Ms Anne Marie Seymour:

The Cathaoirleach expressed concerns regarding substitution. That is an issues we recognise. We hear it is a concern of patients. There are two streams of work that can be done in that regard. The first relates to when a shortage has occurred or is occurring and how we can best support the patient. In that regard, under the medicine shortages framework, there are close relationships between us, the Health Products Regulatory Authority, the various streams in the HSE, including those involved in reimbursement, clinical guidance and supply for hospital and community pharmacies, and our regulators. What we have been doing and what we are doing for this winter is to meet quite regularly, every three weeks or so, to do a bit of horizon scanning as to what issues there are and what clinical guidance might be needed. Those are the kinds of things that can support communication to prescribers and pharmacists and allow them to know what is happening and to be better prepared to support patients when they come in. That is the patient-facing side of the matter.

Some of the legislation is intended to better prepare Ireland through the management of the supply of medicines. That will include reporting of the level of medicines we have and what the requirements are. If there were to be a pandemic or a particular issue in the morning, we would need a certain group to be convened quickly by the Minister. Developing a strategy around medicine shortages and the security of medicine supply would help to mitigate the impact on a patient in the first place. There are two pieces of work to that.

On the emergency supply of controlled drugs, a patient might leave hospital and a palliative care situation on a Friday evening. The reason for the emergency supply is to get such a patient over the day or two before they can access their GPs for a prescription. If things have changed and a patient needs medicine quickly, that is the idea of emergency supply.

The Cathaoirleach mentioned antibiotics and shortages thereof. That is an area where we would invoke the medicine shortage protocol. Work is already being done in the health service. Last year, the antimicrobial resistance and infection control, AMRIC, part of the HSE prepared guidance in the event that an antibiotic is not available and what should be substituted. That was updated on a daily basis over the winter. It prepared guidance for parents in the event of a paediatric antibiotic shortage and advised how they could get a child to take a tablet. Those kinds of things are intended to support patients. As medicine shortages occur, AMRIC will feed in, as required. Everything does not have to be in legislation but the purpose of this legislation is to allow us to build a framework. We can then engage with the various people in the HSE as we need to.

The Cathaoirleach asked about shortages in supplies coming from particular countries. Medicine supply chains are very complex and supplies come from here and there. Work is going on in respect of the security of supply chains. We engage regularly with our colleagues in the Department of Enterprise, Trade and Employment on Ireland's position on open strategic autonomy. The Irish position on the security of medicine supply chains is that we identify what medicines are critical and then look to monitor and enhance those supply chains. It is not a case of being able to say that we can make all medicines in Ireland, Belgium or France. We need the various pieces that are coming from different countries. The Irish position is that we examine which medicines are very important and consider how to monitor and support those supply chains to ensure the security of supply of medicines. It is not necessarily the case that one particular country causes the issues. The supply chains are so complex that it is about building the pieces together.