Consultation outcome

Consultation on community water fluoridation expansion in the north east of England: government response

Updated 7 March 2025

Introduction

The Department of Health and Social Care (DHSC) conducted a public consultation to gather views and evidence on a proposal to expand community water fluoridation schemes across the north east of England. Over 1 million people in the north east currently live in areas with fluoridated water, including in Newcastle upon Tyne and Gateshead, with schemes in place since the early 1970s. The proposal was made because of significant and long-standing oral health inequalities in the region, particularly in children. This report sets out information on responses and views shared through the consultation.

Summary of consultation outcome

The consultation was open between 25 March 2024 and 31 July 2024 and included the reasons for the proposal and the area that would be affected by the proposal. The consultation followed the legal requirements set out in the Water Fluoridation (Consultation) (England) Regulations 2022 (‘the regulations’). Regulation 5 of the regulations sets out certain matters that the Secretary of State for Health and Social Care must have regard to and consider when deciding whether to proceed with the proposal.

Following consideration of the consultation responses and the other factors set out in the regulations, the Secretary of State for Health and Social Care has decided to expand community water fluoridation in the north east, as proposed. We will therefore work with Northumbrian Water Limited to implement the proposal.

Consultation responses

We received a total of 3,336 completed responses via the online consultation survey. We also received fewer than 5 additional responses by email or post. These separate responses have also been considered in line with open text responses. Of the completed online responses:

• 1,776 (56%) were from individuals in the proposal area
• 1,420 (44%) were from individuals not in the proposal area
• 140 were submitted by organisations

Extent of support for the proposal from individuals

Respondents were asked to what extent they agreed or disagreed with the proposal to expand community water fluoridation in the north east. Of the 3,336 responses from individuals:

• 1,217 (36%) strongly agreed
• 143 (4%) agreed
• 14 (less than 1%) neither agreed nor disagreed
• 1,876 (56%) strongly disagreed
• 8 (less than 1%) did not know

Individual respondents based in England were asked to submit the first part of their postcode. This information was then mapped to the first 4 characters of postcodes for the proposal area published in the consultation.

There was more support for the proposal from individual respondents living in the proposal area than from those residing outside. Of those individual respondents living in the proposal area, 968 (54%) agreed or strongly agreed with the proposal while 790 (44%) disagreed or strongly disagreed.

Of those individual respondents not living in the proposal area, 267 (18%) agreed or strongly agreed with the proposal, while 1,149 (81%) disagreed or strongly disagreed.

Respondents were asked to give reasons for their agreement or disagreement with the proposal. There were 8 fixed answers from which respondents could choose multiple responses. These fixed answers were:

• concerns about negative health impacts of water fluoridation
• concerns about the environment
• ethical arguments
• improving other health outcomes
• reducing costs to the NHS
• reducing oral health inequalities
• reducing the number of dental treatments such as tooth extractions or fillings
• reducing tooth decay

Of responses overall, those who disagreed with the proposal and used fixed multiple-choice answers:

• 93% selected concerns about negative health impacts of water fluoridation
• 48% selected concerns about the environment
• 45% selected ethical arguments

Of those who agreed with the proposal and used fixed multiple-choice answers:

• 97% selected reducing tooth decay
• 91% selected reducing the total number of dental treatments such as tooth extractions or fillings
• 88% selected reducing oral health inequalities
• 80% selected the reduced costs to the NHS
• 60% selected improving other health outcomes

The reasons for agreeing or disagreeing with the proposal were largely similar for those who responded from inside and outside of the proposal area. The most significant differences were that a larger proportion of those in the affected region who disagreed cited concerns about the environment. This was 53% in the proposal area compared with 45% outside the proposal area. Of those who agreed, a smaller proportion of those in the proposal area noted the benefits of improving other health outcomes. This was 56% in the proposal area compared with 71% outside.

Extent of support for the proposal from organisations

Of the 140 organisational responses received online:

• 82% strongly agreed with the proposal
• 7% agreed
• 11% strongly disagreed

There was strong support for the proposal from regionally based organisations, including those with responsibilities for improving the health and wellbeing of their communities, including the Association of Directors of Public Health North East, North East and North Cumbria NHS Integrated Care Board, and the local dental committee (LDC). See the 3 organisations’ joint position statement.

Reasons for agreeing or disagreeing with the proposal largely mirrored those of individuals, with 99% of those who agreed with the proposal noting the benefits of reduced tooth decay, while 73% of those who disagreed with the proposal noted concerns about negative health impacts of water fluoridation.

