Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape.

Despite the increasing availability of direct-to-consumer (DTC) genetic testing, it is currently unclear how such services are regulated in Europe, due to the lack of EU or national legislation specifically addressing this issue. In this article, we provide an overview of laws that could potentially impact the regulation of DTC genetic testing in 26 European countries, namely Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the Netherlands and the United Kingdom. Emphasis is placed on provisions relating to medical supervision, genetic counselling and informed consent. Our results indicate that currently there is a wide spectrum of laws regarding genetic testing in Europe. There are countries (e.g. France and Germany) which essentially ban DTC genetic testing, while in others (e.g. Luxembourg and Poland) DTC genetic testing may only be restricted by general laws, usually regarding health care services and patients' rights.

Living Organ Donation by Minors: An Analysis of the Regulations in European Union Member States.

Living organ donation (LD) is an increasingly established practice. Whereas in the United States and Canada LD by minors has occasionally been reported, LD by minors seems to be largely absent in the European Union (EU). It is currently unclear whether this is the result of a different legal approach. This study is the first to systematically analyze the regulations of EU member states, Norway, and Iceland toward LD by minors. Relevant regulations were identified by searching government websites, translated, compared, and sent for verification to national legal experts. We identified five countries where LD by minors is allowed. In two of these (Belgium and the United Kingdom), some minors may be deemed sufficiently mature to make an autonomous decision regarding LD. In contrast, in the three other countries (Luxembourg, Norway, and Sweden), LD by minors is only allowed subject to parental permission and the assent (or absence of objection) of the donor. Where allowed, regulations differ significantly with regard to the substantive and procedural safeguards in place. In view of the controversial nature of the procedure, as illustrated by recent reports and surveys, we argue for a very cautious approach and greater harmonization in countries where LD by minors is allowed.

The storage and use of biological tissue samples from minors for research: a focus group study.

Genetic research on pediatric stored tissue samples raises specific ethical questions that differ from those raised when adults are the donors. To investigate opinions on this matter, we conducted 10 focus group discussions. Five focus groups were conducted with adult participants and 5 had teenage participants between 15 and 19 years old. The discussions were analyzed with NVIVO 8 (qualitative research software). We found the following recurrent categories: the requirement that research should not pose any burden on children and that it should benefit other children, the trust people had in the role of parents, the need for information and the growth towards autonomy. Both the adults and teenagers we interviewed thought that the inclusion of tissue samples from minors in research had ethical implications. A major concern was that nontherapeutic research would pose no extra burden on children, which would assume the use of nonintrusive methods of gathering samples and the use of samples that were gathered in a diagnostic context. Participants, however, also understood the necessity of such research. The overall impression was that parents would be the best persons to make decisions on behalf of a small child and that the same parents would engage their children in the decision-making when they grew older. People thought that there was a duty to recontact minors when they reached the age of competence but on a best-effort basis.

Vaccination against GnRH may suppress aggressive behaviour and musth in African elephant (Loxodonta africana) bulls--a pilot study.

Aggressive behaviour and musth are constant problems in captive and sometimes in free-ranging African elephant bulls. Aggressive bulls are difficult and musth bulls almost impossible to manage without severely restricting their movement either by leg-chaining or using tranquillisers. This study investigated the relationship between faecal androgen metabolites (FAM) and faecal cortisol metabolites (FCM) concentrations and aggressive behaviour and tested a GnRH vaccine as a means of down-regulating aggressive behaviour and musth in 1 free-ranging and 5 captive elephant bulls. The bulls were non-aggressive (n=3), aggressive (n=2) or in musth (n=1) at the onset of the study. The bulls were injected with a GnRH vaccine-adjuvant combination 3 or 4 times at 3- to 7-week intervals. Behaviour, FAM and FCM concentrations were measured during every week prior to vaccination until 4 months after the last vaccination. FAM concentrations were positively correlated with aggressive behaviour before the 1st vaccination. Androgen production, as reflected by FAM concentrations, was down-regulated in 3 of the 6 immunised bulls. At least 2 bulls and possibly a 3rd showed behavioural improvement following GnRH vaccination and in all 3 temporal gland secretion ceased. No further aggressive behaviour was observed until the end of the study in any of the bulls. The results of this 1st GnRH immunisation study suggest that it could be a useful method to control aggressive behaviour and musth in African elephant bulls.

An exploratory survey of professionals on the use of stored tissue samples from minors for genetic research.

he ethical aspects of the use of stored tissue samples collected from minors are of topical interest. However, the views of professionals working in the field of genetics have not been investigated in depth anywhere. We conducted a survey among 194 such professionals in Belgium. This list was composed of the members of the High Council for Anthropogenetics, supplemented with all professionals working in the field of genetics that we found on the websites of the eight Belgian centers of human genetics and of the associated university registries. We achieved a response rate of 35.5%. The vast majority (92%) think that research on stored tissue samples is useful. Most respondents stated that parental consent is valid (82.5%), and 76.5% thought that children should also be given the right to assent when they are able to comprehend the implications of the storage of biological samples and of genetic research. Slightly more than half put the age at which young people can understand storage or research rather high: 16-18 years (51 and 53.1%, respectively). Although there is some consensus in the literature that donors should be allowed to give broad consent for future research on their biological samples, only 47.6% in our survey thought that parents should be allowed to consent to any future research on their children's samples. The aim of our study was to give some basis for future ethical reflections and policies on the subject of stored tissue samples from minors for genetic research. We concluded that a large majority of Belgian researchers and clinicians in the field of genetic research think research on stored tissue samples from minors is useful. They also think that parental consent for such research is valid, but that children should be allowed to assent as they grow older.

