Update on the reported key anti-retroviral (ARV) Tenofovir (TDF) public sector supply shortages

20/06/12:

Johannesburg – over the past days and weeks, there have been widespread reports from various State Clinics, in certain provinces, that patients have been unable to access supplies of TDF, a key ARV, used primarily in first line HIV treatment.

Due to the negative consequences on both patients and the sustainability of South Africa’s Public ARV programme, Aspen as the contracted supplier for 70% of the TDF volume to the State, takes these reports extremely seriously.

In these reports, there has been some suggestions that contracted suppliers have been unable to supply TDF timeously, or in the required quantities. To this end, Aspen is unable to comment on other contracted suppliers of TDF, it does however wish in the clearest terms, to confirm its own supply position as follows:

  • Aspen has met and exceeded, both the timing and required quantity for TDF under the terms of its State contract, which requires it to supply 70% of the TDF volumes;
  • In terms of the contract, Aspen is required to supply TDF within 6 weeks from receipt of orders;
  • January 2012 represented the first month that Donor procured TDF had been depleted and the Department of Health (DOH) returned to normal procurement from its tender Contractors;
  • Accordingly, having regard for its 70%, 6 weeks contractual supply obligation, Aspen would have been required to supply 3,33million TDF packs by the end of June 2012. Aspen confirms that it will have delivered 4,2million packs, or 126% of its required volume during this period;
  • Aspen has met and has had to exceed its supply requirements, as shortages from other suppliers have manifested. In response to these shortages, Aspen has swiftly and through considerable resource application scaled up its manufacturing capacity to ensure the supply of 1,13million TDF packs in May 2012, which exceeds the entire May 2012 TDF public sector requirement. Aspen is also able to supply 1,2million TDF packs in June 2012, which exceeds the entire TDF public sector requirement for the month of June 2012; and
  • Aspen can confirm that it presently has no backorders for TDF, meaning that no orders in the system exceed the contractual 6 week delivery period.

On this basis, Aspen continues to view supply security and the maintenance of the integrity of the South African Public ARV programme as a national imperative. Aspen also views timeous ARV delivery at the required quantities as non-negotiable. To this end, Aspen will continue its excellent track record of meeting its ARV supply commitments and where possible to step in and commit its manufacturing capacity where other suppliers are unable to supply a part or all of their supply commitments.

In the current tender, which commenced on 1 January 2011, Aspen has stepped in and supplied 3 other ARV medicines in addition to TDF, where other suppliers had experienced supply constraints.