Court hears claims GSK 'directed and controlled' HSE
The High Court has heard claims that vaccine makers GlaxoSmithKline "directed and controlled" the Health Service Executive during the procurement process for the Pandemrix vaccine ten years ago.
Lawyers for a woman who says she developed an incurable sleep disorder from the swine flu vaccine said GSK had said certain terms in its contract were non-negotiable and said vaccines ear-marked for Ireland would be given to another country if the terms were not agreed.
Senior Counsel Dermot Gleeson said GSK had anticipated legal action over the Pandemrix vaccine before it was sold to Ireland.
He was continuing an opening statement in the case by Aoife Bennett, a 26-year-old student from Naas Co Kildare, who is suing GSK and the State. Her claims are denied and the case is expected to last ten weeks.
Mr Gleeson said "unusual" contractual clauses insisted upon by GSK showed the pharmaceutical company had anticipated being sued.
The court has heard that GSK insisted on being indemnified by the HSE against any legal action arising from the vaccination programme in 2009.
The court was told that legal correspondence during the procurement process shows some advisers were uncomfortable with the terms being sought by GSK and said they would never agree to them in normal commercial circumstances.
Senior Counsel Dermot Gleeson said the documents showed GSK was also insisting on a clause which meant the HSE could not settle any cases or say anything about it or the vaccine even if it was the right and cost-effective thing to do.
This, he said, amounted to an "unconstitutional agreement" and was "profoundly disquieting" whereby an agent of the State was yielding its power to conduct its own litigation with a citizen of Ireland.
He said the most remarkable clause of the contract was GSK's insistence that it could give confidential information to the HSE's lawyers but the HSE would not have access to that information.
"They anticipated litigation and here they were providing detailed arrangements to control the litigation and to control the way in which the barristers were employed by the HSE," Mr Gleeson said adding: "It lets the cat out of the bag that GSK expected litigation."
The agreement between the GSK and the HSE amounted to a "constitutional conspiracy" where the rights of a citizen are affected.
Mr Gleeson said the clause required the HSE to subordinate their best constitutionally directed instincts and advice to GSK. "An agent of the State was being directed and controlled bya foreign pharmaceutical company."
The case will hear allegations that the Minister and the HSE encouraged vaccination when it was aware the Pandemrix vaccine was not as safe as other vaccines.
It is also claimed the HSE entered into an indemnity agreement with GSK in 2009 as a condition of the company supplying the vaccine.
It is also claimed that the Irish Medicines Board - now the HPRA - wrote to the Department of Health in September 2009 noting there was no safety data available with the swine flu vaccines and no data was yet available from clinical trials which were then underway.
It is claimed that GSK had a liability to Ms Bennett under the Defective Products Act of 1991.
All claims are denied and the defendants will contend the Pandemrix vaccine was properly authorised by the European Commission for use in all EU member states and was required to address the swine flu pandemic.