After several tumultuous years attempting to extricate itself from the EU, the UK finally completed the withdrawal process at the end of last year. The Medicines and Medical Devices Act 2021 is the final piece of legislation that dictates how the medtech industry will now function in the UK, without the EU’s oversight.
The purpose of the Act is to lay out a structure for the UK government to legislate for updates and amendments to existing laws on human and veterinary medicine, clinical trials and medical devices.
The Act has undergone a number of changes since its introduction in February 2020, including the addition of a section mandating the creation of a Patient Safety Commissioner.
Increased powers for the MHRA
The Act has introduced the need for public consultation in relation to proposed changes in regulation and for the UK Medicines and Healthcare products Regulatory Agency (MHRA) to lay periodic reports before Parliament.
The MHRA is now the sole body responsible for the regulation of medical devices in England, Wales and Scotland.
These new powers mean the MHRA can impose civil or criminal sanctions for breaches of the Act, or any secondary legislation to it, against corporations or individuals and company directors.
In practice, this means that the MHRA will be able to require a corporation take action to bring itself into compliance in circumstances where an offence has been committed, followed by criminal prosecution should this fail. The Agency may also look to impose fines instead.
To defend itself before the MHRA, a non-compliant corporation or individual will need to show that they took “all reasonable steps and exercised all due diligence to avoid commission of the offence.”
In a company blog post, Morrison Foerster partner Gareth Rees and associate Jenny Galloway said: “With the objective of the Act being the safeguard of public health and safety it is […] likely that financial sanctions will be onerous and tolerance for corporates without robust procedures in place will be low.”
What defines an ‘attractive’ business prospect?
Ultimate authority over medical device regulations now sits with the UK’s Secretary of State for Health and Social Care, currently Matt Hancock.
The Secretary of State will now set the rules for medical device safety and availability, as well as taking on responsibility for making the UK an attractive place to manufacture medical devices.
Some commentators have expressed confusion and concern about the use of the word ‘attractiveness’ in the final Act.
University of Birmingham academics have recommended that: “The attractiveness clauses should either (a) be removed entirely from the Bill, or (b) a clear statutory definition of attractiveness should be included in the Bill, along with a further clause requiring the appropriate authority to prioritise safety whenever different elements need to be balanced.”
A greater emphasis on patient safety
One aspect where the UK is clearly moving in the right direction is in terms of patient safety.
A Patient Safety Commissioner is being put in place to provide independent oversight over relevant aspects of medicine, medical device use and surveillance. Their job will be to promote the safety and views of patients and other members of the public regarding medicines and medical devices, with all public health bodies and manufacturers expected to cooperate and share information with the Commissioner.
The focus on patient safety and improved communication with patients has stemmed from a public review into the matter, which focused particularly closely on the devastating impact of transvaginal mesh implants.
As a result of this safety review, provisions have been made in the Act for the creation of a medical device database tracking information on post-market performance, the safety of individuals and the improvement of safety and performance through technological advances.