An elegant solution to regulating complementary and alternative medicine (CAM)
Published: Aug. 14, 2012, 7 a.m., Last updated: Aug. 13, 2012, 11:42 p.m.
South Africa is awash with untested complementary and alternative medicines (CAMs). The market for these products is anarchic. Consumers are taken advantage of by unscrupulous salespeople. The government is putting together special rules for this class of products, but it seems an elegant solution to this problem, already contained in the Medicines Act, is being ignored.
The failure to use the Medicines and Related Substances Control Act (Medicines Act) to regulate the sale of CAMs is not because of problems with the Act itself. It is mostly because of poor leadership, lack of capacity and consequently lack of enforcement.
An elegant solution
The elegance of the Medicines Act’s solution to the regulation of CAMs is that it does not divide medicines into CAMs and mainstream pharmaceuticals. Instead, all medicines are regulated by three criteria:
quality (is what's on the label in the product and nothing else?),
safety (which can be controlled by the schedule the product is assigned to) and
claims made about the medicine's use (efficacy).
Because it's not possible to decide anything about safety or efficacy without knowing the quality, let's assume for purposes of this argument that all CAMs must prove their quality.
Here is an example of how efficacy claims are judged: If someone claims that a medicine could prevent HIV infection, the question before the regulator is simply whether the evidence presented supports this claim. It is the evidence for the claim that matters, and not whether the medicine is a CAM or a pharmaceutical.
The Medicines Act provides that certain classes of medicines (like anti-virals) could be called up for registration. So, for example, the anti-viral call-up means that companies are not allowed to claim their products have anti-viral effects without the product being registered with the Medicines Control Council.
The call-up for anti-virals is sensible, since a class of medicines like anti-virals have a related claim – the claim that medicines in this class treat viruses or virally caused diseases. That call-up therefore fits the claim-based nature of the Act.
Unfortunately there was an ill-judged 2002 notice published in the Government gazette that dealt with CAMs. Some people consider this to have been a call-up notice. The problem with the notice is that it was for classes of medicines according to various complementary disciplines, but not classes relating to a claim like anti-viral activity. For example the 2002 notice asked for makers of ayurvedic and Unani-Tibb medicines to send product information to the Medicines Control Council as a first step towards registration. But previously call-up notices called up medicines according to their effects (such as anti-viral or anti-bacterial) not their philosophy, type or paradigm.
So the 2002 notice might be interpreted to have broken the claim-based nature of the Medicines Act and create a back-door by which CAMs can get registered without being subjected to the same kind of scrutiny as pharmaceuticals. I don't agree with this interpretation, but the confusing language of the 2002 notice means that many CAM producers have interpreted it that way.
This is why the first step to solving the problem of regulating CAMs responsibly must be to rescind the 2002 notice.
From there the solution is not to create a special set of rules for CAM’s, but, with quality as a given, to regulate CAMs based on claims and scheduling as is the case with pharmaceuticals.
Reject watered-down rules
I know that some are of the view that CAMs are of a different paradigm and should be judged in terms of that paradigm. But the Medicines Act is beautifully blind to paradigms and does not discriminate against absurd ones. Instead, it sets aside paradigmatic questions and simply limits itself to the question as to what evidence is there that X prevents/treats/cures Y. This approach essentially strips out any bias regulators might have against scientifically implausible systems such as homeopathy.
In addition, the way in which most CAM products are marketed hardly justifies the 'holistic' vale behind which their manufacturers like to hide. On television, in magazines, and on pharmacy shelves, it is claimed that specific homeopathic medicines can reduce flu symptoms or that specific supplements can improve mood. Such claims are perfectly testable by conventional means and there is no good reason why they should warrant watered-down regulation.
Attempts to create special rules for CAMs could only result in lower standards being set for these products. This has been the case in Australia where such special rules are currently facing serious questions since they are failing to provide the public with sufficient protection against misleading claims. It appears to me that having special regulations for CAMs tends to benefit the CAM industry at the cost of the general public.
However, problematic as special CAM regulations are, we cannot just continue on our current course of no regulation either.
The solution is right there in the Medicines Act. The problem is simply that it has not been effectively implemented in recent times. The regulator seldom if ever acts against CAM companies claiming that their products have anti-viral properties (e.g. products that claim to treat HIV/AIDS). Since such products must be registered in terms of the Act and the call-up for anti-virals, the failure is clearly one of implementation and enforcement.
A better resourced regulator with more capacity and a much strengthened enforcement arm will go a long way to solving the problem of the public being misled into self-medicating with CAM products of dubious efficacy. Leadership that has the courage to confront the CAMs industry and not compromise itself would also be needed.
The new South African Health Products Regulatory authority (SAHPRA) is expected to replace the Medicines Control Council in the first half of next year. This transition will create a unique opportunity to deal with the operational issues of regulation more effectively. An enforcement entity should be created within this body that is somewhat akin to the current law enforcement unit in the Department of Health, but it should be much better resourced. This entity must be mandated to act against advertising and labeling that is unlawful under the Medicines Act.
Comments in chronological order (7 comments)
Rene Doms wrote on 20 August 2012 at 4:50 p.m.: