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European Biopharmaceutical Review

The Impact of Brexit on the Pharma Industry

Brexit: with negotiations still ongoing at the time of writing and the situation changing almost daily, it is not surprising that concerns are elevated in pharmaceutical circles – both within the UK and across mainland Europe. Looking at the potential impact of Brexit and the import and export of products between the UK and the EU every month, an important question is: how will this trade keep flowing without major disruption? Everyone is aware of uncertainty at the moment – not just for the UK, but also for the EU manufacturers supplying into it – but, as negotiations continue, industry should prepare itself for the possibility of change.

This is largely attributable to the UK government’s ‘red lines’: according to these, people will not have free movement and being able to freely negotiate global trade deals is required. Additionally, reducing contributions to the EU budget is desired, as well as being free from its courts of justice, and, finally, regulatory autonomy requirements.

If these red lines remain inflexible, but obstacles stalling the negotiation can be overcome, one scenario is that the UK could end up with a Canadian-style deal with the EU, where the country has almost completely tariff-free trade with the EU, but with greater regulatory barriers than member states.

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Lynne Byers is the Executive Director of Pharmaceuticals and Biotechnology at NSF International. She graduated in chemistry in 1985. During her career, which spans more than 35 years, Lynne has gained extensive knowledge in the pharmaceutical manufacturing management and quality assurance (QA) areas, working as Global Head (Vice President) of external supply operations QA for Novartis and as Head of Inspectorate and Licensing for the MHRA, before joining NSF International in 2017. Her areas of expertise include QP training, packaging and labelling control GMP legislation, API manufacture and control, auditing and self-inspection skills, education of auditors, supply chain distribution, quality management of pharmaceutical suppliers, quality management of contract manufacturers, and affiliate quality assurance.
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