Freedom of Information request about data MHRA and its partners hold regarding PPE Medpro Limited (FOI 21/221)
Published 7 May 2021
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Thank you for your information request, dated 04 March 2021, where you asked for
“Any data MHRA and its partners hold regarding PPE Medpro Limited (company number 12597000) which was awarded the following contracts to supply sterile gowns during the pandemic https://www.contractsfinder.service.gov.uk/notice/79397607-466e-4891-b091-3307fd5819d9?origin=SearchResults&p=1 This should include but should not be limited to reports and emails between the MHRA, companies working alongside the MHRA and the government regarding PPE Medro Limited as well as internal emails regarding PPE Medpro Limited.
Was MHRA and/or its partners involved in quality assurance process for the sterile gowns supplied by PPE Medpro Limited?
If so did MHRA or its partners have any concerns about the product? If so, what concerns have been raised?
Are the gowns being used in the NHS? If so, in what settings? Are they used as sterile gowns?”
Response:
Q 1-3:
We do not comment on ongoing discussions with manufacturers or suppliers. The information you have asked for is exempt from disclosure under Section 44 of the Freedom of Information Act 2000 (FOIA) as detailed below. However, we continue to work closely with DHSC to ensure that there is a good supply of protective medical devices that meet the relevant essential health and safety requirements and are fit for purpose.
Patient and public safety is our highest priority. If there are any concerns relating to any medical device, the MHRA will take timely and appropriate action; which includes publicly communicating safety messages when necessary.
Q4: Please contact DHSC with regard to supply of medical devices to NHS during this pandemic
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 PPE Medpro a business which continues to exist.
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.
If you have a query about the information provided, please reply to this email
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: [email protected]
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000