Al­ter­na­tive medicines to be reg­u­lated

Business Day - Business Law and Tax Review - - BUSINESS LAW & TAX REVIEW - NEIL KIRBY

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.

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