Topic analysis

The consultation also asked 3 free text questions. The number of respondents who provided an answer to at least one of these questions was 2,268 (68% of all completed consultation responses). The questions asked respondents to:

• explain their answers in respect of the reasons they gave for agreeing or disagreeing with the proposal and provide any supporting evidence - there were 2,014 responses to this question
• provide any scientific evidence or evidence on the cost-benefit analysis for us to consider in our final impact assessment - there were 934 responses to this question
• add any additional comments they would like us to consider in the consultation - there were 1,260 responses to this question

Through the above free text questions, respondents had the opportunity to submit evidence documents. A summary of the types of documentation provided is below. Submissions included briefings, letters, position statements, opinion pieces and journal articles.

Every free text response was considered, and common topics were identified. Analysis found that similar responses were recorded in each of the different questions, and therefore the topics described below describe the views expressed across all 3 of the free text questions.

Other interventions to improve oral health

Around 40% of those who responded to at least one of the free text questions commented on the importance of individual behaviours and interventions, other than community water fluoridation, to support good oral health.

Around 30% of those who mentioned other interventions were in support of the proposed expansion, noting the importance of the combined impact of individual behaviours, parental responsibilities and other community-based interventions to secure oral health improvement.

Around 60% of those who mentioned other interventions were in opposition to the proposed expansion, suggesting these could or should be used instead of fluoridating the water. Other approaches that were mentioned included:

• personal or parental responsibility for good oral healthcare
• the need for effective tooth brushing at home
• alternative interventions such as supervised toothbrushing for young children
• a reduction in availability of sugar in people’s diets, as this is the main risk factor for tooth decay

Respondents also highlighted current problems accessing NHS dentistry and the impact this has on dental health.

Health harms

Around 65% of those who responded to at least one of the free text questions pointed to concerns about the potential health harms associated with fluoridating the water. The vast majority of these responses were in opposition to the proposal and included concerns about toxicity, the accumulation of fluoride in the human body and the overall consumption of fluoride from other sources, particularly in respect of babies or nursing mothers. This topic also included responses on perceived associations between water fluoridation and other health issues like thyroid problems, hip fractures or perceived impact on the production of hormones.

Recent research from the US National Toxicology Program (NTP) and a meta analysis which conducted a systematic review of published scientific literature on the association between fluoride exposure and neurodevelopment and cognition was also a significant topic highlighted by respondents concerned about potential health harms.

Individual choice or consent

Around 50% of respondents who respondent to at least one of the 3 free text questions noted the need for individual consent as a fundamental constraint on introducing community water fluoridation. Where consent was raised as a topic, this was mostly (around 90%) related to opposition to the proposed expansion. Respondents were particularly concerned that people do not have a choice to opt out or that total exposure to fluoride was not controlled through schemes. These responses also noted concerns about ‘mass medication’ because they consider water fluoridation to be a medicinal treatment, while a small number suggested that community water fluoridation was not in itself a lawful intervention or infringed other legislation.

Positive views of ethics

A relatively small group of respondents (around 5%), who were in support of the proposed expansion, suggested that it is unethical not to implement the proposal because community water fluoridation helps to reduce tooth decay as well as no strong evidence of any harms as a result of the intervention, which has been implemented for many years. This was suggested by these respondents as particularly relevant for the north east region and elsewhere in the country where oral health outcomes are poor.

Environmental concerns and ‘pure water’

Around 25% of responses across the 3 free text questions suggested the need for ‘pure water’, in that fluoridation amounted to tampering with water quality or that it risks environmental harm. The vast majority (around 95%) of these responses were in opposition to the proposed expansion, with some respondents describing potential risks to animal life or concerns about safe operation and the importance of environmental assessments at water treatment works. Some environmental concerns were also raised about the grade or quality of chemicals used to treat water in general, and difference between ‘naturally occurring fluoride’ and that used in fluoridation schemes.

Oral health improvement

Half of respondents who responded to at least one of the 3 free text questions commented on the potential oral health improvement that can be achieved by community water fluoridation schemes.

Of these responses, there was an equal split between comments supporting and opposing the proposed expansion. Around half of the respondents noted the potential benefits of water fluoridation on oral health improvement opportunities, and that this was particularly relevant to the north east, being consistent with other actions in oral health improvement strategies. However, the remaining half questioned these benefits and highlighted research concerns such as the evidence provided on a reduction of health inequalities and the lack of availability of randomised control trials demonstrating effectiveness. Other interventions were also pointed to as a way of providing the same oral health improvement as the proposal.

