[Ip-health] IP Watch IPRs An Issue In Latest HIV Treatment Monitoring Test, Group Says

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Wed Dec 11 00:39:32 PST 2013

IP Watch
 IPRs An Issue In Latest HIV Treatment Monitoring Test, Group Says
Published on 10 December 2013 @ 7:18 pm
By William New, Intellectual Property Watch

CAPE TOWN, SOUTH AFRICA – Intellectual property rights represent a hurdle
to lower-priced, high quality tests of HIV treatment monitoring in
developing countries, public health group Médecins Sans Frontières (MSF,
Doctors without Borders) said today.

The “gold standard” test for HIV treatment monitoring is “viral load
testing,” according to MSF, a way to test the amount of HIV virus in the
patient’s blood to make sure treatment is working and address any problems
with adherence or treatment failure.

But due in part to intellectual property royalties, prices of viral load
tests – which are the norm in developed countries – are too high for many
in developing countries to obtain, according to preliminary data from MSF.
The HIV monitoring test most commonly used today is based on “CD4” cell
response, which reveals problems much later than viral load.

The World Health Organization has recommended the use of one viral load
test once a year for each person on treatment.

Viral load testing measures how many copies of the virus are in the blood,
which indicates how well the virus is being suppressed by the
antiretrovirals. For people doing well with their treatments, the test
ideally shows an “undetectable” level of virus in the blood (below the
lowest level of detection in the test).

MSF is among the hundreds of health workers and others in Cape Town for the
7-11 December International Conference on AIDS And STIs In Africa (ICASA).

MSF is working to scale up viral load testing in numerous countries, and
found that prices for these tests currently ranges from about US$25 to $44,
which is considered expensive in poor countries. The Clinton Health Access
Initiative has negotiated a rate of under US$11 per test in Kenya.
Intellectual property costs have been calculated to be between 19-63
percent of costs.

A six-country survey by MSF showed that prices of roughly US$17-$29 per
test, including implementation, could be obtained if countries had access
to lowest price available. The group called for related IP to be licensed
at a lower cost when sold to low and middle-income countries.

MSF found that costs could go even lower based on analysis of costs of
materials required to run each test. It showed estimated costs of
manufacturing reagents and consumables – which account for some 75 percent
of running a test – to be as low as US$1.60 – $4.50 for the three most
commonly used tests in Africa. This does not include IP costs.

Price was also found to be dependent on the volume of tests run, MSF said,
so it is encouraging global health actors, such as the Global Fund for HIV,
Tuberculosis and Malaria, PEPFAR and countries themselves, to negotiate
lower viral load prices by pooling their procurement. It should also be
ensured that viral load instruments are used at maximal capacity to lower
price per test.

MSF analysis showed IP costs as a percentage of the total viral load test
costs to be:

Lab-based tests:

Abbott 63%
Roche 29%
BioMerieux 0%
Cavidi 0%

Point-of-care tests:
Alere 24%
Diagnostics for the Real World 26%
Wave 80 Biosciences 19%
Lumora 21%

“Looking ahead to the development of new viral load tests, global health
actors should support strategies, such as pooling of patents from third
parties, with reasonable royalty payments, in order to enable the
development of open diagnostic platforms and to ensure affordability,” MSF
said in a brochure.

“If we want to close the gap between rich and poor countries when it comes
to making sure people’s HIV treatment is working, we need to see the price
of viral load testing come down fast,” Sharonann Lynch, HIV Policy Advisor
for MSF’s Access Campaign, said in the press release. “The big agencies
paying for global HIV treatment – the Global Fund and PEPFAR – need to wake
up and see the potential they have to push viral load test prices down and
into the reach of countries affected by the epidemic.”

The MSF press release is available here.

The MSF issue briefs are available here and here.

Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org
T: twitter.com/joanna_keenan


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