Written answers

Wednesday, 19 January 2022

Department of Health

Vaccination Programme

Photo of Seán CanneySeán Canney (Galway East, Independent)
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1789. To ask the Minister for Health if he will establish a reporting group to investigate the instances of the negative effects that Covid-19 vaccines have had on a small minority of persons; the supports and services that will be put in place for those persons; and if he will make a statement on the matter. [1833/22]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland.  The HPRA and the European Medicines Agency (EMA) continually monitor adverse reactions to vaccination. 

The HPRA operates a national adverse reaction reporting system, which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions to.  All Reports received by the HPRA are routinely transmitted to the EMA's adverse reaction database for inclusion in global signal detection and monitoring activities.

The HPRA follows up on reports of suspected adverse reactions received from healthcare professionals and members of the public through the voluntary reporting system, including any deaths notified following vaccination.

The question of providing supports for persons who experience an adverse reaction to Covid-19 vaccination will require further consideration in the context of broader health policy, legal and financial implications which may arise. 

Photo of Mattie McGrathMattie McGrath (Tipperary, Independent)
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1791. To ask the Minister for Health the status of the establishment of a vaccine injury compensation fund specifically relating to Covid-19 vaccine injuries; when this fund will be made available to assist those suffering from adverse effects; the details of the application process; and if he will make a statement on the matter. [1839/22]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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There are no plans at present for the introduction of a COVID-19 specific vaccine compensation scheme.

In June 2018, the Government agreed to the establishment of the expert group to review the management of clinical negligence claims. It was chaired by the High Court judge, Mr. Justice Charles Meenan. The expert group examined the system from the perspective of the person who has made the claim to explore if there is a better way to deal effectively, yet more sensitively, with certain case.

Mr. Justice Meenan submitted the final report on the current system for managing clinical negligence claims to the then Minister for Health and Minister for Justice in January 2020, prior to the onset of the COVID-19 pandemic. The Government subsequently published the Meenan report in December 2020. One of the report's recommendations is for the establishment of a compensation scheme to deal with certain vaccine damage claims.

On foot of a request from the Department of Health, the Health Research Board, HRB, carried out an evidence review on the vaccine injury redress programmes in other jurisdictions, which was completed in March 2019. The expert group's report, in addition to the HRB's evidence review, and consultation with other Departments and relevant State agencies will inform the development of proposals regarding the establishment of a vaccine compensation scheme, including the need for primary legislation. The Department of Health are planning for the development of policy in this regard.

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