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Inside Life Sciences

Future of the EMA and medicines regulation in the UK
Inside Life Sciences

Inside Life SciencesIssue 3 | November 2017

Date
08 November 2017

Nina O'Sullivan Legal Director, Professional Support Lawyer

Natasha Pearman Managing Associate

On 4 December 2017, we are holding a panel discussion at Mishcon de Reya on the future of medicines regulation in the UK post-Brexit.


Future of the EMA and medicines regulation in the UK

On 4 December 2017, we are holding a panel discussion at Mishcon de Reya on the future of medicines regulation in the UK post-Brexit.  Our panel of speakers will focus on how the UK can maintain its position at the forefront of R&D and new product launches and how the MHRA can support this, and will identify the best possible (or most likely) outcome for medicines regulation.

Panel discussion: What will future medicines regulation look like in the UK?

4 December 2017

INTRODUCTION

Rob Murray
Partner
Mishcon de Reya

CHAIR

Natasha Pearman
Managing Associate
Mishcon de Reya

PANELLISTS

Sir Alasdair Breckenridge
Former Chair, MHRA

Steve Bates
Chief Executive, BIA

Sarah Rickwood
Vice President
Thought Leadership (Europe)
QuintilesIMS

The event comes at an interesting time, as the European Council will be announcing the new city hosting the EMA on 20 November – 19 Member States have bid to host the Agency, with their chances of success depending upon both accessibility (for staff, delegates and experts – e.g., proximity to transport hubs and hotel accommodation) and the quality of the premises and facilities. Press reports in September focused on an EMA staff survey which suggested that staff retention rates would be dramatically affected in some of the least popular locations, leading to a potential 'public health crisis'. Even in the best case scenario, retention rates were put at between 65-81%, which will inevitably have a knock on effect on timescales for medicines approval.  Following the press reports, the EMA published its analysis of the bids against the EU27's agreed criteria, with cities appearing to score the highest on its assessment including Amsterdam, Barcelona, Brussels, Copenhagen, Milan and Vienna.

In the meantime, the EMA's aim is to operate as long as it can under a 'business as usual' framework whilst, in parallel, preparing for the consequences of Brexit. If 'business as usual' cannot be maintained, however, its recently updated business continuity plan lays down dedicated arrangements for prioritising EMA activities.

The industry will, of course, be hoping that a sector-focused arrangement with a continuing pan-European regulatory regime will be agreed between the EU27 and the UK, with the latest call for ensuring regulatory stability (perhaps including transitional arrangements) coming in an open letter to the negotiators from the medical devices industry.

The EMA has also reported on its stakeholder meeting in October updating the industry on its preparedness activities.

If you would like further information about our event on 4th December, please contact Kirsty Stevens.