Plan for hard Brexit needed to protect pharma sector, expert warns

Ireland needs to assume a worst case scenario on Brexit to protect its pharmaceuticals sector, a leading industry consultant has warned. But the departure of the UK from the European Union could also offer opportunity.

PharmaLex, an international consultancy specialising in regulatory affairs, compliance, quality management and pharmacovigilance, says 30,000 people are employed directly in the pharma industry in Ireland and it exports €3.22 billion to the UK annually.

Ann McGee, managing director of the Irish business, said planning needed to presume that the UK and the EU would be two separate jurisdictions – something that presents huge problems to the pharmaceutical industry.

“A transition agreement on dual labelling is under negotiation but its 18-month term may be enough time for a mutual recognition agreement to be negotiated,” she said.

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Companies looking to sell into the UK will have to register their products there separately in order to guarantee continuity of supply for patients.

But it’s not all bad news.

“Brexit is a huge opportunity for Ireland to accommodate companies who previously saw the UK as their gateway to Europe,” Ms McGee said. “These companies are now going to need a European regulatory base because every batch of product released has to be signed off by a qualified person based in the EU – a role defined by EU legislation. If a product is manufactured in the UK, their ‘qualified person’ will have no legal standing in the EU.”