E-DRUG: WHO launches first-ever insulin prequalification programme to
expand access to life-saving treatment for diabetes
GENEVA, 13 November 2019 - The World Health Organization (WHO) today
announced the start of a pilot programme to prequalify human insulin to
increase treatment for diabetes in low- and middle-income countries.
The decision, announced ahead of World Diabetes Day (14 November), is part
of a series of steps WHO will take to address the growing diabetes burden
in all regions. About 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.
'Diabetes is on the rise globally, and rising faster in low-income
countries,' says Dr Tedros Adhanom Ghebreyesus, WHO Director-General. 'Too
many people who need insulin encounter financial hardship in accessing it,
or go without it and risk their lives. WHO's prequalification initiative
for insulin is a vital step towards ensuring everyone who needs this
life-saving product can access it.'
Insulin prequalification can lead to lower prices
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.
Insulin was discovered as a treatment for diabetes almost 100 years ago and
has been on WHO's List of Essential Medicines since it was published in
Despite an ample supply, insulin prices are currently a barrier to
treatment in most low- and middle-income countries. Three manufacturers
control most of the global market for insulin, setting prices that are
prohibitive for many people and countries.
Access to insulin a challenge in many countries
Data collected by WHO in 2016-2019 from 24 countries on four continents
showed that human insulin was available only in 61% of health facilities
and analogue insulins in 13%. The data showed that a month's supply of
insulin would cost a worker in Accra, Ghana, the equivalent of 5.5 days of
pay per month, or 22% of his/her earnings.
In wealthy countries, people often have to ration insulin, which can be
deadly for people who do not get the right quantity of the medicine.
'Prequalifying products from additional companies will hopefully help to
level the playing field and ensure a steadier supply of quality insulin in
all countries,' says Dr MariaAngela Simao, Assistant Director General for
Medicines and Health products.
More than 420 million people live with diabetes. Diabetes is 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.
People with type 1 diabetes need insulin for survival and to maintain their
blood glucose at levels to reduce the risk of common complications such as
blindness and kidney failure. People with type 2 diabetes need insulin for
controlling blood glucose levels to avoid complications when oral medicines
become less effective as the illness progresses.
Insulin prequalification is one of a number of steps WHO will take in the
coming year to address the diabetes burden. Plans are underway to update
diabetes treatment guidelines, devise price reduction strategies for
analogues and improve delivery systems and access to diagnostics. WHO also
works with countries to promote healthier diets and physical activity to
lower people's risk of developing type 2 diabetes.
Note to editors
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
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.
Evaluating and prequalifying health products then guides 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.
Fact sheet: https://www.who.int/news-room/fact-sheets/detail/diabetes
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