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.
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 proposed implementation period. However, if it is not implemented in time, the Government has confirmed that UK law will 'remain aligned with parts of the EU's CTR legislation that are within the UK's control'. Of course, there are two significant elements that the UK could not implement without the EU's agreement: use of the shared central portal and participation in the single assessment model.
The MHRA statement also confirms that, if the UK is outside the EU network after the implementation period, sponsors will still be able to run multi-state trials involving the UK. Whilst they will need to apply to the MHRA separately, it 'would take every effort to ensure this parallel submission is as streamlined and efficient as possible'.
The Medical Devices Regulation will apply fully from May 2020, which again falls during the proposed implementation period. However, the In Vitro Diagnostic (IVD) Regulation does not apply until May 2022, although the statement notes that elements of both new devices Regulations have been applying directly in the UK since May 2017, thereby allowing medical devices (including IVDs) to be placed on the UK market if in conformity with the new regulations.
Cancer Research Report
The MHRA statements were published in the same week as a report commissioned by Cancer Research UK (conducted by School of International Futures) as to the priorities during the negotiations and the future of clinical trials post Brexit (both short term and long term). The significance of this issue cannot be over-stated with 823 applications for commercial clinical trials of medicines having been submitted in the UK in 2017.
Proposals in the report include:
- Full alignment with the EU clinical trials regime, and a bespoke agreement for access to the EU portal and database (as noted above, this is the MHRA's priority also).
- Continued access to medicines, Investigational Medicinal Products (IMPs) and medical devices (i.e., no trade barriers impacting on the movement of such products and on clinical trials).
- Funding initiatives for clinical trials should be a priority for the Government.
- Ensuring the right talent through a permissive immigration system and investment in a skilled clinical trials workforce.
In the meantime, Brexit has had a significant impact on the operations of the EMA. The next phase of its business continuity plan (to be launched on 1 October 2018) will involve a temporary scaling back and suspension of activities, in order to safeguard core activities relating to evaluation and supervision of medicines. This has been caused by the 'significant staff loss' caused by the move to Amsterdam in March 2019, which the EMA admits is more than initially anticipated, with staff members already starting to leave. The EMA expects a staff loss of around 30%.
It has also published the results of its Brexit preparedness survey of UK based marketing authorisation holders (or those MA holders with an important step in their regulatory processes in the UK) for centrally authorised products. Whilst the results of the survey indicated preparations had started, the EMA is concerned that, for some medicines, these procedures will not be implemented in time to allow continued supply post-March 2019, and also that many businesses are planning to take the necessary steps in Q1 of 2019, during the peak period for relocation of the EMA.
Developments to look for in the coming weeks, aside from the October deadline, include the long-awaited full report by the Migration Advisory Committee into EEA workers in the UK market due in September 2018. We also await news of the EY study commissioned to assess the impact of Brexit on cross-border medicinal supplies.