Open call for evidence

Substances of human origin (SoHO): review of UK legislation - call for evidence document

Published 25 March 2026

Introduction

The Department of Health and Social Care (DHSC) is seeking evidence and stakeholder views on the UK regulation of substances that are collected from humans and used in medical treatments. These are known as substances of human origin (SoHO).

The aim of this call for evidence is to ensure that the UK legislative framework keeps pace with scientific and technological advances, while maintaining high standards of safety, quality and accessibility for patients.

The regulation of SoHO in the UK is shaped by a combination of domestic legislation and, in some cases, EU law. Historically, UK law has implemented EU directives to set minimum standards for the collection, testing, processing and distribution of blood, tissues and cells. These standards are designed to protect public health and ensure traceability and safety throughout the supply chain.

Current law that applies in the UK

The regulations and laws for the UK currently include:

• Human Tissue Act 2004
• Human Tissue (Quality and Safety for Human Application) Regulations 2007
• Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020
• Blood Safety and Quality Regulations 2005
• Blood Safety and Quality (Amendment) Regulations 2016
• Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020
• Human Fertilisation and Embryology Act 1990 and Human Fertilisation and Embryology Act 2008: the 1990 Act established the UK’s fertility and embryo regulation framework and the 2008 Act updated and expanded that framework to reflect modern science and family structures
• Human Medicines Regulations 2012
• UK general food law under Regulation (EC) No 178/2002 of the European Parliament and of the Council
• UK general food hygiene legislation under Regulation (EC) No 852/2004 of the European Parliament and of the Council
• Directive 2002/98/EC of the European Parliament and of the Council (the Blood Directive, see note below) and implementing directives
• Directive 2004/23/EC of the European Parliament and of the Council (the Tissues and Cells Directive, see note below) and implementing directives

Note: the Blood Directive (2002/98/EC) and the Tissues and Cells Directive (2004/23/EC) are known as the Blood and Tissues and Cells (BTC) Directives.

See annex A for details on the UK legislation and its regulators.

EU SoHO Regulation

Regulation (EU) 2024/1938 of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application (‘the EU SoHO Regulation’), applies in member states and Northern Ireland. The EU SoHO Regulation was published in the Official EU Journal on 17 July 2024, and an explanatory memorandum was submitted to the Northern Ireland Democratic Scrutiny Committee and relevant UK Parliamentary Committees the same month.

From 7 August 2027, the EU SoHO Regulation will repeal the BTC Directives and significantly broaden the scope of what is considered a SoHO in the EU. The EU SoHO Regulation stipulates that SoHO include not only blood, tissues and cells, but ‘any human substance’. Therefore, from 7 August 2027, SoHO in the EU will include:

• human breast milk (currently regulated as a food product)
• intestinal microbiota (currently regulated as a human medicine)
• blood and blood components that are not used for transfusion (currently regulated as a human medicine if used for a medicinal purpose)

The introduction of the EU SoHO Regulation presents an opportunity for the UK to consider if changes also need to be made to UK legislation to ensure patient safety, the quality and continuity of supply - including redefining these other substances as SoHO. For Northern Ireland, the EU SoHO Regulation will apply under the terms of the Windsor Framework and Northern Ireland may apply additional domestic requirements alongside it, where compatible, to maintain high standards of safety and quality across the UK.

For the UK as a whole, UK regulators made recommendations to the EU as part of the EU consultation on and evaluation of the BTC Directives, which directly fed into the development of the EU SoHO Regulation. Their learning from that exercise may be relevant to this review.

This call for evidence seeks stakeholder views on whether, and how, evidence generated through the EU’s regulation review process, including the approaches set out in the EU SoHO Regulation, could inform potential changes to the UK legislative framework in order to ensure that UK regulation of SoHO remains effective, proportionate and fit for purpose. It is important to gather evidence of the risks and benefits of making similar changes to those made in the EU SoHO Regulation.

The call for evidence review will also build on the assessment carried out during the development of the explanatory memorandum and consider how changes to the UK laws could further facilitate the movement of SoHO between the UK and EU, and within the UK itself.

Background to the UK SoHO regulation review

Some legislation applies UK‑wide, while other elements apply in either Great Britain or Northern Ireland, which reflects differences in legal frameworks and the operation of the Windsor Framework in Northern Ireland. These distinctions are central to this review because the new EU SoHO Regulation will apply automatically in Northern Ireland from August 2027, whereas any changes to the legislative framework in Great Britain would require domestic action.

In 2025, DHSC ministers commissioned a review on the impacts for Northern Ireland and potential changes that could be made in Great Britain, as well as other potential changes that could be made in Northern Ireland, as regards the EU SoHO Regulation.

This review aims to:

• assess the detailed impacts of the EU SoHO Regulation in Northern Ireland
• review current legislation to determine whether changes are needed in Great Britain
• consider whether additional changes, beyond those set out in the EU SoHO Regulation, could be made in Northern Ireland

The current pieces of legislation were first introduced over 20 years ago. Therefore, it’s important to consider changes to reflect advancements and future proof for new technologies and emerging risks. 

