For First Time, W.H.O. Names Some Lab Tests ‘Essential’

For the primary time, the planet Health Organization has published an inventory of diagnostic tests that it considers essential to each health care system within the world.

The list, published Wednesday, is analogous to the agency’s essential medicines list, which the W.H.O. launched in 1977.

In its day, the medicines list was revolutionary because it had been both a worldwide guide to rational treatment regimens and since it fostered the thought that certain medicines were so important that they ought to be available to the entire world, no matter price.

The W.H.O. expert panel that created the diagnostics list hopes it'll eventually be even as revolutionary.

“I’m thrilled about it,” said Dr. Madhukar Pai, director of worldwide health for McGill University’s school of medicine and a member of the panel that spent two years creating the list.

“But I’m very aware that publishing an inventory in Geneva won't magically make malaria test kits available in Vietnam. Each country has got to make its own list to offer the thought teeth.”

The W.H.O. lists 113 diagnostics.

Fifty-eight are the routine blood and urine tests that are run in most American medical offices: measurements of red and white blood cells, blood glucose, liver enzymes, and so on, plus tests for one-time events like pregnancy or transfusion blood-typing.

The remaining 55 are tests for diseases the W.H.O. considers of highest priority: H.I.V., tuberculosis, malaria, hepatitis B, hepatitis C, HPV, and syphilis.

Without a diagnosis, care is crippled, Dr. Pai said.

“I grew up in India and sometimes worked without diagnostics, managing with whatever I could get,” he said.

''If you don’t know someone has hep C or drug-resistant TB, how are you getting to cure them?” Panel members hope to soon expand the list by adding tests for viruses like flu, antibiotic resistance in bacteria, cancer, a heart condition, and other ills.

They also hope to feature an important “devices” category to incorporate diagnostic equipment like X-ray and CT scanners, ultrasounds, fiber-optic scopes, automated blood analyzers, PCR machines, and so on.

Although many of those tests and devices are around for many years, there's great variance within the ways diseases is diagnosed in several countries.

Worse, doctors often prescribe antibiotics or other drugs without diagnoses, which may hurt patients and speed drug resistance.

Besides setting universal standards, the list is supposed to encourage countries to create the laboratories needed to try to do the tests. it's also meant to offer the diagnostics industry — which is way more fragmented than the pharma industry — targets to aim at, which should lower prices.

If a dozen manufacturers know that a particular sort of blood analyzer or CT the machine is that the global standard, for instance, they'll compete to form it, driving prices down.

Forty years ago, before the essential medicines list was published, poor countries were largely at the mercy of drug companies — which were often leftover from those countries’ colonial periods.

Companies frequently offered only the medicines they wanted to sell instead of the foremost sensible choices.

When the list was created, it included basic, affordable drugs.

“But the pharma industry still hated it,” said Dr. Hans V. Hogerzeil, a former W.H.O. official who oversaw the list for 25 years.

“They were very powerful within the 1980s, and that they said, ‘If you call these essential, you’re saying our others aren't .’”

In 2002, the W.H.O. raised the stakes by adding a dozen anti-H.I.V. drugs.

It was the peak of the worldwide AIDS crisis, and corporations were refusing to lower prices on antiretrovirals, which then cost up to $15,000 a year.

Listing them was “absolutely” the W.H.O.’s unspoken effort to shame those companies, Dr. Hogerzeil said. The action, he said, led to an intense backlash not just from the industry but from our government, because many companies were American.

A year later, plans to make an “essential devices” list were blocked.

“We were stopped from issuing it,” he said. “Having one begin now would really be a breakthrough .”

Deciding which medicines were essential also opened the way for the Indian generics industry to start producing equivalent drugs at a fraction of the worth.

That the industry is now the main supplier to Africa, Asia, and Latin America.

Now, Dr. Hogerzeil said, finding ways to lower prices for poor countries or to license their inventions to low-cost producers “is just a fact of life for the pharma industry.”

Suzanne Rose Hill, director of essential medicines and health products at the W.H.O., said several factors spurred the creation of the list.

A 2016 article within the New England Journal of drugs and lobbying by Dr. Pai led her to convene an expert panel.

Then the agency’s new director-general, Tedros Adhanom Ghebreyesus, made it a priority because he wants to enhance medical care, she said.

In contrast to 2002, “there has been no pushback from the diagnostics industry in the least,” she said.

“They see it as a possible market instead of a drag .”

The next step, she said, is going to be to figure with countries like India, South Africa, and Ethiopia that are building similar lists to ascertain how the W.H.O.’s are often refined.

Jayasree K. Iyer, executive of the Access to Medicines Foundation, which publishes a biannual ranking of how well pharmaceutical companies do at getting their drugs to the poor, said her foundation will monitor reactions to the new list.

“We’ll see if it moves the industry, and if it moves hospitals,” she said.