Personalised nutrition: paving a way to better population health (A White Paper from the Food4Me project)

1 - food4me Contents Food4me deliverable document 2 Personalised nutrition: opportunities and Challenges 3 About Food4Me and this White Paper 6 the scientific basis for personalised nutrition advice and lessons learned from a proof of principle study 9 technical developments making personalised nutrition offerings possible 22 Attitudes to adoption of personalised nutrition 32 Communication messages for personalised nutrition service providers, to address consumer concerns 47 Business and value creation concepts for personalised nutrition 50 ethical considerations in relation to personalised nutrition 64 Legal barriers and requirements 71 Integrating personalised nutrition 91 2 - food4me Food4Me deLIverABLe doCuMent Project no.: 265494 Project acronym: Food4Me Project title: “Personalised nutrition: an integrated analysis of opportunities and challenges” Theme KBBE.2010.2.3-02 Deliverable reference number anD title: D6.22 Production of a white paper on recommendations & policy applications Due date of deliverable: March 2015 (M48) actual submission date: March 2015 (M48) Start date of project: 1st April 2011 -Duration: 4 years organiSation name of leaD contractor for thiS Deliverable European Food Information Council (EUFIC) Project co-funded by the european commission within the Seventh framework Programme Dissemination level Pu Public x PP Restricted to other programme participants (including the Commission Services) re Restricted to a group specified by the consortium (including the Commission Services) co Confidential, only for members of the consortium (including the Commission Services) 3 - food4me Roger J Williams (1893-1988) was an American biochemist who named the b-vitamin folic acid and who discovered the b-vitamin pantothenic acid. In 1950, in an article entitled “Concept of genetotrophic disease” he wrote thus: PersonALIsed nutrItIon: oPPortunItIes And ChALLenges An introduction to the Food4Me project Thus the concept of genetically based personalised health was first envisaged over 6 decades ago but would remain dormant for over half a century. The sequencing of the human genome changed those dynamics and led to a widespread belief that personalised medicine, where therapeutic strategies would be targeted to patients on a genetic basis, was imminent. Soon, the term “personalised nutrition” began to emerge with a belief that the nutritional management of diet-related chronic disease could be considerably improved, based on an individual’s genomic data. In 2003, about the time of the release of the human genome, the Institute for the Future at Palo Alto issued a report on personalised nutrition in which they concluded thus: Clearly that hasn’t happened but it was against such expressed expectations of the potential of personalised nutrition that the European Commission’s DG Research issued a call for proposals in FP7, specifically to explore this area in 2009. The Food4Me consortium was then developed and the consortium submitted its proposal in 2010. The submission was successful and the Food4Me consortium began its programme in April 2011 to run until March 2015. The project aimed to explore all elements of personalised nutrition using a multi-disciplinary approach. At the outset Food4Me recognised that personalised nutrition would operate at three levels each of which could be stand alone or combined: personalised dietary analysis, personalised phenotype analysis and personalised genotype analysis. The design of the proof-of-principle (PoP) study presented some very novel challenges to the consortium, particularly the recruitment of subjects into a study where all contact between researchers and subjects was via the Internet or the postal services. A standard operating procedure (SOP) of some 900 A genetotrophic disease is one, which occurs if a diet fails to provide sufficient supply of one or more nutrients required at high levels because of the characteristic genetic pattern of the individual concerned. This concept based upon results in genetics and biochemistry is new in medical thought and is believed to be the basis for many diseases, the causation of which is now obscure. Individual patients are far from standardised specimens and medical problems should consistently be considered in terms of the genetically diverse patients, rather than in terms of an absolute normal. “ “ Analysis of the data shows that about one third of American adults are likely to make at least some decisions based on a knowledge of personalized nutrition by 2010. This will create an opportunity for a substantial transformation of the food and nutrition industry in the United States and elsewhere – especially for producers and packagers of foods, retailers, pharmacies, managers of magazines and health reports and health insurance. “ “ 4 - food4me pages was constructed to ensure consistency in a detailed protocol across each of the seven participating centres (Dublin, Reading, Warsaw, Athens, Pamplona, Munich and Maastricht). Two centres started ahead of all others and based on their experience, modifications to the SOP were made and an intense training programme was initiated. The PoP study kicked off in June 2012 and ended in March 2014. Absolutely all objectives, milestones and deliverables were achieved which, given the scale and novelty of the PoP study, remains a credit to all involved. Food4Me recognised that without a detailed understanding of consumer attitudes to personalised nutrition, any foresight in this field would fall well short of ideal. Thus a very significant part of the work-programme was devoted to probing the opinions of EU consumers. An extensive focus group study was carried out in 9 participating centres leading to the development of a questionnaire that would then be administered to 1,000 subjects in each of these 9 centres. In addition, about 700 of those who actually participated in the PoP undertook this same questionnaire. The outcome is an extremely valuable database, which can now be mined to address the many complex questions that will be asked of consumer attitudes to personalised nutrition. Allied to an understanding of consumer attitudes to personalised nutrition is the need to understand the viability of any personalised nutrition enterprise whether driven by either social or private entrepreneurship. Across a series of workshops with stakeholders from across a wide range of interested sectors, a number of scenarios were developed which will help shape our thinking of the viable alternatives for the creation of a sustainable personalised nutrition offering. This work-package on business models drew on the findings of the consumer research group in developing its final set of scenarios. Personalised nutrition is largely driven by technology, with regards to what can be measured to best characterise health status and nutritional needs. The efficiency of assessment and delivery of personalised nutrition advice is also technology-dependent. For this reason, exploring the technologies needed in personalised nutrition is a central focus of the project, with a specific work-package dedicated to the theme. The researchers involved set up a Global Network and online knowledge base to establish the most relevant genes in relation to dietary interactions for health outcomes. In addition, the work-package has developed algorithms for the delivery of personalised nutrition advice and has pioneered novel methods for assessing health parameters using very small blood-spot samples. In the USA, personalised nutrition, specifically personalised nutrition based on genomic data, has come under the scrutiny of regulatory authorities from time to time. In addition, fears are frequently expressed at personalised genomic data becoming available to third parties such as health insurance companies. Thus Food4Me established an ethics and legal work-package devoted entirely to this topic. Several ethical issues have been raised and explored via workshops and scientific publications. These include the autonomy of consumers, the responsibility of disclosing genetic risk factors (particularly over the Internet) and trustworthiness in relation to data handling and storage. This work-package has completed a report which is a Regulatory Analysis of personalised nutrition, with an emphasis on what legislative reform may be needed to develop the current EU legislative framework in the area. Finally, the consortium needed to address the issue of communication and not just communication about the workings and outcomes of the project, but communication in general about personalised nutrition. Social media was at the heart of this communication programme as were workshops at high-level scientific conferences throughout the project. An extended deliberative workshop was completed towards the end of the project, to ascertain in face-toface discussions what consumers thought of the project, its concepts and outcomes. Finally, this White Paper represents the high point of the communication process because it presents all of the detailed studies within Food4Me and all the top line outcomes. 5 - food4me Consumers, industry, regulators, the media and many other stakeholders now have available the most comprehensive analysis ever of personalised nutrition, its opportunities and challenges. As the two who had responsibility for coordinating this project, may we thank all the researchers involved and also thank our project and finance officers at DG Research and Innovation. Prof michael j gibney Project Coordinator Dr marianne Walsh Project manager Institute of Food and Health, University College Dublin, Ireland 6 - food4me ABout Food4Me Food4Me is an EU-funded project under Framework Programme 7. The project started in April 2011 and has run until March 2015. The project aimed to explore all elements of personalised nutrition using a multi-disciplinary approach. The main objectives of the project were to explore the scientific, business and consumer aspects of personalised nutrition, and to determine whether dietary advice, including knowledge of a person’s genes, could deliver consumer benefits. ABout Food4Me And thIs WhIte PAPer Work Package 1: business and value creation models Work Package 2: consumer attitudes to Personalised nutrition Work Package 4: Proof of Principle of models for the delivery of Personalised nutrition Work Package 3: technology for Personalised nutrition Work Package 6: communication Work Package 7: management Work Package 5: ethical and legal WhIte PAPer This White Paper (Deliverable D 6.22 Production of a White Paper on recommendations and policy applications) is a summary of the main outcomes of the work in Food4Me, and their implications. Following an Introduction from the Project Co-ordinators, Professor Michael Gibney and Dr Marianne Walsh of University College, Dublin, Ireland, the White Paper is divided into Chapters that reflect individual Work Packages. Within each Chapter, the research is described, its methodology and results. The implications of the results and how they might translate into practical implications, is discussed, and how they have added to the State of the Art in their respective research fields. Thought is given to what gaps in knowledge still remain, and finally each Work Package chapter reflects on how their research can feed into future Horizon 2020 research calls. the consortium of partners is shown in Appendix 1. the project has been delivered through 7 Work Packages; 7 - food4me ChAPters 1. Personalised nutrition: opportunities and challenges. An introduction to the Food4Me project A description of the background to personalised nutrition, the expectations following the sequencing of the human genome, and the potential for personalised nutrition. A summary of the project proposal and the main project objectives and its multi-disciplinary approach. 2. the scientific basis for personalised nutrition - advice and lessons learned from a proof of principle study This is an overview of Work Package 4, which has been the completion of a Proof-of-Principle (PoP) Randomised Controlled Trial (RCT) on the implementation of personalised nutrition (PN) across seven European centres. The RCT was designed to mimic a real-life internet-based personalised nutrition service and to provide an insight into the effectiveness of PN advice compared with non-personalised “one size fits all” recommendations. 3. technical developments making personalised nutrition offerings possible This is an overview of Work Package 3. This Work Package defined a panel of anthropometric and other measurements needed to define the phenotype for the PoP study, did a scouting of emerging technologies for better phenotyping, developed a data base for validated gene-nutrient-health interactions and developed tools such as a meal coding system and a menu-planning module for future applications in personalised nutrition. 4. Consumer attitudes to adoption of personalised nutrition This is an overview of Work Package 2. The debate about implementation, and subsequent realisation of the public health benefits of personalised nutrition, is dependent on empirical analysis of consumer preferences for its implementation. Research activities in Work Package 2 focused on understanding the specific needs of consumers with respect to personalised nutrition and its delivery to consumers, as well as identification of those factors which prevent consumers taking advantage of personalised nutrition. 5. Communication messages for personalised nutrition service providers This is part of Work Package 6, as it results in Communication Guidelines. Based on the consumer attitudes research in Work Package 2, the deliberative workshop, and other workshops in the Food4Me project, this chapter describes the concerns or perceptions that consumers have about personalised nutrition, measures to lessen the concerns, and suggested communication advice for the use of personalised nutrition service providers. 6. Business and value creation concepts for personalised nutrition This is an overview of Work Package 1. Personalised nutrition concepts could potentially improve the value perception of food and its role in health and in society, with the overall objective of achieving a lasting dietary behaviour change at the core of the personalised nutrition system. But for personalised nutrition to succeed, there needs to be a business case, although there 8 - food4me will be a range of different business models. Based on a wide range of inputs from societal, scientific and industrial stakeholders, a systems view of the personalised nutrition concept and its environment was developed. 7. ethical considerations in relation to personalised nutrition This is an overview of the ethical part of Work Package 5. It considers the debate about whether the current scientific evidence on gene-diet-health interaction is strong enough for taking an ethically responsible decision to offer personalised nutrition advice. Ethical issues in the fields of nutrition, health care, genetics, and public health were studied, and explored through Workshops. The issues around providing personal health data have been debated. A precautionary approach is advocated, as we make cautious estimations of the risk-benefit balance of personalised nutrition, as well as a respect for autonomy, focusing on personal choice. 8. Legal barriers and requirements This is an overview of the legal aspects studied in Work Package 5. The objective of this research was to identify and analyse the legal and regulatory framework of relevance for personalised nutrition services in the EU. Applicability of frameworks and resulting barriers and requirements was made by assessing typical business models of personalised nutrition against the requirements currently set up by legal instruments in the EU, or at Member State level. 9. Integrating personalised nutrition – the way forward? This final chapter paints a vision of what personalised nutrition could deliver. Aspiring to this vision, the chapter summarises the main results and policy implications with respect to the many scientific, technical, legal and ethical hurdles that will arise, and finishes with recommendations for next steps. appendix 1: food4me PartnerS 1University College Dublin 14 Wageningen University 2Ulster University 15 LEI-Wageningen University Research 3Maastricht University 16 Philips Netherlands 4Newcastle University 17 Technical University Munich 5University of Oslo 18 NuGO-A Association 6University of Navarra 18 Keller and Heckman 7Lund University 20 Philips UK 8University of Reading 21 Vitas 9Crème GlobalSoftware Ltd. 22 HLK 10 European Food Information Council 23 Porto University 11 National Food and Nutrition Institute, Warsaw 24 Bio-Sense 12 TNO Quality of Life 25 DSM Nutritional Products Ltd 13 Harokopio University, Athens 26 University of Bradford 9 - food4me the sCIentIFIC BAsIs For PersonALIsed nutrItIon AdvICe And Lessons LeArned FroM A ProoF oF PrInCIPLe study An overview of Work Package 4 IntroduCtIon A major undertaking of the Food4Me project has been the completion of a Proof-of-Principle (PoP) Randomised Controlled Trial (RCT) on the implementation of personalised nutrition (PN) across seven European centres. The RCT was designed to mimic a real-life internet-based personalised nutrition service and to provide an insight into the effectiveness of PN advice compared with non-personalised “one size fits all” recommendations. reseArCh MethodoLogy •study design The Food4Me PoP study was a four arm, internet-based, 6-month RCT conducted across seven European countries, which compared the effects of different levels of personalised nutrition (PN) on health-related outcomes (http://clinicaltrials.gov/show/NCT01530139)[1]. hypothesis: Providing personalised dietary advice will improve dietary intakes and markers of health, including weight and waist circumference. •Primary research questions: does PersonALIsAtIon oF dIetAry AdvICe assist and/or motivate participants to eat a healthier diet in comparison with non-personalised, conventional healthy eating guidelines? Is PersonALIsAtIon BAsed on IndIvIduALIsed PhenotyPIC or genotyPIC InForMAtIon more effective in motivating participants to make healthy changes, than personalisation based on diet alone? 16 - food4me Empty calories, fatty acids, proteins, salt, refined grains, whole grains, total fruit, whole fruit, vegetables, greens and beans and dairy products intake. The main dietary outcomes are summarised below. A healthy eating index (hei) was estimated based on a scoring system of the following foods [2]: the heI score has been associated with a lower risk of major chronic diseases[6]. several studies have demonstrated an association between the heI and healthy ageing and wellbeing[7], lower incidence of obesity[8], lower risk of total prostate cancer[9] and a reduced risk of all cause, cardiovascular, and cancer mortality[10]. The HEI is a scoring system designed to evaluate the healthfulness and quality of an individual’s diet. These indexes, based on established nutrient requirements and dietary guidelines, can help researchers to evaluate the relevance of an individual’s intake of specific foods in a whole diet context [3-5]. Moreover, the scores are easy for clinicians and dietitians to use for monitoring dietary intakes in a clinical setting. ** ** *** *** * * The graph below illustrates the difference in HEI and is expanded using two examples from the pool of nutrients assessed (salt and saturated fatty acid (SFA) intake) between individuals randomised to receive non-personalised advice (control) and those who received personalised advice (mean of L1, L2 and L3) at both month 3 and month 6. After both 3 and 6 months of the intervention, those randomised to PN had a significantly higher HEI than the control group. Intakes of salt and SFA intake were also significantly lower in the PN group at months 3 and 6 of the intervention compared with the controls. (*, P<0.05; **, P<0.01; ***, P<0.001) 17 - food4me Is PersonALIsAtIon BAsed on PhenotyPe or genotyPe More eFFeCtIve than personalisation based on diet alone? In summary, participants ate significantly healthier diets after receiving personalised dietary and lifestyle advice compared with the control group who received non-personalised, population-based advice. Summarised below are the differences in HEI and the examples of salt intake and SFA intake between individuals randomised to receive non-personalised advice (control) and those who received personalised advice based on either diet alone (L1), phenotype (L2) and genotype (L3) at both month 3 and month 6. After both 3 and 6 months of the intervention, there were no significant differences in HEI or intakes of salt or SFA in individuals who received personalised advice based on their phenotype (L2) and genotype (L3), when compared with advice based on current diet alone. In summary, participants who received personalised nutrition advice ate significantly healthier diets compared with the control, regardless of whether this personalisation was based on their diet alone, their phenotype or their genotype. These results indicate a lack of added value from using genomic information to personalise lifestyle-based interventions. healthy eating index Saturated fat (% of total energy)Salt intake (g) 18 - food4me Will the eFFeCt oF Pn AdvICe on Body WeIght ChAnge dIFFer BetWeen IndIvIduALs with different starting body weights The graph below indicates the change in body weight between baseline and Month 6 according to the body weight of individuals at baseline (lightest weight (Q1) to heaviest weight (Q5)). Individuals who were underweight gained over 1% of their body weight, compared with individuals who were overweight or obese, who lost up to 3.5% of their body weight. no added advantage of phenotypic or genetic information Personalised nutrition works Internet-based delivery is effective tAke hoMe MessAges change in body weight between baseline and month 6 19 - food4me IMPLICAtIons oF the resuLts The Food4Me PoP study results have the following implications: 1. With a validation study (n=140) showing high agreement between self-reported and measured anthropometric markers, sex and identity, an internet-based platform can be used to collect reliable and accurate measurements of dietary and anthropometric characteristics. 