Bioethics Law Research Articles

Chapitre 6. Révisions des lois de bioéthique et recherche sur l’embryon humain : une analyse psychosociale des États Généraux de la Bioéthique

Bioethics are widely used in the course of biomedical science’s evolution. It allows to question ethical aspects underlying the setting of new research and clinical intervention techniques. This ethical thinking reflects norms and values socially admitted and question the way new scientific information are integrated to individuals’ system of knowing. Human embryo research, subject to bioethics laws revisions, represents an almost prototypical object of these issues, both lay and scientific. This study aims to study these issues through the context of bioethics revision laws, from users’ comments on Estates-General of Bioethics website, using the social representations theorical frame. A thematic content analysis has been performed. Results shows that embryo status is a structural argument of the debate, and that the opinion on human embryo research results from a set of ethical concerns that come from socially anchored values, accounting for the way individuals define science, biotechnologies and research on the living, that we also find in the bioethics legislation.

Conclusions et ouverture : dialogue intergénérationnel

As the bioethics law has just been voted, several actors during this academic conference have examined the paradigm shift introduced by this resolutely liberal law from their respective perspectives. Using a reading grid inherited from Pascal’s orders, the different dimensions of moral, political, legal, and scientific discourse are used as a reference to evaluate an often highly contrasting discourse. The evolution of the paradigm from bioethics law to zoethics law, in search of social legitimacy and of a response to individual desires, constitutes a turning point in the revision of bioethics laws. Under these conditions, does bioethics law does not lose its universal purpose?

Chapitre 2. La loi de bioéthique : un enjeu de démocratie sanitaire

The law of bioethics defines the judicial framework for governing medical practices and research involving the human body and the embryo. Does any scientific or technologic innovation warrant a modification of the law? To respond to this question, a preliminary reflection is necessary so as to define new equilibria which respect ethical principles, the promotion of solidarity with respect for the autonomy of each person.The CCNE is charged with organizing public debate, in the form of a general assembly of bioethics, with the support of regional spaces of ethical reflection. This extensive experience took place from January to June 2018 and lead to several lessons, notably the strong expression of a need for information and a critical vision of the notion of medical progress.Then, the parliamentary instruction and hearings that accompanied it, from 24 July 2019 to 2 August 2021, contributed developments to the initial bill. Thus, the periodic review of the law of bioethics is now based on citizen participation in the construction of legislative arbitration, demonstrating the French way of social participation.

Chapitre 5. Réalité et ambitions de la démocratisation des lois bioéthiques

Bioethics laws have many particularities because of the technicity and sensitivity of the questions tackled. First, their revision is planned to be made within seven years. Second, since 2011, this revision must be preceded by a public debate called “États généraux de la bioéthique” which aims to involve all part of the society, from experts to uninitiated.The law regarding bioethics enacted on the 2nd of august 2021, is relevant on this point in two ways. First, it is the first law made after the requirements of 2011. It is therefore possible to assess the mild impact of public debate on law-making and decisions. Second, the changes made by the law enacted in 2021 allow us to identity the means mobilized to reinforce and perpetuate public participation in the field of bioethics.

Chapitre 4. PMA : la nouvelle donne. La révision de la loi de bioéthique en 2021

The new version of the bioethics law adopted in 2021 is distinguished first and foremost by its openness. It legitimises access to medically assisted procreation for lesbian couples and single women. It allows young adults born through gamete donation to know their origins. It allows any woman to freeze her oocytes with a view to a subsequent pregnancy, without any medical condition. At the same time, the new law is characterised by its moderation. These new freedoms do not challenge the primacy of conjugal parenthood. Multiple parenthood is not on the agenda. The law establishes a differentiated filiation between heterosexual parentage and homoparentage. It confirms the absolute ban on surrogate motherhood. Between authorisations and prohibitions, the fourth bioethics law promotes a tempered liberalism.

