[Ip-health] South Africa Should Override Patent on Key HIV Medicine After Widespread Stock Out Problem: MSF

Joanna Keenan joanna.l.keenan at gmail.com
Tue Oct 27 03:35:37 PDT 2015

South Africa Should Override Patent on Key HIV Medicine After Widespread
Stock Out Problem

*Patients sent home without drugs while pharmaceutical company AbbVie
refuses to license patent to generic companies  *


*Johannesburg, 27 October 2015*—After six months of persistent supply
problems with the key HIV medicine lopinavir/ritonavir (LPV/r), the
international medical humanitarian organisation Médecins Sans
Frontières/Doctors Without Borders (MSF) urged the South African government
to put the public’s health first and override pharmaceutical company
AbbVie’s patent with a ‘compulsory licence,’ in order to allow generic
versions of LPV/r to be used in the country.

AbbVie, which markets LPV/r as ‘Aluvia’, is the sole supplier in South
Africa for a medicine which is a life-line for nearly 10% of the country’s
approximately 3 million people on HIV treatment. In the majority (65%) of
LPV/r stock out cases reported by patients or health care workers in South
Africa since April 2015 to date, patients were sent away with no medicine,
and in 35% of cases, people were sent away with insufficient supply.
According to a consortium monitoring medicine stock outs in South Africa,
the stock outs were wide spread and acute – about 10% of facilities, mostly
large district hospitals, had more than 500 patients per facility being

“People are being turned away from clinics without medicine and are being
asked to purchase it on the private market. Many simply cannot afford it
and this causes distress,” said Dr. Amir Shroufi, MSF’s Deputy Medical
Coordinator in South Africa. “Alarmingly, people without access to
treatment over time can become resistant to lopinavir/ritonavir and require
more expensive medicines – they also risk falling sick and could even die.”

To assess the current situation, a separate rapid survey was conducted in
October, with 12% of 796 responding facilities experiencing an ongoing
LPV/r stock out. In over 50% of these cases, the duration of the stock out
was longer than 30 days.

Several producers of LPV/r, other than AbbVie, have quality-assured generic
versions of the drug registered in South Africa, or have filed for
registration of other ritonavir-based treatments that the World Health
Organization suggests could be used as an alternative to LPV/r. AbbVie’s
patents prevent the use of generic versions of LPV/r in South Africa, and
the company has refused to provide voluntary licences to the Medicines
Patent Pool which could improve security of LPV/r supply in developing

“Since AbbVie has refused to act appropriately to ensure that patients
obtain the medicines they need to stay healthy and alive, the South African
government should be compelled to take action,” said Dr. Shroufi. “The
government should take steps to ensure that the company’s patents no longer
block people from getting this essential drug from other suppliers.”

LPV/r is protected by multiple patents in South Africa, but the Department
of Health has the authority to allow generic manufacturers to supply
patented medicines when patent holders like AbbVie are not meeting demand.
The process of issuing a compulsory licence has been carried out in
numerous countries, such as Brazil and India, to improve access to
life-saving medicines.

“With thousands of lives hanging in the balance, the challenges of
overcoming LPV/r patent barriers to resolve the current crisis must not
prevent the government from taking action. Many of the patent-related
problems that have led to shortages of LPV/r could have been avoided if
South Africa stopped blindly handing out patents, and had more pro-public
health laws in place,” said Catherine Tomlinson, of MSF’s Access Campaign
in South Africa. “If South Africa examined patent applications, LPV/r might
not have been granted multiple patents for a prolonged patent monopoly, and
if the process for issuing compulsory licences were less onerous,
alternative suppliers could have been on the market years ago.”

A process to reform South Africa’s patent law has been underway at the
Department of Trade and Industry (DTI) since 2009. Two years after the
public comment period closed on a draft national intellectual property
policy, the DTI has failed to finalise it or embark on proposed reform of
the Patents Act.

“MSF calls on the government to take action now: issue a compulsory licence
so generic versions of lopinavir/ritonavir can be imported or produced
in-country,” said Tomlinson. “The South African government must urgently
amend the country’s patent laws so people don’t go without the medicines
they need in the future.”


Today, Doctors Without Borders released a short video featuring Thandi
Shabangu and Khaya Mkhize*, two patients affected by the LPV/r stock outs.
“I went to the clinic, they told me, 'no, we don’t have Aluvia, so you’re
supposed to go to the chemist to buy [it]’… If now my pills are finished,
what am I going to do? [Because] I don’t have money,” said Shabangu. She
fears how the stock outs will impact on her health and treatment, explaining
, “The problem is very big… because it’s life and death, if you don’t drink
your Aluvia you are going to resist.”


* At his request, Mkhize has been given a pseudonym to protect his anonymity

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: @joanna_keenan


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