2. We demonstrated that an internet-based PN intervention can be highly effective in recruiting and retaining participants for at least 6 months across seven European countries. 3. PN advice is effective in improving dietary behaviours compared with conventional, population-based advice. 4. We saw no evidence that adding phenotypic or genotypic data to the information used to develop and deliver PN advice enhanced the effectiveness of the intervention based on analysis of current eating habits. 5. PN advice delivered via the internet offers promise as a scalable and effective route to improving dietary behaviours, which may have important public health benefits. deveLoPIng the stAte oF the Art The Food4Me PoP study has developed the state of the art by: Developing the evidence base for, and practical approaches which can be used to implement, three levels of PN advice (based on diet, phenotype and genotype) in large-scale intervention studies designed to improve dietary habits. Undertaking a pan-European test of the effectiveness of PN in a large representative sample of European adults. Demonstrating the utility of an Internet-based platform for delivering dietary and lifestyle-based PN advice and for supporting and motivating the public to make sustained improvements in eating patterns. WhAt gAPs In knoWLedge stILL reMAIn? The following areas require further investigation: 1. Are three nutrient-related goals optimum in promoting improvements in diet via internetdelivered PN? 2. Are there additional characteristics (beyond diet, phenotype and genotype), which could be included in PN interventions to improve their effectiveness in changing lifestyle behaviours? For example, characteristics such as current conditions (e.g. diseases), psychological characteristics, socio-economic class and ethnicity. 3. Could more engagement with participants e.g. via social media, enhance motivation and improve behavioural changes? 4. What additional feedback mechanisms e.g. home monitoring of physiological responses, could help motivate participants to make appropriate lifestyle changes? 20 - food4me 5. Are the improvements in dietary behaviour, which we observed after 6 months intervention, sustained long-term? hoW CouLd these eFForts Feed Into horIzon 2020 reseArCh CALLs? Findings from the Food4Me PoP study will inform future PN interventions and services. The internet-based design of the study will feed into the development of future e-Health services, which are addressed in various Horizon 2020 research calls. These non-invasive, internet-based tools will feature the self-assessment of diet and lifestyle factors and will include the remote collection of biological samples. As a result, future interventions will be able to reach a larger number of individuals and will be a more cost-effective strategy for improving the health and wellbeing of populations than traditional face-to-face interventions. The platform which we have developed could be tailored to address the needs of particular population groups e.g. the overweight and obese or those with particular diet-related diseases such as type 2 diabetes. In addition, our demonstration that the concept of PN is viable and that it produces bigger and more appropriate changes in diet means that this approach could be a feature of future health care provision and Horizon 2020 research calls. The Food4Me PoP study was the first study to compare the effectiveness of PN advice at the level of diet, phenotype and genotype and to demonstrate that it could be implemented via the internet in multiple European countries. With rates of non-communicable diseases, such as cardiovascular disease and cancer, and obesity at epidemic proportions, the encouraging results from the Food4Me PoP study will stimulate the development and testing of more PN interventions and services to address these societal challenges. ACknoWLedgeMents newcastle university (uk) Carlos Celis-Morales; Katherine M. Livingstone; John C. Mathers; John Matthews; university College dublin (Ireland) Hannah Forster; Clare B. O’Donovan; Clara Woolhead; Eileen R. Gibney; Lorraine Brennan; Marianne C. Walsh; Mike Gibney; university of reading (uk) Anna L. Macready; Rosalind Fallaize; Julie A. Lovegrove; Maastricht university (nL) Cyril F.M. Marsaux; Wim H. Saris; university of navarra (spain) Santiago Navas-Carretero; Rodrigo San-Cristobal; Alfredo J. Martinez; harokopio university (greece) Lydia Tsirigoti; Christina P. Lambrinou; George Moschonis; Yannis Manios; technical university of Munich (germany) Silvia Kolossa; Hannelore Daniel; national Food & nutrition Institute Izz (Poland) Magdalena Godlewska; Agnieszka Surwiłło; IwonaTraczyk; university of oslo (norway) Christian A. Drevon 21 - food4me reFerenCes 1. Celis-Morales C, Livingstone K, Marsaux CM, Forster H, O’Donovan C, Woolhead C, Macready A, Fallaize R, NavasCarretero S, San-Cristobal R, Kolossa S, Hartwig K, Tsirigoti L, Lambrinou C, Moschonis G, Godlewska M, Surwiłło A, Grimaldi K, Bouwman J, Daly EJ, Akujobi V, O’Riordan R, Hoonhout J, Claassen A, Hoeller U, Gundersen T, Kaland S, Matthews JS, Manios Y, Traczyk I, et al. Design and baseline characteristics of the Food4Me study: a web-based randomised controlled trial of personalised nutrition in seven European countries. Genes Nutr. 2014,1:1-13. 2. Guenther PM, Casavale KO, Reedy J, Kirkpatrick SI, Hiza HAB, Kuczynski KJ, Kahle LL, Krebs-Smith SM. Update of the Healthy Eating Index: HEI-2010. Journal of the Academy of Nutrition and Dietetics. 2013,4:569-80. 3. Kant AK. Dietary patterns and health outcomes. J Am Diet Assoc. 2004,4:615-35. 4. Hu FB. Dietary pattern analysis: a new direction in nutritional epidemiology. Curr Opin Lipidol. 2002:3-9. 5. Fransen HP, Ocké MC. Indices of diet quality. Curr Opin Clin Nutr Metab Care. 2008,5:559-65. 6. Chiuve SE, Fung TT, Rimm EB, Hu FB, McCullough ML, Wang M, Stampfer MJ, Willett WC. Alternative Dietary Indices Both Strongly Predict Risk of Chronic Disease. The Journal of Nutrition. 2012,6:1009-18. 7. Samieri C, Sun Q, Townsend MK, Chiuve SE, Okereke OI, Willett WC, Stampfer M, Grodstein F. The relation of midlife diet to healthy aging: a cohort study. Annals of internal medicine. 2013,9:584-91. 8. Boggs DA, Rosenberg L, Rodríguez-Bernal CL, Palmer JR. Long-Term Diet Quality Is Associated with Lower Obesity Risk in Young African American Women with Normal BMI at Baseline. The Journal of Nutrition. 2013,10:1636-41. 9. Bosire C, Stampfer MJ, Subar AF, Park Y, Kirkpatrick SI, Chiuve SE, Hollenbeck AR, Reedy J. Index-based Dietary Patterns and the Risk of Prostate Cancer in the NIH-AARP Diet and Health Study. American Journal of Epidemiology. 2013,6:504-13. 10. Reedy J, Krebs-Smith SM, Miller PE, Liese AD, Kahle LL, Park Y, Subar AF. Higher Diet Quality Is Associated with Decreased Risk of All-Cause, Cardiovascular Disease, and Cancer Mortality among Older Adults. The Journal of Nutrition 2014 6:881-9. 22 - food4me teChnICAL deveLoPMents MAkIng PersonALIsed nutrItIon oFFerIngs PossIBLe An overview of Work Package 3 1 IntroduCtIon By definition, any type of service can only be personalised if appropriate information about the individual is available. Personalised nutrition services rely on knowledge of food choices or total food intake usually recorded by food frequency questionnaires and on phenotypic data (such as gender, age, body height, body mass, physical activity). This may also be extended to include other measurements such as blood glucose, or cholesterol levels or blood pressure reflecting the health status. Not required but easily available nowadays is the analysis of the genetic background by profiling single nucleotide polymorphisms (SNPs) or in the future by exome or whole genome sequencing. Collected data in turn need to be evaluated from a health perspective including questions related to weight management as a key motivator and determinant of compliance to these services. Assessment of the individual’s life style – particularly dietary habits and physical (in)activity – are the leading themes as they provide the closest link to the nutrition-related chronic diseases like diabetes, coronary heart diseases, or cancers. Possible nutrient deficiencies or at least intakes below the recommendations are also addressed, if identified. Finally, analysis needs to be translated into comprehensible, feasible, and maybe even enjoyable recommendations for life style changes, taking into account identified constraints such as food allergies and intolerances, or simply food dislikes, via questionnaires. Within this framework and as a pillar in Food4me, work package 3 (WP3) defined a panel of anthropometric and other measurements needed to define the phenotype, did a scouting of emerging technologies for better phenotyping, developed a data base for validated genenutrient-health interactions and developed tools such as a meal coding system and a menuplanning module for future applications in personalised nutrition. 2 reseArCh MethodoLogy •2.1 data collection It was the prime responsibility of WP3 to identify and implement data collection approaches that provide valid information about the participant, collected at home, i.e. without any support by experts such as dietitians, nurses, or medical doctors. Work thus included the development of methods for collecting various types of personal data and phenotypic measures and the provision of information material (descriptions, instruction videos) on how to do the measurements for the volunteers in the different countries. In addition, the practicability (ease to use) of the methods, and the validity and coherence of the data collected, was assessed. 2.1.1 dietary habits and food preferences Food frequency questionnaires (FFQ) are currently the preferred dietary assessment approach to capture information on long-term food consumption, i.e. dietary habits. The Food4me FFQ 23 - food4me was developed on the basis of the EPIC study FFQ which gathers information on the frequency of the consumption of approximately 150 food items. It was designed as a web-based dietary assessment tool and incorporated into a software system that supports researchers in recruiting and managing study participants, including enrolment, randomisation, and communication. (Fallaize et al. 2014; Forster et al. 2014) 2.1.2 nutrient intakes Frequencies of food consumption can be converted into estimates of nutrient intakes, if information on portion sizes and nutritional composition of food items is available. Such data can be obtained from national dietary intake data bases. In the food4me study, an Irish nutrition database (2008-2010 National Adult Nutrition Survey (NANS) database, Forster et al. 2014) was used to form the basis of the food composition data; this was then expanded to be applicable across 7 EU countries. An automated system was designed to convert food intake data into nutrient information in the context of an individual’s nutrient requirements. 2.1.3 Anthropometric measures Anthropometric measures such as body height and body mass, as well as upper leg circumference and the waist-to-hip ratio, were identified as relevant information for phenotyping and for assessing some critical health parameters (for example waist-to-hip ratio as an established risk factor in the metabolic syndrome). In supporting participants of Food4me to provide such data in a valid and consistent way, instruction sheets, demonstration videos, and lists of frequently asked questions (FAQs) with respective answers were developed and made available (Figure 1). 2.1.4 Biomarkers of health Biomarkers can provide useful additional information on an individual’s heath status, independent of any person-related biases (e.g. recall or interviewer biases). Food4me used dried blood spots (DBS) to profile nutrient status and derive some health-related biomarkers such as cholesterol levels. DBS provide a convenient and inexpensive way of collecting blood samples. For this, subjects are asked to use finger-pricks and fill predefined spots on particular filter cards with drops of blood, dry the cards at room temperature, put them in airtight foil (aluminium) bags, and return them by post to the corresponding research centres (Figure 2). The samples were used for measurements of numerous parameters including total cholesterol, selected carotenoids, vitamin D, and a wide variety of fatty acids. (Celis-Morales et al. 2015) figure 1: Example instruction pictures provided to participants on how to do anthropometric measurement. 24 - food4me 2.1.5 extended phenotyping – scouting for new methods and tools Classic anthropometric measurements such as determination of body mass and height, or waistto-hip ratio provide easy, inexpensive and yet sufficiently reliable information for describing an individual’s basic phenotypic features. But, in recent years, new electronic tools for more extensive phenotyping have appeared on the market which may prove useful for personalised nutrition services. Such technologies comprise mobile applications (Apps), websites and electronic devices for determining body parameters, self-tracking and lifestyle interventions. The Apps work either independently and show simply the evaluation of data entered by the user, or they interface with an external measuring device connected via Bluetooth or via the charger docking port to a smart-phone that allows the assessment of parameters such as blood pressure, blood glucose concentration, sleep quality, heart rate, energy expenditure, or exercise intensity. For some devices it is claimed that they can determine arterial stiffness, others claim to be able to measure antioxidant status in skin. Other devices with a sensor coupled to a smartphone determine excretion of distinct metabolites in urine to assess vitamin status. 2.1.6 genotypic information Genotypic information in Food4me was obtained from buccal cell samples that were provided by subjects using DNA buccal swabs. Participants received detailed instructions on how to collect the sample. The material was used for DNA extraction and genotyping of about 30 SNPs in predefined loci using KASPTM genotyping assays to provide bi-allelic scoring (Celis-Morales et al. 2015). •2.2 data evaluation When individual data on genetic predisposition (SNP´s) in the context of diet and health are used in personalised nutrition services, a key question is on how valid scientific findings are that link dietary intake and genetic variation to health outcomes. For this purpose, a scientific knowledge base was developed, capturing the current knowledge in the field of nutrition with a particular focus on the interaction of food consumption, nutrient intakes, biomarkers, genetic variation to health. SNP information comprises risk allele frequencies as well as gene symbols and functions. The collected scientific knowledge represented in the data base covers currently 35 food items, 92 biomarkers, 36 genetic variations, 16 different health outcomes, and 180 established interactions based on scientific publications and an expert assessment. The knowledge base is a tool that can be used to define desirable ranges for a multitude of health parameters that may serve as a basis to decide on what dietary changes may be advisable. •2.3 recommendations The aim of personalised nutrition services is to advise or provide services or products considering a person’s individual needs and preferences. In large scale applications, this figure 2: Materials provided to participants for DBS sampling. 25 - food4me approach will become laborious and costly. It might therefore be more efficient to provide services tailored to the needs of “nutritypes” as clusters of persons with similar features (food intake patterns, similar risk factors etc.) rather than to every single individual. 2.3.1 Individualised recommendations Based on the participants’ dietary habits and health parameters, recommendations on advisable dietary changes were developed. Personalised nutrition advice can be given at the level of foods (e.g. your folic acid is low, eat more green leafy vegetables), at the level of recipes (e.g. your folic acid is low, here is a recipe for a spinach pie that will boost your intake) and ultimately at the level of meals (e.g. your folic acid is low, here is a combination of meals for a certain period of time that will help boost your intake). 2.3.1.1 Food and nutrient based recommendations A set of algorithms was developed to translate phenotypic as well as genotypic data into recommendations for nutrient intake. These algorithms are comprised of a series of decision trees that lead from a specific phenotypic and/or genotypic characteristic to a concise recommendation to alter nutrient intake. These decision trees were developed in an iterative process also taking into account the experiences made within the Proof-of-Principle (PoP) study (see WP 4). Out of these recommender systems, conflicting or at least inconsistent recommendations may originate. A frequent example is to decrease consumption of dairy products for lowering intake of saturated fatty acids and simultaneously recommending an increased intake of dairy when calcium intake is low. Within Food4me, these flaws were systematically identified and eliminated. The decision trees employed in the PoP study have meanwhile been automated using a MySQL database and incorporated into a web interface (Advice4me) that can be used to generate personalised dietary advice. The anthropometric, dietary and genotype data of a participant at a certain measurement moment as collected from the PoP study serves as input for the Advice4me system. Nutrient values outside certain threshold values are automatically flagged and, based on a complex prioritisation approach, three target nutrients are selected. For each of these, the appropriate decision tree is automatically executed resulting in a set of advice codes that are linked to specific diet related messages available in several languages. 2.3.1.2 recipe based recommendations A personalised recipe advice system (Recipe4me) was developed which adapted food based dietary recommendations to the individual preferences. It aims at bridging the often seen gap between intentions and execution of behavioural changes in healthy eating. Recipe4me provides guidance in the form of tailored recommendations of recipes based on personalised dietary advice. It is a web-based recommender system and cooking guide offering personalised recipe suggestions. Recipe4me comprises a database of 1100 recipes, which were made available by the partners in the project. Along with each recipe, information is available on nutritional composition, cooking instructions, and preparation time. The recommender picks recipes from the database that are in line with a person’s dietary needs and preferences. 