It’s no surprise that we are in the midst of an insulin crisis, with insulin prices shooting through the roof all over the world. The World Health Organization (WHO) announced a plan that could put an end to the global insulin crisis for good.
Diabetes around the world
Worldwide, more than 420 million people are living with diabetes. It is the seventh leading cause of death, plus the cause of dangerous complications such as heart attack, stroke, chronic nerve pain, blindness, amputation, and premature death. Prevalence of both type 1 and type 2 diabetes is increasing worldwide.
People with type 1 diabetes rely on daily insulin to regulate their blood sugar levels. About one-fifth of those with type 2 need insulin as a supplemental medication when their diabetes medications are no longer sufficient.
WHO prequalification program
The WHO’s plan involves a prequalification program for insulin, meaning that new generic versions of insulin would be qualified for use, increasing competition and driving down prices. Currently three major companies have a monopoly on insulin: Novo Nordisk, Eli Lilly, and Sanofi.
Prequalification programs like this have worked well in the past, for HIV, tuberculosis, malaria and other drugs. Today, people all over the world can afford HIV drugs, and many are thriving with a disease that was previously deadly. It is estimated that 80 percent of people with HIV use generic medications approved by the WHO.
The prequalification program would mean that generic insulin and insulin biosimilars would be pre-approved by the World Health Organization. Their process would ensure the product’s quality, safety, efficacy, and affordability. This allows organizations such as the United Nations Development Program, Doctors Without Borders, and Unicef to be able to purchase needed medicines in bulk, in turn giving access to insulin in countries with limited resources.
If a drug maker wants to submit a human insulin for prequalification, they can submit their application to the WHO.
“Too many people who need insulin encounter financial hardship in accessing it, or go without it and risk their lives. WHO’s prequalification initiative for insulin is a vital step towards ensuring everyone who needs this life-saving product can access it,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General.
Implications for insulin prices
The WHO is also planning to update guidelines for diabetes treatment, create strategies to reduce prices for analogue insulin, and improve insulin delivery systems.
It is important that the WHO steps in at a time like this to make sure that it doesn’t get worse for everyone who needs insulin to live. Too many lives have been lost and too many people are making dangerous choices in order to survive. In poor countries, many cannot afford life-saving insulin, or it is not available at all. Even in wealthy countries like the U.S., people are rationing insulin since they can’t afford it.
It remains to be seen whether this move would affect insulin prices in the U.S. since the FDA would need to approve the generics, and the approval process can be costly for smaller drug makers.