As far as the regulation of medicine is concerned, the local pharmaceutical industry has been long-suffering, waiting anything from two to seven years to register new medicines and clinical trials.
It’s been an absolute nightmare. Just ask any CEO of the 26-member companies of the Innovative Pharmaceutical Association of South Africa (IPASA) – 99% will say this is their biggest challenge, says CEO Dr Konji Sebati. “With every delay there is a patient who suffers.”
However, with the South African Health Products Regulatory Authority (SAHPRA) officially in place as of June 1, she hopes this debacle will come to an end. The authority takes over from the Medicines Control Council (MCC) – which has played this role since 1965 and ceased to exist on Wednesday.
“The MCC found it difficult to work through the number of applications it received for new medicines and clinical trials, which quite often resulted in a prolonged period of time before a new product was registered,”explains Suvasha Kander, Ashburton Investments fund manager, adding that the main reason for this was its use of a part-time team of expert reviewers.
SAHPRA is now responsible for the regulation of medicines, medical devices and radiation control. It’s hoped the entity, which now sits outside of the Department of Health (DoH), will gradually improve turnaround times for applications and priority products. In a recent budget vote speech deputy minister of health Joe Phaahla expressed the desire that by 2019/20 about 75% of applications should be approved within three months.
IPASA is perhaps more realistic, suggesting that the new authority brings with it expedited registration, but still-rigorous screening processes for each application, preferably within six to 18 months.
Werksmans Attorneys director Neil Kirby isn’t sure this new body will bring any significant change for pharmaceuticals. “A rose by any other name, is still a rose,” he suggests drily.
On the other hand, for other industries such as those supplying medical devices (including in vitro devices), complementary medicines and supplements, it’s a major shift.
The background to the appointment of a new regulator is the Medicines and Related Substances Amendment Act (2008), which came into operation on June 1, 2017. It made provision for the establishment of SAHPRA, and the regulation of medical devices, complementary medicines and supplements.
“This is the first paradigm shift we’ve seen in medicines legislation in SA in about a decade,” says Kirby.
This is a significant move, because up until now these industries have been largely unregulated. Medical devices, complementary medicines and supplements are now directly controlled by SAHPRA, and as such regulated as much as medication is.
This has pros and cons. “For [these industries] it would mean first and foremost formal regulation – making sure that licences and registrations are in place and, unfortunately, the regulatory burden that comes with that … It’s a complicated piece of legislation. I hope that there is a capacity from the regulatory point of view to handle that degree of query, as well as the actual licensing,” says Kirby.
At this point there is no insight into how the current application backlog will be resolved.
The authority will only be partly funded by government, with about 70% of funds coming from industry bodies, says Pharma Dynamics CEO Erik Roos. “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.”
Kander agrres, saying the ability to retain fees generated from applications would enable it to better remunerate staff. “It is also expected that the staff complement will increase. This should bode well for the pharmaceuticals industry by reducing the time taken to receive approval for new products provided the dossier submitted is of high quality.”
Role players are also hoping that the new regulator will keep an open mind with regard to innovative medicine.
Structure and funding
According to the Act, SAHPRA is an organ of State but outside the public service; a juristic person subject to the Public Finance Management Act (PFMA), and the authority and its CEO are accountable to the minister of health.
“As it’s subject to the PFMA, it may be that there are more funds available to it than those derived from the DoH budget, which in turn might mean that it has access to greater and more efficient resources,” says Kirby. “Time will tell.”
The pharmaceutical sector is hopeful that the new body, which should be fully functional by 2018/19, will streamline processes to effectively deal with the backlog of registrations and fast-track the approval of essential medicines, which is long overdue, adds Roos.
The Department of Health had not responded by publication.
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