South Africa has a new medicines regulator

The board of the South African Health Products Regulatory Authority (SAHPRA) held its inaugural meeting on 1 February 2018, according to Department of Health spokesperson Popo Maja. The inaugural board meeting officially brings SAHPRA into existence.  This means that South Africa’s old regulatory authority, the Medicines Control Council (MCC), no longer exists.

According to a Department of Health media statement, Portia Nkambule, previously a Director in the Cluster: Food Control, Pharmaceutical Trade & Product Regulation, who acted as secretariat to the MCC, has been appointed as the Acting SAHPRA CEO. The statement also announced the names of the fifteen members of the SAHPRA board.

“What we are aiming for with the newly constituted SAHPRA is an efficient, relevant and transparent regulatory authority that ensures that South Africans have access to safe, effective, good quality medicines and medical devices, and the information that allows them to use these products with confidence,” said Professor Helen Rees, chairperson of the SAHPRA board.

Over the last two decades the MCC has been criticised for inefficiency, taking too long to register medicines, and a lack of transparency.

Growing capacity

“All outstanding work that was being done by the MCC will be continued by SAHPRA. The Authority will utilise external experts for evaluation of applications, but over time it will actively grow the in-house capacity of the staff to take over the bulk of its work including registration of medicines and evaluations for clinical trials,” the statement read. “In addition, agreements will be made for recognition of work from recognised international regulatory authorities, resulting in more rapid evaluation timelines.”

The scope of the new Authority has expanded to include not just medicines, but also medical devices (including in vitro diagnostics) and aspects of radiation control.

Maja told Spotlight that “SAHPRA will be partly reliant on Government funding through public money, by means of a transfer from the Revenue Fund, and partly from funds (fees) raised for services rendered within its regulatory ambit.”

The fifteen members of the board are:

  1. Prof Helen Rees (Chairperson)
  2. Dr Nonhlanhla Madela-Mntla
  3. Prof Shabir Banoo
  4. Dr Henry Leng
  5. Dr Thapelo Motshudi
  6. Prof Kelly Chibale
  7. Prof Aimes Dhai
  8. Prof Jeffrey Mphahlele
  9. Dr Ushma Mehta
  10. Dr Mphane Molefe
  11. Adv Hasina Cassim
  12. Ms Mandisa Hela (Vice-Chairperson)
  13. Ms Lesibana Fosu
  14. Mr Norman Baloyi
  15. Prof Craig Househam



Opinion: Return of the quacks

By Anso Thom, Spotlight Editor

For a long time, South Africa has been a country where charlatans are able to flourish and peddle dangerous remedies for all kinds of ailments.

Take a trip on a public train or a walk down a road in our city centres and you will easily find pamphlets marketing remedies for anything, from enlarging penises to bringing back lost lovers. Even more seriously, the city lamp poles are plastered in posters offering cheap pregnancy termination services. Poor people stand on street corners for hours offering pamphlets and directions to the closest ‘doctor’. All illegal, all dangerous, but almost all operating with impunity.

The reasons these quacks proliferate are many. Not so long ago we had a president and health minister who created an enabling environment for them. President Thabo Mbeki questioned the efficacy of lifesaving anti-AIDS medication, told people they were toxic, and dragged his feet when it came to signing into policy the rollout of these medicines for the thousands who were suffering and dying.

His Health Minister, a medical doctor, Dr Manto Tshabalala-Msimang spoke often and passionately about the so-called healing properties of beetroot, garlic, lemon and olive oil. People sniggered, referred to her as Dr Beetroot and shook their heads.

But what Mbeki and Tshabalala-Msimang had done successfully, was to sow seeds of doubt. Many, many people living with HIV, desperate for a remedy not only to control the virus, but to exorcise it from their battered bodies, turned to the quacks, who promised to do so. What was criminal was that these ‘doctors’ were operating with the tacit support of the leaders who had the power to close them down.

