The World Health Organization (WHO) has announced the start of a pilot programme to prequalify human insulin to increase treatment for diabetes in low- and middle-income countries.

Human insulin was discovered as a treatment for diabetes almost 100 years ago and has been on WHO’s Essential Medicines List since the first List was published in 1977. In spite of this, current insulin prices and availability pose a barrier to treatment in most low- and middle-income countries. In wealthy countries, there are several examples of people that cannot reliably access this life-saving medication because it is unavailable, unaffordable or both.

The WHO Prequalification of Medicines Programme contributes to accelerating and increasing access to critical medical products that are quality-assured, affordable and adapted for markets in low- and middle-income countries. 

The programme does this by evaluating medical products developed by manufacturers to ensure their quality, safety and efficacy, in turn expanding the pool of available quality medicines.

WHO prequalification of insulin is expected to boost access by increasing the flow of quality-assured products on the international market, providing countries with greater choice and patients with lower prices.