Recurring concern

Failure to provide safety-critical data promptly to regulators

First to latest report 14 Jul 2014 — 13 Oct 2022

Reports that mention this concern: 2
Times this concern has been raised: 2
Stated actions linked to this concern: 3

What this concern includes

Includes failures of arrangements, powers, duties or supplier processes that delay, restrict or prevent timely provision of relevant clinical, device or other safety-critical data to regulators conducting safety investigations.

What is not included

Excludes ordinary clinical or operational record-keeping failures where the data-provision obligation to a regulator is not the identified concern.
Excludes failures to interpret, investigate or act on data after the regulator has received it reliably.
Excludes generic information-sharing, communication or data-access deficiencies without an explicit regulatory safety-investigation context.
Excludes delays in providing data for purposes unrelated to regulator-led safety investigations.

Trends

Reports over time

Reports mentioning this concern, over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Reports about this concern sent to each recipient.

Department of Health and Social Care2

Medicines and Healthcare products Regulatory Agency1

Medtronic Limited1

Royal College of Pathologists1

Reports and published responses 2 reports

See individual reports that have raised this concern, and the actions taken in response

13 Oct2022
East London
Concerns raised1
1. Inability to compel timely production of relevant clinical data for safety investigations
Linked response

Department of Health and Social Care
Stated actions 3
1. Department of Health and Social Care
  Conduct proactive follow-up and use data-sharing arrangements to obtain additional pharmacovigilance case details.
2. Department of Health and Social Care
  Establish relevant data flows before vaccination commenced to support proactive pharmacovigilance surveillance.
3. Department of Health and Social Care
  Work with the NHS to improve reporting-system interoperability and connectivity, including automatic electronic transfer from LPSE to MHRA databases.
Respondent positions 1
1. Department of Health and Social Care
  MHRA lacks jurisdiction over healthcare professionals and therefore cannot comment on legislative powers to access NHS case notes.
  Outside remit
AI-generated summary

Oli Akram Hoque · Prevention of Future Deaths report

This summary was generated using AI from the published report. Please read the original report for the complete account.

Report summary

Oli Akram Hoque developed worsening headaches after receiving his first AstraZeneca COVID-19 vaccination and later suffered seizures; investigations revealed cerebral venous sinus thrombosis, and he died in hospital on 15 April 2021. The principal concern was that the MHRA could not compel the timely production of relevant clinical data needed for robust vaccine safety investigations.

Read the report on judiciary.uk
Source evidence
How this individual concern was interpreted
PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation
Inability to compel timely production of relevant clinical data for safety investigations
Wider context from the report
“The Inquest heard evidence from a senior medical assessor from the Medicines and Healthcare Regulatory Agency (MHRA). The Inquest heard that from the 25th February 2021 the MHRA investigated the potential signal of immune thrombocytopenia. This identified three cases of cerebral venous sinus thrombosis which could possibly be associated with the Astra Zeneca COVID 19 vaccine. The MHRA could not fully consider these cases as they did not receive all of the necessary clinical information. The Inquest heard that the MHRA do not have the power to compel relevant clinical information, to assist them with safety investigations. In light of the clear public interest in ensuring that the MHRA are able to carry out robust safety investigations, it is a matter of concern that the MHRA are unable to compel the timely production of relevant clinical data. ”
Source location
Oli Akram Hoque · Prevention of Future Deaths report
Page 2 · concerns
Open source report
Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation
Conduct proactive follow-up and use data-sharing arrangements to obtain additional pharmacovigilance case details.

Verbatim wording from the response
“MHRA conducted daily, proactive follow up and utilised a Data Sharing Agreement (DSA) with Public Health England (now UK Health Security Agency, UKHSA) for additional case details where needed. MHRA sought the advice of its COVID-19 Expert Working Group and the Commission on Human Medicines on emerging advice of timeframe for thrombosis with thrombocytopenia and issued regular press releases as evidence continued to amass.”

Source location
Response from Department of Health and Social Care
Page 1 · response
Published 14 October 2022
Open published response
Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation
Establish relevant data flows before vaccination commenced to support proactive pharmacovigilance surveillance.

Verbatim wording from the response
“MHRA recognises the importance of access to relevant clinical information for pharmacovigilance and ensured that relevant data flows were in place prior to commencement of vaccinations in December 2020 to support its four-stranded proactive vigilance strategy - 1) Enhanced passive surveillance – ‘observed vs expected’ analysis; 2) Rapid Cycle Analysis and Ecological analysis (analysing anonymised healthcare for pre-defined events as well as monitoring trends); 3) Targeted active monitoring; and 4) Formal epidemiological studies. It is the view of the MHRA that focus should be placed on encouraging reporting and working across the health family to streamline processes and reduce barriers to reporting.”

Source location
Response from Department of Health and Social Care
Page 2 · response
Published 14 October 2022
Open published response
Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation
Work with the NHS to improve reporting-system interoperability and connectivity, including automatic electronic transfer from LPSE to MHRA databases.

Verbatim wording from the response
“Steps taken to enable this include working with the NHS to enable interoperability and connectivity of reporting system such as the new Learning from Patient Safety Events System (LPSE) to allow automatic electronic upload into MHRA databases in a timely manner. The NHS Digital Clinical Safety Strategy¹ covers integration of LPSE with the Yellow Card system; improvement of adverse events and incident reporting is a commitment made by NHS and MHRA with a clear strategy and shared responsibilities. A recently published NHS standard contract (NHS England “2023/24 NHS Standard Contract) has a focus on interoperability which will help achieve those aims.²”

Source location
Response from Department of Health and Social Care
Page 2 · response
Published 14 October 2022
Open published response
Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation
MHRA lacks jurisdiction over healthcare professionals and therefore cannot comment on legislative powers to access NHS case notes.

Verbatim wording from the response
“MHRA do not have jurisdiction over healthcare professionals, and therefore did not comment on your consideration of whether issuance of this Regulation 28 report regarding legislative powers to access NHS case notes would assist the MHRA. There are professional guidelines in place for healthcare professionals to report safety issues, however, the Department is not aware of any jurisdiction globally that compels relevant clinical follow up information.”

Source location
Response from Department of Health and Social Care
Page 2 · response
Published 14 October 2022
Open published response
14 Jul2014
Inner North London
Concerns raised1
1. Delays in Medtronic providing safety data on request
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
No linked response statements
No respondent-stated action or position is linked to these concerns in the published data.
AI-generated summary

Shayla Anne Walmsley · Prevention of Future Deaths report

This summary was generated using AI from the published report. Please read the original report for the complete account.

Report summary

Shayla Anne Walmsley was found deceased at her home on 9 May 2013; she had diabetes and used a Medtronic insulin pump. The cause of death remained unascertained, and the report raised concerns about delays in providing safety data, inconsistent distribution of Field Safety Notices, and failure to analyse the medical device during the post-mortem investigation.

Read the report on judiciary.uk
Source evidence
How this individual concern was interpreted
PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation
Delays in Medtronic providing safety data on request
Wider context from the report
“(1) Interval to availability of Medtronic data - I am concerned that the investigatory role of non-US regulators could be hampered by the timescale within which Medtronic can provide data on request. Given the potential consequences of a delay in production of this safety data, I believe that future deaths could result and that this warrants consideration by Medtronic. ”
Source location
Shayla Anne Walmsley · Prevention of Future Deaths report
Page 2 · concerns
Open source report