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Covid-19 Pandemic

Dáil Éireann Debate, Tuesday - 8 December 2020

Tuesday, 8 December 2020

Questions (617, 696)

Peadar Tóibín

Question:

617. Deputy Peadar Tóibín asked the Minister for Health if his Department indemnified any private companies in respect of the proposed roll-out of the Covid-19 vaccine; if so, the name of each company any level of indemnity has been provided to; the type of indemnity provided in each case in terms of side effects, illness, potential death, lack of immunity provided, ineffective vaccine, damage to unborn children and so on; if any of the supply, delivery or administering the vaccine elements has been indemnified; if so, the value for each company; and the lowest and highest estimated potential cost to the State if the indemnification is called upon due to legal action in respect of the vaccine. [41365/20]

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Peadar Tóibín

Question:

696. Deputy Peadar Tóibín asked the Minister for Health if a contingency has been put aside to deal with potential cases that may be brought against the State if something goes wrong with the Covid-19 vaccine; and if so, the amount set aside. [41860/20]

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Written answers

I propose to take Questions Nos. 617 and 696 together.

Ireland is currently involved in an EU Procurement Exercise being operated by the European Commission on behalf of member states to procure a portfolio of suitable, safe and effective vaccines, in sufficient quantities, to combat COVID-19.

As part of the exercise, Ireland has already opted into an Advance Purchase Agreement (APA) with AstraZeneca (partnering with Oxford University); Janssen (Johnson & Johnson); BioNTech / Pfizer; CureVac and Moderna.

The European Medicines Agency (EMA) is the body which can authorise vaccines for EU Member States.   It is likely that it will consider ‘conditional’ marketing authorisation for certain vaccines, and its opinion could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine.

The content of the Advance Purchase Agreements, including with regard to liability / indemnity, are negotiated with vaccine suppliers by the European Commission and its negotiation team acting on behalf of Member States. Member States may decide to opt in / opt out, but do not have scope to recast the provisions of any APA. Responsibility for claims management will be assigned to the State Claims Agency.

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