Follow-up: Procurement of Heberon by DoD

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Defence and Military Veterans

24 February 2021
Chairperson: Mr V Xaba (ANC)
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Meeting Summary

17 Feb 2021: Procurement of Heberon by DoD: SAHPRA & DoD briefing; with Minister

The Committee continued its enquiry into the unauthorised importation of the drug interferon from Cuba by the South African National Defence Force (SANDF), with further input from the Auditor-General of South Africa (AGSA), the South African Health Products Regulatory Authority (SAHPRA), and the South African Military Health Service (SAMHS).

The AG’s office clarified an earlier report on the post-importation procedures. The SANDF had not tested if the drug was transported and stored at the required temperatures, which was supposed to be between 2 °C and 8 °C. In the analysis, it was found that 387 000 of the 970 885 vials of imported interferon had not been properly stored, which meant that the integrity of the drug had been compromised. The recommendation was that the SANDF had to investigate all the instances where the cold chains were compromised, so that they could determine the integrity of the drug.

SAHPRA said that there were clear rules to be followed when the procurement of drugs was done. It would be notified at the port of entry if there was a drug that was being imported into the country without proper documentation, and that they should collect samples and do tests. Based on the outcome of the investigation, the product would be destroyed. The product remained unauthorised, and they would engage with the SANDF on how to deal with the product once the results from the analysis of the samples were back.

The SANDF said the SAMHS had advised the military command council and said that the drug would assist the soldiers who were going to be deployed around the country. The engagements between the SANDF and SAHPRA had been productive, and at this stage it would not be advisable to share information on the trials. Once the engagements between the parties were completed, there should be a way forward.

The Committee was told the importation of the interferon had been part of the Operation Thusano contract entered into between South Africa and Cuba. The medical service was the Cuban medical doctors and interferon. In this event, the procurement process had not been followed because it was not considered necessary.

Members wanted to know who had actually placed the order, knowing that interferon was an unauthorised drug, and why SAHPRA had not been notified of the intention to import it. They were generally unhappy with the responses they received from the SANDF.

The Minister of Defence said she was a politician, not a scientist or a medical doctor, but she did take political responsibility for the procurement of the drugs. She had not been aware that they were not registered, but she could not distance herself from the mistake that had been made, because she was part of the ministry. She committed the Department to a full investigation of the matter, and said that there would be consequences for those who had flouted procedures.

Meeting report

The Chairperson welcomed Members to the virtual meeting, and read out the agenda for the day. He briefly explained that the meeting was to continue the discussions that were not finished the previous week, and Members would have an opportunity to get a response from South African National Defence Force (SANDF) since they did not have an opportunity the previous week because of time constraints.

He asked the Auditor-General (AG) office to make brief remarks on one matter that they had raised.

Auditor General of SA

Ms Mbali Tsotetsi, Deputy Business Executive, AG, said that there was a mis-find from the presentation that was made last week, and the AG office wanted to make a clarification on the post importation procedures. It was reported that 40% of the vials were compromised. The findings were on page 123 in the special report which was tabled to the Committee in December. The SANDF had not tested if the drug was transported and stored at the required temperatures, because it was supposed to be stored between 2 °C and 8 °C. The AG’s had office noted that there was an indication which showed that some of the drugs were exposed to temperatures that were below or above the required temperatures, as there was a device that shows a cross sign to indicate if the drug was exposed. In the analysis, it was found that 387 000 of the 970 885 vials of interferon were not properly stored. This meant that the integrity of the drug had been compromised. The recommendation was that the SANDF must investigate all the instances where the cold chains were compromised so that they could determine the integrity of the drug. She said that this finding had been misunderstood in the meeting of the previous week.

Ms Tsotetsi said that the AG office had obtained some information prior to the meeting last week, but some information was still outstanding.

The Chairperson asked if there was any specific reason why the AG office had not received the required information from Sthe ANDF.

Ms Chrisna Janse van Rensburg, Senior Manager, AGSA, responded the AG’s office had met with the SANDF, and they had discussed which information should be submitted. There were constant engagements on what they must provide.

