Anti-retrovirals (ARVs) could cost South Africans as little as about R100 a month and local manufacturing of generics could start as early as next month, it was announced on Tuesday.
This follows the Aspen Pharmacare group in South Africa becoming the first drug manufacturer in the world to receive approval from the United States Food and Drug Administration (FDA) to produce generic ARVs.
The FDA gave notice to Aspen on Tuesday morning, the company announced at a press conference in Johannesburg.
Now, the company is waiting for the government to announce the result of its first ARV tender.
”Aspen is well positioned to be a major player in the supply of cost-effective generic ARVs, both in South Africa and in export markets,” said Stephen Saad, Aspen’s chief executive.
Aspen will be allowed to make the most widely used triple-cocktail generic ARVs. This is a combination of lamivudine, zidovudine and nevirapine tablets in conventional adult dosages.
Saad said that depending on which cocktail combination is required, treatment could cost South Africans as little as R100 a month.
”Manufacturing could start as early as February with maybe a four- to eight-week delivery time, depending on the size of the order,” he said.
Where generic medicines are involved in the package, there will be significant discounts, he said.
Tuesday’s approval has further made Aspen the first accredited generic supplier to have access to the US President’s Emergency Plan for Aids Relief (Pepfar) fund, which offers $15-billion to Aids work in developing countries.
It came to the South African company in the face of competition from Asian manufacturers, said Saad.
FDA to review drugs
US embassy health attaché Gray Handley told the press conference that while the drugs in question are not intended for use in the US, the FDA is willing to review them.
This will ensure that they meet the same standards of safety and effectiveness as drugs used by US citizens.
He said the success of the ARV project depends on health-care workers who will support those who come for treatment.
Elaborating on the Pepfar fund, Handley said $9-billion goes to 15 ”focus countries” that bear the brunt of the global Aids burden.
Allocation includes treatment, the training of physicians and nurses, support for voluntary counselling and testing, prevention activities and care for orphans and vulnerable children.
”Of course I think what Aspen is hoping for is that the South African government tender will shine favourably on Aspen, as this will benchmark prices others will be able to look at and base their decision on,” said Handley.
”Drugs are a challenge. They have side effects and require a lifetime commitment. However, there is no reason that Africans should not have full access to ARVs and a full life.
”It will not lead to a solution to the problem but those involved in the problem are now optimistic.”
‘Good news for SA’
”It is good news for South Africa that the US FDA has given its approval to generic ARVs manufactured by Aspen,” said Democratic Alliance spokesperson Ryan Coetzee.
”But this move will only become important to South Africans with HIV when the Department of Health completes the tendering process for the manufacture of ARVs for the national roll-out.
”Moreover, it amounts to recognition by the US that generic ARVs are a legitimate weapon in the war on Aids. After many years of insistence by the US government that it would vigorously oppose the use of generic versions of ARVs, all of which still fall under patent protection, the testing of these generic ARVs is a definitive change in tone,” Coetzee said.
”The DA hopes that this development will inspire the Minister of Health towards more vigorous and energetic implementation of the ARV roll-out.” — Sapa