How should the chaos be regulated?
Submissions on the draft guidelines and regulations for the registration of complementary medicines
Published: Oct. 25, 2011, 7:17 a.m., Last updated: Oct. 25, 2011, 7:25 a.m.
The government recently published guidelines and regulations for the registration of complementary medicines. Public submissions were requested. Marcus Low has previously written about this for Quackdown. The Association for Responsible Health Information and Advertising (ARHIA) and the Treatment Action Campaign (TAC) have both made submissions.
Marcus Low's article explained the purpose of the proposed guidelines and regulations:
Despite relatively strong legislation in the Medicines Act, so-called complementary and alternative medicines have remained largely unregulated in South Africa. As a visit to most pharmacies would attest, products making unsubstantiated health claims are ubiquitous. Many product labels misrepresent the available evidence. Sometimes the presence of harmful ingredients or possible side effects are not mentioned or underplayed.
This mess is in part what the Department of Health is trying to clean up with these new regulations. All complementary and alternative medicines manufacturers will now be compelled to submit their products for registration with the Medicines Control Counsel (MCC). The MCC will evaluate applications and either register the product or reject the application.
The submission written by Roy Jobson of ARHIA states:
As is stated in the Medicines Act, Section 3, the Council shall have regard only to the safety, quality and therapeutic efficacy of any medicine when determining whether or not such medicine’s registration or availability is in the public interest. We would submit that to date, and mainly as a consequence of the 2002 Complementary Medicines “call up” – the public interest has not been served and that many medicines are presently available (155,000 according to the Minister of Health one year ago) for which the MCC has paid no regard to safety, quality or therapeutic efficacy.
As a result the complementary medicines industry’s interest has been served and not the public interest. We believe therefore that the public interest, safety, quality and therapeutic efficacy must now take precedence over industry interest. This is in line with the National Department of Health’s strategic plan 2009/10 – 2011/12 which explicitly stated that unregulated complementary medicines pose a public health risk. We agree with this consequence of unregulated complementary medicines and urge that the opportunity be taken to finally take full charge of the regulation of these medicines in order to reduce or even eradicate such public health risk.
Marcus Low drafted the TAC's submission. It states:
We recognise that the regulation of complementary and alternative medicines poses a unique and difficult challenge. In some cases, though not all, different rights may have to be weighed against each other in order to strike a balance that is both constitutionally sound and acceptable to the various stakeholders.
Regulation must promote the realisation of both the public’s right to health and the public’s right not to be misled by misleading advertising. At times, these basic rights can be in conflict with the right to freedom of expression of those who practice complementary or alternative medicines or those who sell products described as complementary or alternative medicines. The key question then becomes where to strike the balance when weighing up these rights in the formulation of guidelines or regulations.
In line with the recently enacted Consumer Protection Act, we believe that the rights of patients and consumers should be given significantly greater weight than the rights of those who practice or sell complementary and alternative medicines. We will therefore be suggesting a number of amendments to the guidelines that would raise the bar in relation to the substantiation of claims of safety and efficacy.
There are many problematic parts of the proposed guidelines ranging from the technical, such as the poor definition of a complementary medicine, to the more substantial, such as the insufficient evidence requirements for the registration of these medicines and how they are labeled. The regulations are well-intentioned and aimed at addressing the problem of the huge number of untested remedies on the market. However, they will need to be improved before they are finalised.