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 The forthright comments from the UN agency on
Wednesday add to pressure on drugmakers such as Gilead Sciences — which is already facing protests in the United States over its
$1,000-a-day pill — to do more to improve access.
In its first-ever treatment guidelines for the disease, issued at a
meeting of international liver experts in London, the WHO strongly
recommended new drugs from Gilead and Johnson & Johnson — with a big
caveat on their cost.
Treating the approximately 150 million people in the world living
with chronic hepatitis C infection is the new front-line in the
battle over access to medicines.
As with AIDS 15 years ago, modern drugs are transforming the ability
to fight hepatitis C because pills such as Gilead's Sovaldi are far
more effective and better-tolerated than older injection regimens,
with cure rates well above 90 percent in many cases.
"These drugs are fantastic — they are a real breakthrough," Markus
Peck-Radosavljevic, a professor of medicine in Vienna and
secretary-general of the European Association for the Study of the
Liver, told Reuters. "But the prices are too high."
Pharmaceutical companies say they need to charge high prices on new
successful drugs to cover the huge cost of development, including of
those that fail to make it to the market.
A record number of promising results from late-stage clinical trials
on a range of new oral medicines will be showcased at the
International Liver Congress this week.
Hepatitis C virus, or HCV, is spread through blood, often via
contaminated needles. It causes cirrhosis and liver cancer. The vast
majority of cases are in poorer countries where the complexity, cost
and side effects of current treatments have made treatment
impractical.
The arrival of simple pills, taken for as little as a couple of
months, could revolutionize therapy, if the price is right.
By giving governments a plan setting out how to test for, treat and
prevent HCV, the WHO is laying foundations for tackling the disease,
while spurring demand and sending a strong message on price.
"I hope these guidelines will help to promote a reduction in price
and thereby an increase in access," said Stefan Wiktor, who leads
the WHO hepatitis programme.
COMPULSORY LICENSES?
Drawing a clear parallel with the experience of HIV/AIDS, the WHO
believes a "multi-pronged" approach is needed. This could include
tiered price discounts by branded drugmakers, voluntary licensing
and also compulsory licensing.
Voluntary licensing involves a patent owner agreeing to license its
drug to generic manufacturers, while a compulsory license is issued
by a government without any such agreement — something the
pharmaceuticals industry is keen to avoid.
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After dragging their feet for years over access to AIDS drugs in
Africa, pharmaceuticals makers are trying to take the initiative
this time. Market leader Gilead recently agreed a 99 percent price
discount for Egypt and plans to grant voluntary licenses to several
Indian generics firms.
J&J has also promised to work on access and others entering the area — such as AbbVie, Bristol-Myers Squibb and Merck & Co — are expected
to follow suit.
But campaigners want more. The Medecins Sans Frontieres group
believes a 12-week course of treatment and diagnosis should cost no
more than $500. That compares with the $84,000 and $66,000 charged
by Gilead and J&J respectively for their drugs in the United States.
There is also a big concern about middle-income countries such as
China, India and Russia, which are home to most cases of HCV
worldwide but where drug companies are more reluctant to accept
rock-bottom prices than in the poorest nations.
Charles Gore, president of the patient-led World Hepatitis
Alliance, welcomed the WHO guidelines but said international funding
along the lines of the Global Fund to Fight AIDS, Tuberculosis and
Malaria was now needed.
When it comes to profits, drug companies are expecting to make most
of their money in the United States, where medicines traditionally
fetch a premium.
But the scale of the expected demand for new hepatitis C drugs — which industry analysts believe will translate into annual sales of
$9.1 billion for Sovaldi alone by 2017, according to Thomson Reuters
data — means the industry is under fire.
U.S. lawmakers asked Gilead last month to explain the $84,000 price
tag on Sovaldi, hitting shares in the firm and raising fears across
the biotech sector.
"Until we develop a better model, we are still in the situation
where investors in pharma want to recompensed on the winners for all
the losers — and there have been a lot of losers in hepatitis C over
the years," said Gore.
(Reporting by Ben Hirschler; editing by David Stamp)
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