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[e-drug] MSF: Middle-income countries flex muscles to overcome patents

E-DRUG: MSF: Middle-income countries flex muscles to overcome patents
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Press release from M�decins Sans Fronti�res (MSF) issued at the International 
AIDS conference:

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/M�decins Sans Fronti�res (MSF), UNTANGLING 
THE WEB OF ANTIRETROVIRAL PRICE REDUCTIONS.

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 patents.

�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 Georgia.

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 lopinavir/ritonavir.

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 higher.

To access the report online, visit http://utw.msfaccess.org/downloads/documents
More info at  http://utw.msfaccess.org 
 
Regards

Joanna Keenan
Press Officer
M�decins Sans Fronti�res - Access Campaign
E: joanna.keenan@geneva.msf.org
T: twitter.com/joanna_keenan

msfaccess.org
twitter.com/MSF_access
facebook.com/MSFaccess

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