The Northern Ireland (NI) Protocol was signed by the EU and UK as part of the Brexit Withdrawal Agreement and sets out an outline for changes that will take effect when the UK leaves the EU at the end of December 2020. It aims to avoid a hard border on the island of Ireland in the event of a no-deal Brexit, protect the Good Friday Agreement and ensure that Brexit does not destabilise NI.
Updated: 19 November 2020
However, dispute about the interpretation and implementation of the NI Protocol is proving to be an obstacle to ‘goodwill’ in the Brexit process.
This briefing provides some context around the agreement, the issues it raises for health and social care services, what the protocol means in terms of change for players in the health sector, and explores developments since its agreement.
- The significant integration between NI and the Republic of Ireland (RoI) on a range of health and social care issues means Brexit could affect the sector’s professionals as well as services and patients in areas including:
* trade and regulation of medicines and medical devices data
* mutual recognition of professional qualifications (MRPQ) public service delivery
* EU funding and cross-border working.
- Implementation of the protocol is a major issue for the EU – if the UK government sought to renege on its commitments, the integrity of the EU customs border could be at risk.
- Outside of the honouring of the protocol as signed in January 2020, the key priority now is to find a way to practically operationalise it.
- There is little time to put in place the operational measures for the protocol to function, and there are reports of little preparation having been put in place to date in areas such as trade, despite new border arrangements due to come into force on 1 January 2021.
- The NHS Confederation will continue to follow developments, analyse the implications for the health sector in the UK and push for as much clarity as possible on the implementation of the NI Protocol from 1 January 2021.
On 5 November 2020, the UK government made a statement following the fourth meeting of the Ireland/Northern Ireland (NI) Specialised Committee between the government and the European Commission. The Committee agreed a phased implementation of medicines regulation in NI up to the end of Brexit transition on 31 December 2021, providing the additional time for businesses to prepare in relation to batch testing, importation and Falsified Medicines Directive (FMD) requirements.
There will be a pragmatic one-year time-limited approach to the implementation of FMD ‘safety features’ and regulatory importation requirements which will help ensure no disruption to the critical flow of medicines to NI at the end of transition. The EU has been clear that there will be no further extensions - 12 months remains a challenging timescale within which to mitigate risks to supply into NI and significant work and effort will be required to be ready for the end of 2021.
- The Medicines and Healthcare products Regulatory Agency (MHRA) published guidance on 1 September on the regulation of medicines and medical devices at the end of the transition period. The UK will unilaterally recognise certain EU regulatory processes for a time-limited period. This recognition is known as ‘standstill’.
- In October, the MHRA published further guidance relating to the movement of goods after the end of transition and will continue to publish post-transition guidance to support its stakeholders. All guidance published to date can be found on the Gov.uk website.