After much anticipation and uncertainty, the European Medicines Agency (EMA) has a new home, post-Brexit: Amsterdam.
The EMA is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the European Union. It has been based in London.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The Council of European Union comprised of 27 EU member states arrived at the decision on Monday, November 20 after three rounds of voting and a drawing of lots. The result alleviates the concern of many of the EMA staff who feared many of the contender cities may impinge on critical functions of the EMA due to a dearth of local talent and expertise.
Amsterdam, Milan and Copenhagen were the three finalists that survived the first round of voting. Copenhagen was eliminated in round two and there was a 13-13 tie in round three as a result of Slovakia’s abstention. In the subsequent draw of the lots, Amsterdam emerged victorious.
The dramatic vote caps off more than a year of uncertainty and aggressive bidding to host the agency ever since the UK voted to leave the EU. Earlier this year, the EMA assessed the impact of moving to 19 candidate cities that had made official bids to host the EMA headquarters.
The assessment characterized scenarios ranging from a ‘public health crisis’ if the EMA were to relocate to eight of the 19 candidate cities (primarily those in Eastern Europe) to the ‘possibility of delays’ in approving medicines if any one of five of 19 candidates were chosen (a group that included Amsterdam).
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
With the move to Amsterdam, the EMA is expecting more than a 65 percent staff retention rate and is predicting the impact on functions like corporate governance, audits, attendance of conferences and public health initiatives. The EMA is not expecting a critical impact on the assessment of medicines and safety monitoring but may experience some delays.
The decision comes at a time of regulatory upheaval in the EU with impending implementation of Medical Device Regulations (MDRs), In-vitro Diagnostics Regulations (IVDRs), and others such as the new personal protective equipment (PPE) regulations. Also, it is uncertain how Brexit will affect labeling, regulatory approvals, and clinical trials.
Photo: VitalyEdush, Getty Images