Feedback on the cost-benefit analysis in the impact assessment

Around 30% of respondents commented on the economic costs and benefits calculated and described in the impact assessment. The main issues included:

• respondents queried the applicability of the preventative impact for adult dental health and potential for a 27% reduction in decayed, missing and filled teeth (DMFT). Alternative data or further sensitivity analysis was suggested as necessary
• many respondents pointed to contemporary UK evidence, such as the CATFISH and LOTUS studies. There was a roughly equal split between those who pointed to these studies to evidence that community water fluoridation is good value for money, and those pointing to the studies to suggest that it was not good value for money
• responders noted that within the cost-benefit analysis, the potential costs of treating medical conditions perceived to be caused by community water fluoridation or through ingesting high doses of fluoride from all potential sources were not included
• some responders expressed concern about the cost to treat, and the personal impacts of, dental fluorosis - a risk highlighted in the consultation proposal
• some responders suggested that the environmental impacts should be included within the costs section of the analysis
• some responders noted that, in some cases, the costs of dental treatment fall both on the NHS and on individuals, particularly if individuals utilise private dental care, either by choice or necessity

Consultation process

Just under 15% of responses to free text questions provided suggestions on the consultation and improvements that should be made particularly on communication. These suggestions included that households should be leafleted or that there should have been a referendum as part of decision-making on community water fluoridation schemes. Around 80% of those who provided comments on the consultation process were opposed to the proposed expansion.

Methodology

The consultation included closed tick-box style questions, as well as open-ended questions where respondents could write detailed comments. There were 3 free text boxes, each of which had a limit of 250 words. Respondents were also able to upload documents to support their responses.

Respondents could choose whether to answer each question, and the open-ended questions were not mandatory.

We analysed the responses from individuals to the open-ended questions using a topic modelling and tagging system. Topic modelling grouped similar responses for each question according to the words that best characterise their similarity. Then at least 2 DHSC officials reviewed these groups of words for each of the 3 questions, alongside a sample of representative quotes, to determine an appropriate theme for each group of words. Multiple themes were tagged to capture nuanced and multi-faceted responses.

We analysed the responses from organisations to the open-ended questions using a manual process to theme the responses. We determined the strength of the themes identified in the organisation responses by counting the number of times a theme came up in the responses to a question.

Supplementary documentation

A total of 396 documents were also uploaded as part of the consultation responses. Of these:

• 175 were duplicates
• 214 documents were supportive of water fluoridation
• 125 were against
• 52 were neither for nor against water fluoridation - they highlighted current evidence and need for further research
• there were 2 documents that could not be opened

The themes from the documents reflected themes referred to in the open questions and as such have been addressed in this consultation outcome.

Figure 1: breakdown of supporting documentation submitted to the consultation

Types of supporting documentation provided	Number submitted to the consultation
Toolkits	2
Strategies	2
Impact statements	3
Books or book chapters	3
Briefings	4
Other resources	4
Letters	7
Consultation responses	8
Position statements	14
Online resources	15
Information sheets	16
Published articles	30
Opinions	34
Reports	35
Links and/or references	42

Government response

Health impacts of the proposal including other interventions and access to NHS dentistry

Tooth decay remains a serious public health problem in England and in the north east. Nationally, it is the most common reason children aged 5 to 9 are admitted to hospital, and the north east had the second highest rate in England of hospital tooth extractions for decayed teeth, at 418 per 100,000 population of 0 to 19 year olds for the financial year ending 2024. This is compared with the national average across all England, which was 229.

The prevention of ill health is a clear mission for the government and the cornerstone of this is supporting children to live healthier lives. It is unacceptable that many of our most deprived communities are in the north east and that tooth decay is strongly associated with deprivation, where rates can be nearly 3 and a half times that of those living in the most affluent communities.

Local authorities in the north east had already begun to develop operable and efficient proposals to expand existing community water fluoridation using legal powers available to them between 2013 and 2022, particularly to introduce a public health response to oral health improvement in Tees Valley, County Durham, Sunderland, South Tyneside and parts of non-fluoridated Northumberland. The proposal to expand community water fluoridation is consistent with local oral health strategies.

The proposal’s impact assessment has been updated. The estimated net present social value is £201 million over 40 years. This accounts for estimated benefits through dental healthcare cost savings, productivity gains and quality of life benefits to individuals.

