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To Drive Down Insulin Prices, W.H.O. Will Certify Generic Versions



With insulin prices skyrocketing and substantial shortages developing in poorer countries, the World Health Organization said on

Agency officials said they were hoping to drive down insulin prices by encouraging makers of generic drugs to enter the market, increasing competition. At the moment, the world's insulin market is dominated by three companies – Eli Lilly, Novo Nordisk and Sanofi –

"Four hundred million people are living with diabetes, the amount of insulin Emercooke, the WHO's head of regulation of medicines and health technologies, said that it was announced that the plan was not up for grabs.

The approval process, which the WHO calls "prequalification," will permit United Nations agencies and medical charities like Doctors Without Borders to buy approved generic versions of insulin.

The process thus wants reassure countries without the strong regulatory agencies that are approved for their health ministries to purchase.

The W.H.O. aims to duplicate its success in widening global access to H.I.V. drugs. Started in 2002, in a poor and middle-income country.

At that time, nearly 7,000 Africans were dying of AIDS every day because they could not afford H.I.V. medications, for which Western drug companies charged up to $ 15,000 a year.

Now the drugs are made in India, China and other countries with thriving generic industries, and they cost less than $ 75 a year. About 80 percent of people in the world taking H.I.V. are are generics tested and approved by the W.H.O.

The crisis now facing people with diabetes is equally dire.

[quadrupledto400million Dr. Over the last 35 years, the number of people in the world with diabetes Gojka Roglic, the W.H.O.'s chief of diabetes management guidelines. People with uncontrolled diabetes face premature death, blindness, strokes, foot amputations and other consequences of high blood sugar levels.

The increase in diabetes is a result of population growth and rising obesity epidemic and lack of exercise, which contribute to Type 2 diabetes.

Type 1 diabetes – autoimmune disease that typically begins in childhood and destroys the body's ability to make insulin. Roglic said.

Everyone with Type 1 – about 20 million people, the W.H.O. estimates – needs regular injections of insulin. So, about one-fifth of those with Type 2, another 60 million people.

WHO has not been able to get it yet WHO's essential medicines list for over 40 years, about half of those 80 million people can not get the insulin they need, because they or their country's health systems can not afford it, the WHO said.

In the United States, where the price of a vial has risen to $ 275 from $ 35 over two decades, they can afford to buy insulin on the black market.

Drug companies making insulin for domestic use exist in India, China, Poland, Ukraine, United Arab Emirates, Brazil, Mexico and Russia, Ms. Cooke said. If they can win W.H.O. approval.

Unicef, the United Nations Development Program and Doctors Without Borders have said they would be able to buy insulin from WHO-certified suppliers.

"We've been waiting for this for a long time." , Said Christa Cepuch, the pharmacist coordinator of the access-to-medicines campaign at Doctors Without Borders.

Novo Nordisk "welcomes the new prequalification program, which reflects the WHO," a company spokesman, Ken Inchausti, said. "Novo Nordisk is committed to becoming part of the solution."

Nicolas Kressmann, a Sanofi representative, said he had not heard of the W.H.O. plan and added:

Kelley Murphy, to Eli Lilly spokeswoman, said: "Any program that makes access to insulin easier for people is important."

In a recent WHO 40 percent of health care facilities had no insulin on hand. In some countries, the price of a private vial in private pharmacies was 15 to 20 percent of a typical worker's take-home pay.

Noting that Americans struggle to afford insulin, Ms. Cooke speculated that they might spur the entry of

The W.H.O.

Insulin, which is a hormone typically grown in E.coli bacteria or yeast, is more complex to produce than, for example, H.I.V. drugs, which are laboratory-synthesized chemicals.

But Ms. Cooke said it would not be a problem with different versions and certifying them as safe and effective.

The W.H.O. has already started a program of monoclonal antibodies used to treat cancer. They are "more complex than insulin," she said.


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