Foodstuffs and medicines as legal categories in the EU and China. Functional foods as a borderline case

The thesis discusses the regulation of foodstuffs and medicines, and particularly the regulation of functional foods. Legal systems investigated are the EU and China. Both are members of the WTO and Codex Alimentarius, which binds European and Chinese rules together. The study uses three Chinese berries as case examples of how product development faces regulation in practice. The berries have traditional uses as herbal medicines. Europe and China have similar nutrition problems to be resolved, such as obesity, cardiovascular disease, and diabetes. The three berries might be suitable raw materials for functional foods. Consumer products with health-enhancing functions, such as lowering blood pressure, might legally be classifi ed either as foodstuffs or medicines. The classifi cation will depend on functions and presentation of the product. In our opinion, food and medicine regulation should come closer together so the classifi cation issue would no longer be an issue. Safety of both foodstuffs and medicines is strictly regulated. With medicines, safety is a more relative concept, where benefi ts of the product are compared to side-effects in thorough scientifi c tests and trials. Foods, on the other hand, are not allowed to have side-effects. Hygiene rules and rules on the use of chemicals apply. In China, food safety is currently at focus as China has had several severe food scandals. Newly developed foods are called novel foods, and are specifi cally regulated. The current European novel food regulation from 1997 treats traditional third country products as novel. The Chinese regulation of 2007 also defi nes novel foods as something unfamiliar to a Chinese consumer. The concepts of novel food thus serve a protectionist purpose. As regards marketing, foods are allowed to bear health claims, whereas medicines bear medicinal claims. The separation is legally strict: foods are not to be presented as having medicinal functions. European nutrition and health claim regulation exists since 2006. China also has its regulation on health foods, listing the permitted claims and how to substantiate them. Health claims are allowed only on health foods. The European rules on medicines include separate categories for herbal medicines, traditional herbal medicines, and homeopathic medicines, where there are differing requirements for scientifi c substantiation. The scientifi c and political grounds for the separate categories provoke criticism. At surface, the Chinese legal system seems similar to the European one. To facilitate trade, China has enacted modern laws. Laws are needed as the country moves from planned economy to market economy: ‘rule of law’ needs to replace ‘rule of man’. Instead of being citizens, Chinese people long were subordinates to the Emperor. Confucius himself advised to avoid confl ict. Still, Chinese people do not and cannot always trust the legal system, as laws are enforced in an inconsistent manner, and courts are weak. In China, there have been problems with confl icting national and local laws. In Europe, the competence of the EU vs. the competence of the Member States is still not resolved, even though the European Commission often states that free trade requires harmonisation. Food and medicine regulation is created by international organisations, food and medicine control agencies, standards agencies, companies and their organisations. Regulation can be divided in ‘hard law’ and ‘soft law’. One might claim that hard law is in crisis, as soft law is gaining importance. If law is out of fashion, regulation certainly isn’t. In the future, ‘law’ might mean a process where rules and incentives are created by states, NGOs, companies, consumers, and other stakeholders. ‘Law’ might thus refer to a constant negotiation between public and private actors. Legal principles such as transparency, equal treatment, and the right to be heard would still be important.

New and Emerging Challenges of the ICT-Mediated Health and Well-Being Services

This monograph dissertation looks into the field of ICT-mediated health and well-being services. Through six chapters that extend the work done in the reviewed and published articles, the dissertation focuses on new and emerging technologies, and to impact of their use on the beneficiary; the individual who eventually derives advantage from the services. As the field is currently going through major changes particularly in the OECD countries, the focus is on shortterm developments in the field and the analysis on the long term developments is cursory by nature. The dissertation includes theoretical and empirical elements. Most of the empirical elements are linked to product development and conceptualization performed in the national MyWellbeing project that ended in 2010. In the project, the emphasis was on conceptualization of a personal aid for the beneficiary that could be used for managing information and services in the field of health and well-being services. This work continued the theme of developing individual-centric solutions for the field; a work that started in the InnoElli Senior program in 2006. The nature of this thesis is foremost a conceptual elaboration based on a literature review, illustrated in empirical work performed in different projects. As a theoretical contribution, this dissertation elaborates the role of a mediator, i.e. an intermediary, and it is used as an overarching theme. The role acts as a ‘lens’ through which a number of technology-related phenomena are looked at, pinned down and addressed to a degree. This includes introduction of solutions, ranging from anthropomorphic artefacts to decision support systems that may change the way individuals experience clinical encounters in the near-future. Due to the complex and multiform nature of the field, it is impractical and effectively impossible to cover all aspects that are related to mediation in a single work. Issues such as legislation, financing and privacy are all of equal importance. Consideration of all these issues is beyond the scope of this dissertation and their investigation is left to other work. It follows from this that the investigation on the role is not intended as inclusive one. The role of the mediator is also used to highlight some of the ethical issues related to personal health information management, and to mediating health and well-being related issues on behalf of another individual, such as an elderly relative or a fellow member of a small unit in the armed forces. The dissertation concludes in a summary about the use and functions of the mediator, describing some potential avenues for implementing such support mechanisms to the changing field of ICT-mediated health and well-being services. The conclusions also describe some of the limitations of this dissertation, including remarks on methodology and content.