We agree that community water fluoridation is only one effective intervention available to reduce tooth decay and should be used in conjunction with others. Individual behaviours, including reducing the amount and frequency of sugar consumed and brushing teeth twice a day - last thing at night and on one other occasion with a toothpaste with appropriate fluoride concentration - are essential in reducing the amount and severity of tooth decay.

Community water fluoridation complements targeted interventions, particularly those focused on children or neighbourhoods that are at higher risk of tooth decay. We are committed to introducing a targeted supervised toothbrushing programme for 3 to 5 year olds across our most deprived communities in England. This is evidence based and reduces health inequalities. This will complement local oral health improvement strategies across the north east.

We are working with all sectors of the food industry to make further progress on reducing levels of sugar in the everyday food and drink people buy and ensure it is easier for people to make healthier choices. The final assessment of industry progress on reducing sugar in juice and milk-based drinks, together with the fifth assessment of drinks in scope for the Soft Drinks Industry Levy, is expected to be published this year. A further assessment on the foods included in the sugar reduction programme is expected in due course.

Access to NHS dentistry is also essential. To tackle the immediate crisis in NHS dentistry, a rescue plan will provide 700,000 more urgent dental appointments. Long term reform to the dental contract is needed, as is a greater shift towards prevention.

Consistent with the evidence on cost benefit and the statement on water fluoridation from the UK Chief Medical Officers, community water fluoridation should be seen as a complementary strategy, not a substitute for other effective methods of increasing access to fluoride. It provides an important population-level intervention as part of the overall strategy to improve oral health that will bring benefits to the most disadvantaged communities in the north east, particularly for children.

Health harms

There is a legal obligation to monitor the effects of community water fluoridation schemes on the health of people living in the affected area and publish a report every 4 years. The findings of all health monitoring reports since 2014 consistently show that water fluoridation is an effective and safe public health measure to reduce the prevalence and severity of tooth decay and reduce dental health inequalities. The next monitoring report will be produced in 2026.

There have been many individual studies of the effects of water fluoridation over decades, using a wide variety of research methods, across different countries and investigating a range of health outcomes. Where possible, it is preferable to look at reviews of scientific evidence published in peer-reviewed scientific literature. Too much fluoride can be harmful, which is why schemes are carefully monitored and operate well within safe limits set by the World Health Organization (WHO) and relevant domestic legislation. There have been multiple systematic reviews of water fluoridation schemes from around the world. The common finding of these reviews is that water fluoridation at permitted levels is a safe and effective public health intervention for reducing the prevalence of tooth decay.

Neurotoxicity

The US NTP concluded that there is ‘moderate confidence’ that exposure to levels of fluoride, such as those approximated to be from drinking water concentrations greater than the WHO drinking water guideline of 1.5mg per litre, were associated with lower IQ in children. This has generated further scientific debate on this research and interpretation of the findings. Some international studies have suggested that when pregnant women and babies are exposed to fluoride in drinking water, there might be negative impact on a child’s brain development.

For children, the overall weight of evidence and authoritative reviews of relevant and suitable studies, including the US NTP systematic review, indicate that there is no substantiated evidence of a risk of adverse neurodevelopmental effects for fluoride levels below the WHO guideline and regulatory limit of 1.5mg per litre. In England, water companies that supply fluoridated water are asked to increase the naturally occurring concentration of fluoride in water supplies to 1.0mg per litre. Additionally, the US NTP reported insufficient evidence on fluoride exposure and adverse effects on cognition in adults. Conclusions on fluoride exposure and the plausibility of cognitive or neurodevelopmental effects in humans could not be drawn.

The UK Health Security Agency (UKHSA) conducted a study using the Millennium Cohort to investigate whether there is an association between maternal exposure to fluoride from drinking water and cognitive and developmental outcomes of children (aged 5 to 7 years). The study found no strong evidence of an association between exposure to fluoridated drinking water and child cognitive abilities. The final report and paper on this work will be published in 2025. The abstract for the study has been published in Environmental Epidemiology.

Ethical arguments

Ethical arguments were cited as one of the reasons for both disagreement and agreement with the proposal to expand community water fluoridation.

No new ethical issues have been raised through the consultation. For example, respondents raised concerns that fluoridation in the water was “mass medicine” but fluoridated water is not classified as a medicine by the Medicines and Healthcare products Regulatory Agency (MHRA). Fluoride is a naturally occurring substance present in varying concentrations in drinking water across England. Legislation determines the powers available to introduce or expand community water fluoridation schemes and the requirements for doing so. Target levels and maximum levels of fluoride permitted in drinking water are also set out within legislation.

