Copy and paste…
As with most existing EU legislation, the rulebook for medicines and medical devices will remain in place in the UK for the time being. Although the automatic link with EU law falls away, the Withdrawal Act 2018 serves to duplicate nearly everything for day one of 2021.
The rulebook will not survive unchanged. We have already seen a substantial amount of tinkering as an indication of things to come. So far, this involves fairly light touch changes to the existing rules on medicines and medical devices
After the end of the transition period, however, things will start to change more noticeably. The UK will divide into two regions, with Great Britain able to adjust its laws, and move in a new direction, while Northern Ireland remains tied to EU rules. New approval and certification systems will start to operate and a different direction for both medical devices and clinical trials is expected.
…existing product licences and certifications:
A “grandfathering” system will apply to existing Centrally Authorised Products that received their initial review and approval through the European Medicines Agency. Marketing Authorisation Holders will have a period of 12 months within which to submit essential baseline data to the UK regulator (the MHRA). MAHs have the option to opt out of this process.
For medicines that were licensed through either the mutual recognition or decentralised routes, a UK marketing authorisation will apply from 1 January.
Where marketing authorisation applications are in progress, applicants will be able to request an “in-flight assessment” for a GB marketing authorisation in parallel with the European application, or await a positive CHMP opinion and then use the new “reliance route” in the UK (see below).
For medical devices, CE marking will continue to be recognised in Great Britain until 30 June 2023, as will the work of EU Notified Bodies. (Note that UK Notified Bodies will not be recognised for EU purposes after the end of 2020, although they will still be able to issue certificates for “CE UKNI” marking, valid in Northern Ireland.)
A new outlook for GB regulation
The Medicines and Medical Devices Bill is progressing through Parliament, expected to become law early in 2021. The Bill does not go into much detail on the shape of the future regulatory system, but it gives a huge amount of freedom to UK Government to change the system through the use of delegated legislation.
Three priorities will shape these future changes. They are:
- the safety of medicines
- the availability of medicines
- the attractiveness of the relevant part of UK (GB or Northern Ireland) as a place in which to conduct clinical trials or supply human medicines.
It also brings together and expands the law on enforcement of the medical device rules. The aim here is to achieve greater clarity and specificity to enforcement powers, and remove medical devices from the more general regime for consumer protection and product safety.
A new portfolio of routes to market for medicines
From 1 January 2021, the MHRA will offer four different licensing routes for medicines. Full details of these application routes are not yet available, although the MHRA has provided outline information and will follow up with further detail. The scheme envisages speed and flexibility, to promote speed to market for innovative medicines. Indeed, market participants are encouraged to challenge the current regulatory framework through liaison with the MHRA Innovation Office.
- Reliance route for EU centrally authorised products: GB will recognise decisions to approve medicines receiving EMA approval, subject to a risk-based review in the context of UK clinical practice and any GB specific considerations.
- Innovative licensing pathway: This route envisages a new designation for innovative products offering significant patient benefit. The MHRA will work with other UK organisations, such as NICE, to offer a toolkit of support options. Further information is expected soon.
- The accelerated assessment route: This option will be available for new marketing authorisation applications for both new and existing active substances submitted directly in UK. The MHRA promises a 150-day timeframe for review. Orphan medicine status can be requested within this route.
- Rolling review: This route offers a modular approach to submission and assessment for new active substances. The intention is to offer ongoing regulatory input and feedback to enhance efficiency. This will be open to any new active substance application where a full dossier is submitted in the UK. The MHRA’s rapid approval of the first COVID-19 vaccine provides a great example of this approach.
Holders of UK marketing authorisations will have to be UK-established entities.
Orphan medicine review will fall to the MHRA under a new GB-focused system, similar to the existing EU regime.
This will offer 10 years of market exclusivity for approved products within the orphan indication. With a paediatric investigation plan, applicants can benefit from an additional 2 years of exclusivity.
Those centrally authorised orphan medicines that are converted across to UK authorisations under the grandfathering process discussed above will retain their existing exclusivity rights.
As the UK moves away from a tight linkage with the EU, UK Government has flagged a willingness to embrace a wider international approach. Two recently announced tie-ups with international initiatives will see the UK link into joint projects for the approval of and access to innovative medicines. These projects are:
- Project Orbis with US, Canada, Australia, Switzerland, Singapore and Brazil, to review and approve promising cancer treatments.
- Access Consortium with Australia, Canada, Switzerland and Singapore, to help secure improved patient access to high-quality, safe and effective medicines
Existing EU medical device law is undergoing reform, with new rules on general devices and in vitro diagnostics due to take effect in May 2021 and May 2022 respectively. Despite earlier indications that these updates would be reflected in UK law, this no longer Government intention. Strengthening and updating of medical device law is expected, but not necessarily in alignment with the EU changes. Instead, UK Government promises to take account of international standards and stakeholder views to develop “an attractive world-class regulatory system”. We can expect this to involve tougher standards reflecting the recommendations of the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege.
Meanwhile, a new UKCA marking will be available from the start of 2021. Initially this will run alongside products bearing a CE marking. However, after 30 June 2023, all products on the GB market will have to use the UKCA mark. Existing UK Notified Bodies will support this system, and will become UK Approved Bodies.
Unlike the current system, all medical devices will need to be registered with the MHRA. UK manufacturers are already required to register. However, grace periods apply where registration is not currently required. Higher risk products (Class III and Class IIb implantable devices, all active implantable medical devices and IVD List A products) must be registered from 1 May 2021. Other Class IIb devices, all Class IIa devices, IVD List B products and Self-Test IVDs must be registered from 1 September 2021, and all other products will have until 1 January 2022 to be registered.
Note that Northern Ireland will move to the new EU system in step with other EU countries. This will introduce a degree of complexity as producers and importer grapple with the two different regimes.
The Medicines and Medical Devices Bill offers flexibility for Government to tailor the clinical trials system. We can expect any changes to streamline the clinical trials process, from application and ethical review, to the conduct and reporting of clinical trials. The Bill allows for, but does not commit to, alignment with the delayed EU Clinical Trials Regulation (536/2014). The new EU law can only come into force only once a Clinical Trials Information System is finally complete, and that is not now expected until the end of 2021. As that date approaches, UK Government will have the opportunity to take stock and assess what degree of alignment it wishes to implement.
While alignment offers potential benefits in reducing friction, especially in the context of multi-national clinical trials, a divergent approach could offer different advantages. The freedoms in the Bill suggest an intention to reduce the administrative burden on running low risk clinical trials.
Under the terms of the 2019 Withdrawal Agreement between the EU and the UK, the situation in Northern Ireland will remain closely aligned with EU law. This presents a range of difficulties for those operating in and selling into the Northern Irish market.
In order to assist businesses in navigating these issues, the EU and UK have agreed a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021. This provides additional time to prepare in relation to batch testing, importation and Falsified Medicines Directive (FMD) requirements. Further guidance on sales in Northern Ireland is available here.
Take away points
The coming months will see a substantial amount of regulatory change and complexity. This will be challenging for business to navigate. While remaining within the EU system would have been a more straightforward option for industry, there are prospects for beneficial change within the UK. There is clearly an intention to offer increased flexibility, responsiveness and support for innovation. Once the situation settles down, there may be unexpected benefits for the sector in developing products within the GB system, even with the additional burden of separate regulation and possible border friction.
Learn more about our life sciences services here.