Louise O'Reilly (Dublin Fingal, Sinn Fein)
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819. To ask the Minister for Health the status of the situation regarding medicines in view of the new post-Brexit trading arrangement; if supply chains for medicines are holding up; and if there are concerns regarding medicine shortages. [5707/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The continued supply of medicines to Ireland is one of the Government's key priorities arising from Brexit. The Department of Health, the HSE, and the Health Products Regulatory Authority (HPRA), together with the makers of medicines, wholesalers and pharmacists, continue to monitor the supply of medicines to Ireland closely. The processes and systems to mitigate against any Brexit related issues are functioning well and are kept under constant review by each agency. As part of this coordinated response, all stakeholders continue to develop approaches and implement contingencies to address any identified concerns should they arise.

Although a limited number of individual suppliers and logistics companies have required some initial assistance in understanding and complying with the customs requirements that arose as a result of Brexit, such issues have been resolved in a timely manner, with the assistance of Revenue Customs, and have not reoccurred with subsequent deliveries.  

Arising from detailed and ongoing engagement with the pharmaceutical industry and wholesalers which began in early 2019, there is no evidence to suggest that Ireland is likely to face general medicines supply issues, now or in the near future, as a result of any potential delays in the supply chain due to Brexit. This is also supported by a refresh of previous assessments that were recently undertaken to obtain assurances that all the necessary preparations have been taken by all stakeholders before the end of the transition period and to ensure the resilience of the medicines supply chain into the future.  

Unlike the UK supply chain, there are additional stocks of medicines routinely built into the Irish medicines supply chain. The pharmaceutical industry and wholesalers have provided direct assurances that they are confident they have sufficient stocks to bridge any initial issues at ports. However, medicines shortages inevitably arise from time to time and are a feature of health systems around the world. The potential shortage of any specific medicine will be managed through the existing Medicine Shortages Framework to prevent the shortage from occurring where possible or, where it does occur, to manage the impact in terms of identifying alternative treatments. 

In the case of medicines used most often in Ireland, there are typically multiple forms, strengths, brands, and generic medicines available from a range of sources. In the event that there are some supply issues for individual medicines, it is expected that alternative options such as alternative strengths, brands and generic medicines will be available to ensure continuity of treatment. If a patient has any concerns about their medicine, they are encouraged to speak with their pharmacist or GP.

Ireland is unlikely to face general medicine supply issues and is well placed to deal with these as they arise. However, this is very much based on the normal use of medicines. There is no need for healthcare professionals to order extra quantities of medicines, or for doctors to issue additional prescriptions. Similarly, patients and the general public are asked not to seek supplies of medicines over and above their normal requirements. Doing so will disrupt existing stock levels and hamper the supply of medicines for others.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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820. To ask the Minister for Health if concerns have been relayed to his Department by pharmaceutical companies regarding shortages of ingredients or medicines due to the new post-Brexit trading arrangements. [5709/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Department of Health, along with the HSE and HPRA, have had extensive and detailed engagement with the pharmaceutical industry over the past number of years to ensure the resilience of the medicines supply chain beyond Brexit. This open engagement continues and we will continue to work with all key stakeholders to ensure that patients in Ireland have access to the medicines they need.   

It is important to note that irrespective of Brexit, medicines can continue to be sourced from the UK where needed for individual Irish patients. The Department of Health, HPRA and the HSE have been carefully monitoring the supply of medicines from the UK since the end of the Brexit transition period. Although a limited number of individual suppliers and logistics companies have required some initial assistance in understanding and complying with the customs requirements that arose as a result of Brexit, such issues have been resolved in a timely manner, with the assistance of Revenue Customs, and have not reoccurred with subsequent deliveries.  

Medicine shortages are, unfortunately, a feature of both the global and the Irish market, regardless of Brexit. However, Ireland has an existing multi-stakeholder medicine shortages framework in place, co-ordinated by the HPRA, to help prevent shortages from occurring and to reduce the impact on patients and healthcare professionals by co-ordinating the management of potential or actual shortages as they arise.  

More generally, because of all stakeholders' preparatory work, general medicine supply issues are not anticipated as a result of Brexit. The Department of Health, the HSE, and the HPRA together with the manufacturers of medicines, wholesalers and pharmacists continue to monitor the situation closely. The processes and systems to mitigate against any Brexit related issues are functioning well and are kept under constant review by each agency. As part of this coordinated response, all stakeholders continue to develop approaches and implement contingencies to address any identified concerns should they arise.