Róisín Shortall (Dublin North West, Labour)

Shortages of essential medicines are a source of concern not only in Ireland but also throughout Europe and the rest of the world. It is a global problem affecting health systems in all countries and impacting on patients worldwide. 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 and international impact on health systems throughout the world.

Irish medicine 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 medicine shortages as effectively as possible to minimise the impact on patients. International efforts to manage medicine shortages effectively 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 medicine shortages occurring. The IMB and the HSE continue to work closely to manage operationally medicine shortages when they arise. The PSI works with the pharmacy profession and has recently published guidance for registered pharmacists on managing medicine shortages. Manufacturers, wholesalers and pharmacies all have a responsibility to work together to identify shortages quickly and implement alternative arrangements to meet the needs of patients.

Additional information not given on the floor of the House.

Medicine shortages are not related to the negotiation of pricing and the reimbursement of new and expensive medicines such as Ipilimumab. The recent issue regarding this drug was related to the current pricing and supply agreement with pharmaceutical manufacturers. The Department and the HSE are in contact with the Irish Pharmaceutical Healthcare Association, IPHA, with the intention of securing a new pricing and supply agreement to replace the existing agreement which expired on 1 March. The terms of the previous agreement and savings secured thereunder will continue to apply pending successful negotiation of a new agreement. The Department is committed to securing additional savings in the price of medicines in any new agreement.

There has been recent media coverage of reimbursement approval for new and expensive medicines. The position of the Department and the HSE in the ongoing contacts with the IPHA is that financial space needs to be created within current drug expenditure to facilitate the cost of the new and innovative drugs awaiting reimbursement approval. The Chief Medical Officer is exploring with the HSE the adoption of a new and robust system for decision making in regard to drugs to promote and drive evidence-based prescribing. This should help to create capacity on a sustainable basis to provide for necessary new drugs when there is evidence to support their use.

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