We didn’t think we’d say it but Brexit has finally taken a break from the headlines, with media outlets focusing their attention on the current COVID-19 pandemic. Despite disruptions caused by the crisis, Brexit still plans to take place following the end of its’ transition period on December 31st 2020. The Queen’s speech had its’ first reading in February, detailing the UK’s Medicines and Medical Devices Bill which will come into effect following the end of the UK’s transition period at the end of this year.
Currently, the UK follows EU law regarding medicines and medical devices. This law will still be preserved in UK legislation following the end of the transition period as the European Union (Withdrawal) Act 2018 allows for current EU frameworks to be retained by the UK. However, once Brexit takes place, the UK will no longer be able to amend or update these regulations, unless they introduce new primary legislation.
The Medicines and Medical Devices Bill gives power to the Health Secretary (Northern Ireland Department of Health) to make necessary amendments to retained EU law, once Brexit takes place. The aim of this Bill is to:
- Ensure UK legislation regarding medicines and medical devices can be amended and updated in response to patient safety concerns
- Enable regulators such as the Medicines and Healthcare products Regulatory Agency (MHRA) to quickly develop regulations which facilitate clinical trials in response to advancements in medical treatment such as artificial intelligence
- Implement a scheme to prevent entry of counterfeit medicines into supply chains
- Implement a registration scheme for online medicine and medical device sellers
- Reduce unnecessary burden for lowest risk clinical trials of new medicines and medical devices
The new EU Clinical Trial Regulation No 536/2014 aims to harmonise assessment and supervision processes for clinical trials throughout the EU. This regulation is not set to come into full force until after the Brexit transition period is over, which means that it will not be automatically transposed into UK law. The new Medicines and Medical Devices Bill will enable changes to UK law after Brexit, to reflect the new EU clinical trials regulation.
Similarly, the In vitro diagnostic medical devices regulation which is set to replace currently existing IVD Directive 98/79/EC, will become applicable after the transition period, in May 2022. As a result, it will not be automatically included in UK law. The Bill’s Explanatory Notes state that the UK will have to make its own decision regarding this regulation, which suggests the future possibility that UK in vitro diagnostic medical device regulation may differ from that of the EU.
For more updates on the UK’s regulatory situation, watch this space!
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