Start main page content

Masterclass 3: Pharmaceutical and Medical Device Regulation

Overview

The third Healthcare Law & Policy Masterclass explored the complex regulatory framework governing pharmaceuticals, complementary medicines and medical devices in South Africa. The session brought together regulatory, legal and healthcare experts to discuss evolving compliance requirements, healthcare product governance and the practical realities of medicine pricing and formulary management.

Participants gained valuable insights into the institutions responsible for regulating healthcare products and the legal obligations applicable to manufacturers, marketers, healthcare providers and medical schemes.

Key Topics Covered

Health Product Regulation

The masterclass provided an overview of medicines, complementary medicines and medical devices, examining the legal and regulatory frameworks governing their registration, distribution and use.

SAHPRA and Pharmacy Council Oversight

Presenters discussed the respective regulatory responsibilities of the South African Health Products Regulatory Authority (SAHPRA) and the South African Pharmacy Council, including regulatory offences and enforcement powers.

Scheduling, Marketing and Promotion

The session examined the scheduling of medicines and devices, together with the legal requirements regulating marketing, advertising and promotional activities in the healthcare sector.

Medical Scheme Formularies

Participants explored the important role of formularies within managed healthcare environments, including:

  • The rationale for formularies
  • How formularies are negotiated and structured
  • Open and closed formulary models
  • Permissible and impermissible formulary practices

Single Exit Pricing

Experts examined South Africa's Single Exit Pricing framework and its significance in ensuring pricing transparency and consistency within the pharmaceutical sector.

Presenters

Val Beaumont
Executive Officer, Marketing Code Authority

Inez Naidu
Head of Medicine Unit, Discovery Health (Pty) Ltd

Julie Oppenheim
Partner and Head: Pharmaceutical & Healthcare Sector Group, Bowmans

Facilitator

Daven Dass
Senior Lecturer, University of the Witwatersrand

The masterclass took place on 15 May 2026.

Share