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There are 16000 medicines on the waiting list to be approved for use in South Africa, in a backlog more than six years long - forcing patients to import the drugs they need from overseas at great personal cost.

Just over 8000 of these are applications for new registrations of medicine which is available and in use for patients overseas, but not locally. Half of these drugs have been sitting on the waiting list for more than five years.

Just last month, a revolutionary drug for breast cancer was finally approved for use in South Africa. Its application had been waiting for approval for six years, since 2013. During this time, patients elsewhere in the world were being successfully treated with it.

Visiting Brazilian oncologist Dr Carlos Barrios highlighted just how outrageous this is.

“In the US, it generally takes around six months. In Europe, around a year. Why in South Africa did it take six years after American patients are getting this benefit, for South African patients to get that same benefit?

“It’s not reasonable to have such a long approval process. Six years is far too long.”

Portia Nkambule, acting chief executive of the South African Health Products Regulatory Authority (Sahpra), said they were committed to clearing the application backlog within the next two years. Sahpra was established in February last year to replace the Medicines Control Council, and inherited the backlog of 16000 applications.

“Given the size and history of Sahpra’s inherited backlog, a pragmatic approach to its clearance requires unprecedented collaboration amongst all stakeholders in South Africa’s health system,” Nkambule said. “Clearing the backlog must be a shared responsibility between Sahpra, the private sector and the government and will require trade-offs and compromises from all parties. This will lay the foundations for establishing an effective, efficient and sustainable health products regulator.”

One group of patients who are heavily affected by the backlog is those with rare diseases, said Kelly du Plessis, chief executive of Rare Diseases SA.

“There’s no doubt that Sahpra has dropped the ball in many cases, and a massive overhaul is required,” Du Plessis said. “They have started to implement changes, but materially that still has a really negative impact for people who need the drugs today. It makes no difference to people who are red-taped from getting their drugs right now.”

She explained that if a drug is not registered with Sahpra, then the patient can only access it through a Section 21 application by their doctor, which allows them to import it from overseas - but this process can be financially crippling.

“You can still access the drug, but unregistered medication is automatically excluded from reimbursement from a medical aid perspective,” Du Plessis said. “The other issue is that you can’t access a Section 21 product where there’s a registered alternative of the same molecule.”

For example, there is a registered drug for pulmonary hypertension in SA that costs R25000 per month. Many medical aid schemes won’t cover that whole amount and the patient ends up with a large co-payment. However, there is a generic of the same drug available overseas that costs R6000 per month - but you can’t apply for it through Section 21, because the same molecule is already registered in South Africa under a different brand name.

“It’s holding up the access to affordable medication,” Du Plessis said. “We are the most affected by these issues, because of the financial cost. We have an R80000-per-month drug and no alternative.”

Sahpra has released a draft document that paves the way for exemptions from this rule - but it’s in early phases and not yet implemented, she said. She said that many cystic fibrosis patients were battling to access their treatment because it’s still unregistered, while pulmonary hypertension patients are battling to access second-line treatment because of the generic issue. Those suffering from primary immunodeficiency conditions are also struggling to find reliable treatment thanks to a blood product that has been “held up for years in registration”.

Sahpra’s game plan to address the backlog begins with striking as many drugs as possible off the waiting list. All applications lodged in 2013 or earlier will be automatically erased from the list unless the pharmaceutical company applicant notifies Sahpra that they are opting in.

“These older applications are more likely to be out-of-date, in an old format, of less commercial interest to the industry and/or of less importance to public health,” Nkambule said. “If no ‘opt-in’ is received, these older applications will be eliminated from the backlog.”

Sahpra also plans to segment and prioritise remaining applications, as well as design and implement new models for evaluation to ensure smooth running of the approval process in future.

“Public health need, according to government priority therapeutic areas and unmet medical need, will determine the order in which applications will be evaluated.”