mkamalyanni at Oxfam.org.uk
Wed Jul 30 07:07:26 PDT 2014
World Hepatitis Day: Celebration of a new cure or commiseration for those
who can?t afford it?
It?s not very often that we hear of a new medicine that actually cures a
serious disease. This year, WorlIt?s not very often that we hear of a new
medicine that actually cures a serious disease. This year, World Hepatitis
Day comes with the exciting news of sofosbuvir; the new hepatitis C
medicine with a cure rate of over 90%. Sofosbuvir can be used on its own
in the form of one pill per day for 12 weeks. Existing treatments rely on
a combination of daily oral ribavirin and weekly Interferon injections for
around 48 weeks. The effectiveness of these old medicines is far below
90%, and they also carry painful side-effects in addition to the hassle
associated with weekly injections.
So a new cure is good news? Unfortunately there is a big catch. The
medicine is not affordable, even in high income countries. At the current
price US $1000 per pill, the US public purse may have to pay over US $300
billion if the 3 million infected people are to be treated. For
example, it would cost the state of Oregon $360 million to treat its
infected population. This would deplete the $377 million that the Oregon
Medicaid program spent on all prescription drugs for its 600,000 members
in 2013. US insurance companies are rationing treatment and are telling
doctors not to offer the medicine for all the patients that need it ?
keeping it only for very specific cases.
The situation in Europe is not much better. The cost of a 12-week
treatment is ?50,000 (US$68,000). The French health minister warned that
such a high cost would have a negative impact on the French social
security system, and called on the EU to collectively negotiate a lower
price for sofosbuvir.
If cost is a major problem in the wealthier countries, then the impact of
treatment price in middle-income and low-income countries will be even
more dire. The majority of hepatitis C infected people ? 80% ? live in
these countries. Countries with an infection prevalence rate higher than
10% are: Egypt at 14%, Cameroon 13.8%, Burundi 11.3%, and Mongolia 10.7%
Clearly, none of these countries can afford the current high price. Gilead
has entered into a deal with the Egyptian government to provide a 12-week
course of treatment at US $900 per patient for the public sector. At
14% prevalence in a population of over 82 million people, the potential
number of people living with hepatitis C in Egypt is around 11.5 million
. To treat even just 5 million patients would cost Egypt the equivalent
of nearly two-thirds of its total health budget (US $4.5 billion out of
the current total health budget of US$ 7.22 billion for 2014/15). This
cost is in addition to other drugs ? pegylated interferon and ribavirin ?
which are needed in combination with sofosbuvir to reach the 90% cure rate
for genotype 4, which is the strain of hepatitis C prevalent in Egypt.
Yet the price does not have to be this high, as illustrated in two ways.
Firstly, a study by researchers at Liverpool University looked at the
total real cost of the active pharmaceutical ingredients and the cost of
manufacturing of the new direct anti-viral medicines class, of which
sofosbuvir is one. They estimated the cost of a 12-week course of
treatment with the combination of sofosbuvir and daclatasvir as US $78 per
Secondly, evidence shows that the price of medicines is slashed by generic
competition. HIV treatment is a case in point: in 2000, at the height of
the public outcry campaign against high medicine prices, it was very
difficult to persuade any government or donors to pay for treatment, and
millions of people in poor countries were left to die. The price of triple
therapy for HIV was US $10,000 per patient per year. That was clearly
unaffordable to patients, governments, and donors at the time. Thanks to
generic competition from Indian companies, the price dropped almost
overnight to US $360 per patient per year or US $1 day. Continuation of
competition has resulted in the current price of triple therapy for HIV of
approximately US $100 per patient per year.
Now that Trade Related Aspects of Intellectual Property Rights (TRIPS) is
implemented in almost all countries, including those with manufacturing
capacity such as India, it is much harder to scale up generic competition.
However, TRIPS includes some flexibilities, which countries can use to
help lower prices. For example, India?s patent law has a clause on
?pre-grant opposition?, which allows any interested groups to challenge a
patent application before the patent is granted. Civil society
organisations have used this clause for sofosbuvir and therefore
currently, it does not have a patent in India (although the final decision
is awaiting a court ruling).
Compulsory licensing is an important legal TRIPS tool for governments to
ensure affordable prices of new medicines. Use of this tool in India
decreased the price of sorafenib (Nexavar) for the treatment of liver and
kidney cancer from over US $5,500 per month to US $175. In 2008,
Thailand issued compulsory licenses for 3 cancer medicines, leading to a
big drop in prices. For example, the price of one tablet of 2.5 mg of
letrozole was slashed from the original Novartis price of US $£7.35 to the
generic price of US $0.19-0.22 ? a price differential of 30 times.
Obviously pharmaceutical companies and rich countries who support them do
not like any government using this legal TRIPS tool. When Thailand issued
compulsory licenses for medicines to treat HIV, cardiovascular disease,
and cancer, it came under tremendous pressure from the US and the EU to
stop. Last year there was pressure by US businesses and Congress for
the US government to take actions against India over its intellectual
The fundamental problem is the system of intellectual property rules which
allows big companies to hold a monopoly on the price of medicines, thus
giving them the power to set high prices. Moreover, financing for research
and development (R&D) is still dictated by commercial interests rather
than public health needs all over the world. Pharmaceutical companies are
ferociously lobbying for stricter and stricter intellectual property
protections as the only way to stimulate R&D and to ensure they can
maintain their monopoly to set prices.
The price of the new hepatitis C medicine has given more momentum to the
rising global movement that is challenging the high prices of new
effective medicines for diseases ranging from cancer to cystic fibrosis
. As long as the cost of R&D is linked to drug pricing, pharmaceutical
companies will continue to price medicines to ensure maximum profit, even
if it means decreased access for people who need it. This is a public
health travesty. .
The un-affordability of the most effective medicine that can cure
hepatitis C today highlights the critical need to de-link financing for
R&D from the price of medicines, and for finding new ways to finance R&D
so that effective medicines are available at an affordable price to all
who need them.
 Lavanchy D.( 2011) Evolving epidemiology of hepatitis C virus. Clin
 Forthcoming: New effective hepatitis C medicines must reach all
Mohga (Dictating to the computer so please forgive silly mistakes)
Dr. Mohga M Kamal-Yanni
Senior health & HIV policy advisor, Oxfam GB
John Smith Drive, Oxford, OX4 2JY, UK
UK Mobile + 44 (0)777 62 55 884
Follow me @MohgaKamalYanni
Oxfam works with others to overcome poverty and suffering.
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Registered office: Oxfam House, John Smith Drive, Cowley, Oxford, OX4 2JY.
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