TAOISEACH MICHEÁL MARTIN has said “it’s not possible to quantify” the potential cost to the tax-payer arising from any claims that may arise related to a Covid-19 vaccine.

Under the terms of the Advance Purchase Agreements (APAs) that EU member states signed up to to access EU vaccine allocations, countries were required to indemnify the drug companies involved.

This means if there was some issue with the vaccination, such as a severe side effect in a recipient in Ireland, the State would be liable. Any compensation in the event of a successful legal case would come from the taxpayer and it would mean the vaccine developer could not be pursued. 

Countries can decide to opt in or out of the whole agreement but they cannot change individual provisions of any APA.

Speaking in the Dáil today in response to Catherine Connolly TD, Martin said that the potential cost of this “risk” must be balanced against the need to secure a vaccine.  

“The indemnity clause in the Advanced Purchase Agreements relating to indemnification and liability are open-ended,” Martin said. 

It’s not possible obviously to quantify the extent of any claims that may arise. But the balance here is we do need access to a vaccine. There has to be some element of risk attached to that.

The Taoiseach said this is balanced against “the trillions” that has been spent around the world battling Covid-19 and the health effects and fatalities that have resulted from the virus. 

Martin also said the government today considered a report from Justice Charles Meenan into clinical negligence claims. 

The report recommended developing a vaccine damage compensation scheme. 

“The Minister for Justice and Minister for Health are pursuing and working on producing such a scheme,” the Taoiseach said today. 

In her questions to the Taoiseach, Connolly said that vaccines are “an essential tool in the fight against Covid” but that she believes the Dáil should be have been kept informed about decisions around indemnities to pharmaceutical companies.

“I specifically asked you the details of that indemnity, is it a blank cheque? What are the conditions of that indemnity? Has there been a risk assessment? I perfectly understand there’s a balance of risks,” she said. 

But where was that decision taken? Was it taken at Cabinet, based on what, what was the risk assessment? We should have a full discussion of that in the Dáil.

“If you want full trust in the system, if you want to maximise the number of people who are going to take the vaccine, you must give full and transparent information,” she added. 

In response, the Taoiseach said that people can “poke holes” in plans but that the system of EU member states working together under one agreement is “far better” than the alternative. 

“Up to now it would have been the pharmaceuticals that would have been producing them on their own and charging the highest price to the highest bidder. That’s what you would have had if you didn’t have a coordinated European advanced purchasing agreement,” he said. 

In a previous statement to TheJournal.ie, the Department of Health said that the content of APAs, including with regard to liability or indemnity, are negotiated on behalf of member states.

“Opting into these provisions is one of the pre-conditions for obtaining access to the vaccines,” the statement said.

The department said responsibility for claims management will be assigned to the State Claims Agency.

It said vaccines can only be approved if they comply with all requirements of quality, safety and efficacy and no vaccine will be used until market authorisation is obtained from the European Medicines Agency.

- With reporting by Michelle Hennessy and Órla Ryan