[Ip-health] Fwd: MSF Letter to Mr Gregg Alton concerning Gilead's attempts to remove generic sofosbuvir from Ukraine

leena menghaney leenamenghaney at gmail.com
Tue Sep 6 03:34:32 PDT 2016

Mr. Gregg Alton
Executive Vice President Corporate and Medical Affairs
Gilead Sciences Inc.
333 Lakeside Dr Foster City, CA 94404

Geneva, 5 September 2016

Re: Gilead Sciences attempts to remove generic sofosbuvir from Ukraine

Dear Mr. Alton,

On behalf of Médecins Sans Frontières (MSF), I am writing to express our
serious concerns and strong opposition to Gilead’s on-going efforts to
remove the only existing source of generic sofosbuvir in Ukraine.

MSF is in the process of planning and beginning to deliver hepatitis C
treatment to patients in Ukraine, a country suffering from the highest
hepatitis C prevalence in the region - and which has one of the world’s
highest rates of hepatitis C infection. The availability of multiple
sources of new DAAs - and, in particular, sofosbuvir - is critical for
treatment providers, including MSF, to manage a sustainable and affordable
supply for medical operations.

With the continued reduction of API prices for sofosbuvir and other DAAs,
treatment providers and countries can anticipate much lower prices from
generic producers in the next few years. Availability of generic versions
of DAAs is critical for reducing prices (and ensuring that such prices
remain affordable) and increasing availability of hepatitis C treatment to
all patients.

Multiple suppliers for DAAs and other medicines are also critical to avoid
shortages and stock outs. In our experience, having only one registered
supplier of an essential medicine per country can lead to shortages and
stock outs, including recent shortages and stock-outs of critical medicines
to treat HIV and AIDS.

There are no patent barriers to the introduction of more affordable generic
versions of sofosbuvir in Ukraine. In fact, Gilead did not file for the
primary patents on sofosbuvir in Ukraine, and weak secondary patents have
not been granted in the country.

We are now concerned to learn that Gilead is attempting to remove the only
existing source of generic sofosbuvir in Ukraine, by legally challenging
the market authorization of the generic company, the distributor and
multiple government agencies, pressuring them to withdraw the generic
sofovbuvir from the market. The current attempt to remove the existing
generic source of sofosbuvir could limit our ability to scale-up hepatitis
C treatment in Ukraine. We consider that this attempt was initiated without
consideration of the serious public health consequences.

Over the past two years, MSF has requested that Gilead revise its
commercial strategies on many occasions. These strategies threaten
sustainable access to hepatitis C treatment in a number of countries where
MSF is treating patients. Our requests have included asking Gilead to
revise the current voluntary license agreements with generic manufacturers
to include high-burden middle-income countries including Ukraine, and to
eliminate its restrictive anti-diversion DAA distribution programme.

Once again, MSF urges Gilead to drop the case in Ukraine, and reconsider
its business strategy in high-burden middle-income countries, especially
Ukraine since it has been excluded from relevant voluntary license

We look forward to upcoming discussions with company representatives.

Yours sincerely,

Rohit Malpani

Director of Policy & Analysis

Médecins Sans Frontières - Access Campaign

Leena Menghaney
Mobile: 9811365412

Leena Menghaney
Mobile: 9811365412

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