Chapitre 14. Le nouveau droit de l’assistance médicale à la procréation. Entre démédicalisation et stigmatisation : les tâtonnements du principe d’égalité

The law of bioethics of 2 August 2021 is readily presented as enforcing the “medically-assisted procreation (MAP) for everyone”. It is true that opening up the MAP to female couples and single women made the law depart from the former legal framework which was based on a strong medicalization of this assisted procreation. This shift seems to be justified by the legislator’s intent to ensure equal rights when it comes to parental projects. Nevertheless, this “new” MAP right keeps facing differences in the treatment of applicants based on their gender or sexual orientation.

Chapitre 1. Présentation de la nouvelle loi en contexte

The 2021 bioethics law intends mainly to respond to expectations from society, mainly from minorities regarding procreation and little relayed by the “general states of bioethics”. It therefore looks bioethics, at the legislative level, not as a set of safeguards against the evolution of technologicals resources, but as the granting of new rights using these technologies. Beyond procreation, the law also loosens the constraints on the research and organ donation or genetic information. In so doing, it determines new balances between subjective rights and protective orders, which the Constitutional Council did not wish to examine.

Chapitre 11. Regard philosophique sur le don d’organes du vivant et les particularités du don croisé

Organ donation confronts us with the reality of illness, with the horizon of death and with a material effectivity of corporeality, and at the same time it introduces the possibility of a gift of oneself going as far as the materiality of the organ. Such an approach associating donation and access to the body reality leads us to question the relation of the subject to others and to himself on the moral level: up to what point can one give a constitutive element of one’s body in order to care for another? Can the wish to save others surpass the search for individual preservation? Can organ donation be extracted from an economic system? We propose first of all to bring together conceptual elements for thinking about living organ donation, before focusing more specifically on the implications of cross-donation according to the new provisions of the 2021 Bioethics Law.

Chapitre 15. L’accès aux origines personnelles

Law n° 2021-1017 of August 2nd. 2021 allows children born of assisted reproduction with a third party donor to have access, as of their majority, to non-identifying data and the identity of this third party. Without calling into question the principle of anonymity, it enshrines the right of access to origins. The reasons for this development are to be found in the evolution of European law, rather than in a logical evolution of French bioethics law. However, such an enshrinement is not without difficulties, both in terms of the concrete and technical implementation of this access to origins and in terms of the practical consequences in the realisation of access to this right for the children benefiting from this system.

Chapitre 16. Les effets de la loi sur la filiation

The bioethics law of 2 August 2021 opened up MAP to couples of women, thus enabling a child to have two women as parents and overturning the law of filiation. The legislator has created a new tool for establishing filiation by blood, the joint recognition. Despite its name, this joint recognition only applies to the woman who has not given birth, creating unequal filiation between the two women, and does not fit easily into the common law of filiation by blood.

Two Views of Vulnerability in the Evolution of Canada's Medical Assistance in Dying Law.

Canada is sixyears into a new era of legalized medical assistance in dying (MAiD). The law continues to evolve, following a pattern in which Canadian courts rule that legal restrictions on eligibility for MAiD are unconstitutional and Parliament responds by gradually expanding eligibility for MAiD. The central tension underlying this dialogue between courts and government has focused on two conceptions of how to best promote and protect the interests of people who are vulnerable by virtue of intolerable and irremediable suffering due to an illness, disease, or disability. Do we, as a society, have a duty to protect vulnerable people from seeking certain medical procedures that are contrary to their interests, as those are perceived by others? Or do we have a duty to uphold their rights to autonomy, including the right to make choices within a range that may be constrained by many factors, some of which may be socially unjust? This is a recurrent problem in bioethics and medical law, which we explore through the lens of how Canadian courts and Parliament have grappled with defining eligibility for MAiD.

