This is the finding of a new analysis from Newcastle University in the UK and Makerere University in Uganda, published by the Journal of the Royal Society of Medicine.

Before a medicine can be made available in a country, manufacturers must apply to the medicine regulatory agency of the country for a licence to sell it and demonstrate the medicine is safe and effective. This is known as market registration.

The researchers compared the essential medicines lists in each country with the medicine products on each country’s national drug registers. Their analysis shows that a high proportion of essential medicines are not registered (28% in Kenya, 50% in Tanzania and 40% in Uganda). The lack of registration of essential medicines is, say the researchers, a barrier to availability.

Across the three countries 80–100% of anti-Parkinsonism medicines, 71–90% of antidotes and anti-poisoning medicines, 0–43% of diuretics, 28–41% of antiepileptics, 21–44% of hormonal and endocrine medicines and 21–30% of anti-infectives were not registered and therefore could not be available.

A significant proportion of essential medicines that are registered have less than three products registered (38%, 45% and 36% for Kenya, Tanzania and Uganda respectively).

Market registration

The World Health Organization (WHO) introduced the essential medicine concept in 1977 to enable countries to prioritise medicines for population needs. The WHO essential medicine list is updated every two years on the basis of affordability, evidence of efficacy and safety, and priority health needs. All low income and most middle-income countries have an Essential Medicine List which is used as the basis for government procurement. Before a medicine can be made available in a country, manufacturers must apply to the medicine regulatory agency of the country for a licence to sell it and demonstrate the medicine is safe and effective. This is known as market registration. Manufacturers do not apply for a licence to sell products unless there is a market for them. This study has shown a gap between the registration of medicines and the essential medicines needed to meet priority health needs and an oversupply of non-essential medicines in the market.

“Given that the World Health Organization recommends at least three different manufacturers per medicine to ensure a stable supply, registration of less than three products is insufficient,” said Dr Moses Ocan, a senior lecturer in the department of Pharmacology & Therapeutics at Makerere University College of Health Sciences and co-author of the research.

A sub-analysis of antimicrobials within the research showed that the high registration of non-essential antibiotics in the three countries is likely to lead to inappropriate use and drive antimicrobial resistance. Dr Ocan added: “There are thousands of antibiotic medicine products in the market. This is because manufacturers may apply for licenses for the same medicine in different doses and formulations. We found 2,310 products for the 21 most highly registered antibiotics, of which only 46% were essential medicines.”

Another of the researchers, Professor Allyson Pollock, Clinical Professor of Public Health at Newcastle University, said: “Over-registration of medicines, particularly non-essential medicines, diverts regulatory resources towards registering non-priority and, sometimes, clinically sub-optimal medicines.

“The East African Community Medicines Registration Harmonization Project has the potential to improve access to key medicines if registration of essential medicines is prioritised and registration of non-essential medicines is restricted.” 

Registration of essential medicines in Kenya, Tanzania and Uganda: a retrospective analysis (DOI: 10.1177/01410768231181263) by A Green, R Lyus , M Ocan, AM Pollock and P Brhlikova will be published by the Journal of the Royal Society of Medicine / JRSM Open