The Medicines Control Council has obtained an urgent court order to stop the continued sale of potentially deadly medicines.
The Medicines Control Council (MCC) obtained an urgent court order on Monday to stop the continued sale of potentially deadly medicines.
The MCC, Registrar of Medicines, health minister and director general of health launched the application at the North Gauteng High Court in Pretoria.
They asked for a settlement order between them and Adcock Ingram, granted by the court in October this year to be rescinded.
The agreement allowed Adcock to continue selling the medicines Synap Forte, Lentogesic and Doxyfene which contain dextropropoxyphene (DPP).
The MCC has withdrawn the registration of DPP-containing medicines.
Risks of toxicity
The applicants contended the state attorney and counsel instructed by it had settled the case without any authorisation, without their approval and contrary to the public interest.
In April this year, the council withdrew the registration of DPP-containing medicines, following in the footsteps of five other countries including the US and United Kingdom.
According to its experts, the medicines that were to a large extent used by the elderly, contained risks of toxicity and heart attacks.
Health professionals were given three months to wean patients off the medicines.
Adcock Ingram lodged an appeal against the council’s decision and asked the health minister to appoint an appeal committee to hear further expert evidence.
It insisted that the reasoning of the study placed before the MCC was “totally flawed”.
The company at the same time demanded that the council suspend its decision. When the council refused, the company launched an urgent application to prevent implementation of the decision.
The council and other applications instructed their legal representatives to oppose that application but claimed an unauthorised settlement was entered into contrary to their instructions.
Judge Eberhard Bertelsmann set aside the settlement order and dismissed Adcock Ingram’s application to enforce that order and allow it to continue selling the medicines pending the outcome of their appeal.
Gilbert Marcus SC, for the applicants, argued that the medicines generated an annual turnover of R182-million for the pharmaceutical company.
“One cannot take chances with lives in the face of the evidence. Profits loom large in this matter,” he said.
Marcus referred to a statement by the European Medical Agency indicating that the difference between the dose needed for treating a patient and an overdose was very small.
Ben Bredenkamp, for Adcock Ingram, argued that the applicants had discussed and were aware of the settlement agreement.
He said they were jumping the gun and that another two months before the appeal was heard “would not make that much of a difference”, as the medicines had been sold without apparent negative effect for eight years.
“Obviously money talks but the respondent’s reputation is at stake,” he said.
Bertelsmann said there may be debate about the level of toxicity and statistics, but it was not for the court to decide on any of these considerations.
“It is clear the MCC has at all times acted in the public interest. That was undercut by a most unfortunate error, which should never have occurred.”—Sapa