Mr S Marais (DA) asked about the device that had been mentioned by AGSA and if they would elaborate on that matter so that Members could have a better understanding of how it worked?

Ms Tsotetsi responded that the device had a mark which would show if the medication was exposed to more than 8 °C, and it generally showed an X sign. Medications amounting to 387 000 had been exposed to the temperatures outside the range. They had also tested some of the medicines which were not marked to check if they were not exposed to more than 8 °C, and it was confirmed that they were in the desired range of between 2 °C and 8 °C.

Ms M Modise (ANC) asked if the SANDF had their own facilities to store the medicine, or if they were using facilities from a third party. If they did not have their own facilities, would this not have an impact on the medicine and cost more? Who was covering that cost?

Ms A Beukes (ANC) said that the SANDF was reluctant to collaborate with the AGSA, and it was worrisome. She asked if the AG’s office had received the report on the investigation of the medication.

The Chairperson thanked Members for their questions, and said that they would be answered by the SANDF, as they were still to respond to questions from last week.

South African Health Products Regulatory Authority (SAHPRA)

Prof Helen Rees, Chairperson, SAHPRA, said that there were clear rules to be followed when the procurement of drugs was done, and Dr Semete would elaborate on the matter.

Dr Boitumelo Semete, Chief Executive Officer (CEO), SAHPRA, said that she was present to clarify on the process to be followed when an unauthorised product was in the country. SAHPRA was notified at the port of entry if there was a drug that was being imported into the country without proper documentation, they should collect samples and do tests. Based on the outcome of the investigation, the product would be destroyed.

There had been engagements with SANDF, and a team from SAHPRA had found that the drug at SANDF was stored at the required temperatures, and they had checked the expiry dates and the quantity of the product. Samples had been taken to analyse, so that they could report on that.

The product remained unauthorised, and they would engage with the SANDF on how to deal with the product once the results from the samples were back.

The Chairperson asked about the question which had not been responded to in the previous meeting about the trial size -- how big the sample size could be, and if there was a minimum or maximum threshold for a trial.

Dr Semete said that they had not yet received an application for a trial, and the trial size depended on each case, because it was a matter of what one wanted to do with the drug. In some instances, the trials had three stages. There were international guidelines on how to do the trials, but at this stage they could not state the required number.

Prof Rees added that the complexity of the situation would be that in a clinical trial where there was no evidence of effectiveness, and there were no other products under the vaccine which were being considered, in this situation it meant that the vials would have to be blinded.

The Chairperson asked how long it took for an average clinical trial, taking into consideration the expiry date of the drug.

Prof Rees responded that it depended on the aim of the trial. It was costly and required human resources and skilled researchers. A lot of thought would have to go into what type of data was generated within the sensible parameters. If it was a blinded study, the vials would have to be totally relabeled.

The Chairperson thanked Prof Rees for her feedback.

Mr Marais asked about the 40% vials which had been compromised, and wanted to know about the status of that stock. He wanted to know if the requirements had been met at the storage facility. He asked if SAHPRA had not been informed when the drug was imported, considering that they had to know what happens at the port of entry. Could SAHPRA elaborate on what they meant about the requirement for human resources for clinical trials? Why had SAPRA allowed the SANDF to do a further clinical trial if the World Health Organisation (WHO) had not given a green light for the drug?

Ms Beukes asked for clarity on the issue of temperature, because there were differences in the version of the AG office, compared to what SAHPRA had said.

The Chairperson explained that the AG had looked at the temperatures when they picked up the information from the device, and their focus was not the current temperature but that during transportation. When SAHPRA checked, they had found that it was stored at the required range in the facility, which meant that they were looking at different aspects.

Prof Rees said that Covid-19 was a new virus, and there was a need for additional tools to deal with the virus, and data would be reviewed continuously. Interferon had been included in a solidarity trial for Covid-19 treatments that was conducted by the WHO. The suggestion for a clinical trial was because there was some data. If there was a trial that SAHPRA would want to see, it would be something with a different label.

