UK may not leave the EU regulatory system until after the Brexit transition period

UK Prime Minister (PM) Teresa May has suggested that the UK might remain part of the EU regulatory system and European Medicines Agency (EMA) until after the Brexit transition period.

A delayed departure for the UK would be welcomed by businesses and regulators, as more time would allow organisations to better prepare for a new relationship.

The statement by the PM was made during a House of Commons Debate (23rd October) on last week’s European Council meeting, and was in response to a question from a Labour politician Heidi Alexander.  She asked the PM “Given that the Government now envisage a two-year transition period where the existing structures of rules and regulations apply, can she clarify whether a pharmaceutical company wanting authorisation to market a new cancer drug in the UK during transition would do so via the European Medicines Agency or a new system as yet undefined?

The PM replied “The intention of the implementation period is, as far as possible, to ensure that there is not a cliff edge so that people are able to operate on the same basis as they do at the moment as they put in place the necessary changes leading up to the future partnership. Of course, that implementation period, which is now going to be looked at by the EU27, will be part of future negotiations.”

Until there is an agreement between the UK and the EU27 countries regarding the future relationship of the UK and the EU, there can be no guarantee that a 2 year transition period after March 2019 will be an option – but in this statement the PM is being transparent about her preferred position.

The option of remaining in the EMA during any transition period only became a possibility after it was accepted recently by Mrs May that the UK will remain under the jurisdiction of the European Court of Justice (ECJ) over any implementation period.  At this stage, the Brexit secretary David Davis hopes to reach agreement on a transition period during the first quarter of 2018 – this would give clarity to the pharmaceutical industry, without which there is a real risk that investments may be delayed or diverted elsewhere.

A transcript of the House of Commons debate can be obtained by clicking here.