The Medicines and Medical Devices Act 2021 (MMDA) received Royal Assent on 11 February 2021. The context for the MMDA is, of course, the UK's departure from the EU, given that much of the legal and regulatory framework for medicines and medical devices derives from EU Directives. Whilst these existing frameworks remain in place, through the creation of retained EU law, the MMDA seeks to fill a regulatory gap that would otherwise arise when it comes to updating those frameworks.
The MMDA does this by introducing broad and wide-ranging powers to the Secretary of State for Health to make regulations in relation to human medicines, clinical trials, veterinary medicines and medical devices, albeit these powers may only be exercised in relation to a specific list of matters, and by reference to the overarching objective to safeguard public health. Further, when making any such regulations, the MMDA provides that consideration must be given to the safety and availability of the relevant human or veterinary medicines or devices, and the favourability of the UK as a place to develop and supply such products. It remains to be seen how the regulatory framework for medicines and medical devices in the UK will develop under the powers provided in the MMDA, and the extent to which there is proper and effective scrutiny of that framework.
Medical devices regulation
Aside from the introduction of delegated powers to revise existing regulatory frameworks, the MMDA also includes a number of key provisions relating to regulation of medical devices. In particular, it set outs a new, consolidated and streamlined enforcement regime for medical devices (previously, enforcement was conducted by reference to several pieces of legislation). It also introduces the possibility of civil sanctions (such as a monetary penalty) as an alternative to criminal prosecution for breaches of the Medical Devices Regulations 2002 or a failure to comply with an enforcement notice.
Further, the MMDA provides the Secretary of State with new powers to share information about medical devices, e.g., to warn the public where there are safety concerns relating to a device. The MMDA sets out parameters for such information-sharing, making it subject to data protection laws, and by reference to restrictions relating to disclosure of commercially sensitive information.
The MMDA also provides a power to establish a new statutory expert advisory committee (in place of an existing, non-statutory committee) to provide advice on medical devices, which will inform regulatory decisions and recommendations.
The MMDA includes powers to put in place a bespoke falsified medicine system, with a public consultation expected to be issued within 12 months, subject to other governmental priorities around medicines regulation.
Patient Safety Commissioner
An amendment to the MMDA when it was making its way through Parliament established a Patient Safety Commissioner (PSC) for England, as recommended by the July 2020 report of Baroness Cumberlege (First Do No Harm: the Report of the Independent Medicines and Medical Devices Safety Review). Demonstrating the perceived importance of the PSC's role, and the over-arching focus on patient safety, the appointment of the PSC is dealt with in Part 1 of the MMDA.
The PSC will be a champion for patients, with statutory powers: whilst sponsored by the relevant Government department, the Department of Health and Social Care (DHSC), importantly they will maintain their independence, with safeguards in place to enable this. The PSC will be required to publish a set of principles to govern the way in which they carry out their core duties, and take steps to consult patients and ensure patients are aware of their role. There will be a consultation in relation to Regulations setting out further details about the appointment and operation of the PSC. Whilst the Government notes the urgency in establishing the PSC role, it has also stressed the need to balance that with adopting the required due process to recruit the right person.