2.3.1.3 Meal based recommendations Finally, dietary recommendations were also developed on the level of meals and overall dietary pattern, aiming at providing personalised nutrition in a more holistic and particularly more userfriendly manner. The menu based recommender system includes a questionnaire assessing an individual’s food preferences including favourite dishes but also specific dietary needs (e.g. due to potential intolerances or allergies). Based on such information and on the evaluation of the individual dietary habits, personalised menu plans are produced consisting of different recipes 32 - food4me IntroduCtIon The debate about implementation, and subsequent realisation of the public health benefits of personalised nutrition, is dependent on empirical analysis of consumer preferences for its implementation. It is also important to recognise that some consumers may be reluctant to adopt personalised nutrition, and understanding barriers to adoption will facilitate the “finetuning” of delivery to optimise consumer uptake. Research activities in workpackage 2 focused on understanding the specific needs of consumers with respect to personalised nutrition and its delivery to consumers, as well as identification of those factors (both psychological and pragmatic) which prevent consumers taking advantage of personalised nutrition. The primary objective was to understand consumer behaviour and consumer preferences with respect to the implementation of personalised nutrition. The research also aimed to identify which factors related to consumer decision-making will ensure that the benefits of personalised nutrition impact upon both upon the competitiveness of the european food industry (for example, in relation to the viability of SMEs or other agrifood industries with interests in exploitation of personalised nutrition) and the health and well-being of the European citizen (for example, the inclusion of personalised nutrition in health policies and other health promotion activities). The secondary objectives were to develop a theoretical model of the factors influencing consumer decision–making regarding personalised nutrition, in particular in relation to the perceived risks and benefits and their influences on expressed behavioural intention, and the identification of consumers’ needs, values and preferences regarding provision of personalised nutrition information, including those related to product delivery. It is also important to recognise that consumers are not homogenous with respect to their perceptions, attitudes and health related behaviours. The research aimed to identify differences in consumer preferences in terms of socio-economic factors, cross-cultural preferences, demographic differences and other salient individual difference (gender, other genetic factors, health status, age, income, etc.). The background of the research relates to the issue of consumer uptake of, and demand for, technological innovations associated with food and the food supply. Consumer acceptance of innovative novel technologies is not a given, and, while consumer choice is central to any discussion of food technology and its application, consumer rejection of nutrigenomics may have concomitant impacts on public health, and result in the commercial failure of a AttItudes to AdoPtIon oF PersonALIsed nutrItIon overview of Work Package 2 Primary objective: understand consumer behaviour and preferences with respect to personalised nutrition secondary objective: develop a theoretical model of the factors influencing consumer decisions about personalised nutrition 33 - food4me potentially beneficial technology. Even if putative benefits to individuals and society can be identified, consumer adoption of novel food technologies, including those focused on the improvement of health, should be based on the premise of informed choice. In order to provide this, understanding of the psychological and socio-cultural factors which shape consumers’ perception, attitudes and decision-making related to behaviour, is needed. This understanding was provided by the research conducted in WP 2. At the initiation of the food4me project, there was considerable uncertainty associated with the extent to which personalised nutrition will be adopted by consumers, what psychological, cultural and practical factors might prevent consumer adoption and, as a consequence, the long-term potential for positive impact on public health. As the project progressed, consumers potentially began to encounter real examples of Internet-based nutrigenomics products and services. However, experts still disagree on the exact form and future of nutrigenomics-based personalised nutrition, as well as which commercialisation options are likely to be the most viable. The development of effective business models for introducing novel applications of personalisation is dependent on understanding consumer preferences and priorities for application characteristics, following personal experience with emerging applications, under circumstances where such experience is vicarious, or based on the recommendations of health professionals or other information sources. Public rejection of technologies has frequently resulted in negative consequences for the commercialisation of technologies. In particular, unpredicted events and accidents affecting the public have acted as a signal which has resulted in fear and reluctance to adopt certain technologies, and these have resulted in consumer rejection of the products of these technologies. Perhaps as a consequence, much of the research focused on understanding societal acceptance of technologies has been directed towards risk perception. The usual agrifood application of technology used as an example is the market introduction of the first generation of genetically modified (GM) food crops, which led to polarised GM food debate internationally. The intensive societal discussion that followed was detrimental for the adoption and commercialisation of GM crops and food products at least in some regions of the world. Although the introduction of genetically modified foods is frequently posited as the “normative” societal response to technological innovation in the agrifood sector, public acceptance of technological innovation will occur if perceived benefits outweigh the perceived risks. Occurrence of such events and controversies associated with (agrifood) technologies emphasises the importance of public acceptance in their strategic development, application and commercialisation. Resistance to technologies and factors influencing public acceptance of technologies have generated wide interest in academia, particularly in the arena of social and behavioural research. Whilst the focus of this research has traditionally been the extent to which peoples’ risk perceptions predict acceptance of existing and emerging technologies, more recently benefit perceptions have also been examined. The “trade-off” between risk and benefit perceptions have been shown to be the major factors influencing public acceptance of technologies. Psychological research has focused on how individuals define risks and benefits associated with (different applications of) technologies, and what factors influence these perceptions. Peoples’ attitude towards technological risks and benefits are influenced by risk dimensions that have little to do with the possible consequences of the technology. An individual can evaluate a risk cognitively and react to it emotionally. Pesticides, while considered to be the technology driving the “Green Revolution”, and contributing to international improvement in food security, are primarily associated with consumer negativity linked to “negative affect”, or emotional responses, rather than systematic cognitive evaluation of the issues, although these are also a topic of societal discourse. Cognitive evaluation and emotional response do not necessarily align. Although these two reactions are interrelated, they have different determinants. Exploring these determinants in detail can facilitate our understanding of the socio-psychological process affecting public acceptance of technology. 34 - food4me Understanding the determinants of consumer attitudes towards personalised nutrition needs to take account of how the specific attributes of different types of personalised nutrition application are perceived. For example, at the most “medicalised” level of personalised nutrition, dietary interventions could be developed for groups of individuals with specific genotypes. In contrast, recommendations can also be made based on phenotypical observation of a particular individual, which might be described as a “low level” of medicalisation. An individual’s acceptance or rejection of personalised nutrition may be dependent on the level of medicalisation. Indeed, the use and storage of an individual’s genetic data is an area which has frequently been the topic of societal discussion and concern. In addition, the application of personalised nutrition may also take into account various factors, which contribute to an individual’s phenotype, such as family and personal history, psychological well-being, and environmental, social and lifestyle practices, which may or may not factor in genetic differences, but may independently raise privacy issues. Thus it is also important to consider that the technology associated with nutrigenomics may raise consumer concerns about how human genetics research can compromise the integrity of nature and have a negative impact on privacy, for example, related to the management of DNA banks and how sensitive personal information is handled. It is important that the public expectations and concerns about the potential applications of nutrigenomics are addressed as part of a development and commercialisation strategy. For example, it has been suggested that the commercialisation of nutrigenomics initiatives should align with differences in consumer preferences for different levels of potential “medicalisation”. Individual differences in perceptions and attitudes are relevant here. Consumers’ attitudes may be more favourable where there is potential for individuals to use the information for their own health benefit. Perceived risk, benefit and control are powerful determinants of consumer acceptance of novel food technologies as are perceptions of disease risk and affective responses to different applications of personalised nutrition. Other potentially influential psychological determinants of consumer attitudes include perceived uncertainty associated with both risk and benefits, normative beliefs, health locus of control, the tendency to exhibit habitual behaviours, trust in risk managers in regulatory institutions and industry, inter alia. To date, systematic analysis of these potential predictors of consumer attitude towards different applications of personalised nutrition has not been addressed, nor has their relative impact been evaluated. The importance of these different factors needs to be taken into account if predictive models of consumer acceptance are to be developed and a communication strategy which targets the information needs of different groups of consumers is to be applied to the facilitation of informed consumer choice. All of these factors were taken into account in the research which was conducted in WP2. There are also likely to be socio-cultural differences in requirements of personalised nutrition, for example, related to socio-cultural differences in dietary preferences or food choices, which also need to be considered. A potential barrier to adoption of a personalised diet is the extent to which people with potentially different dietary requirements identified by the science of personalised nutrition “share” food in different cultural settings, for example family meals or social events. Other more pragmatic factors related to how people make food choices in the context of their daily lives also need to be considered. For example, the availably of foods “prescribed” by a personalised diet may be limited if an individual is acquiring food outside of the home. A qualitative investigation of potential barriers to, and facilitators of, the adoption of personalised nutrition is likely to yield further information relevant to pragmatic and sociocultural factors relevant to consumer adoption of personalised nutrition. Such an approach has hitherto been applied only in other areas of food-related consumer behaviour. In comparison to well-formed attitudes about some other recent technological innovations, such as those associated with agricultural biotechnology and GM foods, public opinion on nutrigenomics is in the early stages of societal introduction and as yet uncrystallised. The case of personalised nutrition and nutrigenomics, therefore, also provides a unique opportunity to examine theoretical models of public opinion formation under circumstances consumers are only 35 - food4me beginning to make sense of the potential perceived risks, costs and benefits associated with a specific technological innovation. Other factors may also be important determinants of consumer uptake of personalised nutrition. As stated previously, the adoption of individualised diets may vary cross-nationally and according to local cultural practices regarding dietary preferences and social activities. However, it is quite possible that these do not influence the psychologically (and theoretically) underpinned determinants of whether an individual adopts personalised nutrition – rather they may represent pragmatic barriers to adoption of individualised diets. For this reason, it is important to compare attitudes and perceptions across populations which are associated with different cultural practices regarding food choices. In this regard, comparing populations within EU member countries is useful, as they share a common regulatory regime, “The European Food Law1” regarding food safety standards and implementation, reducing the complexity of potentially influential factors. At the same time, consumers across Europe adopt a wide range of culturally influenced food choices and socially influenced dietary practices. reseArCh MethodoLogy Taking an overview of the work package, the research was conducted in four main “phases”. First, an initial qualitative research investigated pan-European consumer perceptions of benefit, risk and cost associated with personalised nutrition, assessed across different levels of medicalisation. The results, together with insights from the theoretical literature, were then used to develop the second, quantitative phase of the research. The resulting data were subsequently analysed using structural equation modelling to develop and validate an integrated psychological model of the determinants of consumer attitudes towards personalised nutrition. A systematic analysis of individual differences in consumer preferences for different types of personalised nutrition was also addressed in order that an effective development and commercialisation strategy could target the needs of different consumers. Thus, Food4me moved beyond the state of the art by completing a multi-centre analysis of attitudes and preference across European populations, which allowed systematic comparison of demographic and psychological determinants of consumer acceptance. Additional barriers to consumer uptake (for example, related to lifestyle, pragmatic or domestic factors) were examined regarding prevention or facilitation or the adoption of different levels of personalised nutrition. Third, utilisation of the same quantitative survey instrument at the end of the proof of principle study allowed comparison between psychological factors determining uptake in the general population who had not experienced personalised nutrition service provision, with participants who had been involved in such a service for 6 months. Finally, a deliberative workshop exercise was conducted in collaboration with WP 6 to further unpack consumer preferences for communication strategies about personalised nutrition. Details of the methodologies applied will now be described. study 1. qualitative research Focus groups were used for generating data on the basis of their capacity to provide insights into participants’ perceptions of, and attitudinal consistency associated with, substantive issues that arise from both individual contributions and interactive exchanges. The use of focus group methodology facilitated the exploratory analysis in the hitherto not well understood area of public opinion towards personalised nutrition. Data were collected in eight European countries: Ireland, University College Dublin (IE); United Kingdom, University of Reading (UK); Spain, University of Navarra (ES); Greece, Harokopio University Athens (GR); The Netherlands, 1 http://ec.europa.eu/food/food/foodlaw/index_en.htm 36 - food4me Wageningen University (NL); Germany, Technical University Munich (DE); Poland, National Food and Nutrition Institute (PL); and Portugal, University of Porto (PT); University of Oslo (NO). Ethical approval for the research was obtained by each participating institution. A standardised focus group protocol (including focus group composition) was developed by a core of researchers experienced in qualitative research from Ulster, Newcastle, Wageningen and Porto. Two pilot focus groups were conducted in English in Newcastle during September 2011, and the results used to further refine the protocol used in the main study. These data were not used further in the main analysis, to ensure all data had been collected using an identical protocol. About one month prior to the focus groups being held (October 2011), a two day training course was provided to harmonise focus group moderation in all participating centres. The research protocols were translated from English into the national languages of the centres responsible for the data collection and back-translated to ensure consistency in methodology was applied across all the centres. One hundred and twenty six participants were recruited using social research agencies (UK, Spain, the Netherlands, Poland and Portugal) or through distributed flyers and/or posters (Ireland, Greece and Germany). Two focus groups were conducted in each country. Each focus group comprised 6-10 free living, urban dwelling participants. Gender and occupations were mixed within the groups. Individuals who were not healthy (according to their own definition) were excluded. Vulnerable individuals, health professionals with an interest in food or diet, individuals with a background in genomics, nutrigenomics or personalised medicine, individuals who had previously taken part in research related to personalised nutrition, or those who were regular focus group attendees were also excluded. In each centre, one group comprised a mixed age profile (18-65), and one group comprised “older” individuals (30-65), to allow age or cohort specific issues to be investigated. Participant profiles were verified using a questionnaire administered to record sex, age, marital status, household size, number of dependents, and information about occupation. There were no significant differences in the distribution of sex or age group. Marital status did differ across countries, with Germany and Greece having more, and the Netherlands and Poland fewer, single individuals than expected. study 2. development and analysis of survey instrument The focus group study provided source constructs for development of a predictive model of the intention to adopt personalised nutrition. Within this study perceived personal benefit was identified as a positive attribute of personalised nutrition. Perceived risk and perceived benefit associated with a range of potentially controversial issues, including those located within the health domain, and consumer adoption of ICT services, have been found to be inversely correlated in previous research. Thus it is predictable that the greater the perceived benefit, and the less the perceived risk, individuals associate with personalised nutrition, the greater will be their intentions to adopt it. In the focus group research, negative attitudes were reported to be associated with internet delivery of personal and identifiable genetic information. Although participant negativity did not focus on personalised nutrition per se, participants raised concerns about broad technological issues associated with personal data protection, and trust in regulators, the efficacy of legislation put into place to protect privacy and exploitation of consumer data, and the reliability and motivation of service providers in relation to consumer protection. Potentially, the more individuals trust regulatory systems to optimise consumer protection in relation to nutrigenomics, the greater will be their intentions to adopt personalised nutrition. The focus group protocols also took account of the potential for different responses in different countries. In particular, the protocol design acknowledged that the adoption of individualised diets may vary cross-nationally and according to local cultural practices regarding dietary preferences and social activities, and this was systematically explored and analysed between the countries involved. These socio-culturally specific factors may represent pragmatic 37 - food4me barriers to adoption of individualised diets and so it was important to compare attitudes and perceptions across populations which are associated with different cultural practices regarding food choices. However, some psychological factors which potentially influence consumer acceptance of personalised nutrition may be relatively stable across individuals from different cultures. For example, a potentially important determinant of adoption or rejection of personalised nutrition is health locus of control. If people believe that they have control over their own health through their own volitional behaviours, they exhibit a high level of internal health locus of control. The concept of external health locus of control relates to the belief held by some individuals that health status is a matter of chance, or under the control of powerful others. Individuals exhibiting high internal health locus of control may be more likely to adopt personalised nutrition. Similarly, individuals with high levels of perceived self-efficacy (perceived capabilities to perform a desired task) may also exhibit a greater tendency to adopt personalised nutrition. These factors may influence attitude towards personalised nutrition, which, in turn, may influence behavioural intention regarding its