GE drug slipped through checks

WELLINGTON - The makers of a genetically engineered cholera vaccine pulled from sale in New Zealand yesterday face tens of thousands of dollars in costs if they want to get it approved.

Industry sources said only about 1400 doses of the Orochol Berna vaccine had been sold since its arrival on the New Zealand market in 1998.

Such low sales meant its Swiss maker was unlikely to go through the expensive approval process.

The Environmental Risk Management Authority (Erma) asked that the vaccine be withdrawn after discovering it had not been approved under the Hazardous Substances and New Organisms Act.

The vaccine is made using genetically modified live bacteria.

Erma chief executive Bas Walker said the vaccine maker would have to decide whether to invest in gaining approval for its engineered bacteria under the Hasno Act.

Health Minister Annette King and Environment Minister Marian Hobbs said alternative vaccines were being sought urgently from overseas.

In the meantime, Orochol Berna stocks would be placed in secure containment and made available only for use in emergencies.

Dr Walker said the Swiss Serum and Vaccine Institute's costs, if it decided to apply for approval, were likely to run into tens of thousands of dollars.

Until now, the Government has been subsidising public hearings for Erma applications but the subsidies are due to expire at the end of this month.

The vaccine's Auckland agent, Pharmabroker Sales, said the withdrawal meant New Zealanders travelling to high risk cholera areas no longer had access to the world's most effective protection against the disease.

Ministry of Health medicines classification committee chairman Stewart Jessamine said the vaccine's first shipment arrived in New Zealand before the Hasno Act took effect in June 1998.

The vaccine was registered as a new medicine in March.

It was only when it came up in a discussion about the Royal Commission of Genetic Modification it was realised the vaccine should have been put through the Erma approvals process.

Dr Walker said prosecuting the importer would serve no useful purpose.

"They simply didn't realise this sort of instance was captured by the legislation."

- NZPA

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