WHO calls for end to insulin monopoly

“The scientists who discovered insulin 100 years ago refused to profit from their discovery and sold the patent for just one dollar,” WHO Director-General, Dr Tedros Adhanom Ghebreyesus said on 12 November.

“Unfortunately, that gesture of solidarity has been overtaken by a multi-billion-dollar business that has created vast access gaps. WHO is working with countries and manufacturers to close these gaps and expand access to this life-saving medicine for everyone who needs it.”

The WHO position on generics was made clear in a new report to commemorate the centenary celebration of the discovery of human insulin.

Diabetes, once considered the disease of the rich countries, is growing at a faster pace in low- and middle-income countries (LMICs) now. According to estimates by the WHO, three in four people who live with diabetes are in LMICs, but they are also the ones with the lowest access to insulin.

The main barriers to access besides high price is also the faster rate of prescription of analogue insulins which have replaced much cheaper human insulins.

Across the world, three companies—Eli Lilly, Novo Nordisk and Sanofi—control the insulin market. These companies control 95% of the market in LMICs. The cost of insulin for a Type 1 diabetic patient for a month in India is estimated to be ₹10-12,000 depending on the dosage. Associated diabetes treatments could drag the cost of care to ₹20,000.

WHO said it will initiate a new prequalification programme for long-acting insulin analogues. “These programmes aim to provide a regulatory pathway to improve the availability of biosimilar insulins. Upon greater market participation of suppliers of biosimilar insulins, positive competitions on price, quality and supply may ensue, leading to better affordability over time,” the WHO said.

Insulin is a hormone that regulates the blood sugar levels of individuals. However in patients who cannot naturally produce insulin, the insulin injections are a life saver. Over the years the insulin injections have seen an upgrade from human insulins, that is insulins made in labs by growing the proteins inside a bacteria to genetically modifying the DNA of the bacteria to provide faster blood sugar management.

“Unless the price of all types of insulin and the medical supplies required to inject and monitor this treatment comes down, governments will continue to struggle to manage this controllable disease and people with diabetes will keep dying,” said Leena Menghananey, lawyer with Médecins Sans Frontières (MSF), an organization that works for access to medicines. MSF has been pushing Indian drug maker Biocon, which is leading the biosimilar insulin plan across the world, to apply for WHO pre-qualification so that they can start supplying to other LMICs without much regulatory hurdles.