Mary Lou McDonald (Dublin Central, Sinn Fein)
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793. To ask the Minister for Health to set out the short-term measures in place to address the shortages of Ozempic; the reason for the ongoing shortages; the long-term solutions being put in place to prevent these shortages recurring in the future; and if he will make a statement on the matter. [24437/23]

Cormac Devlin (Dún Laoghaire, Fianna Fail)
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930. To ask the Minister for Health if he will provide an update on the supply of a medication (details supplied); and if he will make a statement on the matter. [24991/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 793 and 930 together.

Novo Nordisk, the marketing authorisation holder for Ozempic, has notified the Health Products Regulatory Authority (HPRA) of intermittent supply issues with Ozempic products due to increased global demand. The company anticipates that intermittent supply will continue throughout 2023. Similar supply constraints are being experienced in other EU countries.

Novo Nordisk has implemented monthly allocations to help ensure continuity of supply and equitable distribution of Ozempic stock to Irish patients. The company has issued letters to relevant stakeholders, including healthcare professionals, to ensure they are aware of this supply issue and its management.

In one such communication to healthcare professionals (dated 24 March 2023), the company stated that Ozempic is only indicated for treating adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. Any other use, including for weight management, represents off-label use and currently places the availability of Ozempic for the indicated population at risk. Reimbursement support from the HSE is available for the licensed indication and approved dosage only.

The Department of Health, along with relevant experts from the HSE, HPRA, Pharmaceutical Society of Ireland (PSI) and the Medical Council met recently to review supply issues relating to the GLP-1 agonist, Ozempic. In addition to continuation of efforts to work together during time of limited supply, the group agreed to issue a joint communication to the health system on this situation. This letter issued on 19th May.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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794. To ask the Minister for Health the measures being put in place to address the shortages of 241 medicines, including 13 which are on the World Health Organisation, WHO, critical list; and if he will make a statement on the matter. [24438/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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At any given time, shortages of medicines can occur in any country. Increases in demand for medications and medicines shortages have been observed in the UK, throughout the EU and across the world in recent months.

Ireland experienced some shortages of antibiotics earlier this year – as did most other European countries. The increase in shortage notifications from the pharmaceutical industry in the first quarter of the year was directly related to the increased demand due to the winter surge.

There has been reduction in notifications since this time, coinciding with a stabilisation in the supply, for example, with paediatric antibiotics. Shortages have not disappeared, but there are factors, such as the winter surge, that can put additional pressure on a health system and on medicine supply. It will take time for supply chains to stabilise following this period of excess demand.

In Ireland, whilst individual brands or strengths of a medication may be temporarily unavailable, for the vast majority of medicines supplied in Ireland, there are alternatives, such as different strengths, brands or similar classes, to ensure continuity of care.

Unfortunately, medicine shortages are a feature of modern health systems worldwide which have been exacerbated by recent worldwide events. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; sudden unexpected increase in demand; or product recalls due to potential quality issues. Ireland has a multi-stakeholder medicine shortage framework in place, operated by the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health. The medicine shortage framework aims to prevent, where possible, and mitigate the impact of medicines shortages. The framework allows for shortages to be carefully managed by the HPRA in close collaboration with the Department, the HSE, industry and healthcare professionals. The HPRA maintains regular contact with the Department of Health regarding medicines shortages.

The HPRA publishes a list of medicines currently in short supply on its website, at www.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 to hand.

Regarding the WHO list of essential medicines, this is a general list aimed at, in the main, developing countries. For example, the list includes treatments for African trypanosomiasis, snake anti-venom and non-medicinal products, such as condoms. It is not a comprehensive list of medicines critical for Irish citizens.

Mary Lou McDonald (Dublin Central, Sinn Fein)
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795. To ask the Minister for Health to elaborate on the media comments made by his Department regarding the Government's consideration of the introduction of a serious shortage protocol, SSP; and if he will make a statement on the matter. [24439/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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In other jurisdictions outside of Ireland Serious Shortages Protocols (SSP) are used to facilitate community pharmacists to supply either an alternative quantity, strength, pharmaceutical form, or medicine. Legislation in Ireland already allows for generic substitution (alterative strengths, quantity and forms) but does not allow for therapeutic substitution.

Shortages protocols are product specific and are only used in very limited situations. For example, in the UK every draft SSP is reviewed by NHS England’s National Medical Director and Chief Pharmaceutical Officer, who can suggest amendments and raise any potential safety concerns, and Ministerial authorisation is necessary to give effect to the protocol. Each SSP is time limited.

The Department of Health is scoping the introduction of a similar framework, a limited stock supply framework (LSS) in Ireland which will only be used in certain emergency situations such as shortages. This is the case in all other countries that have a protocol in place. Legislative amendments will be required.

There are risks associated for both the pharmacist and patient with substituting prescriptions and the Department will need to be satisfied that these risks are addressed which will impact the timeframe for implementation. An initial proposal on implementation of this policy option is complete and work to develop the governance, legal, training and patient safety aspects of this proposal will be completed this year. The Department will engage with key stakeholders as this policy is developed.