Industry sceptical as new health regulatory body introduced

THE introduction of a new regulatory board for health products in the country has been met with mixed feelings in the medical fraternity.

Some health professions were sceptical about the efficiency of the new regulatory board that has replaced the Medicines Control Council (MCC).

Last week, the South African Health Products Regulatory Authority (SAHPRA) became the new governing body for health products.

The role of the Medicines Control Council was to apply standards laid down by the Medicines and Related Substances Act, (Act 101 of 1965) which governs the manufacture, distribution, sale and marketing of medicines.

The prescribing and dispensing of medicines is controlled through the determination of schedules for various medicines and substances.

SAHPRA is set to have a much wider mandate than the MCC that includes the regulation of medical devices and complementary medicines.

MCC has received criticism for being unable to cope with the volume of applications it receives for new medicines and clinical trials, and takes up to three years to register new products.

Acting registrar at the MCC, Joey Gouws, said the MCC depended on a part-time team of expert reviewers, a model that was in line with international best practice in 1965, but is now hopelessly out of date.

East London doctor Siya Bungane said: “We can only hope that things will improve. Changing the name will not make the people more efficient. I do not think it is going to make any difference.

“At the moment, there is a problem with health in South Africa.”

The South African Medical Association’s Dr Mzukisi Grootboom echoed Bungane about being “hopeful”.

“On paper it is a good move. There are many supplements that are on the market and they are not registered and this new body is said to have good quality control,” he said.

“What is envisaged is great if it will be implemented as such.

“The difficulty is that there are many independent bodies that look good on paper but in reality nothing happens. Implementation is key,” Grootboom said.

According to Erik Roos, chief executive of Pharma Dynamics – a leading generics medicines company – SAHPRA could usher in a new and much more effective era for the pharmaceutical sector as the MCC has struggled to cope with the volume of applications for new medicines and clinical trials.

“SAHPRA’s new structure will follow a similar model to the US Food and Drug Administration (FDA) in that it will be more independent than the MCC.

“Another benefit is that it will only be partly funded by government, with approximately 70% of funds coming from industry bodies,” he said.

“This will not only enhance the entity’s ability to attract and retain the necessary skills and resources it requires to function optimally, but is critical to its success.”