With insulin prices rising and growing shortages in poorer countries, the World Health Organization said on Wednesday it will begin testing and approving generic versions of the drug.
Agency officials said they hoped to reduce insulin prices through promotion. generic manufacturers to enter the market, increasing competition. At present, the global insulin market is dominated by three companies – Eli Lilly, Novo Nordisk and Sanofi – and they have been raising prices continuously for two decades.
"Four hundred million people live with diabetes, the amount of insulin available is too low and the price is too high, so we really need to do something," said Emer Cook, WHO's head of drug and health technology regulation, when it announced plan.
The process will also reassure countries without strong regulatory agencies that approved drugs are safe for their health ministry to purchase.
The W.H.O. aims to duplicate its success in expanding global access to H.I.V. medicines. Started in 2002, retraining has helped to reduce the prices of these medicines in the poor and middle income sectors quickly.
At that time, nearly 7,000 Africans were dying of AIDS every day because they could not afford H.I.V. drugs that Western drug companies charge up to $ 15,000 a year.
Now, drugs are manufactured in India, China and other countries with a thriving generic industry and cost less than $ 75 a year. About 80 percent of people around the world who take H.I.V. the drugs take cheap generic drugs tested and approved by W.H.O.
The crisis facing people with diabetes is just as severe.
In the last 35 years, the number of people in the world with diabetes has tripled to 400 million said Dr. Gojka Roglic, W.H.O., head of diabetes management guidelines. People with uncontrolled diabetes face premature death, blindness, strokes, foot amputations and other consequences of dangerously high blood sugar levels.
The increase in diabetes is partly a result of population growth and an increase in life expectancy, but is mostly driven by the obesity epidemic and the lack of exercise that contribute to type 2 diabetes.
Type 1 diabetes – autoimmune a disease that usually starts in childhood and destroys the body's ability to produce insulin – also increases by about 3 percent annually for unknown reasons, says Dr. Roglik.
Everyone with type 1 – around 20 million people, WHO estimates – needs regular insulin injections. So do about one-fifth of those with type 2, another 60 million.
Although insulin has been on the WHO's list of essential medicines since 1945 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 to afford it, the WHO
In the United States, where the price of a vial has risen to $ 275 from $ 35 in two decades, diabetics without good health insurance are forced to rent whatever they can afford, or to buy insulin on the black market.
Medicinal companies producing insulin for home use exist in India, China, Poland, Ukraine, United Arab Emirates, Brazil, Mexico and Russia, Ms Cook said. Several have already expressed interest in entering the global market if they succeed in winning W.H.O.
Unicef, the United Nations Development Program and Doctors Without Borders said they were likely to buy insulin from WHO-certified providers, she said.
"We've been waiting for this for a long time," says Krista Chepukh, Pharmaceutical Coordinator of the Doctors Without Borders Drug Access Campaign.
Novo Nordisk "welcomes the new pre-qualification program, which reflects an increased focus on diabetes by WHO, spokesman for the company, Ken Inchausty, said. "Novo Nordisk is committed to being part of the solution."
Nicola Kressmann, a Sanofi representative, said he had not heard of the WHO plan, but added: "We definitely we support any solution that facilitates patient access. " Kelly Murphy, spokeswoman for Eli Lilly, says, "Any program that facilitates access to insulin for people is important."
In a recent WHO survey of 24 countries, most of them low- or middle-income, 40 percent of In some countries, the cost of a vial at private pharmacies was 15 to 20 percent of the pay for a homeworker.
Noting that Americans are also struggling to afford insulin, Ms. Cook speculates that her agency could encourage the entry of generic products into America skiing, working with the Food and Drug Administration to "increase confidence in the products we have approved."
But a move by a health agency is unlikely to immediately affect the high cost of the hormone in the United States, the US market is regulated by the FDA, and applying for approval is extremely expensive for many small companies.
Insulin was discovered almost 100 years ago. The medicine itself is not patented, although there are different ways to prepare and deliver it. In the United States, established pharmaceutical companies often file claims for patent infringement to drive generic competitors out of the market.
However, Americans are increasingly aware that virtually every country in the world pays less for a drug, a realization that has set off. congressional hearings have become a gathering cry for presidential candidates.
In July, for example, Bernie Sanders took a group of Americans with diabetes to Canada to buy insulin, saying that corporate greed had made the price in that country nearly 10 times higher than the price in Canada.
President Trump has said he will lower drug prices, although a plan has not yet been adopted.
The Director of the Insulin Available Now Campaign, Rosemary Enobakhare, on Wednesday called W.H.O. announcing "a good first step towards acceptable insulin worldwide" but said it would not help 30 million people with diabetes in the United States.
Any measure to lower US prices "should require Congress to give Medicare the power to negotiate drug prices," she added.
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Ms. Cook said it was cheaper insulins can hit the market in up to two years.A meeting of all global insulin makers is scheduled for March.This will take time for everyone to submit data showing how they are doing and testing their own
The WHO currently takes about nine months to complete the inspection and approval process.
Insulin, which is a hormone commonly grown in bacteria or yeast from E. coli, is more complex to produce than it is for example, HIV drugs, which are laboratory-grade chemicals.
But Ms Cook said she expects problems with testing different companies' versions and certifying them as safe and effective.
The W.H.O. a program has already begun that looks at monoclonal antibodies used to treat cancer. Confirming that the different versions are biologically similar is "more complicated than insulin," she said.