adoption or otherwise. Social trust in regulators and service providers may also affect people’s tendency to adopt personalised nutrition, as well as perceptions of affordability of services. This would reflect a key finding in the focus group research. A total of 9381 participants from 9 EU countries (Germany, Greece, Ireland, Poland, Portugal, Spain, the Netherlands, the UK, and Norway) were quota sampled to be nationally representative for each country, on sex, age (18-29, 30-39, 40-54, 55-65 years) and education level (highest level of education completed based on International Standard Classification of Education levels ISCED 0-2, ISCED 3-4, ISCED 5-6). Participants were drawn from an existing panel held by a social research agency. Additional research agencies were subcontracted by the primary agency to supplement panels if needed. A total of 29,450 individuals were contacted, and the overall response rate was 31.9%. Data were collected in February and March 2013, using on-line survey methodology. After reading an introductory text, participants provided informed consent prior to completing the questionnaire. Ethically approved research procedures were noted by the lead academic institution. In addition, data regarding peoples’ willingness to pay (WTP) for personalised nutrition services was included in the survey described above, as well as in the research survey instrument utilised in WP 1 after the WP2 data collection had been finalised. This data enabled assessment of the extent to which different groups of individuals were willing to pay for personalised nutrition services, which is particularly relevant from a business development perspective. At the time of writing, there have already been several initiatives which have attempted to exploit personalised nutrition as a business opportunity (see the chapter on WP 1). It is, however, not clear how much consumers are willing to spend on personalised nutrition services in comparison to existing dietary advice which should deliver health benefits to the entire population, without taking account of individual differences in dietary requirements. It is assumed that the perceived risks and benefits of personalised nutrition which are held by individuals, as well as the perceived benefits of specific personalised nutrition services, will influence the potential success of commercialising a personalised nutrition service. On one hand, assuming behavioural adoption is contingent on perceived benefit of adoption, it could be posited that consumers who perceive greater benefit will be willing to pay more for personalised nutrition services. However, increasing the use of genetic data in personalised nutrition may have a larger effect on increasing risk perception related to potential privacy issues, than on benefit perception related to better advice. This raises the question to what extent the increasing levels of personalisation facilitated by more specific and more privacy sensitive data contribute to the market potential of personalised nutrition services using different levels of data. In particular it raises the question if consumers are willing to pay for the required additional analyses needed 38 - food4me on blood and DNA samples. The two waves of the cross-national surveys (in WP 1 and WP 2) were conducted nine months apart, in February/March 2013 (WP 2) and November/December 2013 (WP 1). In both waves, willingness to pay for a personalised nutrition service was measured next to various other constructs, to predict the potential market for such services. In addition, income was surveyed to investigate to what extent such nutritional service might be adopted across income classes. In both surveys, data was collected on people’s willingness to pay for different personalised nutrition services. In both surveys, the “sensitivity” of the information that the end-user had to provide to receive personalised nutrition advice was varied. Sensitivity of information depended on provision of (1) dietary lifestyle information, (2) lifestyle information and blood samples and (3) dietary lifestyle information, blood samples and DNA samples. The combination of data sets allowed us to answer the following questions: •To what extent do people differentiate their willingness to pay depending on sensitivity of provided information? •How much influence does income have on willingness to pay for a personalised nutrition service? •To what extent do people show a stable willingness to pay over time? study 3. Comparisons with participants in the Proof of Principle study In addition to the studies above, the same survey was administered to participants in the Proof of Principle study being conducted in WP 4. This allowed some comparisons to be made regarding the importance of the psychological factors which determine potential adoption of personalised nutrition in the general population being surveyed in the large survey (who were only expressing their theoretical intentions to adopt personalised nutrition) and those participants who had been recruited into the personalised nutrition trial (who, as self-selected and interested individuals may have been expected to hold more positive attitudes towards personalised nutrition as compared to the general population on recruitment, but none-the-less may have moderated these attitudes positively or negatively after recruitment into the trial, following their allocation to trials focused on different levels of medicalisation of personalised nutrition in WP4). Two analyses were conducted. The first analysis focused on understanding differences in relevant psychological traits between the different levels of personalised nutrition included in the PoP study. The second compared attitudes of the general population with individuals recruited into the PoP study itself. study 4. the “citizen’s panel” Finally, a deliberative workshop was set up to produce guidelines on effective communication for people interested in developing and delivering personalised nutrition services. The citizen’s panel was held in London in November 2014. Participants (n=22) were recruited by a social research agency according to a sampling frame based upon age, gender, social class and ethnicity that was broadly representative of the wider UK population. Criteria for exclusion included people working in nutrition and genomics related areas or who had taken part in a clinical trial. The deliberative workshop was delivered by OPM Group and took place in one day over a 6 hour time period (10am-4pm) and included the following activity sessions: 1) introducing the topic of personalised nutrition; 2) introducing personalised nutrition; 3) discovering personalised nutrition; 4) data collection for personalised nutrition; 5) reporting personalised nutrition outputs; 6) designing your ideal personalised nutrition service; and 7) message prioritisation. During these sessions and over the course of the workshop, participants 39 - food4me were exposed to several knowledge sources that were used to prompt discussion and deliberation, and enabled the participants to construct, reflect upon and discuss their understanding of personalised nutrition. The knowledge sources included; a formal presentation to the whole group, made by a technical expert, describing personalised nutrition, a technical video clip, information embedded in stimulus materials such as personalised diet reports, examples of devices to collect phenotypic and genotypic data, informal ‘round table’ interactions facilitated by a trained moderator in small groups of 5-7, and informal interactions between participants during lunch and tea breaks. Participant outputs were captured through a variety of pre-tested media including; audio recordings of discussions, written comments in pre-prepared work books, plans written on flipcharts, and electronic voting system and moderator notes. The data generated throughout this workshop process both complemented and extended an understanding of attitudes and perceptions of personalised nutrition communication. key resuLts qualitative research2 The results of the focus groups indicated that European consumers may construe personalised nutrition in terms of benefit in terms of potential improvements to both individual and public health. In contrast to other agrifood technologies, perceived risks are more closely linked to general concerns about genetic privacy and data security, and are not specifically linked to personalised nutrition per se. Furthermore, the results suggested that consumer acceptance may be dependent on the development of an efficacious, transparent and trustworthy regulatory framework associated with human genetic technologies, which would apply to other types of application as well. While data privacy was also important for those levels of personalised nutrition which did not involve the sampling of genetic data, most concern expressed by study participants related to the need to ensure that the principle of “genetic privacy” was enshrined in regulation. The results suggested that participants thought that developing trust in service providers is important, in particular for service providers located within the commercial sector rather than in the public health sector. It was also found that a possible barrier to adoption may be represented by optimistic bias, where participants indicated that they thought personalised nutrition services were being developed to benefit individuals at greater risk of disease development than they were personally. This suggested that communication about personalised nutrition might usefully target those individuals who might potentially experience benefits from the adoption of personalised nutrition, but who do not perceive that personalised nutrition will benefit them personally. In particular,this might include younger consumers, for whom the benefits of personalised nutrition will potentially accrue for longer. Communication might also discuss specific benefits for those consumers with existing medical conditions. In addition, focus group participants were concerned that adoption might be difficult, and foods inconvenient to obtain. Communication about personalised 2 Stewart-Knox, B., Kuznesof, S., Robinson, J., Rankin, A., Karen Orr, K., Duffy, M., Poínhos, R. Vaz de Almeida,M.D., Macready, A., Gallagher, C., Berezowska, A., Fischer, A.R.H., Navas-Carretero, S, Riemer, M., Gjelstad,I.M.F, Christina Mavrogianni, C., Frewer, L.J. (2013). Factors influencing European consumer uptake of personalised nutrition.Results of a qualitative analysis. Appetite, 66, 67-74. 40 - food4me nutrition might focus on convenience of adoption, as well as the provision of individually tailored benefits for health and fitness, which were identified as important benefits of adoption by some focus group participants. An important finding was that advice should be tailored to align with people’s lifestyles and preferences, including those related to food choices, anonymity, and motivational factors. Cost may also be a factor in determining whether an individual may adopt personalised nutrition. No evidence of cross-cultural differences was found between the countries surveyed in the focus group results, although this issue was analysed further in the survey study. Main survey A structural equation model was developed (figure 1) which examined the relationship between perceived risk, perceived benefit, health locus of control, perceived self-efficacy, attitudes towards personalised nutrition, and behavioural intention to adopt personalised nutrition.3 The psychological factors included in the analysis were chosen to be relatively stable across 3 Poínhos, R., van der Lans, I. A., Rankin, A., Fischer, A. R., Bunting, B., Kuznesof, S., Stewart-Knox, B. and & Frewer, L. J. (2014). Psychological determinants of consumer acceptance of personalised nutrition in 9 European countries.PloS one, 9(10), e110614. figure 1: Structural Equation model. Psychological determinants of personalised nutrition in 9 European countries (source, Poinhos et al, 2014). 41 - food4me cultures in order to develop a predictive model which was stable across cultures and likely to maintain stability with time. A priori hypotheses about the relationships between the different factors could also be developed, and these were confirmed in the analysis. The extent to which individuals trusted relevant regulatory systems was also assumed to be a good predictor of an individual’s intention to adopt personalised nutrition. The results of the analysis imply that attitudes towards, and adoption of, personalised nutrition appear to be primarily driven by perceptions of benefit, together with the extent to which an individual perceives that adoption of personalised nutrition is achievable (reflected by selfefficacy scores). In addition, the extent to which an individual trusts those regulatory systems associated with consumer protection and personalised nutrition, (in particular in relation to personal genetic data protection), and the extent to which individuals are committed to improving their own health status through their own actions, influences attitudes towards personalised nutrition, and subsequently behavioural adoption. In spite of local socio-economic and cultural factors that may influence the extent to which adoption of personalised nutrition is operationalised by consumers, the research demonstrated that the associations appeared stable across a range of European countries. •Willingness to Pay for different types of personalised nutrition service. The Willingness to Pay (WTP) data from the WP 1 and WP2 nationally representative population surveys was collated and analysed4. The results indicated that a limited group of about 30% of the population is willing to pay more for a personalised nutrition service than for a generic nutrition service, which is currently provided by health professionals. The additional price people are willing to pay for a personalised nutrition service was, however, also somewhat limited. The results suggested that, based on consumer WTP for personalised nutrition services, that additional price of personalised nutrition services over and above standardised nutritional advice should be less than 50% (or 50€) in comparison to generic services. The additional prices people are willing to pay for increasing levels of medicalisation (dietary and blood collection, and dietary and DNA collection) are very small indeed (below 5% of the total price, representing a 5€ difference between increased levels of medicalisation of personalised nutrition). The data in survey 2 was collected about a year after survey 1. Comparative analysis of the WTP data acquired in the first and second waves of data collection suggests that the amount participants are willing to pay for personalised nutrition services was fairly stable when surveyed over this time period, which suggests that people have long term preference regarding what they see as an appropriate price for personalised nutrition services utilising different levels of medicalisation in their “diagnosis” of individualised diets. Perhaps as might be expected, people in the highest income groups report being willing to pay the greatest additional price. This raises a question of whether access to personalised nutrition services should be determined by financial restrictions, which raises ethical issues about access to a healthy life for all, independent of income. Furthermore, equal access to personalised nutrition services will prevent the development of dietary related diseases, reducing the burden of health care costs. It may be an important public health measure to routinely include personalised dietary advice as part of health service provision, health insurance coverage or human resource management programs. Finally, an analysis of different participant motives for adopting personalised nutrition was applied to the general population data collected in the WP 2 research5. Included in the survey 4 Fischer, A.R.H, Berezowska, A., Ronteltap, A. , van der Lans, I.A., van Trijp. H.C,M., Rankin, A., Frewer, L.J., Kuznesof, S., Panzone, l., Poinhos, R., Oliveira, B., Markovina, J. and Stewart-Knox, B. (2014). Food4me Deliverable 2.8 – Report on relationship between consumer attitudes and personalized nutrition. 5 Rankin, A (submitted) Motives for food choice and individual’s intention to adopt personalised nutrition. chapter 5. “Factors determining the uptake and effectiveness of personalised nutritional interventions”, PhD thesis, Ulster University. 48 - food4me concern or perception measure to highlight perception, lessen concerns and improve acceptance communication advice Security and information misuse Major concerns were expressed related to data handling and online security/ safety. Concerns of misuse that individual health data could be passed onto insurance companies, marketers and even employers. A PN service administered by a local GP or a dietitian was seen as most trustworthy. Make sure that maximum IT (protocols and software) security measures are undertaken. Provide valid and recognisable security certificates and logos. Allow for secure payment channels (cooperation with online banking such as PayPal). explain that personal information will be kept confidential. highlight safety and security of the service (explicitly state that data will not be forwarded to any other/third parties outside of the Pn service). Positive testimonials from other consumers. Provide endorsements by recognised institutions. highlight confidentiality of the Pn service.highlight confidentiality of the Pn service. make clear that there is a team of health professionals also behind the internet service. Anonymity and privacy Anonymity was seen as an advantage, as it would reduce the perceived risk and protect an individual’s privacy. Wherever possible provide detailed information on data protection guidelines. Latest encryption protocols and standards should be employed. explain that personal information will be anonymised.clearly state why the protection of users’ identity is of foremost importance. Trust – up to a level Misuse of biological material, especially DNA, was seen as a possibility. Genetic testing was often mentioned as a step too far The competency of the “behind the screen” PN individual was questioned. Provide information of the different steps of the PN analysis and where and why the samples are going to be used. Explain how different types of samples provide different information, to produce a different level/ depth of advice. Give supporting credentials of the PN specialist. clearly explain that the only purpose that the samples will be used for is the Pn analysis. highlight the benefits and importance of genetic testing. communicate about science and technology as the sheer carriers of progress. highlight that the service is administered by health professionals. Cost - a burden or an assurance? A segment of participants believed that a PN service should be provided for free. Alternatively, having to pay for a PN service was seen as a guarantor for a quality service. Provide an overview of the different steps of the PN programme and where and why costs arise for the provider. Provide a selection of cost/ payment options available to the consumer. highlight that costs will be tailored to the individual, just as their personalised nutrition results will be. justify that the safety and quality of the service, cannot be given for free. emphasise value for money. 49 - food4me concern or perception measure to highlight perception, lessen concerns and improve acceptance communication advice Psychological wellbeing – fear of failure PN services were associated with a fear of failure (or of getting uninterested), as signing up and keeping to a programme requires strong motivation and will-power. Motivate people with key motivation messages. Make available trained and friendly advice via specialists on the phone or online. explain risks to future health if no action is taken. Provide reassurance that support is provided every step of the way. Psychological wellbeing – fear of truth PN testing was linked to a possibility of identifying serious disease risks. Provide professional advice and explain pros and cons of knowing one’s genetic predispositions. explain risks to future health if no action is taken. Provide reassurance that support is provided every step of the way.make clear that what is written in genes is not set in stone. one can always influence their health by making better choices. Psychological wellbeing – personal contact Personal contact was considered important both to motivate and emotionally support an individual, also to prove the legitimacy of the service. Use personalised letters or emails to directly communicate with individuals. Establish a telephone help line or an online chat service for guidance and explanation. highlight ‘personal touch’ provided by the Pn service. be transparent who the team are, with profiles, photo, qualifications. reassure people that operators are an experienced and trained team of specialists. give positive testimonials from other consumers. 