Wednesday, 8 May 2019

Questions (921)

Clare Daly


921. Deputy Clare Daly asked the Minister for Health the level of liability of the pharmaceutical industry in respect of vaccine injury; and if it has been indemnified by the State with the Exchequer taking on liability such as in the Pandemrix vaccination programme. [19548/19]

View answer

Written answers (Question to Health)

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 events 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.

In Ireland the pharmaceutical industry does not seek indemnification as part of the normal tendering process in relation to providing vaccines. However, the contract for the supply of pandemic influenza vaccine during the 2009 pandemic included clauses concerning indemnification of the manufacturers at that time. The same indemnification clause applied to all other countries availing of the pandemic vaccine. As all vaccines used in Ireland’s immunisation programmes have been approved for use in the European Union by the EMA there is no requirement for indemnity.