30 November 2000 Included in this email are a press release and a letter from the MCC to the Treatment Action Campaign. ********************************************************* MCC GRANTS A CONDITIONAL SECTION 21 EXEMPTION FOR GENERIC FLUCONAZOLE Council further noted the serious challenge posed by the HIV/AIDS epidemic to the health sector, and the profound suffering that this disease inflicted on those infected. Medicines Control Council Resolution granting a section 21 exemption for generic fluconazole. On 29 November 2000, the Treatment Action Campaign and the AIDS Law Project met with Dr Helen Rees chairperson of the Medicines Control Council and Dr. Precious Matsoso the Registrar of Medicines. The meeting was productive and the following issues were agreed. The Brooklyn Medical Centre would be granted a section 21 exemption allowing the use of the generic fluconazole under the following conditions. · All doctors and patients using the medication would be registered with the MCC. · The generic fluconazole would be subjected to an assay and identification test at an accredited South African facility. · The exemption would be reviewed once the Pfizer pills reach patients. TAC and the MCC representatives agreed on the following: The MCC is governed by statute and the Constitution. Its work only involves regulating medicines in the public interest for safety, efficacy and quality. The MCC stated categorically that it does not enforce patent laws. Dr. Rees and Dr. Matsoso made it clear that the MCC would consider any application for generic medicines. TAC and the MCC agreed that the section 21 exemption is a temporary measure. Generic drug companies must apply to have their products registered. The MCC commitment to fast-track medicines for conditions such as HIV/AIDS was reiterated. TAC welcomes the section 21 exemption and especially the opportunity to demonstrate scientifically that Biozole is a generic fluconazole that will save people’s lives. This is the first time that a civil society body has ensured that people who need medicines will get them. We have also exposed the profiteering of drug companies such as Pfizer. TAC and Medicins Sans Frontieres (MSF) will organize a meeting of all generic companies in early 2001 to ensure that applications for generic anti-retrovirals and generics for all opportunistic infections are made to the MCC. We will import Biozole as soon as we have complied with the MCC requirements. The fluconazole campaign has been a unified effort of grassroot activists, civil society organisations and health care professionals. TAC especially wants to thank Dr Steve Andrews, Prof Greg Hussey, Prof Leslie London, Dr Farid Abdullah, Sister Sue Roberts, Dr Carol Cragg, Dr Beth Harley, Dr Herman Reuter, Dr Leon Geffen and the 200 health care workers who signed the petition. The MCC’s courageous decision shows that action by people with HIV/AIDS and civil society will save lives. TAC extends its thanks to Medicines Sans Frontieres, HealthGap Coalition and all our international allies campaigning to make essential medicines available to poor people across the world. And we say, the Defiance Campaign against unjust trade laws continues. ************************************** Below is the letter sent by MCC to TAC: The AIDS Law Project University of the Witwatersrand Private Bag 3 WITS 2050 Dear Sir/Madam APPLICATION FOR SECTION 21 EXEMPTION OF BIOZOLE FROM THE AIDS LAW PROJECT ON BEHALF OF THE BROOKLYN CLINIC Kindly find the attached Medicines Control Council Resolution. REGISTRAR OF MEDICINES APPLICATION FOR SECTION 21 EXEMPTION OF BIOZOLE from the AIDS LAW PROJECT on behalf of BROOKLYN CLINIC Council notes that the AIDS Law Project had applied on behalf of the Brooklyn private clinic, for a Section 21 application for the approval of Biozole. Council further noted that the indications applied for are the following: ¨ Cryptococcal meningitis; ¨ Oral- and eosophageal candidiasis. Council also noted that the applicant has stated that they intended to apply for the registration of the generic Biozole. While the applicant has provided data in support of Good Manufacturing Practice, Council noted that the safety and quality of the product had yet to be confirmed. It was further noted that the Minister of Health has just accepted an offer of free donation of tablets of the patented fluconazole (Diflucan), which will be made available in the public sector for the indications of Cryptococcal meningitis and oral- and eosophageal candidiasis. This product in tablet form is not yet registered but has been fast tracked. The capsule form of Diflucan is registered and is marketed but the applicant argues that this is too expensive for patients to purchase, and that this is the basis for their Section 21 request. Council noted the legal opinion supplied to it by the State Law Advisors. Council further noted that the intention of Section 21 is for exceptional or special circumstances and not to make medicines widely available to the public. Section 21 is not intended as an alternative to registration, and there are precedents where Council has requested registration of products where it was clear that the intention ceased to be 'exceptional' and appeared to be for routine use. Council further noted the serious challenge posed by the HIV/AIDS epidemic to the health sector, and the profound suffering that this disease inflicted on those infected. Council resolved: That the Section 21 request for this be granted subject to the following: 1. That the names of the prescribing doctors be submitted; 2. That the names of patients to be treated are provided and the quantities of medicine required are specified; 3. That the applicants be asked to furnish evidence of quality of the Biozole, as generated by identification and assay undertaken by the reputable South African laboratory before the Section 21 can be granted; and 4. That this Section 21 be reviewed once the free fluconazole has been made available in the public sector.