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BREXIT
Getting to the heart of a no-deal Brexit
The term ‘no-deal Brexit’ has been used so much over the last year that many have become all but immune to its real meaning. The Clinical Services Journal examines what the impact of this may mean to the NHS.
At the beginning of 2019
GOV.UK published guidance on how medicines, medical devices and clinical trials would be regulated in the event of a ‘no-deal’ Brexit. This guidance was withdrawn on 17 July 2019 and has been replaced by ‘Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal’. The technical notice provides information on the implications if the UK leaves the EU with ‘no-deal’ and offers guidance for continued planning.
Also included is an overarching framing notice explaining the government’s approach to preparing the UK for this outcome, in order to minimise disruption and ensure a smooth and orderly exit. The guidance states: “We are working with the devolved administrations on technical notices and we will continue to do so as plans develop.”
The purpose of this notice is to update businesses on the arrangements that will come into force for human medicines regulation currently subject to EU rules if the UK leaves the EU with no deal.
Before the UK leaves the EU
Under the current EU membership, the UK is integrated in the EU Medicines Regulatory Network (EMRN), including the European Medicines Agency (EMA).
The EU legal framework for human medicines sets standards to protect public health and ensure medicines are safe and effective. The rules for marketing authorisation and monitoring authorised products are primarily laid down in Directive 2001/83/EC and in Regulation (EC) No 726/2004. In UK law, the Human Medicines
Regulations (2012) (HMRs) set out a comprehensive regime for the authorisation of products, including their manufacture, import, distribution, sale and supply, as well as labelling, advertising and
pharmacovigilance (monitoring the effects of medicines).
The Medicines and Healthcare products SEPTEMBER 2019
Regulatory Agency (MHRA) is the national regulator for human medicines (as well as medical devices, clinical trials and blood products).
The EMRN manages some aspects of
regulation, including EU licensing procedures, pharmacovigilance and legal presence requirements.
Medical devices
In the UK, all medical devices are subject to EU legislation, which use a CE marking to show compliance.
Medical devices are regulated under three EU directives: l Active Implantable Medical Devices (AIMDD) (1990)
l Medical Devices (MDD) (1993) l In Vitro Diagnostic Medical Devices (1998).
Higher risk devices (such as Class IIa, IIb and III medical devices, and in vitro diagnostic devices in list A and list B in Annex II of the EU Directive, plus those for
self-testing) must be certified by an independent conformity assessment body, called EU Notified Bodies (NB). EU NBs must be designated and overseen by their national authority (the MHRA in the UK), following joint audits by two other national authorities and the European Commission. Clinical trials are managed nationally - in the UK by the MHRA. Some aspects of clinical trials are shared across the EMRN. For example, a clinical trial sponsor or legal representative for clinical trials in the EU should be based in the EU/EEA. The requirements and procedures for clinical trials in the UK are set out in the Medicines for Human Use (Clinical Trials) Regulations 2004. These regulations require all interventional clinical trials to be authorised by the MHRA and ethically approved. They also include requirements for the application and assessment, the supply of investigational medicinal products and safety reporting.
The EU is planning to implement new
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