WOZA (Johannesburg)
Marjolein Harvey
1 August 2000
Johannesburg — The Pharmaceutical Manufacturers' Association of SA has resumed litigation against the Medicines and Related Substances Control Act No 90 of 1997, arguing that it still undermines patent protection for pharmaceuticals.
The SA Medicines and Medical Devices Regulatory Authority Act (Sammdra) - the act housing act 90 of 1997 - would be returned to parliament for extensive amendments, Health Minister Manto Tshabalala-Msimang announced in August 1999 and the PMA followed with a suspension of its litigation in September.
But PMA CEO Mirryena Deeb says the organisation has failed to reach a negotiated settlement with government and is forced to resume litigation.
She said the PMA was dismayed that the minister's legal advisers have insisted the association files answering affidavits on legislation which, by their client's own announcement, is to change.
"Continuing litigation under these circumstances can only amount to an exorbitant waste of taxpayers' money funds that could be better appropriated towards saving lives," Deeb said in a statement on Tuesday.
"Underpinning the PMA's rejection of attempts to generally abrogate patent rights is our unflinching belief that patent protection does not stand in the way of access to medicines and healthcare."
She says there is evidence that countries with an absence of patent protection still have a lack of access to quality healthcare.
"Many Asian, South American and African countries in the absence of any legal hindrance, are able to source their drugs from any supplier internationally and are free to allow local manufacturing of any drugs, yet quality and affordable drugs are still not available to the people," says Deeb.
She says that sound economic policies and sufficient healthcare funding, government commitment and political will, adequate infrastructure and capacity are equally important for access to improve.
Interestingly, a leading health analyst predicted in September that the suspension would not last, saying the move may be only a calm before a new storm over the access to treatment.
"The suspension of the lawsuit might well be interpreted by SA as a signal that they can begin the manufacture of cheaper versions of the most widely used drugs to treat HIV," associate executive director for programmes and policy at the US Public Health Association (Apha), Richard Levinson was reported as saying by IPS.
"However, it seems likely that the drug companies might later re-institute their suit, if the promised changes in relevant SA legislation does not satisfy them," says Levinson.
"It seems unlikely that pharmaceutical firms will surrender their profit margins without a major battle. Therefore, this may be a lull before the storm," he said.
According to the World Health Organisation (WHO), drug companies spend nearly R400 billion on health research; but only 10% of that figure is spent on diseases that affect 90% of the global population.
Research and development is claimed to be expensive - one reason drug companies are reluctant to expend efforts on products that will not make a profit. However, it is unlikely that drug makers would lose much profit by allowing poorer nations access to cheaper drugs, because they represent such a small proportion of the market.
"The PMA would ultimately prefer a negotiated settlement and partnership with government," says Deeb.
The health department could not yet comment on the matter at the time of writing.
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