Cormac Devlin (Dún Laoghaire, Fianna Fail)
Link to this: Individually | In context

2646. To ask the Minister for Health the current days of cover for the top 100 essential medicines, by category; the medicines experiencing repeated shortages since 2023; the plan to establish a rotating national reserve and domestic fill finish capacity; and if she will make a statement on the matter. [47208/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

There is currently no national list of medicines classified as 'essential medicines' however through a combination of legislative action, regulatory expertise, and collaborative strategies, Ireland and relevant European institutions are taking affirmative measures in strengthening healthcare resilience and safeguarding continued access to medicines.

Several initiatives have been taken over recent years at a European level to improve security of supply and address supply chain vulnerabilities that are common to multiple markets. These include an expansion of the mandate of the European Medicines Agency (EMA) to optimise the management and prevention of shortages at European level. The EMA has been formally mandated to address shortages, on behalf of EU citizens, and the regulatory footing for this new role has been provided through the introduction of EU Regulation 2022/123 (‘EMA expanded mandate’).

The introduction of the legislation provides for the development of a European shortages monitoring platform (ESMP), in place since February 2025. The ESMP is a centralised electronic platform for pharmaceutical companies and national competent authorities (NCAs) to notify shortages to the EMA. It will also serve as a monitoring tool and a platform through which Medicine Shortages and Safety Steering Group (MSSG) crisis and preparedness activities will be conducted.

Advancing NCA national stock monitoring systems is required to ensure an effective interface with the ESMP. The intention is to build national stock monitoring systems that are both efficient and informative, which will only be possible through collaboration with all stakeholders in an open and transparent manner. The Health (Miscellaneous Provisions) Bill 2024 will also significantly enhance the Health Products Regulatory Authority’s (HPRA) capabilities to address medicine shortages by providing a solidified legislative requirement for the HPRA to be furnished with information for the purposes of managing medicines availability. Specific provisions to further develop monitoring and reporting systems are expected to be in place over the course of 2025-26.

At present companies should notify the HPRA of medicines shortages or potential shortages impacting the Irish market. The HPRA maintains a list of current shortages on its website and is in regular contact with suppliers in relation to these shortages with a view to minimising their duration and impact on patients. The webpage of the HPRA is updated daily as the HPRA receives new information related to ongoing and newly notified shortages.

When published, shortages remain active until supply returns to an acceptable level to meet demand, irrespective of whether there is a suitable alternative supply available that is meeting that demand. This is an important feature of the shortages list. Regardless of patients being treated with suitable alternatives – a different brand for example – the shortage of each individual medicine will remain listed until supply returns to an acceptable level. Many medicines supplied in Ireland have more than one strength, form, pack size or brand available from different suppliers. Typically, if a specific medicine is not available, a doctor or pharmacist will be able to supply an alternative strength, form, or product. This helps ensure continuity of treatment.

The details the medicines (based on the International Non-proprietary Name (INN)) associated with the most frequent number of shortage cases (limited to top 10 medicines) opened by the HPRA between 1st of January 2024 to 4th September 2025 are set out in the below table.

Within each case file the HPRA will have recorded whether a shortage occurred or not, but this is not readily extractable from the data maintained for historical shortages.