The minister and the metaphor – a patient’s guide to legal medicine imports

You can’t buy medicine for a friend overseas and carry it into South Africa as easily as you’d bring them a keyring or a curio. 

Pharmaceutical products, for people and animals, are strictly regulated, and for good reason. 

But in July, Tourism Minister Lindiwe Sisulu was quoted as saying she’d brought back cancer medicine from Russia, but that she’d been too late to save her friend, Jessie Duarte. The late deputy secretary-general of the ANC died of cancer on 17 July. 

The South African Health Products Regulatory Authority (Sahpra) sent questions to Sisulu’s office to investigate, and the minister has since said that the media misinterpreted her statements. She had been speaking metaphorically, she told The Weekend Argus. 

Before medicines are allowed to be sold in the country, Sahpra sifts through reams of evidence submitted by manufacturers. A team of experts then weighs up the data against international quality standards and decides whether they can be put on the market. 

This process applies to all medicines, and clinical trials, and is being expanded to cover medical devices. Sahpra also makes the rules to control the movement of medicines after they’ve been approved. That also includes who can import, export, make, distribute, sell or prescribe them. 

In July, Tourism Minister Lindiwe Sisulu was quoted saying she’d brought back cancer medicine from Russia. (Photo: Waldo Swiegers / Bloomberg via Getty Images)

But many cancer patients do travel abroad and bring back medicines – literally – either because a drug is cheaper elsewhere or it’s not available in South Africa. It’s a risky move, however, and many people have burnt their hands trying to save money this way. 

We answer five questions about the complex and highly regulated world of medicine imports. 

Who is allowed to import medicines?

No one can bring unregistered medicines into South Africa without approval from Sahpra, and only licensed companies can do it. They are subject to strict rules to make sure the medicines they import are safe to use. 

https://www.dailymaverick.co.za/article/2019-10-24-dying-for-treatment-the-struggle-for-affordable-breast-cancer-medicines-in-south-africa/

For example, any vaccines brought into the country must first pass quality checks at the National Control Laboratory for Biological Products in Bloemfontein before they can be sent to pharmacies and clinics. 

But these rules don’t apply to those who enter or leave the country with medicines for personal use that have been registered in South Africa. 

Travellers can have up to six months’ worth of medicines on them as long as they have a letter from a doctor or pharmacist to prove they got the drugs legally (so no approval is necessary from Sahpra). This applies to drugs such as cough syrup (schedule 2), antibiotics (schedule 4) or antidepressants (schedule 5). 

Sahpra decides on a medicine’s scheduling based on safety factors such as how easily people can become dependent on it, or how dangerous its active ingredient could be if it’s taken incorrectly – the higher the schedule, the more restrictions there are on how the medicine can be sold.  

For medicines scheduled 6 and higher (such as morphine), no more than 30 days’ supply is allowed, along with a doctor’s prescription. 

When does Sahpra allow individuals to import a drug?

Doctors can apply to Sahpra to bring an unregistered medicine into South Africa on behalf of an individual patient. 

Such requests are only approved if there are no other drugs available in the country, or if the other options haven’t worked. 

For some rare diseases, the number of people in South Africa who would ever need a drug is so small that it doesn’t make sense for a company to pay the thousands it will cost to register the medicine with Sahpra. 

Or, a similar medicine may already be registered in South Africa, and the second manufacturer may not think it’s worth competing. 

https://www.dailymaverick.co.za/article/2022-02-03-cancer-is-universal-but-the-heaviest-burden-falls-on-the-developing-world-we-must-do-more-to-close-the-gap/

The melanoma (the most serious form of skin cancer) and the lung cancer drug, Keytruda, for instance, is registered by Sahpra, but Opdivo (also used to treat melanoma and lung cancer) isn’t. 

Keytruda may not be the right medicine for every patient though, in which case a doctor could apply to import Opdivo instead. 

These requests are called “Section 21” authorisations (because that’s the section of the Medicines Act that allows it) and Sahpra usually responds to such queries within a day or two.

How do Section 21 requests work?

There are three parties involved in a Section 21 request: 

The clinician: A doctor applies to Sahpra and explains why a patient needs access to the drug. If the request is approved, the physician must report on the person’s progress on the treatment. This includes any side-effects that they may experience while using the unregistered medicine. 

The company: The firm that will bring the drug into the country applies as a co-applicant with the doctor. A number of licensed pharmaceutical companies specialise in doing this. 

The patient: A patient must pay the admin fee (R350 for each application) and for the imported medicine. The state covers the cost for public sector patients. Medical aid members are reimbursed in certain cases. 

Are there any drawbacks?

Any medicine sold in the South African private sector is subject to a price control mechanism called the Single Exit Price (SEP). Although the initial launch price is set by the manufacturer or importer, the SEP is the price paid by all buyers, regardless of volume. In addition, the health minister sets a maximum annual increase in the SEP. Retailers can still add a dispensing fee, but there are caps on this amount as well.

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The SEP doesn’t apply to drugs people get through a Section 21 request, so they could be exploited. 

Since the patient is paying for the products that will be imported for their treatment, they also have a right to choose the most affordable option. Exercising that right, however, is by no means simple.  

https://www.dailymaverick.co.za/article/2022-06-06-medical-cannabis-offers-huge-opportunities-but-there-are-hurdles-to-clear/

Doctors rarely have access to information about cheaper options and drug companies don’t advertise to patients. 

There’s also nothing in South Africa’s laws that obligates manufacturers to apply to register drugs that are often requested through Section 21, which would subject those drugs to the SEP and possibly bring down the price. 

Does the price problem disappear when a drug is registered?

No. When someone was getting access to a less-expensive medicine through Section 21, it can be bad news when a similar medicine is registered by Sahpra, because it nullifies the motivation that there are no other options for this person. The registered medicine may be more expensive. 

This is what happened with lenalidomide, which is used to treat a type of blood cancer called multiple myeloma. 

The drug was approved for use in South Africa in 2016 under the name Revlimid, which cost R70,000 per month more than the generic previously imported in terms of Section 21. 

Only nine patients got permission to keep using the cheaper generic version through Section 21. 

The Cancer Alliance and patients challenged this to no avail, so sick people had to wait until a cheaper medicine came onto the market – which didn’t happen until four years later. 

https://www.dailymaverick.co.za/article/2022-04-20-cutting-edge-cancer-treatment-may-also-have-potential-for-treating-hiv/

Most medicines that are needed to treat cancer and rare diseases will never be considered as essential medicines, so the Health Department won’t buy them for the public sector. That means they’ll be unavailable to people who use the state sector. For the fortunate few who belong to private medical schemes, such drugs may still be subject to out-of-pocket payments that can amount to thousands of rands per month. 

Plus, it’s not clear what cancer care could look like under South Africa’s proposed National Health Insurance (NHI), which will buy the same package of health services for everyone. And the department’s Nicholas Crisp, who is in charge of rolling out the scheme, told delegates at the Hospital Association of South Africa’s annual conference in August that the NHI is likely to only be implemented in “years to decades, rather than months to years”.

In short, the possibility of equitable access to cancer drugs in South Africa remains elusive. DM/MC

Salomé Meyer is an activist with the Cancer Alliance. Andy Gray is a senior lecturer in pharmacology at the University of KwaZulu-Natal. 

This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.