Preimplantation Genetic Diagnosis: The Situation in France and in Other European Countries.

Preimplantation genetic diagnosis (PGD) relates exclusively to in vitro fertilisation techniques (IVF) that aim to prevent transmission of a serious genetic abnormality to the child. The genetic characteristics of the embryo created through IVF are analysed, and only the embryos free of the genetic abnormality are implanted in the womb. Performed worldwide since 1990, this technique has raised many legal and ethical debates due to the very wide variations of lawgiving between countries. This is shown by the report of the UNESCO IBC (2003), which described the techniques and the issues raised by preimplantation genetic diagnosis. In this article, the authors present the differences between prenatal diagnosis and preimplantation genetic diagnosis, the French legislation, then the range of legislation in Europe and finally the position of the European Court of Human Rights which sanctioned Italy and Latvia for refusing access to PGD.

Chapitre 3. Inégalités dans le dépistage et la prévention du VIH/SIDA.

Despite progress in the detection and treatment of the Human Immunodeficiency Virus (HIV), major challenges remain in developing countries due to insufficient resources and infrastructure. The number of people living with HIV who do not know their serostatus has fallen worldwide. However, a number of existing obstacles stand in the way of better results. The socio-cultural context in Africa hampers knowledge and understanding of the disease, leading to stigmatizing attitudes, reluctance to undergo screening and poor access to treatment.Inequalities also exist within the countries of the North, as in the case of the French West Indies, which benefit from a policy to combat HIV/AIDS, with results that fall short of those in mainland France. For this reason, we have chosen to compare the situation in the West Indies with that in Benin, in the context of African culture.Our analysis takes stock of the issues and prospects linked to the accessibility and use of screening care in sub-Saharan Africa and the French Departments of America (DFA).In both cases, fear of the disease, stigmatization, fear of a positive HIV test result and fear of disclosing the test result limit preventive and treatment actions for an effective fight against HIV.In sub-Saharan Africa, women are more likely to accept a screening test than men. Certain populations, including adolescents and homosexuals, are in a vulnerable position. The comparison reveals similar attitudes and suggests actions or recommendations in both countries that have produced results.Innovative strategies and specific programs must be implemented to turn the tide in the fight against the HIV epidemic.

The European Medicines Agency: a public health European agency?

The European Medicines Agency (EMA) is a European Agency as it is a decentralized body governed by European public law; it has its own legal personality and is also distinct from the European Union institutions (Council, Parliament, Commission, etc.). The EMA presents itself, and is commonly recognised, as a public health agency. This is notably supported by its recent transition from the Regional Direction of Research to the Regional Direction of Public Health. Four recognized principles of public health can be identified as such: assessment, transparency, precaution and independence. These principles appear to be closely linked to those forming the basis of good European governance regarding agencies: efficacy, coherence, openness, participation and responsibility. Thus, it is interesting to study how these principles are applied by the EMA in order to assess the reality of its qualification as a Public Health European Agency. The principles of assessment and transparency seem to be largely applied whereas the principles of precaution and independence are more problematic.

Consent to medical research of vulnerable subjects from the French point of view: the example of consent in research in the case of Alzheimer disease.

The consent to research is the expression of autonomy. Some groups are vulnerable and cannot give free consent because their conditions limit their decision making or because they are unable to consent themselves (minor, incompetent adults). International standards and recommendations for medical research protect vulnerable subjects (article 17 of the Helsinki declaration, guidelines 9 and 13 of the CIOMS, article 17 of the Oviedo Convention). French Law protects mostly three categories of vulnerable people: minors, adults with a legal representative, and the people living in sanitary and social establishments. Specific protection is given as well to pregnant women, detainees and persons with psychiatric disorders in involuntary commitment. From the example of research with Alzheimer patients the authors show the original provisions of French legislation to involve in medical research incompetent patients with or without legal protection. Clinical research on Alzheimer's disease poses challenges as never before to research ethics. In fact, the development of the disease progressively reduces the patient's ability to make choices: the latter is no longer capable, but is not totally incapacitated. Several solutions are offered for a "proxy" consent or authorisation.

