WHO says it will approve generic insulin to lower costs, improve access

The World Health Organization said Nov. 13 that it will begin a prequalification program to test and approve generic versions of insulin to lower costs and improve access around the world. 

Agency officials said during a meeting in Geneva that they hope to drive down insulin prices by encouraging generic drugmakers to enter the market and increase competition. 

"The amount of insulin available to treat diabetes is too low, the prices are too high, so we need to do something," said Emer Cooke, the WHO director of regulation of medicines and other health technologies.

The insulin market is currently dominated by three drugmakers — Eli Lilly, Novo Nordisk and Sanofi — all of which have steadily increased prices over the last two decades, according to The New York Times

The prequalification program will allow United Nations agencies and medical charities like Doctors Without Borders to buy approved generic versions of insulin. The inspection and approval process currently takes about nine months. 

UNICEF, the UN Development Program and Doctors Without Borders have all said they would likely buy insulin from the WHO program, according to The New York Times

Ms. Cooke said cheaper insulin products could be on the market within two years. 

However, the program likely won't immediately affect insulin prices in the U.S., as the application process for FDA approval is prohibitively expensive for many small drugmakers, according to The New York Times

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