Thursday, 16 May 2019
Department of Health
Medicinal Products Regulation
As the Deputy would be aware, it would be inappropriate for me to comment on individual cases or matters that are the subject of ongoing litigation.
As of 13 May 2019, the State Claims Agency (SCA) has been notified of potential claims being initiated against the Minister for Health, the Health Services Executive and GlaxoSmithKline Biological SA by one hundred and fourteen (114) individuals and in seventy (70) of these cases formal legal proceedings have been issued. However, these cases relate to a purported linkage between the Pandemrix vaccine and narcolepsy rather than Chronic Fatigue Syndrome.
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.
All medicines, including vaccines are subject to on-going review and evaluation of all available data from a range of sources, including systematic scientific literature review, to consider any impact that their data may have on the overall assessment of the benefits and risks of a medicinal product. The safety of these vaccines continues to be monitored at EU level through the EMA and its expert committees, which includes representatives from member state competent authorities such as the HPRA.
My main priority as Minister for Health is that individuals and families affected receive appropriate health and social care supports. My Department continues to engage with the Health Service Executive, the Department of Education and Skills, and the Department of Employment Affairs and Social Protection to ensure the provision of a wide range of services and supports, on an ex-gratia basis for those who have received a diagnosis of narcolepsy following administration of the H1N1 pandemic vaccine. The HSE’s Advocacy Unit acts as liaison with other service providers and Government Departments to facilitate access to required services. It is in regular contact with the individuals affected and their families; and regional co-ordinators have been appointed to assist by providing advice, information and access to local services. These supports include discretionary medical cards, reimbursement of expenses associated with diagnosis and treatment, home tuition and learning supports.