As part of this review, we are launching this call for evidence to gather stakeholder evidence and views on:

• the EU SoHO Regulation
• current UK legislation
• proposals for potential changes to the current UK legislation

As part of this, considerations will be made for:

• patient safety
• quality and standards
• intra-UK and UK-EU supply of SoHO
• innovation within the sector
• health inequalities

A critical principle of the review is to maintain compatible high levels of minimum safety and quality standards for:

• blood and blood components
• tissues and cells
• human breast milk
• intestinal microbiota
• blood and blood components that are not used for transfusion but for other clinical purposes

Compatible minimum safety and quality standards would support public health and the movement of SoHO.

This call for evidence provides the opportunity to share views and highlight issues and opportunities. Once the review has concluded, a decision will be made about potential changes to legislation.

Background to the EU SoHO Regulation

The EU SoHO Regulation will come into force in the EU and Northern Ireland on 7 August 2027. It will continue to cover blood, blood components tissues and cells but broadens its remit to include any substance collected from the human body, bringing the following into scope of the definition of a SoHO:

• human breast milk (currently regulated as a food product)
• intestinal microbiota (currently regulated as a human medicine)
• blood and blood components that are not used for transfusion (currently regulated as a human medicine if used for a medicinal purpose)

Products that are out of scope of the EU SoHO Regulation are:

• solid organs intended for transplantation
• human breast milk used exclusively for feeding one’s own child

The purpose of the EU SoHO Regulation is to provide consistent preparation and treatment for substances intended for human application, and improve the safety, quality effectiveness and accessibility of SoHO across the EU.

The EU SoHO Regulation deals with the interaction between the EU regulatory regimes that apply to SoHO, and medicinal products and medical devices. Where SoHO are used as starting materials for medicinal products, both EU SoHO Regulation and medicines legislation (Regulation (EU) 2017/745), Directive 2001/83/EC, Regulation 536/2014 and/or Regulation 1394/2007 will apply.

The EU SoHO Regulation also sets out a mechanism by which borderline cases should be determined. This ensures appropriate oversight for substances that may fall between SoHO, medicinal products and medical devices. 

SoHO are frequently used as a critical component in advanced therapy medicinal products (ATMPs) or blood products for example, albumin (a protein in human plasma). Therefore, the EU SoHO Regulation will require that manufacturers meet obligations under both the SoHO and pharmaceutical legal frameworks (which applies to medicinal products and medical devices) to guarantee safety, traceability and quality throughout the production process.

The EU SoHO Regulation covers a wide range of activities including:

• registration and testing of donors
• collection and processing to human application
• clinical outcome monitoring

This legislation also aims to future-proof EU legislation by including any substance collected from the human body therefore covering other SoHO that may be applied to humans in new ways in the future and allowing more flexible future updates.

One of the things this call for evidence is seeking views on is whether similar changes, which would apply in Northern Ireland by default under the Windsor Framework, should be made in Great Britain.

How to respond

Please respond using the online survey.

You do not need to respond to every section or question. However, you do need to reach the end of the survey and select ‘submit’ to ensure your response is recorded.

When answering the questions, where possible please provide evidence and examples to support your answers.

Do not provide personal data when responding to questions or giving evidence or examples. Any personal data included will be removed prior to analysis of these responses and will therefore not be considered in our analysis.

This call for evidence is open for 12 weeks and will close at 11:59pm on 17 June 2026. If you respond after this date, your response will not be considered.

If you have any queries relating to this call for evidence, email sohoregulationreview@dhsc.gov.uk. Do not send your call for evidence responses or any personal information to this email address.

Call for evidence questions

The survey is not as long as this section implies because the questions listed here will not be asked of every respondent. The questions you’ll be asked will depend on the substance or substances you select to comment on.

About you

In what capacity are you responding to this survey?

• An individual sharing my personal views and experiences
• An individual sharing my professional views
• On behalf of an organisation

Questions for individuals sharing their personal views and experiences

What is your age?

• 16 to 24
• 25 to 34
• 35 to 44
• 45 to 54
• 55 to 64
• 65 to 74
• 75 or above
• Prefer not to say

What is your sex?

• Male
• Female
• Prefer not to say

Is the gender you identify with the same as your sex registered at birth?

• Yes
• No
• Prefer not to say

What is your ethnic group?

• White - includes British, Northern Irish, Irish, Gypsy, Irish Traveller, Roma or any other White background
• Mixed or multiple ethnic groups - includes White and Black Caribbean, White and Black African, White and Asian or any other Mixed or multiple background
• Asian or British Asian - includes Indian, Pakistani, Bangladeshi, Chinese or any other Asian background
• Black, Black British, Caribbean, African or any other Black background
• Other - includes Arab or any other ethnic group
• Prefer not to say

Where do you live in the UK?

• England
• Scotland
• Wales
• Northern Ireland
• I live outside the UK

Question for individuals sharing their professional views

Which area of expertise will you draw upon to share your professional views? Please select the option that best describes your expertise.

• Clinician
• Researcher
• Academic
• Regulator
• Industry representative
• Policy maker
• Public health professional
• Patient representative
• Biomedical scientist
• Laboratory technician
• Laboratory scientist
• Ethicist
• Other, please specify

Questions for people responding on behalf of an organisation and individuals sharing their professional views

What type of organisation do you work for or are you responding on behalf of? Please select the option that best describes your organisation.

