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Major victory on anti-retrovirals

Jillian Green. 11 December 2003. The Star. Republished courtesy of Independent Newspapers (Pty) Ltd.
It has come late - and at the cost of many lives - but cheaper HIV/AIDS drugs will soon be available to everyone. This comes as a result of a settlement agreement between pharmaceutical giant GlaxoSmithKline (GSK) and the Competition Commission.

The agreement states that GSK agrees to allow up to three more companies to manufacture generic versions of three of its anti-retroviral drugs. Already, the pharmaceutical company has given a licence to Aspen Pharmacare to produce a generic version of its drugs - availability of the generic was until now limited to government and non-governmental organisations as well as employers who treat their workers who do not belong to medical schemes. This licence did not entitle Aspen to sell to the private sector.

"It has come late, and at the cost of many lives. Let's put that behind us," Zackie Achmat, of the Treatment Action Campaign (TAC), said on Wednesday. According to the TAC, a regimen containing a three-in-one fixed-dose combination costs more than R1 000 a month. This could in future cost between R140 and R160 a month.

"It has been a difficult five years, but this is an important step for public health," Achmat said. The competition commissioner, Menzi Simelane, said it had been a "particularly difficult" case.

The settlement is the result of a complaint raised by an HIV-positive woman, Hazel Tau who alleged that GSK and Boehringer Ingelheim (BI) were contravening the Competition Act by abusing their dominant position in the manufacture of anti-retrovirals. Following Tau's complaint, a number of NGOs, including the TAC and trade federation Cosatu, added their names to the complainants' list. An investigation into the allegations revealed that the firms had engaged in "restrictive practices", including excessive pricing, denying a competitor access to essential facilities and engaging in an exclusionary act.

But before the matter could be taken to the competitions tribunal, where the companies, if found guilty, could be fined, the settlement agreement was reached.

In terms of the agreement, GSK has undertaken to:

  • Extend its voluntary licence granted to Aspen Pharmacare
  • Grant up to three more voluntary licences on terms no less favourable than those granted to Aspen Pharmacare, based on reasonable criteria. This includes registration with the Medicines Control Council and the meeting of safety and efficacy obligations
  • Permit the licensees to export the relevant anti-retroviral drugs to sub-Saharan African countries
  • Permit the importation of the drugs for distribution in South Africa where the licensee does not have manufacturing capability in South Africa
  • Permit licensees to combine the relevant anti-retrovirals with other medicines
  • Charge royalties of no more than 5 percent of the net sales of the relevant anti-retrovirals


  • The commission is hoping to reach a similar agreement with BI in the coming week. "As the agreements provide for more than one generic manufacturer, there will be competition among them, which should push prices even lower."

    "GSK will be making financial sacrifices by licensing the ARVs to generic manufacturers at a royalty rate of only five percent, for both the public and private sector," Simelane said. He hoped this impact would be felt before the end of next year.

    Speaking at the announcement on Wednesday, Tau said were it not for anti-retrovirals, she would not be living today. A donor was sponsoring her treatment at a cost of R1 200 a month. "Let's not waste more time, (but) save lives in South Africa," she said.

    Achmat said the TAC also intended to approach the Competition Commission over the cost of diagnosis and monitoring of HIV patients, which it believed were far too high.
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