50 - food4me BusIness And vALue CreAtIon ConCePts For PersonALIsed nutrItIon overview of Work Package 1 IntroduCtIon New scientific advances still face important barriers in becoming accepted and applied by society, even though benefits seem very obvious. There are a multitude of factors at play that may drive or block acceptance for successful uptake of novel business or value creation concepts. A fundamentally new development such as personalised nutrition is particularly delicate to evaluate because it touches upon two primary human needs; health and food. These are today at the heart of a major societal debate because the growing pressure in public health care results from health issues that are, to a large extent, a consequence of inappropriate dietary behaviour. There is an urgent need to help citizens to adjust their dietary behaviour. Personalised nutrition offers a new approach by advising food choices and eating patterns that fit individual needs and are in line with personal preferences. This should help a person to achieve a lasting dietary behaviour change that supports optimal health. This inherent link between individual behaviour change and the societal impact of it means that personalised nutrition as a concept is deeply embedded in societal tissue. Its introduction is likely to have significant societal consequences and on the other hand societal changes to cope with this issue are likely to embrace personalised nutrition concepts. That makes value creation models for personalised nutrition interesting but also very challenging. Personalised nutrition concepts need to integrate very different elements such as personal coaching principles and a wide range of new technological tools, from self-sampling diagnostics and wearable lifestyle and food intake monitoring, to mobile interfaces for dietary coaching. Moreover personalised nutrition concepts hold the potential to substantially improve the value perception of food and its role in health and in society. This requires a fundamental understanding of the system and the dynamics of the personalised nutrition concept. Based on a wide range of inputs from societal, scientific and industrial stakeholders, a systems view of the personalised nutrition concept and its environment were developed. Achieving a lasting dietary behaviour change is at the core of this personalised nutrition system. In order to explore what value creation models could emerge in the future, it was necessary to explore the possible future societal context in which this is bound to take place. Four scenarios about evolution of the nutrition and health issues in Europe served as a basis to conceive 10 value creation concepts for personalised nutrition. These illustrated very different options in personalised nutrition concepts but also the extent to which these may be inherently linked to changes in our future society. Since personalised nutrition is just starting to take shape, it is inevitable that many of the aspects described here are still very speculative. However, the insights developed in this research seem to indicate that personalised nutrition may be a trigger for important changes in the way our society deals with health and food behaviours. 51 - food4me 1 reseArCh MethodoLogy The process for developing business and value creation models is different from other scientific research performed in this project. The stepwise approach outlined below was based on a combination of field research, systems analysis, scenario planning and creative multi-stakeholder processes, gradually gaining deeper insight into the subject, its elements and its environment. Business value Creation Concepts ConsuMer PersPeCtIves sCIentIFIC BAsIs teChnoLogy oPPurtunItIes figure 1: The research process to develop and assess business and value creation models. 1.1 Market analysis of existing personalised nutrition offerings An inventory of existing business propositions involving some form of personalised nutrition or a similar type of service in Europe, India, Japan and Australia was obtained by an internet and trade press search. This sample was analysed to identify the possible key differentiating characteristics between the offerings and the basic business model archetypes. 1.2 societal and business stakeholder analysis Perceptions about personalised nutrition were collected from a wide stakeholder field, including societal, policy and industrial stakeholders, through extensive interviews (by phone or face to face) organised as open-ended conversations. Identifying the key statements and clustering related statements resulted in a set of elements that form the basis for a generic activity model for a personalised nutrition business approach. It also enabled the identification of 7 critical issues that need to be addressed in the development of any personalised nutrition approach. 1.3 A systems view of personalised nutrition The inherent complexity of a personalised nutrition approach was explored by creating a systems view in the form of an influence diagram that visualised the main drivers and how they interact in shaping the environment in which a personalised nutrition approach is embedded. This “system map” was developed in a co-emerging process in parallel with the analysis of the 52 - food4me outcome of the multi-stakeholder interviews. The modelling process starts by trying to identify the core variables that constitute the ‘central engine’ of the system. Step by step, other drivers influencing these core variables are then added to the system map and the logical context starts to build up. Variable definitions are gradually refined during the process to arrive at a more accurate description of the environment of the personalised nutrition system. 1.4 Future scenarios about health and nutrition Future scenarios were designed to provide insight about possible future environments in which personalised nutrition business models could emerge and operate. The two questions driving the scenario building were: •How will the issues around nutrition and health impact our society and the future business and regulatory environment? •What opportunities for economic and societal value creation will exist in this vast and complex arena and how can personalised nutrition contribute to this? In a facilitated and structured scenario planning process, a group of about 25 representatives from a variety of industrial, societal and academic backgrounds participated in three consecutive workshops to design four scenarios. Each scenario was described in detail in terms of a storyline, key events, food consumption patterns and health care sources, as well as business, regulatory, ethical and information environments. A final assessment explored the possibility for personalised nutrition to emerge in these scenarios. 1.5 Business model development The aim was to explore which novel business and value creation concepts based on personalised nutrition may be possible and useful in the future. Two interactive creative sessions were held with a limited group of participants, selected from those participating in the future scenario planning and reinforced with representatives from a wide range of industries, such as food, wellness, health, diagnostics, medical and pharmaceutical players. As a basis for the creative process, an overview was presented of all the insights so far available on personalised nutrition, from the market analysis, the stakeholder interviews, the systems view and the scenarios, as well as the first results from the other work packages of the project dealing with consumer, technological, legal and ethical aspects. In the first session the creative space was left entirely open to the participants, whereas the second session more specifically explored business model concepts that may emerge within the boundaries of each of the four future scenarios. The Osterwalder business model canvas was used to describe the concepts. Business model concepts were analysed for: •fit within each of the four scenarios •capacity to overcome the 7 critical issues for development •sustainability of the concept in the long run 1.6 economic evaluation A first estimate of the economic value of personalised nutrition has been based on desk research, taking into account the previous analyses combined with consumer insights and 53 - food4me experience from the development of health and nutrition related businesses over the last 20 years. It includes estimating the cost and value of a personalised nutrition service as well as the potential market and the degree of penetration. This is then considered within the broad societal context of health care costs and prevalence of diet-related diseases to determine the possible contribution of personalisation in providing a solution to these issues. 2 key FIndIngs •2.1 existing business model archetypes The present market is characterised by a flurry of commercial offerings, many of which could be considered rather opportunistic, simple and sometimes doubtful or misleading in nature. Advice is typically based on very limited data, probably because of the cost to collect and diagnose, and hence the advice is quite basic, limited to nutritional elements, food choices and in some cases a meal plan. The scientific evidence for the advice is often unclear. Many offerings appear to be a means for selling health foods, supplements, diet coaching services or monitoring apps and devices. This is a typical pattern for the early stages of an emerging market and holds major risks for consumer disappointment in the quality of such novel services. This environment of purely commercial opportunism puts the few more extensive offerings, which are obviously also more expensive, under an enormous pressure to survive as some premature cessations have shown. This market analysis resulted in identifying 9 business model archetypes, each of which can be described by various combinations of the following 6 key differentiating features: The majority of current offerings are organised by small companies, use the internet as their main interface, work on the basis of self-estimated and self-reported inputs from consumers and focus on dietary and lifestyle advice based on dietary intake profiles. Regular feedback and progress tracking are not commonly provided by the offerings. It is clear that future business model concepts will need to leverage many more of the above options in order to be perceived of sufficient quality and reliability. •2.2 seven critical issues to implement personalised nutrition The combined perceptions of a wide range of stakeholders revealed 7 important concerns to address when operationalising a personalised nutrition approach. These have obviously been noted from the perspective of today’s environment and therefore can be seen as a set of criteria that need to be fulfilled to facilitate introduction and/or acceptance of personalised nutrition approaches in the future. 2.2.1 there is still doubt about the strength of the scientific evidence for personalising dietary advice This is a concern shared by many, including those in scientific communities, industries and society. It relates especially to the need and possible usefulness of using individual genetic type of organiser type of interface used type of data gathered nature of feedback evolution tracking frequency of feedback business corporate government ngo internet email telephone face to face self reported +bmi phenotyping genotyping health status, food & diet plan activity profile lifestyle none limited rigorous one-off self-requested organised - monitoring figure 2: Six key differentiating features of business model archetypes. 54 - food4me information to produce the advice but it also relates to concerns that the existing knowledge about biomarkers can be insufficient. Such measures are key in tracking progress when implementing the advice. An underlying reason for this concern is the fact that currently used research models have not been designed to deliver proof of efficacy on an individual level, but only on a research cohort level. In general there was a feeling that adding more scientific arguments in health and nutrition advice might be counter-productive to achieve dietary behaviour change. This may be particularly the case in providing genetic information, which may be counterintuitive for those with a fatalistic view i.e. they can’t change their genes so it is beyond their control. 2.2.2 Making diagnostics feasible and reliable is a huge barrier Extensive diagnostic testing such as that required for personalised nutrition, is perceived to be a major cost barrier for any business model aimed at general use. While it was postulated that health professionals would have to be involved in the execution and distribution of the diagnostics, they were also perceived to be the most critical in adopting it because of concerns about quality, reliability and usefulness of such diagnostics. 2.2.3 Providing nutritional advice at an individual level is not realistic, it should be delivered at a nutritype level. There was significant doubt that it was possible and even useful to develop nutritional advice at an individual level. It was suggested that it could be possible to identify large groups of individuals (nutritypes) having very similar metabolic profiles for which similar nutritional advice could be generated. However individual analysis would still be needed to identify to which nutritype an individual belongs. Providing nutritional advice on a nutritype level therefore would not take into account any individual preferences or limitations in terms of food choice, eating patterns and psycho-social factors that would influence adopting a dietary behaviour change. 2.2.4 Personalising food products is economically not feasible Mass customisation of foods is perceived to be economically impossible and will at most consist of special product ranges designed to fit the largest nutritypes. Moreover health-related claims on food products can be a regulatory nightmare and impossible without strong clinical trial evidence and intellectual property protection. Also decades of changing product/diet recommendations with doubtful health benefits have made the market wary of new health and nutrition related product innovation. 2.2.5 there is a need for economic feedback signals to adopt a healthier lifestyle Without an economic stimulus, it will be difficult to trigger a change in diet and lifestyle. The economic benefit is complex to assess and therefore defining assessment measures will be difficult. Private health care actors are expected to lead this initiative because authorities until now have shown little drive to change public health care systems. Also it could be expected that the pharmaceutical industry would be a strong adversary to personalised nutrition based on food and not dietary supplements. A harmonised approach in Europe will face important barriers due to regional and cultural differences. 2.2.6 Providing and delivering useful dietary advice at a personal level is the most controversial issue in implementing a personalised nutrition approach There is doubt that consumers, especially those who need it most, may be hard pressed to seek such professional advice due to ignorance, confusion or fear. Even if they do, it may still be very difficult to provide good personalised dietary advice due to inaccurate or incomplete reporting 55 - food4me of their behaviour and the social environment, thus limiting the effectiveness of the advice. The underlying reason for advising a dietary behaviour change is to ‘prevent’ disease, however the health care logic in our societies is still dominated by the ‘curative’ approach. 2.2.7 Personalised nutrition is about achieving a lasting dietary behaviour change Food as a vector to deliver health is not self-evident. Health is not the most compelling factor for consumers when choosing food, therefore dietary behaviour changes that benefit health are difficult to achieve. Moreover, the perception of food as a vector of health is hampered by several factors: •lack of understanding about food, its constituents and its preparation •a decline in the social aspect of eating •a perceived low value as a result of low pricing, abundance and ubiquitous availability •extremely confusing and conflicting information streams on food and health •the perceived inefficacy of dieting Therefore the main role of personalised nutrition is not to improve nutritional advice or to make it more accessible, but to facilitate a process that will help an individual in achieving a lasting dietary behaviour change that results in experiencing better health. This points to the importance that coaching will have to play. •2.3 the personalised nutrition system: a systems perspective on achieving a lasting dietary behaviour change The previous insights were consolidated into a personalised nutrition system. It was visualised in the form of an influence diagram (Figure 3) that shows the causal relationships between societal, economic, technical, psychological and biological drivers that affect a personalised nutrition approach. Groups of related drivers are highlighted in the map. 56 - food4me Health Care System Scientific Support Economy & Work Food Production Food Consumption Diagnostic Testing Individual Psychology Bio-Sense 3$ Dietary Behaviour Change figure 3: The personalised nutrition system map. 57 - food4me The “core engine” of the system consists of a set of key activities enabling an individual to achieve a lasting dietary behaviour that is appropriate for his/her individual health and well-being. The map shows that 6 drivers can be considered key leverage points because they are influenced by many other drivers and transfer these on to many other parts of the system, in particular to the core engine of the system. These are: •The effectiveness of support and coaching in nutritional counselling •The financial pressure on health care systems, which feeds into the central engine via the effectiveness of the economic feedback signal •The force of dietary habits keeping people from adopting healthier dietary alternatives •The level of psychological ambivalence experienced by people in deciding dietary and lifestyle choices (food, exercise) •The acceptance of genetic diagnostic information making the use of genetic information useful in driving dietary behaviour change •The reliability of the risk/need profile assessment which is the basis for proper nutritional counselling figure 4: The core engine of the personalised nutrition system: achieving lasting dietary behaviour change. 