Dear Sir or Madam,

Please can you clarify:

1. Whether the immunity from liability for any adverse vaccine effects granted to manufacturers of the H1N1 influenza vaccine by the UK Government applies to vaccination in Scotland.

2. If it does not apply in Scotland can you state whether or not the Scottish Government has granted or intends to grant vaccine manufacturers similar immunity from liability.

3. Whether such immunity could be granted directly by the Scottish Government under existing legislation (please specify which act/s) or if it would require the consent of the Scottish Parliament.

Yours faithfully,

Mr McGillivray

Scottish Government

1 Attachment

Chief Medical Officer and Public Health Directorate abcdefghijklmnopqrstu

Public Health Division

T: 0131-244 5662 F: 0131-244 2606

E: [email address]

Mr McGillivray

By email to: abcd
[1][FOI #17582 email]

___

Our ref: FoI/09/01147

11 September 2009

Dear Mr McGillivray

Thank you for your further email request dated 1 September for information
under the Freedom of Information (Scotland) Act 2002 about the plans to
vaccinate against influenza A (H1N1). We have now completed our search
for the information you requested and I have been asked to provide a
response to the questions you have raised.

The UK Government, on behalf of the four administrations, signed advance
purchase agreements in June 2007 and accepted liability for the safety of
any vaccines that would be produced as a contingency. All governments
signing up to an advance purchase agreement were expected to provide an
indemnity for the vaccine and neither manufacturer would sign the
contracts without it. The Government's decision was based on the best
procurement and legal advice. Accepting liability in this way is in line
with Government accounting rules and was cleared by the Public Accounts
Committee at the time.

The A (H1N1) vaccines that will be used in Scotland and the UK will be
subject to the licensing and regulation requirements for any new
vaccines. We will only use influenza A (H1N1) vaccines if we have
confidence in their safety.

If you are unhappy with this response to your request, you may ask us to
carry out an internal review, by writing to Dr Kevin Woods, Director
General - Health, Floor 1E.07 - St Andrews House, Regent Road, Edinburgh,
EH1 3DG. Your request should explain why you wish a review to be carried
out, and should be made within 40 working days of receipt of this letter,
and we will reply within 20 working days of receipt. If you are not
satisfied with the result of the review, you then have the right to make a
formal complaint to the Scottish Information Commissioner.

Yours sincerely

Syed Kerbalai

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References

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Keith Weir left an annotation ()

Fears that priority groups are being used as guinea pigs

Immunity granted to controversial flu jab

By Iain Harrison

TAXPAYERS could face a multi-million-pound compensation bill if patients suffer side effects from the swine flu vaccine.

The Sunday Post has learned that the UK government has granted legal immunity to the makers of the controversial jab.

That means the State will be liable for any claims for damages that might result from the planned mass vaccination programme.

The news comes a week after a poll revealed that up to half of family doctors are refusing to be vaccinated against swine flu.

Almost three in four claimed this was because of safety concerns. A third of nurses are taking a similar stance.

The jab is currently being fast-tracked through normal development stages and will not be fully tested before being administered to patients.

Fears

Last night a patients’ watchdog voiced fears that those receiving the drug first because they are in a priority group will be “guinea pigs” for the pharmaceutical companies.

Margaret Watt, chair of the Scotland Patients’ Association, said, “It’s morally wrong to give the vaccine makers legal immunity.

“If these vaccines haven’t been fully tested and the vaccination programme backfires then the public should not have to foot the bill.

“It worries me that the manufacturers are refusing to accept liability. The health authorities must make this abundantly clear to people who take the vaccine.”

The decision by the UK Government to grant swine flu jab makers legal immunity mirrors a settlement struck by the US authorities in June.

The last time a mass swine flu inoculation programme was conducted there it caused more deaths than the disease it was designed to combat.

That campaign, in 1976, was halted after thousands filed compensation claims contending they’d suffered side-effects from the shots.

Unsurprising

Cameron Fyfe, a litigation specialist at Ross Harper solicitors in Glasgow, said it was unsurprising pharmaceutical firms had taken steps to avoid a repeat scenario.

But he added, “I haven’t come across this type of arrangement before but I can understand it given they’ve had their fingers burnt in the past.

“To succeed with an action a litigant would have to show that the vaccine manufacturers did have enough time to develop a jab that was safe.

“The pharmaceutical firm would then claim its losses back from the Government.”

Health officials in Scotland say they hope to begin vaccinating priority groups, including pregnant women and front line medical staff, from mid-October.

Early indications suggest the jab will be available by then, although doubts about its safety remain due to the limited number of clinical trials.

Professor Hugh Pennington, one of the UK’s foremost microbiologists, believes there is no justification for fast-tracking the vaccine.

He said, “The number of swine flu cases has dropped like a stone in recent weeks so I don’t see any real need to rush the vaccine through.

“We should be using the same kind of testing as for the seasonal flu jab.

Risks

“But we’ve had many years of experience in producing flu vaccines so if there are any risks they are likely to be very remote.

“I’m not in a priority group so won’t be eligible to have the jab but if I were I wouldn’t have any reservations.”

A spokesman for GlaxoSmithKline, one of two firms processing the swine flu vaccine, said, “The clinical trials are ongoing. But the decision as to who gets the vaccine and when is a matter for individual governments.”

A Department of Health spokeswoman said it had accepted liability for the safety of the vaccines as a contingency.

She added, “All governments signing up to an advance purchase agreement were expected to provide an indemnity for the vaccine and neither manufacturer would sign the contracts without it.

“The Government’s decision was based on the best procurement and legal advice.”

Dear Sir or Madam,

Please can you comment on the annotation to this request left by Keith Weir on 12th September 2009 quoting an article in the Sunday Post regarding the vaccination.

