Generic drug import warning
2000-10-19 10:07
Special Report
The South African government has announced a joint venture to reduce the cost of anti-retroviral drugs with a Swiss company.
Johannesburg - Importing generic drugs without the approval of the SA Medicines Controls Council and in breach of international patent rights set a dangerous precedent, Generix International said on Wednesday.
Generix International chief executive Iqbal Moosa was reacting to the Treatment Action Campaign's announcement on Tuesday that a TAC representative had smuggled a generic version of the drug
Fluconazole, manufactured by Pfizer, into the country in contravention of both patent law and Medicines Controls Council rulings.
"The people of South Africa have a right to affordable, first world medical care and drugs that extend human life and limit suffering
and pain," Moosa said in a statement.
"However, emotions aside, when anyone illegally imports generic drugs without the go-ahead of the Medicines Controls Council the consequences can be tragic."
Generix International is a company that distributes generic medicines under licence.
Moosa, however, agreed with the TAC that the price of drugs supplied by multinationals in South Africa were "often obscenely high".
"There are some interesting statistics indicating that the prices charged for these drugs are in fact artificially high. For instance
South African drug sales contribute one percent towards the turnover of the multinational drug manufacturers, but a far higher
percentage of profit.
"This is evidence of where the priorities of the multinationals lie."
TAC chairman Zackie Achmat said on Tuesday this action was part of a defiance campaign against "patent abuse and Aids profiteering" by
multinational pharmaceutical companies.
He said campaigners faced the choice of watching friends, family and children dying of the disease because the medicines that could
treat it were too expensive, or they could defy patent and other trade laws.
"The choice is clear," Achmat said.
"The right to life and access to health care are non-negotiable. Profiteering, at the expense of life, even when protected by law,
is not a right."
Achmat said the group had imported 5000 Biozole capsules from Thailand and would distribute it to a network of doctors and pharmacists.
Biozole is a generic equivalent to United States pharmaceutical giant Pfizer's Fluconazole.
But, said Moosa: "These actions are illegal. How could any doctor in good faith use drugs which have entered a country illegally? The
potential for breaking the Hippocratic Oath and ignoring the proviso to 'first do no harm' is enormous."
If anything went wrong the medical practitioner would be open to malpractice suites, aside from the very real danger to the patient,
he said.
Moosa said that Generix International was in the process of lodging a dossier on Fluconazole and that he was confident the process of
approval would be fast-tracked.
In terms of international law, generic drugs can be manufactured and sold once the original patent has expired - in the case of Fluconazole this is next year.
Raymond Mallach, deputy chairman of Generix International, said in a statement on Wednesday that "daring a multinational pharmaceutical company to take you to court for infringing their
patent was foolhardy".
"Challenging a company with a turnover in excess of the GDP (Gross Domestic Profit) of South Africa, that relies almost solely
on research and patents for its livelihood means that either you're searching for ongoing publicity, or that you honestly believe
Pfizer will ignore the issue, which is extremely unlikely."
However, Aids Law Project head Mark Heywood said the TAC was not averse to court action as it would allow the issues of humanitarian
needs and the abuse of patents to be aired in court.
TAC wanted to challenge the right of profit-driven companies to set
the prices of essential medicines.
Pfizer said on Tuesday that they would take legal action for violation of intellectual property rights against the TAC.
The TAC has not received notification of this.
Heywood said the TAC would approach the MCC to register Biozole under section 21 of the Medicines and Substances Control Act.
It would also submit the product to the council for official verification that it was a high quality generic, which the TAC had
already established. - Sapa
- SAPA