Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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Question 48: To ask the Minister for Health and Children if her attention has been drawn to the recent situation where Health Service Executive supplies of the BCG vaccine ran out; if she has sought a report on same from the HSE; the measures she has initiated to ensure that there is no repetition; and if she will make a statement on the matter. [11811/07]

Mary Harney (Dublin Mid West, Progressive Democrats)
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The National Immunisation Office, which is part of the Population Health Directorate of the Health Service Executive (HSE) is responsible for overseeing the day to day implementation of the Immunisation Programme, including vaccine procurement and management of the National Cold Chain Delivery Service. Vaccines are procured from manufacturers based on national requirements and are delivered at specified regular intervals to the Cold Chain distributors.

The "Cold Chain" is the system of correct storage, transport and maintenance of vaccines to ensure that they are protected from inappropriate temperatures and light from the time of manufacture to the time of administration. The National Cold Chain Delivery Service has been in operation since 2005. This service is provided under contract by a pharmaceutical distribution company. All vaccines are stored and delivered under temperature controlled conditions to General Practitioners surgeries, HSE health centres and hospitals, ensuring compliance with Irish Medicines Board (IMB) licensing requirements.

This delivery system is continuously monitored to ensure that the Cold Chain is maintained and that vaccines are distributed efficiently and is overseen by the National Immunisation Office. Since the introduction of the National Cold Chain Delivery Service, there has been a significant reduction in vaccine wastage and there is now a comprehensive vaccine tracking system from the manufacturer to GP surgery, health centre or hospital.

I have been informed by the HSE that in the past few weeks there was a temporary shortage of BCG vaccine in Ireland. BCG vaccination is carried out on newborn babies in maternity hospitals and HSE health centres by HSE community health doctors. There is only one licensed supplier of BCG for Ireland — Statens Serum Institute (SSI) based in Denmark. The HSE has a contract with SSI to provide annual requirements for BCG. These are sent under temperature controlled conditions on a planned basis. The shortage was caused when two shipments in 2006 had problems. One shipment arrived into the country outside the temperature requirements and could not be used. Any vaccine that has not been stored at a temperature as per licensing conditions is no longer a licensed product. A second vaccine order had a manufacturing problem and so was not sent from Denmark.

An alternative batch of BCG arrived into Ireland in December but this did not meet IMB requirements and therefore could not be distributed. From the middle of December there were no supplies centrally for distribution, however, there were supplies still available locally in a number of areas up to the beginning of February. All HSE staff were informed about the situation on a regular basis to ensure clinics were not scheduled when there was no vaccine available.

BCG vaccine was delivered to the Cold Chain Distributors and became available for delivery on 16 February. The Cold Chain Distributors immediately ensured that back orders were filled. Further BCG deliveries are scheduled for March and May of this year. The HSE is in contact with the company to ensure continuation of quality supply.