How do Section 21 requests work? 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 they might experience while using the unregistered medicine. 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.
Doctors rarely have access to information about cheaper options and drug companies don’t advertise to patients. There’s also nothing in South African law 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. No. When someone is 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.
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