Doctors Without Borders wants the South African government to issue a landmark compulsory license to allow generic manufacturers to come to the aid of thousands of HIV patients in need of Lopinavir/Ritonavir (LPV/r).
“People are being turned away from clinics without medicine and are being asked to purchase it on the private market," said MSF’s Deputy Medical Coordinator in South Africa Dr. Amir Shroufi in a statement on Tuesday.
“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,” he warned.
The critical second-line HIV drug, supplied by pharmaceutical company AbbVie, has been in short supply for the past six months and is affecting thousands of patients countrywide.
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 affected.
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.
The demand for LPV/r will continue to grow especially with the government's aims to scale up access to HIV treatment, noted MSF.
"As the country with the largest global demand for LPV/r, South Africa cannot rely on individual pharmaceutical companies if it wants to secure adequate supplies of this and other HIV treatments.
"While generic versions of LPV/r are already pre-qualified by the World Health Organisation, with some of these suppliers actually registered in South Africa, AbbVie holds exclusive patents on LPV/r."
MSF said this is preventing generics from being produced locally or imported into South Africa until 2028, which is when AbbVie's numerous patents on LPV/r end.
“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," said Catherine Tomlinson of MSF’s Access Campaign in South Africa.
She said that 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.
“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.
Watch this short video about two patients affected by the LPV/r stock out:
For any patient currently suffering from stock outs of Lopinavir/Ritonavir or any other medicine, contact the Stop Stock Outs Project on 084 855 7867 (SMS, Please Call Me, Phone, Whatsapp). You can also anonymously report medicine shortages by sending a mail to firstname.lastname@example.org
Image: Pills spilling out of pill bottle from Shutterstock