Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I propose to take Questions Nos. 50, 67 and 68 together.

The safety features delegated regulation introduces new rules for the supply of medicines from 9 February 2019. As Deputy Brassil noted, the safety features include a form of an anti-tamper device and unique identifiers embedded in a two-dimensional barcode on the pack. The purpose of the regulation is to improve patient safety and maintain confidence in the safety of medicines supplied to patients.

A statutory instrument will provide that the Irish legislative system is consistent with the requirements of the regulation. Nothing in the new regulations seeks to alter the existing legal and regulatory responsibilities of persons authorised to place medicinal products on the market or supply them to the public. It will apply to manufacturers, wholesalers, pharmacy owners and pharmacists equally.

The regulation provided for a three-year transition period, starting in 2016, to facilitate preparation for its introduction. Details of the requirements of the delegated regulation have been communicated to all sectors during this period by the Irish Medicines Verification Organisation, the Health Products Regulatory Authority, the Pharmaceutical Society of Ireland and the Irish Pharmacy Union.

I recognise the sincere concerns raised by stakeholders and articulated by the Deputies regarding the practical implementation of the regulation. Above all, I want to ensure that the normal supply of medicines to patients is maintained. I intend, therefore, to implement the system in a pragmatic manner and defer operating the offences provisions in the legislation for an initial period. This will allow everyone involved to develop familiarity with the new arrangements and overcome any teething issues before we proceed to the introduction of the provisions that deal with offences.

I considered the implementation issues and, on 25 January, decided that a pragmatic approach should be taken to the use of the system. This approach will ensure there is no break in the supply of medicines to patients, which is crucial, until the new system is bedded in, alleviate the concerns of pharmacists as to whether the offences and enforcement provisions would be commenced on 9 February and ensure that the offence's commencement and the proposed pragmatic implementation period will be subject to ongoing review. These three policy decisions, which I took at the end of January, were communicated by the implementation stakeholders to all parties concerned on Monday, 4 February in a co-ordinated manner, and have been well received by such stakeholders. We are trying to do what we need to do under the regulation and achieve what we need to achieve, but in a pragmatic way that does not rush in offences until the new system is bedded in.

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