64 - food4me ethICAL ConsIderAtIons In reLAtIon to PersonALIsed nutrItIon An overview of Work Package 5, with respect to ethics IntroduCtIon Ethics is the analysis of normative dimensions of human relations and experiences. Such analyses are often based upon basic values related to normative ethical theories. One of the aims of ethics is to discuss arguments and suggest solutions to relational situations, real or imagined, and not least to suggest solutions to complex dilemmas. Our use of ethics as a research tool in this project is an example of applied ethics, also commonly labelled practical ethics. We have started by examining the situation where the practice of personalised nutrition is introduced in the near future. We have then related this understanding to values and normative standpoints that can be drawn from human experiences already analysed in ethical theory. reseArCh MethodoLogy Personalised nutrition services are related to several fields, such as nutrition, health care, genetics, and public health. In order to deal with ethics in relation to personalised nutrition, we explored ethical issues arising in varying fields while focusing on those aspects that constitute the specific and ethically relevant differences that distinguish personalised nutrition from other health services. One specific characteristic is that personalised nutrition services require personal health data, which qualifies as sensitive information, in order to advise the consumer on how to manage their health. Since a person gives personal data to an institute or company, aspects of trust and trustworthiness become significantly important as well as issues regarding consumer or patient protection. The patient or consumer has to assess the potential benefits of using the service and the risks related to sending in personal health or life-style data. Other characteristics are the focus on prediction and prevention of health problems, as well as the individualising approach to health management and, indirectly, individual responsibility for one´s own health. However, these general characteristics of personalised nutrition vary between 65 - food4me different types of services for personalised nutrition. Therefore, general ethical issues have to be carefully distinguished from specific personalised nutrition services. It matters, for example, what kind of health data are used (e.g. physiological information, genetic information etc.), whether a service requires individual DNA information, or whether a service is based exclusively on direct to consumer (DTC) tools. •ethical dilemmas Sometimes new information or options for action creates situations where we are unsure about what choice to make, or where all the alternatives for action we identify seem problematic, but for different reasons. This is what we commonly call ethical dilemmas. What dilemmas can be identified related to the introduction of personalised nutrition? Ethics tries to cast light on ethical dilemmas by identifying values and responsibilities discussed in ethical theory. In work package five, we have discussed values and societal or personal responsibilities that may be involved. In some cases it has been possible to give specific advice as a result of ethical reflection. •Identification and Mapping of the ethical Issues One of the objectives of Food4Me work package five included identification and mapping of the ethical issues related to personalised nutrition. We identified four issues, or themes, as in need of further ethical analysis: State of the art of personalised nutrition – do we know enough?; Commercialisation; Food and health; and Values at stake. In October 2011 we also hosted a two-day workshop in Lund, Sweden, targeting these themes. Speakers and participants consisted of both researchers within the Food4Me project, researchers external to the project, and stakeholders representing health insurance companies, patient organisations, professional dietitians’ associations, and food and beverage companies. Below we will present the key questions and results included in the analyses conducted within each theme. key resuLts The objectives of Food4Me work package five included a baseline assessment of the ethical and legal aspects of personalised nutrition at the start of the project, as well as a final assessment at the end of the project, taking into account results achieved in other work packages. The initial assessment made a number of ethical issues visible, most of them relating to the consumer of personalised nutrition services. These issues often concern values such as autonomy, trustworthiness, and consumer protection. The results depicted below indicate that many of these questions remain unsolved, and in some cases they seem to be neglected in relation to the services offered by Internet companies. However, the aim of both the baseline assessment at the start of the project and the final assessment at the end of the project was not to provide definitive guidelines or specific advice, although this has been done in some cases. Instead, the primary objective has been to point out major opportunities and challenges for further analysis and discussion. theMes For ethICAL AnALysIs do we know enough? Commercialisation Food and health values at stake 66 - food4me •theMe 1: state of the art of personalised nutrition – do we know enough? A fundamental and debated question concerns whether or not the current scientific evidence regarding the different gene-diet-health interactions is sufficient for taking an ethically responsible decision to offer personalised nutritional advice to consumers. On the one hand, there is a widespread belief that there are many more studies, in different areas, needed to be done. According to this view, the scientific evidence for personalised nutritional advice is quite limited, and more research regarding, for example, behavioural and motivational aspects is also needed. On the other hand, in specific cases of gene-diet interactions, individuals could benefit from following personalised rather than general dietary recommendations. According to this view, personalisation of dietary recommendations is both possible and ethically justified in some instances and should, therefore, be made available for consumers to use. In light of these opposing views, an ethically sound and responsible way forward is suggested to make use of the precautionary principle, which is often used in situations where we only have limited (or no) knowledge of the possible consequences following different alternatives of action. The precautionary principle can be understood in different ways, and we suggest it to be understood in line with what is considered as “prudent housekeeping”. It is suggested that, in good housekeeping, it is appropriate to underestimate incomes (benefits), while overestimating expenses (risks). This will result in cautious estimations of the balance between risks and benefits, while also allowing an appropriate modification of this balance as scientific research is conducted further. Arguing from a precautionary approach, we suggest that personalised dietary advice should be offered only when there is strong scientific evidence for health benefits, followed by stepwise evaluation of unforeseen behavioural and psychological effects. However, this raises questions about how to deliver these recommendations, yet another ethically significant issue to be handled. To give advice based on genetic analyses could be perceived as telling people what they ought to do and, thus, runs the risk of involving a certain amount of paternalism, i.e. an attitude of superiority. From an ethical perspective, paternalism poses a questionable way of dealing with situations where advice and recommendations are given to individuals in order for them to improve certain areas of their lives. Not only from an ethical, but also from a psychological perspective, alternative approaches involving respect for individual integrity as well as individual autonomy, can be seen as more viable. In the article “Do we know enough? A scientific and ethical analysis of the basis for geneticbased personalized nutrition”, questions like these are raised and elaborated in part by confronting two opposing expert opinions with each other. •theMe 2: Commercialisation Consumers often have a positive attitude to the option of receiving personalised nutritional advice based upon genetic testing in order to better manage their health, and a variety of companies are presently marketing different kinds of personalised nutrition services over the Internet. Given the current state and amount of scientific evidence for these kinds of services, this raises important ethical (as well as legal) questions. Psychological and behavioural studies indicate that consumer acceptance of a new technology is primarily explained by the end user’s rational and emotional interpretation as well as moral beliefs. Results from such studies indicate that personalised nutrition must create true value for the consumer. Also, the freedom to choose is crucial for consumer acceptance. Studies have shown that current direct-to-consumer services for personalised nutrition often suffer from a questionable level of truthfulness and an imbalance between far-reaching promises of the effects of personalised advice and contrasting disclaimers of the companies’ 67 - food4me services. Since consumers often show an interest in these kinds of services, and also are willing to pay a certain amount of money for it, this could pose a threat to their ability to make informed and autonomous decisions in relation to the services offered, as well as a threat to different aspects of consumer protection. We have discussed the possibilities of offering consumers personalised nutritional advice over the Internet (by ways of direct-to-consumer genetic tests) in an ethically and legally safe and sound manner securing different aspects of consumer protection. Such aspects include recommendations that are useful, easily understood and valid, as well as safe handling of genetic and other health information and honest marketing methods that enable the potential consumers to make well-informed decisions as to whether or not to make use of the service offered. From an ethical point of view, consumer protection is crucial and we argue that caution must be taken when putting nutrigenomic-based tests and advice services on the market in order to prevent harm. In relation to legal regulation, personalised nutrition poses a distinctive phenomenon, located on the borderline between nutrition and medicine. Current regulation in this area is perceived as incomplete and, therefore, we argue that there is a need to carefully examine personalised nutrition services on the Internet in order to develop guidelines and rules that safeguard privacy, consumer protection, and safety. These questions are further developed and discussed in the article “Consumers on the Internet: ethical and legal aspects of commercialization of personalized nutrition”. •theme 3: Food and health In human life, food is not only perceived as nourishment and a means for health. Our choice of food is deeply influenced by cultural traditions. A meal is often an important aspect of our social life. Today, food is also to an increasing extent an expression of personal choice. What to eat, with whom and in what kind of context, denotes an important aspect of one´s identity. This means that food is a carrier of values that shape our behaviour.In the context of personalised nutrition, however, food is predominantly seen as a tool for achieving good health. We explored different connotations of the concept of food and how these might be affected by personalised nutrition. In people’s daily lives, various factors have an influence on the actual food consumption pattern. Factors such as the cultural understanding of what is good food, traditional dishes, the social context, availability and affordability influence what people eat. We argue that even if the scientific and health related approach to food is predominant in personalised nutrition, this perspective should be seen as complementary to the social and cultural aspects of food. The feasibility of personalised dietary advice is therefore likely to depend in part on its compatibility with local food traditions, seasons and social patterns. Factors such as the cultural understanding of what is good food, traditional dishes, the social context, availability and affordability influence what people eat. 68 - food4me Likewise, the concept of health has been discussed as playing an important role for the way in which personalised nutrition is perceived. The concept of health in itself can be understood in a variety of ways, most of them associated with either a holistic or a biostatistical interpretation. The biostatistical concept of health focuses on survival, while the holistic interpretation focuses on ability as a precondition for health. We suggest that in relation to personalised nutrition, a holistic and individualistic understanding of health and illness has advantages compared to a reductionist biostatistical theory. This may reinforce the benefits of the individualistic approach of personalised nutrition, while also allowing an understanding of health in subjective terms. For personalised nutrition services, this should imply that the personalisation also affects the idea of health. Different people have different preferences and varying levels of ambition with regard to their health. The holistic connotation of health relates to wellbeing and thus widens the term beyond biomarkers. Consequently, different people in varying life-stages and situations will be motivated by different concepts of what health means for them when receiving and applying life-style and dietary advice. From an ethical perspective, personalised nutrition therefore seems promising, when contributing to the promotion of personal preferences with regard to health. This could imply that certain groups in society are less likely to use and benefit from personalised nutrition, which could be remedied by preventive medical programs focusing on equity and the society as a whole. In “Food and health: individual, cultural, or scientific matters?” these issues are raised and elaborated further. •theMe 4: values at stake In light of the individualising objective of personalised nutrition, it is of relevance to consider which ethical values might be at stake. One such core value identified is autonomy. We have discussed autonomy in relation to other values of relevance for personalised nutrition, such as responsibility and trustworthiness. As a consequence of the individualising focus, personalised nutrition has the potential to empower the individual who makes use of such services, but may also work the other way around, by attributing exaggerated individual responsibility for health. This can be said to constitute the Dilemma of inDiviDualiSation. When personalised nutritional advice based on personal health data and personal health risks is available to the consumer, this information could be considered valuable, since there is reason to expect it to be more precise and accurate than traditional population based advice. Thus, better information could facilitate more informed decision making processes and, in this way, enhance individual autonomy. However, when knowledge on personal health risks, as well as information and advice about how to manage these personal risks, is available, individual responsibility and liability might increase as a consequence. If one knows how to improve one’s health, but chooses not to follow the advice given – how will this affect that person? In societies where increasing health care costs are an object of policy makers’ concerns, there is a risk of individuals being confronted with increased expectations to be compliant with advice regarding healthy nutrition and life style. Thus, technologies such as personalised nutrition services could be said to both contribute to enhanced as well as weakened autonomy. That is, personalised nutrition has the potential to strengthen as well as weaken individual autonomy. Individualisation also affects the concept of responsibility. Not all people are equal with respect to their abilities or preferences concerning responsibility for health and this poses yet other ethical issues worthy of recognition. From an ethical perspective there might be good reasons to motivate different health policies for promoting individual responsibility in a proactive way. However, according to our understanding, this should be separated clearly from retroactive accountability for bad health. 69 - food4me A discussion of different values at stake in relation to the implementation of personalised nutrition can be found in the article “Values at stake: autonomy, responsibility, and trustworthiness in relation to genetic testing and personalized nutrition advice”. In addition to the results presented above, there is ongoing work on several ethical questions raised during the work in the Food4Me project. One of these is an ethical analysis of possible future scenarios identified in Food4Me for distribution of personalised nutrition services. How will personalised nutrition services within these different scenarios affect social relations, values, and justice? Such possible effects will be discussed from a perspective of social ethics. Another study (publication in progress) addresses issues of solidarity, integrity, and justice in relation to personalised nutrition and the function of health insurances within the scope of compulsory health insurance. We analyse how increasing applications of personalisation in diagnosis and treatment, and consequently of health risk analysis and management, might challenge current systems of solidarity within compulsory health insurance. Will increasing knowledge of individual risks change our view on how health care costs should be shared in the future? Will emerging possibilities to manage individual risks by a corresponding, adjusted lifestyle, influence our view on how we ascribe responsibility for health? Other questions currently examined relate to consumer protection issues. IMPLICAtIons oF the resuLts ethICAL ConsIderAtIons - BALAnCe transparency of information Free market competition Individual responsibility data protection society framework regulation for mandatory insurance Cost-eFFeCtIveness FAIrness InCentIves As mentioned above, the objective within work package 5 has not been to produce a set of definitive guidelines either for future research within the area of personalised nutrition or the societal implementation of the concept. However, we have pointed out a number of areas in which important ethical issues arise. As personalised nutrition services are already on the market, it is crucial that these issues are recognised and dealt with in a proper manner in order for the services to be both effective and safe for the individual consumer to use. hoW CouLd these eFForts Feed Into horIzon 2020 reseArCh CALLs? The research conducted within work package 5 of Food4Me is well suited to be used and, in some cases, to be further developed within a range of Horizon 2020 research calls, mainly the 70 - food4me ones related to part 16 of the work programme, “Science with and for Society”, and also through the Responsible Research and Innovation package. Many of the topics brought up, discussed and processed within Food4Me´s work package 5 relate to societal, legal and ethical challenges concerning consumers and society and address issues of empowerment, trustworthiness, online health services, individual vs societal health responsibility, insurance issues, consumer protection etc. These are also issues related to a range of the topics of Horizon 2020 research calls, for example: Self-management of health and disease and patient empowerment (PHC-27-2015), Public procurement of innovative eHealth services (PHC-29-2015), Self-management of health and disease and decision support systems based on predictive computer modelling used by the patient him or herself (PCH-28-2015) and Advancing active and healthy ageing with ICT: Early risk detection and intervention (PHC-21-2015). The knowledge developed within Food4Me regarding issues like this is can provide a good basis for further research within Horizon 2020 ACknoWLedgeMents The ethical aspects of Work Package 5 were carried out by: Jönköping university Ulf Görman, Karin Nordström Lund university Jennie Ahlgren reFerenCes Ahlgren, Jennie; Nordgren, Anders; Perrudin, Maud; Ronteltap, Amber; Savigny, Jean; van Trijp, Hans; Nordström, Karin; Görman, Ulf (2013). ”Consumers on the Internet: ethical and legal aspects of commercialization of personalized nutrition”; Genes & Nutrition, 8:4, 349-355, Springer Verlag Görman, Ulf; Mathers, John C.; Grimaldi, Keith A.; Ahlgren, Jennie; Nordström, Karin (2013) “Do we know enough? A scientific and ethical analysis of the basis for genetic-based personalized nutrition”; Genes & Nutrition, 8:4, 373-381, Springer Verlag Nordström, Karin; Coff, Christian; Jönsson, Håkan; Nordenfelt, Lennart; Görman, Ulf (2013). ”Food and health: individual, cultural, or scientific matters?”;Genes & Nutrition, 8:4, 357-363, Springer Verlag Nordström, Karin; Juth, Niklas; Kjellström, Sofia; Meijboom, Franck L. B.; Görman, Ulf (2013). ”Values at stake: autonomy, responsibility, and trustworthiness in relation to genetic testing and personalized nutrition advice”; Genes & Nutrition, 8:4, 365-372, Springer Verlag 71 - food4me LegAL BArrIers And requIreMents Work Package 5: Legal IntroduCtIon The purpose of the research was to identify and analyse the legal and regulatory framework of relevance for ‘personalised nutrition’ (PN) offerings in the European Union (EU). The concept of personalised nutrition typically refers to the activity of adjusting personal dietary counselling and advice to information from genetic tests, combined with knowledge received from current and future development in nutritional genomics. For conducting the research, it was assumed that a service provider, that may be based within or without the EU, offers ‘PN advice’ to ‘customers’ in different EU countries. The potential customers find the information about the service offered on the internet, at the consulting room of their general practitioners, at the gym, on TV, etc. The service provider may involve different categories of professionals, from doctors of medicine to sports trainers, etc. The offering aims at delivering recommendations concerning diet, but possibly also regarding physical activity and lifestyle in general. The advice is based on the information provided by the customers with regard to their lifestyle, dietary habits and food intake. The offering also gives the possibility to provide an even more ‘customer tailored advice’ which would be based on body dimensions, analysis of blood samples and the analysis of the DNA of the customer (using nutrigenomics). It is up to the customer to choose what would be the basis for the advice they will receive. The PN advice may be delivered to healthy people wanting to change their diet or lifestyle; but it foresees providing an age or disorder related advice as well. The service is typically provided via the Internet, i.e. through a website using a computer or through an application using a mobile device, where the customer establishes an account secured with a password. The customer may also be contacted by the offering through email, telephone and possibly in person. Before the contract with the customer is signed, the customer is briefed on the details of the service. This includes information on the option of providing the advice on the basis of diet and lifestyle (level 1), phenotypic (level 2) and genetic data (level 3), as well as details regarding the way the data concerning him or her will be handled. The customer chooses the option of the PN advice most suitable for them, and gives consent to the handling of their personal data. The customer will deliver such information by filling in an online questionnaire. Also, if