SANDF returned controversially procured 'Covid-19 drug' to Cuba, MPs told

The SA National Defence Force (SANDF) on Wednesday confirmed that it has returned 500,000 vials of the Heberon interferon alpha-2B Covid-19 drug to Cuba.

This follows instructions and recommendations by a ministerial task team and the SA Health Products Regulatory Authority (Sahpra) on the illegal procurement of the drug which cost the taxpayer millions of rand.

SANDF chief Gen Rudzani Maphwanya told parliament's portfolio committee on defence and military veterans that the defence force was instructed to either return the medicine or have it destroyed as it was due to expire.

“The SANDF has complied and sent the medicine back to Cuba. We are writing to Sahpra and the auditor-general as the interested parties that we felt we should be re-engaged after we complied,” said Maphwanya.

The task team was appointed in February 2021 to investigate a raft of allegations against the department of defence, particularly the SANDF, including the procurement of interferon.

In November the Sunday Times reported that, according to a preliminary report by AG Tsakani Maluleke which was sent to the SANDF and the department of defence for comment, military officials effectively broke just about every law governing the importation and registration of medicines in SA.

The SANDF smuggled the illegal drug into the country from Cuba, going to extreme lengths to conceal the deal, doctoring customs documentation and using a payment code for training to mask that it was paying for the medication.

TimesLIVE previously reported that Maluleke confirmed the department had been invoiced for R260m for the unregistered drug. Maluleke’s office found that R34.68m had already been paid.

MPs heard the initial complaint was laid by a Maj-Gen LC Ford in a classified internal memorandum which accused the SANDF of irregularly procuring the drug.

“Maj-Gen Ford questioned whether there was a need to procure interferon, the period in which this was decided, the period in which it was procured, the approval for its use, the processes followed during the procurement, the delivery and storage, the payment, and whether the procurement was conducted within the prescripts,” said committee chair Zolile Ngcakani.

Principle investigator Cassius Lubisi said after the investigation SA faced an impending crisis, as the drugs were due to expire before Sahpra’s approval in April 2022.

“It was too late, even if Sahpra approved the trial.”

The best-case scenario at the time would have been for Sahpra to approve the bulk use of the medication after the trial on 8,000 members, to enable the SANDF to use all 80,000 vials from the first and/or second consignment and all 131,101 vials of the third consignment before the expiry date of July 2022.

“The best-case scenario would see the use of 211,101 of the 970,695 vials delivered, representing 21.75% of the received vials by the end of July 2022,” he said.

The worst case scenario would have been the expiry of all remaining vials at the end of July 2022.

“In the best-case scenario, the department will see wasteful and fruitless expenditure of about $11,773,505.50 (roughly R178,700,000) and in the doomsday scenario the department will see wasteful and fruitless expenditure of about $15,045,571 (roughly R228,407,500). The difference in both is $3,272,065.50 (roughly R49,700,000),” said Lubisi.

“We advised the minister there was no difference between the best and the worst case scenario because whichever way, you lose. It was checkmate time.”

Two recommendations were made.

“We said to the minister you should consider acceding to the Cuban request to return 500,000 vials (or more) for urgent use in Cuba before expiry of the medication. This should be accompanied by high-level diplomatic engagement with the Cuban government to manage the political fallout that would result.”

It was common cause that the Cuban and SA military shared a “close relationship” post-1994.

“We warned that as we give you advice to return this there might be serious fallouts, so please engage the Cuban government so that you mitigate this fallout.”

The second recommendation pertains to consequence management.

“We said to the minister to consider taking this report to the relevant structure, particularly the inspector-general and the provost marshal-general for those officials to determine whether steps should be taken against any person or group of people mentioned in this report, in terms of the PFMA and the Medicines and Related Substances Act.”

Sahpra CEO Boitumelo Semete-Makokotlela confirmed that the regulatory authority received correspondence from the SANDF on Tuesday informing them “they have repatriated Heberon alpha and they have provided us with the evidence required and we are reviewing that confirmation.”

Maphwanya said an application was made to Sahpra for the use of the drug as an immunomodulator in August 2020.

“On October 5, Sahpra granted us the section 21 approval for Heberon to be used as an immunomodulator for one patient and that was the initial engagement we had with Sahpra.”

The SANDF also applied for bulk use of the drug, “which was rejected”.

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