The recent shortage of a crucial antiretroviral drug, Tenofovir, is but just a symptom of an underlying general problem of health management in South Africa. Part of this is the lack of oversight on drug supplies and availability by the national Health Department.
At the heart of the seven months’ long shortage of Tenofovir, which started running out in October last year is nothing else, but poor planning. For the whole of last year, the Health Department had a donated stock of the drug from the United States’ government and retained two pharmaceutical companies, Aspen Pharmacare and Sonke Pharmaceuticals to produce a tiny fraction of the supply. It was only when small quantities of the donated stock of Tenofovir were left that the Health Department urgently requested the two drug manufacturers in November to increase their production and supply 100 % of the stock, with Aspen Pharmacare responsible for producing 70% and Sonke Pharmaceuticals 30% of the required Tenofovir packs for an estimated 1.2 million patients. But the two failed to meet the demand at short notice, leaving patients in dire straits. Director of Section 27 and executive member of the Treatment Action Campaign, Mark Heywood, says this demonstrates a general lack of planning by the Health Department to address drug shortages in the country.
“Planning is absolutely crucial. If I was the Minister of Health, then I would instruct that the relevant official in the Department of Health has a monthly meeting with the pharmaceutical companies, with key people in some of the provinces just to assess on an on-going basis, not necessarily because there’s a crisis, but just to make sure that they are looking at what are the drugs… are the drugs in the system, are the drugs in the pipeline, are we getting to people, where is the weak point in the chain? If you put that type of system in place, then we wouldn’t be facing what we are facing now”, according to Heywood.
The recent shortages of Tenofovir, for example, occurred as a result of the Health Department not informing the contracted drug manufacturers in good time that a shortage was looming. Thus, they were not able to produce the required amounts. In addition, Aspen Pharmacare and Sonke Pharmaceuticals neglected to inform the Health Department that producing 1.2 million packs of Tenofovir within the required time would not be possible.
This shows that “they need to plan much better ahead in terms of the quantities that are needed, the suppliers have to be much more honest about their capacity to produce and the quantities that are required, it may mean that we need to bring in other companies. Suppliers, pharmaceutical companies should stop trying to block each other in the interest of their own profitability, but should recognise that there is a common good that has to be served here”, Heywood says.
The Health Department admits that there needs to be a change in how it awards tenders for drug manufacturing, especially in cases where it relies on fewer companies to produce and supply medicines as in the case of Tenofovir.
“Given the volume, South Africa has the largest ARV programme and it’s very clear that we’re going to have to increase the number of suppliers”, Dr Anban Pillay of the Health Department’s Finance and Economics unit, acknowledges.
“The other thing that we’re learning from this experience… You see… suppliers… when they make a bid for a tender, often try to create the impression that they can supply all the stock. It’s only after the tender is awarded that you have these problems, that you then go back and find out they actually didn’t have the capacity to supply it. So, the latest tender for tablets, for example, we are demanding information about their capacity so that we can assess how much capacity do they truly have. We’re upfront now. We want to make some decisions about whether this supplier will be able to produce this amount of tablets. And if they can’t, we’re not going to award and we’ve made it very clear. Not only are we asking you to provide information about your price and other things, but we also want to get evidence about how much of tablets can you produce or syrup or whatever”, Pillay adds.
He says the Tenofovir crisis has been a tough lesson for both the Health Department and medicines’ suppliers.
“On the supplier side, I would think that the supplier would be more open about how much they can supply because that’s the responsible thing to do because you can get the short-term gain in getting the tender, but you will lose in the long-term because you’ll get a bad name and, then we would never want to give you another tender because we now have a bad record in terms of supply. On our side, obviously, maybe we should have been smarter about assessing this risk and earlier on instituted something that monitors closely supplier capacity”.
As the situation cannot continue unabated, the Health Department also aims to have a more hands-on involvement before the end of the year to monitor and assist provinces and health facilities with general drug procurement.
“We’re establishing a central procurement unit here in the national Department (of Health) that will become more active in the ordering and supply of drugs to facilities. We’ve already started staffing the unit and we hope in the next few months it will become operational. This will then provide greater oversight on our part in terms of orders”, says Pillay.