[Civil commitment of mentally ill patients: developments in Flanders]. / Gedwongen psychiatrische opname: ontwikkelingen in Vlaanderen.

The Belgian law of 1990 concerning the protection of the mentally ill was the principal achievement of the last 25 years in the field of civil commitment of mentally ill patients in Flanders. Since that time there have been very few alterations in the criteria determining civil commitment. Very little legislation has been passed on this subject. The pragmatic and casuistic way in which the law is applied hinders any discussion of the principles on which these criteria are based. In spite of the large increase in the number of civil commitments, so far the law has remained unchanged.

UNESCO Global Ethics Observatory: database on ethics related legislation and guidelines.

The Database on Ethics Related Legislation and Guidelines was launched in March 2007 as the fourth database of the UNESCO Global Ethics Observatory system of databases in ethics of science and technology. The database offers a collection of legal instruments searchable by region, country, bioethical themes, legal categories and applicability to specific articles of the UNESCO Universal Declaration on Bioethics and Human Rights and International Declaration on Human Genetic Data. This paper discusses the background and rationale for the database and its role as a consultative and comparative resource hub for the study of ethics related legal instruments across the world, with the purpose of informing and inspiring relevant stakeholders on the implementation of the principles contained within the UNESCO declarations on bioethics.

Minors and informed consent in carrier testing: a survey of European clinical geneticists.

PURPOSE: A study was made of attitudes of clinical geneticists regarding the age at which minors should be allowed to undergo a carrier test and the reasons they provide to explain their answer. METHODS: European clinical institutions where genetic counselling is offered to patients were contacted. 177 (63%) of the 287 eligible respondents answered a questionnaire. RESULTS: Clinical geneticists were significantly more in favour of providing a carrier test to a younger person if the request was made together with the parents than if the adolescent requested the test personally. Although a large fraction of respondents (16%-30%) were "neither unwilling nor willing" to provide a carrier test to a 16-year-old adolescent who requested the test personally, for most disorders slightly more clinical geneticists were "very willing" or "willing". CONCLUSION: Age is not the only decisive element when considering the participation of adolescents in decisions affecting their health. The clinical geneticists referred to cognitive, emotional and sexual maturity and the support of parents as crucial elements in their comments regarding when to tell children about their genetic risk or to allow adolescents to request a carrier test.

[When is psychosis dangerous? Ethical, professional en juridical considerations concerning psychosis and coercion in Belgium]. / Wanneer is een psychose gevaarlijk? Ethische, professionele en juridische afwegingen inzake psychose en gedwongen opname in België

BACKGROUND: In Belgium a patient can only be compulsorily admitted to a psychiatric hospital if he is a danger to himself or others (law concerning coercion in Belgium, 26/06/1990). AIM: To explore the relationship between psychosis and danger, and to analyse the various interpretations of the 'dangerousness' criterion in the context of psychotic disorders and the underlying ethical positions. METHOD: We studied the literature by means of PubMed, PsycINFO, manuals and references and used the search terms: 'coercion', 'commitment of mentally ill', 'dangerous behaviour', and 'psychotic disorders'. results The correlation between psychosis and danger is limited but is strengthened by comorbid substance abuse and non-compliance. The clinical assessment of danger does not have a firm scientific basis. The underlying ethical position determines when danger is regarded as being serious enough to justify coercion. CONCLUSION: Danger is a problematical criterion for coercion. We propose a model that weighs up the likelihood of danger against the expected pros and contrasts of coercion and the extent to which the disorder can be treated. The fluid nature of the 'dangerousness' criterion and the principle of proportionality call for a more varied arsenal of coercive measures which are less drastic than compulsory admission.

Impact of cost containment measures on medical liability.

RATIONALE: Owing to the growing health care expenditure and the need to improve efficiency, public authorities have since the 1980s changed their policy with respect to health care. Financial pressures encouraged them to investigate methods to control health care costs. One recent method is the enactment of cost containment measures based on clinical practice guidelines (CPGs) that provide financial or administrative sanctions. AIMS AND OBJECTIVES: This article describes the legal value of CPGs, the evolution towards cost containment measures based on CPGs, and finally the legal value of these new cost containment measures. It questions whether these measures may have an impact on the medical liability rules and it wants to open the debate on the legal value of these measures based vis-à-vis the professional autonomy of the physician and patients' rights on quality care. METHODS: The research for this article is based on a comparative analysis of the legal literature and jurisprudence of a number of legal systems. RESULTS AND CONCLUSIONS: The article concludes that, as a result of the rising costs, it becomes increasingly difficult for a physician to balance his duty to take care on the one hand and his duty to control costs on the other. Maintaining a high standard of care towards patients becomes difficult. Consequently, one wonders whether the law should then allow the standard of care to be adjusted according to the available means. Until now, courts in a fault based system have not been willing to accept such an adjustment of the standard of care, but it might well be possible that this attitude will change in case of no-fault compensation systems.