They included the likes of German multi-vitamin peddler Matthias Rath; KwaZulu-Natal truck driver and seller of a concoction called uBhejane (the recipe of which he said was revealed to him in a dream by his ancestors) Zeblon Gwala and the likes of Tine van der Maas a barefoot Dutch nurse who pushed lemon, garlic, beetroot and olive oil concoctions at the behest of the health minister, or Belgian eccentric Kim Cools who continues to claim that he had injected himself with the HI virus but remains negative due to his remedies (see previous Spotlight).

Activists told stories and journalists wrote articles of the heartache these people had caused – the undignified deaths of mothers who left families orphaned as they dumped their antiretrovirals for Rath vitamins, the fatal and excruciating suffering of the much-loved DJ Khabzela after the health minister sent Van der Maas to heal him, or the illegal Rath clinical trials conducted on poor people, made to strip, have their photographs taken and give their blood.

And then there was Virodene – a powerful chemical detergent peddled by a bunch of crazy scientists as a cure for AIDS, which had as its cheerleader President Mbeki.

Mbeki and Tshabalala-Msimang were not alone in the rejection of proven treatments. Tshabalala-Msimang’s MECs either turned a blind eye to the fact that people were being used as guinea pigs, or did everything in their power to deny poor people access to lifesaving drugs.

Sibongile Manana was the MEC of Health in Mpumalanga at the height of the denialism years from 1999 to 2003. Now she is a Member of Parliament. As MEC she gave the Greater Rape Intervention Project (GRIP) in Nelspruit hell. She bullied Rob Ferreira Hospital’s Dr Thys von Mollendorff, a gentle caring doctor whose only crime was to try and help rape survivors. He offered them a dignified, safe space in his hospital where they were given the option of accessing legal, tested antiretrovirals to prevent infection. But Manana hounded Von Mollendorff and GRIP out of the hospital and treated them like criminals, dragging them to court and evicting them from the hospital.

Penny Nkonyeni, MEC for Health in KwaZulu-Natal during the Manto years, often rolled out the red carpet for her Minister. She printed quack pamphlets for distribution, hounded doctors who dared to offer pregnant mothers the option of treatment to prevent transmission of HIV to their babies, and she was a willing partner in finding crooked NGOs prepared to run illegal clinical trials using quack concoctions. Nkonyeni was later the speaker in the provincial parliament and Education MEC before being removed in a Cabinet reshuffle earlier this year. She indicated she was joining the private sector.

The examples are many and for those who were there, these memories are painful. Those who were there made a pact saying, never again.

Fast forward to 2016 

Dr Benny Malakoane is a medical doctor and was until recently Health MEC in the Free State. Over a three-and-a-half year period he oversaw the collapse of the public health-care system in the province, and turned the state machinery on elderly community health workers who were asking inconvenient questions, while facing multiple charges of fraud and corruption (these cases are still ongoing due to continued delays).It now appears that, much like Manana and Nkonyeni, Malakoane enabled a quack to operate with impunity in a state hospital, using unsuspecting state patients as guinea pigs in an illegal stem cell trial. In fact, this operation had been signed and sealed in a three-year contract which was due to further impoverish the Free State health system and enrich the shareholders of ReGenesis Health with millions of rands.

Questions must be asked over the enthusiasm of the MEC in signing this contract and personally overseeing its implementation. One has to ask how the MEC could be so enthusiastic in rolling out an untested stem cell intervention in the Pelonomi hospital’s orthopaedic department while his health system is collapsing and failing to get basic medicines to clinics and hospitals.

The Medicines Control Council led by Professor Helen Rees intervened within days of health minster Dr Aaron Motsoaledi becoming aware of this contract. It is refreshing and heartening to know and see in action the difference an ethical, incorruptible and no nonsense health minister and medical doctor can make. If only we had someone like Dr Motsoaledi in the early 2000s.

