After years of Brexit uncertainty for businesses in the healthcare and life sciences sectors, the Windsor Framework (the Framework) was published on 27 February 2023 following extensive EU/UK negotiations. The Framework should pave the way for the smooth supply of medicines from Great Britain (GB) to Northern Ireland (NI), much to the relief of industry stakeholders and patients alike.
The Framework has been approved by EU Member States and, on 22 March 2023, received approval in the House of Commons.
An overview of the key elements of Framework is set out in our earlier article addressing the impacts on the logistics sector.
The Northern Ireland (NI) Protocol
The NI Protocol forms part of the EU-UK Withdrawal Agreement and came into force on 1 January 2021. It sets out NI’s relationship with the EU and GB post-Brexit and was necessary to account for the land border between the Republic of Ireland and NI, being the only land border between the UK and the EU.
Under the terms of the NI Protocol, NI is required to follow EU’s single market rules in relation to the movement of goods, avoiding checks on goods that move between NI, Ireland and the rest of the EU. Incoming goods from GB are subject to checks and/or paperwork to show compliance with EU regulations.
There has however been significant concern over the disruption this has caused to the supply of goods to NI, including medicines.
For medicines, the NI Protocol requires:
- All medicines brought into NI to be subject to EU rules and authorisation requirements. This has resulted in increased costs and red tape for GB-based pharmaceutical manufacturers and suppliers who are required to meet EU testing and labelling requirements in addition to UK rules.
- The European medicines regulator, the European Medicines Agency (EMA), not the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), to approve novel and innovative medicines for the NI market, notwithstanding that the majority of medicines to NI come from GB. This has caused supply delays and shortages of vital drugs.
Action was taken by the EU and NI to temper the impact of the NI Protocol, which included:
- The EU removing some of the regulatory hurdles, including allowing all regulatory functions to remain in the UK if they are currently located there.
- EU support for the MHRA to authorise generic drugs (e.g. paracetamol) under national UK procedures.
- Patients in NI to have access to innovative life-saving medicines, including cancer drugs, at the same time as any other person in the UK.
- The removal of the requirement for manufacturing authorisation and import licenses for medicines supplied from GB to NI, subject to certain conditions.
These were not viewed as a long term solution by many industry stakeholders. There was also concern that these arrangements did not address the role of the EMA in licensing novel medicines, leaving NI exposed as UK and EU rules diverged in future.
The Framework – key provisions for medicines
Having heeded the concerns of the healthcare and life sciences industries, the EU and UK governments have pledged under the Framework, to safeguard and simplify the supply and access of medicines from GB to NI.
Key provisions include:
- The MHRA will be responsible for approving all drugs for the whole UK market. This will enable all types of medicines to be supplied in single packs, within UK supply chains, with a single license for the whole of the UK. Individual packs of all medicines placed on the NI market should bear a label indicating “UK only”, indicating compliance with UK regulations.
- Medicines approved by the EMA will no longer be placed on the NI market. Medicines can, however, be manufactured in NI for placement on the EU market, indicating that NI businesses that wish to place medicines on the EU market will require authorisations from the EMA.
- The EU’s Falsified Medicines Directive will no longer apply in NI. The disapplication of the Directive ends the unnecessary situation in which (even with grace periods) wholesalers and pharmacies in NI were expected to keep barcode scanners to check individual labels.
- UK regulation to apply for the provision of innovative drugs. For the provision of innovative drugs to patients, NI will be reintegrated back into a UK-only regulatory environment. The EMA will not play a role in this.
- The implementation of a grace period for veterinary medicines. A grace period will apply until the end of 2025 to enable veterinary medicines authorised or approved in the UK, or which are moved via GB, to continue to be placed on the market in NI. This is in order to safeguard supplies whilst allowing time to establish a long-term solution to maintain the uninterrupted supply of veterinary medicines from GB into NI.
The Framework states that this “responds to the overwhelming calls from industry for stability and certainty, and can give reassurance to patients and clinicians in Northern Ireland well into the future”. It is also said to safeguard “frictionless access to the EU market for world-leading Northern Ireland pharmaceutical and medical technology firms”.
The Framework has been welcomed by many life sciences industry stakeholders. As reported in the BMJ, Alan Stout, chair of the NI BMA’s General Practitioners Committee has described it as a “massive relief” and that the solutions proposed are “almost exactly” what he and others had suggested.
However, there is also a notable omission within the Framework to medical devices, notwithstanding concerns raised by the House of Lords Sub-Committee on the NI Protocol about “the burdensome impact of import requirements for medical devices moving from GB to NI”. This omission suggests that, for now, EU law will continue to be followed in the NI market in respect of the movement of medical devices and that the safeguarding and supply of medicinal products to NI takes precedence for the time being.
We will continue to monitor the Framework and report on future developments.