Medilink East Midlands patron Mills and Reeve examines how the the new Medicines and Medical Devices Bill sets the UK and the EU on a post-Brexit regulatory path.
An important development for life science businesses is the publication of the Medicines and Medical Devices Bill. As expected, this draft legislation will provide for the UK Government to take over the rulebook for human and veterinary medicines, clinical trials and medical devices after the end of the transition period on 31st December 2020. Currently very closely harmonised at EU level, the legislation is not expected to diverge rapidly from EU law. However, there are clear signals in the Bill and Explanatory Notes that a separate approach is likely to evolve.
Legislation in this area has previously been updated at EU level, with the changes flowing through into UK law. The Medicines and Medical Devices Bill will allow the Health Secretary to take over that task.
Human medicines regulation, clinical trials and medical devices
The Bill proposes to give broad powers to the Health Secretary (or Northern Ireland Department of Health) to make regulations amending or supplementing the law relating to human medicines and clinical trials. This allows for a wide range of possible changes. When the Bill was foreshadowed in the new UK Government’s Queen’s Speech, the stated aim was to
“ensure that our NHS and patients can have faster access to innovative medicines, while supporting the growth of our domestic sector.”
References in the Queen’s Speech briefing to policy aims such as:
- “Removing unnecessary bureaucracy for the lowest risk clinical trials, to encourage rapid introduction of new medicines” and
- “Enabling our regulators… to develop innovative regulatory approaches to respond quickly to developments such as artificial intelligence in treatments and ensure the UK can break new ground in complex clinical trials”
are not played out in full in the Bill, but actions to implement these would be enabled by the extensive powers it gives to the Health Secretary.
The Bill mentions the possibility of changes to reflect the new EU Clinical Trials Regulation. Although that legislation is already in force, its application is currently suspended pending full rollout of the EU clinical trials portal and database. On current timetable estimates, the new EU clinical trials system will not be introduced before the end of the Brexit transition period and so will be too late for automatic inclusion in UK law. (The latest EMA website update indicates that the audit of the Clinical Trials Information System will begin in December 2020, while the Brexit transition period is due to end that same month.)
The Bill proposes similar powers to amend or supplement the medical devices legislation. Of course, the existing EU directives in this area are due to be replaced by two new Regulations:
- Regulation 2017/745 on medical devices (applicable from 26 May 2020)
- Regulation 2017/746 on in vitro diagnostic medical devices (applicable from 26 May 2022).
The second of these is expected to apply after the end of the transition period, and so will not be automatically included in UK law. The Bill’s Explanatory Notes state that the UK will need to make its own decisions about the future regulation of IVDs, raising the prospect of a divergent approach.
Note that, any regulations made under this Bill must take account of the following factors:
- the safety of human medicines/medical devices
- the availability of human medicines/medical devices
- the attractiveness of the UK as a place in which to conduct clinical trials, supply human medicines or develop or supply medical devices.
The third of these is an interesting addition to the usual policy considerations in this area, and reflects the UK Government’s current approach to the future relationship. A prior consultation process is also required so that those affected will have an opportunity to comment.
Medical devices enforcement
The Bill includes extensive provisions on enforcement of the medical devices regime. The intention here is to bring together in one place enforcement rules affecting medical devices – they are currently scattered across several different pieces of legislation. The Bill proposes a scheme of enforcement notices: compliance notices, suspension notices, safety notices and information notices, with a specific criminal offence for breach of these enforcement notices. A due diligence defence may be available for those accused of an offence.
The Bill also provides for a method for affected individuals to bring civil proceedings if they are affected by a breach of medical devices legislation. This raises the prospect of a clear path to damages claims, without resorting to general product safety legislation.
Watch this space
The Government’s powerful position in Parliament suggests that the Bill will become law with few changes. The next stage will be tracking, and where necessary intervening, as the Health Secretary begins to make of the powers it confers.
