Triennial Review of the Medicines and Healthcare Products Regulatory Agency - Call for Evidence

Closed 9 Jan 2015

Opened 1 Dec 2014


In recent years, the health and social care system in England has undergone substantial change. The Health and Social Care Act 2012 and the Care Act 2014 have devolved functions and powers away from the Department of Health to local and arm’s length bodies.

In this new system, the Department has the key stewardship and assurance function designed to ensure that the new system, and so the multiple new and reformed bodies within it, have the appropriate functions and are performing to a high standard.

To perform this stewardship function, the Department is putting in place Triennial Reviews of all of its Arm’s Length Bodies. This includes all Executive Non-Departmental Public Bodies (ENDPBs), Advisory Non-Departmental Bodies (ANDPBs), Executive Agencies and Special Health Authorities. The Medicines and Healthcare Products Regulatory Agency (MHRA, or the Agency), an Executive Agency, is subject to review in 2014-15.

The programme of reviews builds on the approach developed by the Cabinet Office as part of their work on public bodies reform.

Why We Are Consulting

As noted above, this review is part of a wider programme the Department of Health has developed as part of its stewardship and assurance function. The review will have two main stages:

  • The first is to provide a robust challenge of the continuing need for the Agency, both in terms of the functions it performs, and the way in which these are delivered.
  • If it is agreed that the Agency should retain its current function and utilise the same delivery model, the second stage of the review will then consider its performance, capability and governance, as well as considering opportunities for efficiencies.

This Call for Evidence seeks views from respondents to assist its consideration of both of the above stages.

Review Scope

On 20 November 2014, George Freeman (Minister for Life Sciences) announced a review (The Innovative Medicines and MedTech Review) to examine:

  • How new approaches to the development of medicines, diagnostic and devices, based on precision medicine and emerging technologies, could speed up access to innovative products for NHS patients;
  • How more collaborative work between companies and regulatory and evaluation bodies could ensure that innovative products can be assessed more quickly, using better data;
  • How charities and patient groups can play a greater role in research, so that NHS patients can get access to cutting-edge treatments; and
  • What more can be done to promote the rapid adoption of important medical innovations into clinical practice.

This review will start in early 2015 and will report recommendations to the new Government..

The Triennial Review of the Agency will generally have a more immediate operational focus and any overlap between the reviews will be kept to a minimum.  Where appropriate, the Triennial Review could feed evidence into this review.


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