the customers wish to be consulted on the basis of the phenotypic and genetic information, they will be requested to collect the blood and buccal samples at home. To do so, the customer will use medical devices which will be sent to them by the service via post. Following the instructions of use sent to the customer together with the devices and the information on the website of the service, the customer will provide the service with the data. On the basis of the information provided by the consumer, the PN advice will be generated and delivered to the customer via their account and/or through email. If the option with inclusion of the genetic information has been chosen, the customer will be informed on the dispositions towards certain disorders, if any. The advice may include a food shopping list, diet plan for a certain period of time, inclusion of specific food products in the diet, consumption of food 72 - food4me products designed specifically for the needs of the particular consumer, recipes, physical activity recommendation, etc. The customer will be contacted on a regular basis in order to get feedback on his/her progress in improving their diet and lifestyle in accordance with the PN advice. Also, the customer will be asked to repeat the measurements in order to assess the changes in the body dimensions and in the levels of certain nutrients in the blood. reseArCh MethodoLogy The determination of the relevant legal and regulatory frameworks applicable to PN and the resulting barriers and requirements has been made by assessing typical business models of PN against the requirements currently set up by legal instruments that have been or will soon be adopted at EU or at Member State level, and in light of international instruments where they exist. To this effect: •While compiling the legal framework relevant for PN, both ‘hard law’ and ‘soft law’ were considered, at international, EU and national level. •With regard to international law, the research addressed the relevant instruments where EU law was not addressing the domains of interest, and identifying areas where international law is susceptible to fill the gap. •The research analysed national law in place in the EU Member States in situations where EU law does not provide satisfactory harmonisation and/or where the legislative competence is in the remit of the Member States. •In several domains of relevance for PN, the EU legislation is currently being revised and it was therefore not possible to analyse in sufficient depth the impact of these changes given that the proposed provisions are still under intensive discussions. key resuLts 1. neither the eu nor its member States have legal instruments specifically dealing with Pn. instead, due to its nature and characteristics, Pn falls within the ambit of several legal instruments, and the determination of which legal instruments are susceptible to apply to any specific Pn offering necessitates reviewing the different components of the offered service. Unlike human genetics in general, the legal issues surrounding the use of gene testing in the context of nutritional advice have been largely unexplored so far, both at international level and in the EU. By contrast with population-based nutritional advice, PN triggers additional legal issues related to the rights of individuals. Notably, conducting genetic testing and collecting sensitive data requires consent of the person concerned; tests have to be safe, i.e. they have to be provided in accordance with the quality standards; data has to be protected according to the policy established for this purpose, access to it should be restricted; etc. At international level, EU countries can only be bound by international instruments if they have signed/ratified them themselves or if the EU has the competence to sign/ratify them as By contrast with population-based nutritional advice, Pn triggers additional legal issues related to the rights of individuals 73 - food4me an international entity. As a result, very few instruments addressing certain components of PN offerings can be considered as ‘hard law’ creating enforceable obligations and rights for the EU countries. Rather, there are several pieces of ‘soft law’ not directly enforceable but bearing relevance for the matter. While healthcare is the responsibility of the Member States, the interactions it involves with people (e.g. professionals and patients), goods (e.g. foods, pharmaceuticals and devices) and services (e.g. provided by health care funders and providers) are nevertheless subject to EU law and policy so as to guarantee freedom of movement across borders. By nature, a PN offering involves the provision of services to the consumers. Accordingly, for services provided to consumers that are based in the EU, the offerings will have to comply with the legal requirements that are applicable in the EU to service providers. For providers that are not established in the EU, it must be determined whether the law of the country of the EU consumer (“country of destination”) or that of the vendor outside the EU (“country of origin”) should apply. 2. as a service contract, a Pn offering will be subject to the provisions of Directive 2006/123/ec on services in the internal market unless it is regarded as a healthcare service, in which case, notably, the provisions of Directive 2011/24/eu on the application of patients’ rights in crossborder healthcare will apply. The classification of the PN offering as healthcare or not is dependent on the status of the various professionals involved in the Member State where they are established. Such classification has a significant impact on the legal provisions applicable to the related PN contract of service. Indeed, while in the case of healthcare services, EU provisions are limited to patient’s’ rights in cross-border situations, non-healthcare services are subject to pretty detailed harmonised rules guaranteeing the protection of consumers in all circumstances. In this sense, the legislation applicable to PN as a service has turned out to be very fragmented and to result in legal uncertainty with regard to (1) the protection of the consumer and (2) the resulting obligations of PN providers depending on the status of the professionals involved in the PN offering. While PN offerings have to comply with the EU legal requirements that are applicable to service providers, which specific legal instruments will apply will depend on whether the offering is, or is not, regarded as a heath care service. Indeed, although Directive 2006/123/ec on services in the internal market contains provisions enabling the exercise of the freedom of establishment of service providers and the free movement of services throughout the EU and should therefore apply to PN offerings, that Directive excludes from its scope: (f) healthcare services whether or not they are provided via healthcare facilities, and regardless of the ways in which they are organised and financed at national level or whether they are public or private. At the same time, Directive 2011/24/eu on the application of patients’ rights in cross-border healthcare set specific rules for facilitating the access to cross-border healthcare and to promote cooperation between Member States in the health care area. 2.1 Conditions for a Pn offering to be regarded as a healthcare service Per Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare, any PN offering that (1) involves health care professionals (defined as: a doctor of medicine, a nurse responsible for general care, a dental practitioner, a midwife or a pharmacist within the meaning of Directive 2005/36/EC, or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC, or a person considered to be a health professional according to the legislation of the Member State of treatment) and (2) is intended to assess, maintain or restore patients’ 80 - food4me In essence, the form of a Regulation has been chosen as a legal instrument. Its direct applicability in all EU Member States is intended to reduce legal fragmentation and to provide greater legal certainty by introducing a harmonised set of core rules. This should generally lower the cost associated with the processing of sensitive data in the context of PN services offered to EU customers. 3.2.1 territorial scope As per the initial Proposal by the Commission, the territorial scope of the legislation would be clarified, so that it applies to the processing of personal data of subjects residing in the EU: whether the data controller is established or not in the EU would no longer matter. The European Parliament introduced amendments to the effect that the Regulation would apply to controllers or processors whethertheprocessingtakesplace in the EU or not. Also, the Parliament dropped the requirement of the data subject residence in the EU: the Parliament suggested that the Regulation should apply to processing of personal data of data subjects in the EU by a controller or processor not established in the EU, where the processing activities are related to the offering of goods or services to such data subjects in the EU, irrespective of whether a payment by the data subject is required, or the monitoring of such data subjects. The Commission agreed with those amendments, underlying however that in the second case, i.e. when the processor or controller are not established in the EU, the Regulation applies regardless of whether the processing takes place within the EU or not. In addition, in a partial general approach on specific aspects announced by the Council on 10 October 2014, the Council confirmed the requirement of the designation of a representative of a controller not established in the EU, if this controller is processing personal data of data subjects residing in the EU. The controller should designate a representative, unless the processing it carries out is occasional and unlikely to result in a risk for the rights and freedoms of data subjects, taking into account the nature, scope, context and purposes of the processing or the controller is a public authority or body. 3.2.2 definition of ‘personal data’ The Regulation amends the definition of ‘personal data’ to include an explicit reference to ‘genetic identity’ of an identifiable person. A single and consistent definition of ‘data subject’s consent’ is introduced referring to the criterion ‘explicit’ in order to avoid confusing parallelism with ‘unambiguous’ consent (Article 7 of the Data Protection Directive). Also, it introduces new key definitions for the protection of sensitive data: ‘genetic data’, ‘biometric data’ and ‘data concerning health’. (Art. 4) 3.2.3 Consent The conditions for consent to be valid as a legal ground for lawful processing of the data are further clarified (Art.7), placing explicitly the burden of proof on the controller, introducing the right to withdraw such consent at any time and losing its validity when the purpose ceases to exist or as soon as the processing of personal data is no longer necessary for carrying out the purpose for which they were originally collected. 81 - food4me 3.2.4 Prohibition of processing ‘sensitive data’ and its exceptions Article 9 sets out a general prohibition for processing sensitive categories of personal data, including explicitly genetic data and the exceptions from this general rule. As in Article 8 of the current Data Protection Directive, the prohibition can be lifted where the data subject has given consent to the processing of those personal data, except where Union law or Member State law provide that this prohibition may not be lifted by the data subject. Differences between the Member States may therefore subsist under the Regulation. The explicit inclusion of genetic data as a special category of personal data requiring specific safeguards (“sensitive data”) would bring about an important positive impact for PN consumers as it should address the particular concern that genetic data is properly and securely dealt with in all Member States. Additional exceptions from this prohibition would be introduced in relation to: •The processing of data concerning health (Art. 81), including where such processing is necessary for reasons of public health, such as ensuring high standards of quality and safety, inter alia for medicinal products or medical devices. •The processing for scientific research purposes (Art. 83) on the condition that: the purpose of the research cannot be otherwise fulfilled by processing data which does not permit, or no longer permits, the identification of the data subject; data enabling the attribution of information to an identified or identifiable data subject is kept separately from the other information under the highest technical standards, and all necessary measures are taken to prevent unwarranted re-identification of the data subjects. 3.2.5 other requirements The Proposal also contains provisions on information requirements, the data subject’s right of access to their personal data, the data subject’s right to erasure, a limit to profiling, the obligation for controllers and processors to maintain documentation of the processing operations under their responsibility. It also introduces the obligation of controllers and processors to carry out a data protection impact assessment prior to risky processing operations (Art. 33). Those operations are subject to mandatory consultation by the supervisory authority prior to the processing (Art. 34). 3.2.6 harmonised enforcement The draft Regulation also sets harmonised rules for enforcement so that, as opposed to the current situation where businesses are supervised by a different authority in each Member State where they are established, there would be only one responsible data protection authority – the national authority of the Member State in which the company has its main establishment. 3.2.7 Legislative process To become law, the proposal must be approved by the Council and the Parliament. The first reading of the Regulation in the plenary of the European Parliament took place on 12 March 2014. We are awaiting now the reading of the Regulation in the Council. Obviously, the Regulation is of great interest for many different stakeholders. Therefore, it is expected that the final Regulation will undergo several amendments compared to the initial Commission’s proposal. 82 - food4me At this stage, the practical impact of an increased level of protection of data subject’s rights, notably with regard to sensitive data may result in new obstacles for the development of PN offerings depending on the final wording of the provisions. However, it can already be anticipated that the harmonised approach would bring about positive impacts for PN companies who process genetic data, as they could enjoy legal certainty for this processing in all Member States and would only have to deal with a single national data protection authority in the EU country where they have their main base. Also, the objective to improve personal data protection for individuals appears achieved in this proposal, hence increasing trust by the PN consumers/users. The level of trust, however, will depend of the consumers’ awareness of their rights given by the new legislation. Finally, from the PN offering stand point the proposed legislation is expected to facilitate the processing of data by the providers across the EU. 4. devICes used In the deLIvery oF Pn servICes MAy Be suBJeCt to the LegAL requIreMents APPLICABLe to MedICAL devICes or In vItro dIAgnostIC (Ivd) MedICAL devICes PN offerings may involve the use of various devices, alone or in combination, notably products for the collection of specimens (mainly blood and buccal cells) to be performed by the consumer himself (self-testing), software to process the data or to assist in determining the appropriate recommendations for diet and lifestyle and selfmonitoring solutions (e.g. Activity Monitor). As a matter of principle, devices used in PN offerings must have a medical purpose to be qualified as medical device; only the intended purpose as described by the manufacturer of the device is relevant for its qualification and classification, irrespective of how it may be called. It could be argued that PN offerings have generally not a medical purpose as described in the definition of medical device notably diagnosis, prevention, monitoring, treatment or alleviation of disease as commonly interpreted. The devices used in the PN context are intended to provide ‘lifestyle’ services and might be considered as not covered by the rules applicable to medical devices although they can indeed improve health and contribute to the prevention of diseases. Importantly, the medical purpose remains unclear and it currently leads to different interpretation on the qualification of the devices used in the context of PN offerings (‘lifestyle services’) within the EU. For instance, the Human Genetics Commission noted in its 2003 report the definitive interpretation from the UK Medical Devices Agency that lifestyle tests are within scope because it sought to measure a physiological state, namely the presence of SNPs in particular metabolic genes and hence the activity of certain metabolic pathways. While there should ideally be a very broad interpretation of the medical purpose in the definition of medical device as they apply to lifestyle testing kits or services, the situation remains unclear under the current definition of medical device. Similarly, while in case of doubt the industry should be encouraged to agree to voluntarily comply with the medical devices legislation and submit to the CE mark process (themanufacturer’sdeclarationthattheproductmeetstherequirements of the applicable EC directives), there is no guarantee yet that all operators in the sector will do so, creating therefore a situation of legal uncertainty in the EU. 83 - food4me Even though a given device that does not fall under the definition of medical device, or is excluded by the scope of the Directives, may be subject to other Community and/or national legislation, this alternative framework does arguably not provide the same level of safety, quality and accuracy of the tests as set by the medical devices legislation. Further, when a device is considered to have a medical purpose, it is not automatically covered by the medical device definition. And, to be qualified as an IVD medical device, devices must first fulfil the definition of a medical device. Given the speed of technological developments and the development of mobile solutions in a health context, preventive and self-monitoring solutions via mobile devices (‘mHealth’), such as mobile phones, personal digital assistants (PDAs), and other wireless devices, are also growing rapidly, such as health and fitness applications. The current legal framework is not clear with regard to its application to these new devices. There is therefore a need to develop guidance in this area to clarify who is responsible under the medical device legislation: the App distributors as a sales channel? The manufacturer of the phone that a medical App runs on although the phone is not intended for use as a medical device?The medical App writer? As stated in the Commission eHealth Action Plan, the health and well-being applications require a legal regulation in order to ensure their quality and transparency. As a step forward the Commission adopted in April 2014 a Green Paper on such applications. 4.1 the directive 93/42 eeC 11 on medical devices provides rules for placing on the market and putting medical devices into service in the eu 4.1.1 definitions The Directive defines ‘medical device’ as: any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: •diagnosis, prevention, monitoring, treatment or alleviation of disease, •diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, •investigation, replacement or modification of the anatomy or of a physiological process, •control of conception, •and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. 4.1.2 requirements The Directive lays down the general requirements medical devices have to comply with, i.e. the safety of the device, its design and construction, as well as its suitability for its purpose. The Directive groups medical devices in Classes: I, IIa, IIb and III. The higher the classification, the greater the level of assessment required by the national notified body (which ensures that conformity assessment procedures are completed according to the relevant criteria). 11 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, (OJ L 169, 12.7.1993, p. 1) 84 - food4me It is the intended purpose of the device that determines the classification and not the particular technical characteristics. Considerations for classification include the duration of contact with the body, degree of invasiveness and local versus systemic effect12. Irrespective of the class of the device, all devices must: •Meet the essential (technical and labelling) requirements, including the requirements regarding the information to be supplied by the manufacturer; •Evaluate clinical efficacy and any side effects, if applicable, by means of a pre-clinical and clinical evaluation; •Be subject to the reporting requirements under the medical device vigilance system; •Be CE marked (except accepted exemptions); •Be registered with the competent national authority where the manufacturer (or the authorised representative) has a registered place of business. 