FACTSHEET: How are drugs and vaccines approved in South Africa?

As the world waits for an effective Covid-19 vaccine to be developed, the processes by which medicines are approved have received increased attention. We explain how it works in South Africa.

As the Covid-19 pandemic continues, scientists everywhere are working to develop a vaccine that will prevent people from contracting the disease.

Africa Check has debunked many false claims suggesting that a “cure” or vaccine for the disease already exists. Many such claims are false. Others involve potential treatments that have not been shown to work.

So what standards would a Covid-19 vaccine – or any medical product – have to meet in order to be approved for use in South Africa? And how long does approval take? This factsheet answers these and other frequently asked questions. 

Who approves medicines in South Africa?

The South African Health Products Regulatory Agency (Sahpra) regulates all medical products in the country under the Medicines and Related Substances Act.

Safura Abdool Karim is a senior researcher and public health lawyer at the Wits University School of Public Health and the South African Medical Research Council’s Centre for Health Economics and Decision Science, both in Johannesburg. She also works at Priceless SA, a research group which focuses on improving health in South Africa.

“If you want to sell a product in South Africa, you need it to be registered with Sahpra” she said. Without Sahpra registration, a health product cannot be prescribed, sold or even advertised.

The agency itself does not run safety trials. Instead, it approves trials designed by drug manufacturers, to ensure they are run fairly, and reviews the results afterwards.

What steps are involved in a clinical trial?

Clinical trials involve multiple phases in which a product is tested on increasingly larger groups of people.

Dr Gale Ure is a research specialist at Life Healthcare Group, a private South African healthcare provider. She is also an honorary lecturer at Wits University’s Steve Biko Centre for Bioethics and Health Law

Human trials test for more than just safety, she said. They assess how effective a vaccine or drug is and determine whether the medication has side effects. They also determine if there are groups of people where the treatment might not be effective or have risks. 

A May 2020 announcement from Oxford University in the United Kingdom explained the three trial phases of its potential Covid-19 vaccine:

  • Phase 1 trials are conducted on a very small group of people to show that the vaccine is not dangerous;
  • Phase 2 trials expand the number and age range of people, to show that particular groups don’t have bad reactions to the vaccine;
  • Phase 3 trials involve a very large group of people and focus on determining how well the vaccine works.

Sahpra told Africa Check that it continues to monitor products after they have been registered in what it calls “phase 4”. This monitoring process is “ongoing and not limited in terms of time”.

Tip: Check Sahpra’s list of registered products, which dates back to 1969, to check if a drug or vaccine you hear about has been approved. 

How long does it take?

Trials and other parts of the regulatory process are lengthy. Ure told Africa Check that under normal circumstances it is common for vaccine development to take several years.

“From a clinical trial to the product on the shelf, you’re looking at about three to five years,” said Karim. 

This can vary though. If, for instance, Sahpra concluded that clinical trials were inconclusive, it might request further trials before it considers a product for approval.

And even before trials begin, just developing a drug or vaccine can take a long time. A Covid-19 vaccine faces similar issues, even though development has been sped up by scientists advocating for sharing of research and data.

Moderna, a company whose trial Covid-19 vaccine has generated a great deal of interest, estimates that its phase three trials will only be completed by 27 October 2022. Phase three of a similar trial being conducted in South Africa is expected to be completed in December 2021.

Sahpra has said it would “expedite the review” of any Covid-19 treatments, but it would not alter the clinical trial process in any way.

Trials and approval periods may not even be the main source of delay in distributing a Covid-19 vaccine. Safura Abdool Karim of the Wits University School of Public Health told Africa Check: “I don’t think it’s really a question of how long it will take regulatory-wise. I think it’s a question of how fast can they produce a vaccine and where we land in the order of places that are going to get the vaccine.”

Global distribution issues could add 12 to 18 months to the time taken to administer a vaccine through the South African healthcare system, she said.

It’s also likely South Africa will not be among the first countries to get the vaccine, as the majority of vaccines are being developed elsewhere.

So, how does Sahpra regulate products from other countries?

What about medicine approved for use outside of South Africa?

“It’s unlikely that the vaccine that proves effective for Covid-19 will be the one vaccine that’s being trialled in South Africa,” Karim said.

This means that the vaccine will probably be approved by another regulatory agency before it is submitted to Sahpra. And in the best case scenario, it will be approved by a “stringent regulatory authority”, or SRA.

These are authorities that Sahpra recognises as especially thorough, often because they require a stricter approval process than Sahpra itself. Examples include the US’s Food and Drug Administration (FDA) and the European Union’s European Medicines Agency.

If an SRA has approved a product for use elsewhere, then Sahpra can expedite the approval of the product locally. In such  cases, Karim told us, the South African approval could take “a year or two depending on how efficient Sahpra is and how compliant the application is”.

No product can be sold in South Africa purely on the approval of another country’s regulatory authority. According to Sahpra, it is required to review evidence of safety and efficacy “irrespective of whether [health products] are developed outside of South Africa or not”.

Are traditional or ‘complementary’ medicines subject to the same process?

Early in 2020, Madagascar’s president Andry Rajoelina announced “Covid Organics”. He claimed this “herbal tonic” could cure Covid-19.

There is no evidence that the mixture is able to cure or prevent Covid-19. It did, however, launch discussions about whether “traditional” or “complementary” medicines could be used to fight Covid-19, and what regulations they should face.

Sahpra is able to regulate complementary medicines by an amendment to the Medicines and Related Substances Act. It says that these fall into six major categories: “Aromatherapy, Ayurveda, Homeopathy, Traditional Chinese Medicine, Unani Tibb and Western Herbal Medicine”. “African Traditional Medicines” are also included, Sahpra told Africa Check.

The regulations  define complementary medicines simply as health products derived from substances like “plants, fungi, algae, seaweeds, lichens, minerals, [or] animals”.

Karim said Sahpra was relatively unique in regulating complementary medicines, which many other authorities, including the FDA, do not. The process of  regulating complementary medicines is different from that of conventional drugs.

“Obviously the product needs to be safe. Sahpra can’t approve anything that’s dangerous,” she said. “But where the approval comes in is if they want to advertise it and sell it.”

Complementary medicines usually make less specific health claims than conventional medicines. The manufacturers only need to prove that these claims are not deceptive. This is not the same as proving that they can prevent or “cure” a specific disease. Approval from Sahpra thus only indicates that the medicine will not cause harm and does not make false claims about its effectiveness.

“Harm does not necessarily mean that the medication will hurt the person,” said Ure. It also includes preventing deceptive advertising that may mislead people into taking a medication which does not do what it claims to.


 

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