Stakeholder consultation of draft guidance on individualised mRNA cancer immunotherapies

You can read the MHRA Privacy Notice to find out in general terms the types of personal data we process and why; as well as information about your rights and how to raise concerns.

This privacy notice sets out the approach to this consultation that the MHRA will take to handle information appropriately and to comply with information legislation.

This privacy notice covers documents gathered and created during this consultation and anything in which information of any description is recorded, whether in paper or electronic form.

The consultation complies with data protection legislation including the Data Protection Act 2018 and the UK General Data Protection Regulation (UK GDPR).

We rely on UK GDPR Article 6(1)(e) as our legal basis for processing your personal data. This allows us to process personal data when this is necessary for the performance of our public tasks in our capacity as a regulator.

The consultation may collect and use personal information for the purpose of gathering views to inform our approach to potential regulation of individualised mRNA cancer immunotherapies. The collection of name and contact details (where this is provided) will solely be used for the purpose of conducting this consultation and will not be used for any other purpose.

In the case of personal information, the purpose is to read and analyse the information provided to improve understanding of the key considerations raised by individuals and organisations for our work to effectively regulate individualised mRNA cancer immunotherapies.

The information may also be used to help explore issues and direct further areas of research. Where this may be done, no personal information will be used.

Only members of the MHRA working on this consultation will have access to the data. These would include the following: Healthcare, Quality and Access; Safety and Surveillance and the Inspectorate. Authorised personnel from SurveyOptic Ltd (the online survey platform) will also have access to personal information. Those who do are aware of their obligations and responsibilities when handling personal and confidential information. They are subject to employment, contractual and other professional obligations regarding confidential and official information, both during the review and afterwards.

All personal and confidential information is stored securely to prevent loss or inappropriate access.

The MHRA will hold the personal information you provide in this consultation and use it for the purpose of informing the approach to regulating individualised mRNA cancer immunotherapies. 

Information published in response to this consultation, excluding personal information, may be published or disclosed in accordance with the access to information regimes. These are primarily the Freedom of Information Act 2000 (FOIA), the Data Protection Act 2018 (DPA), the UK General Data Protection Regulation 2016 (GDPR) and the Environmental Information Regulations 2004.

Any information not published, including personal information, may still be subject to disclosure in accordance with the Freedom of Information Act. We cannot give an assurance that confidentiality can be maintained in all circumstances. We will not take a standard confidentiality statement included in an email message as a specific request for non-disclosure.

The MHRA does not intend to publish any data that can identify individuals. Responses to this consultation will be processed in accordance with the DPA and UK GDPR. However, (non-identifiable) information you send us may need to be published in a summary of responses to this consultation.

Following the consultation, a response to the consultation will be published outlining its findings and recommendations. It is anticipated that the final response will not include any personal data. The contributions will be retained for a period of 5 years after the final consultation response has been published.

You have several rights which are outlined in the MHRA Privacy Notice: https://www.gov.uk/government/publications/mhra-privacy-notice. For greater detail on when they apply please refer to the Information Commissioner’s website If you wish to exercise any of your rights, or have any questions or concerns, please contact our Data Protection Officer at dataprotection@mhra.gov.uk