• Blood establishment
• Blood bank
• Blood facility
• Local authority
• Hospital or hospital unit
• Pharmacy
• Medically assisted reproduction establishment or facility
• Non-reproductive tissue or cell establishment
• Human milk bank (NHS or Health and Social Care (HSC) Northern Ireland)
• Human milk bank (independent)
• Manufacturer
• Regulator
• Charity
• Patient organisation
• Advisory committee
• Academic institute
• Religious group
• Other, please specify

Where does your organisation operate or provide services? Select all that apply.

• England
• Wales
• Scotland
• Northern Ireland
• Outside the UK

If you are responding on behalf of an organisation, what is the name of your organisation?

Question for all respondents

Which substance or substances will you be submitting a response for? Select all that apply. You will be shown questions relevant to the substance or substances you select, as well as questions that apply to SoHO overall. This includes those substances that will come under the scope of the new EU SoHO Regulation.

• Blood and blood components used for transfusion
• Blood and blood components that are not used for transfusion, but for other clinical purposes (for example, plasma used to make immunoglobulins)
• Non-reproductive tissues and cells
• Reproductive tissues and cells
• Intestinal microbiota
• Human breast milk
• Another SoHO not listed above

If you said another SoHO, please specify the name of the SoHO you are submitting a response for. Only enter the name of one substance in the free text box. You will be asked questions about this substance later in the survey. Do not add any comments at this stage.

Supply

This section seeks your views on how current UK laws support the supply of SoHO, including those substances that will come under the scope of the new EU SoHO Regulation. We are interested in understanding whether the existing legal framework ensures a reliable, safe and effective supply of these substances for patients and providers, and whether there are any challenges or risks related to supply that need to be addressed.

Your feedback will help us assess whether current arrangements are sufficient to maintain the supply of SoHO, and identify any areas where improvements or additional safeguards may be needed.

Please tell us to what extent you agree or disagree with the following statements. If you wish to provide more detail about your response, you can do so in the free text box below each statement.

Current UK laws support the free movement and safe supply of SoHO between Great Britain and Northern Ireland.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Current UK laws support the free movement and safe supply of SoHO between the UK and European Union countries.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Current UK laws support the free movement and safe supply of SoHO between the UK and non-European Union countries.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Current UK laws are effective in mitigating risks related to the supply of SoHO between Great Britain and Northern Ireland.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Current UK laws are effective in mitigating risks related to the supply of SoHO between the UK and European Union countries.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Current UK laws are effective in mitigating risks related to the supply of SoHO between the UK and non-European Union countries.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Classification and reporting of SoHO (questions for organisations and professionals only)

The questions in this section are for people responding on behalf of an organisation and individuals sharing their professional views.

This section seeks your views on how SoHO are classified and regulated under current UK law. We are interested in understanding whether the existing regulatory framework provides clear and appropriate classification for all relevant substances, and whether there are areas where the classification or regulation could be improved to enhance safety, quality or effectiveness.

Your feedback will help us identify any substances for which the current regulatory status is unclear, or where changes to the legal framework could provide more appropriate protections or benefits.

To what extent do you agree or disagree with the following statement?

The current UK regulatory requirements adequately ensure the reporting, investigation and follow‑up of adverse events and serious adverse reactions involving SoHO.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Are there any human substances or SoHO for which the current UK regulatory classification is unclear?

• Yes
• No
• Don’t know

If you said yes, please state the substances for which current UK regulatory classification is unclear, and explain why this is the case. (Optional, maximum 250 words)

Are there any UK regulated human substances which should be regulated under a different framework in order to provide greater safety, quality or effectiveness?

• Yes
• No
• Don’t know

If you said yes, please state which substances should be regulated under a different framework, and explain why this is the case. (Optional, maximum 250 words).

Technical requirements

This section invites your views on what should be considered when developing technical requirements and guidelines for SoHO. We are interested in understanding which standards, processes or safeguards are most important to ensure the safety, quality and effectiveness of SoHO therapies.

Your feedback will help inform the development and use of technical guidelines and requirements that support best practice across the sector.

Which sources should be used to develop technical guidelines, processes or safeguards for SoHO? (Optional, maximum 250 words)

EU SoHO Regulation

This section asks for your views on how the new EU SoHO Regulation compares with current UK laws in relation to areas such as:

• donor protection
• recipient protection and safety
• supply resilience
• innovation
• adaptability to future developments

Your responses will help us understand any similarities and differences between the EU SoHO Regulation and current UK legislation, and whether there are specific elements that stakeholders consider relevant for future UK policy development.

The EU SoHO Regulation is a framework regulation and some technical detail will be set out in implementing and delegated acts that are not yet available. When answering the following questions, please respond based on what is known from the EU SoHO Regulation itself (and any published supporting materials). If you do not have enough information to compare, please select ‘Don’t know’ and/or explain what additional detail would be needed.

In your opinion, which approach better achieves the aim of protecting donors while ensuring adequate supply?

• Current UK legislation on SoHO
• The new EU SoHO Regulation
• No difference
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

In your opinion, which approach provides the most appropriate protection for offspring born from medically assisted reproduction and the donor’s partner?

