Regulatory framework
What is the applicable regulatory framework for the authorisation, pricing and marketing of pharmaceutical products, including generic drugs?
The Medicines and Related Substance Act, No. 101 of 1965, as amended (the Medicines Act), as well as the regulations promulgated under the Medicines Act regulate the authorisation, pricing and marketing of pharmaceutical products.
Regulatory authorities
Which authorities are entrusted with enforcing these rules?
The South African Health Products Regulatory Authority (SAHPRA) is entrusted with enforcing the rules set out in the regulatory framework. The objectives of SAHPRA are to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials, medical devices, in vitro diagnostics and related matters in the public interest.
Pricing
Are drug prices subject to regulatory control?
Drug prices are regulated in terms of section 22G of the Medicines Act, which provides for the establishment of a pricing committee that makes recommendations to the Minister of Health. The Minister of Health may make regulations on a transparent pricing system for all medicines and scheduled substances sold in South Africa. The transparent pricing system includes a single exit price that is published as prescribed.
The Department of Health published Regulations Relating to a Transparent Pricing System for Medicines and Scheduled Substances (30 April 2004) under the Medicines Act (Transparent Pricing Regulations). In terms of the Transparent Pricing Regulations, manufacturers and importers are required to determine a single exit price for each medicine and scheduled substance that is the price at which the relevant medicine must be sold by manufacturers, importers, distributors and wholesalers to all persons, other than the state, and must, inter alia, conform to international benchmarks and may only be increased in accordance with Transparent Pricing Regulations. Provision is made for a logistics fee and dispensing fee. The extent to which the single exit price may be increased will be determined annually by the Minister of Health, after consultation with the pricing committee, having regard to the average CPI and PPI for the year, changes in foreign exchange rates and purchasing parity power, international pricing information relating to medicines and scheduled substances, comments received from interested parties and the need to ensure availability, affordability and quality of medicines and scheduled substances in South Africa.
This report was first published on Lexology Getting Through The Deal website. You can read the full article here.
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