Please can you state what measures the government will take to allay any public concerns that may be raised by the poll that suggests half of doctors and a third of nurses will decline to receive the vaccine.

In light of the polls suggesting half of doctors and a third of nurses will refuse the vaccine, what does the government anticipate will be the percentage of vaccine uptake in the population as a whole and will it adjust its vaccine purchase requirements accordingly to reduce costs?

What measures has the government taken to counter "scaremongering" over the vaccine by certain individuals including journalist Jane Burgermeister who has set up a website www.theflucase.com

Is the Scottish Government aware of the Criminal Charges filed in Austria and the USA against the vaccine manufacturers by Jane Burgermeister. If so what measures if any have been taken to satisfy the government that these charges are vexatious.

Is the Scottish Government aware of claims in the media that the UK Government has asked senior neurologists to be alert for an increase in cases of the neurological condition Guillain Barre Syndrome (GBS) once the vaccination programme begins?

Yours faithfully,

Mr McGillivray

Scottish Government

1 Attachment

Chief Medical Officer and Public Health Directorate abcdefghijklmnopqrstu

Public Health Division

T: 0131-244 2330  F: 0131-244 2606

E: [email address]

Mr McGillivray

By email to: abcd
[1][FOI #17582 email]

 

 

 

 

 

 

 

___

                        

Our ref:     FoI/09/01254

12 October 2009

Dear Mr McGillivray

Thank you for your further questions dated 14 September for information
under the Freedom of Information (Scotland) Act 2002 (FOISA) about the
plans to vaccinate against influenza A (H1N1). We have now completed our
search for the information you requested and detail this below.

            1. Please can you state what measures the
Government will take to allay any public      

            concerns that may be raised by the poll that
suggests half of doctors and a third of

            nurses will decline to receive the vaccine.

The Scottish Government is working closely with other UK administrations
to develop a coherent UK-wide advertising campaign to ensure the public
and professionals can make an informed personal choice about the influenza
A (H1N1) vaccines based on accurate information. Whilst the Scottish
Government strongly advises healthcare professionals in the vaccination
priority groups (including GPs and Nurses) to receive the vaccine, we are
aware that not everyone will wish to do so. Vaccination is not mandatory
for anyone, including healthcare professionals.

2. In light of the polls suggesting half of doctors and a third of nurses
will refuse the

vaccine, what does the Government anticipate will be the percentage of
vaccine uptake in the population as a whole and will it adjust its vaccine
purchase requirements accordingly to reduce costs?

While we would hope that a high number of people will receive the
vaccination in order to protect themselves from the H1N1 virus, the
Scottish Government has not anticipated a specific level of uptake rate.
However experience from the annual seasonal flu vaccination programme,
which currently sees a 75% uptake rate in people aged over 65 years and
almost 50% in those under the age of 65 receiving the seasonal flu
vaccine, indicates that at risk are willing to attend for vaccination and
recognise the benefits and protection that being vaccinated provides.

In relation to vaccine contracts currently in place with vaccine
manufacturers are on a UK wide basis and Scotland cannot act on its own to
alter these purchase arrangements. There does however already exist a
break point in the contract whereby the UK and administrations can
consider the need for further vaccines in early 2010 based on the severity
and spread of the virus.

            3. What measures has the Government taken to
counter "scaremongering" over the      

            vaccine by certain individuals including journalist
Jane Burgermeister who has set up

            a website [2]www.theflucase.com.

            4. Is the Scottish Government aware of the criminal
charges filed in Austria and the

            USA against the vaccine manufacturers by Jane
Burgermeister.  If so what measures

            if any have been taken to satisfy the Government
that these charges are vexatious.

I am unable to comment on issues published by a third party particularly
if the content of such an article relates to legal charges that have been
filed. The UK-wide advertising campaign will provide accurate information
to inform the public about the risks and benefits of vaccination to allow
them to make informed decisions.

            5. Is the Scottish Government aware of claims in
the media that the UK Government

            has asked senior neurologists to be alert for an
increase in cases of the neurological

            condition Guillain Barre Syndrome (GBS) once the
vaccination programme begins.

I am unable to comment on claims made in the media however can advise that
the European Medicines Agency (EMEA) have requested that manufacturers
implement plans to actively investigate and monitor the safety of vaccines
as soon as they are used across the EU so that action can be taken as
early as possible if a safety issue emerges. The Medicines Healthcare
Regulatory Authority, which is the agency responsible for the safety of
medicines in the UK, has developed detailed real-time surveillance for
serious adverse reactions such as Guillian-Barré Syndrome based on their
experience in previous vaccination programmes.

If you are unhappy with this response to your request, you may ask us to
carry out an internal review, by writing to Dr Kevin Woods, Director
General - Health, Floor 1E.07 - St Andrews House, Regent Road, Edinburgh,
EH1 3DG.  Your request should explain why you wish a review to be carried
out, and should be made within 40 working days of receipt of this letter,
and we will reply within 20 working days of receipt.  If you are not
satisfied with the result of the review, you then have the right to make a
formal complaint to the Scottish Information Commissioner.

Yours sincerely

Mike Palmer

Deputy Director

Public Health Division

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Communications via the GSi may be automatically logged, monitored and/or
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References

Visible links
1. mailto:[FOI #17582 email]
2. http://www.theflucase.com/

Kevin left an annotation ()

People are waking up........ the house of cards is falling....... the new world order is failing....... TRUE FREEDOM is awakening, not the freedom they call "democracy" keep up the fight against the system. Oh by the way, do you want to buy this tablet I just invented ? It cures all cancer and HIV and it extends your life by fifty years, it also might make you autistic and make you infertile, but if you get those things from it, its not my fault !!!

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