• Current UK legislation on SoHO
• The new EU SoHO Regulation
• No difference
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

In your opinion, which approach provides the most appropriate protection for recipients of autologous SoHO (this is when SoHO is collected from an individual and later administered to the same individual)?

• Current UK legislation on SoHO
• The new EU SoHO Regulation
• No difference
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

In your opinion, which approach provides the most appropriate protection for recipients of donated SoHO?

• Current UK legislation on SoHO
• The new EU SoHO Regulation
• No difference
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

In your opinion, which approach better supports robust data reporting systems for donor registration, collection, processing and clinical outcome monitoring?

• Current UK legislation on SoHO
• The new EU SoHO Regulation
• No difference
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

In your opinion, which approach better supports the safe supply of SoHO and protects patients from supply risks and shortages?

• Current UK legislation on SoHO
• The new EU SoHO Regulation
• No difference
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

In your opinion, which approach better supports innovation?

• Current UK legislation on SoHO
• The new EU SoHO Regulation
• No difference
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

In your opinion, which approach better future proofs for technological and scientific developments?

• Current UK legislation on SoHO
• The new EU SoHO Regulation
• No difference
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

In addition to existing safety and quality standards, should regulatory requirements also include requirements for establishments to demonstrate the clinical efficacy of SoHO when they are prepared or applied using new methods?

• Yes
• No
• Don’t know

If you answered yes, please explain your answer. (Optional, maximum 500 words)

Impact on private businesses

The questions in this section are for people responding on behalf of a private business or organisation.

This section seeks evidence from private businesses on the potential impacts of different regulatory approaches for SoHO organisations operating in this sector.

We are interested in understanding the potential benefits and costs for businesses of making similar changes to those in the new EU SoHO Regulation, compared with retaining the current UK legal framework in Great Britain. Your responses will help us assess how different approaches may affect businesses.

What costs, if any, do you expect to your business from aligning with EU SoHO Regulation? (Optional, maximum 500 words)

What benefits, if any, do you expect there would be to your business from aligning with EU SoHO Regulation? (Optional, maximum 500 words)

What costs, if any, do you expect to your business from retaining the current UK legislation? (Optional, maximum 500 words)

What benefits, if any, do you expect there would be for your business from retaining the current UK legislation? (Optional, maximum 500 words)

Oversight

This section examines whether current UK legislation enables the robust oversight of the quality and safety of SoHO (that is, regulatory oversight and adequacy of enforcement mechanisms). This includes substances that have not previously been considered SoHO in the UK but that will come under the scope of the new EU SoHO Regulation (for example, human breast milk) and whether regulating these substances as SoHO, rather than under alternative frameworks such as food law, would improve oversight. See annex A for more detail on UK legislation.

We are seeking your views on the effectiveness of the regulatory oversight and enforcement mechanisms that apply to the collection, management, monitoring and control of SoHO from donation to end use.

Your feedback will help us assess whether current oversight arrangements are sufficient, and identify any areas where improvements or additional safeguards may be needed.

Question for people responding about blood and blood components used for transfusion

How effective are the regulatory oversight mechanisms and enforcement arrangements in UK law at ensuring that blood and blood components used for transfusion are safely handled and closely monitored from donation to use?

• Extremely effective
• Very effective
• Somewhat effective
• Slightly effective
• Not at all effective
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about blood and blood components that are not used for transfusion

How effective are the regulatory oversight mechanisms and enforcement arrangements in UK law at ensuring that blood and blood components that are not used for transfusion are safely handled and closely monitored from donation to use?

• Extremely effective
• Very effective
• Somewhat effective
• Slightly effective
• Not at all effective
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about non-reproductive tissues and cells

How effective are the regulatory oversight mechanisms and enforcement arrangements in UK law at ensuring that non-reproductive tissues and cells are safely handled and closely monitored from donation to use?

• Extremely effective
• Very effective
• Somewhat effective
• Slightly effective
• Not at all effective
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about reproductive tissues and cells

How effective are the regulatory oversight mechanisms and enforcement arrangements in UK law at ensuring that reproductive tissues and cells are safely handled and closely monitored from donation to use?

• Extremely effective
• Very effective
• Somewhat effective
• Slightly effective
• Not at all effective
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about intestinal microbiota

How effective are the regulatory oversight mechanisms and enforcement arrangements in UK law at ensuring that intestinal microbiota are safely handled and closely monitored from donation to use?

• Extremely effective
• Very effective
• Somewhat effective
• Slightly effective
• Not at all effective
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about human breast milk

How effective are the regulatory oversight mechanisms and enforcement arrangements in UK law at ensuring that human breast milk is safely handled and closely monitored from donation to use?

• Extremely effective
• Very effective
• Somewhat effective
• Slightly effective
• Not at all effective
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about another SoHO

How effective are the regulatory oversight mechanisms and enforcement arrangements in UK law at ensuring that the other SoHO you’re submitting a response for are safely handled and closely monitored from donation to use?

• Extremely effective
• Very effective
• Somewhat effective
• Slightly effective
• Not at all effective
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Patient protection

This section focuses on how current UK laws protect donors, recipients who receive donations of SoHO and offspring born from medically assisted reproduction.

We are seeking your views on whether the existing legislation ensures high standards of safety and quality throughout the process, from donation to treatment, and whether further improvements are needed.

