I propose to take Questions Nos. 332 and 456 together.
As part of the overall Government response to Brexit, my Department is working on a comprehensive and coordinated set of actions to ensure, as far as is possible, continuity of supply of medicines in the event of a "no-deal" Brexit.
Significant work has been undertaken by my Department, the HSE, and the Health Products Regulatory Authority (HPRA), together with medicines manufacturers and suppliers, to ensure that risks to the continuity of supply are mitigated to the greatest possible extent.
No major supply issues have been identified through this preparedness and contingency planning work.
The Department of Health, HSE and HPRA do not anticipate an immediate impact on medicine supplies should there be a no-deal Brexit on 29 March. There are already additional stocks of medicines routinely built into the Irish medicine supply chain, and these additional stocks, together with planning by Revenue to allow the fast-tracking of essential drugs into Ireland, where necessary, will help deal with any delays that may arise.
It is important to note that there is no need for hospitals, pharmacists or patients to order extra quantities of medicines, or for doctors to issue additional prescriptions. To do so could disrupt existing stock levels and hamper the supply of medicines for other patients.
In 2018, the HPRA developed and launched a multi-stakeholder Medicine Shortages Framework to anticipate and manage medicine shortages when they occur. This framework is used to manage and address an average of 45 shortage notifications a month. 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 is being given to those categories of medicines which are considered most essential to public health. HSE and HPRA technical experts are undertaking a process to verify the contingency planning in place for the continuity of supply of medicines essential to public health, including those with a narrow therapeutic index, in order to determine those medicines that have the potential to be vulnerable to supply disruption and, where necessary, identify clinically appropriate alternatives. Work on this process is ongoing and will continue in the months before and after Brexit.
Both the HPRA and HSE have requested that medicines manufacturers and suppliers highlight any issues regarding the availability of specific products associated with Brexit and, to date, no major issues have been identified through this process.