3061
       Fax: 021 403 3334