Ethics committees for biomedical research in some African emerging countries: which establishment for which independence? A comparison with the USA and Canada.

CONTEXT: The conduct of medical research led by Northern countries in developing countries raises ethical questions. The assessment of research protocols has to be twofold, with a first reading in the country of origin and a second one in the country where the research takes place. This reading should benefit from an independent local ethical review of protocols. Consequently, ethics committees for medical research are evolving in Africa. OBJECTIVE: To investigate the process of establishing ethics committees and their independence. METHOD: Descriptive study of 25 African countries and two North American countries. Data were recorded by questionnaire and interviews. Two visits of ethics committee meetings were conducted on the ground: over a period of 3 months in Kigali (Rwanda) and 2 months in Washington DC (USA). RESULTS: 22 countries participated in this study, 20 from Africa and two from North America. The response rate was 80%. 75% of local African committees developed into national ethics committees. During the last 5 years, these national committees have grown on a structural level. The circumstances of creation and the general context of underdevelopment remain the major challenges in Africa. Their independence could not be ensured without continuous training and efficient funding mechanisms. Institutional ethics committees are well established in USA and in Canada, whereas ethics committees in North America are weakened by the institutional affiliation of their members. CONCLUSION: The process of establishing ethics committees could affect their functioning and compromise their independence in some African countries and in North America.

Pandemic influenza control in Europe and the constraints resulting from incoherent public health laws.

BACKGROUND: With the emergence of influenza H1N1v the world is facing its first 21st century global pandemic. Severe Acute Respiratory Syndrome (SARS) and avian influenza H5N1 prompted development of pandemic preparedness plans. National systems of public health law are essential for public health stewardship and for the implementation of public health policy. International coherence will contribute to effective regional and global responses. However little research has been undertaken on how law works as a tool for disease control in Europe. With co-funding from the European Union, we investigated the extent to which laws across Europe support or constrain pandemic preparedness planning, and whether national differences are likely to constrain control efforts. METHODS: We undertook a survey of national public health laws across 32 European states using a questionnaire designed around a disease scenario based on pandemic influenza. Questionnaire results were reviewed in workshops, analysing how differences between national laws might support or hinder regional responses to pandemic influenza. Respondents examined the impact of national laws on the movements of information, goods, services and people across borders in a time of pandemic, the capacity for surveillance, case detection, case management and community control, the deployment of strategies of prevention, containment, mitigation and recovery and the identification of commonalities and disconnects across states. RESULTS: Results of this study show differences across Europe in the extent to which national pandemic policy and pandemic plans have been integrated with public health laws. We found significant differences in legislation and in the legitimacy of strategic plans. States differ in the range and the nature of intervention measures authorized by law, the extent to which borders could be closed to movement of persons and goods during a pandemic, and access to healthcare of non-resident persons. Some states propose use of emergency powers that might potentially override human rights protections while other states propose to limit interventions to those authorized by public health laws. CONCLUSION: These differences could create problems for European strategies if an evolving influenza pandemic results in more serious public health challenges or, indeed, if a novel disease other than influenza emerges with pandemic potential. There is insufficient understanding across Europe of the role and importance of law in pandemic planning. States need to build capacity in public health law to support disease prevention and control policies. Our research suggests that states would welcome further guidance from the EU on management of a pandemic, and guidance to assist in greater commonality of legal approaches across states.

European recommendations integrating genetic testing into multidisciplinary management of sudden cardiac death.

