[Ip-health] MSF: Middle-income countries flex muscles to overcome patents in face of unaffordable drug prices

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Thu Jul 26 04:23:51 PDT 2012

*Middle-income countries flex muscles to overcome patents in face of
unaffordable drug prices*

* *

*Washington, DC, 25 July 2012*—Middle-income countries are increasingly
taking measures to overcome the patents that price drugs out of reach,
according to a new report released today from the international medical
humanitarian organization Doctors Without Borders/Médecins Sans Frontières

In March, India for the first time issued a ‘compulsory license’ to
override a drug patent on the cancer drug sorafenib tosylate, produced by
Bayer. The move sets an important precedent for access to ARVs that are
unaffordable. China has also just confirmed its mechanism to override

“Our report shows that the newest HIV drugs are now patented in India, the
pharmacy of the developing world, and this blocks the production of more
affordable generic versions that we need for some of our patients,” said
Nathan Ford, Medical Director of MSF’s Access Campaign. “The power balance
has to change as developing countries begin to make use of their rights to
overcome patents when monopoly sellers price their drugs out of reach. For
this reason, we fully support countries like India that are using their new
patent laws to deal with monopoly abuses. If high prices prevent access to
life-saving medicines, they override them.”

The newest ARVs are unaffordable: a triple combination of the three drugs
raltegravir, etravirine and darunavir boosted with ritonavir for people who
have failed a second-line regimen, costs $2,486 per person per year in
least-developed countries and sub-Saharan Africa—nearly 15 times the price
of a first-line regimen. Meanwhile, middle-income countries pay many times
more: MSF’s HIV and TB treatment program in India pays more than $2,147 per
patient per year for just the drug raltegravir; in El Salvador the drug
etravirine alone costs $6,917, while darunavir costs $8,468 per year in

Additionally, over the last two years, lower-middle- and middle-income
countries have been locked out of company discount programmes and are
forced to negotiate prices on a case-by-case basis, which has lead to
higher prices. The *UNTANGLING* report shows that the patient-friendly
one-pill-a-day combination of TDF/FTC/EFV (produced by Merck/BMS/Gilead)
for the last five years has remained at $1033 in lower-middle income
countries, six times more than the generic first-line combination, and
countries locked out of these discounts must pay many times more.

Lower-middle-income and middle-income countries are also increasingly being
blocked from accessing medicines produced under voluntary license
agreements between multinational pharmaceutical companies and generic
manufacturers, where the terms and conditions are largely kept secret. The
report finds that there is no voluntary license agreement for ARVs that
covers all developing countries.

“Multinational companies are trying to give the impression that with
voluntary license agreements, all HIV drug access problems are solved, but
our report shows that some countries are deliberately being left out, and
there are other terms that restrict competition,” said Michelle Childs,
Director of Policy/Advocacy at MSF’s Access Campaign.

Several of the newest ARVs are already priced out of reach because they
have been patented in India, blocking the production of more affordable
generic versions.

Until 2005, India did not grant patents on medicines which allowed free
competition among generic producers. This helped drive prices down by 99%
for the first generation of ARVs, from more than $10,000 per person per
year in 2000 to roughly $120 today.

While the country had to begin granting patents under WTO rules in 2005,
India designed a patent law that is strict about what merits a patent. The
law also allows any interested party to oppose a patent before or after it
is granted. Such patent oppositions have already led to multiple ARV
patents being rejected in India, such as for the drugs tenofovir and

In contrast, South Africa’s law is particularly lax about patenting, with
2,442 pharmaceutical patents having been granted in 2008 alone compared to
just 278 in Brazil for the five-year period of 2003 to 2008.

“As more people need access to newer drugs that are priced out of reach,
countries should take a close and hard look at their patent laws to make
sure that monopolies aren’t being handed out left and right, with dire
consequences,” said Childs. “The fact that countries are putting flexible
mechanisms into place and are using these is a game-changer.”

*MSF provides HIV treatment to 220,000 people in 23 countries.  *

*Highlights from UNTANGLING THE WEB, 15th Edition: *

·        The price of tenofovir-based regimens is now nearly the same (when
combined with nevirapine), or lower (when combined with efavirenz), than
AZT-based regimens, for countries that can access generic versions because
patents do not form a barrier, or where voluntary licences allow access to
generic versions.

·        The fixed-dose combination of TDF/FTC/EFV (produced by
Merck/BMS/Gilead) – which is an adherence-friendly once-a-day pill – has
remained priced at $613 and $1033 per patient per year (ppy) for
lower-income and lower-middle-income countries, respectively, for the last
five years. For middle-income countries, prices can be even higher, as most
companies have eliminated their standardised discount programmes for these
countries, in favour of case-by-case price negotiations.

·        The price of the TDF/3TC/EFV co-pack of two pills to be taken once
a day has come down by 20% since last year, to $113 ppy, making it the most
affordable option of the WHO recommended first-line regimens, with the
added benefit of once-daily dosing.

·        Today’s most affordable second-line regimen (AZT/3TC + ATV/r) is
priced at $399 ppy, down from $442 for last year’s most affordable
combination. This however is still three times more than the most
affordable first-line regimen. For countries where generic versions cannot
be used because of patent barriers or because they are excluded from the
geographical scope of the voluntary licences, the price can be many times

* *

*To access the report online, visit  utw.msfaccess.org*



Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
E: joanna.keenan[at]geneva.msf.org
T: twitter.com/joanna_keenan


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