Prof Shabir Banoo, Board Member, SAHPRA, told the Committee that the context of whether there was a need for a clinical trial was complex. With interferons, there was a range of molecules that had slightly varying effects on the immune system. The WHO study had looked at a different interferon -- and there was a range of interferons. In the context of the specific interferon, there were two studies which were conducted in China and Cuba. The studies were small and conducted in the early stages of the pandemic. A study would have to be conducted with enough participants to be able to define the outcome. There was very little research that was being done on interferon now.

On the issue of temperature monitoring, the assessment that had been done must still be implemented, and what SAHPRA had not yet ascertained was if the drugs had experienced temperature excursions. It was critical that the temperature was maintained throughout the supply chain. The temperature devices were important, as they assisted in determining if a product had been stored in a proper manner and if not, the product was then returned to the manufacturer.

SAHPRA needed to do further investigations on the issue of temperatures.

The Chairperson asked if SAHPRA was committing to doing an investigation on the temperatures of the drug.

Prof Rees said that whether or not the temperatures were checked, it did not take away the fact that the drug was not imported following the correct channels.

Dr Semete said that each point of entry had a pharmacist. SAHPRA had received the first application only in August 2020, yet the first consignment had arrived in the country in April 2020. They did not know which port of entry had been used, nor the reasons why SAHPRA was not notified.

The Chairperson thanked SAHPRA for their engagement, and introduced the Surgeon General from the SANDF to engage with the Committee.

South African National Defence Force (SANDF)

Lt Gen Zola Dabula, Surgeon-General, SANDF, said that the military command council takes full responsibility for what happens with the procurement of drugs and medical aspects. A lot of information had been given to the Committee about the storage of the drug, and who was responsible, amongst other issues. It was important for the Committee to understand that at the time when the drug was imported, no one had a good understanding on how to deal with the pandemic.

The SA Military Health Service (SAMHS) had advised the military command council and said that the drug would assist the soldiers who were going to be deployed around the country. The soldiers who were to be deployed would have some protection from the drug.

It was unfortunate that the drug was being labeled as unlicensed. The engagements between the SANDF and SAHPRA had been productive and at this stage it would not be advisable to share information on the trials. The issue was complex, which meant that it should not be taken at face value. SAMHS had sufficient capacity for the trial, and all the required personnel for the trial. Once the engagements between the parties were done, then there should be a way forward.

SAMHS was working in collaboration with other academic institutions for the clinical trials because of the requirement for collaboration. It was unfortunate that the issue of temperature about the drug had arisen, but the SANDF did have the capacity to do research to check if the storage requirements were met.

Lt Gen Dabula said that it was unfair to talk about the drugs that have been impacted at this stage because of the temperature breaches, because more tests need to be conducted.

The size of the trial would be discussed by the regulatory authority to determine the numbers that could be put forward.

SANDF had never said that interferon must be used as a vaccine -- it was one of the medications that would be effective in the management of patients who were not hospitalised, and the trial would only assist in clarifying some of the questions that were being raised towards interferon. Some research would be put into the global space once the trials were concluded.

SAHPRA had given permission for the utilisation of ten vials of interferon. The number of infected cases in the Defence Forces during the lockdown had been higher, and this may be attributed to the direct involvement of its personnel. Several medical personnel in the Defence Force had had to be laid off because of the 14-day quarantine rules.

On the issue of how many soldiers were infected and how many had lost their lives due to Covid-19, the response was that it was classified information.

The only provinces where the SANDF did not have a high number of infections was in the North West and Northern Cape.

The relationship between SAHPRA and SANDF was a matter of collaboration, and it was going well now.

The Secretary General knew of the importation of the drug, and though he might not have been present in all the meetings, he was kept up to date on what was happening regarding the drug.

Col Thabo Mnisi, Head of Department (HOD), SAMHS, said that the technical team from SAMHS had engaged with the technical team from SAHPRA to find ways in which the clinical trials could be conducted. This was a new interferon, and it would bring in new knowledge, and the problems encountered during the importation of the drug must not hinder the process of getting more knowledge. The SANDF was waiting for a report from SAHPRA so that they would know which drugs to use going forward and follow the law as required.

