In a two-year period, the program is to evaluate medical products developed by manufacturers to ensure their quality, safety and efficacy, in turn expanding the pool of available quality medicines. It will also guide international procurement agencies, such as the Global Fund, Gavi, the Vaccine Alliance, and UNICEF, and increasingly countries to make bulk purchases of medicines vaccines, diagnostics and other critical products at lower prices, the WHO said.
According to WHO estimates, globally 65 million people with type 2 diabetes need insulin, but only half of them are able to access it, largely due to high prices. All people with type 1 diabetes need insulin to survive. 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.
Data collected by the WHO in 2016-2019 from 24 countries on four continents showed that human insulin was available only in 61 percent of health facilities and analogue insulins in 13 percent, according to the WHO.
"Prequalifying products from additional companies will hopefully help level the playing field and ensure a steadier supply of quality insulin in all countries," says Mariangela Simao, WHO assistant director-general for access to medicines, vaccines and pharmaceuticals.
According to WHO statistics, with more than 420 million people worldwide living with diabetes, the disease has become the seventh leading cause of death and a major cause of costly and debilitating complications such as heart attacks, stroke, kidney failure, blindness and lower limb amputations.