Findings of Ministerial Task Team on procurement of Heberon from Cuba, with Deputy Minister

Meeting report

The Committee Programme for 2022 had been revised to accommodate the State of the Nation Address on 16 February 2022.

The Minister of  Defence and Military Veterans, Minister Thandi Modise, was indisposed and had submitted an apology for being unable to attend the Committee meeting. Minister Lamola was acting as Minister of Defence and Military Veterans in her absence but he, too, was unable to attend the meeting. The Deputy Minister (DM) of  Defence and Military Veterans, Deputy Minister Thabang Makwetla, would lead the delegation in the meeting.

Guests from the three agencies involved in the matter were welcomed by the Portfolio Committee Chairperson: Prof Helen Rees, Chairperson, and Dr Boitumela Semete-Makokotela, Chief Executive Officer, of the South African Health Products Regulatory Authority (SAHPRA); executives from the Office of the Auditor-General South Africa, Business Executive, Mr Lawrence van Vuuren and Ms Mbali Tsotetsi, Deputy Business Executive; Gladys Sonto Kudjoe, Secretary for Defence and Lieutenant-General Rudzani Maphwanya, Chief of the South African National Defence Force. The Chairperson also acknowledged the three Members of the Ministerial Task Team: Chairperson Zolile Ngcakani and members Dr Cassius Lubisi and Mr Billy Masethle.

Presentation on the findings of the Ministerial Task Team on the procurement of Heberon medication from Cuba by the South African National Defence Force
Deputy Minister Thabang Makwetla stated that, although the Committee would be briefed on the report, it was regrettable that, for reasons beyond her control, the Minister was unable to attend the Committee meeting. The actual report would only be released when the Minister returned to Office from sick leave as the task team was, in fact, a Ministerial Task Team (MTT), established by the previous Minister of Defence and Military Veterans, Minister Nosiviwe Mapisa-Nqakula, after hearing the concerns of the Portfolio Committee, amongst others. The briefing would be presented by the MTT and not the Department of Defence and Military Veterans as it was a report on investigations in the Department and the South African National Defence Force (SANDF). He stated that he would share whatever was appropriate after the presentation.

Prof Rees requested to speak but the Chairperson requested that she hold her point until after the presentation.

The Chairperson of the MTT, Mr Zolile Ngcakani (former Inspector General of Intelligence) addressed the Committee. Maj-Gen LC Ford, in a classified internal memorandum, had accused the SANDF of irregular processes during the procurement of Heberon® Alpha R 2B (Human Recombinant Alpha 2B Interferon) from Cuba in order to fight the Covid-19 pandemic. Ultimately that had led to the establishment of the Task Team and the investigation which had culminated in a report that provided a history of the procurement of Interferon Alpha 2B for the SANDF. The report recorded the findings and presented commentary on the matters raised by Maj-Gen Ford, SAHPRA, and the AGSA. The report identified key role players and assessed the mischief faced by the SANDF and the DoD. It also made two recommendations for consideration by the Minister of Defence and Military Veterans.

Dr Cas Lubisi, a member of the MTT, presented the contents of the report but, firstly, he explained that the Heberon Alfa R had been received in very small bottles or vials, a picture of which was presented, and so, when he spoke of the quantities of the drug, the quantities referred to the number of tiny bottles or vials.

Dr Lubisi presented a detailed chronological narrative of events relating to the Heberon Alfa R. He stressed that the whole world was caught unawares by the onset of the Covid-19 pandemic and sought desperately for drugs to contain the virus. He explained that an unrelated matter raised by South African cadets in Cuba had led to the involvement of the Department with Heberon Alfa R produced in Cuba as a possible solution to Covid-19.

Dr Lubisi noted that the ports of entry of drugs into SA were regulated and they did not include Waterkloof Airforce base, but he stressed that a key issue in the saga appeared to be the differing ideologies of the SAPHRA and the Department/SANDF doctors. SAPHRA seemed to stifle competition from non-US and non-European source for medicines, especially Cuba, whereas the military had a strong relationship with Cuba.

