Becoming ‘a patient focused regulator’? MHRA Patient and Public Involvement Strategy

  • 1st July 2021

In this blog Patient Safety Learning outlines key points included in its response to the consultation on the Medicines and Healthcare products Regulatory Agency’s (MHRA) proposed Patient and Public Involvement Strategy 2020-25. It sets out its feedback to this consultation and describes the change required for the regulator to improve its approach to engaging and involving patients to improve patient safety.

In its investigation of the serious patient safety failings regarding hormone pregnancy tests, sodium valproate and pelvic mesh implants, the Independent Medicines and Medical Devices Safety (IMMDS) Review (also known as the Cumberlege Review) highlighted significant concerns about the MHRA’s role in this. In its recommendations it stated:

“The MHRA needs substantial revision, particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients have an integral role in its work.”[1]

Patient campaigners have also cited serious concerns about its performance, describing it as ‘falling asleep at the medical regulation wheel’.[2] Through its consultation processes the MHRA has recognised its own shortcomings in patient engagement and involvement. Reflecting on feedback last year, the MHRA set out a range of concerns, including that ‘the agency has not always responded in either a timely or proportionate manner when patients have raised concerns with us’.[3]

It is within this context that the MHRA has published its proposed Patient and Public Involvement Strategy 2020-25, with the stated aim of ‘adopting a more systematic approach to listening to and meaningfully involving patients and the public’.[4] Here we will outline the strategic objectives of this new Strategy before reflecting on the key elements of our consultation response.

Five strategic objectives

The MHRA has set out its proposals to improve its engagement and involvement with patients and the public under five strategic objectives:

  1. Patient and public involvement – developing clear processes to engage patients in MHRA activities and embedding this across the organisation.
  2. Responsiveness – ensuring that its services meet the needs of patients and members of the public.
  3. Internal culture – changing its processes and training so that all its staff consider the patient and public perspective in their decisions.
  4. Measuring outcomes – creating a patient outcome evaluation framework to measure their progress towards becoming ‘a patient focused regulator’.
  5. Partnerships – working with others to improve its effectiveness and share patient insights.

Patient Safety Learning believe that too often patients are treated as passive participants in care processes. Safety concerns are not always acted on and, when harm occurs, patients are too frequently left out of the investigation process. In our report, A Blueprint for Action, we identify patient engagement as one of the six foundations of safer care needed to reach a patient-safe future.[5]

We outline how patients should be engaged for safety:

  • at the point of care
  • if things go wrong
  • in improving services
  • when advocating for changes
  • to hold the system to account

We therefore welcome the ambition set out by the MHRA to place patient and public involvement at the heart of their work, as we believe this is crucial to improving patient safety. But will this Strategy help them put this change into practice? In the remainder of this blog, we set out our thoughts and reflections on this.

Importance of implementation

The proposed Patient and Public Involvement Strategy sets out a positive vision for the MHRA’s approach involving and engaging of patients. However, too often there remains a gap between what healthcare organisations say about their patient engagement ambitions and what happens in practice.

For many of those patients impacted by the shocking avoidable harm investigated by the IMMDS Review, there remains a significant lack of trust and confidence in the MHRA when it comes to patient engagement. Rebuilding this will take time and will require clarity and transparency around the implementation of this Strategy and assessment of its progress against this.

To assure patients and the public that this will embody a real change in approach, we believe that the Strategy needs to be accompanied by:

  • An implementation plan – setting out specific activities for each strategic objective and timeframes for their completion.
  • Regular assessments of progress – against the implementation plan.
  • Public reporting on progress – in our consultation response we suggested that this could take the form of an annual patient engagement plan, outlining how the MHRA will deliver its goals and reporting back its achievements.

Evaluation of progress and impact will be needed to evidence a commitment to sustainable change, not what might be seen as just well-intentioned rhetoric in the face of the criticism of the MHRA.

Patient involvement and co-production

The first objective of the Strategy places significant emphasis on directly involving patients and the public in MHRA processes and decision making. It provides some tangible examples of where this can take place, such as involvement in regulatory decision-making processes and drafting of public-facing information materials.

