Michael Healy-Rae (Kerry South, Independent)
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Question 503: To ask the Minister for Health his views on a matter (details supplied) regarding the unavailability of a drug; and if he will make a statement on the matter. [33413/12]

Róisín Shortall (Dublin North West, Labour)
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Shortages of essential medicines are currently a cause of concern not just in Ireland but throughout Europe and the rest of the world. It is a problem affecting health systems in all countries and impacting on patients world-wide. Medicines shortages can be the result of one, several or any combination of factors throughout the pharmaceutical supply chain such as manufacturing difficulties, industry consolidation, and commercial decisions by manufacturers to withdraw unprofitable lines.

Irish Medicines Regulations place an obligation on both manufacturers and pharmaceutical wholesalers within the limits of their respective responsibilities, to ensure the adequate availability and supply of medicines on the Irish market in order to meet patient needs. Eltroxin, which contains the active substance levothyroxine, is a long-established medicine that is used to control hypothyroidism, congenital hypothyroidism and juvenile myxoedema. It is marketed in tablets containing 25, 50 and 100mcgs and is the subject of a marketing authorisation in Ireland.

Before anyone is allowed to market a medicine in Ireland they are required to apply for a marketing authorisation from either the Irish Medicines Board (IMB) or the European Medicines Agency (EMA). The IMB and EMA examine the safety, quality and efficacy of medicines. The Marketing Authorisation Holder (MAH) for Eltroxin is the Mercury Pharma Group of which Goldshield Pharmaceuticals is a part. The product is manufactured under contract in the United Kingdom. The current shortage of Eltroxin emerged in February 2012 when the UK's Medicines and Healthcare Products Regulatory Agency suspended the authorisation of an alternative levothyroxine 100mcg tablet product, which was not on the Irish market, with the effect that the overall supply of levothyroxine on the Irish and UK markets was reduced.

The Health Service Executive (HSE) and the IMB have been managing the shortage of Eltroxin and issued a joint communication (26th April 2012) via the Pharmaceutical Society of Ireland (PSI) updating pharmacists on management of the shortage. The HSE put in place special arrangements to reimburse suitable UK licensed product stock and this was notified to community pharmacists on 1st May 2012. The HSE and IMB continue to closely monitor this issue to ensure ongoing access to this important medicine. In addition, the PSI has recently published guidance to registered pharmacists on managing medicines shortages.

The MAH for Eltroxin is continuing to liaise with the IMB and HSE on this matter and has confirmed to the HSE there are stocks of 50mcg and 100mcg in the country at the moment with further supplies of the 25mcg expected this week. To avoid stockpiling of this product in some locations and to ensure that all patients throughout the country have access to this medicine, the Mercury Pharma Group has had to apply a quota system to quantities supplied to pharmacies. My Department has been engaging with the IMB, the HSE and the PSI to identify ways in which the Irish system can manage medicines shortages as effectively as possible in order to minimise the impact on patients. International efforts to effectively manage medicines shortages are also being considered.