Intended for healthcare professionals


Putting patients first in medicines regulation?

BMJ 2021; 375 doi: (Published 30 November 2021) Cite this as: BMJ 2021;375:n2883
  1. Huseyin Naci, associate professor of health policy1,
  2. Robin Forrest, postgraduate student1,
  3. Courtney Davis, reader2
  1. 1Department of Health Policy, London School of Economics and Political Science, UK
  2. 2Department of Global Health and Social Medicine, King’s College London, UK
  1. Correspondence to: H Naci h.naci{at}

MHRA’s new delivery plan strikes the wrong note

On 4 July 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) published its delivery plan for 2021-2023: Putting Patients First: a New Era for our Agency.1 In this plan, the MHRA promises to make drug regulation in the UK more patient centred, while being “an agile and supportive regulator” to accommodate the interests of the United Kingdom’s life sciences industry.

The MHRA’s latest commitment to put patients first follows last year’s landmark report by the Conservative peer Julia Cumberlege.2 The Independent Medicines and Medical Devices Safety Review (2020) chronicled the failure of regulators, alongside those of clinicians and other healthcare professionals, to tackle decades of patient reports of harm from medical treatments.3 The Cumberlege report characterised a healthcare system that is unfit for protecting patients and preventing harm, recommending that the MHRA engage more with patients and their outcomes.

Going forward, the MHRA plans to include patients on all decision making committees.4 It will also support the development of patient reported outcome measures to make their use more widespread in clinical trials. The recent …

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