Introduction

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines and medical devices, and monitors them to ensure they continue to meet quality and safety standards.1 However, recent controversies with both medicines2 and devices3–6 suggest the current system may be failing patients. In the UK, the 2000 Freedom of Information (FOI) Act provides public access to information held by public authorities, and can be used as one method to hold them accountable, and ensure they are promoting adequate patient safety.7

Under this Act, the MHRA must disclose information on request. Requests can come from any member of the public and relate to any process the MHRA is responsible for. These requests are important to facilitate independent assessment of the regulatory process the MHRA undertakes. There are two predominant ways a request can be made. First, it can be submitted by contacting the MHRA directly. Alternatively, it can be sent via the website WhatDoTheyKnow, which forwards requests to the MHRA, and subsequently publishes and archives the response.8 Section 10 of the FOI Act dictates that responses should be received within 20 working days.7

The FOI Act, however, has 24 provisions and sections that allow the MHRA to refuse particular requests.7 Given the importance of transparency and accountability, we set out to audit FOI requests made to the MHRA to determine the proportion of successful requests, evaluate the reasons for refusal and provide advice for those considering future requests.