Section 21 and the architecture of access

People treat Section 21 of South Africa's Medicines and Related Substances Act as a workaround. A way to get an unregistered medicine to a patient when the proper channel, full registration with the regulator, has not happened or never will. The word that gets used is loophole, said with a slight wince, as though the section exists in spite of the system rather than because of it. I read it differently. Section 21 is not a gap in the architecture of access. For a large class of medicines in this part of the world, it is the architecture.

What the section actually does

The mechanism is narrow and deliberate. A medicine that is not registered for general sale in South Africa can still be supplied to a named, identified patient, on application by a prescriber, with the regulator's authorisation. It is patient-specific and indication-specific. It is not a marketing licence. You cannot advertise the product, stock it speculatively, or treat the authorisation as a substitute for registration. Each authorisation is, in effect, a small individual permission granted against a documented clinical need.

That narrowness is the point. Registration is built for volume. It asks a manufacturer to commit to a dossier, a local presence, pharmacovigilance obligations and a commercial footprint, all justified by the expectation of a market large enough to repay the effort. For a medicine treating a few hundred patients in a country, that maths does not work, and it never will. The product is not absent because anyone decided those patients should go without. It is absent because the registration pathway was designed for a different kind of product. Section 21 is what stands in for registration when registration is the wrong tool.

Seen that way, it stops looking like an exception and starts looking like a parallel route built precisely for the medicines that the main route cannot economically carry. Rare disease therapies, newly approved oncology agents not yet filed locally, products in shortage, treatments where the registered alternative has failed a specific patient. These are not edge cases that slipped through. They are the intended population of the section.

A loophole has no infrastructure

The tell that Section 21 is infrastructure rather than a loophole is that a whole supply chain has organised itself around it. A genuine loophole is exploited quietly and individually; nobody builds durable operations on top of something that might be closed tomorrow. What has grown around Section 21 is the opposite. Specialist importers, cold-chain logistics calibrated to the small, high-value, temperature-sensitive consignments these authorisations generate, pharmacovigilance reporting adapted to named-patient supply, prescriber networks that know how to document need, and reimbursement conversations with medical schemes that have learned to fund authorised unregistered products.

That ecosystem is the proof. You only build cold storage, customs expertise and reporting systems for a channel you expect to persist. The participants treat Section 21 as a permanent feature of the landscape because, functionally, it is. The regulator relies on it to handle exactly the cases the registration system cannot. Patients depend on it. Schemes pay through it. An arrangement that load-bearing is not a loophole. It is a road that simply was not built to look like the main highway.

It also imposes real discipline, which loopholes do not. Because each authorisation is individual and documented, the channel produces an audit trail. Who needed what, why, with what clinical justification. That accountability is more rigorous in some respects than a blanket registration, because it forces a per-patient case rather than a one-time market approval after which the product flows unwatched.

The blueprint travels

Here is why this matters beyond South Africa. The named-patient logic is not a South African peculiarity. Compassionate-use and named-patient provisions exist, in various forms and various states of repair, across many African jurisdictions. South Africa's version is simply the most developed and the most clearly worked through, which makes it the readable blueprint for what the others are groping towards.

The continental problem is exactly the one Section 21 solves at national scale. You have fragmented regulators, dozens of them, each with its own registration burden, and a long tail of medicines that no manufacturer will ever register country by country because the per-market volumes are too small. The African Medicines Agency is meant to ease the registration side by harmonising and reducing duplication, and it should. But harmonised registration still serves the high-volume case. The low-volume case, the rare therapy, the specialist product, the shortage substitute, will always need a named-patient route alongside it. Section 21 shows what a functioning version of that route looks like, what supply chain it requires, and how payers can be brought to fund it.

For anyone building access across African markets, the lesson is to stop waiting for full registration everywhere and to read the named-patient pathway as the primary route for an entire category of medicine, not a fallback. The infrastructure that makes Section 21 work, the importation, the cold chain, the documentation, the reimbursement relationships, is transferable. It is, in fact, the harder thing to build than the regulatory permission itself. The permission already exists, in one form or another, in most places. What is scarce is the operational competence to use it well. South Africa wrote the manual. The opportunity is to read it as a blueprint, not as a confession of a system's failure.