Simon Harris (Wicklow, Fine Gael) | Oireachtas source

A rare moment of harmony is to be welcomed. I thank Deputies Brassil, O'Reilly and McLoughlin, along with other Deputies, for their advocacy on this issue and for highlighting people's concerns. I will reflect on Deputy O'Reilly's comments and revert to her.

We will adopt a pragmatic approach. Once the new system becomes live on 9 February, it should be considered to be in a use-and-learn mode. Pharmacists will be able to continue for a defined period to dispense packs unless they have an overriding concern that a falsified medicine is involved. Within the defined period, which will possibly be between six months and a year, further intensive work can be carried out to devise and communicate a workable EU-wide process for the management of alerts and ensure that all parties affected by the regulation comply with its requirements and can join the new system. There will be a review by regulators after three months to assess the initial implementation period and whether the pragmatic approach needs to be continued for a further period. After 9 February, pharmacists will continue to carry out the professional product checks that they have carried out to date, which are important when dispensing any medicine to a patient.

Some other EU member states have voiced concerns about implementation at a technical group meeting in Brussels last week. While we cannot speak for them, it is likely that other member states, due to their size, will have similar implementation and alert problems and may well also operate a national pragmatic approach, such as that taken by Ireland.

See this speech in context