With the objective of sharing best practices and finalizing no deal Brexit preparations, the NBCC Health Care Forum event about “The new context for health care due to Brexit” took place on 16 May 2019 at the premises of AstraZeneca in the Hague.
Valuable insights were presented by the speakers: Maurice Galla, Brexit coordinator at the Ministry of Health, Welfare and Sports of the Netherlands, Fabien Roy, partner at Hogan Lovells, Fons Cazius, project leader & advisor at the Vereniging Innovatieve Geneesmiddelen, and last but not least, Ad Antonisse, director market access & external affairs at AstraZeneca. Lyne Biewinga, director at NBCC, introduced and moderated the meeting.
It was clear that due to the uncertainties related to the form of the new trading relationship between the UK & EU, the medical devices industry had to address several outstanding issues. These concerned, among others, logistic and supply (potential delays, additional costs & shortages), post market surveillance & vigilance, authorised representatives, notified bodies, labelling changes, the influence of the MHRA in legislation and guidance and UK regulation of medical devices.
The Dutch government has taken wide-ranging steps to prepare the health care sector for an eventual no deal scenario. It has assessed and evaluated the supply chains and potential risks, made preparatory legal measures, addressed contingencies, introduced targeted information channels for the sector (the so called “Brexit zorginformatiepunt”), coordinated the work of key departments (e.g. customs), expanded the capacity of medicines authority, inspectorate and registration authority, and has been involved in the EU-agenda setting & collaboration. The representatives of the health care business environment present at the event praised highly the efforts of the Dutch government and found them exemplary in the European context.
There was a general impression that the overall awareness of the health care sector has grown in the past six months in the Netherlands. Health care institutions have conducted Brexit impact scans and identified risk areas. The Brexit delay is offering more time to companies, but that should be used wisely in pursuing further preparatory action.