Patients can’t get life-saving medicine
Red tape holds up supply and makes survival for sufferers a life or death struggle
JENNA Lowe was a dancer and a swimmer, but now she uses a mobility scooter to get to her matric classes at Herschel, and can’t walk any distance without becoming dizzy and weak.
Every day, the 18-year-old Claremont girl breathes oxygen through a tube, swallows Warfarin to prevent her blood from clotting, and takes imitation Viagra designed to dilate the vessels in her lungs.
But it’s the Bosentan which will help prolong her life.
Bosentan is FDA-approved in the US, but is not available in South Africa, and has to be imported from Switzerland. And it comes at a massive cost: R32 000 a month, and a swamp of essential paperwork.
Jenna is one of some 50 to 80 South Africans living with pulmonary arterial hypertension (PH). And she’s the only one who has access to Bosentan, which she gets thanks to a permit and a special favour from a pharmaceutical import company.
Getting permission from the Medicines Control Council (MCC) to import it is a harrowing process, says Jenna’s mother, Gabi Lowe: “The first time we needed to get permission, it took five months. When you’re looking at a life-threatening illness, five months is a long time.
“All the drugs my daughter needs are FDA-approved, so the question is why are they not registered in this country? People are dying because the figures don’t work out.”
For a drug to be legally available here, it has to be registered with the MCC, a government body.
According to MCC registrar Mandisa Hela, anyone can apply to register a medication, as long as there is a pharmacist or similarly qualified person to take care of the technical aspects of the application.
Asked about the length of time to register new medicines, Hela replied: “It depends on the complexity of the application and the quality of the data submitted.
“New medicines and biological medicines are more complex compared to generic medicines and may take 30 to 36 months and generics 18 to 24 months.”
Only a licensed company is allowed to handle and distribute these medicines.
As Kelly du Plessis, founder of the Rare Disease Society of South Africa, says: “By the time you get the right diagnosis, you don’t have time to wait around for the Medicines Control Council’s approval.”
In 2010, her son Juan was diagnosed with Pompe disease at just 10 months old.
His muscles weren’t devel- oping, so he couldn’t hold his head up or crawl, and kept choking on his food.
An application had already been submitted to the MCC to get the medication for Pompe registered here.
Despite the “significant pressure” Du Plessis put on the suppliers, the registration process was only completed in July last year.
Juan’s weekly treatments cost R2.5 million a year, but now that the medication is registered in South Africa, medical aid schemes are obliged to cover this cost. Pompe disease is listed as a Prescribed Minimum Benefit – a safety net afforded to few rare conditions.
“Most rare diseases aren’t listed as Prescribed Minimum Benefits because no one has even heard of them,” says Du Plessis, who has turned her attention to helping others with rare diseases.
But this doesn’t always benefit patients either.
Denneys Niemandt, who suffers from pulmonary hypertension and is chairman of the Pulmonary Hypertension Association of SA, explained: “Before my medicine was registered in South Africa, I got it free of charge on a compassionate basis. The moment it was registered I had to pay R6 000 per month.”
Even so, registration is the best hope for Niemandt and his community of pulmonary hypertension patients.
He is busy putting together an advisory body of 11 specialists to try and speed up the process.
“The first step would be to legalise the medication and get it at a cost that is viable,” he says, “and then also get the medical aids to buy into it so that they can cover it.”
Niemandt, just like Du Plessis and the Lowe family, has been continually frustrated by the long line of legal hoops they have to jump through for the life-saving medicine.
“People in Europe told us that we can get a container full of medication free of charge,” says Niemandt, “but because of medical red tape, if that container lands in Cape Town, it will be confiscated and destroyed.”
Hela also disputed the reputed high costs of register
ing new medicines, saying these varied from R11,500 for additional strength medicine
applications to a high of R53, 000 for new chemical
medicines. Before treatment even begins, though, there is the monumental difficulty of diagnosis.
“A GP can’t just diagnose you,” says Niemandt, who spent nearly R40 000 on the testing procedures which detected his pulmonary hypertension. “It’s very expensive and also very complicated.”
The cost of testing for rare diseases continues to prevent the vast majority of sufferers from ever being diagnosed.
Meanwhile, Jenna and hundreds of other rare disease patients are running out of time.
“I’m concerned about whether I’ll always have a secure supply chain,” she says. “Knowing you’re the only one on a drug and you can’t just pop down to the pharmacy and get more is daunting.”
To raise the funds she needs to import medication from Switzerland, Jenna wrote a song called I Need More Time , which her younger sister Kristi recorded with the help of jazzy pop duo Goodluck. It is available for download on iTunes.
LIFE-THREATENING: Jenna Lowe, right, with her sister Kristy. Jenna has pulmonary arterial hypertension, a rare lung condition. A life-prolonging drug she requires is not available in South Africa and costs a crippling R32 000 a month to import.