Your responses will help us understand how well patients are protected under current arrangements and identify any areas where additional safeguards or changes may be required.

Please tell us to what extent you agree or disagree with the following statements. If you wish to provide more detail about your response, you can do so in the free text box below the statement.

Question for people responding about blood and blood components used for transfusion

Current UK laws are effective in ensuring blood and blood components used for transfusion are collected, stored and used safely, from donor to recipient.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about blood and blood components that are not used for transfusion

Current UK laws are effective in ensuring medicinal products made from blood and blood components that are not used for transfusion are appropriately manufactured, authorised, supplied and monitored with adequate safeguards in place to protect both donor and recipient.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Questions for people responding about non-reproductive tissues and cells

Current UK laws are effective in ensuring non-reproductive tissue and cells are handled safely and ethically when they are donated by living patients. This includes tissue and cells used for healthcare, research or public display and covers aspects such as the safety of the donor and recipient.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Current UK laws are effective in ensuring non-reproductive tissue and cells are handled safely and ethically when they are donated by deceased patients. This includes tissue and cells used for healthcare, research or public display and covers aspects such as the safety of the recipients.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about reproductive tissues and cells

Current UK laws are effective in ensuring assisted reproduction and embryo treatment and research are carried out safely and ethically, including the use, storage and regulation of reproductive tissues and cells.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about intestinal microbiota

Current UK laws are effective in ensuring medicinal products made from intestinal microbiota are appropriately manufactured, authorised, supplied and monitored with adequate safeguards in place to protect both donor and recipient.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about human breast milk

Current UK laws are effective in providing adequate safeguards for the collection, storage and use of donated human breast milk to ensure donor and recipient safety and the quality of human breast milk.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about another SoHO

Current UK laws are effective in ensuring there are adequate safeguards in place to protect both donors and recipients of the other SoHO you’re submitting a response for.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Innovation

This section explores whether current UK laws create the right conditions for safe and effective innovation in the field of SoHO. We are interested in your views on how well existing laws support the development and introduction of new therapies, technologies and approaches, while maintaining high standards of safety and quality.

Your feedback will help us understand whether the current legal framework encourages innovation and adapts to scientific and technological advances, or if there are barriers that need to be addressed.

Please tell us to what extent you agree or disagree with the following statements. If you wish to provide more detail about your response, you can do so in the free text box below the statement.

Question for people responding about blood and blood components used for transfusion

The current UK laws for blood and blood components used for transfusion allow for safe and effective innovation in the SoHO sector.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about blood and blood components that are not used for transfusion

The current UK laws for blood and blood components that are not used for transfusion allow for safe and effective innovation in the SoHO sector.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about non-reproductive tissues and cells

The current UK laws for non-reproductive tissues and cells allow for safe and effective innovation in the SoHO sector.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about reproductive tissues and cells

The current UK laws for reproductive tissues and cells allow for safe and effective innovation in the SoHO sector.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about intestinal microbiota

The current UK laws for intestinal microbiota allow for safe and effective innovation in the SoHO sector.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about human breast milk

The current UK laws for human breast milk allow for safe and effective innovation in the SoHO sector.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Question for people responding about another SoHO

The current UK laws for the other SoHO you’re submitting a response for allow for safe and effective innovation in the SoHO sector.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Future proofing

In this section, we are seeking your views on how well the current UK legal framework can adapt to scientific and technological developments, emerging risks and crisis preparedness in the SoHO sector.

Your feedback will help us assess whether existing laws are sufficiently forward looking, and identify any areas where greater adaptability or resilience may be needed.

To what extent do you agree or disagree with the following statements?

Questions for people responding about blood and blood components used for transfusion

The current UK laws for blood and blood components used for transfusion are flexible and robust enough to keep pace with scientific and technological developments.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The current UK laws for blood and blood components used for transfusion are flexible and robust enough to keep pace with emerging risks (before they escalate into a crisis), such as infectious diseases.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The current UK laws for blood and blood components used for transfusion are robust and flexible enough to support with crisis preparedness (plans to ensure supply continuity during crises).

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Questions for people responding about blood and blood components that are not used for transfusion

The current UK laws for blood and blood components that are not used for transfusion are flexible and robust enough to keep pace with scientific and technological developments.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The current UK laws for blood and blood components that are not used for transfusion are flexible and robust enough to keep pace with emerging risks (before they escalate into a crisis), such as infectious diseases.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The current UK laws for blood and blood components that are not used for transfusion are robust and flexible enough to support with crisis preparedness (plans to ensure supply continuity during crises).

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Questions for people responding about non-reproductive tissues and cells

The current UK laws for non-reproductive tissues and cells are flexible and robust enough to keep pace with scientific and technological developments.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The current UK laws for non-reproductive tissues and cells are flexible and robust enough to keep pace with emerging risks (before they escalate into a crisis), such as infectious diseases.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The current UK laws for non-reproductive tissues and cells are robust and flexible enough to support with crisis preparedness (plans to ensure supply continuity during crises).

