FOI release

Freedom of Information request on Yellow Card reports relating to specific insulin pumps for the last five years (FOI 22/695)

Published 27 March 2023

17th June 2022

FOI 22/695

Dear

Thank you for your freedom of information request, dated 10th May 2022, where you asked for the following:

‘Access the last five years of Yellow Card reporting data for the following insulin pumps:

• DANA RS

• Kaleido

• Medtronic

• Medtrum

• OmniPod

• Roche Accu-Chek

• Tandem

• Ypsopump

Specifically, I’d like to know the number of deaths and hospitalisations connected to these products. But, if possible, I’d to see specific reports (i.e. description of the faults which led to death/hospitalisation).’

Unfortunately, the information is exempt from release under Sections 40 and 44 of the FOIA:

Section 40 – Personal information:. Section 40 protects personal data, the disclosure of which would breach one or more of the data protection principles. The Agency is satisfied that disclosure here would breach the first data protection principle, in particular the requirement of fairness on the basis that disclosure would not be reasonably expected by the people mentioned in the information.

Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.

The MHRA is satisfied that the information you have requested:

• constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.

• relates to the affairs of SOOIL, ViCentra, Medtrum, Ypsomed, Tandem, Insulet, Roche and Medtronic, all of which are businesses which continue to exist.

On that basis we are satisfied that Section 44 of FOI Act applies and the information is exempt from release.

Furthermore, some of the information is exempt from release under Section 12 of the Freedom of Information Act and we cannot process your request pertaining to the report descriptions that include hospitalisations any further.

Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

We advise that you narrow your request and suggest the following as an alternative means to acquiring the information:

Number of reports received since 1st January 2017 via Yellow Card for any model of Insulin Pump where a death was determined to have been a result of a pump defect.

We do not disclose information from any individual reports (even redacted) to third parties. We can only send a report to the original reporter, their legal representative or manufacturer.

If you have a query about the information provided, please reply to this email.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division