We recognise that community water fluoridation can provoke strongly held and polarised views. This is evidenced in the responses received where an overall majority of total respondents were opposed to the proposal but that there was more support from respondent individuals and organisations from within the proposal area. Experience from parts of the country where schemes have operated for many years, including within the north east, shows community water fluoridation is not an ongoing issue of controversy for the majority.

We have received expert external advice confirming that there are no ethical issues that have been overlooked in preparing the consultation and considering the responses, and that it is ethically appropriate for the extension of community water fluoridation to go ahead if the government is satisfied that it is cost-effective and an appropriate priority when compared with other claims on resources. This advice is set out below.

The government continues to consider that use of community water fluoridation is an ethical way to improve public health.

Environmental concerns

All water contains small amounts of naturally occurring fluoride. Fluoride in water at the optimal concentration can help reduce the likelihood of tooth decay and minimise its severity. Where the naturally occurring fluoride level is too low to provide these benefits, a water fluoridation scheme adjusts the level of fluoride to 1mg per litre.

The Water Industry Act 1991 permits 2 chemical compounds to be used in fluoridation schemes. Their quality and purity must comply with the relevant British (EN) Standards. Fluoride in drinking water has the same chemical properties whether it originates from naturally occurring fluoride in water, derived from fluoride-bearing minerals in the ground, or from the fluorine compounds used in water fluoridation.

Carbon generation for the provision of fluoride is very small and should also be considered against the prospect of a reduced carbon footprint of NHS dentistry. Water fluoridation had the lowest environmental impact as shown by research published in the British Dental Journal compared with community programmes that prevent tooth decay, including supervised toothbrushing, fluoride varnish programmes and provision of toothbrush and toothpaste packs.

Community water fluoridation is an effective intervention for reducing tooth decay, thereby minimising the need for dental restoration or fillings and reducing the amount of dental amalgam used. The UK is a party to the Minamata Convention on Mercury and required to take measures to phase down the use of dental amalgam, a filling material used in dentistry which contains mercury.

As published in the consultation proposal, for example, in 2011, the European Commission Scientific Committee on Health and Environmental Risks concluded that fluoridation of drinking water is not expected to lead to unacceptable risks to the environment. Additionally, based on levels permitted by law, releases of fluoride to the environment will not exceed the Environment Agency’s non-statutory quality standard, which is set to protect aquatic life.  

The Drinking Water Inspectorate (DWI) also published a code of practice on technical aspects of fluoridation of water supplies in 2021. Published feasibility studies highlight that environmental risks through operation of fluoride equipment are low. As part of implementation arrangements, Northumbrian Water Limited will make the Environment Agency aware of proposals to fluoridate a water treatment site and ensure this is covered under any discharge consents applicable to the site.

Impact assessments, capital and operating costs

An equalities impact assessment has been published as part of the consultation (available on the original consultation page). No consultation responses focused on equalities aspects or the assessment against protected characteristics. Respondents to the survey noted their ethnicity as follows:

• White (81%)
• Asian (3%)
• Mixed (2%)
• Black (1%)
• preferred to not say (13%)

Since the consultation was launched, an updated Cochrane review has been published (Does adding fluoride to water supplies prevent tooth decay?). This review has highlighted that adding fluoride to water supply may lead to slightly less tooth decay in children’s baby teeth and may also lead to slightly more children being free of tooth decay, with benefits now less than before the widespread use of fluoride toothpaste. This evidence confirms that cost-effectiveness will be sensitive to population size and should be calculated on a case-by-case basis, considering the scale of oral health needs.

Capital and operating costs have been published alongside fuller discussion of comments and evidence supplied. A final impact assessment has been published on the consultation page outlining expected costs and benefits.

Randomised control trials are not generally feasible with many public health measures, including water fluoridation. Health and other impacts can be assessed in other ways including the health monitoring reports on the health impacts of community water fluoridation schemes which must be published every 4 years. Expansion in the north east will also create further research opportunities to understand the impacts of optimally fluoridated water. We describe evaluation plans in the final impact assessment.

Consultation process

Some respondents provided suggestions on the consultation and improvements that should be made, particularly on communication. These suggestions included that households should be leafleted or that there should have been a referendum as part of decision-making on community water fluoridation schemes. We thank respondents for their feedback, which has been considered. However, the consultation on GOV.UK meets the requirements set out in the regulations.