Sudden cardiac death (SCD) accounts for 10-20% of total mortality, i.e., one in five individuals will eventually die suddenly. Given the substantial genetic component of SCD in younger cases, postmortem genetic testing may be particularly useful in elucidating etiological factors in the cause of death in this subset. The identification of genes responsible for inherited cardiac diseases have led to the organization of cardiogenetic consultations in many countries worldwide. Expert recommendations are available, emphasizing the importance of genetic testing and appropriate information provision of affected individuals, as well as their relatives. However, the context of postmortem genetic testing raises some particular ethical, legal, and practical (including economic or financial) challenges. The Public and Professional Policy Committee of the European Society of Human Genetics (ESHG), together with international experts, developed recommendations on management of SCD after a workshop sponsored by the Brocher Foundation and ESHG in November 2016. These recommendations have been endorsed by the ESHG Board, the European Council of Legal Medicine, the European Society of Cardiology working group on myocardial and pericardial diseases, the ERN GUARD-HEART, and the Association for European Cardiovascular Pathology. They emphasize the importance of increasing the proportion of both medical and medicolegal autopsies and educating the professionals. Multidisciplinary collaboration is of utmost importance. Public funding should be allocated to reach these goals and allow public health evaluation.

Grâce au développement dérogatoire pendant le COVID-19, la télémédecine en France est mieux encadrée juridiquement et plus accessible / Gràcies al desenvolupament derogatori durant la COVID-19, la telemedicina a França està més ben regulada legalment i és més accessible / Gracias al desarrollo derogatorio durante la COVID-19, la telemedicina en Francia está mejor regulada legalmente y es más accesible / Thanks to the derogatory development during the COVID-19, telemedicine in France is better legally regulated and more accessible

La télémédecine existe depuis les années 1980 et met en relation um patient à distance avec un médecin ou un professionnel de la santé qui échange des données numériques grâce à des outils informatiques. L'Ordre des médecins considère que les nouvelles technologies facilitent l'accès aux soins et à l'expertise, même si cela va à l'encontre des principes éthiques fondamentaux. Elle se substitue à l'acte médical traditionnel, et il est nécessaire de s’interroger sur sa pertinence et sur l’intérêt de ses conditions d’application pour le patient. Pendant l'épidémie de COVID-19, les conditions de la télémédecine ont été assouplies et le système d'assurance maladie a facilité son remboursement de manière dérogatoire. Les professionnels de la santé, les établissements de soins et les patients ont pu apprécier les nouvelles possibilités offertes par la télémédecine et en reconnaître les limites. Cependant, la sécurité n'est pas la principale préoccupation des patients, qui utilisent largement les outils informatiques pour surfer sur Internet et considèrent la médecine à distance comme un exercice facilement accessible sans en connaître les limites. Ils ne font pas de distinction entre la télémédecine clinique sous contrôle médical et les services de santé en ligne proposés sur Internet, qui sont des offres commerciales de bien-être. Dans cette présentation, nous décrirons d'abord l'évolution de la télémédecine, mise en œuvre depuis longtemps en France sous diverses formes, puis le développement spectaculaire des téléconsultations lors de l’épidémie COVID-19, dont les conséquences bénéfiques permettent une meilleure accessibilité et un meilleur remboursement par la sécurité sociale.(AU)

La telemedicina existe desde los años 80 y pone en contacto a distancia a un paciente con un médico o profesional sanitario que intercambia datos digitales mediante herramientas informáticas. La Orden de Médicos considera que las nuevas tecnologías facilitan el acceso a los cuidados y a los conocimientos especializados, aunque vaya en contra de principios éticos fundamentales. Se trata de un sustituto del acto médico tradicional, y hay que cuestionarse su pertinencia y si las condiciones de aplicación aportan un beneficio al paciente. Durante la epidemia de COVID-19, las condiciones para la telemedicina se relajaron y el sistema de seguros sanitarios facilitó su reembolso de forma derogatoria. Los profesionales sanitarios, las instituciones sanitarias y los pacientes pudieron apreciar las nuevas posibilidades que ofrece la telemedicina y reconocer sus limitaciones. Sin embargo, la seguridad no es la principal preocupación de los pacientes, que hacen un amplio uso de las herramientas informáticas para navegar porInternet y consideran la medicina a distancia como un ejercicio de fácil acceso sin conocer sus límites. No distinguen entre telemedicina clínica bajo supervisión médica y servicios de salud electrónica ofrecidos por Internet, que son ofertas comerciales de bienestar. En esta presentación expondremos en primer lugar la evolución de la telemedicina, implantada desde hace tiempo en Francia bajo diversas formas, y a continuación el espectacular desarrollo de las teleconsultas durante la epidemia de COVID-19, cuyas beneficiosas consecuencias permiten una mejor accesibilidad y reembolso por parte de la seguridad social.(AU)