In our consultation response we advise this could be strengthened by including an explicit commitment to co-production. Co-production is an activity, an approach and an ethos which involves members of staff, patients, and the public working together, sharing power and responsibility across the entirety of a project.[6] [7] We believe that this is particularly important to consider in relation to patient safety programmes and guidance and information for the public.

Given the complexity of some of the regulatory issues dealt with by the MHRA, we also suggested in our response that they consider working directly with patient organisations going forward to help ensure that their public facing guidance is easy to use and navigate.


We believe that good leadership will be central to MHRA fulfilling their aim of improving their engagement and involvement with patients and the public. In our consultation response we set out two areas where this is of particularly importance:

1. Internal leadership

In its internal culture objective, the Strategy states that by June 2022 it aims to reach a point where ‘every member of staff considers the patient and public perspective in their decisions, and that all staff are well supported and involved in delivering that change’.

We believe that there also needs to be an explicit commitment to this at a leadership level. Good leadership can be one of the most influential positive factors in shaping organisational culture in healthcare; poor leadership can have the oppositive effect. There needs to be a pledge that this extends to those in senior roles at the MHRA, who should be modelling positive patient engagement and involvement behaviours; consistently demonstrating the change they want to see. Beyond the scope of this Strategy, we would also be keen to see a similar commitment regarding understanding and assessment of patient safety issues at all levels of the organisation.

2. External leadership

If the MHRA is serious about becoming ‘a patient focused regulator’, we also think that it needs to consider its role in influencing the wider industry on patient and public involvement.

Although it may not be considered part of its formal legislative or regulatory role, we believe the MHRA is in a powerful position to raise awareness and promote the importance of patient and public involvement. Over time it could potentially develop and share good practice, which may prove invaluable to the design of more responsive and safe products and services elsewhere. Patient Safety Learning would welcome the opportunity to discuss with the MHRA how this innovative and ambitious approach might be developed.

Building partnerships

Turning now to the final objective in this Strategy, centred around developing ‘a cross sector partnership plan that builds and delivers collaborations with partners across the health sector to improve the effectiveness of engagement and share patient insight’.

In our consultation response we welcome this emphasis on partnership. We believe that healthcare organisations, professionals and patients sharing knowledge, insights and experiences is key to improving patient safety; a true system-wide approach. In addition to individual engagement with patients and healthcare organisations, we also emphasised the importance of the MHRA giving further thought to how they engage with patient groups and campaigners.

This is a theme we also picked up with the Care Quality Commission in our recent response to the consultation on their new Strategy and in our consultation response on the proposed Patient Safety Commissioner for Scotland.[8] [9] The IMMDS Review clearly demonstrated the vital role that patient groups can play in highlighting systemic safety failings.[10] At Patient Safety Learning we are currently working closely with patient groups to highlight patient safety concerns impacting people living with Long Covid and women who have experienced painful hysteroscopy procedures in the NHS. We believe there is a significant opportunity for insights from such groups to help inform the MHRA’s work with patients and improve patient safety.

[1] The IMMDS Review, First Do No Harm, 8 July 2020.

[2] Kath Sansom, Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies, 15 April 2021.

[3] MHRA, Consultation outcome – Response: What we will do differently, 15 June 2020.

[4] MHRA, Proposed Patient and Public Involvement Strategy 2020-25, 24 May 2021.

[5] Patient Safety Learning, The Patient-Safe Future: A Blueprint for Action, 2019.

[6] Dr Erin Walker, What should co-production look like?, 1 April 2019.

[7] National Institute for Health Research, Guidance on co-producing a research project, March 2018.

[8] Patient Safety Learning, Reflections on the CQC’s new strategy, 15 March 2021.

[9] Patient Safety Learning, Patient Safety Commissioner for Scotland: Consultation Response, 9 June 2021.

[10] The IMMDS Review, First Do No Harm, 8 July 2020.

MHRA Patient Consultation Image


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