Colm Burke (Cork North Central, Fine Gael)
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1319. To ask the Minister for Health if he will consider the expansion of medicines noted in Schedule 8 of the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended, to include the full range of oral hormonal contraceptives and injectable long-term contraceptives (details supplied); and if he will make a statement on the matter. [12931/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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As you will be aware, and by way of context the free contraception scheme was launched on 14th September 2022, and is currently open to women aged 17-26 who are ordinarily resident in Ireland and will be extended to women aged 30 and under by September 1st, 2023. The potential to make some forms of prescription contraception available through pharmacies, without prescription by medical practitioners, was considered as part of the work of the Contraception Implementation Group and is wider than the free contraception scheme.

In Ireland at present, accessing oral contraceptives is regulated and requires a prescription from a medical practitioner in accordance with the requirements of the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended. These regulations apply a comprehensive system of control to medicinal products and identify those products which may only be supplied on medical prescription, and also specify the circumstances excluding medicinal products from prescription-only control. Schedule 8 to the regulations lists those medicinal products which may be supplied and administered by pharmacists pursuant to regulation 4B, where that pharmacist has completed approved training regarding the administration of such products and the management of any adverse reaction.

In order to enable pharmacists to supply the specified products alluded to in your question without the need for a prescription, detailed clinical consideration is required in the first instance to ensure that various patient safety issues are fully respected. Following previous engagement with representative groups, my officials at my direction, are currently engaged in a process, which includes obtaining recommendations from relevant clinical experts within the HSE as to the clinical appropriateness of making some forms of currently prescription controlled contraception, available through pharmacies without the need for a prescription. This process is ongoing.

Thereafter, and with due consideration of the policy position adopted and underpinned by appropriate clinical recommendations and advice, the modality of giving effect to this decision will be considered. Any mechanism introducing this change, or indeed giving effect in a given instance to any other policy decision, must be robust, appropriate in the given context, and legally sound.

Colm Burke (Cork North Central, Fine Gael)
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1320. To ask the Minister for Health the proactive steps he will take to address the management of medicinal shortages, and to ensure the ongoing continuity and security of Ireland’s supply chain; and if he will make a statement on the matter. [12932/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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Medicine shortages are increasingly prevalent worldwide over the past decade. The causes of such shortages are multi-factorial, including shortages of raw materials, manufacturing difficulties, increased demand, product recalls due to potential quality defects, and industry consolidations. Medicine shortages can originate at any point in the supply chain. They can involve and impact many stakeholders in different ways, as the supply models and clinical use of therapies can vary across national health systems.

Medicine shortages and their prevention are not unique to Ireland. Similar increases in demand and medicines shortages have been observed in the UK, throughout the EU and across the world at present. In the case of medicines used most often in Ireland, there are typically multiple alternatives available from various sources that remain available to ensure continuity of treatment. Of the products currently in short supply, alternative treatments are available for every single product.

Management of medicines shortages necessitates a multi-faceted, multi-stakeholder response to ensure patient safety, continuity of care and protection of public health. To that end, at the request of the Department of Health, the Health Products Regulatory Authority (HPRA) has assumed a coordinating function in Ireland’s response to managing medicine shortages when they occur. The HPRA is generally informed of a medicine shortage by the relevant pharmaceutical company. Shortages can also be notified to the HPRA by other stakeholders across the health system. In each case, the HPRA will work with relevant stakeholders as necessary, including the HSE, to coordinate an effective approach to the management of a confirmed product shortage. The HPRA engages with stakeholders to coordinate actions and share information to prevent or mitigate the impact of medicine shortages when they occur.

The HPRA publishes a list of medicines currently in short supply on its website (Medicines Shortages (hpra.ie) with the reason for the shortage and expected dates for the return of supply. The information is available to assist healthcare professionals in managing medicine shortages when they arise and reduce their impact on patients. The information relating to shortages on the HPRA website is dynamic and changes depending on the current information the HPRA has to hand, including removal from the list when a shortage has been resolved.

The Department of Health and the HPRA are working closely together to identify any further steps that can be taken to optimise the national response to shortages.