Sahpra approaches Lindiwe Sisulu’s office over Jessie Duarte medication claims

Lindiwe Sisulu minister of Tourism Development and Environmental Affairs Bongani Mbatha: African News Agency /ANA

Lindiwe Sisulu minister of Tourism Development and Environmental Affairs Bongani Mbatha: African News Agency /ANA

Published Jul 21, 2022


Durban - The South African Health Products and Regulatory Authority has confirmed that it is engaging with Minister Lindiwe Sisulu's office following claims that the Minister had secured medication for African National Congress Deputy Secretary-General Jessie Duarte, but Duarte died before the medication arrived in South Africa.

At the weekend, the ANC confirmed that Duarte succumbed to cancer. National spokesperson Pule Mabe said 68-year-old Duarte had been undergoing treatment for cancer and had been on medical leave since November last year.

According to reports, Sisulu claimed to have secured medication from Russia for Duarte's treatment.

The Weekend Argus reported that Sisulu was looking into the efficacy of Russian cancer medication. Sisulu added that the media misinterpreted her comments.

In the wake of her statements, Sahpra's Dr Boitumelo Semete said there are strict rules and guidelines in place regarding the import and export of medication.

"It must the noted that there are numerous oncology medicines that are registered by Sahpra and are available in South Africa for a range of cancers. In the event that a treating oncologist needs to secure an unregistered medicine for a specific patient, Sahpra does have a mechanism in place as guided by section 21 of the Medicines and Related Substances Act (Act 101 of 1965 as amended)," Semete explained.

She added that this process enables authorised access to specific quantities of the unregistered medicine for a specific patient, post a review of the application as submitted to Sahpra by the treating oncologist.

"In an effort to enable access to the specific medicines, which vary depending on the type of cancer, Sahpra reviews the application and makes a decision within a period of three working days," she said.

Semete added that Sahpra has strict rules and guidelines on the importing and exporting of medicines.

"South African legislation prescribes that only a South African registered company that is licensed by Sahpra can import medicines registered by Sahpra into South Africa. In the event that a medicine that is not registered in South Africa is to be accessed, the guideline on importing and exporting of medicines states explicitly that no person shall order any medicine from abroad for personal use unless Sahpra has granted the said person an authorisation in terms of section 21 of the Medicines Act," she said.

Furthermore, Regulation 8 (1) of the Medicines Act stipulates that "any person entering or departing from the Republic of South Africa may be in possession, for personal medicinal use, of a quantity of a Schedule 3, Schedule 4, Schedule 5 or 6 substance which shall not exceed a quantity required for use for a period of one month; and a) the said person must have- a valid prescription for such Scheduled substance or medicine; b) a certificate to the effect that the Scheduled substance or medicine concerned including its quantity was prescribed for the person including the name and address of such authorised prescriber; and c) his or her particulars of residence in the Republic, in the case of the person entering the Republic, recorded at the port of entry".

In terms of Section 21 of the Medicines Act, unregistered medicines on a named patient basis can be accessed under strict conditions as stipulated in the Sahpra guideline, wherein it states: “In terms of Section 21 of the Act, Sahpra may in writing, authorise any person to import and sell during a specified period to any specified person or institution a specified quantity of any particular medicine, which is not registered. This permission is, however, subjected to confirmation from a medical professional that the product is needed and that no similar product is available in the country. Sahpra will evaluate the requests and may grant the authorisation which will be issued by the CEO in the prescribed manner, and subject to such conditions as Sahpra deems fit.”

"Thus, all medicines that would be available in South Africa must either be registered by Sahpra or have the Section 21 authorisation," Semete said.