A new Brexit deal for Northern Ireland announced by the UK government and European Commission has been welcomed by pharmacy sector leaders.

The Windsor Framework, agreed by the Prime Minister and European Commission President on Monday (27 February), replaces the old Northern Ireland Protocol and promises to ‘fix everyday problems in medicines supply’ by ‘disapplying swathes of EU law and restoring UK rules in their place’.

The original Protocol applied all EU rules and authorisation requirements for medicines. This meant that for novel medicines, including innovative cancer drugs, it was the European Medicines Agency (EMA), not the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which approved medicines for the Northern Ireland market.

‘This failed to recognise or accommodate for the fact that the overwhelming flow of medicines to Northern Ireland is from Great Britain, with medicines provided for the UK market as a whole,’ the new framework says.

The EU made a series of changes to its rules last year to address some of these issues, addressing regulatory requirements which prevented medicines flows and supporting the MHRA’s continued ability to authorise generic drugs under a single licence for the whole United Kingdom.

‘This, combined with the UK’s own Northern Ireland Medicines Authorisation Route (NIMAR), has ensured that medicines have continued to flow uninterrupted into Northern Ireland,’ the new framework says. ‘But these arrangements were not a complete solution for the long-term and did not address the EMA’s role in licensing novel medicines, leaving Northern Ireland exposed to divergence as UK and EU rules changed into the future.’

The Windsor Framework recognises that ‘this uncertainty, as well as the requirement for Northern Ireland drugs to meet various EU labelling requirements, risked discontinuations if firms were unwilling to maintain two sets of labels and packs for Great Britain and Northern Ireland. It says ‘this was not a sustainable way forward, and has been addressed by this deal’.

Pharmacy leaders and industry representatives have previously raised concerns that increased bureaucracy could threaten industry desire to supply to the market.

Under the Windsor Framework, over 1,700 pages of EU law have been removed, allowing the same medicines, in the same packs, with the same labels, to be available across the UK.

‘It will be for the MHRA to approve all drugs for the whole UK market,’ the Windsor Framework says. ‘This will enable all types of medicines to be supplied in single packs, within UK supply chains, with a single licence for the whole UK. This will provide a long-term, durable basis for medicines supplies into Northern Ireland.’

For the provision of innovative drugs to patients, Northern Ireland will be reintegrated back into a UK-only regulatory environment, with the European Medicines Agency removed from having any role. ‘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,’ the framework says.

NI’s healthcare industry will have full access to both UK and EU markets under the new framework. ‘The agreement safeguards frictionless access to the EU market for world-leading Northern Ireland pharmaceutical and medical technology firms,’ it says. ‘This pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee the supply of medicines within the whole United Kingdom.’

Meanwhile, the whole of the Falsified Medicines Directive has been disapplied for medicines supplied to Northern Ireland, ‘ending the unnecessary situation in which wholesalers and pharmacies in Northern Ireland were expected to keep barcode scanners to check individual labels,’ the framework says.

The Healthcare Distribution Association (HDA) said it ‘welcomes the Windsor agreement wholeheartedly - common sense has prevailed’, with HDA’s executive director, Martin Sawer, adding: ‘It will be good news for the community pharmacy sector in NI and relieves them of some of the supply issues they would undoubtedly have faced otherwise.’

‘Under the Windsor agreement, the EU and UK have put patients first and the agreement will allow medicines to flow seamlessly from GB to NI once again,’ the HDA said.

Dr Layla McCay, policy director at the NHS Confederation, has called the Windsor Framework ‘a positive step’ which will ‘come as a welcome relief to those affected by the decision’, while the British Medical Association Northern Ireland ‘welcomes the news that patients in NI will be able to access medicines the same as the rest of the UK’, and says ‘the removal of the “cliff edge” in relation to the Falsified Medicines Directive is a positive move’.

Meanwhile, the PAGB, which represents manufacturers of over-the-counter (OTC) medicines, has also welcomed the announcement and the ‘positive outcome’ of negotiations.

‘Whilst further work is needed to go into the details of the agreement and to ensure that this agreement can be implemented effectively in practice, this is a very positive step forward and will be welcomed by all those seeking to secure the vital role the OTC sector plays in UK and Northern Ireland health,’ it said.

PAGB’s chief executive, Michelle Riddalls, added: ‘We congratulate the UK and EU governments on this very positive outcome which will help to secure the supply of medicines to Northern and Ireland and the UK and secure the huge contribution our sector makes to healthcare in the UK.

‘This agreement shows that the parties have been listening to and prioritising our sector’s concerns. Great progress has been made over recent years to avert many of the issues which could have prevented medicines being supplied to Northern Ireland. This has been possible because of the expert voice of the sector being heard and a constructive attitude being adopted by both sides.’

However, Ms Riddalls said ‘work still needs to be done to make sure that this agreement is implemented in the right way, and that the knowledge and expertise of industry is made use of as we move into implementation’.

The National Pharmacy Association (NPA) says it is ‘cautiously optimistic’.

‘While the devil may yet be in the detail, the Windsor Framework would appear to be good news for pharmacies in Northern Ireland,’ NPA’s Northern Ireland manager Anne McCalister said. ‘It seems to address the main concerns we have expressed about medicines supplies to NI, but we want to examine the small print to ensure the new arrangements meet the needs of our members and the patients they serve.

‘Given the complexities of political life in Northern Ireland, we are not celebrating a done deal just yet, however we are cautiously optimistic about the progress made.’

The government says the implementation of the agreement will be phased in, with some of the new arrangements introduced later this year and the remainder in 2024.