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    Press Statement

    Treatment Action Campaign
    http://www.tac.org.za
    808 Dumbarton House, Church Street, Cape Town. Tel: 021-423 5026 Fax: 4265046 PO Box 31104, Braamfontein 2017, Johannesburg. Tel: 011-403-0265 Fax: 011-403 2106

    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 ìin 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. 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 "availableî" 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 ìcaughtî 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.

    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.

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