The World Health Organization (WHO) announced on Wednesday that it would begin testing and approving generic versions of insulin in an effort to lower prices and increase availability of the life-saving drug.
“The simple fact is, that the prevalence of diabetes is growing, 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, Director of Regulation of Medicines and other Health Technologies at WHO.
Currently, three manufacturers control most of the global market for insulin--Eli Lilly, Novo Nordisk and Sanofi—and they have been pushing up prices for two decades. The WHO hopes that opening the market to generic manufacturers will encourage competition and drive prices down.
From 1997 to 2016, insulin prices rose from about $20 per vial to over $250 per vial, according to a report from the Washington Post. That is a 700% increase after accounting for inflation.
The high prices have forced some people with diabetes to use expired insulin, rely on crowdfunding, or taking less insulin than they need in order to ration their supplies. Since 2017, at least 10 Americans have died from having to ration their insulin, according to the Right Care Alliance. Seven of the victims were in their 20s.
“This is a drug that we need to live by," said Local 4′s Brandon Roux, who lives with diabetes. "There’s no doubt about it. This is not, ‘Well, maybe I’ll take it today, maybe I won’t.’ I don’t live without this drug.”
How did prices get so high?
Insulin was developed in 1921 by three young scientists at the University of Toronto. They filed for a patent and sold it to the university for $3. They believed this was the best way to ensure that affordable treatment would be available for all who needed it.
After the original patent expired, the three major insulin manufacturers have been making incremental improvements to the drug that generate new patents and profits.
“I don’t think it takes a cynic such as myself to see most of these drugs are being developed to preserve patent protection,” Harvard Medical School Professor David Nathan told the Washington Post. “The truth is they are marginally different, and the clinical benefits of them over the older drugs have been zero.”
List prices began to rise when Novo Nordisk started making its own bioengineered human insulin in 1991, reports the Post. The higher prices recalibrated how much it cost to treat the disease, paving the way for new drugs to be launched at even higher prices.
WHO aims to duplicate HIV drug success
The process the WHO is undertaking is known as prequalification. The agency says it has been done in the past for HIV drugs and resulted in wider access for patients around the world. Today, 80 percent of HIV patients rely on generic products, according to the agency.
When drugs for HIV treatment were first introduced, the cost per patient was $10,000. Today the price is $300 per year, according to the WHO.
Generic meds will still require FDA approval
It is unlikely that the WHO’s move will immediately affect insulin prices in the United States, where the market is regulated by the Food and Drug Administration (FDA). Applying for approval from the FDA can be prohibitively expensive for small companies, which will most likely be the ones developing the generic drugs.
Rosemary Enobakhare, director of the Affordable Insulin Now campaign, called the new program “a good first step toward affordable insulin for all around the world,” but says it won’t do much to help the 30 million Americans with diabetes.
Several presidential candidates have been outspoken in their calls for lower drug prices.
In July, Bernie Sanders made headlines when he brought a group of people with diabetes from Detroit to Windsor, Ontario, where insulin costs one-tenth the price in the US.
“This vial of insulin costs just $6 to manufacture. At this pharmacy in Windsor, Ontario, it can be purchased for $32. Twenty minutes away, in Detroit, the same exact vial costs $340,” the Senator wrote on Twitter. “It is time for a government that works for the American people, not drug companies’ profits.”
This vial of insulin costs just $6 to manufacture.— Bernie Sanders (@BernieSanders) July 28, 2019
At this pharmacy in Windsor, Ontario, it can be purchased for $32. Twenty minutes away, in Detroit, the same exact vial costs $340.
It is time for a government that works for the American people, not drug companies' profits. pic.twitter.com/Uo2T8GG54T