Presymptomatic and predictive genetic testing in minors: a systematic review of guidelines and position papers.

The objective of this study is to review ethical and clinical guidelines and position papers concerning the presymptomatic and predictive genetic testing of minors. The databases Medline, Philosopher's Index, Biological Abstracts, Web of Science and Google Scholar were searched using keywords relating to the presymptomatic and predictive testing of children. We also searched the websites of the national bioethics committees indexed on the websites of World Health Organization (WHO) and the German Reference Centre for Ethics in the Life Sciences, the websites of the Human Genetics Societies of various nations indexed on the website of the International Federation of Human Genetics Societies and related links and the national medical associations indexed on the website of the World Medical Association. We retrieved 27 different papers dealing with guidelines or position papers that fulfilled our search criteria. They encompassed the period 1991-2005 and originated from 31 different organizations. The main justification for presymptomatic and predictive genetic testing was the direct benefit to the minor through either medical intervention or preventive measures. If there were no urgent medical reasons, all guidelines recommend postponing testing until the child could consent to testing as a competent adolescent or as an adult. Ambiguity existed for childhood-onset disorders for which preventive or therapeutic measures are not available and for the timing of testing for childhood-onset disorders. Although the guidelines covering presymptomatic and predictive genetic testing of minors agree strongly that medical benefit is the main justification for testing, a lack of consensus remains in the case of childhood-onset disorders for which preventive or therapeutic measures are not available.

Human rights: implications for patients and staff.

Originating from wider declarations of fundamental human rights, individual human rights in the field of health care, also called patients' rights, have been elaborated, developed and implemented by most international organisations, including the European Union and the World Health Organisation. The Council of Europe is however, particularly prominent in its work in the field of human rights, having drawn up a number of vital international treaties, among them and most importantly the Convention on Human Rights and Biomedicine, which strengthens internationally the legal position of the patient and the research subject in setting a minimum level of protection in respect of individual human rights and health and is binding upon the member states that have ratified it. Nonetheless, it needs to be examined to see if the European Union would be a better alternative to regulate these patients' rights.

[The European Convention of Bioethics. Objectives, guiding principles and possible limitations]. / La Convención Europea de Bioetica. Objetivos, principios rectores y posibles limitaciones.

In the present work a detailed study is given of the European Convention on Bioethics, with discussion of its guiding principles--protection of human beings, their dignity and identity-, its objectives and the limits imposed by the Convention on the exercise of rights and freedoms in the case of the application of biology and medicine.

Professional autonomy in Belgium.

The Belgian health care system has a few features that may have contributed to the rising costs of health care: patients' free choice of physicians, large clinical freedom of physicians, essentially a fee-for-service remuneration for medical specialists in which the fees are agreed between insurance funds and physicians. The increased medical consumption and costs have prompted the state and insurance companies to take measures that limit the professional autonomy of the physicians. Access to medical education, free until 1997, is now restricted. The medical profession is organized in the Order of Physicians that has established a code of professional ethics that has moral but not legal force. So far, there is no special legislation for the patient-physician relationship, though laws on specitic issues like organ transplantation contain duties for physicians. In recent years a debate is taking place on patients' rights, of which informed consent is central and gaining importance in medico-legal publications. An analysis of (ethical and legal) regulations concerning the withholding or withdrawal of treatment by physicians demonstrate that the profession still enjoys a large clinical autonomy, though due discussion with the patient has become more explicitly required. The respect for professional autonomy is not primarily due to any formal power that the Order of Physicians would have, but is rather grounded in the generally high quality of the patient-physician relationship that in ethical terms is considered essentially as a confidence relationship rather than a contractual relationship.

Sterilisation of incompetent mentally handicapped persons: a model for decision making.

Doctors are regularly confronted with requests for sterilisation of mentally handicapped people who cannot give consent for themselves. They ought to act in a medical vacuum because there doesn't exist a consensus about a model for decision making on this matter. In this article a model for decision making is proposed, based on a review of the literature and our own research data. We have attempted to select and classify certain factors which could enable us to arrive at an ethically justifiable method of making a medical decision. In doing so we distinguish two major criteria: heredity and parenting competence, and six minor criteria: conception risk, IQ, age, personality, medical aspects and prognosis and finally support and guidance for the mentally handicapped person. The major criteria give rise to a "situation of necessity". In this situation the physician is confronted with a conflict of values and interests. The minor criteria are of an entirely different ethical order. They can only be considered once the major criteria have created a "situation of necessity". Ultimately it comes down to deciding whether the benefits of sterilisation outweigh the drawbacks and whether the means are appropriate to the end, where efficient contraception is the end and irreversible sterilisation is the means.