The development comes as the risk of early death from diabetes is increasing, underscoring why countries must tackle the disease and bring treatment to all who need it, 100 years after the discovery of insulin.
Under a plan launched by WHO in November 2019, overly expensive insulin was a thing of the past. It was life-changing news for millions of diabetics, coming ahead of the World Diabetes Day that year.
Announcing the initiative in Geneva, the UN agency said that it had already had informal expressions of interest from pharmaceutical companies looking to produce insulin and have WHO assess whether it is safe for people to use.
Director of Regulation of Medicines and other Health Technologies at WHO, Emer Cooke, said“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.”
Coinciding with the project launch, which came ahead of World Diabetes Day marked each November 14, UN Secretary-General, Antoni Guterres, highlighted the impact of “catastrophic” medical expenses on sufferers.
“Diabetes damages health and undermines educational and employment aspirations for many, affecting communities and forcing families into economic hardship”, he said, particularly in low and middle-income countries.
The unveiled WHO’s a two-year pilot project involved the evaluation of insulin developed by manufacturers to ensure their quality, safety, efficacy and affordability.
Room for expansion of diabetic care
Assuming there is enough interest from manufacturers and, crucially, more insulin available for diabetics, the scheme could be expanded more widely.
“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”, Ms Cooke said.
The procedure was known as prequalification and WHO has done it in the past for non-brand vaccines, including those used to treat TB, malaria and HIV.
This had resulted in massive savings for sufferers around the world, with 80 per cent of HIV patients now relying on generic products, Ms Cooke said.
She noted too that some companies had already committed to lowering prices.
“When (HIV) antiretrovirals were first produced, the cost per patient per year was $10,000”, she said. “Once we opened prequalification for generic HIV products, the price went down to $300 per year.”
She added: “We’re also confident that competition will bring prices down. That way, countries will have a greater choice of products that are more affordable.”
Three manufacturers control most of the global market for insulin, which was discovered as a treatment for diabetes in 1921.
The medicine works by lowering blood glucose levels, a task that is usually carried out by natural insulin, which is produced by the pancreas whenever we eat.
The quadrupling in the number of people with diabetes since 1980 – to around 420 million today, mostly in low and middle-income countries – is widely attributed to poor diet and a lack of exercise.
Those with type one diabetes – around 20 million people – need insulin injections to survive, while only around half of the 65 million type-two sufferers who need insulin are able to get it, WHO said.
In some countries, prices are so prohibitive that some people are forced to ration their insulin.
This leaves them susceptible to heart attacks, stroke, kidney failure, blindness and lower limb amputations.
And while diabetes was the seventh leading cause of death globally in 2016, the finding is only worrying because the disease kills people prematurely, said Dr Gojka Roglic, WHO medical officer and diabetes expert.
“We all have to die of something and why not of diabetes – but (only) after celebrating our 90th birthday,” she joked. “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, the percentage rises to around 60 per cent, Roglic added.
Data collected by WHO from 24 countries on four continents showed that human insulin was available only in 61 per cent of health facilities.
The data from 2016-2019 also showed that a month’s supply of insulin costs a worker in Accra, Ghana, more than a fifth of their take-home pay.
Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys, and nerves.
The most common is type 2 diabetes, usually in adults, which occurs when the body becomes resistant to insulin or doesn’t make enough insulin. In the past three decades the prevalence of type 2 diabetes has risen dramatically in countries of all income levels.
Type 1 diabetes, once known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or no insulin by itself.
Gestational diabetes is a third type, characterised by hyperglycaemia, or raised blood sugar, with values above normal but below those diagnostic of diabetes, during pregnancy. Women and their children are also at increased risk of type 2 diabetes in the future.
The COVID-19 connection
“The need to take urgent action on diabetes is clearer than ever”, said Tedros Adhanom Ghebreyesus, WHO Director-General.
“The number of people with diabetes has quadrupled in the last 40 years. It is the only major non-communicable disease for which the risk of dying early is going up, rather than down. And a high proportion of people who are severely ill in hospital with COVID-19 have diabetes.”
More than 420 million people worldwide live with diabetes, a group of chronic diseases characterized by elevated blood sugar, which can cause damage to the heart, blood vessels, eyes, kidneys and nerves.
The most common is type 2 diabetes, which occurs when the body becomes resistant to insulin, the hormone that regulates blood sugar.
The global compact focuses on several priorities. Among the most urgent is increasing access to diabetes diagnostic tools and medicines, particularly insulin, in low and middle-income countries.
Roughly half of all adults with type 2 diabetes remain undiagnosed, according to WHO.
Additionally, half of all people with the condition do not get the insulin they need, putting them at risk of irreversible complications such as early death, amputation and sight loss.
The insulin market is currently dominated by three companies, but a pilot programme for WHO prequalification of the medication, introduced two years ago, could change the situation. The prequalification process ensures medicines meet global standards for quality, safety and efficacy.
“Prequalification of insulin produced by more manufacturers could help increase the availability of quality-assured insulin to countries that are currently not meeting demand”, WHO said in a statement.
In the meantime, discussions are underway with manufacturers of insulin, and other diabetes medicines and diagnostic tools, which could help meet demand at prices that countries can afford.
Quantifying costs, meeting targets
Another key aim of the compact is to set a “global price tag” that quantifies the costs and benefits of meeting new targets for diabetes care. Governments also will be encouraged to meet their commitments to include diabetes prevention and treatment in primary healthcare and universal health coverage packages.
Director of the Department of Non-communicable Diseases at WHO, Dr Bente Mikkelsen, added that the compact seeks to rally key stakeholders, as well as people who live with diabetes, around a common agenda to generate new momentum and create solutions.
“The ‘all hands-on deck’ approach to the COVID-19 response is showing us what can be achieved when different sectors work together to find solutions to an urgent public health problem”, he said.
Share knowledge, foster collaboration
The new compact was launched at the Global Diabetes Summit, co-hosted by WHO and the Government of Canada, with the support of the University of Toronto.
“Canada has a proud history of diabetes research and innovation. From the discovery of insulin in 1921 to one hundred years later, we continue working to support people living with diabetes,” said Patty Hajdu, the country’s Minister of Health.
“But we cannot take on diabetes alone. We must each share knowledge and foster international collaboration to help people with diabetes live longer, healthier lives — in Canada and around the world.”