CSL bird flu vaccine may be granted indemnity

The federal government is considering whether to protect vaccine company CSL (ASX:CSL) against lawsuits by patients who suffer adverse reactions from its bird flu vaccine if production is fast-tracked in the event of pandemic.

In a move that will bring Australia in line with the US, CSL would be given legal indemnity if the drug is rushed to market before clinical trials are completed.

In December, US health and human services secretary Mike Leavitt was given the power by Congress to grant vaccine makers immunity from liability over pandemic flu vaccines. The measure is part of the defence budget and aims to encourage vaccine makers back to the American market.

"Unless governments worldwide are prepared to provide these indemnities these vaccines will never get made," said Melbourne University's Prof Ian Gust, who is the director of the World Health Organisation Collaborating Centre for Influenza in Melbourne.

"Where governments mandate manufacturers to produce vaccines in an emergency situation and they don't have years to conduct the huge clinical trials required to license the vaccine, then the immunisation program involves a calculated risk," said Gust, who is also a member of the National Influenza Pandemic Planning Committee.

"No commercial manufacturer would be prepared to make vaccines under these circumstances unless they are indemnified against something that might go wrong, other than through their own negligence, because they could potentially be bankrupted by it," he said.

CSL's director of public affairs said that CSL "is completely confident in the safety of the product."

"The government is using this as a way of protecting the population against any potential delays in supply," she said.

The government has already provided CSL with indemnities for its current range of bird flu research programs.

"We will want to see all the results of the current testing program before we take this further," federal health minister Tony Abbott told AAP this week. "But obviously we want to protect the Australian population as fully as we can and if that involves further production, further testing and further indemnifying, we're certainly going to look at all of that."

US critics of flu vaccine indemnities argue that people who are genuinely hurt by vaccines need some compensation mechanism.

However, Gust said, "People are generally being immunised at government expense for the benefit of the entire community. No matter how good the vaccines are, there will always be some low level of risk associated with it. Personally I believe there is a lot of merit in the no-fault compensation system for programs that are government mandated and funded."