The World Health Organization (WHO) has announced plans to make "over expensive" insulin a thing of the past for the millions of people suffering from diabetes.
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The agency wants pharmaceutical companies to make generic versions of insulin and has said that some companies have already informally expressed an interest.
Director at the WHO, Emer Cooke, says: "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."
Diabetes damages health and undermines educational and employment aspirations for many, affecting communities and forcing families into economic hardship."
Emer Cooke, Director of WHO
A generic version of insulin
Currently, three pharmaceutical companies control most of the insulin market. A generic version would be chemically similar to the existing drug but would be produced by a different manufacturer. The generic version would then be tested by the WHO for quality and safety.
This process of having manufacturers produce a generic version and then testing it for quality and safety is referred to as a prequalification program.
Drugs have been prequalified by the WHO before. They have also generated non-brand vaccines for diseases, including TB, malaria, and HIV.
This resulted in massive savings for sufferers around the world, and about 80% of HIV patients now rely on generic products, says Cooke.
"When (HIV) anti-retrovirals were first produced, the cost per patient per year was $10,000," she says. "Once we opened prequalification for generic HIV products, the price went down to $300 per year… We're also confident that competition will bring prices down. That way, countries will have a greater choice of products that are more affordable."
About diabetes and insulin
Diabetes is a chronic, metabolic illness characterized by a high blood sugar level that eventually causes serious damage to nerves, blood vessels, and the heart, kidneys, and eyes. The number of people with diabetes has quadrupled since 1980 and now sits at around 420 million.
Insulin works by reducing blood sugar levels, a process that is usually carried out by naturally occurring insulin produced by the pancreas when a person eats.
The most common form of diabetes is type 2, which usually arises in adults. The body either becomes resistant to the effects of insulin or fails to make the hormone. The condition is generally brought on by an unhealthy diet and/or lack of exercise.
Type 2 diabetes can often be managed through physical activity and a healthy diet or drugs other than insulin, such as metformin. Over the past thirty years, type 2 diabetes has become significantly more prevalent in countries of all income levels.
Type 1 diabetes, also called insulin-dependent diabetes, is a chronic autoimmune condition in which the pancreas produces too little insulin or none at all. Insulin injections are required regularly to help the body regulate the blood glucose level.
According to the WHO, approximately 20 million people have type 1 diabetes and rely on regular insulin injections to stay alive. There are also 65 million people worldwide with type 2 diabetes that requires treatment with insulin, but only about half of these people are able to obtain it.
Insulin is so expensive that some people are forced to ration their use
In some countries, the price of insulin is so high that people are forced to limit their insulin use, which leaves them vulnerable to heart attack, stroke, blindness, kidney failure, and lower limb problems that require amputation.
WHO medical officer, Gojka Roglic, says diabetes is a particularly concerning condition because it kills people prematurely: "The problem with diabetes is that it accounts for a large proportion of premature diabetes – almost half of them occur before 70."
In low and middle-income countries, that figure rises to around 60 percent, Roglic added.
WHO estimates based on 2016-2019 data from 24 countries across four continents have shown that human insulin was only made available in 61% of health facilities.
The data also showed that just one month's supply of insulin costs more than a whole fifth of a worker's take-home pay in the city of Accra, Ghana.
The current scheme
Assuming enough manufacturers take an interest in the prequalification process and assuming that enough insulin is made available, the scheme could be expanded and applied more broadly.
"We're going to look at the number of companies that will apply, we're going to look at how long it takes, we're going to look at the outcomes, and we're going to see whether this makes sense and it really is increasing access," says Cooke.
Once a generic version of insulin has passed tests for safety, quality, efficacy, and affordability, it would be made available on the global market much more cheaply, thereby driving down costs.
The WHO announced the plans for its two-year scheme at a conference in Geneva, Switzerland.