Medicines nightmare: Delayed approval of life-saving drugs could cost lives

The sick are paying inflated prices for treatments and are being denied access to new drugs because approval for their use in this country is being held up in a regulatory backlog that amounts to a bureaucratic disaster.

It takes three to five years on average for a medicine - pain killers, sleeping tablets, contraceptives and even treatments for life-threatening diseases - to be approved by the Medicines Control Council.

One medicine, the only treatment for a rare disease, has been waiting to be registered for seven years, said Kelly du Plessis, CEO of the Rare Disease Organisation.

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As a result, parents of children who need it to stay alive have to apply to the council every six months for permission to import it, sometimes leading to delays in treatment.

"These people die a painful death by suffocation [if not treated]," said Du Plessis.

She asked The Times not to name the medicine or the disease because patients feared their access to the treatment would be denied in reaction to the publicity.

Du Plessis said a year of treatment with the drug cost R3-million and Discovery Health was the only medical aid that would pay for it because medical aids are not obliged to pay for unregistered medicines.

She said that in one instance she phoned the Medicines Control Council every working day for six weeks to ask for the extension of a licence to import a drug for the treatment of Wilson's disease - a genetic condition leading to copper build-up in the body - "but the phone just rang".

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"The council expects us to send faxes!" said Du Plessis.

The Wilson's disease patient became desperate when she could not get her medication and flew to the UK to buy it.

"People are denied their constitutional right to medication because of the bureaucratic disaster that is the Medicines Control Council," said Du Plessis.

Fourteen years ago, a fast-track process was set up so that a medicine needed urgently could be registered in nine months.

But the fast-track process for new, important drugs takes between 12 and 18 months, said Stavros Nicolau, of drugsmaker Aspen.

In case of "real emergencies", he said, the council can be "very receptive" and register a new drug in a few months.

The council's registrar, Joey Gouws, said it had a backlog of routine applications going back to 2012 because of the number of products waiting to be fast-tracked.

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This meant a five-year wait for a non-urgent application.

Gouws said 7900 products were awaiting registration and, of these, 3500 were under review by the council and 4400 were waiting to be allocated to evaluators.

Nicolau said the council had too few expert evaluators.

Research by the University of the Western Cape's emeritus professor of public health, David Saunders, published in The Conversation, found that the delays in granting approval are partly caused by multiple applications for generic versions of the same drug.

Saunders called for a limit on the number of applications that can be made for a generic medicine.

Because South Africa is used to register medicines to be sold elsewhere in Africa, sometimes manufacturers of generics register the same product five times for sale in five jurisdictions.

Nicolau said drugs could also be resubmitted for evaluation because of a change of supplier of an ingredient or a change in the manufacturing process.

It can take 24 months merely to get approval to move production of a drug to another factory run by the same company, leading to a shortage of the drug.

In 2015, there were many shortages of antibiotics, painkillers, stomach medicines, cough syrups and anaesthetics in South Africa.

The delays in new drugs coming to market hits consumers' pockets.

"Generic medicines are up to 80% cheaper than branded equivalents but are used by only 56% of the population," said Eric Roos, CEO of Pharma Dynamics, a generic medicines company.

"The savings would be massive if more generics were brought to market."