Brexit And Life Sciences Update

We last reported on Brexit developments in the May 2018 edition where we focused on the resounding message that the industry still had to prepare for a hard Brexit, whilst hoping for an agreement incorporating an implementation period to allow breathing room to adjust to the post-Brexit position, and for bespoke arrangements to be made on certain key issues. These could include perhaps the UK's continued membership of the EMA, with a majority of MPs voting in July that the UK should negotiate for this. As we approach the October deadline for an agreed position on the draft withdrawal agreement, a number of important statements and reports have been issued.

MHRA Statements

In early August, the MHRA issued a series of statements intended to allay the fears of industry in relation to certain aspects. However, the statements are all premised on the basis that an agreement will be reached which includes the implementation period until the end of 2020. By failing to deal with the steps needed to prepare for a no deal Brexit, it is questionable how reassuring these statements will be.

The MHRA's statements cover the following topics:

Impact of the implementation period for the sector

Assuming an implementation period is agreed, it will remain business as usual in relation to the following aspects during that period:

Batch testing and Qualified Person certification can continue in the UK. Marketing authorisation holders and qualified persons for pharmacovigilance will still be able to be based in the UK and access EU markets. UK-based firms will continue to be able to apply for marketing authorisations using either the centralised or decentralised procedures. CE marking for medical devices will continue to be used and recognised for both markets and UK-based firms and they will not need an authorised representative established in the EU. UK notified bodies will also continue to conduct third party conformity assessment in the UK. The statement also notes the agreement reached in March that the UK will be treated as a Member State for the purposes of international agreements, including Mutual Recognition Agreements, during the implementation period.

However, and significantly, during the implementation period, the UK will effectively be a 'rule-taker', with no voting rights in the EMA and EU committees.

Impact on forthcoming EU Regulation

The new Clinical Trials Regulation is anticipated to be implemented during 2020, i.e., before the end of the...