To Cut Insulin Prices, WHO To Certify Generic Versions

Geneva, 15 Nov 2019:

With insulin prices skyrocketing and substantial shortages developing in poorer countries, the World Health Organization said on Wednesday that it would begin testing and approving generic versions of the drug.

Agency officials said they hoped to drive down insulin prices by encouraging makers of generic drugs to enter the market, increasing competition. At the moment, the world’s insulin market is dominated by three companies — Eli Lilly, Novo Nordisk and Sanofi — and they have steadily pushed up prices for two decades.

“Four hundred million people are living with diabetes, the amount of insulin available is too low and the price is too high, so we really need to do something,” Emer Cooke, the WHO’s head of regulation of medicines and health technologies, said as she announced the plan.

The approval process, which the WHO calls “prequalification,” will permit United Nations agencies and medical charities to buy approved generic versions of insulin.

The process also will reassure countries without strong regulatory agencies that the approved drugs are safe for their health ministries to purchase.

The crisis now facing people with diabetes is equally dire.

Even though insulin has been on the WHO’s essential medicines list for over 40 years, about half of those 80 million people cannot get the insulin they need, because they or their country’s health systems cannot afford it, the WHO said.

In the United States, where the price of a vial has risen to $275 from $35 over two decades, diabetics without good health insurance are forced to ration whatever they can afford or to buy insulin on the black market.

Drug companies making insulin for domestic use exist in India, China, Poland, Ukraine, United Arab Emirates, Brazil, Mexico and Russia, Cooke said. Several have already expressed interest in entering the global market if they can win WHO approval.

UNICEF, the United Nations Development Program and Doctors Without Borders have all said they would be likely to buy insulin from WHO-certified suppliers, she said.

“We’ve been waiting for this for a long time,” said Christa Cepuch, the pharmacist coordinator of the access-to-medicines campaign at Doctors Without Borders. ET Healthword