With less than a week before MPs in the House of Commons vote on Theresa May’s Brexit deal on the 15th January 2019, the Government’s “Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal” seems timely. Much of the guidance repeats and expands on what the Government has already said (see our article from October 2018) so we have focussed on some of the most important updates and key considerations.
- Orphan Medicines: the 10 year orphan market exclusivity period (i.e. the period during which similar products for the same indication will not be approved unless clinically superior) will be replicated within the UK as will fee discounts. This confirmation will be welcomed by the sector.
- Legal Presence Required: marketing authorisation holders (MAHs) will need to be established in the UK by the end of 2020. However, MAHs not established in the UK on exit day must nominate a UK based contact person within 4 weeks after exit date.
- Licensing regime for wholesalers importing QP certified medicines: Wholesale licence holders who wish to continue to be able to purchase medicines from the EU/EEA must notify the MHRA within 6 months after exit date and request a revised Wholesale Dealer Authorisation.Holders of this amended licence will be required, from the date of Brexit, to establish an assurance system to ensure that medicines they import have been QP certified. This system should be overseen by a new role of Responsible Person for Import (RP-I) and companies will have 2 years after the exit date to name their RP-I.
- Parallel imports: medicinal products that hold a marketing authorisation (MA) in the EU/EEA (or a MA authorised by the Community) and are essentially similar to a product with a UK MA will still be able to be imported under a parallel import licence post-Brexit. However, the MHRA reserves the right “to vary, suspend or revoke a parallel import licence if the UK reference product is suspended, revoked or varied.” This appears to contradict existing EU case law, i.e. Case C-15/01, which notes national legislation cannot provide for the automatic withdrawal of a parallel import licence if the relevant national MA is withdrawn at the request of the MAH unless there is a risk to human health.
- Notified Bodies (NBs): UK-based NBs will no longer be recognised in the EU post-Brexit so any devices certified by a UK-based NB will no longer conform to the relevant EU Directive (subject to any future agreement that provides for continued recognition or a grace period in EU Member States). The press release in respect of the guidance indicates that “for a time-limited period, devices that have a CE-mark from a notified body based in the UK or an EU country will continue to be recognised by UK law and allowed to be placed on the UK market”. However, competent authorities for medical devices in the EU may not take such a charitable view and so manufacturers with UK-based NBs should contact their NB urgently to discuss migrating to an NB established in the EU. We understand that a number of UK-based NBs have stated that this migration will take place automatically to a “sister NB” established in an EU Member State. However, all manufacturers should clarify the position with their NB. The below table summarises changes that will likely be required in a no-deal Brexit scenario.
Obtain certificates from an EU-based NB before 29 March 2019
None in the short term
Transfer to a UK-based NB in due course
- Clinical Investigations: the UK will continue to recognise existing clinical investigation approvals (both regulatory and ethics approvals) so there will be no need to reapply post-Brexit.
- New EU regulations: the guidance document provides more details regarding how medical devices will be regulated post-Brexit. However, it is worth noting that the UK Government still only promises compliance with the “key elements” in Regulations 2017/745 and 2017/746 (the MDR and IVDR) rather than full regulatory alignment. This statement leaves some ambiguity as to whether the UK may choose to depart from certain provisions within the MDR/IVDR.
- Registration of medical devices on the UK market: after Brexit, all medical devices, active implantable medical devices, in vitro diagnostic medical devices and custom-made devices will need to be registered with the MHRA prior to being placed on the UK market. However, as this is a new requirement the following “grace periods” will apply:
Class/ Type of medical device
Class III medical devices, Class IIb implantable medical devices, Active implantable medical devices, IVD List A
Class IIb non-implantable medical devices, Class IIa medical devices, IVD List B, Self-test IVDs
Class I medical devices, Self-certified IVDs, Class A IVDs
Also, custom-made devices will be provided a grace period in line with their risk class.
Clinical Trials of IMPs:
- Regulation requirements for running a trial: The new EU Clinical Trials Regulation 536/2014 (CTR) will not apply in the EU on exit day. However, the guidance reiterates that the UK Government made a commitment during the implementation period “to align where possible with the CTR without delay” when it does apply and in the event of a no-deal Brexit “the Government will realign with the parts of the [CTR] that are within the UK’s control”. Therefore, those who plan to carry out clinical trials should prepare for compliance with the CTR in the UK regardless of the outcome of Brexit.
- Import licensing: as with wholesale dealers, those holding manufacturing licences (MIA) for investigational medicinal products (IMPs) will be required to set up an assurance system to check IMPs have been QP certified in the EU/EEA. However, unlike the system for authorised medicinal products, this assurance system will be overseen by the QP. Also, clinical trial sponsors will have 12 months after EU exit to comply with these requirements.
If the House of Commons rejects Theresa May’s proposed withdrawal agreement, the UK may well leave the EU without a deal if exit day is not pushed back. Therefore, those working in the life sciences sector should continue to plan for the no deal scenario in order to mitigate the risks this scenario would impose. Guidance from the UK Government (including further guidance that is likely to be published if the withdrawal agreement is not agreed to) should be carefully considered as it will hopefully provide greater clarity on what is expected of those working in the life sciences industry.