The Chairperson thanked the SANDF delegation for their feedback, and asked Members if they had follow-up questions from last week.

Follow-up questions

Mr Marais asked about the acknowledgement of the drug from the SANDF. He wanted to know why the SANDF had supported the importation of an unauthorised drug, and if they were not subject to the rules of SAHPRA.

The Chairperson said that SANDF had accepted that wrongs had been committed, and had acknowledged being wrong on the issue of the drug importation. He advised Mr Marais to ask new questions so that the Committee could get a better understanding.

Mr T Mmutle (ANC) was of the view that the questions raised in the previous meeting had not been answered. He asked why SANDF did not follow the correct channels when procuring the drug. He also asked about the number of vials that had procured. The numbers of the SANDF did not tally up, and he wanted to get a comment on the issue from the SANDF delegation.

SANDF response

Lt Gen Dabula started by apologising for not responding to the question of Mr Mmutle. The issue of expediency in the procurement must be considered, because the country was under lockdown. This meant that the acquisition of the drug and how much was to be acquired was based on the total number of dependents of the SANDF, excluding the military veterans. The idea was not to use the interferon for the soldiers only, but to extend it to their family members also.

When most departments were shutting down around the country because of the pandemic, it was necessary to procure interferon.

The door to clinical trials on this drug must not be shut down, because even the academic knowledge acquired would be utilised for future purposes.

Mr Marais said that his questions were not answered, and it was disappointing. He asked why SANDF continued to procure a drug that was not registered, and if they did not follow the rules of SAHPRA.

The Chairperson was of the view that the question might have been answered, and asked if Members still had questions.

Mr Marais asked whether SAMHS had competent knowledge on the import and storage of medicines, and why they did not inform SAHPRA about the procurement of the interferon.

The Chairperson interjected and said that Mr Marais should not ask questions that were not covered by the agenda.

Mr Marais wanted to know about the clinical trial, and asked about the cost of having a clinical trial. If SAMHS was convinced about the clinical trial, they should have done a cost analysis to see how much it was going to cost. He also asked why China and Cuba could not do a clinical trial, because they were the ones manufacturing the drug.

The Chairperson said that the SANDF was still in consultation with SAHPRA, and only after such consultations were concluded should some questions be asked because now there were no answers. There would be a time for those specific questions.

Mr Marais said that the facts were present. The military command council did not act without the approval of SAMHS, so there was a need to get a response.

The Chairperson told Mr Marais that the SANDF had accepted their wrongdoings.

There was a back and forth discussion between Mr Marais and the Chairperson.

Ms Modise raised a concern that the Chairperson was allowing Mr Marais to lead the meeting into a dialogue. This was not acceptable, as it was time consuming.

The Chairperson pleaded with Members to accept that some of the matters were still being dealt with between the SANDF and SAHPRA, which meant that once those processes were completed, and then the Committee would be able to engage on them.

Lt Gen Jabulani Mbuli, Chief of Logistics, SANDF, said that Maj Gen Joseph Tyhalisi was responsible for Project Thusano, and the contract was structured in a manner that looked at professional and technical services. Medical services fell under the branch of technical services. The other part of the contract was vocational training of the medical personnel of SANDF.

The Chairperson asked what the service was and who was providing the service in terms of the contract. He also wanted to know the contracting parties of the contract.

Gen Mbuli said that before the two parties signed any contract, the requirements would come from the Chief of Staff for approval.

The Chairperson said that the Committee wanted to know who the supplier of the drug to the SANDF was.

Gen Mbuli said that SANDF was part of the contract and technology import, he said that Maj Gen Tyhalisi would explain further details of the contract.

The Chairperson asked if Gen Mbuli could not provide straightforward answers on the contract.

Gen Mbuli responded by saying that SANDF was receiving the drug as part of the contract.

