The future supply of medicinal products in Northern Ireland
There has hopefully been a breakthrough agreed by the EU and the UK in relation to the post-Brexit deadlock that was created by the Northern Ireland Protocol – on 27th February, the Windsor Agreement was agreed in principle.
Captured within the Agreement is an attempt to simplify the supply of medicines between Great Britain and Northern Ireland (NI), and ensure that only one authorisation is needed, and only one set of rules need be followed, to place medicines on the market within the whole of the UK.
However, whilst the UK Government and the EU leadership applaud the Windsor Agreement, much detail still needs to be published so that pharmaceutical companies can fully understand the impact of the changes on their supply chains.
The current position on supply of medicines in Northern Ireland
Following Brexit, from 31st January 2020, the UK is no longer subject to EU single-market rules or the EU legislative framework. However, under the EU-UK Withdrawal Agreement’s Northern Ireland Protocol, NI continues to follow EU rules. This is to avoid customs checks (and therefore a hard border) between Northern Ireland and the Republic of Ireland.
This arrangement means that medicinal products on the market in NI must be authorised in line with the EU regime, which no longer applies in Great Britain. This causes difficulties for companies marketing their products in the UK, as different authorisations, following different rules, apply in different parts of the UK. Having different licences and packages for Northern Ireland is unviable for many companies, given the size of the market. The difference in regulation can also mean that patients have access to different products in Great Britain and NI.
In addition, the requirements under the EU Falsified Medicines Directive (such as anti-tamper packaging and tracking using a unique identifier) continue to apply in Northern Ireland. This causes complications where products move through Great Britain and into Northern Ireland, leading to fears of the discontinuation of medicines in Northern Ireland.
What the Windsor Agreement means for medicines
The Windsor Agreement promises to restore the smooth flow of trade within the UK internal market. The headline grabbing part of the deal relates to the “red” and “green” customs lanes that distinguish between goods intended for the Northern Ireland market and those intended for the EU market: a green lane will be introduced for goods moving from Great Britain to NI, with reduced requirements and checks. A red lane will apply where goods are intended for onward supply to the Republic of Ireland, with additional checks as goods enter the EU market.
In relation to medicines, and to overcome the current practical difficulties for the supply of these products, the EU and UK have agreed to the suspension of application of certain EU provisions to medicinal products intended to be placed on the market in NI.
Within the proposal, the following key elements have been agreed:
- Centralised marketing authorisations granted by the European Commission will no longer be applicable in Northern Ireland, and products cannot be placed on the NI market under a centralised marketing authorisation. Instead, the UK regulatory agency, the MHRA, will regulate and authorise medicines in Northern Ireland under a UK-wide marketing authorisation granted in line with UK law.
- Centrally authorised products may be placed on the market in Northern Ireland only if the MHRA has also granted a UK marketing authorisation for the product.
- Medicines can be imported into Northern Ireland without the need for a manufacturing import authorisation.
- The Falsified Medicines Directive will no longer apply in Northern Ireland, and safety features should not be included on UK packs.
- UK medicines will need to carry a ‘UK-only’ marking, and one pack can be used across the UK, including Northern Ireland.
- Companies based in Northern Ireland will be able to supply medicines in both the EU and UK, where the products meet the relevant requirements for the destination market. The UK Government has stated that the health industry in NI will continue to have full access to the UK and EU markets and therefore jobs and investments are secure.
- Products that are already on the market when the arrangements come into force do not need to be withdrawn and can remain on the market.
- The MHRA will oversee this process and monitor movement of products to ensure that UK-only products do not enter the EU.
- These amendments shall apply from 1st January 2025.
Lack of clarity about what this means for companies
Although hailed as a success in the media, it is currently unclear how these principles will operate in practice, and how they apply to products that are already on the market. For example, where a product currently has a centralised marketing authorisation, which applies in Northern Ireland, many companies have also sought an authorisation from the MHRA to cover Great Britain. It is unclear whether currently granted centralised marketing authorisations will stay in place for NI, or whether certain Great Britain authorisations will be automatically converted into UK-wide authorisations, or whether companies will be required to make a variation to their current Great Britain authorisations. Similarly, it is unclear if a UK authorisation will always be required, and whether the ‘UK-only’ marking must be used for all products. Many products currently on the market in Northern Ireland are authorised through the decentralised procedure and it is not clear if these products can remain part of these procedures or must now be part of a UK-wide authorisation with a ‘UK-only’ mark.
The public documents do not make clear to what extent Northern Ireland still needs to follow EU rules, over and above the authorisation requirements set out in the agreement, or whether the provisions set out above mean that only the UK rules need to be followed for these authorisations. There are therefore practical questions for companies, such as how the pharmacovigilance rules will apply to their authorisations, the relationship between the UK and EU vigilance regimes, and to whom reports should be made.
What about medical devices?
The current agreement does not address the supply of medical devices, although such products may be able to benefit from the customs procedures that have been put in place, i.e., the green lanes, which will reduce requirements on companies to meet both EU and UK rules where the devices are for the Northern Ireland market.
The principles are expected to be approved shortly by the EU-UK Joint Committee. The UK Government and the EU institutions will then enact legislative measures to make the necessary amendments to their laws. It is at this stage that pharmaceutical and medical device industries will need to engage with the consultation documents to ensure there is clarity and certainty on these points to avoid an unworkable framework for the future.
About the authors
Jacqueline Mulryne is a Partner in the Life Sciences team at law firm Arnold & Porter, London. She provides regulatory, policy, and compliance advice to clients in the pharmaceutical, medical technology, cosmetics, and foods sectors. She advises on complex regulatory issues that arise throughout the product life cycle, including maximising regulatory protections and the overlap with IP rights, borderline classification, clinical research, authorisation, advertising and promotion, and market access strategy.
Libby Amos-Stone is Counsel in the Life Sciences team at law firm Arnold & Porter, London, and acts for life sciences companies in product liability and public law litigation before the UK and EU Courts and advises clients on the pharmaceutical, medical device, food, cosmetic, and cannabis regulatory framework in the UK and EU.