On 23 August 2018, the UK Government published 25 notices (published as part of a series in August and September), which set out guidance from the Government in order to allow businesses and citizens to prepare for a “no deal” scenario following Brexit. The Government is keen to emphasise that the UK and EU are still working towards reaching a deal and these notice setting out the UK’s plans are there “in the unlikely scenario that they need to be relied upon”. All of these notices will require careful consideration as they will set out how the UK will work from the 30 March 2019 in the event of no deal being reach.
The present series of notices cover 11 key areas including, importantly for those in the pharmaceuticals and medical devices space: importing and exporting; labelling products and making them safe; and regulatory medicines and medical equipment. Potentially the most crucial notice for those in the pharmaceutical and medical device industries is the guidance on “How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal”. The key points of this guidance regarding what will happen after 29 March 2019 if there is no deal are summarised below.
- Medicines: the UK’s participation in the European regulatory network would stop and so the MHRA would take on the functions carried out by the EU, e.g. the EMA, which would require updates to the Human Medicines Regulations 2012 (the UK legislation).
- Medical Devices: while UK presence in any EU committees will cease, the UK will recognise medical devices approved for the EU market and which are CE marked (if this changes the Government promises to give “adequate time” for business to make the necessary changes). The UK will also comply with all “key elements” of the new regulations coming into force, i.e. the Medical Devices Regulation in 2020 and the In Vitro Diagnostic Device Regulation in 2022.
- Clinical Trials: The requirements and procedures for clinical trials in the UK are set out in the Medicines for Human Use (Clinical Trials) Regulations 2004 and these will stay in force post-Brexit (subject to some modification to make sure they still work). However, the Government states that while the new EU Clinical Trials Regulation 526/2014 will not be in force as of the date of Brexit it will be incorporated into UK law on 30 March 2019.
The guidance then goes on to detail some of the implications of these changes. We have not covered these all in detail here; however, some of the key points are mentioned below:
- Medicines: all centrally authorised medicines will automatically be ‘grandfathered’ into national UK marketing authorisations (MAs) on 29 March 2019; future MA applications will have to be submitted to the MHRA as well as the EMA but the UK Government has promised the process will be streamlined so there is no greater burden on the industry; the UK MA holder will need to be established in the UK by the end of 2020 and certain personnel (the Qualified Person Responsible for Pharmacovigilance (QPPV) and the Qualified Person for manufacture (QP) if the product is manufactured in the UK or a country not on a designated “whitelist”) will need to be established/reside in the UK.
- Medical Devices: the UK will, for a time limited period, continue to recognise the CE mark so devices would be accepted on the UK market if they meet EU requirements; however, the MHRA will no longer be able to oversee Notified Bodies under the EU regime.
- Clinical trials: these are currently managed nationally and so clinical trial applications will continue to be authorised by the MHRA; the UK is seeking to preserve the requirement that the sponsor/ legal representative needs to be based in the EU/EEA but the Government anticipates there will need to be someone based in the UK with overall responsibility and there is an intention to align the UK’s transparency provisions with those currently within the EU.
There are four other guidance documents specifically regarding the regulation of medicines and medical equipment, which are:
- Batch testing medicines if there's no Brexit deal;
- Ensuring blood and blood products are safe if there’s no Brexit deal;
- Submitting regulatory information on medical products if there’s no Brexit deal; and
- Quality and safety of organs, tissues and cells if there’s no Brexit deal.
These documents are welcomed as providing some clarity as to the no deal scenario and should be considered by all those in the pharmaceutical and medical device sectors.