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Questions for people responding about reproductive tissues and cells

The current UK laws for reproductive tissues and cells are flexible and robust enough to keep pace with scientific and technological developments.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The current UK laws for reproductive tissues and cells are flexible and robust enough to keep pace with emerging risks (before they escalate into a crisis), such as infectious diseases.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The current UK laws for reproductive tissues and cells are robust and flexible enough to support with crisis preparedness (plans to ensure supply continuity during crises).

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Questions for people responding about intestinal microbiota

The current UK laws for intestinal microbiota are flexible and robust enough to keep pace with scientific and technological developments.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The current UK laws for intestinal microbiota are flexible and robust enough to keep pace with emerging risks (before they escalate into a crisis), such as infectious diseases.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The current UK laws for intestinal microbiota are robust and flexible enough to support with crisis preparedness (plans to ensure supply continuity during crises).

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Questions for people responding about human breast milk

The current UK laws for human breast milk are flexible and robust enough to keep pace with scientific and technological developments.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The current UK laws for human breast milk are flexible and robust enough to keep pace with emerging risks (before they escalate into a crisis), such as infectious diseases.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The current UK laws for human breast milk are robust and flexible enough to support with crisis preparedness (plans to ensure supply continuity during crises).

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Questions for people responding about another SoHO

The current UK laws for the other SoHO you’re submitting a response for are flexible and robust enough to keep pace with scientific and technological developments.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The current UK laws for the other SoHO you’re submitting a response for are flexible and robust enough to keep pace with emerging risks (before they escalate into a crisis), such as infectious diseases.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

The current UK laws for the other SoHO you’re submitting a response for are robust and flexible enough to support with crisis preparedness (plans to ensure supply continuity during crises).

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Novel SoHO therapies

This section seeks your views on how current UK legislation addresses new and emerging types of therapies involving SoHO. We are interested in understanding whether the legal framework provides clear guidance on how novel SoHO treatments and therapies should be defined, classified and regulated, especially when other legal rules may also apply.

Your feedback will help us assess whether the current approach supports innovation while maintaining high standards of safety and quality, and whether any changes are needed to better accommodate future developments in this field.

Questions for people responding about blood and blood components used for transfusion

Thinking about blood and blood components used for transfusion, to what extent do you agree or disagree with the following statements?

The current UK laws enable new types of SoHO treatments and therapies to be clearly defined and classified under the relevant legal framework (that is, how they are defined in legislation and regulated) even when other legal rules might also apply.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

The current UK requirements for authorising new methods of preparing SoHO adequately ensure that these preparation methods are demonstrated to be safe, high‑quality and effective before clinical use.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Questions for people responding about blood and blood components that are not used for transfusion

Thinking about blood and blood components that are not used for transfusion, to what extent do you agree or disagree with the following statements?

The current UK laws enable new types of SoHO treatments and therapies to be clearly defined and classified under the relevant legal framework (that is, how they are defined in legislation and regulated) even when other legal rules might also apply.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

The current UK requirements for authorising new methods of preparing SoHO adequately ensure that these preparation methods are demonstrated to be safe, high‑quality and effective before clinical use.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Questions for people responding about non-reproductive tissues and cells

Thinking about non-reproductive tissues and cells, to what extent do you agree or disagree with the following statements?

The current UK laws enable new types of SoHO treatments and therapies to be clearly defined and classified under the relevant legal framework (that is, how they are defined in legislation and regulated) even when other legal rules might also apply.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

The current UK requirements for authorising new methods of preparing SoHO adequately ensure that these preparation methods are demonstrated to be safe, high‑quality and effective before clinical use.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Questions for people responding about reproductive tissues and cells

Thinking about reproductive tissues and cells, to what extent do you agree or disagree with the following statements?

The current UK laws enable new types of SoHO treatments and therapies to be clearly defined and classified under the relevant legal framework (that is, how they are defined in legislation and regulated) even when other legal rules might also apply.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

The current UK requirements for authorising new methods of preparing SoHO adequately ensure that these preparation methods are demonstrated to be safe, high‑quality and effective before clinical use.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Questions for people responding about intestinal microbiota

Thinking about intestinal microbiota, to what extent do you agree or disagree with the following statements?

The current UK laws enable new types of SoHO treatments and therapies to be clearly defined and classified under the relevant legal framework (that is, how they are defined in legislation and regulated) even when other legal rules might also apply.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

The current UK requirements for authorising new methods of preparing SoHO adequately ensure that these preparation methods are demonstrated to be safe, high‑quality and effective before clinical use.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Questions for people responding about human breast milk

Thinking about human breast milk, to what extent do you agree or disagree with the following statements?

The current UK laws enable new types of SoHO treatments and therapies to be clearly defined and classified under the relevant legal framework (that is, how they are defined in legislation and regulated) even when other legal rules might also apply.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

The current UK requirements for authorising new methods of preparing SoHO adequately ensure that these preparation methods are demonstrated to be safe, high‑quality and effective before clinical use.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Questions for people responding about another SoHO

Thinking about the other SoHO that you’re submitting a response for, to what extent do you agree or disagree with the following statements?

The current UK laws enable new types of SoHO treatments and therapies to be clearly defined and classified under the relevant legal framework (that is, how they are defined in legislation and regulated) even when other legal rules might also apply.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

The current UK requirements for authorising new methods of preparing SoHO adequately ensure that these preparation methods are demonstrated to be safe, high‑quality and effective before clinical use.

