The Medicines and Medical Devices Act 2021 (MMDA) became law when it received Royal Assent on 11 February 2021. The MMDA can be viewed here:
Its stated aims included the following:
- establishing a Patient Safety Commissioner, with the core duty of promoting patient safety in relation to the regulation of human medicines and medical devices;
- introducing targeted delegated powers in the fields of human medicines, veterinary medicines and medical devices to enable the existing regulatory frameworks to be updated following the UK’s departure from the EU;
- providing “information sharing gateways” to enabling sharing of information with regulators outside the UK in order to give effect to international agreements and arrangements for the regulation of human medicines, veterinary medicines and medical devices;
- providing a delegated power to establish information systems in relation to medical devices;
- providing a delegated power to establish, on a legislative basis, a medical device expert advisory committee; and
- consolidating the enforcement provisions for medical devices and introduction of civil sanctions.
Why is the MMDA important? By far and away the most important provisions of the MMDA relate to the powers given to the UK to depart from the EU regulatory framework in order to give effect to the end of the Brexit transition period and to allow relatively easy amendment of existing UK laws and regulations through secondary legislation, known as statutory instruments.
Statutory instruments often receive less legislative scrutiny than primary legislation. The MMD Bill had a controversial path through parliament with Lord Blencathra describing, in the second reading in the House of Lords, the future powers of delegation as “absolutely atrocious and an affront to parliamentary democracy”.
What will be absolutely key for the currently globally-leading life science sector will be the detail set out in future statutory instruments which have not yet been published, but which industry observers believe might be fairly soon. Whether the life sciences sector benefits from “slashing red tape” to make the UK an even more attractive place to do life sciences business, as the government hopes, or whether there is, as detractors fear, a “race to the bottom” in terms of a rapid move away from EU regulatory standards remains to be seen. It’s a matter of watch this space.Whatever happens, it’s bound to be an interesting time for the industry.
Prospect Law will publish an update when the draft statutory instrument is published.
About the Author
David McIntosh was admitted as a Solicitor in 1988 and is a highly experienced commercial projects lawyer who has advised clients in a number of different fields including intellectual property, data privacy, procurement law (both public and private), manufacturing, distribution, information governance and general regulatory matters covering both the nuclear and pharmaceutical sectors.
Prospect Law is a multi-disciplinary practice with specialist expertise in the energy, infrastructure and natural resources sectors with particular experience in the low carbon energy sector. The firm is made up of lawyers, engineers, surveyors and other technical experts.
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