Extract from HMi’s December/January issue published December 3, 2021
On October 13, 2021, the European Commission (EC) announced a new package of proposals relating to the implementation of the Northern Ireland Protocol. Xisca Borrás, Of Counsel at Bristows, and associate, Hugo Kent-Egan, consider the ‘new model’ and the impact this will have on the availability of medicines in Northern Ireland
The Northern Ireland Protocol, agreed during the Brexit negotiations, has been the focal point of tensions between the EC and the UK government over the past months. In basic terms, according to the Protocol, once medicines are placed on the market in Northern Ireland, they must comply with most of the regulatory requirements under EU medicines law. These requirements include steps in the supply of medicines in the EU, such as all medicines being subjected to batch testing and release by a Qualified Person in accordance with EU law. The Protocol also requires certain goods, including medicines, to be checked when they enter Northern Ireland from Great Britain to ensure that they comply with EU standards which apply in Northern Ireland post-Brexit.
Many medicines are supplied into Northern Ireland from distributors and manufacturers based in Great Britain. Both the EU and the UK agreed a ‘grace period’ meaning that stakeholders would have more time in the transition towards full compliance with the requirements for medicines set in the Protocol. The EC stated that it envisaged the grace period allowing supply chains to adapt as needed. With the end of this period fast approaching, the UK government sought an indefinite extension, but the EC had not pronounced itself.
Some firms supplying medicines into Northern Ireland are fearful of the expensive and onerous new regulatory processes due to kick in next year and have indicated to the Northern Irish Department of Health that they intended to stop supplying medicines to Northern Ireland once the requirements were introduced – reports point to more than 900 medicines are due to be withdrawn and a further 2,400 are at risk.
The EC has voiced its concerns regarding the supply of medicines into Northern Ireland over the summer and aims to ease concerns with the publication of this package of proposals. These proposals are a significant concession by the EC, although with a very narrow scope, and follow threats by the UK government to unilaterally take appropriate safeguard measures regarding the Northern Ireland Protocol altogether, as renegotiations appeared to be deadlocked.
The EC’s package includes a dedicated ’non-paper’ related to medicinal products. The most relevant proposals are:
1 Purely national UK Marketing Authorisations (MA)
The EC proposes a permanent derogation from the relevant provisions of the European human medicines Directive for these MA so that regulatory compliance functions may be located in Great Britain for medicines supplied to the Northern Ireland market only. In addition, no manufacturing import authorisation would be required for bringing medicines into Northern Ireland from or through Great Britain, and no repeat of the certification by a Qualified Person and batch release would be necessary for medicines that are exported to Great Britain from a Member State in view of subsequent importation into Northern Ireland. This would be on the condition that the batches concerned have undergone the necessary controls in a Member State and are accompanied by the control reports signed by the qualified person meeting the legal requirements.
This proposal means that holders of purely national MA would not need to relocate infrastructure (including testing facilities) or regulatory compliance functions to Northern Ireland or the EU and could therefore continue to supply the whole UK market, including Northern Ireland, from where their infrastructure and regulatory functions are currently located. This proposal is very narrow in scope as it only applies to MA that have been granted by the MHRA independent of the European routes (i.e. does not apply to centrally authorised MA or MA granted by the MHRA further to the decentralised procedure or the mutual recognition procedure).
The EC is also subjecting this derogation to some important conditions (for example, the MA should contain a legal prohibition of sale (resale) outside its geographical scope, meaning that medicines with an authorisation for Northern Ireland cannot be legally sold anywhere else in the EU and the specific authorisation code for Northern Ireland should be stamped on each pack).
2 UK national MA issued through the DCP/MRP
The EC wants to continue discussing with the UK and relevant stakeholders how to ensure that the UK national authorisation procedures for Great Britain (governed by UK domestic law) and for Northern Ireland (governed by EU law) are in practice operated and coordinated in such a way as to ensure the continued use of a single medicine pack and a single leaflet for patient information for the whole UK market, in order to address the concerns raised by stakeholders.
3 Unique identifier decommissioning
The EC proposes a further three-year derogation from the obligation to decommission the unique identifier when medicines are exported from the EU to the UK in respect of both single- and multi-market packs.
This is aimed at providing further flexibility with respect to compliance with the safety features (namely, an anti-tampering device and unique identifier) that are mandatory for prescription medicinal products for human use pursuant to applicable EU legislation.
The proposals would require changes to EU law on medicinal products. For these amendments to apply to and in the UK in respect of Northern Ireland, they would have to be added to the list of EU legislation on medicinal products included in the Northern Ireland Protocol.
Currently we are not aware of a specific reaction from the UK on these proposals regarding medicines and it remains to be seen what the UK will come back with.
We view these proposals as a welcome step towards easing concerns regarding the supply of medicines into Northern Ireland. However, the most profound of concessions only relate to purely national UK MA, leaving most MA outside of its scope.