Sunday February 22 2009 marked the seventh anniversary of the well-intentioned but ultimately misguided call-up of medicines frequently referred to as complementary medicines. Officially the call-up ended on August 22 2002, but the Medicines Regulatory Affairs Cluster of the Department of Health continues to accept documentation for these products. The Medicines Control Council (MCC) seems to have turned a blind eye to this practice, even though it -– and not the Medicines Regulatory Affairs Cluster, carries the statutory responsibility for ensuring that all medicines meet acceptable standards of quality, safety and efficacy.
In a nutshell what this means dear reader, is that
of the unregistered complementary medicines that you may so trustingly have spent your hard-earned disposable income on has been independently validated in South Africa to ensure that what is said/claimed to be in that medicine, is actually in that medicine. For the last seven years at least. Or perhaps longer.
Seven fat years for the manufacturers, distributors and sellers of these products.
Whether the products work or not, whether they are safe or not, is irrelevant when the ingredients of the products are not scientifically validated. Next time you buy a product that does not have an MCC registration number in terms of Act 101 of 1965, you should be aware that you cannot be sure that any independent testing of that product has ever been done or is presently being done. You may be buying a product that contains certain active ingredients in unknown amounts. You may be buying a product that contains no active ingredients at all. You may be buying a product that possibly contains heavy metal toxins or other poisonous components. But this is seemingly your choice and your right. (Unfortunately, as you are not provided with all the information to make a fully informed choice, it is a somewhat flawed right.)
However, the MCC does not have the choice nor the right to allow such medications to be made freely available to the public of South Africa. It is their statutory duty to assess the data provided by the manufacturers, distributors and sellers. These data are mostly unavailable, insufficient or inappropriate for assessing whether complementary medicines (so-called dietary supplements, etc.) are quality controlled, effective or safe. It’s the proverbial catch-22 situation. The MCC is responsible for assessing the data. The manufacturers are responsible for providing the data to be assessed. The manufacturers claim that they cannot afford to pay for adequate scientific testing of their products (despite the explosion in the industry to an estimated R4-billion a year). In the end, no data are submitted to the MCC. The MCC does not make a decision. The industry continues to market their products without any controls.
The attempts in 2004 and 2008 to introduce regulations to the Act that would control complementary medicines have so far been quite inadequate. The 2004 regulations were not accepted after vigorous opposition by the complementary medicines industry. They found them too restrictive. It would not serve them to have to actually prove that their products were of satisfactory quality, effectiveness and safety. The 2008 regulations are still in limbo, but do not even include a reasonable definition of complementary medicines that is substantively different from prescription or conventional medicines. It’s frankly a mess.
If this is all a bit confusing, let me re-state it in simple terms: you, the consumer, have been ripped off by a R4-billion a year industry over the past seven years that cares nothing for you, and everything for its profits. Do not be misled by the “natural” jargon. The marketers are not naturally or sympathetically inclined to your health problems. They are only in it for their profits. The profit that comes from your money. The irony of their accusations against the conventional pharmaceutical industry only being interested in protecting their markets and their profits is breathtaking.
The MCC has failed in its statutory obligation to ensure that the availability of any medicine is in the public interest in terms of its quality, safety and therapeutic effectiveness. The public is consequently at risk of poor quality, unsafe and ineffective medicines as far as unregistered complementary medicines are concerned.
Disclaimer: Although Prof Jobson was formerly a member of the MCC, this is written in his personal capacity.