I propose to take Questions Nos. 173, 177 and 181 together.
The Safety Features Delegated Regulation (EU 2016/16) provides that from February 2019, most prescription medicines and a very small number of non-prescription medicines will have to carry ‘safety features’ on their outer packaging. These safety features take the form of an anti-tamper device (e.g. foil seal, breakable cap) and a set of unique identifiers embedded in a 2D barcode on the pack.
The Delegated Regulation is directly applicable across all EU Member States. However, a Statutory Instrument is being prepared to ensure that the Irish legislative system is consistent with the requirements of the new Regulation.
The Delegated Regulation was finalised and published in 2016. The intervening 3 year transition period allowed more than ample time for all concerned parties to prepare well in advance of the legislation coming into full effect on 9th February 2019. Details of the requirements of the Delegated Regulation have been widely communicated to all sectors throughout this 3 year transition period, including to the HSE.
The intention of the provisions of the national Regulations in respect of persons authorised to supply medicinal products to the public, is that the offences for non-compliance with this EU Commission Delegated Regulation will be in line with offences already set out in other national medicinal product legislation. The new national Regulations, The Medicinal Products (Safety Features on Packaging) Regulations 2019, currently in draft form, are made under Section 32 of the Irish Medicines Board Act, 1995, as is the case with existing medicinal product Regulations which already provide for such rules and offences for non-compliance occurrences.
As with other medicinal products Regulations, this national legislation will provide that the ‘persons’ upon whom any proposed sanctions or penalties are placed may be a body corporate as well as an individual. This is dealt with by section 18(c) of the Interpretation Act 2005, which provides that a reference to "person" in any enactment includes a body corporate as well as an individual.
To reiterate this important point, the liable parties and the corresponding offences for this Delegated Regulation are in line with existing legislative arrangements governing the sale and supply of medicinal products to the public. There is nothing new in terms of the obligations under this legislation in terms of the focus of where the legal obligations lie. It is the responsibility of the body corporate to ensure that the infrastructure is in place and correctly functioning to facilitate the pharmacist decommissioning the medicinal product from the national repository prior to supplying to the patient. It is also the responsibility of the pharmacist that dispenses the medicinal product to comply with their requirements under this legislation. It will be for the appropriate regulator to decide who might be prosecuted for an offence specified in the Statutory Instrument.
The Department recommends that HSE personnel who have questions or concerns relating to their obligations and the obligations of their organisation under Commission Delegated Regulation (EU) 2016/161 and the draft Medicinal Products (Safety Features on Packaging) Regulations 2018, should seek guidance from HSE Management in the first instance, including the readiness of the infrastructure to facilitate decommissioning of medicines, and from their professional Regulator.
The Department is considering all points submitted in the consultation.