Conclusion

We are grateful to members of the public and organisations that responded to the consultation proposal. Responses to the consultation showed strong, polarised views both agreeing and disagreeing with the proposal. We have taken into account consultation responses in reaching a decision.

Implementation of community water fluoridation is intended to improve dental health of adults and children in the north east. Water fluoridation has the benefit of successfully reducing the amount and severity of tooth decay and does not require sustained behavioural change by individuals.

Contemporary evidence shows that water fluoridation has benefits in reducing tooth decay. While the scale of these benefits may be smaller than in the 1970s, the problem of poor dental health remains a serious concern in the north east and elsewhere in England. We will continue to monitor and compare data on the health of people living in areas of England who have differing concentrations of fluoride in their drinking water supply.

In the government’s view, the oral health needs of the region justify implementation of the proposal and the long-term investment needed. This will help to improve outcomes, particularly for children and vulnerable adults, alongside the manifesto commitments on dentistry and our ambitions to shift from treatment to prevention.

Ethics advice

Summary

The moral value of promoting public health has deep foundations. Good health depends on a wide range of social and economic determinants, many of which can be influenced by the choices that we make as a community. The obligations of governments to their citizens include taking appropriate steps to protect them from ill-health and making it easier to live healthier lives.

Many systems of faith and belief call for us to be concerned for the interests of others, especially those who are vulnerable or less able to promote their interests. International human rights commitments are particularly strong in relation to the rights of children to the ‘enjoyment of the highest attainable standard of health’ (Article 24 UN Convention on the Rights of the Child). The legislative duties of the NHS include provisions securing health improvement and on the reduction on inequalities (NHS Act 2006, as amended - sections 1 and 1C).

Local authorities also have duties to improve the health of their communities. All these factors show why it is ethically appropriate to take steps that will protect and promote the health of members of our communities.

The ethics of fluoridation have been extensively discussed and the main issues are well understood. Some issues concern the duty of government to protect citizens from specific harms - both from avoidable ill-health (such as tooth decay or harms from unnecessary dental procedures) and from environmental hazards (including water that is unsafe for consumption). Scientific rather than ethical expertise is required to identify and quantify these hazards, the likelihood of them materialising and the possibility of mitigating any risks that are identified.

Ethical reflection can clarify the nature and strength of claims made about the values at stake in decisions about water fluoridation. Some claim that there are ethical and legal constraints on government decisions, such as those from fundamental human rights that arise in relation to water fluoridation. We have reviewed arguments of this kind that have been raised in literature, in previous campaigns and the consultation. We believe that they have been previously considered by Parliament and should be regarded as settled in favour of water fluoridation being available in appropriate cases and subject to specific procedural requirements.

It follows that the decision that needs to be taken about the extension of water fluoridation in the north east of England is a matter of balancing the anticipated benefits, costs and risks. This is properly a matter for government, although ethical considerations generate procedural requirements for good decision-making. These should inform the process but they do not remove the responsibility for setting policy from the government.

We have advised on the consultation process and reviewed the responses. Our advice is that procedural requirements have been met, that there are no ethical issues that have been overlooked, and that it is ethically appropriate for the extension of water fluoridation to go ahead if the government is satisfied that it is cost-effective and an appropriate priority when compared with other claims on resources. We explain our advice further below.

Issues previously settled

Opponents of fluoridation raise a number of general issues that are not specific to the context of the north east of England and have been raised in the past. These were reflected in the consultation responses but we regard many of these as settled for the purpose of the decision before the government.

Some regard the requirement of individual consent as an inviolable constraint on public health activity. This is inconsistent with the legislative position on factors to be considered when considering water fluoridation. This position is often linked with claims that water fluoridation is in law a form of medication, or that there is a legally recognised human right to unfluoridated water, both of which have been rejected by the courts and relevant regulators. Fluoridated water is not classed as a medicine.

Concerns were raised about the safety of water fluoridation. These have been addressed by Parliament when it placed limits on the concentration of fluoride that would be permitted generally and through a fluoridation scheme. It is our understanding that no new evidence has become available since the Water Industry Act 1991 was passed that suggests that the safety issue based on levels permitted in England needs to be revisited, noting that amendments were made in 2022, confirming that Parliament remains satisfied of this.

