Brendan McGahon
Question:56 Mr. McGahon asked the Minister for Health and Children if he has given consideration to the appointment of an independent inspector on vaccine safety who would make public his or her reports. [5519/01]
Written Answers. - Vaccination Programme.
The Irish Medicines Board is the competent authority for the authorisation, supervision and control of medicinal products, including vaccines, placed on the market in this country and in the ordinary course of its work it monitors adverse reactions notified by healthcare professionals and pharmaceutical companies.
Information collected through this system is an important method of monitoring drug safety in normal clinical practice, by increasing knowledge about known adverse drug reactions and by acting as an early warning system for the identification of previously unrecognised adverse reactions. Such information is vital in identifying drugs where a change in their authorisation – licence – status is required such as restriction in usage, additional warnings and precautions for use, or rarely, withdrawal from the marketplace.
The Irish Medicines Board issues a drug safety newsletter which is circulated to doctors, dentists and pharmacists several times a year, providing updated information on adverse reactions and providing advice on the safe use of specific medicines. In the above circumstances, I do not see the need for the appointment of an independent inspector on vaccine safety.