7 June 2012

South Africa: Addressing Tenofovir Shortages

The inability of contracted pharmaceutical companies to produce enough of the antiretroviral drug, Tenofovir, has forced the Health Department to increase the number of manufacturers that can produce the medicine in the face of worrying shortages.

The Health Department has directed provinces to order Tenofovir from two additional suppliers after the two pharmaceutical companies contracted to supply the drug failed to meet the demand.

"Adcock Ingram Pharmaceuticals as well as Cipla Medpro Pharmaceuticals are supplying as well to provinces. So, now we have effectively four suppliers supplying to keep up with the demand. The procurement rules allow that. There's a good reason for it. The current suppliers are not able to keep up with the total need. So, for the balance they are allowed to go out and get it from other suppliers", explains the Health Department's Dr Anban Pillay.

Aspen Pharmacare and Sonke Pharmaceuticals were initially the two companies contracted to supply Tenofovir for the public sector antiretroviral programme. They won the tender to augment a donated supply of Tenofovir from the United States' government. But from November last year, they were required to produce and supply all stocks of Tenofovir as the donation started to run out. But production of the drug ran into problems. Both companies were initially unable to meet the demand. Aspen Pharmacare only increased its production in recent weeks.

"The split between Aspen Pharmacare and Sonke is a 70 - 30 split, meaning that 70% of the volume goes to Aspen and 30% to Sonke. Unfortunately, Sonke has not been able to ramp up its production to the level that is required to meet the demand", says Dr Pillay.

The Health Department estimates that about 1.2 million patients need Tenofovir every month. With Sonke Pharmaceuticals not being able to supply its quota of the tender agreement, the supplies from Aspen Pharmacare are still not sufficient to serve all patients on Tenofovir, whose shortage was acutely felt from the beginning of the year. But Dr Pillay is confident that with Aspen's increased production the demand for Tenofovir will now be met.

"By April 2012, Aspen Pharmacare was able to ramp up its production and on a week on week basis since then, they have been increasing their production. They are now providing over one million units of Tenofovir a month", he says.

Sonke, however, is still unable to contribute significantly.

"That facility is able to produce around 200 000 units per month. The operation is very small and that unit is not able to go beyond that. I cannot confirm exactly what they've been supplying because it's more difficult to get a sense from Sonke of what their actual supplies have been on a month on month. But Aspen's far more efficient at providing us with information. What I know is that Sonke can provide us with about 200 000 maximum in a month".

Aspen Pharmacare is now forced to make up the shortfall that Sonke Pharmaceuticals is failing to fulfill. A senior executive of Aspen Pharmacare, Stavros Nicolaou, says the company is committed to meeting the demand.

"We were servicing 250 000 patients, roughly, in a month. That increased in December quite dramatically to around 800 000 patients. Tenofovir has ramped up in its present form to around between 1.1 (million) and 1.2 million patient treatments per month. And I can tell you that Aspen is only required to supply 70% of that. So, we should be responsible for around 750 000 - 800 000 maximum packs per month. I can tell you that, for example, this month we will supply almost 1.2 million packs. We are, in fact, over-supplying, according to the requirements right now. We've stepped in where others cannot supply. Now we're supplying the full 1.2 million units a month. The second supplier, who has got the 30% obligation, they don't seem to be fulfilling their 30% commitment", Nicolaou says.

CEO of Sonke Pharmaceuticals, Sotse Segoneco, ignored requests for comment. But Director of Section 27 and executive member of the Treatment Action Campaign, Mark Heywood, says drug manufacturers are not entirely to blame for the shortage of Tenofovir.

"The suppliers are part of the problem. But I think there are a number of other factors. One is that the scale of the antiretroviral programme has grown immensely. The figures show us, for example, that in the last calendar year 600 000 people were newly-enrolled onto antiretroviral treatment. That is phenomenal and it is phenomenally large. So, it means that we have to have a degree of sophistication in monitoring the programme, which we don't have at the moment. And the second is that the Department of Health is custodian of this programme and that means that's it's custodian of people's lives. They have to have oversight. The problem should be identified before it becomes a problem within the Department of Health and they should find means to address it", says Heywood.

Meanwhile, the national Health Department has assured patients that with the current production of Tenofovir, every patient should be able to get the drug at their health facility.

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