[Ip-health] Multi billion dollar Hep C drugs may force compulsory licensed generics. UN Report on HCV Drug Access

Jamie Love james.love at keionline.org
Fri May 31 03:19:54 PDT 2013

Via James Driscoll <jdriscoll2 at cox.net>

Future Hepatitis C Blockbusters May Spawn Compulsory Generics: HCV
Drug Access Highlighte

By Bloomberg on 7:53 pm May 30, 2013.

Hepatitis C drugs like Gilead Sciences Inc.’s sofosbuvir, which
analysts forecast will become the company’s top-seller, may spawn
compulsory generics in countries that can’t afford them, according to
a report backed by billionaire Richard Branson.

While health officials are negotiating with drugmakers including
Gilead over the price of new medicines for the deadly liver virus,
developing nations should issue so-called compulsory licenses for the
therapies if price reductions aren’t sufficient, according to the
report by the Global Commission on Drug Policy, of which Branson and
former Federal Reserve Chairman Paul Volcker are members.

Under a World Trade Organization agreement known as trade- related
aspects of intellectual property rights, or TRIPS, member countries
can give licenses to generic-drug makers to make low-cost copies of
treatments protected by patents that are needed to address a public
health emergency.

“If the prices were to be unaffordable once more in history, it would
be one more scandal around inequity of access to health care,” Michel
Kazatchkine, the United Nations Secretary General’s Special Envoy on
HIV/AIDS in Eastern Europe and Central Asia, said at a briefing in
Geneva Thursday.

“There’s no reason why a country like Ukraine wouldn’t go for this and
declare a public emergency.” Liver Damage About 170 million people are
infected with hepatitis C, which is transmitted commonly among drug
users who share contaminated needles, and can cause liver damage and

Of 16 million people estimated to inject drugs globally, about 10
million have hepatitis C, according to Thursday’s report, which didn’t
specifically name sofosbuvir.

Spokeswomen for Gilead didn’t immediately respond to a call and e-mail
requesting comment sent outside regular business hours.

Gilead applied for U.S. regulatory approval of sofosbuvir last month,
and the drug may cost as much as $100,000 per patient, according to
Mark Schoenebaum, an analyst at ISI Group in New York. The Foster
City, California-based company gained the drug with its $11.1 billion
acquisition of Pharmasset Inc. last year.

The pill may earn Gilead almost $4 billion in 2015 and $6.3 billion
the following year, according to the average analyst estimates
compiled by Bloomberg.

Johnson & Johnson, AbbVie Inc., Merck & Co., Bristol-Myers Squibb Co.
and Vertex Pharmaceuticals Inc. are among other companies developing
new hepatitis C treatments.

Excerpts from Report:

The World Health Organization has referred to hepatitis C as a ‘viral
time bomb’ due to the global human, social and economic costs that the
epidemic threatens to inflict.

Governments should enhance their efforts to reduce the costs of new
and existing hepatitis C medicines – including through negotiations
with pharmaceutical companies to ensure greater treatment access for
all those in need. Governments, international bodies and civil society
organisations should seek to replicate the successful reduction in HIV
treatment costs around the world, including the use of patent law
flexibilities to make them more accessible

If treatment access remains low, there will be a rising number of
people who use drugs who develop advanced or fatal liver disease. On
the other hand, scaling-up treatment will have a major impact on the
prevalence of the disease – curing individuals who may have otherwise
spread the virus, including people who continue to use drugs or who
are at risk of relapse.46 As such, this is a highly cost-effective
public health policy, especially when compared to offering no
treatment or treating only those who do not inject drugs.57

Yet hepatitis C has not received the widespread attention and
international pressure – from governments, international donors, the
United Nations and others – that has helped to dramatically reduce the
price of antiretroviral therapy for HIV.68 Recent calls have been made
for the World Health Organization to include hepatitis C treatments in
their list of essential medicines, and also for UNITAID to include
hepatitis C in its new four-year strategy in the hope that the
organization can replicate its significant impact in making HIV and
tuberculosis treatments more affordable and accessible

Even at current prices, however, hepatitis C treatment is
cost-effective from a public health perspective due to the significant
costs of treating liver disease caused by chronic, untreated
infections. In the USA, for example, the one-off cost of hepatitis C
treatment (between US$ 16,300 and US$ 32,700) is far exceeded by the
cost of treating liver cancer (at an average of US$ 44,200 per

With regards to the new hepatitis C medicines in the development
pipeline, their use will be severely limited if they are not
affordable for low and middle income countries. If negotiations with
pharmaceutical companies do not lead to sufficient reductions in
prices, countries should turn to the flexibilities that are permitted
for public health emergencies as part of the World Trade
Organization’s Agreement on Trade Related Aspects of Intellectual
Property Rights (TRIPS).75 These include the issue of compulsory
licenses for the import or production of cheaper generic or
‘biosimilar’ versions of these medicines, despite them being under

Reducing the costs of existing and future hepatitis treatments should
be an urgent priority for all national and international authorities.

Evidence-based national hepatitis C strategies have the potential to
reduce the financial and societal burden of the epidemic. The
Hepatitis C Action Plan for Scotland is an impressive example of a
national strategy that has successfully focused on people who use
drugs. Within a period of six years, hepatitis C testing, prevention
and treatment have all been improved.

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