The MCC swiftly closed the ReGenesis operations at Pelonomi and have made it clear that according to the information they have, an illegal trial was being conducted, using an untested intervention.

For now, the operations have been brought to a halt and the Free State Department of Health has cancelled the contract. The MCC has sent ReGenesis a comprehensive list of questions, and Free State Premier Ace Magashule has been left with the task of holding his MEC accountable. Don’t get your hopes up.

Within a day of the information being revealed by Spotlight and the investigative television show, Carte Blanche, Free State premier Ace Magashule shifted his Health MEC to Economic and Small Business Development, Tourism and Environmental Affairs, and installed his former Police, Roads and Transport MEC Butana Kompela as the health custodian.

However, we cannot allow another quack enabler to get away without being held accountable.

The Free State Department of Health and Premier Magashule have to provide answers to some very serious questions. For instance, why did the Free State Department of Health publish a tender for stem cell therapy in the first place? On what basis was ReGenesis appointed in June? Why was Malakoane so closely involved with the project, chairing the board that would provide oversight of the work and research done by ReGenesis?

Simply shifting Malakoane to another post doesn’t make these questions go away. For there to be any accountability we need answers to these questions. The people of the Free State are not guinea pigs. They are not pawns in an alleged scam to enrich charlatans.

Not on our watch. The ball is in your court Premier Magashule.


A new dawn for medicines regulation in South Africa

The Medicines Control Council (MCC) regulates medicines in South Africa. Without the council’s permission, medicines may not be marketed and clinical trials may not be conducted. The MCC plays a critical role in protecting both the broader public and study-participants against the dangers of unproven medicines.

The MCC will soon be replaced by the South African Health Products Authority (SAHPRA). Spotlight asked MCC registrar Dr Joey Gouws and MCC chairperson Professor Helen Rees about changes at South Africa’s medicines regulator.

Spotlight: What still needs to happen before the MCC becomes SAHPRA? And, when is this change expected to happen – is the April 1 2017 date that has been quoted in the media realistic?

Gouws: On 24 December 2015, the State President, signed The Medicines and Related Substances Amendment Act, 2015 (Act 14 of 2015) into law. However, the said Act has not yet been proclaimed by the President as a number of administrative transitional arrangements require implementation prior to the date MCC would cease to exist and SAHPRA be established. The MCC is working towards the 1 April 2017 date for SAHPRA to be established.

Spotlight: By how much have staff levels at the MCC increased in recent years and how much will they increase further once the SAHPRA is fully in place?

Gouws: The staff component at the MCC has been increased by 52 staff over the last 24 months with the view to employ another 30 staff members once SAHPRA is fully in place.

Spotlight: What is being done to ensure new molecular entities (NMEs) are more quickly registered in South Africa? Can you share any evidence that registration times are being reduced? Is the MCC working toward a target time for registering NMEs?

Gouws: Registration timelines for a medicine depends on the submission by the pharmaceutical industry of a quality dossier, with the Regulator having available sufficient resources, with appropriate expertise, to conduct a review of the dossier. Over the last 24 months, additional staff have been appointed at the Regulator and staff have been exposed to various training sessions on regulatory matters. In addition, workshops have been conducted with the industry to explain the requirements for a quality dossier. Registration timelines are still being worked on.

Yes, the MCC is working towards a target time for registration of new molecular entities of 36 months.

Spotlight: Can you share more detail on what is being done to ensure generic medicines are more quickly registered in South Africa? Again, if you can share evidence of reduced registration times it would be appreciated. An idea of a target registration time for generic medicines would also be useful.

Gouws: See the response as per point three, with registration timelines for a generic application of 24 months.

Spotlight: At the moment it is relatively difficult to find information regarding the registration status of medicines in South Africa (certainly compared to the FDA). Are there any plans to make registration information, including assessments of the evidence and reasons for decisions, more readily accessible to the South African public?

