‘Backlog fee’ would speed up registration of drugs in SA, industry body says
South African drug makers may be asked to pay a "backlog fee" to help clear a pipeline of medicines waiting years for approval, according to a proposal being considered by a new industry regulator.
Delays for hundreds of medicines have kept the latest treatments off South African shelves and have hampered the fight against cancer, heart disease and other illnesses, in a country that also has more people receiving anti-retroviral (ARV) drugs than anywhere else in the world.
Besides improving access to life-saving medication, analysts say the South African Health Products Regulatory Authority’s (Sahpra’s) proposal could help boost revenue streams for companies competing in the $3.8bn-a-year market.
"It’s the first time SA offers this and we would support a backlog fee, provided it is performance-driven," said Stavros Nicolaou, senior executive for strategic trade at Aspen Pharmacare.
Sahpra wants to cut the backlog and allow the regulatory assessment of all products in an "achievable but ambitious" timeframe, the authority said.
"As part of this process, Sahpra is also exploring other potential sources of revenue, including a backlog fee to … speed up the registration of products in the current backlog," said Helen Rees, chairperson of Sahpra’s board.
Talks with the industry on cost implications, procedures and the schedule for implementation were continuing, she said.
Adcock Ingram said it was keen to discuss Sahpra’s proposal to expedite reviews of its treatments.
"Adcock Ingram currently has more than 250 dossiers awaiting approval," spokesperson Kavitha Kalicharan said.
The company has waited up to seven years for a regulatory decision on some of its products, she said, and speeding up the process could bolster its prescription division.
SA’s pharmaceutical market is forecast to grow at a compound annual rate of 7.3% over the next decade, reaching R87.5bn by 2027 from R45.4bn now, according to BMI Research.
Focus on cheaper generics
Replacing an apartheid-era Medicines Control Council lacking enough funds and expert staff, Sahpra will, for the first time, refer to prior reviews from other regulators when registering drugs and medical devices.
It will also prioritise treatments that meet public health needs and potentially reduce prices by boosting competition and licensing cheaper generics.
"Sahpra will prioritise the review of generic medicines to encourage market competition and improve affordability, but once market saturation has occurred, there will not be further prioritisation," Rees said.
SA has a history of pushing to cut the prices of vital medicines, including winning concessions from big pharmaceutical firms to reduce the cost of ARVs used to control HIV.
The Innovative Pharmaceutical Association SA (Ipasa), which represents just under half of SA’s pharmaceutical private sector, said that while generic medicines were good for bringing prices down, it wanted to avoid perceptions of bias.
"The government should not myopically just want to push generics at the expense of branded medicines," Ipasa CEO Dr Konji Sebati said.