Exploring the Impact of Mental Health Education on Adolescents’ Perceptions About Mental Health and Mental Illness. Improving community health

The purpose of this study was to explore perceptions of mental health and mental illness as well as the perceptions towards people with mental illness among adolescents, and further to examine the impact that a mental health educational intervention has on these perceptions. The review of the literature revealed a small number of publications on mental health educational interventions among adolescents which aimed at increasing knowledge and affecting attitudes towards mental illness with positive results. Fifty nine pupils (13-16 years old) from two randomly selected secondary schools around Athens, Greece, participated in this study. These schools were randomly selected as the experimental group (n=28) which participated in the mental health educational intervention, and the comparison group (n=31), which did not receive any intervention. Data were collected using individual interviews with open-ended questions, drawings and a questionnaire (Opinions about Mental Illness - O.M.I. scale). The participants described mental health and mental illness before and after the intervention, using the same expressions for both terms. Among the experimental group, changes were seen within the same expressions after the intervention, although some descriptions did not change. However, after the intervention, participants in the experimental group did not confuse mental health with mental illness and they also included specific diagnostic examples or stated that mental illness can happen to anyone and it can be managed. Moreover, they expressed positive attitudes towards mentally ill people, which they had not done before the intervention. The analysis of the drawings before the intervention showed that mentally ill persons were drawn similarly in both groups. After the intervention, the drawings of the participants in the experimental group changed, including fewer negative elements, while the drawings of the comparison group did not change. Regarding the results on the O.M.I. scale, it was found that the score on the Social Discrimination factor significantly decreased from pre-test to post-test in both study groups. The experimental group had higher levels on Social Discrimination at pre-test compared to the comparison group, but this difference was not significant at post-test. No significant changes were found for the Social Restriction factor for either study group. Scores of the Social Care and Social Integration factors increased significantly only in the intervention group. Overall, the results of this study indicate that the mental health educational intervention had a positive impact on the perceptions about mental health and mental illness among adolescents, and (mental) health professionals can use these results for implementing similar interventions and further research.

Patient-perceived health-related quality of life during recovery after total hip arthroplasty – a 6-month follow-up study

Potilaiden käsitys terveyteen liittyvästä elämänlaadusta lonkan tekonivelleikkauksen jälkeisenä toipumisaikana – kuuden kuukauden seurantatutkimus Tässä kaksivaiheisessa seurantatutkimuksessa tarkasteltiin potilaiden käsitystä terveyteen liittyvästä elämänlaadusta lonkan tekonivelleikkauksen jälkeisenä toipumisaikana. Tutkimuksen ensimmäisessä vaiheessa tarkoituksena oli sekä kuvailla potilaiden kokemuksia potilaana olosta, saamastaan hoidosta ja terveyspalveluorganisaatiosta että analysoida aikaisempien tutkimusten perusteella leikkauksen tuloksia potilaan kannalta. Toisessa vaiheessa tarkoituksena oli arvioida potilaiden kokemaa elämänlaatua leikkauksen jälkeen, ja sitä vaikuttivatko primaaritulokset (fyysinen toimintakyky, kipu, ahdistus) tai taloudelliset seuraukset (potilaiden itsensämaksamat kustannukset, palvelujen käyttö) terveyteen liittyvään elämänlaatuun. Tutkimuksen tavoitteena oli löytää mahdolliset kriittiset ajankohdat tai tekijät, jotka saattavat hidastaa toipumista ja siten huonontaa potilaiden elämänlaatua. Tätä tietoa voidaan käyttää hoitotyössä kun suunnitellaan sopivaa hoitoa ja tukea toipumisajalle. Tutkimuksen ensimmäisessä vaiheessa primaarileikkaukseen tulevat potilaat (n = 17) kuvailivat teemahaastatteluissa kokemuksiaan kahdesti leikkauksen jälkeen. Haastatteluaineisto analysoitiin induktiivisella sisällönanalyysilla. Lisäksi 17 tutkimusartikkelista analysoitiin deduktiivisella sisällönanalyysilla leikkauksen tuloksia potilaalle, tuloksiin vaikuttavia tekijöitä ja käytetyt tutkimusmetodit. Toisessa vaiheessa primaari- tai revisioleikkaukseen tulevat potilaat (n = 100) arvioivat leikkauksen tuloksia kuuden kuukauden ajan leikkauksen jälkeen: terveyteen liittyvää elämänlaatua, primaarituloksia ja taloudellisia seurauksia. Aineisto kerättiin erilaisilla mittareilla: Sickness Impact Profile, Finnish Version, Stait-Trait Anxiety Inventory, ja Numeric Rating Scale. Lisäksi käytettiin tätä tutkimusta varten tehtyjä kyselylomakkeita: Fyysinen toimintakyky-mittari, Palvelujen käyttö-mittari ja Kustannusmittari. Tutkimuksen toiseen vaiheen tulokset analysoitiin tilastollisilla menetelmillä. Potilaiden terveyteen liittyvä elämänlaatu parani ja kipu lievittyi leikkauksen jälkeen ja fyysinen toimintakyky lisääntyi toipumisaikana. Positiivisista muutoksista huolimatta potilaat kokivat ahdistusta samassa määrin kuin ennen leikkaustakin. Palvelujen käyttö vaihteli toipumisajan kuluessa ja potilaiden maksamissa kustannuksissa oli suuria vaihteluita. Fyysisen toimintakyvyn lisääntyminen ja kivun lieveneminen paransivat terveyteen liittyvää elämänlaatua. Sen sijaan huonompi elämänlaatu toipumisaikana oli yhteydessä suurempaan palvelujen käyttöön, kun taas kustannuksilla ei ollut yhteyttä elämänlaatuun. Potilaiden ominaispiirteet tulisi ottaa enemmän huomioon suunniteltaessa sopivaa leikkauksenjälkeistä hoitoa ja tukea. Potilaat tarvitsevat yksilöllisiä ohjeita, sillä monet taustatekijät (esim. ikä, sukupuoli, preoperatiivinen kipu, siviilisääty, ja leikkaustyyppi) vaikuttavat toipumiseen.