Telemedicine has existed sincethe 1980s and puts a patient in contact with a doctor or health professional at a distance who exchanges digital data using computer tools. The Ordre des Médecins considers that new technologies facilitate access to care and specialised expertise, even ifit goes against fundamental ethical principles. It is a substitute for the traditional medical act, and one must question its relevance and whether the conditions of implementation bring a benefit to the patient. During the COVID-19 epidemic, the conditions for telemedicine were relaxed and the health insurance system facilitated its reimbursement in a derogatory manner. Healthcare professionals, healthcare institutions and patients were able to appreciate the new possibilities offered by telemedicine and recognize its limitations. However, safety is not the main concern of patients, who make extensive use of IT tools to surf the Internet and consider remote medicine as an easily accessible exercise without knowing its limits. They do not distinguish between medically supervised clinical telemedicine and e-health services offered over the Internet, which are commercial wellness offerings. In this presentation, we will first describe the evolution of telemedicine, which has long been implemented in France in various forms, and then the spectacular development of teleconsultations during the COVID-19 epidemic, the beneficial consequences of which allow better accessibility and reimbursement by social security.(AU)

Chapitre 6. Cells? safety in Europe: Towards an ethical safety.

To encourage and maximise the use of human biological material in Europe, the European Commission instigated a main Directive in 2004 (Directive 2004/23/EC), four technical ones in 2006 (Commission Directives 2006/17/EC and 2006/86/EC) and in 2015 (Commission Directives (EU) 2015/565 and (EU) 2015/566). They encourage the donation of tissues and cells for transplant purposes in the safeguard of public health. Another major aim of Directive 2004/23/EC is to guarantee recipients' safety in transplantation. Hence, measures for accreditation of establishments storing, preparing and distributing tissues and cells are required to be implemented in Members States' jurisdictions. In addition, adequate training is required for the personnel directly involved in such activities. Despite the adoption of a ?full legislation,? the EU legal framework for cells cannot be seen as totally harmonized. In this article we first address the issues posed at the European level by the uses of human cells as therapeutic agent with regards to their qualification: body elements? Medicinal product? We study the ways to address these bioethical dilemmas at an EU level. Then we discuss the impact of this qualification in terms of safety through the definition of safety's measures and their limits regarding the directive's scope. We conclude with the emergence of an ?ethical safety?.

[Prescribing drugs by international non-proprietary name: the perception of health and non-health professionals]. / La prescription médicamenteuse en denomination commune: perception des acteurs de santé en midi-Pyrénées.

AIM: The aim of this study was to evaluate the perceptions of health professionals and non-health professionals with regard to prescribing drugs by their international non-proprietary name (INN) in the Midi-Pyrénées area, France. METHODS: We developed a score to assess the perception of the four criteria that make up therapeutic progress: efficacy, safety, convenience and cost for the National Health Insurance. Changes in perception under these criteria were scored between 0 and 10 (0 for no change and 10 for maximal change). The questionnaire was answered by 142 general practitioners, 161 pharmacists and 132 healthy subjects (public). RESULTS: The median value (first quartile to third quartile) for the perceived change in efficacy was 0 (0-3) for physicians and pharmacists, and 0 (0-0) for the public. The median value for the perceived change in safety was 0 (0-3) for practitioners and pharmacists, and 0 (0-5) for the public. The median value for the perceived change in convenience was 0 (0-6) for practitioners, 5 (0-6) for pharmacists and 0 (0-0) for the public. The median value for the perceived change in cost was 6 (3-8) for practitioners, 8 (5-10) for pharmacists and 10 (6-10) for the public. CONCLUSION: This study shows that there is generally favourable acceptance of prescribing by INN by those in the health area. However, general practitioners seem to be more reluctant to accept this than pharmacists or the general public.

