Transparency of the UK medicines regulator: auditing freedom of information requests and reasons for refusal

• Published in: BMJ evidence-based medicine Vol. 24; no. 1; pp. 20 - 25
• Main Authors: Grigg, Sam E, O’Sullivan, Jack William, Goldacre, Ben, Heneghan, Carl
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.02.2019
• Subjects: Access to information; Access to Information - legislation & jurisprudence; Accountability; Conflict of Interest; Cost-Benefit Analysis; Disclosure - legislation & jurisprudence; Disclosure - standards; Equipment and Supplies; EU membership; Health Policy; Humans; International relations; Management Audit; Medical equipment; Patient safety; Regulation; Regulatory agencies; Transparency; United Kingdom; Vaccines; Web sites; United Kingdom; United Kingdom > UK; risk management; clinical governance; health policy; quality In health care
• ISSN: 2515-446X; 2515-4478
• DOI: 10.1136/bmjebm-2018-111018

A total of 658 were subsequently classified as ‘other’, and 192 requested information not held by the MHRA. [...]we included 1034 eligible requests in our analysis (figure 1). Section 43 (commercial interests) was the most commonly used section overall, while section 44 (prohibitions on disclosure) was the main reason for device and test request refusal.Table 2 Sections of the Freedom of Information Act used for refusal Grounds Overall (n=784) Medication (n=637) Devices (n=95) Vaccines (n=41) Tests (n=11) Section 1 (More details needed) 15 (2%) 9 (1.4%) 3 (3.2%) 2 (4.9%) 1 (9.1%) Section 12 (Exceeds cost limits) 74 (9.4%) 62 (9.7%) 3 (3.2%) 7 (17%) 2 (18%) Section 21 (Accessible elsewhere) 58 (7.4%) 47 (7.4%) 7 (7.4%) 4 (9.8%) 0 Section 22 (For future publication) 28 (3.6%) 27 (4.2%) 0 0 1 (9.1%) Section 27 (International relations) 31 (4%) 29 (4.6%) 1 (1.1%) 1 (2.4%) 0 Section 30 (Ongoing investigation) 5 (0.6%) 4 (0.6%) 0 1 (2.4%) 0 Section 31 (Law enforcement) 4 (0.5%) 4 (0.6%) 0 0 0 Section 35 (Policy making) 3 (0.4%) 1 (0.2%) 1 (1.1%) 0 1 (9.1%) Section 38 (Health and safety) 3 (0.4%) 2 (0.3%) 1 (1.1%) 0 0 Section 40 (Personal information) 136 (17%) 116 (18%) 10 (11%) 8 (20%) 2 (18%) Section 41 (Confidentiality) 145 (18%) 123 (19%) 15 (16%) 7 (17%) 0 Section 42 (Legal privilege) 2 (0.3%) 2 (0.3%) 0 0 0 Section 43 (Commercial interests) 223 (28%) 199 (31%) 13 (14%) 10 (24%) 1 (9.1%) Section 44 (Prohibited by another act) 57 (7.3%) 12 (1.9%) 41 (43%) 1 (2.4%) 3 (27%) Table 3 Summary description of sections of the Freedom of Information Act used for refusal Section 1 The MHRA requires more information to be able to fulfil the request Section 12: If a request is too broad or general in nature (for example, seeking information on a topic over many years), public authorities have a duty to provide advice and assistance to the applicant in order to focus the request” 12 (Exceeds cost limits) For each vaccine (and brand) in the UK, the writer requested from 2000 to present: total number of adverse drug reaction (ADR) reports, total number of ADR reports categorised as serious and non-serious, total number of doses administered, total number of doses distributed, total number of ADRs by type of reporter (eg, general practitioner, pharmacist, patient etc), total number of ADRs by nature of ADR (broadest heading, eg, neurological conditions etc) and total number of deaths reported “In order to provide the data by vaccine and by brand, this would be in excess of 50 different brands for the vaccines currently on the immunisation schedule. Unfortunately, The Independent Commission on Freedom of Information report, published in 2016, did not explicitly address the balance of public and commercial interest in this context.16 We therefore need to open a dialogue where we debate the merits of the legislation.Table 6 Sections related to commercial interest Section Example request Example refusal 41 and 43 (Confidentiality, Commercial interests) A list of all drugs and vaccines, which have had their license withdrawn, including the brand name and manufacturer “Please find attached a list of medicines which have been withdrawn…