Drug firms dodge swine flu liability

Ministers have taken on all the risk for the 60 million doses they have ordered from GlaxoSmithKline and the Baxter group, after both firms said they would refuse to produce it unless legally protected.

A swine flu vaccine produced in America during the last recorded outbreak of the virus in 1976 was linked to a rise in Guillain-Barre syndrome, a paralysing muscular disorder.

While there was no conclusive evidence that the jab caused the syndrome, 25 people subsequently died from the condition after the vaccination programme began, triggering mass panic.

In a separate development, the scale of the mass vaccination programme in Scotland has brought a warning that other routine immunisation programmes might have to be delayed.

The head of the NHS in Scotland has told health boards that the delivery of the vaccine to the country's five million residents will be a challenge "unprecedented in scale and in scope".

NHS Scotland chief executive Kevin Woods said that while boards should plan to deliver the routine seasonal flu and childhood vaccination programmes, this is "being kept under review".

Due to the workload pressure on GP surgeries, healthcare staff may have to give the swine flu and the seasonal flu vaccine at the same time, and delay the childhood illnesses vaccination programme.

Meanwhile, Scot Sharon Pentleton, 26, was yesterday still "critically ill" in a Stockholm hospital after being flown there for specialist treatment. The mother of one from Ayrshire, who is expecting her second child, is suffering a rare, severe reaction after contracting the H1N1 swine flu virus and is undergoing a procedure whereby her blood is circulated outside her body. No beds were available in the UK for the procedure she needed.

The first batches of vaccine are expected to arrive in the UK in early September, prior to limited clinical trials. Five manufacturers, including GSK and Baxter, are producing a new vaccine across the world and all of them are understood to have stipulated that they are not to be held liable for any deaths or illnesses caused by the immunisation programme.

Health experts last night advised that it was unlikely that anyone would suffer serious side-effects from the swine flu vaccines currently being developed for use in the next few months.

But medical lawyers said that if people died or fell seriously ill after taking the vaccine, cases could easily end up in court with the bill running into hundreds of millions of pounds. With 60 million vaccines being produced for Britain alone, scientists say it is "reasonable" for all the companies involved to ensure they were not liable.

The Department of Health has taken on legal responsibility for the swine flu vaccine across the UK. In a statement, it said:

"The UK Government signed the advance purchase agreements in June 2007 and accepted liability for the safety of the vaccines as a contingency."

The link between the rise in Guillain-Barre syndrome and the swine flu vaccine in 1976 is by no means clear, amid suggestions it was caused not by the vaccine itself but by bacteria which contaminated it.

Professor Hugh Pennington, one of Britain's leading microbiologists, said: "Nobody can say there wasn't a problem with the vaccine but nobody can say it was the vaccine that caused it either." He said it was "highly unlikely" that people getting the virus would suffer serious illness or die as a result, but he said there still needed to be caution.

Mary Scanlon, health spokeswoman for the Scottish Conservatives, said the risk of side-effects should not be ignored in the rush to make the vaccine available. "There is a very fine line between getting this vaccine out rapidly to the bulk of the population or delaying the vaccine for further clinical trials," she said. "It is vital for the government to get information out there relating to side-effects so that individuals can make their own judgment."

Last night, it emerged that the NHS is planning to fly swine flu patients by private jets to European hospitals if Britain's intensive care services become overwhelmed.

Yesterday, the World Health Organisation said 160 countries were affected by swine flu, and around 800 people had died worldwide. At least 30 have died in the UK.