The Chairperson asked if Gen Mbuli was taking full responsibility for what had happened. Gen Mbuli responded that he did take full responsibility.

Mr Mmutle said that the Committee was not questioning the contract nor the Cuban relationship with the SANDF, but the question was whether under project Thusano the SANDF had permission to procure the drug, because the approval should come from the Secretary General. Did Project Thusano have the capabilities to handle procurement?

The Chairperson added that Maj Gen Tyhalisi should answer the questions asked by Members.

Maj Gen Tyhalisi said that the authority to engage with the Cubans was based on the contract. SANDF was not hiding anything, and they would invite Members to view the contract. When SANDF referred to a service, they meant medical doctors and the medication that came with the Cuban doctors, and Techno Import was a government-owned entity. In the current scenario, the contracting part was done by the Department of Defence (DoD) and by extension the SANDF was duly appointed to deal with the issues.

Responding to Mr Mmutle’s question, he said Project Thusano manages the contract between Cuba and SANDF, together with managing the deliverables of the contract. The medical service was the medical doctors and interferon. In this event, the procurement process had not been followed because it was not necessary.

Members had to understand that if there was an existing contract between parties, it meant that the deliverables of the contract could be dealt between the parties in terms of the contract.

What Project Thusano had done was to manage the deliverables signed between the parties. He also invited Members to have a look at supplement 10 of the contract, as it shed more details.

The Chairperson asked if the contract had been submitted to the AG’s office.

Maj Gen Tyhalisi said that all the documents had been submitted, together with the provisional contract.

The Chairperson asked Maj Gen Tyhalisi if he did not deal with the contract, and he responded that he manages the deliverables of the contract.

Mr Mmutle said that he was not pleased with the response from Maj Gen Tyhalisi, because it sounded as if the Committee was not aware of what were deliverables.  He also mentioned that he used to do contracts, and procurement was a different thing altogether. Anything that was to be procured under Project Thusano had to go through a different process, because it was a transaction on its own and the drug required approval. The SANDF could not use the excuse that the drugs fell under the protection of project Thusano.

Mr Marais agreed with Mr Mmutle, and asked who in the SANDF was the contracting party and the procurer of the drug. There were a few items that were strange in the responses by the SANDF. He wanted to know if there were any exceptions for the SANDF when it came to procurement. The drug had been declared illegal in South Africa, so why did the SANDF sign off the procurement paperwork. Why was SAHPRA not informed of the importation of the drug into the country? He asked if Maj Gen Tyhalisi was referring to the reasons given by SANDF, that biological warfare was threatening the country. What did the SANDF rely on to declare that the country was in a state of war, because only the President of the country could declare a state of war after reporting to Parliament?

The Chairperson reminded Mr Marais not to debate the matter, but to ask direct questions, because some of the answers were already part of the record.

Mr Marais wanted to know what provision had been relied upon by the SANDF.

The Chairperson said that the meeting was not a discussion, and Members should wait for the Parliamentary sessions.

He asked Maj Gen Tyhalisi who the contracting parties in the contract with the Cubans were -- whether it was the DoD or Department of Health (DoH) and what the involvement of the SANDF had been in the coming to South Africa of the Cuban doctors.

Maj Gen Tyhalisi said that when the Cubans arrived in South Africa, 29 of the doctors were directed to the SAMHS.

The Chairperson reminded Maj Gen Tyhalisi that he was not asking about the deployment, but who was responsible for the contract

Maj Gen Tyhalisi responded by that the SANDF and the DoH were the contracting party for the 29 doctors, and in Cuba it was the Department of Defence and Techno Import. The military doctors from Cuba were part of the medical team.

The Chairperson reminded Maj Gen Tyhalisi what he had said about the contracting parties earlier.

Maj Gen Tyhalisi said that the issue of the contract and deliverables in Project Thusano, related to the technical and professional services, which included all the Cuban services being provided in South Africa. To sustain the services, SANDF members had to be trained, and it was still under Project Thusano. When the SANDF talked about services, they referred to the military personnel from Cuba who had come to train SANDF members. The Cuban delegation came with personnel to assist the SANDF and the country to deal with the pandemic, and if there were technical questions, they should be directed to the medical practitioners, not the military staff of the SANDF.