• Strongly agree
• Agree
• Neither agree nor disagree
• Disagree
• Strongly disagree
• Don’t know

Please explain your answer. (Optional, maximum 250 words)

Proposals for future changes (questions for organisations and professionals only)

The questions in this section are for people responding on behalf of an organisation and individuals sharing their professional views.

This section invites you to share any evidence-based proposals or suggestions for changes that could improve the safety, quality, accessibility or efficacy of SoHO and therapies involving SoHO. This may include proposals relating to:

• oversight
• supply
• classification and reporting
• innovation
• technical requirements
• future proofing
• novel SoHO therapies

We are particularly interested in practical ideas or recommendations that could help shape future policy and practice in this area.

Please outline your proposals as clearly as possible. Where relevant, provide supporting evidence, examples or references to help us understand the potential impact of your suggestions. Your input will be valuable in informing future developments and ensuring that the UK’s approach to SoHO continues to meet the highest safety and quality standards.

If you have any evidence-based proposals for changes that could be made to improve the safety, quality, accessibility and efficacy of SoHO and SoHO therapies, please upload them here. Proposals should be submitted as a Word document, PDF or ODT file of no more than 2,000 words.

Annex A: relevant UK legislation and regulators

Human Tissue Act 2004

The Human Tissue Act 2004 provides the legal framework for the removal, storage, use and disposal of human bodies, organs and tissue for scheduled purposes such as research, transplantation, education and public display. The act established the Human Tissue Authority (HTA) as the regulator for England, Scotland, Wales and Northern Ireland, with a focus on ensuring activities are conducted safely, ethically and with proper consent.

The act sets out strict consent requirements and licensing arrangements for organisations handling human tissue. The Organ Donation (Deemed Consent) Act 2019 amended the act to allow deemed consent for organ donation by adults with capacity, who have been ordinarily resident in England for 12 months immediately prior to death and who die in England.

Human Tissue (Quality and Safety for Human Application) Regulations 2007

The Human Tissue (Quality and Safety for Human Application) Regulations 2007 implement EU Tissues and Cells Directives in UK law to ensure the quality and safety of human tissue and cells used for human application, including transplantation and treatment. The regulations require establishments involved in procurement, testing, processing, storage, distribution, import and export to be licensed and inspected by HTA. The regulations:

• set standards for traceability, adverse event reporting and confidentiality
• establish vigilance systems and record-keeping obligations
• establish compliance with EU coding and import requirements

Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020

The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020 implements EU Directive 2004/23/EC, Commission Directive 2006/17/EC and Commission Directive 2006/86/EC. These regulations establish safety and quality requirements in relation to human tissue and cells intended for human application, including stem cells and cell lines grown outside the body. The regulations regulate activities concerning the use of human tissue and cells intended for human application.

Blood Safety and Quality Regulations 2005

The Blood Safety and Quality Regulations 2005 implement EU Directive 2002/98/EC, establishing minimum safety and quality standards for the collection, testing, processing, storage and distribution of human blood and blood components. Its aim is to ensure a high level of health protection for recipients of blood transfusions. The regulations cover all steps from donation to distribution, including traceability and notification requirements for serious adverse events or reactions.

In the UK, equivalent standards continue to apply post-EU exit, with the Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020. The Medicines and Healthcare products Regulatory Agency (MHRA) regulates blood and blood components.

Blood Safety and Quality (Amendment) Regulations 2016

The Blood Safety and Quality (Amendment) Regulations 2016 updated the 2005 regulations to implement stricter safety measures set out in relevant European Commission directives. Changes included allowing West Nile virus (WNV) testing as an alternative to the 28-day donor deferral period and relaxing pH quality controls for platelets at expiration.

Human Fertilisation and Embryology Act 1990 and Human Fertilisation and Embryology Act 2008

The Human Fertilisation and Embryology Act 1990 (‘the 1990 Act’) and The Human Fertilisation and Embryology Act 2008 (‘the 2008 Act’) provide the legal basis for regulating assisted reproduction and embryo research in the UK. It is regulated by the Human Fertilisation and Embryology Authority (HFEA) who are UK-wide. The acts cover the licensing of fertility clinics, the use and storage of gametes and embryos, donor anonymity and legal parenthood.

The 1990 Act was amended by the 2008 Act which expanded definitions, modernised parenthood rules, updated welfare considerations and strengthened safeguards. The 1990 Act was also amended by the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007, which implemented the EU Tissues and Cells Directives into UK law to ensure the quality and safety of human reproductive tissue and cells used for human application.

Human Medicines Regulations 2012

The Human Medicines Regulations 2012 (HMRs) govern the arrangements across the UK law for the manufacture, authorisation, supply and pharmacovigilance of medicines for human use. They originally implemented EU Directive 2001/83/EC, but have been amended a number of times, including following EU exit.

The regulations set out requirements for licensing, labelling, advertising and safety monitoring of medicines, and establish MHRA as the UK regulator. The regulations also cover blood components not used for transfusion and intestinal microbiota (faecal microbiota transplants), which are currently classed as medicinal products if used for a medicinal purpose.