Critically, the drug was ordered without approval from SAHPRA and the AGSA noted that as an irregularity. Subsequently the AGSA had raised questions of irregularity in respect of the supply chain management for the procurement of Heberon. 1.2 million doses were ordered for the treatment for 100 000 persons. In total 970 659 vials were actually delivered in three batches to South Africa. The initial batch arrived on a public holiday and there were allegations that the staff had not stored the vials in a refrigerator with appropriate temperature control but that suggestion was disproved. However, it was true that when the SANDF paid for the first batch of Heberon, payment was made against an incorrect classification. While the SANDF was attempting to gain approval for use of the drug, the Cuban had government requested the return of 500 000 vials that were urgently required for use in Cuba and promised to replace the vials, if the SANDF secured approval.

As the expiry date for the first of the three batches of drugs would be reached as early as March 2022, the MTT advised the Minister that the best case scenario would only see the use of 200 000 vials and that there was little difference between best case and worst case scenarios.

MTT recommendations to Minister:
1. Accede to the Cuban request to return 500 000 vials, or even more. The return of the drug should be supported by high level engagement that respected the close relationship between the South African and the Cuban governments and military forces and would address any possible fall-out over the matter.
2. Present the report to the Inspector General of Defence to determine whether steps should be taken against anyone in respect of the Medicines Board and call such persons to appear before the Military Board of Inquiry.

Dr Lubisi added that, subsequent to the submission of the report by the MTT,  one recommendation had been acceded to. The MTT could not report on that matter as it had taken place after the MTT had concluded its work and the Task Team had become functus officio.

The Chairperson noted that the slides provided a great deal of information and that information had been supplemented by oral information. That was why he had said that only after the presentation could one determine whether the information provided was adequate.

Additional comments on the procurement of Heberon medication
The Chairperson stated that AGSA had sent a letter to him as Chairperson of the Committee. Mr Lourens van Vuuren would speak to it. SAHPRA had some comments it wished to make and he was not sure whether anyone could speak to the implementation of one of the recommendations.

AGSA
Mr van Vuuren referred to slide 22 of the presentation which stated that “It is worth noting that the AG flagged only the irregularity of procuring the Interferon without SAHPRA’s approval, and not an irregularity related to supply chain management (SCM) lapses.”  He explained that, in addition, the AGSA had raised a finding in the Special Report on Covid in 2019/2020 which had highlighted shortcomings in relation to Operation Thusano for the procurement of the drug, including the use of an open-ended contract. In the 2020/2021 Audit Management Report for the SANDF, a finding was raised in relation to the procurement under Operation Thusano. That procurement was not in compliance with section 217 of the Constitution or with National Treasury Notes and Prescripts and, as a result, all expenditure under Operation Thusano had to be regarded as irregular expenditure. At that point in time, the expenditure on Operation Thusano was in excess of R1 billion. The Department disagreed with the finding and it therefore formed part of the qualification on the completeness of irregular expenses. The Audit Report was issued on 17 September 2021.

The Chairperson agreed that in subsequent reports further findings were raised, but that, at the time, the MTT report was correct.

SAPHRA
Prof Rees stated that the SAHPRA Board and Executive had not had sight of the report and so could only respond to the slides but that some things had to be corrected in the slides. The introduction that showed the context at the start of the Covid-19 pandemic was very important. At the very beginning, as indicated in the first slide, it was hoped that Interferon would be one of many drugs that would make a difference to the pandemic, but trials had shown that it was not effective. That was the view of the World Health Organisation (WHO) and the relevant committees dealing with Covid in SA. When negotiations began, there had been hope, but, as with other medications, that hope for Interferon to address the virus had fallen away. SAHPRA had sent a letter to the Chairperson of the Portfolio Committee and she would ask the CEO to address the issues raised in that letter.

Prof Rees supported Dr Lubisi’s comment that SAHPRA was keen to work closely with the SANDF. It was critical to get a common understanding of the legislative framework within which they were working as that might be one of the misunderstandings that had created certain challenges.

