Billy Timmins (Wicklow, Fine Gael)
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Question 172: To ask the Minister for Health the position regarding the severe shortage of essential medicines to pharmacies (details supplied); and if he will make a statement on the matter. [25968/12]

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 global 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. In some cases pharmaceutical manufacturing is concentrated to such an extent that a production problem in one pharmaceutical plant can have wide-ranging and international impact on health systems throughout the world.

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.

My Department has been engaging with the Irish Medicines Board (IMB), the Health Service Executive (HSE) and the Pharmaceutical Society of Ireland (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.

Pharmaceutical production is carried out by private enterprises, and the State or my Department can only intervene to a limited extent to prevent medicines shortages occurring.

The HSE negotiates with drug companies seeking to have their products placed on the list of reimbursable products under the General Medical Services (GMS) Scheme and the community drugs schemes. The current supply agreements require manufacturers and importers to notify the HSE as soon as they are aware of foreseeable or prolonged stock shortages.

However the IMB and HSE continue to work closely to operationally manage medicines shortages when they arise. In addition, the PSI has recently published guidance to registered pharmacists on managing medicines shortages. Manufacturers, wholesalers and pharmacies all have responsibility to work together to identify shortages quickly and implement alternative arrangements to meet the needs of patients.