The Secretary of State for Health and Social Care also has a duty to monitor the health impacts of water fluoridation schemes. If new evidence does become available, then it would need scientific consideration. Ethical issues may arise if additional potential harms are identified that need to be balanced against the benefits. This is particularly so when the risks and benefits will fall on different members of society so that a judgment is required on how their interests should be weighed against each other. The consultation has not elicited new concerns that suggest the safety considerations need to be revisited, although there is recent evidence on efficacy and cost-effectiveness that government will want to take into account.

Procedural ethics

Where judgments have to be made in the public interest about trade-offs between risks and benefits, on how resources should be prioritised (including how cost-effective a policy option needs to be in order to be adopted), then ethical insights can contribute to procedural requirements for good decision-making. These include:

• the democratic legitimacy of decision-makers and their accountability for their decisions
• transparency of decision-making so that options under consideration are identified, the evidence on which they are based is publicly available, and the reasons are articulated
• opportunities for public engagement prior to decisions being made

We consider that these procedural requirements have been met. The principal factors that lead us to this conclusion are as follows.

The legislation makes the Secretary of State for Health and Social Care the ultimate decision-maker on water fluoridation alongside other responsibilities for democratic deliberation by local government and health bodies who are charged with the responsibility for the health and wellbeing of residents. It is significant that these locally accountable bodies are all in support of the proposal to extend fluoridation.

The recent consultation process has set out the rationale for the proposed extension of water fluoridation and summarised the evidence on which proponents have concluded that it would be an appropriate step. There has been an appropriate opportunity for expert groups and campaigners to review and challenge that evidence in the consultation process. They have done this and their contributions have been carefully reviewed.

There has been an appropriately wide opportunity for members of the public and interested organisations to contribute views before a final decision is made. We note that there had been previous local public engagement before the formal consultation. This has enhanced awareness and opportunities to contribute to the assessment of benefits and to raise concerns.

We were able to contribute to the design of the consultation to ensure that there was a full opportunity for respondents to address ethical issues. The consultation questions drew attention to the most commonly discussed issues and gave respondents the opportunity to indicate whether they were significant factors in reaching their views on whether the extension of water fluoridation should go ahead. Respondents were able to make free text comments, but these elicited variations on the issues already identified rather than additional concerns. This provides assurance that nothing has been overlooked.

We have been able to review the analysis of the consultation responses and satisfy ourselves that views have been fairly evaluated through a quality assured process.

Substantive questions

We have considered separately the pattern of consultation responses from those within the area and those external to it. The views of those not personally affected are as relevant to the identification of ethical and scientific issues as those directly affected. The overwhelming concern identified by those who objected was the safety of water fluoridation (93% of those who disagreed identified this and there was no significant variation according to whether respondents would be personally affected or not). A significant proportion of those disagreeing with the proposal cited environmental concerns (48%), with a slightly higher level of concern from those in the affected area (53%) than those not in the area (45%). As noted above, we regard safety issues as having been settled by previous democratic processes and ongoing responsibilities to monitor science on health effects and that there is no ethical or moral requirement to reopen those issues.

Acceptability to those affected is an issue on which local views are particularly significant. We note that there was a small majority of directly affected respondents in favour of the extension of water fluoridation (54% agree or strongly agree, 44% disagree or strongly disagree). The 2021 survey of residents in the north east found slightly higher levels of support, with 60% of respondents supporting adding fluoride to water. However, it is important to recognise that the responses in the recent consultation showed strong views (48% strongly agreeing and 41% strongly disagreeing) indicating that the issue has polarised opinions. This suggests that the majority support should not be seen as sufficient in itself to indicate that fluoridation should be extended, any more than a slim majority against would preclude it. In these circumstances, it is appropriate to place considerable weight on the views of locally accountable bodies in health and local government.

Ethical issues were cited as the basis for both disagreement (43% of individuals in affected area, 46% of individuals not in the affected area) and agreement (9% of individuals in the affected area, 23% of those not in the affected area) with the proposed extension. The questions asked, drafted on our advice, gave the opportunity to express agreement or disagreement with the main ethical issues that we identified as relevant. For those who believe water fluoridation is unethical, the issues were adverse health impacts and environmental concerns. For those who believe that ethical issues indicate that water fluoridation should be supported, the issues were improving health outcomes, reducing NHS costs, reducing oral health inequalities, reducing numbers of dental treatments and reducing tooth decay.

