Future of the EMA and medicines regulation in the UK

Posted on 08 November 2017

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, which includes Sir Alasdair Breckenridge, the former chair of the Medicines and Healthcare Regulatory Authority (MHRA), 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 has just announced the new city hosting the EMA as Amsterdam, following a closely fought bidding process by 19 different cities. Amsterdam was only one of a handful of the bidding cities which met the EMA's staffing retention criteria, to ensure that it continues to operate on time, so there will no doubt a sigh of relief across the agency.

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.

However, this is just one of many issues for the wider pharmaceutical sector which requires urgent clarification. The next battleground is the extent to which (if any) the UK will remain part of the EU's medicines' regulatory framework. For example, there are 1,500 clinical trials for new drugs currently taking place where the UK is the sponsor state, 50% of which will be ongoing in March 2019 (Brexit EFPIA survey published 8/11/2017).

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.

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

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