EMA: Down, but Not Out, After Brexit Vote

The shockwaves of the UK Brexit vote continue to ripple through Europe, and the London-based European Medicines Agency, one of the prominent institutional victims, now faces questions over its location, while its staff face distressing uncertainty over their future.   But EMA is much more than just an office space in the British capital city's docklands development. It is more accurate to view it as a process, with 20 years of achievement in European medicines regulation behind it, with a full agenda, and with an unrivaled pool of expertise. It is not going to be blown apart, even by such a seismic event as the UK vote to drop out of the EU.   On the morning that the surprise news of the "leave" vote was announced, EMA's boss, Guido Rasi, delivered what agency insiders have described as a moving address to the entire staff, offering what reassurance he could. Sensitive to the psychological or emotional aspect of the referendum result, he characteristically urged staff to "hug a Brit".   In more practical terms, EMA is getting on with business as usual, as its charged agenda demonstrates. The month of July will see meetings of the Committees for Medicinal Products for Human Use, for Orphan Medicinal Products, Herbal Medicinal Products, Medicinal Products for Veterinary Use, Advanced Therapies, and the committee responsible for assessing the content of paediatric investigation plans.   In the first week of July it published minutes of the meetings of its paediatric committee and its monthly report of opinions on paediatric investigation plans, and a summary of a recent workshop on immunogenicity assessment of biotechnology-derived therapeutic proteins. It released agendas and notices for forthcoming meetings of its Pharmacovigilance Risk Assessment Committee and a scientific workshop on applying regulatory science to neonates. And it issued revised European public assessment reports on 20 human medicines including Viagra, Genvoya, and NovoThirteen - as well as an update about the EMA infringement procedure against Roche in relation to suspected shortcomings in pharmacovigilance procedures.   The agency also has in train a series of projects widening its contacts with and impact on medicines regulation in Europe. Its work with adaptive pathways and on unmet need through its PRIME scheme has already been widely reported on, in ACT and elsewhere, but a glance at its most recent newsletter reveals not only opinions on dozens of marketing authorization applications but also the agency's involvement in discussions and reflections across the broadest range of related issues. The list includes a discussions on subjects as diverse as whether regulators can influence medicines affordability, how to improve safety of first-in-human clinical trials, what support can be given to innovative small firms in the pharmaceutical sector, how far efficacy and safety can be extrapolated in medicine development, fostering development and patient access to advanced medicines in Europe, and the use of single-arm trials in oncology.   And the agency is currently consulting on more than 60 draft guidelines and reflection papers, on everything from clinical investigation of products for the treatment of axial spondyloarthritis or requirements for quality documentation for biological investigational medicinal products in clinical trials, to the dissolution specification for generic oral immediate release products and non-spontaneous adverse event reports in peer-reviewed literature, on the internet or in social media.   One of its latest ventures is a new outreach to the academic community. During June it held a workshop with representatives from academia to explore new ways to engage with academics and researchers. Already many academics are involved as experts in the evaluation of medicines, but EMA says it wants "a new level of collaboration" to help it to cope with the speed of scientific progress and the "unprecedented level of complexity in the development and evaluation of new medicines." A framework will be presented to the December meeting of the EMA’s management board.   Yann Le Cam, Chief Executive Officer of EURORDIS, who was recently appointed to the agency's management board, has his eyes fixed firmly on the future as he takes up his responsibilities there, "with a focus on the product life cycle and particular attention to patient access." He says he wants to make sure the patient perspective is taken into account in EMA debates on precision medicine, data collection, e-health, registries, and healthcare systems. He isn't planning on stopping because of Brexit – and neither is EMA.