GSK grants license to Cipla in South Africa

The Treatment Action Campaign (TAC) welcomes today’s announcement that GlaxoSmithKline (GSK) has granted a licence to Cipla-Medpro for the importation and sale of generic versions of antiretroviral (ARV) medicines containing zidovudine (AZT) and/or lamivudine, two crucial drugs used both in the prevention and treatment of HIV infection. As Cipla-Medpro has already obtained approval from the Medicines Control Council (MCC) to sell AZT and lamivudine (adult and paediatric formulations) in South Africa, these ARV medicines are now available in private pharmacies and may be purchased by the state for use in public health facilities.

The TAC hopes that today’s announcement concludes a lengthy dispute that resulted in its formal complaint to the Competition Commission in September 2002. Our initial assessment is that GSK seems to have complied with its obligations as contemplated by the settlement agreement. Once we are satisfied that this is indeed the case, we will issue a public announcement to this effect.

The complainant […] argued that GSK and Boehringer Ingelheim (BI) had been unlawfully charging excessive prices for their ARV medicines, resulting directly in the premature, predictable and avoidable deaths of people with HIV/AIDS. In exchange for legally binding guarantees to issue multiple licences on their patented ARV medicines on specified terms and conditions, the complainants agreed to withdraw their complaint.

To date, GSK has also granted licences to Aspen Pharmacare, Thembalami Pharmaceuticals, Feza Pharmaceuticals and Biotech Laboratories for the importation and/or local production of the same essential drugs. Of these companies, only Aspen is currently supplying these medicines, which are manufactured locally.

The TAC has requested MSD, the distributer of efavirenz, an essential antiretroviral medicine, to grant voluntary licenses to generic manufacturers on similar terms to those reached with GSK or Boehringer Ingelheim. Should MSD fail to do so, we will consider litigation for compulsory licenses.