EXPLAINER | Sisulu meds comments: What does the law say about importing medicines?

Minister Lindiwe Sisulu

Minister Lindiwe Sisulu
PHOTO: Rapport
  • The SA Health Products Regulatory Authority is engaging with Tourism Minister Lindiwe Sisulu after reports that she brought medicine from Russia for ANC deputy secretary-general Jessie Duarte.
  • Duarte died on Sunday after a battle with cancer.
  • News24 looked at the laws in place to control the importation of medicine.

The SA Health Products Regulatory Authority (Saphra) has approached the office of Tourism Minister Lindiwe Sisulu for clarification after she reportedly said on Sunday that she brought medication from Russia for ANC struggle stalwart Jessie Duarte.

Duarte died of cancer earlier that day.

TimesLIVE reported that Sisulu was speaking at Duarte’s home in Observatory, Johannesburg at the time and that she said she arrived with the medication in South Africa too late.

But when she spoke to the Weekend Argus, she said the media had misinterpreted her comments outside of Duarte’s home and the medicine was all “in my head”.

“The medicine is in my head, not in my pocket.”

News24 looked at the rules in place to control the import and export of medicines. 

What does the law say about bringing medicine into the country? 

In a statement on Wednesday, Sahpra CEO Boitumelo Semete said it noted the numerous media articles on the matter and that it was therefore engaging with the minister.

Semete indicated there were strict rules for the import and export of medicines and that only a South Africa-registered company that was licensed by Sahpra could import medicines.

Semete added that Sahpra had a mechanism in place that authorises access to specific quantities of a product for a specific patient if a treating oncologist needs to secure an unregistered medicine for a patient.

Werksmans Attorneys’ head of healthcare and life sciences, Neil Kirby, told News24 that while the circumstances around Sisulu’s comments were unclear, the import of medicines was strictly controlled in terms of the regulations promulgated under the Medicines and Related Substances Act, 1965.

“More particularly, Regulation 6, which requires that a person importing medicines or scheduled substances must have a licence to do so,” Kirby added.

He said:

A person may, however, import medicines or scheduled substances for their personal use in terms of Regulation 8, but only under certain conditions.

The conditions include Schedule 3, 4, or 5 substances where the quantity does not exceed the quantity required for use over six months, or Schedule 6 substances where the quantity does not exceed the required use for a period of 30 days.

Schedule 3 to 6 drugs are drugs that are only available on prescription.

Kirby said an individual had to be in possession of the original prescription for such a substance, a certified copy of the prescription or a certificate or letter issued by the person who prescribed and dispensed the substance.

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