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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 concomitance of a migratory wave and the hospital crisis once again raises the question of the care that the French healthcare system is able to provide to migrants. On the occasion of SFFEM's 19th annual day, we present a synthesis of the research work that has been communicated at that time. Firstly, we will discuss how doctors have been able to overcome strangeness to revive the notion of hospitality according to Levinas; secondly, we will discuss how the hospital is departing from its mission of institutional hospitality because of administrative injunctions; thirdly, we will discuss how ethnomedicine gives us keys to open up to other cultural norms; fourthly, we will see the inadequacy that exists between rights of access to medical care and their effectiveness; finally, the conclusion of Xavier Emmanuelli, founder of the social ambulance service, will remind us how much the values of the French Republic call us to the notion of care and openness to otherness., (© 2021 Elsevier Masson SAS. All rights reserved.)

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.

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?.

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.

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.

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.

In Tunisia as in France, the legislator recognized the organ harvesting as of public health priority. To promote it, cells of coordination are created, and controlled by regulatory texts. There are differences in the strategy of organ harvesting in minor but whether he is alive or dead, he is well protected by law. Organ harvesting in alive child is prohibited in both Tunisia and France but the haematopoietic cells one is authorized. In the minor deceased organ harvesting obeys common principles, appearing in the bioethical law (France) and the law n°91-22 of March 25, 1991 (Tunisia) with a difference in the procedure of the assent of the legal guardian.

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.

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.

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.

Background: French and Quebec legislation allow the inclusion of decisionally-incompetent subjects in research, provided certain conditions are met. In both jurisdictions, ethics committees are charged with ensuring that research protocols meet these conditions. We investigated committee members' knowledge and opinions regarding substitute consent for research purposes., Methods: Two consecutive postal surveys were conducted among all members of ethics committees from France and Quebec. Knowledge and opinions about proxy consent were measured with clinical vignettes describing hypothetical situations involving incapable adults. For each vignette, respondents were asked to either identify the person legally authorized to consent or choose the substitute decision-maker whom they considered best suited to do so., Results: Knowledge of the legislation governing substitute consent was poor in both samples, especially in situations involving an incompetent person who did not have a legal representative. Knowledge was worse among French ethics committee members (p<0.001). In hypothetical clinical studies that involved no risk to the subject's health, 59% of respondents favored consent from a close relative. As the risk increased, the proportion gradually decreased to 14.2%, while the proportion against soliciting the cognitively impaired older adult tended to increase (from 5.8 to 31.2%). These trends were observed in both samples., Conclusion: These findings underscore the need to better educate ethics committee members about legislation regarding prospective subjects who lack decisional capacity. Such efforts could improve both knowledge of and compliance with legal provisions that enable or restrict the participation of cognitively-impaired patients in research projects. Moreover, study findings provide some support for enlarging the category of persons who are authorized to consent to low-risk research on behalf of incapacitated adults who lack legal representation.

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.

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.

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.

Representatives from eight European countries compared the legal, ethical and professional settings within which decision making for neonates takes place. When it comes to limiting treatment there is general agreement across all countries that overly aggressive treatment is to be discouraged. Nevertheless, strong emphasis has been placed on the need for compassionate care even where cure is not possible. Where a child will die irrespective of medical intervention, there is widespread acceptance of the practice of limiting aggressive treatment or alleviating suffering even if death may be hastened as a result. Where the infant could be saved but the future outlook is bleak there is more debate, but only two countries have tested the courts with such cases. When it comes to the active intentional ending of life, the legal position is standard across Europe; it is prohibited. However, recognising those intractable situations where death may be lingering and unpleasant, Dutch paediatricians have reported that they do sometimes assist babies to die with parental consent. Two cases have been tried through the courts and recent official recommendations have set out standards by which such actions may be assessed.