The commercialisation of pharmaceutical products has become more complex as the competitive and regulatory environment has evolved. Today, regulatory regimes not only aim to protect public health and to ensure that there is robust data to support the safety and efficacy of pharmaceutical products, but also to limit expenditure on pharmaceutical products by countries (for example, market access, pricing and reimbursement and distribution channels, among others). This is the view of Dr. Oliver P. Kronenberg, Group General Counsel at Galenica, in his foreword to the 2018 Global Guide to Distribution and Marketing of Drugs by Thomson Reuters.
The guide book focuses on the legal environment surrounding the distribution and marketing of medicines. “The legal framework has been tightened and the standards for compliance have been raised by the regulators. This has led to an increasing need for legal support (whether in-house or external). Jurisdictions differ significantly around the world and, consequently, this book has become an important reference guide for the industry.”
Partner at Adams & Adams, Jenny Pienaar, and Senior Associate, Jeanette Visagie, were responsible for writing the South Africa Q&A chapter of the guide – giving a high-level overview of distribution and marketing of drugs law in South Africa, including pre-conditions for distribution; licensing; wholesale distribution; marketing to consumers; marketing to professionals and engagement with patient organisations.
The distribution of medicines in South Africa is governed strictly by the Medicines and Related Substances Act No.101 of 1965, as amended (Medicines Act). The most recent amendments were brought into effect on 1 June 2017. Other pieces of legislation govern the movement of medicines in the supply chain and persons authorised to
distribute medicines within the supply chain including the:
- Pharmacy Act No. 53 of 1974, as amended;
- Health Professions Act No.56 of 1974, as amended (HPA);
- National Health Act No 61 of 2003, on human tissue;
- Animal Diseases Act No 35 of 1984, on medicines with animal content.
The authors would like to thank Consultant, Elsabe Klinck, of Elsabe Klinck Associates (Pty) Ltd for her assistance in preparing the chapter.
You can download the full South Africa Q&A section HERE or access the global Q&A Tool HERE.