The World Health Organization will begin testing and approving generic versions of insulin to expand access and try to reduce diabetes drug prices.
The decision, announced in the framework of World Diabetes Day (November 14), is part of a series of measures aimed at addressing the growing burden of the disease that affects 400 million people and is the seventh cause of Death in the world.
About 65 million people with type 2 diabetes need insulin, but only half of them can get it, largely due to high prices. @WHO launches programme to expand access to life-saving treatment in low- and middle-income countries. #WorldDiabetesDayhttps://t.co/E0702pvxBH
— United Nations (@UN) November 14, 2019
Starting next year, insulin will be part of the WHO Drug Prequalification Program that accelerates the approval process and increases access to quality essential medical products.
This will allow UN agencies and organizations such as Doctors Without Borders to obtain approved generic versions of insulin and that governments in developing countries can be assured that these approved drugs are of quality. This was the case with HIV antiviral drugs that were added to the prequalification program in 2002 and are now available in less expensive generic versions and certified by WHO.
More competition to lower prices
Until now, the insulin market is dominated by three pharmaceutical companies – Elli Lilly, Novo Nordisk and Sanofi- that have been increasing the price progressively. In the US, for example, the price of a vial has increased from $ 35 to $ 275 in two decades, according to the New York Times.
“The amount of insulin available in the world is too low and the price too high, so we really need to do something,” said Emer Cooke, director of the WHO’s Department of Medicines and Other Technology Regulation.
In the last 35 years, the number of people with diabetes has quadrupled not only because of the increase in population and life expectancy, but especially because of the obesity epidemic, which is a contributing factor to the development of type diabetes. two.
Insulin is a hormone that the body naturally generates to control sugar and convert glucose into energy. Its discoverer, Frederick Banting, sold the patent for just $ 1 in 1921 to guarantee access to it.
Type 1 diabetics and those who suffer from type 2 diabetes but are insulin-dependent should take it to keep blood sugar levels regulated.
According to WHO estimates, 65 million people with type 2 diabetes worldwide need to be treated with insulin injections; while all people diagnosed with type 1 diabetes – about 60 million – need it to survive.
However, half cannot obtain it because the health system of their countries cannot afford it, WHO said.
“Too many people who need insulin face financial difficulties to access it, or they run out of it and risk their lives . The WHO insulin prequalification initiative is a fundamental step to ensure that everyone who needs this vital product can access it, ”said WHO Director General, Tedros Adhanom Ghebreyesus.
According to data collected in 24 countries on four continents between 2016-2019 by the multilateral entity, 40% of hospitals do not have insulin available and the price in private pharmacies reaches up to 20% of the salary of an average worker.
A good first step
In the US, many patients are in need of rationing or buying it on the black market. In reference to this, Cooke indicated that the measure could facilitate the entry of generics into the US market by increasing the confidence of the Food and Drug Administration (FDA) in those products approved by WHO.
But, as an article in the New York Times points out, it is unlikely that the WHO measure will have an immediate impact on the US where only applying to the approval of the regulatory body – the FDA – is almost prohibitive for small businesses.
The director of the Affordable Insulin Campaign Now, Rosemary Enobakhare, said that the WHO announcement was “a good first step towards affordable insulin for everyone in the world,” but that it will not help the 30 million people with diabetes in U.S.