As Brexit is finally completed in the UK, from 1 January 2021, the Medicines and Healthcare products Regulatory Agency (“MHRA”) will be the UK’s standalone medicines and medical devices regulator. Transition from the EU allows the UK to offer fully independent regulatory decisions for both devices and pharmaceuticals, both nationally and in joint work with other international regulators.
The frequent changes to legislation on these issues will no longer flow through from updates at the EU level. The Medicines and Medical Devices Bill (“the Bill”), which has almost completed its passage through Parliament, creates the structure for the UK Government to legislate for updates or changes to our existing laws on human and veterinary medicines, clinical trials, and medical devices at the end of the Brexit Transition Period in January 2021.
The UK Government post-Brexit position is clear:
“Our goal is this: we want the UK to be the best place in the world to design and trial the latest medical innovations. This bill gives us the powers we need to make that happen. It will mean that the NHS has access to the most cutting-edge medicines and medical devices, with enhanced patient safety; it will help our life sciences seize the enormous opportunities of the 2020s, supported by a world‑leading regulator . . . ”
When the Bill becomes law, the MHRA will have several new enforcement tools at its disposal, including enforcement undertakings and civil monetary penalties. As with other UK regulators, the MHRA will have powers to choose between civil and criminal penalties for breaches of the regulations, which will apply to the corporate, but also individuals and directors.
The MHRA will be able to require a corporate to give undertakings that it will take specific action to bring its business into compliance in circumstances where the regulator has reasonable grounds to suspect that an offence has been committed. Ultimate failure is likely to lead to a criminal prosecution.
However, as an alternative, the MHRA may be able to impose a civil monetary penalty, as opposed to the criminal route, which provides a strong enforcement result for the regulator and a non-criminal outcome for the corporate. All this is achieved more quickly, at lesser cost, and it appears likely it will be available without public scrutiny.
For some of the new corporate criminal offences, for breach of regulatory notices or any of the major requirements of the medical devices’ regulations, there will be a new defence of due diligence. But, this will require the corporate to show it took “all reasonable steps and exercised all due diligence to avoid commission of the offence.”
All of this is consistent with the structure of UK legislation, in particular, the UK Bribery Act 2010. The Bill places responsibility on corporates to have systems and procedures in place and will require some robust compliance procedures in place to prevent the risk of hefty financial sanctions and possibly criminal prosecutions.
When the Bill receives Royal Assent and becomes an Act of Parliament, we will be able to understand the fine detail before guidance is provided by the government. Then it will be interesting to see the extent to which the UK takes a unilateral position separate to the EU or if it will be nervous that the cost of divergent regulatory compliance for corporates takes business to the larger EU market. We will keep bring further news on the new law when the bill completes its passage through Parliament.