Alternative medicines to be regulated
LONG-awaited changes to regulations governing the sale and use of complementary medicines in SA are set to bring the extensive alternative medicines market in this country under formal regulatory control for the first time.
Draft regulations published for public comment in July by the Department of Health, in conjunction with the Medicines Control Council, also seek to regulate the use of “medical devices”, In both instances, the period for public comment expired late last month.
If the regulations proceed in their current format, complementary medicines and other substances as defined in the proposed regulations will be subject to the registration processes applicable in the Medicines Act.
Complementary medicines will therefore be treated in almost the same way as branded or allopathic medicines, from a regulatory and registration point of view.
However, such a system of registration presents unique challenges in controlling complementary medicines, bearing in mind the broad nature of the types and variations of substances that fall within the category of complementary medicines.
One failing immediately apparent in the proposed regulations is the division of complementary medicines into two distinct markets. The first of these is the section of the market regulated by the Allied Health Professions Act. The second is the market category comprising complementary medicines used by professions not governed by this act, or certain other related healthcare legislation.
The legality of such a definition will have to be carefully examined in relation to the principles of administrative law including the South African constitution. This could lead to a situation in which the definition of “complementary medicine” — upon which the legality of the balance of the regulations pertaining to complementary medicines rests — may be too vague to enforce in the existing law.
The proposed regulations relating to medical devices are independent of those already in place under the Medicines Act. Basically, the scope and ambit of the regulations will depend largely on whether or not a particular medical device falls within one of eight defined categories.
The legal obligation to supply spec- ified information about medical devices on the market will come into effect once the regulations are finally published. The sale of an unregistered medical device will become prohibited. The device must be registered with the Medicines Control Council.
Manufacturers of medical devices and their local representatives, as well as importers of medical devices, will, at the instance of the Medicines Control Council, have two years to provide specified information to the Registrar of Medicines once the regulations come into effect, including the name and address of the manufacturer or importer and a brief description of the medical device and its use.
Advertisements and promotions will also be closely controlled. The Medicines Control Council may prohibit the promotion, or restrict the ad- vertisement of certain medical devices to the public.
Contravention of the final regulations on medical devices could lead to a fine or imprisonment of up to five years, or both.