FOI release

Freedom of Information request (FOI 22/828)

Published 17 January 2024

9th August 2022

FOI 22/828

Dear,

Thank you for your information request, dated 14th July 2022, where you asked for:

To whom it may concern,

I am writing to make an open government request for all the information to which I am entitled under the Freedom of Information Act 2000.  

If possible, can you please provide information on the following:

Please can you provide details of the number of individuals (either workers or non-workers) raising concerns about wrongdoing or malpractice (whistleblowing) who have contacted you in relation to your duties as a regulator for each month in 2021, and for January to June in 2022? The definition of ‘workers’ is staff at firms authorised and regulated by the MHRA who submit whistleblowing reports about their own firm to the MHRA

Where possible, can you please also provide the following details:

1. The breakdown of workers vs. non-workers raising claims, either as a percentage or numerically;
2. Whether each individual contacted you on an anonymous, confidential, or self-identified basis;
3. A brief summary of the types of concerns raised and a breakdown of how many concerns of each type were raised, broken down by percentage or numerically;
4. If information was passed on to another regulator or enforcement body. If so please indicate the identity of the regulatory body and a breakdown of the number of cases referred to each, broken down by percentage or numerically;
5. The number of cases which involved the Employment Tribunal;
6. In respect of the above, please identify (if appropriate) whether any subsequent action was taken and any compensation awarded.

If this request is too wide or unclear, I would be grateful if you could contact me as I understand that under the Act, you are required to advise and assist requesters. If any of this information is already in the public domain, please can you direct me to it, with page references and URLs if necessary. 

If the release of any of this information is prohibited on the grounds of breach of confidence, I ask that you supply me with copies of the confidentiality agreement and remind you that information should not be treated as confidential if such an agreement has not been signed. 

I understand that you are required to respond to my request within the 20 working days after you receive this letter. I would be grateful if you could confirm in writing that you have received this request.  

I look forward to hearing from you.  

We are pleased to provide you with the information requested, see below.

• Please can you provide details of the number of individuals (either workers or non-workers) raising concerns about wrongdoing or malpractice (whistleblowing) who have contacted you in relation to your duties as a regulator for each month in 2021, and for January to June in 2022? The definition of ‘workers’ is staff at firms authorised and regulated by the MHRA who submit whistleblowing reports about their own firm to the MHRA.

Jan to Dec 21 – 101 Whisleblower, 33 other category.

Jan to Jun 22 – 27 Whisleblower, 13 other category.

• The breakdown of workers vs. non-workers raising claims, either as a percentage or numerically.

Jan to Dec 21 - 76% Whisleblower, 24% other category.  

Jan to Jun 22 - 68% Whisleblower, 32% other category.

• Whether each individual contacted you on an anonymous, confidential, or self-identified basis.

92% identify – 8% anonymous. Caveat: some individuals make it clear that the details they provide have been anonymised, others may contact us using pseudonyms. The MHRA will accept a referral from an anonymous source.

The MHRA treats all whistleblower referrals confidentially. The personal information provided by a whistleblower is not shared with a third party without their consent. The MHRA, through the whistleblower team, adopts the principle of the ‘sterile corridor’. Access to a whistleblowers personal information is restricted.  

• A brief summary of the types of concerns raised and a breakdown of how many concerns of each type were raised, broken down by percentage or numerically.

The majority of referrals received from external whistleblowers raise concerns that are regulatory in nature. Each referral is allocated to a team or teams depending on the area of concern. Referrals that are purely regulatory account for the majority. They are sorted by inspection category, i.e. Good Manufacturing Practice, Good Distribution Practice, Good Clinical Practice, Good Pharmacovigilance Practice and Good Laboratory Practice. Other referrals may relate to criminal allegations dealt with by various sections within the Criminal Enforcement Unit. Other referrals will be handled by MHRA staff that regulate medical devices, the advertising of medicines or devices, or that determine whether a borderline product meets the definition of a medicine.

2021                                            2022                    

GMP	37	20
GDP	19	4
GCP	10	4
GPvP	1	1
GLP	5	1
Criminal Enforcement	29	8
Medical Devices	20	7
Borderline	4	1
Advertising	1	1
Defective Medicines	1	0

• If information was passed on to another regulator or enforcement body. If so please indicate the identity of the regulatory body and a breakdown of the number of cases referred to each, broken down by percentage or numerically.

It has not been possible to discriminate to the extent requested data held on numbers of referrals to other regulatory or enforcement bodies. Some referrals are received by the MHRA and partially actioned. If the information is relevant to another body, the concerns may be shared. In the period under review the MHRA whistleblowing team has shared information on at least one occasion with the following external partners.

General Pharmaceutical Council (GPhC)
Trading Standards (TS)
Health and Safety Executive (HSE)
General Medical Council (GMC)
Nursing and Midwifery Council (NMC)
Care Quality Commission (CQC)
Revenue and Customs (HMRC)
National Crime Agency (NCA)
Police
Food Standards Agency (FSA)
Border Force (UKBF)

In addition to this list, the MHRA has also provided information to medicine regulators based overseas.

• The number of cases which involved the Employment Tribunal.

The MHRA whistleblower team is not required to record if an individual whistleblower has brought their case to an ET, this information is therefore not held.

• In respect of the above, please identify (if appropriate) whether any subsequent action was taken and any compensation awarded.

The MHRA whistleblower team is not aware of any action taken, or compensation awarded as a result of an ET.

The Freedom of Information Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you have a query about this letter, please do not hesitate to contact us at IE&[email protected]

If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: [email protected]  

After that, if you remain dissatisfied, you may write to the Information Commissioner at;

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.

Yours sincerely

MHRA Customer Experience Centre

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU