With the UK bracing itself for a ‘no-deal’ Brexit or some other outcome that has not yet been determined, pharma experts discussed the potential effect of Brexit on the supply chain and how to best prepare for it against the upcoming deadline.
Earlier this month, over 120 delegates from the pharma supply chain gathered for the 10th Pharmaceutical Industry Network Group (PING) Conference, held for the second successive year on Brexit and in conjunction with Ethical Medicines Industry Group (EMIG).
Highlights from the conference included likely regulatory impact on medicine trading, supply chain concerns, EU database access, management of tax implications, importance of Tier 2 sponsorship and secured, continuation of businesses.
EMIG’s Chair, Leslie Galloway, opened by saying: "Our friends at Westminster are very good at articulating what they don’t want, but no that they do want."
He gave an overview of the different routes that Brexit may take, commenting on how "businesses, particularly healthcare businesses, thrive on certainty and the last almost three years have undermined their ability to invest and grow….hopefully soon, we will be able to deal with those challenges head on." He also discussed stockpiling, saying, "we are in unchartered water – we’ve never been here before."
As the conference unfolded, various pharma areas were addressed, with input from leading pharma experts.
Regulatory plan and changes
NSF Pharma Biotech‘s Executive Director Dr Peter Gough, presented the likely regulatory impact on the trade in medicines between the UK and EU post-Brexit, including necessary changes to marketing authorisations, the site of QC testing and QP certification, and the impact on clinical trials.
After explaining the different approaches that the UK and EU are taking in terms of mutual recognition, Dr Gough said: "It is hoped that regulators in UK and EU will put patients first and adopt pragmatic positions regarding the application and regulations."
He pointed out we already have casualties from Brexit, including the loss of the EMA.
Research and development
Dr Jonathan Sheffield, Chief Executive of the Clinical Research Network at the National Institute for Health Research (NIHR), gave a very positive message. He said that work continues to increase regardless of Brexit. He commented, "There has been relentless investment in improving the life sciences research environment, which now makes UK the best place globally to conduct clinical trials of all phases. Brexit will not affect further improvements envisaged in Digital Health".
He explained that the UK is one of the leading countries in R&D in the world. With over 650 clinical trials in motion, the UK is second only to the United States, and the leading country in Europe. The number of people participating in clinical trials has also increased in the UK, with participation increasing by 25 percent since 2010/11.
Sheffield said that rather than worrying about the impact of regulations and Brexit, we should embrace this. "We will have a research economy that can engage with a global research economy," he said. "We need to stop using our hearts to make decisions and start looking at the facts," he said. "We have a fear of regulation – Brexit is not the issue."
Immigration
Despite Brexit uncertainty, the pharma and life sciences sector still relies heavily on highly skilled research and development roles, with a large proportion – around seven percent of the workforce – being sourced from EU countries and further afield. It is ever more imperative to prepare for the UK’s future. Tom Brett-Young, Head of VWV’s specialist Immigration team, stated, "For future planning, Tier 2 sponsorship is a key part of the immigration system…those without a sponsor licence should consider applying for one now, and those who already have one should ensure that it is fully compliant and not at risk of being revoked."
Retail pharmacy and stockpiling
Gareth Jones, Head of Corporate Affairs at the National Pharmacy Association, said that medicine supply and shortage is worse than it has ever been before. He addressed Brexit concerns from a retail pharmacy perspec...
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