Patient’s guide to legal drug imports

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You cannot buy medicine for a friend abroad and transport it to South Africa as easily as you would bring him a key ring or a curio.

Pharmaceuticals, for humans and animals, are strictly regulated – and for good reason.

In July, South Africa’s tourism minister, Lindiwe Sisulu, reportedly said she had brought cancer medicine back from Russia, but had arrived too late to save her friend Jessie Duarte. ANC deputy general secretary dies of cancer July 17.

The South African Health Products Regulatory Authority (Sahpra) sent questions to the Sisulu office investigate and the minister has since said the media misinterpreted her statements. She only spoke metaphorically, she said The Argus of the weekend.

Before drugs are allowed to be sold in the country, sahpra sifts through tons of evidence submitted by manufacturers. A team of experts then evaluates the data against international quality standards and decides whether it can be put on the market.

This process applies to all drugs and clinical trials, and is being extended to cover medical devices. Sahpra also sets the rules for controlling the movement of drugs after they are approved. This includes who can import, export, manufacture, distribute, sell and prescribe them.

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

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

  1. Who is authorized to import medicines?

No one can bring unregistered medicines into South Africa without Sahpra’s approval and only licensed companies can do so. These companies are subject to strict rules to ensure that the drugs they import can be used safely.

For example, all vaccines introduced into the country must pass quality controls at the National Laboratory for the Control of Biological Products in Bloemfontein before they can be sent to pharmacies and clinics.

But these rules do not apply to those entering or leaving the country with personal-use medicines that have been registered in South Africa.

Travelers can have up to six months worth of medication on them, as long as they have a letter from a doctor or pharmacist proving they obtained the medication legally. No approval is needed from Sahpra. This applies to medicines such as cough syrup (schedule 2), antibiotics (schedule 4) and antidepressants (schedule 5).

Sahpra decides when to schedule a drug based on safety factors such as how easily people can become addicted to it and how dangerous its active ingredient is if not taken correctly. The higher the schedule, the more restrictions there are on how the drug can be sold.

For drugs planned 6 and more (such as morphine), no more than 30 days supply is allowed, accompanied by a doctor’s prescription.

  1. When does Sahpra allow individuals to import a medicine?

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

These requests are only approved if there are no other drugs available in the country or if the other options have not worked.

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

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

melanoma (the most serious form of skin cancer) and the lung cancer drug Keytruda, for example, is registered by Sahpra, but Opdivo (also used to treat melanoma and lung cancer) is not.

Keytruda might not be the right medicine for every patient, in which case a doctor might ask to import Opdivo instead.

These requests are called “Rule 21” permissions (because this is the section of the Medicines Act permitting) and Sahpra usually responds to such queries within a day or two.

  1. How do Section 21 requests work?

There are three parties involved in a section 21 application:

  1. The clinician

A doctor speaks to Sahpra and explains why a patient needs access to the drug. If the request is approved, the doctor must report on the progress of the person’s treatment. This includes any side effects they might experience while using the unregistered drug.

  1. The company

The company that will bring the medicine into the country applies as a co-applicant with the doctor. A number of licensed pharmaceutical companies specialize in this area.

  1. The patient

A patient has to pay the administrative fee (R350 for each request) and for the imported drug. The state covers the costs for patients in the public sector. Members of medical aid are reimbursed in certain cases.

  1. Are there any disadvantages?

Any medicine sold in the South African private sector is subject to a price control mechanism called ifsingle exit price (SEP). Although the initial introductory price is set by the manufacturer or importer, the SEP is the price paid by all buyers, regardless of volume. In addition, the Minister of Health sets a maximum annual increase in the SEP. Retailers can still add a preparation fee, but this amount is also capped.

SEP does not apply to drugs that people obtain through a Section 21 application, so they could be exploited.

Since the patient pays for the products that will be imported for his treatment, he also has the right to choose the most affordable option. However, exercising this right is not easy.

Doctors rarely have access to information about cheaper options, and pharmaceutical companies do not advertise to patients.

Additionally, nothing in South African law requires manufacturers to apply for registration of frequently requested drugs through Section 21, which would subject those drugs to SEP and possibly drive down the price.

  1. Does the problem of price disappear when a medicine is registered?

No. When a person has access to a cheaper drug through Section 21, it can be bad news when a similar drug is registered by Sahpra, as it negates the motivation that there are no other options. for that person. The registered drug could be more expensive.

That’s what happened with lenalidomidewhich 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 Revlimidwhich costs R70,000 more per month than the generic previously imported under Section 21.

Only nine patients were granted permission to continue using the cheaper generic version through Section 21.

The Cancer Alliance and patients disputed this to no avail, so sick people had to wait for a cheaper drug to hit the market – which did not happen until four years later.

Most drugs needed to treat cancer and rare diseases will never be considered essential drugsso the health department will not buy these drugs for the public sector.

This means that they will not be available to people using the public sector. For the lucky few who belong to private medical plans, these drugs can still be subject to out-of-pocket payments of up to thousands of rands per month.

Also, it’s unclear what cancer care might look like under South Africa’s proposal. National health insurance, a medical plan that aims to buy the same set of health services for everyone. Nicholas Crisp of the health department, which is responsible for rolling out the program, told the delegates at the annual conference of the Association of Hospitals of South Africa in August, the NHI would probably 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.

Salomé Meyer is an activist with the Alliance Against Cancer.

Andy Gray is a lecturer in pharmacology at the University of KwaZulu-Natal.

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

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