Gillian Toole (Meath East, Independent)
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554. To ask the Minister for Health the reason drug companies are indemnified if vaccines are presented to the public as being safe and effective. [29477/26]

Gillian Toole (Meath East, Independent)
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558. To ask the Minister for Health the reason drug companies indemnified are if vaccines are presented to the public as being safe and effective. [29492/26]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 554 and 558 together.

Vaccines can only be approved and used if they comply with all the requirements of quality, safety and efficacy set out in relevant EU pharmaceutical legislation. Any authorised vaccine will be subject to ongoing monitoring in Ireland by the Health Products Regulatory Authority (HPRA). Vaccination is a key public health intervention and plays an important role in protecting individuals and the wider population from serious disease.

The Health Product 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, to which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions. 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.

Where vaccines are procured by the State, contractual and legal arrangements, including provisions in relation to liability and indemnity, may be entered into. Such arrangements are intended to support the timely and effective delivery of vaccination programmes and do not indicate any concern regarding the safety or effectiveness of the vaccines themselves.