Seán Kyne (Galway West, Fine Gael)
Link to this: Individually | In context | Oireachtas source

441. To ask the Minister for Health if his attention has been drawn to the issue of manufacturers of pharmaceuticals not renewing licences for certain medications with the Irish Medicines Board due to the fact that the number of persons using such medication or medication type is outweighed by the cost of seeking the licence; if his attention has been drawn to the restrictions this places on pharmacists to offer customers the best value medication or medication format; and if he will make a statement on the matter. [20320/14]

Alex White (Dublin South, Labour)
Link to this: Individually | In context | Oireachtas source

My Department works closely with the Irish Medicines Board (IMB) and the Health Service Executive (HSE) to identify and address medicines shortages so as to minimise their impact on the market. Each year a number of medicines are withdrawn from the Irish market for commercial reasons. Manufacturers are obliged to notify the IMB of their intention to withdraw a medicine from the market. When they intend to withdraw a critical product for which there is no alternative in Ireland, they must notify the HSE nine months in advance to give it and the IMB the opportunity to source an alternative product for the Irish market.

The IMB engages with manufacturers to facilitate continuity of supply of all medicines and particularly critical medicines on the market. Among the steps taken by the IMB are an expedited review of submissions for authorisation and the facilitation of joint packs with other EU markets to improve efficiencies for manufacturers. In terms of best value for patients, the introduction of generic substitution and reference pricing under the Health (Pricing and Supply of Medical Goods) Act 2013 means that patients may now opt for lower cost interchangeable medicines, where available.