PRESS STATEMENT TACS BIOZOLE EQUIVALENT TO PFIZERS DIFLUCAN SAVE LIVES PRODUCE, IMPORT AND DISTRIBUTE GENERICS 18 December 2000 ************************************************** Generic fluconazole Biozole is as good as Pfizers Diflucan. This is the result of an independent test conducted by a laboratory regularly used by by the Medicines Control Council. The test confirms other independent international laboratory studies that TAC relied on to import the medication in defiance of patent laws. The Brooklyn Medical Centre (BMC) has met all the Medicines Control Councils (MCC) conditions for it to receive a section 21 exemption on Biozole, the generic fluconazole imported by TAC. The exemption means that the BMC will be able to distribute this essential life-saving drug at no charge on a limited, patient-name basis to people who need it. The availability of this medicine is limited by the funds TAC can raise for the Christopher Moraka Defiance Campaign. Biozole has been successfully quality tested in an approved South African laboratory, as requested by the MCC. The quality test ensured that Biozole capsules contain the correct amount of fluconazole (101.1%). It further confirms that Biozole is a safe, generic equivalent of Pfizer's fluconazole, as has already been shown in laboratories in Switzerland, France and Thailand. In August 2000, the Nobel Prize winning humanitarian organisation, Mdecins Sans Frontires (MSF) requested that Biozole be tested by an independent laboratory in France. Their result showed that Biozole was 104% equivalent to fluconazole. A test is considered satisfactory if the generic medicine has between 90% and 110% of the active ingredient of the brand-name drug. This additional evidence has also been submitted to the MCC. Anita Kleinschmidt, attorney at the AIDS Law Project said that BMC has provided the Medicines Control Council with details of the test, a list of doctors who will be acting on behalf of the BMC, and it will provide the patient names as soon as the Biozole is prescribed. BMC requested an initial amount of 5000 X 200mg - Biozole capsules per month. "This completes the conditions stipulated by the MCC, which is now obliged to grant the Section 21 exemption immediately. Any further delays will result in more unnecessary suffering and deaths" Kleinschmidt said. Nontsikilelo Zwelidala, who has HIV and whose husband Christopher Moraka died asked Dr. Helen Rees to ensure that the Biozole handed over by TAC to the Health Department is given to government clinics who need fluconazole or BMC immediately. "My husband died after asking Parliament for this medicine, I ask the MCC to save the lives of other people who need this medicine now", she said. According to Zackie Achmat, TACs chairperson, the organisation has always been confident of the safety, efficacy and quality of generic Biozole. The real question is the profiteering by Pfizer. "Fourteen days after the third announcement of the Pfizer donation, the public sector still awaits a single pill. TAC is ready to import fluconazole within 24 hours with the Brooklyn Medical Centre. This proves that government political will and economic commitment by generic companies will save lives. It is time to act", Achmat said. A Section 21 exemption is a step in the right direction, but it is not a panacea. Only a few people will benefit directly from it. For access to affordable medicines to be improved sufficiently, the state must obtain and distribute essential generic medicines. Therefore, TAC urges the MCC to register safe, effective and affordable generic medicines, as they have promised to do. The MCC has agreed that it is not their responsibility to enforce patents. The Minister of Health, Dr. Manto Tshabalala-Msimang is in Brazil to explore generic production of anti-retrovirals and all other essential medicines. Mark Heywood, AIDS Law Project Head said: "TAC welcomes this as the most positive step taken by the South African government in more than three years. We urge the government to lead the fight for access to treatment by following the example of the Brazillian government which manufactures and imports essential medicines through the use of compulsory licenses. This has greatly reduced the cost of medicines in Brazil, and lengthened and improved the lives of many Brazilians with HIV/AIDS." All donations to the Christopher Moraka Defiance Campaign are used for the purchase and distribution of essential, safe, affordable and effective generic medicines. For further comment, please call Nathan Geffen (082 693 8826 or 021 462 6322) or Zackie Achmat (083 467 1152 or 021 788 5058).