Challenges of preconception genetic testing in France: A qualitative study

Preconception genetic testing is carried out to inform couples on their carrier status for recessive or X-linked genetic disease, and aims to extend their possible reproductive choices. These genetic tests are available in several countries and are currently being considered in France in the context of bioethics laws revision, raising multiple medical, ethical, and societal concerns. To provide insights into questions relative to preconception genetic testing implementation, we conducted, through a qualitative research methodology, individual and group interviews in families with experience of genetic disease, physicians and researchers in the human and social sciences, and an ethics committee. In particular, the respondents agreed on the importance of a free test and an informed choice. The economic stakes of the test appeared to be a major determinant of its development for the participants. The use of genetic data has been a source of raised fears of a eugenic drift. The remaining questions were relative to the pathologies to be tested, the access to the test, its supervision, the role of physicians and in particular of primary care professionals. Based on individual opinions and collective debates, our work delimits the challenges of preconception genetic testing implementation in France through a qualitative methodology, providing further data necessary to its introduction in the health care system.

Quels enjeux et adaptations pour les centres d’AMP dans le cadre de la mise en place de la nouvelle loi de bioéthique ?

ObjectiveThis review intends to introduce the changes of the new Bioethics law in the reproductive field and its application in French ART centers. Material and methodsThe review details the main provisions of the Bioethics Law of August 2nd 2021 as well as the three decrees published since: the first one on September 29th 2021, which specifies in particular the age conditions to benefit from ART and self-preservation of one's gametes; another decree on December 31st, 2021, to set the terms and conditions for gamete self-preservation activities for non-medical reasons and the last decree on April 14th 2022, relating to the allocation of donated gametes and embryo donation. ResultsSince the law of August 2nd, 2021, access conditions to assisted reproductive technology (ART) have evolved in France. Previously based on pathological infertility or the risk of transmission of a serious disease, ART is now intended to respond to the parental project of a couple formed by a man and a woman, two women or an unmarried woman. With the widening of access conditions, the use of gamete donation will likely increase. The upcoming raise of children born from gamete donation has led the legislator to question their right to access their origin. From September 1st 2022, adults born from gamete donation will be able to request a special administrative authority in order to access the donor's non identifying data (age, physical characteristics, family and professional situation, motivation for the donation…) and/or the donor's identity. Moreover, the new bioethics law opens up the possibility of autologous gamete cryopreservation without medical reasons, under specific age conditions, in order to carry out an assisted reproduction technique later. If gametes are not used, autologous gamete preservation could also allow an increase in gamete donation. However, the modification of gamete donation conditions could suggest a short term decrease in donors’ number. Finally, the new bioethics law further opens up research on human embryos and embryonic stem cells. ConclusionThe arrangements introduced by the Bioethics Law promulgated on August 2nd, 2021 represent a major revolution in the field of Reproductive Medicine and are expected to transform the practices of reproductive biology centers and CECOS in France.

Les demandes d’analyses des caractéristiques génétiques par séquençage dans les recherches cliniques : considérations juridiques et éthiques

More and more practitioners are being led to propose to their patients an analysis of their genetic characteristics (structural or functional genomics) either to confirm a diagnosis or to adapt a treatment (personalized medicine). Patients treated in hospitals are also offered analyses of their genetic characteristics either because they have not objected to their biological samples taken during care being used for research, or because they are included in a clinical study. The revised bioethics laws for application on 1/1/2021 provide a complete and clear framework for practices concerning genetics. However, most patients or healthy volunteers who have agreed (or not objected) to genetic testing are not aware of the potential consequences for them and their families. This is mostly due to a lack of information (inclusion of a sample without seeking express consent) or partial information due to either a lack of training of the prescriber himself or, in the context of clinical trials, an inadequate information leaflet. In order to help prescribers and evaluators of clinical trial applications to propose fair and clear information and consent letters to patients and thus ensure patient protection, we have produced an exegesis of the legal and ethical elements on which to base a proposal for genetic characteristics analysis. We include examples of requests for analysis of genetic characteristics, specifying the cases in which the research is authorized or not and mentioning the corresponding legal texts. We have generated here a useful pedagogical tool for all prescribers, researchers or simply French citizens.

What to think about the law of bioethics 2021?

What to think about the law of bioethics 2021?