Gouws: Medicine is registered by the MCC at each of their six weekly meetings. Following the MCC meeting, the medicines registered are published in the Government Gazette and on the MCC website, With the view of the MCC transferring to SAHPRA, systems are under investigation to allow for greater transparency in the decision making process of the Regulator. However, the MCC must take into consideration the provisions of Section 34 of the Medicines Act, dealing with confidentiality.

Spotlight: The MCC responded very quickly in relation to ReGenesis in the Free State and other specific cases in recent years. However, quackery and the unlawful marketing of health products remains widespread in South Africa. What is being done to ensure that the MCC has sufficient capacity to clamp down on unlawful marketing of health products, including complementary and alternative medicines and supplements?

Gouws: Complementary medicines have been called up in 2014, with certain pharmacological categories of medicines making therapeutic claims to treat a disease asked/instructed to submit applications to the MCC for registration over a period until 2019, based on disease risk.

In addition, the  maximum levels of certain vitamins and minerals allowed in complementary medicines without requiring the product to be submitted to Council as a high-risk product, have been published. These products require the submission of a so-called orthodox application, which requires safety, clinical, efficacy and quality data before they can be sold.

Finally, legislation requiring the label of the product to include a disclaimer that the MCC has not evaluated the medicine for safety, quality and efficacy, has been implemented since 2014. By the implementation of these measures, the public can make an informed decision on the use of these medicines.

In July 2016, proposed legislation has been published to address the definition of health supplements, which will allow MCC to have regulatory oversight over this category of medicines, once enacted.

The marketing and sale of unregistered medicine is an illegal activity, which is a matter for the police and the courts and not that of the MCC. The Council’s mandate is the evaluation of a dossier submitted, and the registration of the said medicine, if the information evaluated supports safety, quality and efficacy of the medicine under review.

Spotlight: Some commentators and advocates are alarmed by what they see as a lowering of regulatory standards through initiatives like the 21st Century Cures Act in the United States and the Adaptive Pathways pilots in the EU. Can you reassure the South African public that regulatory standards will remain robust in South Africa?

Gouws: Measures such as the 21st Century Cures Act and Adaptive licensing are means to allow, in a limited way, access to specific medicines in a controlled matter, without lowering standards but to increase pharmacovigilance monitoring within the space of ethics versus science.

The regulatory standards in South Africa have been robust, thorough and in line with international best practices. In addition, regulatory standards and requirements are published on the MCC website for scrutiny and comment by all stakeholders prior to implementation.

Spotlight: To what extent and in what ways is the MCC sharing information and cooperating with other regulatory agencies such as the FDA and EMA?

Gouws: The MCC is a member of various international medicines initiatives that include the FDA and EMA. This includes but is not limited to:

  • PIC/S – Pharmaceutical Inspection Co-operation Scheme: allows the exchange of medicine manufacturing site inspection reports amongst/between regulators to allow/facilitate work-sharing and to harmonise technical guidelines on inspections.
  • ICMRA – International Coalition of Medicines Regulatory Authorities: supports training activities, regulatory cooperation, sharing of regulatory information and concerted strategic leadership.
  • IGDRP – International Generic Drug Regulator’s Programme: supports work-sharing on active substances, mutual reliance in assessment of active ingredients and application of biowaivers.
  • WHO – World Health Organisation: supports medical devices and medicines with respect to quality assurance, safety, medicine access and rational use.
  • EDQM – European Directorate for the Quality of Medicines and HealthCare: supports certification of suitability of active ingredients to the monographs of the European Pharmacopoiea (MCC observer status).

In addition, the MCC has signed a Memorandum of Understanding with the FDA and SwissMedic (Switzerland) to allow exchange of information.

We are keen to increase the transparency of the work of the MCC including giving more feedback to applicants about decisions made, more opportunities for pre-application discussions with applicants for issues that are unusual and/or of critical public health interest, and more transparency to the broader community about the workings and decisions of Council.’ – Professor Helen Rees, MCC chairperson.