Access to health care for illegal immigrants: a specific organisation in France.

Health care is a fundamental human right in Europe, and all Member States recognise everyone's right to the access to preventive healthcare and to receive medical care in the event of sickness or pregnancy. Nevertheless, this right is focused on citizens and the application to migrants, particularly undocumented migrants, varies widely in the EU. The French legislation is organized with a humanitarian approach. In this article, the authors present the French system of social protection, the "Couvernture médicale universelle" or CMU, which provides the same protection to asylum seekers and documented immigrants as to nationals, and the "Aide médicale d'état" or AME, that is open to every person who does not fulfil the legal conditions to obtain the CMU, such as illegal immigrants. Created in 1995, recently access to the AME has been restricted. A claim of discrimination has been rejected by the Conseil d'Etat and 215,000 persons received the AME in 2009. The expenses incurred by the AME increased by 17% in 2010, and there is a debate in Parliament to limit care and to ask the recipient for a financial contribution.

Issues in networking and research funding for the European Association of Health Law.

All academics, perhaps with the exception of those who are hermits with independent private means, are concerned with questions of networking and research funding. The nature of academic life is to search out new ideas and revisit old ones, and to discuss these ideas with others. This requires networks of colleagues and funding to provide the basic resources of time and literature. This may be at the local level, but increasingly the expectation is that these activities should become more and more elaborate; our networks are now international, and our time and resources cost ever increasing amounts which, for many if not most academics, must be found outside the general budget of the home University. Our success as academics is measured, in increasing part, on our ability to show our networking and external funding credentials. There is a more resounding reason to pursue both networking and externally funded research: through such projects the experience of each individual can be increased such that the result is far greater than one could achieve alone. Networking and external funding are not ends in themselves, but they can and should be a great enhancement to academic life and contribution. None of this is news or a novel claim; it is simply today's environment. This paper considers some opportunities for how networking and externally funded research might help the EAHL to realise its aims in developing the discipline of health law. We, as authors, do not claim any special expertise in the area, and readers are quite justified in thinking "who are they to talk to us about what we clearly know much more about?" However, we were asked to start a discussion at the inaugural conference of the Association, and the thoughts that we present now were designed to do that. It is a discussion which will form one of the early activities of the Association. Here the paper is divided first issues concerning networking, and second those concerning research funding from sources external to one's home University. We draw upon our own experiences, and would be grateful to hear of better examples, and particularly about contradictory experiences.

Substitute consent for research involving the elderly: a comparison between Quebec and France.

The authors first describe the rules enacted in Quebec and France to protect adults with decisional impairment who may be approached by investigators to participate in research protocols. They then present two consecutive postal surveys conducted among Quebec and French researchers in aging and designed to (1) assess their knowledge of the legal provisions implemented to protect decisionally incapable adults, (2) elicit their opinions regarding the person best suited to provide substitute consent for research participation, and (3) document their conduct related to obtaining consent for prospective subjects with impaired decisional capacity. Knowledge of the legislation governing substitute consent was poor, even more so among French than Quebec researchers (p < 0.001). In both samples, the majority of respondents felt that the substitute decision-maker does not have to be legally appointed when the study poses little risk to the participant. Practice data revealed a certain discrepancy between the conduct of researchers in aging and the legal provisions regarding consent for research purposes that prevail in their jurisdictions. These findings underscore the need to better educate clinical investigators about existing measures to protect prospective subjects who lack decisional capacity. They also provide some support for allowing close relatives to consent to research participation on behalf of older adults who are unable to consent by themselves and have not been appointed a legal representative.