The passage of the Brexit vote on 23 June for the UK to leave the European Union shocked many, with immediate repercussions on financial markets. One of the many questions that arose -- and remain -- was how the move would impact the pharma sector, particularly with the key regulatory healthcare body for the EU, the European Medicines Agency, located in London. This concern trickles down into how the drug approval, development and manufacturing processes would alter once the UK leaves the EU, which is scheduled for March 2019.
Post-Brexit, the various scenarios on how drugs will be regulated in the UK will each impact big pharma’s decisions on whether to delay launching innovative drugs in the country, experts BioPharm Insight spoke to said. Three major options are possible: the UK continuing to contribute to EMA drug approval decision-making; the UK accepting EMA approvals but with no voice within the agency; or a severing of ties with the EMA as the UK creates a new national approvals process. Drug access in the UK could be hampered if drug companies choose to forego the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and instead focus on the wider EU drug approvals.
BioPharm Insight has also reported the UK’s decision to leave the EU will likely drive much of the country’s life sciences R&D work to the continent, as exiting the single market and potential immigration restrictions will make it a less attractive place for drug firms. A desire to be closer to bodies making IP rulings may also prompt an exodus of drug company operations to the EU.
Jennifer C. Smith-Parker
Editor, EMEA
Jennifer C. Smith-Parker is an award-winning healthcare journalist with a deep knowledge of the US and European pharmaceutical, regulatory and pricing/reimbursement sector. Her passion for healthcare and science-related news, with a particular focus on government and public and social policy, has led to a diverse reporting experience across the US and internationally over the past decade. She manages a team of six journalists and analysts in the London office. She works closely with other management on editorial strategy and output, mentors and trains junior reporters and is responsible for wide-ranging editorial projects.
Alan Boyd
President, Faculty of Pharmaceutical Medicine of the Royal College of Physicians, UK, and CEO of his eponymous Crewe, UK-based healthcare consultancy
Alan Boyd is a Fellow and currently President of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians, UK and a Council Member of the Academy of Medical Royal Colleges, UK. He is graduate in Biochemistry and Medicine from the University of Birmingham, UK. Following post-graduate medical training, he joined the pharmaceutical industry and worked for Glaxo and AstraZeneca where he became the Global Head of Medical Research for the company. In 1999 he became the R&D Director for Ark Therapeutics Ltd in the UK, specialising in the development of gene therapy products. In April 2005, he set up Boyd Consultants. The focus of which is to aid and support early stage life-science based companies and universities. His clients now include many companies in Europe, North America and Japan. In November 2009 he was appointed an Honorary Professor at the Medical School at the University of Birmingham Medical School, in recognition of his expertise in medicines development.
Steven Bradshaw
Managing Director, Valid Insight
Steven Bradshaw is Founder and Managing Director of Valid Insight (www.validinsight.com), an expert-led global pharmaceutical market access consulting firm. Steve has two decades’ experience in healthcare and consulting, spanning senior roles in market access and pricing strategy consultancy, academia and decision maker in UK healthcare. Steve and his team works with a large range of pharmaceutical, biotechnology and medtech companies across EU, US and Asia Pacific.
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