Five arguments about
an industry

“Sovereignty” is one of the most-used words in health policy since 2020, and one of the least costed. In manufacturing terms it has a precise content, and the price of each component is known.

Lamia Tazi’s formulation of the problem is unusually direct: Covid, she has said, was a real crash test, and it showed what happens when you do not have pharmaceutical sovereignty. What follows is an attempt to set out what that sovereignty consists of.

Layer one: formulation capacity

This is the layer everyone builds first, because it is the most visible. A plant that can turn active ingredients into finished medicines — tablets, capsules, sterile injectables, biologicals. It is capital-intensive but tractable: the technology can be purchased, the plant can be built, the standards are documented.

Africa has roughly 690 such plants. The difficulty is that they are concentrated: eight countries account for about 85% of them, and typical capacity utilisation runs between 30 and 60 per cent, against more than 70 per cent in developed economies. Half-empty plants are expensive plants, and expensive plants lose to imports, which keeps them half-empty.

Layer two: ingredient security

This is the layer almost nobody builds, and it is the one that determines whether the first layer means anything. More than 95% of the active pharmaceutical ingredients used on the continent are imported, mainly from India and China.

A country can manufacture every finished dose it consumes and remain entirely dependent, because the molecule at the centre of every one of those doses arrives by sea. Closing that gap requires a fine chemicals and fermentation industry — a different sector, with different economics, longer payback and environmental requirements that pharmaceutical formulation does not face. It is the honest reason sovereignty remains partial almost everywhere outside a handful of countries.

Layer three: regulatory capability

A plant cannot supply what a regulator cannot approve. Assessing a biosimilar dossier requires reviewers competent in comparability science; inspecting an aseptic facility requires inspectors who have seen one operating properly. Where that capability is thin, capable manufacturers are throttled by incapable approval systems — and the African Medicines Agency exists precisely to pool this scarce expertise across the continent.

Layer four: people

Formulation scientists, bioprocess engineers, analytical chemists, qualified persons, regulatory affairs professionals. This layer takes the longest to build — a decade from first-year undergraduate to competent independent practitioner — and it is the one most often assumed rather than funded.

The uncomfortable conclusion

Sovereignty is not achieved by a policy announcement or by a single plant. It is achieved by four simultaneous, expensive, decade-scale programmes, of which the visible one is the easiest.

Morocco’s position — roughly 65% of domestic demand met locally, exports reaching more than seventy countries — was assembled over five decades. Sothema was founded in 1976 and was producing insulin at Bouskoura by the early 1980s. That is the realistic timescale, and it is worth stating plainly whenever the word is used.

Contract manufacturing is usually described as a low-margin service business — renting out capacity to companies who own the valuable part. That reading misses what it does to the plant doing the renting.

Sothema manufactures under contract for more than thirty-five national and international laboratories, reported to include major research-driven groups. Its own portfolio runs alongside that work in the same facilities, under the same quality system, operated by the same people.

Three things that move in the wrong direction

The commercial flow is outward: product leaves, fees arrive. But three other things flow inward, and they are the reason the arrangement is strategic.

Audit pressure. A multinational principal audits its contract manufacturer to its own global standard, repeatedly, with the power to withdraw the work. Passing those audits year after year forces a quality system to a level that domestic regulation alone would not require. That level then applies to everything the site makes, including its own products.

Process technology. Manufacturing another company’s complex product means receiving its process, its analytical methods and its handling know-how. Under a properly structured technology-transfer agreement, the capability to execute remains in the receiving plant after the relationship ends.

Reference credibility. A site that manufactures for the world’s most demanding customers carries an implicit reference into every regulatory conversation and every new export market. That is worth more, in a registration dossier, than any amount of marketing.

Why this matters for a country, not just a company

A national pharmaceutical industry cannot bootstrap itself to international standard by serving only its own market, because its own market cannot generate the audit pressure or the volume that forces the standard. It can, however, be pulled up to that standard by customers who demand it.

That is what contract manufacturing does at national scale. It imports quality expectations that no domestic regulator would be politically able to impose unilaterally, and it pays the plant for absorbing them.

The same logic explains why Morocco exports around a tenth of its pharmaceutical output to more than seventy countries. Export markets are not merely a revenue line. They are the mechanism by which a manufacturing sector is held to a standard.