Mixed Opinions on Post-Brexit Approach to Northern Ireland Protocol

The protocol on Northern Ireland (NI) once Brexit has been completed has received mixed opinions in industry, according to various press releases. Almac Group has welcomed the decision for maintained regulatory alignment between NI and the European Union, and the UK BioIndustry Association (BIA) finds the lack of information on supply of medicines disappointing.

In a June 4, 2020 press release, Almac Group confirmed its positive opinion about the continuation of regulatory alignment between NI and the EU, which will ensure the NI-based company can proceed with production to both the United Kingdom and EU, without any potential disruption that may be caused by Brexit. As a result of the regulatory alignment, the company’s manufacturing and associated qualified person (QP) certification, performed at the NI site, will be recognized in both the UK and EU.

“This latest confirmation, coming from both the EU and the UK, is a welcome step and ensures our current and future clients can continue to receive an unfettered solution with exclusive access to both the EU and UK marketplace,” said Alan Armstrong, CEO, Almac Group, in the press release. “Crucially, our unique location in Northern Ireland ensures we can provide uninterrupted service provision now, and into the future, maintaining our position as a global leader in the life-sciences sector.”

However, commenting on the UK government’s approach to the NI protocol, which was released in May 2020, Steve Bates OBE, chief executive of BIA, highlighted the disappointment the association has over the lack of information provided on the supply of medicines in NI. “The UK’s approach to the supply of medicines in the Northern Ireland Protocol is sadly missing in the document published,” Bates said in a May 21, 2020 press release. “This is deeply disappointing. Industry needs to know now what the legal framework to continue to dispense pharmaceutical products to the NHS [National Health Service] in Northern Ireland in seven months’ time will be. The government has been aware for over six months that this is a major issue for the industry. We need more detailed guidance as soon as possible. Patients in Northern Ireland, including many who travel for treatment from the Republic of Ireland need certainty that their treatments will continue to be supplied.”

Sources: Almac Group, BIA