Dr Boitumela Semete-Makokotela, CEO, SAHPRA, stated that she was unable to make substantive comments at that stage as she had not seen the report. The objectives of SAHPRA was to ensure a safe health environment and to ensure the implementation of the relevant Acts and regulations in the interest of the safety of the public, without any exception. The Medicines and Related Substances Act applies to all government departments and there was no exemption for military personnel. SAHPRA had been in engagement with the Department of Defence and Military Veterans since 2020 to address the issue. As they were both arms of the state, it had been important for SAHPRA to find a way of dealing with the matter.

She wished to make the point that SAHPRA had not withdrawn its offer of clinical trial: the trial was not authorised because, despite many delays, it had not met the regulatory requirements. SAHPRA had turned to the inter-governmental framework for a mechanism to assist the Authority to deal with the matter. She noted that the report stated that SAHPRA had insufficient scientific evidence to reject the drug and that was not true. Lastly, the import of the medicines had been inadequately managed.

The Chairperson stated that Dr Semete-Makokotela was addressing issues that were in the report and not in the presentation.

Dr Semete-Makokotela concluded that SAHPRA had received communication that vials had been repatriated to Cuba and the Authority was reviewing the evidence.

SANDF
Ms Sonto Kudjoe, Secretary for Defence, agreed that the report belonged to the Minister. There were clear recommendations in the report. She confirmed that a process could be followed through the Intergovernmental Relations Framework Act if two state entities could not find each other. She added that the Chief of the SANDF would deal with the details of the matter as it related to military personnel.

Lieutenant-General Rudzani Maphwanya, Chief, South African National Defence Force (SANDF), said that the SANDF had had an engagement with SAHPRA in relation to Heberon, starting off with an application for the use of Heberon for Covid-19. On 5 October 2020, there was an agreement by SAHPRA that the SANDF could use Heberon on one patient. The SANDF had also applied for a bulk trial but that was rejected. The SANDF had then applied again for a single patient trial but had found that certain fields on the electronic application form were closed and that was the beginning of an impasse between the two entities. There had been interaction between SAHPRA and the Department of Defence.

Lieutenant-General Maphwanya drew the Committee’s attention to the matter of the port of entry for vials of Heberon. The SANDF respects the laws of the country and is aware that the Act indicates the ports of entry but the Act was silent on the interface with the Defence Act and transportation of critical military goods, including nuclear weapons, are permitted to enter the country via the Waterkloof Airforce base, so Waterkloof was the right place for the SANDF to import Heberon. In addition, on 26 March 2020 all ports of entry into the country were closed as a result of the pandemic and so the only way to protect the soldiers was to use a military base.

Lieutenant-General Rudzani Maphwanya thanked SAHPRA and the Portfolio Committee for the recommendation to send the medicine back to Cuba. SANDF had sent back the medication back to Cuba and was in the process of  informing interested parties that SANDF had complied.

Invited to comment, the Deputy Minister agreed that a full discussion should be deferred until the Minister returned. She would  provide her own report stating what actions should be taken.

The Chairperson noted that there was support for the deferral of discussion on the matter. He invited Members to raise questions of clarity and to make general comments.

Discussion
Mr S Marais (DA) stated that his biggest concern was the report itself, as SAHPRA had noted. Before Parliament had adjourned for Members to prepare for local government elections in 2021, the Minister had promised the report within three weeks. As could be seen, it was impossible to get an objective perspective on the matter without the report. Would the Ministerial Task Team and SAHPRA attend the follow-up meeting with the Minister as he had questions of clarity for both entities?

Mr T Mmutle (ANC) supported the Chairperson’s proposal for a deferred meeting so that the Minister could provide her own report. SAHPRA would then be able to object to specific items. He requested that everyone prepare for the deferred meeting so all matters could be put to rest at that meeting.

The Chairperson concurred with Mr Mmutle’s line of thought.

Mr M Shelembe (DA) concurred that the matter should be deferred until the Minister was available. His concern was that money was being stolen from government departments and no one was being penalised. That matter was very, very urgent. When would the Minister be available to the Committee? It was too open-ended to say “when the Minister was available”. A specific timeframe had to be given. People would be looking to steal. There was never any money for operational matters in the Defence Force but money for stealing and corruption was another matter. How could the Committee be sure that the Minister would avail herself as a matter of urgency so that the matter could be addressed?

