Defence minister wants controversial Cuban drug to be used in clinical trials

About 40% of a drug acquired by the defence force at a cost of more than R200m from Cuba may have to be destroyed after indications that it was not stored at the correct temperature.

Parliament’s portfolio committee on defence on Wednesday heard that 387,000 of the 970,885 vials of interferon may be useless after the SANDF — which earlier argued that the drug confers heightened protection against Covid-19 — failed to store it between 2°C and 8°C.

The committee heard about how medication stored either above or below the required temperature was useless but that further investigations would be conducted.

It was the office of the auditor-general that found that at least 40% of the vials were not stored properly by the SA military health services (SAHMS) for at least 20 hours.

“So in our analysis we then found out that 387,000 of the 970,885 vials were indeed exposed to temperatures outside the required range during transportation and/or warehousing thereof,” said Mbali Tsotetsi of the auditor-general's office. “ ... we noted that the drugs were exposed to those temperatures that are outside the norm for more than 20 hours.”

The SA Health Products Regulatory Authority (Sahpra) said that they would go back to confirm the auditor-general's analysis as there would be “no point in storing” vials that were useless, said Sahpra's Prof Helen Rees.

Rees said her major concern was that this large consignment of unregistered medication was brought into the country illegally. The military did not follow proper procurement processes and had not sought clearance from Sahpra ahead of bringing in the medication.

Sahpra said it was not even sure which port the medication came through.

“Even if some drug was and some drug wasn’t [stored properly], we still are stuck with the problem that this was an illegally imported product, a large quantity of an illegally imported product and that is the biggest problem that faces us,” Rees said. “We will certainly look, because clearly if things are not viable there’s no point storing them. But we cannot get away from the fact that this hasn’t been brought in according to South African law.”

Defence minister Nosiviwe Mapisa-Nqakula, however, sought to dismiss the notion that failure to seek clearance could point to a possibility of the medication being smuggled into the country.

“My understanding was precisely that [it went through Sars and port health], that is why I have the courage to stand up and say this medication has not been smuggled into the country because it came through the ports of entry,” Mapisa-Nqakula said.

“So maybe then they can unpack exactly what is it ... because you see now, even the fact that not all documents have been submitted to the [auditor-general] in relation to the clearance of the medication it worries me because I don’t know why people would not provide necessary documents.”

She said that though she had given the SANDF support in acquiring the medication, she was not responsible for the supply chain and procurement processes.

She said those responsible would face consequences.

“I must say it’s a matter which has been a very sore point, a matter which has been very difficult for me to deal with because indeed I was not aware. I did not know that we should have sought permission from Sahpra before we bring in medication. That I should be honest about, that is why I am saying I take full political responsibility for that ignorance.

“Of course I know people say ignorance is no excuse but it’s a reality. I did not know,” she said.

Mapisa-Nqakula and the SANDF surgeon-general Lt-Gen Zola Dabula pleaded with the committee to allow the drug to be taken through clinical trials to confirm its efficacy.

Dabula said it had been successfully used by Cubans and since there was little to no information about it, a clinical trial could be ground breaking.

“Members of the committee should not shut the door on the military health service in terms of the utilisation of this drug for clinical trials. We might just find ourselves making history in terms of the efficacy of this drug,” said Dabula. “Obviously all the necessary academic work is being done and we’re going to put it in place in such a way that the information that is going to come out of whatever study we’re going to put in place is going to be of value to the rest of the world.”

In supporting this notion, Mapisa-Nqakula said this would prevent the purchase being regarded as wasteful and fruitless expenditure.

“Yes, it will be fruitless expenditure if this work which we are proposing should [not] be done. Because obviously none of us want this to be fruitless expenditure. Certainly I don’t want it. I’m not looking forward to it because it has serious implications for the defence force.

“However, my appeal right up until now is that let us please continue to allow the process of engagement between Sahpra and the defence force. I accept that it was wrong of the defence force to bring it in before they had engaged Sahpra,” said Mapisa-Nqakula.

Sahpra said clinical trials would be costly. ​

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