What face for Medically Assisted Procreation with a third-party donor after the vote of the bioethics law in 2021? The questioning of the Cecos biologists

What face for Medically Assisted Procreation with a third-party donor after the vote of the bioethics law in 2021? The questioning of the Cecos biologists

Sperm donation after the vote on the bioethics law of 2 August 2021: should we fear a shortage of donors?

Sperm donation after the vote on the bioethics law of 2 August 2021: should we fear a shortage of donors?

Bioethics law 2021: very political, not very bioethical

Bioethics law 2021: very political, not very bioethical

Bioethics laws Developments and disappointments in reproductive medicine

Bioethics laws Developments and disappointments in reproductive medicine

P-454 Less than half of men with testicular cancer or lymphomas banked sperm before gonadotoxic treatment in France in 2018

Abstract Study question What is the proportion of men treated for testicular cancer or lymphoma who banked sperm before gonadotoxic treatment in France? Summary answer In 2018, 41% of men with testicular cancer and 28% of men with lymphoma banked sperm before gonadotoxic treatment in France. What is known already Cancer treatments significantly improved survival rates in men. In Europe, the 5-year survival rate is above 90% for testicular cancer (TC) and Hodgkin lymphoma (HL), which, with Non Hodgkin Lymphoma (NHL), are the most frequent cancers in men of reproductive age. However, surgery, chemotherapy and/or radiotherapy may damage male fertility: between 15% and 30% of men remain permanently infertile after treatment. Since 2011, the French bioethics law recommends and guarantees free access to fertility preservation for all patients needing gonadotoxic treatments. Few international data are available about the rate of male cancer patients who receive sperm cryopreservation before cancer treatment. Study design, size, duration We analyzed the data of male cancer incidence in 2018 published by the French National Institute of Cancer (INCa), only available and latest French national data, estimated from cancer registers of selected metropolitan departments (Defossez et al. 2019). We organized a survey among the 27 metropolitan centers of the CECOS network (public centers for study and conservation of human eggs and sperm) to collect the annual number of sperm cryopreservations for TC, HL or NHL. Participants/materials, setting, methods We compared the number of 0-59 years-old men with TC, HL or NHL in metropolitan France (extracted from 2018 INCa data) and the number of sperm banking for TC, HL or NHL in metropolitan centers of the CECOS network. Main results and the role of chance INCa estimated that 38,048 new cancers were diagnosed in metropolitan France in 2018 in men aged 0-59 years. TC accounted for 2,630 new cases and lymphomas for 3,913 new cases (943 HL and 2,970 NHL). Twenty-six out of 27 metropolitan CECOS centers answered the survey (96% participation rate): in 2018, 1,079 men banked sperm for TC, 375 for HL and 211 for NHL. In 2018, the fertility preservation rate in metropolitan France was 41% for TC and 28% for lymphomas (51% for HL, and 15% for NHL). The results of our national study are in accordance with Uçar et al. 2020, a monocentric study on 110 TC patients showing a 43% fertility preservation rate, but differ from those of Abdel-Razek et al. 2020, a monocentric study on 59 NHL and 26 HL patients, showing respectively 32% and 14% fertility preservation rates. A limit of our study is to be based on estimated cancer incidence from INCa reports without stratification on age and parenthood; sperm banking activity was measured in the CECOS network, which performs 90% of French male fertility preservation (French Biomedicine Agency 2018 data). This design may induce an underestimation of cancer incidence and of sperm banking activity. Limitations, reasons for caution Our study did not consider patients who were informed of fertility preservation but did not want to/could not bank ejaculated sperm (azoospermia, sperm collection failure, no-show). In CECOS network, the estimated rate of such patients is 10%. French overseas regions were not studied (lack of INCa data). Wider implications of the findings Our results suggest that despite the recommendations and facilities offered by the French bioethics law, the male patients’ pathway for fertility preservation before cancer treatments could be improved. Further study should evaluate if this suboptimal rate of fertility preservation is homogeneous on French territory or related to postal code. Trial registration number Not applicable