OBJECTIVES: Most new innovative medicines access European markets through the European Medicines Agency (EMA) centralised authorisation procedure. Post-Brexit, a new UK national regulatory process will be required. This research explores possible UK regulatory access scenarios post-Brexit and discusses their market access implications.

METHODS: Publically available resources from the EMA, Swissmedic, NoMA, MHRA, BAG, EAK, HOD were screened for information on regulatory approval process(es). All NICE and SMC single technology appraisal guidances were screened and the outcome and date extracted (01/01/2011 to 31/05/2017).

RESULTS: Norway is not in the EU but is in the EEA and is a full member of CHMP and participates in the centralised authorisation process. Switzerland is an independent country within Europe with a separate regulatory process, but has a customs-union with Liechtenstein, which is in the EEA, where precedence has been set on recognition of Swiss Marketing Authorisations. NICE and the SMC conduct HTAs for reimbursement of new therapies in the UK. However, 11% and 14% of their appraisals have been non-submissions, and recommendations have been at an average delay of 17.1 and 10.5 months, respectively. Whilst the UK is 7^th largest market in the World, the top 20 list includes 5 other EU countries.

CONCLUSIONS: Post-Brexit, UK regulatory approval could follow a model of rapid targeted assessment and approval of EMA-authorised products, parallel work-sharing of UK-EMA hybrid application, and/or mutual recognition agreements. These could substantially impact market access; although the UK is a large market, many companies already choose not to submit to NICE/SMC due to the difficulties in securing positive reimbursement recommendations. The prospect of an additional access hurdle formed by a separate UK-specific regulatory process may further deter some companies. Negotiations need to minimise the potential disruption to current approval and HTA recommendation timeframes to ensure that life-saving medicines are available in the UK.