[Pharm-policy] TAC Press Release: Generic Fluconazole Test Successful

[James Love]

Subject: TAC Press Release: Generic Fluconazole Test Successful
   Date: Mon, 18 Dec 2000 11:59:22 +0200 (SAST)
   From: Nathan Geffen <ngeffen@cs.uct.ac.za>


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).




-- 
James Love  <love@cptech.org>  http://www.cptech.org
Consumer Project on Technology, P.O. Box 19367, Washington, DC 200036
voice 1.202.387.8030 fax 1.202.234.5176