Lance B Sherriff helped in researching this article
The high cost of antiretroviral drugs sold in their own country has forced possibly thousands of HIV positive South Africans to import lower cost generics from Swazi Pharm, a company based in neighbouring Swaziland. Recently, however, South Africa’s Medicines Control Council (MCC) put an abrupt halt to the practice, leaving many patients whose health had stabilized on generic antiretroviral medications, stranded without treatment. Yet many doctors and even South Africa’s Treatment Action Campaign support the MCC action.
“I think the MCC behaved correctly with regard to Swazi Pharm” says TAC’s Nathan Geffen. The advocacy organisation had received complaints about Swazi Pharm months earlier, when the company had switched from supplying generic drugs made by a respected Indian company, Cipla Pharmaceuticals, to cheaper products from companies that could not demonstrate whether their drugs were bio-equivalent to brand name products sold in the West. Geffen had threatened to “go public” about the practice if bio-equivalence data were not made publicly available. The MCC beat him to it, however, after a long investigation into the company’s other questionable dealings — of which most South Africans are still unaware.
But now the problem is what to do for these patients. “Many of Swazi Pharm’s customers had paid in advance for their meds” says Geffen “and they have not received their money back since the shipments stopped.”
“Nothing has been done for these patients,” agrees Dr. Douglas Wilson of Grey’s Hospital in KwaZulu Natal.
One such patient is M. Mashonga (name changed), a domestic worker with HIV who lives with her mother and two children in an informal settlement near Cape Town. Mashonga became aware of her HIV status while receiving TB treatment (provided free in South Africa). Though she was responding to her TB therapy, her health was still deteriorating.
“I also had HIV,” she explains. Earning less than £150 per month, she could not afford to pay for HIV-treatment, but at the same time she was afraid of what might happen to her family if she could not continue working. With help from her employer, she had begun taking Triomune (a one-pill twice daily combination of nevirapine/d4T/3TC) made by Cipla and imported via Swazi Pharm (at a cost of around £35 per month).
Her health was improved dramatically and taking on more work, she was able to raise the money for her next order of Triomune.
But it never arrived.
“I don’t know what to do. That was all the money we had,” she says. She’s tried calling Swazi Pharm but the number has since been disconnected, and only rumours offer an explanation. “I really don’t know what has happened.”
She is not alone. Many other patients and doctors were also importing medications from Swazi Pharm. Only a few are willing to go on the record.
“I had a handful of patients,” says Dr. Eve Sudotsky, who works in the public sector with mostly indigent patients including prisoners. “I have hundreds of patients who need medication, but most can not afford to pay the 500-600 Rand (£45-50) per month to import them. I have five who were buying antiretrovirals from Swazi Pharm who have now been cut off. But many doctors were doing this and most of them have more patients who could afford treatment.”
Dr. Wilson, who previously worked in Cape Town, says that “there were possibly hundreds of patients in that province importing Swazi Pharm drugs, and the practice seems to have been even more widespread in Gauteng and KwaZulu Natal. “We were under the impression that the MCC was turning a blind eye on the practice as long as the drugs came from reputable manufacturers,” say Dr. Wilson.
This turns out not to have been the case, according to representatives from the MCC. The agency had only become aware that doctors and patients were importing antiretroviral drugs from Swazi Pharm in November, 2002. However, the MCC had long been investigating the company for engaging in other illegal practices.
As far back as August 2001, the DOH had received information that medicines sold into Swaziland at export prices were being re-imported illegally into South Africa at prices lower than those at which they were exported. A police investigation led to the arrest of Mr Arshad Ghoor, Managing Director of MagPharm, who has been charged with the illegal importation of unregistered medicines (valued at around R350 000 or £29,000) from Swazi Pharm.
“Africa has a well documented problem with counterfeit medicines,” explains an MCC official who wishes to keep his identity off record. “A counterfeit medicine is one that has had its packaging deliberately and fraudulently changed to hide its true origin. It is not possible to detect a good counterfeit - thus the integrity of the supply chain is essential to ensure the authenticity of medicines. It should be noted that South Africa also has a serious problem with the theft of medicines from the State which are being sold in the rest of Africa.”
"South Africa has no control over the manner in which medicines are manufactured, packaged, acquired, stored or sold in the countries bordering it. Re-imported and sometimes repackaged drugs could be stolen, poor quality, past their expiration date or maybe even fakes."
Investigators continued to watch Swazi Pharm which continued operating even though Magpharm never paid it for the goods, seized by the South African Police Services (SAPS). A sudden cash shortage may explain why Swazi Pharm suddenly began shipping cheaper and possibly counterfeit medications to patients in South Africa.
In November 2002, the MCC became aware of rumours that certain doctors were selling antiretrovirals at discount prices — investigation revealed that they were buying them in Swaziland. The Swazi border was monitored and a number of shipments of medicines from Swazi Pharm to South Africa via couriers were intercepted by customs.
“The products concerned are not registered in South Africa,” said the MCC official. “There is no guarantee of their quality, safety and efficacy or even if they are genuine. One of the products seized was fluconazole (capsules) purportedly packed for Swazi Pharm by "Nicosia, Cyprus". The quality of the labels and package insert points to a really cheap and nasty backyard job.”
At this point, the MCC has blocked all shipments from Swazi Pharm into South Africa. Eight complaints relating to the conduct of the doctors have been laid with the SAPS relating to this second incident.
Dr. Wilson says that he is "bitterly disappointed that corrupt businessmen should target HIV-infected patients and their doctors who are desperate to access antiretroviral treatment... the MCC comes out of this smelling like roses."
Nathan Geffen agrees that “the MCC is absolutely within its rights for stopping Swazi Pharm. The people who suffer most from these unscrupulous business practices are the patients. However, I empathise with people trying to bring lifesaving medications into this country. The fault for the black market trade in antiretrovirals lies squarely with the South African government for failing to provide antiretroviral treatment to people with AIDS.”
The MCC action against Swazi Pharm has received little publicity in South Africa. Most doctors and patients remain unaware of why their drug shipments have stopped, frustrated over their lost money, and anxious about where now to turn for treatment.