MHRA continues to regulate these areas UK-wide, with some reserved matters for Wales and Scotland. In the UK, equivalent standards continue to apply post-EU exit, with the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 and the Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024.

HMRs also rely on the:

• Blood Safety and Quality Regulations 2005 for the donation and testing of blood used for the manufacture of blood products
• Human Tissue (Quality and Safety for Human Application) Regulations 2007 for the donation and testing of tissues and cells used in the manufacture of ATMPs

UK general food law (under EU Regulation 178/2002) and food hygiene legislation (under EU Regulation 852/2004)

Human breast milk is currently regulated as food by the Food Standards Agency in England, Wales and Northern Ireland and by Food Standards Scotland in Scotland. EU Regulation 178/2002 sets out the general principles and requirements of food law, including food safety, traceability and the establishment of the European Food Safety Authority (EFSA). EU Regulation 852/2004 lays down hygiene requirements for food businesses, covering all stages of production, processing and distribution.

In the UK, these regulations are assimilated into domestic law. Human breast milk will be reclassified as a SoHO in Northern Ireland from 2027 under the new EU SoHO Regulation.

Blood Directive 2002/98/EC and implementing directives

The Blood Directive and implementing directives aim to establish minimum safety and quality standards for human blood and its components to ensure a high level of health protection. It covers blood collection (including donation) and testing, as well as the processing, storage and distribution of blood when it is used in transfusions.

EU Tissues and Cells Directive 2004/23/EC and implementing directives

The EU Tissue and Cells Directive and implementing directives aim to establish minimum safety and quality standards for tissues and cells (reproductive and non-reproductive) to ensure a high level of health protection. It covers issues such as donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human application. The directive does not cover the use of tissues and cells where they are not for human application (for example, transplantation) so do not regulate their use for, for example, research, education or training.

Privacy notice

Data controller

DHSC is the data controller.

What personal data we collect

We will ask for the following personal data (it’s not mandatory for people to give this information to respond to the policy questions):

• age band
• sex
• gender identity
• geographical location
• ethnicity

We will collect the following data about your work:

• your area of expertise
• the type of work and location
• name of organisation (if completing the survey on behalf of an organisation)

When answering the free text questions or giving evidence or examples, do not provide personal data relating to you or other individuals.

How we use your data (purposes)

DHSC will use the data to support patients by reviewing the current SoHO legislation. The personal data collected will enable us to identify issues and health inequalities across the service. It will help to identify gaps or areas of particular concern so that we can work to tackle the issues and health inequalities.

Legal basis for processing personal data

Under article 6 of the UK General Data Protection Regulation (UK GDPR), the lawful basis we rely on for processing this personal data is:

• e) the processing is necessary to perform a task in the public interest or for our official functions and the task or function has a clear basis in law

In addition, we are also processing special category data under the following condition as per article 9 of the UK GDPR:

• g) reasons of substantial public interest (with a basis in law)

Data processors and other recipients of personal data

This call for evidence is hosted on an online platform owned by SocialOptic, who are a contracted supplier of DHSC. SocialOptic will delete any personal data in line with the retention and disposal periods outlined in this privacy notice, or earlier if instructed to do so by DHSC. Only anonymised data will be shared with stakeholders.

International data transfers and storage locations

Storage of data by SocialOptic is provided by secure servers located in the UK. Storage of data by DHSC is provided by secure computing infrastructure on servers located in the UK.

Retention and disposal policy

The data will be retained by SocialOptic for a period of one year.

DHSC will retain the data for one year, during this time the data will be anonymised. Anonymised data may be retained for longer, in line with DHSC’s retention policies.

How we keep your data secure

DHSC uses appropriate technical, organisational and administrative security measures to protect any information we hold in our records from loss, misuse, unauthorised access, disclosure, alteration and destruction. We have written procedures and policies which are regularly audited and reviewed at a senior level.

SocialOptic is Cyber Essentials certified. This is a government backed scheme that helps organisations protect themselves against the most common cyber-attacks.

Your rights as a data subject

By law, data subjects have a number of rights, and this processing does not take away or reduce these rights under the EU General Data Protection Regulation (2016/679) and the UK Data Protection Act 2018 applies.

These rights are:

• the right to get copies of information - individuals have the right to ask for a copy of any information about them that is used
• the right to get information corrected - individuals have the right to ask for any information held about them that they think is inaccurate, to be corrected
• the right to limit how the information is used - individuals have the right to ask for any of the information held about them to be restricted - for example, if they think inaccurate information is being used
• the right to object to the information being used - individuals can ask for any information held about them to not be used. However, this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case
• the right to get information deleted - this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case

Comments or complaints

Anyone unhappy or wishing to complain about how personal data is used as part of this programme should contact data_protection@dhsc.gov.uk in the first instance or write to:

Data Protection Officer
1st Floor North
39 Victoria Street
London
SW1H 0EU

Anyone who is still not satisfied can complain to the Information Commissioner’s Office.

Their postal address is:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Automated decision making or profiling

No decision will be made about individuals solely based on automated decision making (where a decision is taken about them using an electronic system without human involvement) which has a significant impact on them.

Changes to this policy

We keep this privacy notice under regular review, and we will update it if necessary. All updated versions will be marked by a change note on the call for evidence page. This privacy notice was last updated on 25 March 2026.