When national medicines regulators fail, African Medicines Agency must step in

Lenias Hwenda.

MEDICINES regulators have a duty to protect African populations from being harmed by medical products that are of substandard quality and safety. When they fail, the results can be fatal.

No parent should ever have to bury their own child. Families in Gambia, Indonesia and Uzbekistan had to bury more than three hundred children under five years old in recent months. Each one of those deaths was preventable.

These children were poisoned by a cough syrup containing high levels of diethylene glycol (DEG) and ethylene glycol (EG) — toxic chemicals used as industrial solvents and antifreeze agents. These chemicals are fatal even when ingested in small amounts.

They should not be swallowed at all. When ingested they cause kidney damage and death and therefore should never be a component of any medicine at all.

However, the syrup taken by the deceased children had very high levels of these toxic chemicals.

Incidents over the last four months have prompted the World Health Organization (WHO) to make an urgent plea on January 23, 2023 for countries to do more to prevent, detect and respond to cases of substandard and falsified medical products.

WHO believes more countries may be affected including Senegal, the Philippines, Timor Leste and Cambodia. This means that the recorded deaths are likely an underestimation of the true fatalities. Many other victims may have gone unreported.

Most people will not notice what medicines regulators do until they do not do it. Medicines regulators have a duty to protect African populations from being harmed by medical products that are of substandard quality and safety.

This is why here in South Africa, the South African Health Products Regulatory Authority works closely with the police, defence force and the Department of Home Affairs to seize shipments of unregistered medicines worth millions of rands, and other products like skin-lightening creams which are banned because they contain nerve toxins like mercury, known to cause paralysis.

When regulators fail in performing their duty, the consequences for the public can be fatal.

That the poisoned cough syrups reached pharmacy shelves in Gambia at all highlights a series of unfortunate regulatory failures in the factory that manufactured those medicines, in the country that provided oversight over their production, and on the market to which those medicines were sold.

We may not know the precise point(s) at which the failure occurred. It is possible that failure happened at multiple levels.

Firstly, failure of the quality assurance processes of the factory that manufactured the cough syrup that include four Indonesian manufacturers, PT Yarindo Farmatama, PT Universal Pharmaceutical, PT Konimex and PT AFI Pharma.

The quality assurance processes of these companies may have failed to ensure that the ingredients used to make the medication were of good quality.

They could assure themselves of this by buying their ingredients from qualified reputable suppliers. They could also test their ingredients before use to be certain of their quality.

Then after making the medicines, they should have tested the product made from those ingredients, keeping meticulous records every step of the way to make sure that they were safe and worked as expected.

Failure to do one or all of these processes may have resulted in poisonous medicines being released for sale around the world.

It was, however, not too late to stop them reaching the hands of patients.

They could have still been stopped if the regulators of the countries in which the medicines were made and those in the country where the medicines were sold had inspected the manufacturing facilities to make sure that correct standards were being met.

Medicines regulators have the responsibility to make sure that all medical products on their market are approved for sale by an authority with a mandate to do so and that all suppliers of medical products are appropriately authorised, licensed and their premises regularly inspected.

However, many African regulatory authorities need to have the capacity to send inspectors to foreign sites where medicines used in their country are manufactured to verify that manufacturers are compliant with regulatory requirements.

Suppliers and distributors have a responsibility to check for signs of falsification, including by having a sample of each medicine lot being tested before it is shipped to make sure that it is safe and of good quality. Suppliers and distributors in African countries sometimes skip this step to save costs and time.

All these checks and balances can fail and often do. Regulators take the additional step of performing market surveillance, that is, doing routine spot checks of medicines available in their countries.

When done frequently enough, paying adequate attention to areas where risk of unauthorised or substandard products is greatest, market surveillance enables effective and rapid detection and removal of harmful products that slip under the radar of regulatory policing, allowing regulators to take action to protect the public as needed.

What happened in Gambia is the worst-case scenario of the devastating consequences of regulators failing in their duty to protect.

In most African countries, such failures are a result of long-standing, well-recognised challenges facing individual medicine regulatory agencies across the continent.

The limitations may be at country level, but the consequences of failure, however, go beyond individual countries to negatively impact other countries on the continent.

This is one of the major reasons driving African regulators to create a continental body, the African Medicines Agency (Ama).

The preventable death of children from being poisoned by medicines containing toxic chemicals is a strong reminder of why Africa urgently needs Ama to start its work to help regulators in countries be more effective at protecting public health.

Ama will expand the resources and capacity of countries to perform risk-based inspections of manufacturing sites in countries exporting medical products to African — countries such as India and China, among others.

This will help to make sure that the medicines imported to African markets meet international standards of quality and safety.

Ama will be able to co-ordinate robust and more frequent market surveillance activities among African countries, including targeted testing based on the risk of sub-standard, falsified medical products entering the African market — including informal markets.

There will always be irresponsible manufacturers who knowingly disseminate sub-standard illicit medicines for the money.

Our best defence against such unscrupulous businesses is national regulatory agencies that are better equipped to protect public health.

Many countries on the continent face various regulatory constraints that Ama can support them to overcome. At their best, African regulators must do better in preventing illicit medicines from ever reaching patients in the first place.

That requires better enforcement of laws and other regulatory counter-measures for preventing substandard and falsified medicines and prosecuting manufacturers and distributors of illicit products.

Ama is our best hope. It can minimise the occurrence of fatal failures by complementing national regulators to better succeed at protecting public health.

African patients need Ama urgently, and all governments who have not yet done so — including the government of South Africa — must ratify the Ama Treaty without delay.

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