Simon Harris (Wicklow, Fine Gael) | Oireachtas source

It is fair to say that in recent weeks concerns were raised by hospital pharmacists and other pharmacists about who might be prosecuted for a breach of the statutory instrument, as noted in my initial reply. Pharmacists who are employees of a pharmacy owner or the HSE are concerned that if they were to dispense a medicine where the pharmacy was not connected to the new system through an omission of the employer or issue a medicine that failed in its alert, they could end up being prosecuted. The concerns that were raised were valid and helped to inform the decision that while certain elements of the statutory instrument will be commenced before 9 February, the offences provision will not be commenced for a period afterwards to let the final registrations of the new system take place, the system be bedded down and a definitive alert system be developed.

There are some challenges remaining, including the impossibility of predicting the volume of alerts and identifying the percentage which are true alerts. It would probably be a small percentage. There is also the matter of possible medicine shortages while alerts are investigated and medicine supply must be a key priority. We must also manage good communication between parties and queries from pharmacies about refunds for products with alerts. Ireland will proceed to implement the regulation, but it will do so in a common sense and pragmatic way. As I said, I do not expect that we will be alone in this with regard to the position of other EU member states.

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