Aspen To Supply R17.5m Worth Of Toxic Drug

A closer look at South Africa's ARV tenders

It is six years since World Health Organisation recommended the phasing out of Stavudine, why is the Department of Health spending millions buying the toxic drug?

In Brief

  • The health department has contracted eight suppliers, among them pharmaceutical companies Sonke, Aspen’s Pharmacare, Mylan and Cipla, to supply R14.19 billion worth of antiretroviral drugs. Over 2.7 million people are reportedly on ARVs in South Africa
  • Stavudine, a toxic drug that should by now have been phased out as per guidelines by the World Health Organisation (WHO), is one of the drugs Pharmacare has been contracted to supply
  • While government’s efforts to provide more patients with ARVs are notable, capability of suppliers to meet their obligations must be scrutinised, especially with the reported stockouts 

It's anybody’s guess why the Department of Health has not phased out Stavudine, six years after a WHO-issued guideline cited irreversible side effects of the ARV. Tucked in the R2.67 billion contract awarded to Aspen’s Pharmacare Ltd is a R17.5 million order for Stavudine.

In 2010, WHO published a detailed advisory acknowledging that cumulative exposure to Stavudine or d4T can cause disfiguring, and other painful and life-threatening side effects such as lipodystrophy, peripheral neuropathy and lactic acidosis. To help especially poor countries phase out Stavudine, global health initiative UNITAD committed US$77 million in 2013.

The long-term impact of buying Stavudine can only be disastrous

Despite the warnings and interventions, government’s plan for the toxic drug is not visible. The health department has contracted Pharmacare Limited (a trading (briefcase) outfit wholly owned by JSE-listed Aspen Holdings Limited) to supply one million and seventy-four thousand (1,074,000) units of Stavudine at a cost of R17.5 million. Why would the department spend that much of taxpayers’ money on a product whose side effects would cost the health system massively? Is it likely some of the drugs on the catalogue specifically made the list to mitigate Stavudine side effects?

Nearly half of the department’s R29b expenditure on drugs procurement, (gleaned from its pharmaceutical procurement catalogue), goes to procurement of anti-retriviral drugs for the over 2.7 million people currently on treatment. Worth R14.19 billion, Contract No. HP13-2015ARV was awarded to just eight suppliers.

Mylan South Africa - R4.19b

A local subsidiary of the Dutch-registered and US-based global generic and specialty pharmaceutical, Mylan N.V, Mylan South Africa (Supplier Code V3PS6) has been contracted to supply various quantities of Tenofovir, Emtricitabine Efavirenz, Zidovudine and Lamivudine in tablet and capsule form.

Sonke Pharmaceuticals (Pty) Ltd - R3.2b

Created in 2006 as a joint venture between Ranbaxy (Pty) Ltd and Community Investment Holdings, Sonke Pharmaceuticals (Pty) Ltd (Supplier Code  V1VD1) contract involves supply of various quantities of Efavirenz, Lamivudine, Tenofovir and Emtricitabine – also in tablet and capsule form.

Aspen Holdings’ Pharmacare Limited - R2.67b

Among the drugs Pharmacare Ltd (Supplier Code V2205) has been contracted to supply are Stavudine, Abacavir, Atazanavir, Darunavir, Etravirine, Lamivudine, Nevirapine, Tenofovir, Emtricitabine and Efavirenz.

The ARV pie distribution

Other suppliers include VXZ32 - Cipla Medpro South Africa Limited (R2 billion), V3PG3 - ABBVIE (Pty) Ltd (R1.3 billion), V2272 - Adcock Ingram Healthcare (Pty) Ltd – the briefcase outfit of Adcock Ingram Limited (R708.7m), V1MV2 – Aurobindo Pharma (Pty) Ltd (R53m) and MSD (Pty) Ltd (R9.9m).

The department’s efforts to rollout ARVs in public health facilities is laudable, but reported stockouts must be examined against the ability of all contracted suppliers to meet their obligations. Decisive action must be taken if a supplier can not source the required active pharmaceutical ingredients (API). The additional cost of bridging shortfalls is weighty and must be avoided at all costs.

In response to the shortfalls, the department invited the public to report shortages to various provincial managers. The invitation read in part; “The contact details of the Provincial HIV and AIDS and STIs (HAST) Programme Managers are provided herein with respect to any stockout of Anti Retroviral Treatment (ART) and TB treatment in any Public Health Facility in the country."

CLICK HERE for the complete list of Contract No. HP13-2015ARV.