In an interview with Express.co.uk, Martin Sawer, executive director of the Healthcare Distribution Association, described removing drugs from the post-Brexit deal as “a serious and mature solution”. It comes after Boots – the UK’s largest pharmacy chain – recommended such a move in written evidence to a House of Lords committee on protocol, in a report published last week.
The drugs were a key sticking point during protocol renegotiations – which Foreign Secretary Liz Truss took over from Lord Frost at the end of last year – as concerns were raised that a fragmented or complex regulatory system would increase costs, deter manufacturers and threaten their supply in Northern Ireland.
Boots told politicians that some of its drug suppliers have already been deterred by regulatory uncertainty and complexity in Northern Ireland, which forms a small market, and “some have already decided to stop supplying their products. in Northern Ireland or to increase their prices”.
Mr Sawer estimates that only around 30% of Northern Ireland’s medicines are stored in the country; it receives the majority by daily ferries from mainland Britain. If the protocol were fully implemented, these drugs would be subject to EU controls, which could lead to delays.
The street chemist has already spent an additional £250,000 on customs issues across the Irish Sea and expects full implementation of the protocol to result in a 5% impact on its income in Northern Ireland (equivalent to around 6 million pounds per year).
READ MORE: UK action on Northern Ireland ‘may be needed’ – health chief
In October, the European Commission said the UK ‘can keep all its regulatory functions where they currently are’ in relation to pharmaceuticals, and admitted that the rest of the UK could continue to act. as a “hub”.
But health chiefs still fear that, as it would only last until 2024, the ‘lack of clarity’ on the regulatory situation thereafter ‘would not create an enabling environment for companies to invest and maintain supply ” in Northern Ireland now.
Mr Sawer said: ‘Politicians on both sides – especially the UK government – should try to make the case that because drugs are a global business you want as smooth distribution as possible.’
In Ms Truss’ Northern Ireland Protocol Bill – which will be debated in the Lords after the summer recess – it is expected that suppliers will choose to take a UK or EU regulatory route when sending medicines to Northern Ireland.
James Cleverly said he hoped the proposed system would be “flexible and scalable”.
The bill was seen as a one-sided step in Brussels, but Mr Sawer said ‘the UK government’s priority is to seek a deal with the EU – and I know they tell me that until let them be blue in the face”. The bill was a “safety measure” or an “insurance policy”, he suggested.
He said negotiations between the UK and EU over medicines had been “quite intense” and each side “just needed to go a little further to agree on where the regulations can be. flexible,” but argued that the “ultimate way” to prevent regulatory issues from affecting patients was to remove the drugs from the Protocol entirely.
Mr Sawer said the wholesale community he represents ‘will always stick to the mandate that medicines are far too important to patients in Northern Ireland to get tangled up in all the politics and deadlocks that we have right now.”
DO NOT MISS
Russian military positions wiped out by Ukrainian forces [VIDEO]
Putin ‘eats easily’ from Moscow stash as Russia teeters on brink [INSIGHT]
China’s Aggression Against Taiwan Risks Provoking War in Asia: “Choose a Side! [ANALYSIS]
He said the “initial request” from the supply chain was: “Why aren’t we removing the drugs from the Northern Ireland protocol?”
Mr Sawer continued: “There are precedents for this in international agreements – that medicines are just too complicated and too regulated – why can’t you put that aside? And allow the flow of drugs as has happened before? »
Asked how this could work – given that the protocol was being considered to delineate the settlement on Northern Ireland – Mr Sawer said there were several ways to honor the country’s unique status while allowing medicines that pass through it to remain in a single package and under a single licence.
He said there “should be a special case where there might be double regulation”, with “the MHRA and the European Commission working together to administer the regulations – making it one package for Ireland of the North, rather than two packages of drugs or two different licenses for drugs”.
However, “there might be a way to put two licenses on the same pack – EU and UK – which are also recognized in the UK, so we have the same packs.
“The MHRA is authorized to issue a UK-wide licence; this would also apply in Northern Ireland. The EU could therefore recognize it.
“And if the UK regulator for Northern Ireland, which is the MHRA, recognizes EU licenses in Northern Ireland, that could start to make the challenge easier – as both regulators would see that packs in Northern Ireland were legal under both auspices. But I agree that it is not easy.
The Ministry of Foreign Affairs has been contacted for comment.