Pharmacy leaders and industry representatives have told the House of Lords that the Northern Ireland Protocol has resolved most of the potential issues with medicines supply in Northern Ireland (NI) post-Brexit.

However, they raised concerns that increased bureaucracy could threaten industry desire to supply to the market.

The comments were made at a follow-up investigation into the impact of the Northern Ireland Protocol and the provision of medicine to Northern Ireland, held at the House of Lords in two parts, on 18 and 25 January.

Why is there an issue with medicines supply in Northern Ireland?

The post-Brexit deal known as the Northern Ireland Protocol means that NI is still inside the European Union (EU)’s pharmaceutical regulatory system, but most of its medicines come from Great Britain (GB).

Due to a change in EU regulation in April 2022, medicines entering NI from GB will not need additional labelling or testing.

However, depending on how a drug was originally approved for use in the EU, it may now need two licenses – one for GB and one for NI, which adds additional cost.

This could result in problems in the future with some medicines that were licenced pre-Brexit to the whole of the UK having to move to a GB-only licence, while NI products would retain their original licence.

The process is due to be completed by the end of December 2023, at which point the same pack could not be supplied to both GB and NI.

It could lead to some products being withdrawn from NI, if manufacturers decide it is not worthwhile making separate packs.

In autumn 2021, an inquiry was launched to investigate the impact of the Northern Ireland Protocol on medicines supply.

This month, the House of Lords Protocol on Ireland/Northern Ireland Sub-Committee heard evidence discussing how the situation has evolved since then.

Ongoing talks are being held between London and Brussels to resolve issues with the protocol, with the aim of finalising the arrangement by the 25th anniversary of the Good Friday Agreement in April – although Northern Ireland secretary Chris Heaton-Harris has said that this is not a fixed deadline.

Protocol resolves issues – but for how long?

Michelle Riddalls, chief executive of PAGB, which represents manufacturers of over-the-counter (OTC) medicines, told the House of Lords last week that the issues had for the most part been resolved.

She said: ‘Two years ago there was a very real risk that Brexit and the Northern Ireland Protocol could have threatened the supply of medicines and medical devices to Northern Ireland.

‘Hard work, technical discussions and positive negotiations over the last few years have ensured that most of the potential barriers have been resolved.’

She added that some manufacturers of OTC medicines will produce joint packs for a small number of products.

Measures are simply ‘sticking plasters’

Martin Sawer, executive director of the Healthcare Distribution Association, which represents medicines wholesalers, told the committee last week that problems remain despite the EU changing its laws to ease the flow of medicines from GB to NI.

Mr Sawer said that said supplying NI remains ‘challenging, problematic and inefficient’ and that he had concerns about the future, describing measures to keep NI and GB together as ‘sticking plasters’.

His concerns were reiterated by Paul Williams, from pharmaceutical manufacturer Teva UK, who said there are outstanding issues to be addressed including with licensing and packaging of medicines.

Giving evidence on Wednesday 25 January, Kate Ling, European policy manager for the NHS Confederation, told the House of Lords that ‘the important thing is that medicines are getting through’.

However, she added that this was likely to be because ‘a lot of the pain has been absorbed by the suppliers and the distributors’ who now faced additional hurdles and bureaucracy.

This had led to increased carriage charges and transportation costs which were being passed on to community pharmacists in potential rising generic medicines costs, Ms Ling said.

She added: ‘I think there are issues in the longer run for the NHS England: if it's costing more for companies to warehouse and transport the products into Ireland, then it is reasonable to suppose that at some point that this will increase costs and service pressures at the other end.’

She also said that community pharmacies had reported some increases in delays of around a day for some medicines, but that it was difficult to separate the impact of the Northern Ireland Protocol from wider issues with global supply chains affecting the whole of the UK.

Future uncertainty feels like a ‘cliff edge’

Mark Dayan, policy analyst and head of public affairs at the Nuffield Trust, said that in addition to problems currently being experienced, like frictions at customs, uncertainty around the future led to a sense of a series of ‘cliff edges’.

For instance, he said that the outcome of talks in April could both ‘issue some new options to get medicines legal for use in Northern Ireland’, as well as potentially adding ‘additional burdens and complexities’.

He also said that while medicines supply routes to Northern Ireland had remained predominantly through Great Britain, rather than through the EU, there was still a risk of this changing in the future, ‘which is why further changes can still feel like something like a cliff edge’.

Alan Stout, deputy chair of BMA NI Council, chair of the NI GP Committee and co-chair of the UK GPC, said that as a GP he had so far not experienced any issues with medicines supply.

However, he voiced concerns that when the current mitigations and derogations run out, ‘we may now see what we thought was an uninterrupted supply then become an interrupted supply’.

Witnesses also warned that regulatory divergence between GB and the EU was increasing and could lead to additional costs and barriers for an increasing number of drugs.

Risk of industry stopping supply

Ms Ling, of the NHS Confederation, said that evidence from manufacturers and distributors had made it clear that ‘there is a lot of extra time and hassle involved in supplying products to Northern Ireland, particularly when they're very small quantities for a small number of patients; particularly when you have to supply separate packaging – [it's] simply an absolute pain for them.

‘And hence the problem that you're well aware of some companies deciding that it's really just not worth having separate supplier groups for Northern Ireland.’

What solutions are possible?

Dr Stout told the House of Lords that the biggest single factor causing additional paperwork was the falsified medicines directive (FMD), which requires additional packaging and other measures for medicines in Northern Ireland.

‘If we were to look to one single solution, or one fundamental solution would be to remove Northern Ireland’s requirements of FMD to solve the huge amount of problems that are being faced at the moment’, he said.

He said that the FMD was a ‘disproportionate’ way to address the potential problem of falsified medicines, which he said affected 0.005% of drugs, which he described as ‘tiny, tiny numbers’.

Mr Dayan said that mutual recognition of batch testing would also enhance the level of ease by which medicines could be supplied to the Northern Ireland market.

Ms Ling said that she didn’t think that community pharmacy contractors would ‘relish having to deal with two different regimes dealing with possibly two different lots of medications that have been licenced under different routes’.

Instead, she suggested that manufacturers could choose to license their products for sale in Northern Ireland either under the EU route or the UK route, depending on which market was more attractive to them.

Ms Ling also said that progress needed to be made in the negotiations, including for the medicinal products working group, which was set up under the terms of the trade and cooperation agreement, to meet for the first time.

‘It is quite frustrating that those technical discussions which could have been taking place or could have been forming the talks throughout, they haven't really been happening’ she said.

Further negotiations needed

After presenting her evidence at the House of Lords last week, Ms Riddalls of PAGB told The Pharmacist that ‘while there are a few remaining issues which still need resolving’, ‘this should happen via a negotiated solution’ rather than ‘unilateral action’.

‘We are encouraged by the improvements in tone we have seen by both sides in recent discussions, and we are looking forward to a long-term sustainable solution which works in the interests of patients and consumers in Northern Ireland,’ she told The Pharmacist.

Ms Ling also said that she wanted to see a long-lasting, stable solution, rather than something being ‘rushed through’ that did not deal adequately with outstanding and potential issues.