The pattern of responses show that these were the main issues for respondents. Those who disagreed with the proposal overwhelmingly cited concerns about the negative health impacts (93%) and very rarely cited potential benefits as reasons for their decisions (5% cited improving health outcomes, 2% NHS cost reduction and only 1% for the other potential benefits). Those who agreed with the proposal to extend fluoridation did recognise safety (6%) and environmental concerns (4%) but strongly cited reductions in cost (81%), inequalities (88%), dental procedures (90%) and tooth decay (96%).

The review of free text comments indicated that some respondents expressed the view that fluoridated water was toxic, an unlicensed medicine, unregulated and administered without consent. We have explained above why we believe that these claims have been resolved by previous processes and therefore should not influence the decision that now needs to be taken.

There is one further issue that was touched upon in some free text comments. This concerns the view of some that there might be alternatives to water fluoridation that were ethically preferable. Suggestions included individual self-administration of fluoride and addressing dietary causes of dental ill-heath such as diet, cheap calories and sugary drinks and foods. The extent to which these alternatives could hope to achieve equivalent benefits to the extension of water fluoridation is properly a matter for scientific assessment. We note that some respondents suggested that some of the cost-effectiveness assumptions should be re-examined. We understand that these concerns are being considered by appropriate experts. Once such expert assessments are available, then it is ethically appropriate to compare the cost-benefit evaluations of the options. As we have indicated, it is a matter for government how to determine the threshold for cost-effectiveness.

Background to moral and ethical advice

To ensure ethical issues were considered as part of the north east consultation, an external ethics group based on the Moral and Ethical Advisory Group was set up. The group first met in October 2023 to inform preparation of the consultation so that content was appropriate and that there were effective means of gauging public views for analysis.

The following points were made by the group at this first meeting:

• it would be difficult to treat ethical arguments in isolation to other evidence and details of the proposal
• consider presenting the risks and benefits of water fluoridation at an individual level as well as a population group level. Reducing inequalities was important in considering ethical arguments
• there could be opportunities to supplement digital consultation methods with other approaches, to support an informed engagement approach, particularly with communities directly impacted by the proposal, and opportunities for securing wider democratic representation with councillors and Parliamentarians or with children and communities directly affected
• children have rights to express views under international human rights law and to have those views given due weight. Parental views were important, as well as securing responses and children’s voices
• the consultation needed to support responses informed by robust science, particularly contemporary evidence following introduction of fluoride toothpaste. Forthcoming studies were due to be published during or after the consultation, which reported smaller effects from community water fluoridation schemes than older studies
• the consultation needed to be clear on cost-benefit implementations for other ways of increasing access to fluoride
• content and the phrasing of questions that balanced trade-offs and uncertainty were more likely to provide informed choices from respondents. The framing of benefits and risk was particularly important to boost understanding

Having helped shape consultation content and questions, a second meeting was held in September 2024. The group focused on providing ethical advice to support decision-making by ministers. At this meeting the analysis of public consultation responses was summarised, including 3 open questions and selected quotes representative of free text answers.

The group also discussed the following issues for the consultation response:

• how it would be useful to categorise different messages to those that were substantive or unsubstantiated
• that the framing of concerns was important. For example, claims of ‘unlicensed medicine’ were intended to frame the issue in a particular way, but this sort of claim was not reasonable in light of prior regulatory consideration
• that responses showed this was a polarising issue
• local democratic committees responsible for health and wellbeing of communities in the region were supportive, and the outcome report should clarify organisational representation
• the importance of clear and accessible information. The public need to trust information presented to them is comprehensive and accurate. There should be lessons on provision of such information in water fluoridation consultations
• a limitation of the consultation was that not everyone invited to would respond. Being sensitised to an issue made a response more likely. There was strong opposition outside of the proposal area, suggestive of organised interests
• children’s views were largely missing from consultation responses
• the ethics themes raised through public consultation were the same as those identified in the past
• specific analysis on benefits for the north east communities had been published
• unsubstantiated claims in consultation responses about health harms were damaging and advice to ministers should be clear on this. Advice on addressing ethical concerns around ‘mass medication’ choice and consent would be beneficial. This could be based on previous work by Nuffield Council on Bioethics
• there may be different ethical perspectives across faith communities. For example, the Christian community would have a strong communitarian bias and a bias to compassion when supported by scientific evidence. The group suggested that members unable to attend should be prompted to consider points set out in the minutes
• the group discussed that there is not an exact equivalent found for public health interventions and medical interventions. Advice should be framed alongside other public health interventions. It was agreed that a small subgroup would consider this and prepare a small number of points