I propose to take Questions Nos. 950 to 952, inclusive, 956, 957, 959, 960 and 1034 together.
As part of the whole-of-government response to Brexit, the Department of Health has established dedicated structures to manage the approach to preparing for the UK’s exit from the EU. The Department, the Health Products Regulatory Authority (HPRA) and the Health Service Executive (HSE), with the full support of stakeholders, are implementing a comprehensive and coordinated set of preparations to ensure continuity of health services and continued supply of medicines and medical devices in a ‘no deal’ Brexit.
Chapter 24 of the Government’s Contingency Action Plan for Brexit, updated in July 2019, details work underway in this area as outlined in https://www.dfa.ie/brexit/getting-ireland-brexit-ready/governmentcontingencyactionplan/
The preparations include developing contingency plans to mitigate potential supply problems arising from Brexit. The Department, the HSE and the HPRA have facilitated ongoing engagements with manufacturers and suppliers of medicines and medical devices, to ensure that they are Brexit-ready, to discuss any potential issues that could affect supply to Ireland and to identify solutions to maintain supply to the market.
As a result of measures undertaken at industry, national and EU level, Brexit is not expected to have an immediate impact on the supply of medicines in Ireland. Pharmaceutical manufacturers and wholesalers have provided assurances that there will be sufficient stocks to bridge any initial issues at ports, should they occur. However, given the size of our market, Brexit may cause those with a small share of a particular medicine market to consider the ongoing viability of supply to Ireland. However, it is considered that any such products are unlikely to be critical to continuity of care, as there are and will be alternative suppliers or therapeutic alternatives available.
Medicine shortages are a feature of modern health systems, but Ireland has a multi-stakeholder system in place to prevent and manage shortages when they occur. Any shortages currently affecting the Irish market are not directly attributable to Brexit.
The HPRA has worked with stakeholders, including the HSE, to develop an effective approach to the management of medicine shortages in Ireland. In 2018 the HPRA launched the “Medicine Shortages Framework”, which is built in a pragmatic and collaborative approach involving the wide range of stakeholders within the medicine supply chain. The HPRA coordinates all stakeholders to share information in order to prevent or mitigate the impact of medicine shortages when they occur. The health system is therefore well placed to anticipate and respond to any additional shortages, should they arise because of Brexit.
As an additional safeguard, consideration continues to be given to those categories of medicines which are considered most essential to public health. The HSE and HPRA are continuing to undertake criticality assessments, seeking additional and updated assurances from stakeholders, including pharmaceutical manufacturers, wholesalers and healthcare professionals, to verify contingency planning to date and, where necessary, identify clinically appropriate alternatives for those products most critical to public health with potential to be vulnerable to supply issues.
Manufacturers and suppliers of medicines and medical devices have been asked to further review their supply chain for products that travel from or through the UK, determine any products or services that are certified for compliance with EU standards by a UK body and communicate any potential vulnerabilities to the Department of Health, HPRA or HSE.
Work on this will continue up to, and in the months following, Brexit. This will include ongoing monitoring of supplies in Ireland and engagement with industry to adapt supply chains, where necessary, to minimise any potential disruption.
The Department of Health and the HPRA will also continue to engage with the European Commission, the Brexit Preparedness Group and Task Force 50 to identify the most appropriate means to mitigate any remaining risks to the supply of medicines and medical devices posed by a no-deal Brexit. However, it remains vital that industry continues to prepare for a no-deal Brexit.
It is important to note that there are already additional stocks of medicines and medical devices routinely built into the Irish medicine supply chain. This is a different supply model to that which operates in the UK. The pharmaceutical industry and wholesalers have provided assurance that they are confident they will have sufficient stocks to bridge any initial issues at ports, should they occur. The key message to emphasise to citizens and patients is that there is no need for hospitals, pharmacists or patients to order extra quantities of medicines, or for doctors to issue additional prescriptions, as doing so could disrupt existing stock levels and hamper the supply of medicines for other patients.