4.2 directive 98/79/eC provides rules for the marketing of in vitro diagnostic (Ivd) medical devices 4.2.1 definitions The Directive defines IVD medical devices as: any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: • concerning a physiological or pathological state, or • concerning a congenital abnormality, or • to determine the safety and compatibility with potential recipients, or • to monitor therapeutic measures. Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination; Also, the Directive provides for a definition of devices for self-testing: Any device intended by the manufacturer to be able to be used by lay persons in a home environment. 4.2.2 requirements The Directive lists essential requirements applicable to in vitro medical devices, which in a large extent are comparable to the essential safety requirements applicable to all medical devices (including CE marking). 12 Commission Guidance document: classification of medical devices. Version: June 2010. 85 - food4me In addition, the Directive provides for rules directed to devices for self-testing. Users of IVD for self-testing (‘self-tests’) will not have the benefit of a healthcare professional at hand to advise them how to perform the test or to analyse and interpret the results. It is therefore vital that selftests are suitable for lay use. This will include aspects affecting its suitability for non-professional users in such a way as to: •ensure that the device is easy to use by the intended lay user at all stages of the procedure, and •reduce as far as practicable the risk of user error in the handling of the device and in the interpretation of the results. Devices for self-testing must, where reasonably possible, include user control, i.e. a procedure by which the user can verify that, at the time of use, the product will perform as intended. Also, the devices for self-testing have to bear specific particulars into the official language(s) of the Member State in which the device for self-testing reaches its final user. 4.3 tAkIng Into ACCount the vArIous guIdAnCe doCuMents PuBLIshed By the CoMMIssIon, the FoLLoWIng CLAssIFICAtIon WouLd APPLy to soMe oF the devICes thAt MAy Be used In Pn oFFerIngs IF ConsIdered to hAve A MedICAL PurPose medical device? in vitro diagnostic (ivD) medical Device? Specimen receptacles: blood collection tubes or filter paper, DNA collection tubes for buccal swab (including kits with swab) yes yes (mainly self-tests subject to additional specific requirements) Products used to obtain specimen: needles, mouthtubes, swabs etc yes no Software combining medical/ nutritional knowledge and algorithms with consumer specific data intended to provide the professionals and/ or user with recommendations for diet and lifestyle (Decision Support System) yes no Software intended only to store, archive and transfer consumer data related to his health (information System) no no Software intended to transfer electronic information (Communication System) no no 86 - food4me medical device? in vitro diagnostic (ivD) medical Device? Software intended for the analysis and interpretation of blood/buccal specimen (interpretation of raw Data) yes Yes if it is specifically intended to be used together with an IVD to enable it to be used in accordance with its intended purpose No (accessory to the IVD) if only necessary to render raw data obtained from an IVD Software intended for archiving consumer results or for transferring results from the environment to the PN advice provide (home care monitoring) no no 4.4 Proposed new regulations on medical devices and Ivd medical devices Medical devices Per the proposed new framework for medical devices that has been reviewed in the research, the situation of devices used for the purpose of providing ‘lifestyle services’ would change. Tests providing information about the predisposition to a medical condition or a disease (genetic tests as well as other tests measuring the physiological state such as e.g. glucose or cholesterol level in blood in the context of ‘lifestyle services’) should fall within the scope as soon as they provide information about the predisposition to a medical condition or a disease and therefore participate in the prevention of disease. Regarding the potential impact of these new requirements on PN, the use of genetic testing may be restricted to PN offerings involving health professionals entitled under the applicable national legislation to prescribe such test after a personal consultation and may be prohibited from advertising to consumers. Such provisions would obviously have a significant impact on the development of PN, notably in its level 3 (genetic tests), and would lead to the automatic classification of a large number of business models as healthcare. The proposed Regulation is still under discussion by the EU legislators and significant amendments to the proposal were suggested by the European Parliament at first reading. The vote in plenary took place on 2 April 2014 and adopted the text that had been referred back to the committee at the 22 October 2013 plenary session. It is already anticipated that a second reading will be necessary to reach an agreement between the Parliament and the Council. The Council has confirmed that the work on its position will continue in 2015. 87 - food4me Ivd medical devices Among others, the proposed Regulation amends the definition of IVD medical devices, to cover medical devices used for DNA-testing. Also, it defines devices for genetic testing as: in vitro diagnostic medical device, the purpose of which is to identify a genetic characteristic of a person which is inherited or acquired during prenatal development. The proposed Regulation provides specification regarding devices for self-testing, including testing services offered by means of information society services. Another important aspect is the introduction of the concept of novel devices which are devices incorporating technology (the analyte, technology or test platform) not previously used in diagnostics, or existing devices which are being usedfor a new intended purpose for the first time. The proposed Regulation contains specific definition and requirements for ‘devices for near patient testing’: these include devices intended to perform testing outside a laboratory environment by a healthcare professional not necessarily a laboratory professional, generally near to, or at the side of, the patient, and will be regulated in a similar way to self-test devices. Finally the Regulation states that each manufacturer and authorised representative will require a person responsible for regulatory compliance. The proposed Regulation is still under discussion by the EU legislators. Significant amendments have been discussed by the European Parliament already at first reading. The vote in plenary took place on 2 April 2014.The Council confirmed that the work on its position will continue in 2015. 4.5 Impact of these proposed new texts on the devices used in Pn offerings First and foremost, the harmonisation of the rules through Regulations has the potential to solve most of the implementation differences between the Member States and should notably harmonise their respective approach with regard to genetic testing. The proposed definition of medical device as amended by the European Parliament at first reading does change the situation with regard to devices used for the purpose of providing ‘lifestyle services’ by including the term ‘prediction’ among the purposes of medical devices and the idea of the indirect medical purpose. Also, the amendment of the IVD medical device definition clearly covers tests providing information about the predisposition to a medical condition or a disease. Arguably, genetic tests as well as other tests measuring the physiological state (such as e.g. glucose or cholesterol level in blood in the context of ‘lifestyle services’) would now fall within the definition of medical device as soon as they provide information about the predisposition to a medical condition or a disease and therefore participate in the prevention of disease. Also, they are covered by the IVD Regulation. The proposal brings direct-to-consumer (Dtc) internet-based testing services (whether for genetic tests or other types of tests) within the scope of the new regulation. Although the proposal does not make clear that DTC internet-based testing services are ‘devices for selftesting’, they are arguably subject to the conformity assessment requirements for that class of device, including the need to carry out studies of the test in use by its intended users, and the need to provide user information in the language(s) of member states of intended users. These requirements will directly apply to DTC PN offerings involving genetic tests or blood tests. The classification of certain ivD as ‘prescription only’ is not addressed in the proposal. This leaves unaffected national laws which require that certain devices may only be supplied on a medical prescription. However, the European Parliament introduced an amendment to the text, requiring that Class D and C devices for genetic testing would require medical prescription. The Commission agreed with this amendment. Also, some restrictions are enshrined in international guidelines that have the support of many Member States such as e.g. OECD guidelines on quality assurance in Molecular Genetic Testing and Council of Europe’s additional protocol 88 - food4me on genetic testing. In that regard, the proposed amendment 268 by the European Parliament states that certain devices may only be supplied on a medical prescription, particularly Class D devices (high risk) and Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics. If such provision is adopted as is, this would restrict the use of genetic testing in PN offerings to offerings involving health professionals entitled under the applicable national legislation to prescribe such test after a personal consultation. Also, the new rules would subject the use of a genetic test to genetic counselling and informed consent. Last, as proposed by the Parliament, the Dtc advertising of devices classed as prescription only (notably devices for genetic testing) will be illegal. The Commission did not agree on this amendment. We still need to wait for the final result of the discussion between the EU legislative bodies. In any case, such a ban would be an additional burden to PN offerings. Indeed, any PN offerings involving the use of genetic testing could no longer be advertised to consumers directly, hence significantly limiting its marketing development. 5. other AsPeCts 5.1 Conflicts of law and jurisdiction issues The relevant implications of the existing law regulating the conflicts of law and jurisdictions both at EU or international level, have been addressed in the research. When the PN offerings are provided by actors established within the EU territory, the existing EU frameworks appear sufficient to address the potential conflicts. However, when the PN providers are located outside the EU, determination of the competent jurisdiction and the applicable law is subject to the rules on private international law and have been revealed to be very complex. The current international framework is arguably insufficient to adequately protect the consumer. 5.2 Food law Regarding the impact of food law on PN, irrespective of the model and concept chosen for the development, production and distribution logistics of foods delivered in the context of a PN offering, and ranging from self-choice in shops, over foods for target groups (from healthy consumers to patients) right up to customised production and delivery systems, the food products susceptible to be recommended or delivered will be covered extensively by the provisions that apply ‘horizontally’ to all foods and food ingredients. Also they will be subject to the specific provisions applicable to the category to which such food or food ingredient belongs, if any, recognising that the degree of personalisation of the food will itself impact the regulatory classification of that food. This food law framework, although not addressing ‘personalised food’ as such, appears sufficient to protect the consumers in the various aspects of the food (notably composition and labelling). Regarding the potential impact of the medicinal product legislation, it has been noted that the personalisation of food products may result in situations where the food product could be classified as medicinal product (either by function or by presentation). The classification Classification Composition Labeling Source – Keller and Heckman 89 - food4me of personalised foods as medicinal products would result in disproportionate pre-marketing requirements given the various levels of counselling, coaching and support of the consumer (depending on the level of PN) that should typically be part of a PN offering. IMPLICAtIons oF the resuLts The determination of the status of the PN offering as ‘healthcare or not’ will have a significant impact on the legal provisions applicable to the related contract of service. If regulated as a conventional business to consumer service contract, the consumer rights appear well protected in a harmonised way by the various EU legal instruments in place. If, however, the PN offering is regulated as a healthcare service, the patient rights will vary from one Member State to another, subject to harmonised rules when the PN offerings is provided in a cross-border situation. Therefore, the determination of the status of each individual PN offering, taking into account the status of the various professionals involved in the Member State where they are established, will be a critical step in the development of PN offerings. The impact of the personal data regulatory frameworks on the field of PN, is that there are wide divergences between Member States, so that in reality the protection of personal data across the EU cannot be considered as equivalent today. It results in important obstacles to the processing of health data; the explicit consent of the consumer may not be sufficient in some Member States. Also, the current framework does not address the particular risks raised by the processing of very sensitive data, such as genetic data, that is an important aspect of PN. It is anticipated that the contemplated new framework should improve personal data protection for individuals, hence increasing trust in the PN consumers/users and facilitating the processing of data by the providers across the EU. On the other hand, while positive impacts for PN companies who process genetic data are anticipated as they could enjoy more legal certainty for processing sensitive data (including genetic data) in all Member States, the practical impact of an increased level of protection of data subject’s rights, notably with regard to genetic data may also result in new obstacles for the development of PN, depending on the final wording of the provisions. So shaped, the regulatory frameworks that apply to PN raise both conceptual and practical issues resulting from the dichotomy in the EU legal framework between medical versus nonmedical purposes. As a new type of business offerings connected to the concept of ‘lifestyle’ or ‘wellbeing’, PN cannot by definition fit into this framework. The applicable framework has therefore turned out to be fragmented, creating an important source of legal uncertainty requiring a high degree of specification in the definition of the PN offering to determine which parts of the legislation applies. Some effort should therefore be made at EU level to reflect this new category of health related offerings, which are not clearly pursuing medical nor purely nutrition purposes, but rather ‘in-between’. The role of the EU should be pivotal both to guarantee the protection of the consumers and the promotion of innovation in the field of PN by (1) defining such ‘lifestyle’/’well-being’ purposes and (2) coordinating the adjustment of the various legal frameworks to reflect this new concept. deveLoPIng the stAte oF the Art Similar to the situation from the beginning of the research, i.e. year 2011, the PN offering remains the determination of the status of the personalised nutrition offering as ‘healthcare or not’ will have a significant impact on the legal provisions 96 - food4me Personalised nutrition also offers a means to cost effective health care and health insurance. However today’s health insurance approach that is based on a principle of solidarity, i.e. sharing protection against unforeseeable risk, will be difficult to maintain when risk assessment becomes individualised. This raises questions about how to organise solidarity and on the other hand how to preserve social justice and fairness in a common health insurance system. Important choices will need to be made about how to balance individual interests with the common good. Possibly a new stratification of health risks, between controllable (diet-related) and non-controllable risks, needs to be defined as a new basis for the solidarity principle. For health risks and health maintenance that can be assessed individually, the notion of shared risks and benefits will be no longer applicable. Finally, the high degree of personalisation of the service raises the question of trustworthiness of the providers, both with regard to competence and the technical ability to deliver appropriate advice and coaching as well as motivation (moral integrity). Ethical standards will be important for providers to establish themselves in the market. All these issues need to be thoroughly reflected upon by all the stakeholders in order to set clear ethical and moral standards for all personalised nutrition services. •the consumer challenge The biggest challenge is obviously to convince consumers/citizens to start using a personalised nutrition service. Food4me has shown that consumers are interested to adopt a service that will help them make healthier dietary choices and that they do perceive the benefit for their health, but there are a lot of concerns that may prevent them from doing so. The most prominent concern is about the safety and privacy of personal data, especially when these are to be exchanged over a digital interface. The same is true for sending diagnostic samples over the mail. Another important concern is the trust in the provider, be it a private or public service. Consumers see health professionals as the most appropriate interface to get personalised nutrition advice as opposed to offerings from a commercial service. Companies will therefore need to find ways to include health professionals in their business models. While feedback is important to all consumers, it is vital to strike the right balance between empowerment and freedom of use. A too intensive feedback may be counterproductive. It is striking that most of the concerns are related to the way the service is organised rather than to the principle and perceived benefit of personalised nutrition. The format in which a personalised nutrition service is provided will have to deal with those concerns. Obviously, there will be vast differences between consumers and hence there is a need for a wide range of offerings to accommodate the very different wishes and personal preferences of consumers. reCoMMendAtIons For Further stePs First and foremost the scientific evidence needs to be further developed further to assure that the relationship between nutrition and genes (SNPs), biomarkers, metabolism and health is substantiated further. While the principle has been proven, there is a large set of genes for which the evidence is completely lacking. 97 - food4me There is an important role for the H2020 program to assure that these research lines are prominently taken up in future calls. Also the algorithms to derive nutritional recommendations on the basis of genes and biomarkers need to be elaborated further. This will finally lead to the characterisation of a number of frequently found metabolic profiles for which the nutritional advice will be more or less identical. Converting nutritional advice into dietary behaviour patterns, meal plans and food choices also requires further work to assure that these plans are perfectly suitable and amenable to a variety of situations in daily life. Without such useful plans, the adoption of personalised nutrition will remain difficult and uncertain in impact. It is important for all stakeholders in the area of personalised nutrition to start considering the creation of ethical standards and a code of conduct in order to reduce potential criticism in the early phases of introduction in society. Uncertainty about the purpose and the moral integrity of the actors involved will otherwise quickly generate adverse reactions that may be difficult to counter once they have been in the public domain. Policy makers need to reflect on the recommendations from the Food4me project and take them into consideration in the development of novel regulations for e-health and m-health. ACknoWLedgeMent This summarising chapter was written by Jo Goossens of Bio-Sense, Belgium.