A New Regulatory Regime for Medicines Comes into Force in SA

With effect from June 1 2017, the Medicines and Related Substances Amendment Act, No 72 of 2008, came into force by proclamation by the President of the Republic of South Africa.

The coming into force of the Amendment Act is significant insofar as it shifts and fundamentally changes the medicines regulatory regime in South Africa, and alters the Medicines and Related Substances Act, No 101 of 1965, as amended (the Medicines Act).

The Amendment Act of 2008 must be read together with a further Amendment Act, being the Medicines and Related Substances Amendment Act, No 14 of 2015. Both Amendment Acts come into force simultaneously and give effect to numerous amendments to the Me-dicines Act.

In addition to amendments to the Medicines Act, the amendments attempt to reconcile an arguably uncomfortable relationship between the Medicines Act, prior to its amendment, and the contents of various general regulations promulgated under the Medicines Act, which deal with such matters as complementary medicines and the registration and licensing of medical devices.

The most fundamental change brought about by the Amendment Acts is the change in the regulatory authority in charge of the regulatory oversight over medicines, medical devices, complementary medicines, foodstuffs, cosmetics, in vitro diagnostic medical devices and related substances, from the Medicines Control Council to the South African Health Products Regulatory Authority, or SAHPRA.

SAHPRA is an organ of state, but is outside of the public service. In terms of the now-amended Medicines Act, SAHPRA is a juristic person and subject to the provisions of the Public Finance Management Act, No 1 of 1999, but reports to the Minister of Health. The Registrar of Medicines now becomes the Chief Executive Officer of SAHPRA.

Powers vested in SAHPRA include those to register products as one or more of a medicine, medical device, complementary medicine, foodstuff, cosmetic or in vitro diagnostic medical device. To this end, amendments have been effected to section 14 of the Medicines Act, which require that only registered products are allowed to be sold in South Africa.

Accordingly, the manner in which the reimbursement for the costs of such products takes place will be affected in terms of, for example, the Medical Schemes Act, No 131 of 1998, as amended, insofar as medical schemes may only reimburse the costs of registered products.

In respect of products currently available in the South African marketplace but are not registered, the provisions of amended section 14(3) allow for such products to continue to be sold in the South African marketplace, but application for the registration of such products must be made within six months of the date of declaration published by SAHPRA requiring registration.

In terms of Amendment Act No 14 of 2015, certain fundamental definitions change in respect of both how one identifies a particular substance as a medicine or medical device, respectively. Therefore, the amended definitions become important in order to determine what substances must be registered in terms of the Medicines Act and are subject to the regulatory restrictions now imposed by the Medicines Act, as amended.