THE Health Department is redesigning the new antiretroviral tender in the hope of procuring cheaper ARV medicine, amid claims that South Africa pays about 30 percent more than the global rate for the drugs.
The government will start procuring drugs under the new tender from June, and the Clinton Health Access Initiative (Chai) is helping the Health Department design a tender that will enable it to secure cheaper antiretroviral drugs for what is now the world's largest HIV treatment programme.
Last month, the DA's Mike Waters wrote to Health Minister Aaron Motsoaledi asking him to source the drugs overseas if they were cheaper than locally manufactured versions. But the department has long been working behind the scenes to find cheaper sources.
Waters said the previous tender requirement that companies be locally owned meant paying 30 percent more than necessary. "The government is helping the local pharmaceutical industry, but causing the deaths of people who cannot afford to pay for their treatment," he said.
Vishal Brijlal of Chai said there was an urgent need to minimise and control ARV costs and improve the efficiency of laboratory services in South Africa.
Around 40 percent of the HIV/AIDS budget is now spent on ARVs, according to the Treasury.
"It is partially correct to say that South Africa pays too much for ARVs," Brijlal told the Budget and Expenditure Monitoring Forum (BEMF) meeting.
For example, the price of the active ingredients for efavirenz, one of the most widely prescribed ARVs in South Africa, was high when the last tender closed in March, 2008. By May, 2008, it had dropped 45 percent, but South Africa did not benefit from the reduction, said Brijlal.
"We need to ask the question whether the drug company had a moral obligation to sell the drug at the lower price," said Brijlal.
The last tender catered only for price increases, not decreases. New tender conditions are expected to rectify this.
He said that when criticised, drug companies often said governments got access to the drugs at the lowest median international price. South Africa, as one of the world's biggest buyers, should get the lowest price, not the lowest median price, according to Brijlal.
He said Chai was not a drug buyer, but had agreements with 72 countries, and pooling their volumes gave it a powerful negotiating platform. South Africa is not part of this pool.
Chai makes each supplier sign an agreement to deliver a drug at a price no higher than the negotiated ceiling.
Brijlal said recent negotiations would see efavirenz drop by between 35 percent and 40 percent below the current tender price.
South Africa is changing its first-line regimen from April 1 to tenofovir, 3TC and efavirenz. At current tender prices, this would cost the government R4 000 a person a year. The Chai initiative would bring this down to R2 200.
The current regimen of d4T, 3TC and efavirenz costs R2 080 a person a year. Chai can procure this combination at R1 300 (excluding VAT and freight charges).
The new guidelines are poised to remove d4T (stavudine) as a first-line drug because of debilitating side effects including lipo-atrophy, peripheral neuropathy and lactic acidocis. But patients doing well on d4T might be kept on it.
Chai has also helped generic companies develop cheaper active pharmaceutical ingredients.
Brijlal said that if the tender process was transparent the new treatment guidelines could lead to savings.
Brijlal urged clinicians and activists at the BEMF meeting to pay close attention to business relationships between pharmaceutical manufacturers that might prevent some drugs reaching South Africa.
He said lopinavir/ritonavir, which was urgently needed for adult and paediatric HIV, remained expensive and was not available in the required formulations.
For children a heat-stable version needed to be registered urgently as the health system now relied on a solution that required refrigeration.
Another critical drug is the fixed-dose combination that combines tenofovir, 3TC and efavirenz in a single pill that is taken once daily.
This is also not yet available in South Africa, and activists have questioned whether the business relationship between Aspen and Matrix has prevented a much cheaper generic version of the drug being marketed in South Africa.
Commenting on the matter, Aspen CEO Stephen Saad said: "You cannot register the generic until the innovator has been registered - it is not registered."
Saad said their files were with the Medicines Control Council awaiting registration.
However, a council source said Saad's comments applied only to individual products. "If the three separate innovator drugs (or any combinations) are registered, which is the case in South Africa, the fixed-dose combination can be registered. This has happened before."
Dr Andrew Boulle of the University of Cape Town said the tender offered South Africa "an opportunity to get it right, given our enormous purchasing power".
"We should not allow this tender to go ahead unless we get it right. We need to ensure we get the one-pill-once-a -day regimen packaged in adherence-promoting 28-day blister packs with the days of the week indicated. Well-prepared treatment literacy material should be included in the pill packets," he said.
The Treatment Action Campaign said the coming tender must include special provisions that allow for companies to submit bids involving drugs such as the tenofovir-3TC-efavirenz fixed-dose combinations not yet registered here but already approved by stringent drug regulatory authorities such as the US Food and Drug Administration.
The TAC also called on the Health Department to commit itself to procuring available fixed-dose combinations and the council to fast-track the registration of all crucial ARVs and their combinations to ensure a competitive tender.
Anso Thom: Health-e News Service via The Cape Argus,
