JOHANNESBURG—After six months of persistent supply problems with the key HIV medicine lopinavir/ritonavir (LPV/r), the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (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 that is a life-line for nearly 10 percent of the country’s approximately 3 million people on HIV treatment. In the majority (65 percent) 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 percent of cases, people were sent away with insufficient supply. According to a consortium monitoring medicine stock outs in South Africa, the stock outs were widespread and acute—about 10 percent of facilities, mostly large district hospitals, had more than 500 patients per facility being affected.
"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 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 percent of 796 responding facilities experiencing an ongoing LPV/r stock out. In over 50 percent 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 countries.
"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 lifesaving 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 finalize 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."