[Pharm-policy] TAC statement on South Africa imports

[James Love]

Subject: [Ip-health] Press statement
   Date: Fri, 20 Oct 2000 21:23:59 +0200
  From: Zackie Achmat <zackie@pixie.co.za>


For Immediate Release: 20th October 2000

THE MEDICINES CONTROL COUNCIL:
PROTECTING PFIZER OR PROTECTING PATIENTS?

The MCC has attacked the Treatment Action Campaign in an
unsigned press statement as well as in comments by Dr Helen
Rees, the Chairperson of the Council. The MCC has also laid a
criminal charge against TAC Chairperson, Mr. Zackie Achmat,
who was today being interviewed by the police.
The TAC fully accepts the letter of the law that requires that ?in
determining whether or not the registration or availability of a
medicine is in the public interest, regard shall be had only to
the safety, quality and therapeutic efficacy thereof in
relation to its effect on the health of a man?. (our emphasis)
Flowing from this the TAC believed the MCC should
concentrate its investigation on determining the ?public interest,
safety, quality and efficacy ? of the Biozole that has become
?available? as a result of TAC?s actions.

It is a red herring to suggest that TAC?s action countenances
drug smuggling. The TAC action did not become public because
TAC was ?caught? but because TAC voluntarily announced and
explained its action. The TAC fully accepts that proper import
controls and policing is necessary to protect against counterfeit
and dangerous drugs. This is especially so in a country like
South Africa where the high price of medicines makes poor
people vulnerable to exploitation. But this is not the issue here.

On Thursday 20th October the reason for the TAC?s action was
explained to Dr Rees by the TAC?s legal representative, the
AIDS Law Project,
It was pointed out that this was a symbolic act of defiance
carried out on humanitarian and emergency grounds. The target
of the defiance was Pfizer?s callous and cynical abuse of the
Patents Act - not the country?s regulatory system. To stress the
TAC?s bona fides the TAC offered to seek Section 21
exemption for the humanitarian (not for sale) use of Biozole. This
application has been made. The TAC also offered to seek
registration for Biozole - despite knowledge that this would be
opposed by Pfizer.

The TAC is therefore surprised by Dr Rees? statements. The
impression is that the MCC is losing sight of its primary duty to
ensure safety, efficacy and quality. It would seem as if Dr Rees
can?t see the patients behind the patents.
Dr Rees has said that the TAC could have used ?other legal
means?. Given that the TAC?s action is driven by a medical
emergency -- where every day people die of treatable
conditions whose medicines they cannot afford - we ask what
other means, and at what cost?
·   Currently, the Patents Act of 1975 prohibits use of
    generics, until the expiry of the period of market
    exclusivity held by the Patentee.
·   Although the Minister of Health complains loudly
    about prices and pharmaceutical company
    profiteering she is unwilling to use powers she has
    under the Patents Act to issue a compulsory licence
    for drugs like  Fluconazole. This is something that is
    allowed by the WTO under its TRIPS agreement.
·   The Medicines and Related Substances Control Act
    allows for the sale of unregistered medicines only in
    limited circumstances, for clinical trails or named
    patients. The Biozole is not for sale. It is for ongoing,
    appropriate prescription to patients who cannot
    afford Fluconazole  and who would die or suffer
    severe pain without  treatment.
·   Since 13th March 2000 the TAC has repeatedly
    sought a voluntary licence from Pfizer or a price
    reduction. Pfizer has declined both. Instead it has
    offered to donate Fluconazole to the government, an
    action that will protect both its profits and its patent.
    It can in no way be described as a humanitarian
    gesture.
·   Legislation passed by Parliament in 1997, allowing
    parallel importation and generic substitution has been
    held up  by the Pharmaceutical Manufacturers
    Association (PMA) since 1997. This legislation was
    an attempt to meet Constitutional duties to improve
    access to health care services. Three years later
    TAC? s action is motivated by the same duty.

Nevertheless, TAC is making every effort to co-operate with the
police, the Department of Health and the MCC. The defiance
campaign is not aimed at them; it is aimed at Pfizer. Therefore,
we met with the police and a pharmacist from the Department of
Health today to hand over a receipt of the medication bought
and a sample of the medication. Zackie Achmat made a full
statement to the police regarding the importation.
In addition, TAC has agreed to give 3000 of the 5000 capsules
we bought to the Department of Health for safe-keeping and
testing. We have given them two weeks to accept our Section
21 application. If the Department of Health, the MCC or the
police fail to keep the medication safe and secure or fail to
accept TAC's application, the remaining 2000 capsules that we
have purchased will be brought into the country and distributed
via doctors to patients who need fluconazole. We will continue
to buy and distribute generic medication until the pharmaceutical
companies have brought their prices down to generic
levels or granted voluntary licenses.


-- 
James Love  mailto:love@cptech.org http://www.cptech.org
Consumer Project on Technology, P.O. Box 19367, Washington, DC 20036
voice 1.202.387.8030  fax  1.202.234.5176