The Chairperson noted that it was not of the Minister’s choosing to be absent from the meeting; she had a valid apology as she was not well. Once the Minister was fit, she would be back, but he could not say when that would be. He would discuss with the Minister the release of the report. SAPHRA had also requested the report so that it could respond to issues before the Committee. AGSA required a copy of the report, as did the Committee. At least those three bodies required a copy of the report.

The Deputy Minister stated that the matter would be better concluded with the advice of Minister. He noted the requests for reports by fraternal statutory bodies and he would attempt to address that requirement. The Minister would share her views on the report as well as the two recommendations, one of which had already been complied with. She would ensure an appropriate conclusion to the matter. The Minister would also speak to processes. He thought that the meeting was helpful in ensuring that everyone was on the same wavelength. It was good that the meeting had addressed solutions and was charting the way forward.

The Chairperson of the MTT had nothing to add to the discussion.

The Chairperson thanked participants for dealing with the matter in a mature manner. The three agencies – AGSA, SAHPRA and DoD/SANDF – had clarified their involvement in the matter.

Mr Marais asked if the agencies would attend the follow-up meeting. He asked for clarity on exactly how many vials had been returned to Cuba. The recommendation had been to return 500 000 or even more.

The Chairperson noted that because discussion on the matter was being deferred, the agencies would be requested to attend the follow-up meeting. He also requested that each of the agencies supply a written report on the MTT report prior to the deferred meeting. He asked the SANDF to indicate how many vials had been returned. Was it 500 000 or more?

Lieutenant-General Maphwanya stated that “all vials that were required to be returned” had been returned; the number had exceeded 500 000. He did not provide further clarity on the number.

The Chairperson noted that all available vials had been returned.

Mr Marais asked if the CSANDF could be more transparent

Lieutenant-General Maphwanya repeated that “all that was required to be returned had been returned, even above the 500 000.” The Minister would present the details at the next meeting.

The item was concluded and further discussion deferred to a later meeting.

Mr Marais said that media had attended the Portfolio Committee meeting. He had no desire to make it a spectacle. The saga had begun two years previously and the DoD/SANDF should display the highest level of discipline in government but it was not displaying that discipline and there had to be a discussion by the Committee on the issue of discipline in the SANDF. It was very frustrating when things were dragged out,

Consideration and adoption of the revised Committee Program
A closed meeting had been set down for 16 February 2022 for a briefing by the Minister of Defence and Armscor on the future of Project Biro, Hotel and Hoefyster, including past payments, and plans to address the combat vehicle requirements for the SA Army and the status of maintenance of the SA Air Force fleet by Denel and other service providers. The date coincided with the State of the Nation Address by the President so that meeting was transferred to 9 March 2022. It would still be a closed meeting.

Mr Marais supported the change but requested that prioritisation be  given to the meeting with the Minister on the MTT report on Heberon. The Committee should be flexible and prepared to defer one of the meetings planned for the term to accommodate the Minister.

The Chairperson concurred.

Mr Marais asked about oversight in the programme. The parliamentary Chair of Chairs had said that no oversight visits would be undertaken in January 2022, but Mr Marais noted that other Committees had been given permission to conduct oversight visits.

The Chairperson did not know why the Chair of Chairs had refused permission.

The Committee Secretary said that there had been no provision for oversight visits in the Chair of Chairs programme. Some Committees were doing public hearings, but he did not know how others had managed to gain approval to conduct oversight visits. He pointed out that the Committee’s programme made provision for oversight visits but he had not yet detailed those visits.

Mr Shelembe asked why no overseas visits were planned.

Consideration and adoption of outstanding Minutes
In the minutes of 08 December 2021, a correction was made to Mr Xaba’s initials and the minutes were adopted by the Committee.

Concluding remarks
Mr Mmutle requested a report on the fire at Waterkloof Airbase.

The Chairperson requested Mr Peter Daniels, Committee support staff, to incorporate the letters of deployment into the Committee programme, along with a briefing on the fire at the Waterkloof Airbase.

The Chairperson closed the meeting.