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

Baker, Brook b.baker at neu.edu
Fri May 31 06:49:59 PDT 2013

Compulsory licensing for hepatitis medicines may well be a very important
idea for increasing access to over-priced medicines that are unaffordable
in low- and middle-income countries (and excessively priced even for
upper-income countries).  However, it is disappointing that the article
and the underlying study suggest that compulsory licenses would only be
available in emergency circumstances.  Article 31 of the TRIPS Agreement
allows countries total independence to determine allowable grounds for
compulsory licenses and that Doha Declaration on the TRIPS Agreement and
Public Health went to considerable length to clarify that flexibility.
Admittedly, expedited procedures bypassing the need for prior negotiation
apply to compulsory licenses issued to address emergencies or other
matters of extreme urgency, but we should be long past the point where
compulsory licenses are discussed as applying to emergency circumstances

Professor Brook K. Baker
Northeastern U. School of Law
Affiliate, Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
Senior Policy Analyst Health GAP (Global Access Project)
Alternate NGOs Board Member UNITAID
(w) 617-373-3217
(cell) 617-259-0760
(fax) 617-373-5056
b.baker at neu.edu

On 5/31/13 6:19 AM, "Jamie Love" <james.love at keionline.org> wrote:

>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.¹s sofosbuvir, which
>analysts forecast will become the company¹s top-seller, may spawn
>compulsory generics in countries that can¹t 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 aren¹t 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.
>³If the prices were to be unaffordable once more in history, it would
>be one more scandal around inequity of access to health care,² Michel
>Kazatchkine, the United Nations Secretary General¹s Special Envoy on
>HIV/AIDS in Eastern Europe and Central Asia, said at a briefing in
>Geneva Thursday.
>³There¹s no reason why a country like Ukraine wouldn¹t go for this and
>declare a public emergency.² 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 Thursday¹s report, which didn¹t
>specifically name sofosbuvir.
>Spokeswomen for Gilead didn¹t 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 Œviral
>time bomb¹ 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
>Organization¹s 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
>Œbiosimilar¹ 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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