Building contingency plans for an ambiguous post-Brexit market
One company's positive approach to Brexit preparations, despite the lack of definition.
Despite a lot of discussion surrounding Brexit and Parliament’s recent vote to remain as part the EMA, there remains a lot of ambiguity and a lack of clear advice for the UK’s pharmaceutical industry. So, it is not a surprise that many businesses in the UK are yet to undertake the necessary work to build contingency plans that will ensure their medicines can continue to be licensed for sale in mainland Europe no matter what the eventual outcomes are of leaving the EU. Colin Newbould, director of regulatory affairs and QP services, Wasdell Group, provides Part II of CPHI Online's focus on Brexit and its effect on the UK pharmaceutical industry.
"As a contract services provider headquartered in the UK, we have been developing a strategic approach that will allow us to continue business-as-usual-across the globe regardless of the final decisions surrounding Brexit.
"Ultimately, despite requiring a lot of time and resource, the potential impact of Brexit has presented us with an interesting opportunity. It has given us the chance to review and refine our manufacturing, clinical and commercial operations and develop new ways to support more life-cycle management. For example, our new facility in Ireland will open later this year and it will allow us to carry out any necessary importation testing for our customers supplying to the EU. The new facility means that although our headquarters will remain in the UK, our operations and quality systems will continue to meet EU GMP standards as a minimum. The increased capacity will also help us to cater for increasing customer demand for our clinical and packaging services.
"As a result of this forward-planning we already have short, medium and longer term plans in development for many of our customers. These plans include a range of measures such as safety stock building to remove pressure from supply chains, changing contractual derogated responsibilities, changing importation sites and ultimately ensuring full technical transfer to our new facility as and when required.
"For companies that are yet to embark upon their Brexit preparations, we recommend actively engaging with all customers, sharing guidance, support and facts. So long as uncertainty prevails, strategic decisions around post-Brexit operations will be delayed which will inevitably have an impact on supply chains. Regulators and politicians need to offer clear guidance as soon as possible, while drug makers and contract services providers should be doing their best to prepare for every outcome."
As the director of regulatory affairs and QP services at The Wasdell Group, Colin is responsible for developing and implementing the company strategy to ensure world-class compliance, effective processes and customer satisfaction. Along with his position as director of QP services, he is also one of Wasdell’s QPs for certification to the European market. Colin holds a BSc in Chemistry with Analytical Chemistry and Toxicology and is a current management committee member of the Pharmaceutical and Healthcare Sciences Society (PHSS) and has previous terms with the Pharmaceutical Quality Group (PQG).
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