A survey conducted by the European Medicines Agency (EMA) has identified gaps in the pharmaceutical industry’s preparedness for Brexit. The aim of the survey, which was launched in January 2018, was to identify CAPs that are potentially at risk of supply shortages and to obtain information on the timelines for submission of the necessary regulatory changes.
The survey was sent to marketing authorisation holders of the 694 CAPs (661 human and 33 veterinary products) who are located in the UK or who have quality control, batch release and/or import or manufacturing sites in the UK. According to EU law, the marketing authorisation holder, the qualified person for pharmacovigilance (QPPV), the pharmacovigilance system master file (PSMF) and certain manufacturing sites need to be based in the EEA for a company to be able to market a medicine in the EU.
Following this survey, Tom Moore, Senior Healthcare Analyst at GlobalData, a data and analytics company, offered his view based on GlobalData’s own findings.
Moore said: "In results from a survey carried out by the EMA, it was found that only 58% of market authorisation holders for pharmaceutical products in the EU are on track with their regulatory planning in preparation for the UK’s exit from the European Union in March 2019. Failure to properly put in place the required regulatory frameworks for centrally authorised products (CAPs) could result in them no longer having marketing approval in the UK after Brexit."
“These survey results are in line with GlobalData’s own findings, published in a recent report: Brexit and the Healthcare Industry – Implications for Pharma, Q1 2018. When professionals from within the healthcare industry were asked about their concerns after Brexit, 46% of those surveyed identified regulatory issues as being the most significant. The results published by the EMA provide some explanation as to why healthcare and pharma professionals foresee regulatory issues are so important post-Brexit."
“Other factors identified as being of significant concern in GlobalData’s survey include continued research funding and supply chain disruption, which were both highlighted as the greatest concern by 13% of participants. The survey was carried out as part of a quarterly report by GlobalData, monitoring the Brexit sentiment of healthcare and pharmaceuticals professionals both within and outside the UK. Research into the sentiment in Q2, 2018 is currently ongoing, with publication of the next report in this series expected in the near future."
For marketing authorisation holders of CAPs, this may imply changes to the marketing authorisation itself, including, for example, a transfer of the marketing authorisation to a legal entity established in the European Economic Area (EEA), or a change of the QPPV or PSMF to a location in the EEA, as well as adaptations to their logistics, manufacturing sites, supply chains and contracts.
However, for 108 (88 human products and 20 veterinary products), or 16%, of these medicines with manufacturing sites located in the UK only, there are serious concerns that the necessary actions will not be carried out in time.