South Africa

The OTC and pharma market in South Africa

According to CPC’s projections, South Africa’s phar­ma­ceu­ti­cal mar­ket is expected to increase at a CAGR of 5.8% from 2012 to 2020, by which time its value will have risen in value from US $3.61 bil­lion to US $5.1 bil­lion. This expected fast growth will be dri­ven by the government’s health­care reforms, which include improv­ing access to health­care ser­vices by expand­ing National Health Insur­ance (NHI) cov­er­age to the entire South African pop­u­la­tion, and over­haul­ing the nation’s drug reg­u­la­tory processes to make them faster and more trans­par­ent. These moves, together with the intro­duc­tion of a new reg­u­la­tory agency and efforts to aug­ment eco­nomic growth, will advance the country’s phar­ma­ceu­ti­cal sec­tor and boost for­eign invest­ment.

South Africa is also mod­ernising its reg­u­la­tory struc­ture to speed up drug approvals and increase for­eign invest­ment in the coun­try. Under the old reg­u­la­tory regime, drug approvals took a long time and the process was not trans­par­ent, and this led many Pharma multi-­na­tion­als to con­sider invest­ing in other mar­kets where there was greater clar­ity, more stream-­lined processes, and less risk. To this end, the gov­ern­ment is estab­lish­ing the South African Health Prod­ucts Reg­u­la­tory Agency (SAHPRA) to replace the Med­i­cines Con­trol Coun­cil (MCC). The new body will have a wide range of respon­si­bil­i­ties, includ­ing chipping away at the country’s back­log of drug appli­ca­tions and speeding up the reg­is­tra­tion process from its current five years to one year.