Treatment Action Campaign Press Release 19 July 2001 DIFLUCAN WATCH : ASSESSMENT OF PFIZER'S DIFLUCAN DONATION On April 1st 2000 Pfizer announced a donation of fluconazole (Diflucan) to the South African government. This was after pressure brought by TAC and a number of international organizations, particularly Medecins Sans Frontieres (MSF). TAC's demand was simple: "reduce the price of fluconazole to R4.00 a capsule" or issue a voluntary license to TAC or the SA Government to purchase and distribute a generic version of Diflucan at the lowest possible price. This would make this essential drug accessible to most people. In answer, Pfizer decided on a public relations exercise and announced a free donation, initially limited only to people with AIDS who had cryptococcal meningitis. The donation agreement was signed with the SA Government on 1 December 2000, 9 months later. Within this period, TAC lost 5 volunteers due to illnesses that could have been treated with fluconazole. Undoubtedly, many more people died within this period. The first batch of free Diflucan arrived in March 2001 -- a full year after the donation was announced. Again how many more lives could have been saved if Pfizer had responded with an immediate price reduction? TAC congratulates the Diflucan Partnership for the effort they have made in distributing Diflucan to all 9 provinces in SA. The drug is now available in many public hospitals. Patients who present with symptoms defined in the donation programme can access Diflucan. These illnesses are cryptococcal meningitis and esophageal candidiasis. However, TAC remains critical of the serious shortcomings of the donation which continue to cause great suffering and loss of life. We draw attention to the fact that the donation is: Denied for paediatric prescription, because it is not being made available in an oral formula; Denied to women with HIV/ AIDS who have severe vaginal candidiasis, where Diflucan would be the most effective treatment. Denied to patients in the private sector, many of whom are terribly poor. Denied to people with HIV in most other developing countries, despite empty promises from Pfizer to extend the donation. TAC believes the donation is a greedy attempt to squeeze the maximum profits out of Diflucan in the dying days of Pfizers patent on the drug. In view of this TAC believes that there remains a moral imperative and a legal right to defy the Diflucan patent, and ensure that people who are not benefiting from the donation have access to essential generic brands of fluconazole. In this respect TAC has twice submitted the generic Biozole for identification assay tests at independent laboratories, as well as a bioequivalence study. These tests have found Biozole to be identical to Diflucan but for a fraction of its cost. TACs Diflucan Watch has been monitoring the programme since May 2001. These are some of the main issues we have come across: There is no national standard distribution guideline that allows distribution up to clinic level. The drug is still not equally accessible in all provinces (it depends on the commitment of the Health Department in each province). Some hospitals have not received stock. Some hospitals have stock -- but are not distributing. (Umtata General hospital). KwaZulu Natal has 68 public hospitals and fluconazole is available in all hospitals but no clinic has fluconazole. Gauteng has the worst distribution plan. All major hospitals have the drug but there is no commitment to distribute to clinics. Soweto clinics do not have fluconazole. People in Eastern Cape and Northern Province have to travel long distances to hospitals, not all of which have stock. Terminally ill people who cannot go hospitals will never access fluconazole. There is no public campaign to make patients or health care providers aware of the donation. Very few people are aware of the donation programme even within the medical fraternity. Most PWAs still go to private doctors and pay a private sector rate. This can be up to R90 a capsule! We are shocked that Pfizer and the Ministry of Health are keeping parts of the donation agreement, and the experience of its implementation, secret. Why is this necessary? TAC believes an urgent review of the distribution programme is required. The donation must continue, but an improved distribution strategy is needed. Pfizer must reduce fluconazole to R4 a capsule, or publicly state that it will not oppose an application for a voluntary licence. The MCC is currently close to registering at least one generic version of fluconazole, submitted by a major South African manufacturer. PWAs and AIDS Service Organisations must be part of all negotiations that directly affect them. The secrecy clause binding parties to the Diflucan partnership should be removed. If the government is serious about treating Opportunistic Infections, as it happily says all the time, demonstrate it by ensuring that all PWAs who need fluconazole have access to it anywhere is SA, rural and urban. Until this is done people will continue to die and suffer pain and indignity from treatable illnesses. 19 July 2001 Zamokuhle Zwane (031) 304 3673 (031) 301 1015 (031) 304 9743 hivtreatment@mweb.co.za