Nigel Hawkes’ feature in the BMJ (http://www.bmj.com/content/357/bmj.j2168 published 17th May 2017) outlines some of the concerns raised at the DSRU’s Forum on UK Pharmacovigilance post-Brexit, which was held in London on 26th April. He notes that while the European Medicines Agency (EMA) would have to be relocated in order to remain within the EU, UK pharmacovigilance specialists faced an uncertain future. DSRU Director, Saad Shakir, highlighted the need to avoid overlooking pharmacovigilance and medicines regulation amongst the many other niche areas where Brexit decisions need to be made by the government.
The UK punches above its weight in EU Pharmacovigilance and it is estimated that there are 500 – 2000 qualified persons for pharmacovigilance (QPPVs) located in the UK, many of them consultants. As noted by Vicki Edwards, QPPV for AbbVie, although the Directive states that each pharma company should have a QPPV who resides and works in the EU, it is not clear how this should be interpreted in practical terms. Virginia Acha of the ABPI outlined a preference for close regulatory ties between the UK and the EU post-Brexit, but warned that it can take decades to put new systems in place, especially given the likely need for a bespoke solution. Thomas Lönngren, former executive director of the EMA, stated that the MHRA (the UK regulator) will need to be enhanced and also expressed a hope that the UK and EU regulatory systems will remain harmonised.
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