|
 Delays for hundreds of medicines have kept the latest treatments off
South African shelves and hampered the fight against cancer, heart
and other diseases in a country which also has more people receiving
anti-retroviral drugs (ARVs) than anywhere else in the world.
Besides improving access to life-saving medication, analysts say the
South African Health Products Regulatory Authority's (SAHPRA)
proposal could help boost the revenue streams for companies
competing in the $3.8 billion-a-year market.
"It's the first time South Africa 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 told Reuters.
"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,
chairwoman of SAHPRA's board.
Talks with industry on cost implications, procedures and schedule
for implementation are ongoing, 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," spokeswoman 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.
[to top of second column] |
South Africa's pharmaceutical market is forecast to grow at a
compound annual rate of 7.3 percent over the next decade, reaching
87.5 billion rand ($7.3 billion) by 2027 from 45.4 billion rand 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 prioritize treatments that meet public health needs and
potentially reduce prices by boosting competition and licensing
cheaper generics.
"SAHPRA will prioritize the review of generic medicines to encourage
market competition and improve affordability, but once market
saturation has occurred, there will not be further prioritization,"
Rees told Reuters.
Africa’s most industrialized economy 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
the HIV virus.
Industry body IPASA, which represents just under half of South
Africa'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," said Dr Konji Sebati, chief
executive of the Innovative Pharmaceutical Association South Africa
(IPASA).
(Editing by Ed Stoddard and Mark Potter)
[© 2018 Thomson Reuters. All rights
reserved.] Copyright 2018 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content. |
