An elegant solution to regulating complementary and alternative medicine (CAM)

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.

Elegant Ladies Fishing by Georges Jules Victor Clairin. Source Wikigallery.

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.

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Comments in chronological order (7 comments)

Kevin Charleston wrote on 14 August 2012 at 7:19 a.m.:

An excellent piece, thanks Marcus.

Do you have any thoughts on whether the reluctance of the MCC to act on the existing regulations against CAMS was an attempt to protect the 'traditional' medicines/practitioners? I can't believe the lemon and garlic brigade were keen to do so. In the wake of that though, the existing health hierarchy appears to have done little.

And, the regulation of CAM products is going to be a huge task. It seems to me that the MCC is already struggling with the regulation of ordinary medicines - Is SAHPRA is going to get any more resources, and willing-and-able administrators to make it work?

benjaminsa wrote on 14 August 2012 at 10:25 a.m.:

Ah but you see if you water down regulation you only make it stronger.

It is actually hard to come up with a test for CAM. If the prior is so unplausable it is almost impossible to differentiate a false positive from a real one.

Roy wrote on 16 August 2012 at 12:56 p.m.:

Thanks Marcus.

I think it's worth pointing out that products which are being sold and advertised as a result of the 2002 "call up" nevertheless remain subject to the rest of the Medicines Act. In particular, as far as advertising goes, no "false or misleading advertisement" may be published (Section 20(1)(a)). There is no reason why the MCC cannot take action against such false and misleading advertisements.

Harris wrote on 16 August 2012 at 2:15 p.m.:

Great article Marcus. You wrote: "This is why the first step to solving the problem of regulating CAMs responsibly must be to rescind the 2002 notice."

The MCC had planned on doing exactly that. However Solal Technologies appealed the 14 August 2009 decision of the MCC to rescind the 2002 call up, which has in effect prolonged the general "paralysis" of regulating CAMs and allowed the industry to continue selling these products.

Marcus wrote on 16 August 2012 at 2:53 p.m.:

Thank you Roy for pointing that out. You are correct.

Kevin. I have no idea whether the SAHPRA will solve the many problems (not only CAM) that we’re facing with the regulation of medicines in South Africa. I think the basic idea of the restructuring is good – but it will stand or fall by the quality of leadership, the independence of the authority from industry and government, and whether or not the authority has the resources it needs to carry out its work effectively.

As to your other question. Testing CAMs for quality is a huge (but necessary) undertaking. I think that regulating efficacy claims is potentially simpler - once the authority shows they will actually act on unlawful claims and enforce the law, I think such unlawful claims will dry up quite quickly.

Rene Doms wrote on 20 August 2012 at 4:50 p.m.:

Hello Marcus This is a good start to the interpretation of the Medicines Act. There may however be a fourth criteria for registration purposes that is often overlooked - "that the medicine in question is suitable for the purpose for which it is intended" which may put a different gloss on the mentioned three criteria in your article. Does this not open the door to the non-scientific paradigms? Perhaps the Medicines Act is smarter than we think?

Roy wrote on 23 August 2012 at 8:12 a.m.:

@ René

Perhaps you could expand on your "may however be a fourth criteria (sic)". Section 3 of the Medicines Act specifically uses the word "only" as follows: ". . . regard shall be had only to the safety, quality and therapeutic efficacy. . ."

The initial qualifier of this Section is "in the public interest" and the latter part refers to "the health of [humans] or any animal".

Your suggestion of a medicine "being suitable for the purpose for which it is intended" (i.e. "purporting to be suitable for use in" - which forms part of the very definition of a medicine in the Act) is, in my view, entirely incorporated into the three criteria of safety, quality and therapeutic efficacy in relation to the health of humans (or animals). I don't see it as being a separate criterion.

What would be very interesting to know is how you interpret "in the public interest" and how that is determined.

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