The country's patent law is yet again under the microscope in light of World Aids Day and following the recent shortage of HIV medicine Lopinavir/Ritonavir (LPV/r), which is a life-line for nearly 10% of the country's approximately 3 million people on HIV treatment.
The Fix the Patent Laws (FTPL) coalition, led by the Treatment Action Campaign (TAC) and Doctors Without Borders (MSF), has been campaigning for reform of South Africa’s patent laws to prevent abuse of patent monopolies by pharmaceutical companies since 2011.
The government was recently called on to issue a landmark compulsory license to allow generic manufacturers to come to the aid of thousands of HIV patients in need of LPV/r. This after the critical HIV drug was in short supply for over six months affecting thousands of patients countrywide.
Pharmaceutical company AbbVie holds exclusive patents on LPV/r, which is sold as Aluvia in South Africa. The patent prevents generics from being produced locally or imported into South Africa until 2028, which is when AbbVie's numerous patents on LPV/r end.
Keeping the virus under control
MSF Deputy Medical Coordinator in South Africa Dr Amir Shroufi explained to Health24 the importance of LPV/r.
"Most adults and adolescents who become resistant to the standard, first line, treatment that most people in South Africa take will be moved to LPV/r, a second line antiretroviral medicine, in effort to keep the virus under control and so keep them healthy."
He added that LPV/r is also recommended as a first line treatment for young children starting Antiretroviral Therapy. "Many children living with HIV need to be able to get this medicine to stay well."
Shroufi also pointed out the many dangers of supply interruption of LPV/r on patients.
"Although resistance to LPV/r is not currently too common, it is very important to try to prevent it becoming more common because once patients become resistant to this medicine their options for treatment become much more limited, expensive and harder to obtain."
He said with time, the immune system of people who stop taking this medicine will become weak as the amount of virus in their body increases. "Opportunistic infections will take advantage of this, and so such people will be at risk of becoming sick, and in some cases this sickness could lead to death."
When a person begins a new antiretroviral medicine they are told that they must take that medicine every day to stay alive, said Shroufi.
More trips to the clinic
"We have spoken to people who couldn't obtain their medicines due to stock outs and it is understandably distressing to them, not be able to get something they know they need in order to stay alive; this can also lead to people losing faith in the system."
Shroufi noted that being turned away with little or no medicine also meant more trips to the clinic and that each unnecessary visit has a financial cost that for some means other necessities cannot be afforded. "For some people, particularly those who have to pay a lot to reach clinics by public transport, it may leave them unable to collect their medicine when it eventually becomes unavailable."
He warned that these situations risk people becoming lost to the system, potentially leading to long periods without treatment and so leading to sickness.
Speaking to Health24 in a telephonic interview from Dubai, AbbVie spokesperson Ahmed Negm said the company is committed to help improve the lives of HIV patients in South Africa.
"The shortage of LPV/r was not because of AbbVie not being able to meet the contractual obligation, but because there was an increase in demand for the medicine."
Negm assured Health24 that AbbVie has since ramped up its manufacturing capacity supplying in excess of what is needed.
Catherine Tomlinson of MSF's Access Campaign in South Africa told Health24 that under section 4 of South Africa's Patents Act, a government official may issue a government use license to allow for the manufacture and use of generic products for public purposes such as for use in the public healthcare sector.
Complexity and lack of clarity
"If an agreement of the conditions of the license cannot be made between the government and the patent holder then the Commissioner of Patents [a High Court judge] must set conditions of the license. Under section 56 of SA's Patents Act, government and other interested persons can apply to the commissioner of patents for a compulsory license."
While South Africa’s laws currently allow for the issuing of government use and compulsory licenses, these types of licenses have never been issued, said Tomlinson.
She said this is in part due to complexity and lack of clarity in law for issuing government use and compulsory licenses.
Tomlinson recommended to ensure more workable and expeditious procedures for granting government use and compulsory licenses, South Africa should reform the Patents Act to:
1. Adopt a simple, expeditious administrative procedure for hearing applications by government (or other individuals) for these licenses
2. Clarify royalty rates and set time periods for negotiations
3. Explicitly prevent stays of operation of licenses during hearings on the application (i.e. prevent injunctions from delaying the use of these licenses)
"As a member of the World Trade Organisation, South Africa is required to uphold minimum standards of intellectual property protection as defined by the international Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). This includes granting 20 year patents on medicines. However, South Africa also has significant flexibility under TRIPS to amend national legislation, in order to improve access to medicines."
Tomlinson said reforms could include the government taking measures to limit abusive patents being granted on applications that don't meet patentability criteria.
"At the same time, government could establish easier procedures for overcoming legitimate patent barriers by issuing compulsory of government use licenses, when medicines are unaffordable, unavailable, or not adapted for patient needs."
According to Tomlinson it is estimated that 80% of patents granted in South Africa do not meet the country’s patentability criteria. "This is largely due to the fact that patents are granted without substantive examination of applications to ensure that patentability criteria are met."
End to excessive patenting
The FTPL campaign wants the government to remedy shortcomings in South Africa’s current intellectual property legislation that facilitate abusive patenting of medicines – at the expense of affordable access.
A process to reform South Africa's patent law has been underway at the Department of Trade and Industry (DTI) since 2009. However, 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.
"Ultimately what we want to see is an end to excessive patenting that stops generic companies from making medicines well after the initial 20 year patent period is up," TAC Senior Researcher Lotti Rutter told Health24.
"This kind of behaviour is an attempt to squeeze as much money out of a medicine as possible."
She said the reality for millions of people across the country is that they suffer without access to important medicines for longer.
"TAC calls on the Department for Trade and Industry to urgently finalise the stalled National Policy on Intellectual Property that calls for reform into our patent laws that would ensure that these kind of abusive practices don't occur."
The DTI did not respond to Health24 for comment.