What does the Northern Ireland Protocol mean for the life science industry?
The conclusion of the Northern Ireland Protocol will have a direct effect on the life science industry who have current or potential sales to Northern Ireland.
Q. What is the Northern Ireland Protocol?
A. Before Brexit, the Republic of Ireland (ROI) and Northern Ireland (NI) shared the same European Union (EU) rules on trade meaning no checks were needed on goods travelling from one country to another. When the UK (England, Scotland, Wales and Northern Ireland) left the EU, new rules were needed to ensure there were no border controls established. The Northern Ireland Protocol came into force on 1 January 2021 and is now part of international law.
Q. Why is there a Protocol?
A. Because the UK Government and the European Union (EU) agreed, in the Northern Ireland/ Ireland Protocol concluded in December 2020, that there should be an open border for goods between NI and the ROI to limit social and economic disruption and to maintain the peace agreed by the Good Friday Agreement of 1998.
Q. Is the Protocol indefinite?
A. The Protocol lasts for four years and then, if the NI Assembly approves it, it will be extended for another four years and so on. If the Assembly rejects any extension, the Protocol will continue for another two years before ending. So even if rejected on the first voting occasion, it must continue until 1 January 2027.
Q. Is NI being treated differently in important ways by the European Union (EU) compared to the rest of the UK?
A. Yes. NI remains in the UK, but it is bound by the rules of the EU single market in many areas including food and animals, construction products, textiles and other areas of NI and ROI cooperation (full details are in Annex 2 of the Protocol). Alignment also applies to VAT, State aid and the Single Electricity Market.
Q. Does this include medicines, medical devices and diagnostics?
A. Yes. NI remains aligned to EU regulations and UK law in terms of medicines and their supplies.
Q. Does this mean that a marketing authorisation (MA) from the EU (via the European Medicines Agency) will automatically include NI?
A. Yes. However, for centrally authorised medicinal products, the local representative for the UK must be replaced with a local representative for the territory of NI, to be located in the EU or European Economic Area or NI. Since 31 December 2020 a revised marketing status template has been used for reporting the marketing status of centrally authorised medicinal products.
Q. Can a NI manufacturer or wholesaler with an EU MA sell medicines directly to Great Britain?
A. Yes. The Medicines and Healthcare products Regulatory Agency (MHRA) will allow companies to keep their products on both the NI and Great Britain (England, Scotland and Wales) market under one authorisation, with the UK automatically recognising the EU decision. The product licence numbers will need to be marked with a ‘(UA)’ suffix on the packaging and summary of product characteristics. A medicine with a ‘(UA)’ suffix may only be purchased from a NI manufacturer or wholesaler or from a wholesaler in Great Britain.
Q. What about exports of medicines going the other way, from Great Britain to NI?
A. This is more complicated as the EU does not recognise MAs issued by the MHRA. Any such medicines moving from Great Britain to NI are seen as foreign imports into the EU. For this reason, medicinal products currently referencing ‘United Kingdom (GB)’ will, if also sold to NI, need to change the country of authorisation to ‘United Kingdom (Northern Ireland)’ with the assigned country code ‘XI’.From 1 January 2022, thereby allowing a year for businesses to adjust, such medicines will face the following import controls in NI:
- importation via a Manufacturer and Import Authorisation (MIA) holder
- batch testing
- certification by a Qualified Person.
The UK Government has asked for the preparation period before these controls are brought in to be extended at least until 1 January 2023.
Q. Is all this necessary? What can be done about it?
A. The easiest and best way forward is for the UK and EU to agree to a Mutual Recognition Agreement, similar to those other countries that have negotiated with the EU, and to make such controls unnecessary. This is explained in a recent MAP Insight, asking if clients would support a MAP campaign working with other industry bodies to achieve this aim, which would benefit the whole of the UK life sciences industry. (https://www.mapbiopharma.com/insights-the-vital-importance-of-future-ema-and-mhra-relations-for-uk-life-sciences.html)
Q. What about medical devices?
A. Under the Protocol, devices placed on the market in NI must comply with EU medical devices legislation. From July 2023 a UK Conformity Assessment (UKCA) will be required for devices on the British market, and these will be permitted on the NI market if accompanied by a CE mark (as is currently the case) and a UKNI mark. A UKCA mark replaces a European CE mark and a UKNI mark is for goods placed on the NI market that have undergone mandatory third-party conformity assessment by a body based in the UK.
Q. What about clinical trials?
A. Medicines on a clinical trial in NI (but not in Great Britain) will follow EU regulations. The Qualified Person of a clinical trial can be established in NI. However, if the sponsor is in NI, a legal representative cannot be in NI and must be established in an EU or a European Economic Area country. Third country rules apply to all clinical trial Suspected Unexpected Serious Adverse Reaction occurring in the UK, including NI.
Q. What is likely to happen in the future and where can I find the latest updates?
A. The current dispute over the Protocol arose from the UK unilaterally delaying the introduction of new sea border checks on food, parcels and pets until October 2021. Lord Mandelson, a former Northern Ireland Secretary of State and EU Commissioner, has pointed out that the UK Government can de-escalate the situation by reaffirming its determination to make the Protocol work, in order to rebuild trust, and then address the issues at a technical level which should ideally involve some flexibility from both sides. With added pressure from the EU and the US, it seems plausible that a solution will emerge in the near future. MAP will track developments and release material updates accordingly. The Protocol can be accessed here: Northern Ireland Protocol - Gov.uk