Pa­tients can’t get life-sav­ing medicine

Red tape holds up sup­ply and makes sur­vival for suf­fer­ers a life or death strug­gle

Weekend Argus (Saturday Edition) - - NEWS - CHELSEA GEACH chelsea.geach@inl.co.za

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.

PIC­TURE: DAVID RITCHIE

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.

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