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 a wide-ranging impact on health systems throughout the world.
Irish Medicines Regulations place an obligation on both pharmaceutical manufacturers and 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.
The Health Service Executive (HSE) engages in agreements with manufacturers and importers to supply medicines under the community drugs schemes. These agreements require manufacturers and importers to notify the HSE as soon as they are aware of foreseeable or prolonged stock shortages.
My Department has been engaging with the Irish Medicines Board (IMB), the 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. The IMB and HSE work closely with each other to operationally manage medicines shortages when they arise. The PSI has recently published guidance to registered pharmacists on managing medicines shortages. International efforts to effectively manage medicines shortages are also being considered.
Manufacturers, wholesalers and pharmacies all have responsibility to work together to identify shortages quickly and implement alternative arrangements to meet the needs of patients.