The SANDF had received the drugs, and it had not taken them long to transport them.

The Chairperson reminded Maj Gen Tyhalisi not to discuss matters that were still going to be investigated.

Maj Gen Tyhalisi said that an investigation would determine whether the SANDF had been wrong in the procurement of the drugs from Cuba.

Mr Marais wanted to ask a question about biological warfare, but the Chairperson did not allow him because he was of the view that Mr Marais was wasting time.

He said that there was an indication that the SANDF had breached procedures, and an assessment to be made would determine if the action was reasonable. What was clear from the SANDF presentation was the irregular procurement and the possibility of wasteful expenditure.

The Chairperson invited the Minister to address Committee Members.

Mr M Shelembe (DA) raised a concern on how Mr Marais was treated by the Chairperson, and said that he had been unfairly treated. This led to a back and forth discussion between the Chairperson and Mr T Walters (DA) on the issue.

Minister’s response

Ms Nosiviwe Mapisa- Nqakula, Minister of Defence, said she was a politician, not a scientist or a medical doctor, and whatever questions were related to medical issues should be directed to the SAMHS. However, she did take political responsibility for the procurement of the drugs. She had not been aware that the drugs were not registered, but she could not distance herself from the mistake that had been made, because she was part of the ministry.

A memo which had been submitted had revealed some of the issues that were being discussed by the Committee. A team had been put together and the terms of reference had been developed.

She said that the doctors from Cuba had come at the request of South Africa and the DoH.

SAHPRA should continue to work with SANDF to resolve the issues that had been raised by the Members, especially about the matter of temperatures.

The Minister said that some of the issues raised by Members would be covered by the investigation and Members would have the answers to their questions. There was no reluctance by SANDF to account to Parliament, and the Minister had insisted that all the required information should be submitted to the AG.

She said was not aware of the issue about the SANDF not having authorisation to acquire interferon.
Her understanding from the contracting partners was that the SANDF had been offered medication by Cuba which would assist in boosting the immune system so that people could fight Covid-19, and the medication was already being used in China and Cuba. The Minister raised the issue with the national command council, and the SANDF had received the drugs through the bilateral agreements between the countries.

The matter would lead to fruitless expenditure, and it had serious implications for the SANDF. She appealed to the Committee to allow the SANDF to continue engaging with SAHPRA so that the process could be finalised.

She said that she had been the first person to raise the issue of medication from Cuba at the national command council, but she did not know about the company that was dealing with the importation logistics and who was manufacturing the drug. Her knowledge was that everything was done by the Cubans.
 
There would be consequences in terms of the failure to comply with the procurement procedures.
The Minister said that it had been difficult to deal with the importation of the interferon, because even she herself did not know that clearance was supposed to be given by SAHPRA.

Her understanding was that the drugs were not smuggled into the country, because they came through the port of entries, but she was worried why the necessary documentation was not submitted to the AG’s office.

She was concerned like everyone else, and although she was not responsible for the procurement processes, she was politically responsible.

The Chairperson reminded the meeting what the President had said about the issue, and said that the Committee would give her time to conduct the investigation. He asked about the vetting process of members who would be in the investigation team.

The Minister responded that the vetting process was conducted by the State Security Agency, and the members would sign non-disclosure agreements. The team had been appointed, and they had been given three to six months to conduct the investigation.

The Chairperson thanked the Minister for attending the meeting and for her honesty when she addressed the Committee.

The Minister closed off by saying that the SANDF was not perfect, but the Committee had to remember how they had served the country. Covid-19 was a state of war, but it could not be classified as biological warfare. The SANDF had tried their best under the circumstances, as they had done in many instances around the continent and the country.

What had been done wrong should not erase all the good work done by the SANDF. The interferon had been imported without proper documentation, and whatever would come out of the investigations had to take into consideration the conditions that the SANDF was working under.

The meeting was adjourned.





 

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