The MMDA has been a catalyst for a potentially transformative shift in the UK’s regulatory framework since it became law. In this revisit, we delve into the developments that have unfolded over the past two years.
This is the second of 2 articles on this subject. The first article can be accessed here: The Medicines and Medical Devices Act 2021: Stated Aims and Significance | Prospect Law
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:
https://www.legislation.gov.uk/ukpga/2021/3/pdfs/ukpga_20210003_en.pdf
The MMDA grants expansive powers to the Secretary of State for Health and the Department of Health in Northern Ireland, offering a “dynamic” means to amend regulations governing human and veterinary medicines, as well as medical devices. This adaptability becomes crucial as the UK charts its course post-EU departure. Aligned with the Department of Health and Social Care’s (DHSC) vision, these powers are designed to bolster the Life Sciences sector by fostering innovation and supporting advancements in medical technologies.
Since the enactment of the MMDA, the DHSC has laid a number of Statutory Instruments (SIs) to make legislation. Examples include The Coronavirus Test Device Approvals Regulations 2021, a new validation process for home COVID-19 testing kits, and the Coronavirus and Influenza Regulations 2022 – which enabled the mass vaccination programme against both covid-19 and the flu to continue to be carried out at speedily as required whilst safeguarding patients and limiting disruption to other NHS services.
In March 2022, the DHSC and the Medicines and Healthcare products Regulatory Authority (MHRA) made an SI that placed the Early Access to Medicines Scheme (EAMS) on a statutory footing. This scheme, established in 2014, offers patients with life-threatening or seriously debilitating conditions safe and timely access to medicines pre-marketing authorizations. The statutory backing aims to enhance efficiency, reduce regulatory burden, and increase visibility, ensuring swifter access to life-saving medicines for a broader demographic.
The MMDA’s commitment to patient safety materialised in the creation of the “Patient Safety Commissioner” (PSC) role. Dr. Henrietta Hughes, appointed in September 2022, spearheads this initiative. The move emphasises a dedication to ensuring the safety of patients in the evolving healthcare landscape.
“My role is to promote patient safety in relation to medicines and medical devices and to promote patients’ voices. This site is for everyone interested in promoting patient safety and making sure that patients’ voices are heard.”
Dr Henrietta Hughes OBE
The Lucy Letby trial and murder convictions understandably dominated the UK media for a substantial period of time and readers of this newsletter may be interested to read the response from Dr Hughes on this subject in the link below:
The growing list of SIs made so far include:
- The Coronavirus Device Test Approvals The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (legislation.gov.uk) (July 2021)
- The Patient Safety Commissioner The Commissioner for Patient Safety (Appointment and Operation) (England) Regulations 2022 (legislation.gov.uk) (Feb 2022)
- The Coronavirus and Influenza Regulations (The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022 (legislation.gov.uk) March 2022)
- Early Access to Medicines Scheme The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (legislation.gov.uk) (March 2022)
- MHRA Fees Medicines The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (legislation.gov.uk) (March 2023)
- MHRA Fees Blood & Devices The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (legislation.gov.uk) (March 2023).
As we delve deeper into the landscape shaped by the Medicines and Medical Devices Act 2021, our next instalment will unravel the DHSC’s envisioned “three flagship Brexit Opportunities.” Stay tuned — the best is yet to come!
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.
For personalised advice and comprehensive information on medicine and medical matters, reach out to David McIntosh on dmc@prospectlaw.co.uk or +44 (0) 7483 300 132.
Prospect Law is a multi-disciplinary practice with specialist expertise in the energy and environmental sectors with particular experience in the low carbon energy sector. The firm is made up of lawyers, engineers, surveyors and finance experts.
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