2021 Bioethics law: What is new in organ donations ?

2021 Bioethics law: What is new in organ donations ?

by | July 19, 2024 | Bioethics Law

2021 Bioethics law: What is new in organ donations ?

Table of contents

I. The 3 major principles which govern organ donation in France

II. What is a crossed donation ?

III. A few figures on kidney transplants

IV. What are the other changes introduced by the 2021 bioethics law ?

I. The 3 Major principles which govern organ donation in France :

 

  • The principle of “assumed consent” : In France, the law specifies that we are all organ and tissue donors, unless whilst living we have expressed our refusal to donate (by recording the said refusal on the national register of refusals, from the age of 13 years, or if a family member of the deceased reports the refusal for the donation of organs which the deceased declared expressly whilst living). Minors may be donors. However, the law in France specifies that the donation of organs and tissues may only be undertaken with the consent of the holders of parental authority.
  • Gratis: Organ donation is an act of generosity and solidarity. The law prohibits any reward in compensation for the donation.
  • Anonymous: The name of the donor cannot be revealed to the recipient, and vice-versa. The family of the donor may however be informed of the organs and tissues collected as well as the result of the grafts, if they so request.

The bioethics law adopted in August 2021, whose application details are defined by decrees (Nos. 2021-1627 and 2021-1626 dated 10th December 2021), introduces a few changes on organ donation, in particular the “crossed donation”.

II. What is a crossed donation ?

 

The 2011 law already included this innovation. A crossed donation is a specific organisation for kidney transplants involving a living donor. One of the main difficulties in the field of transplants is the requirement for “compatibility” between the donor and the recipient. As it is quite possible to live with a single kidney, a family member of a person waiting for a transplant may wish to donate one of their kidneys, but it is not “compatible”.

Whence the idea of a “crossed donation” : When the donation is not possible within the same family, a grouping of two couples of donor-recipients is established who exhibit joint compatibility in order to exchange the respective donors. It is therefore  an encouragement to finding living donors within the entourage of those waiting for a transplant in order to be able to “exchange” transplants with other families.

The French Biomedicine Agency (ABM) describes the procedure on its web-site :

“A donor D1 wishes to donate to a family member, recipient R1, but is not compatible with him/her. At the same time, a donor D2 also wishes to donate to a family member, recipient R2, but is not compatible with him/her. If donor D1 is compatible with recipient R2 and donor D2 is compatible with recipient R1, a transplant can be considered between donor D1 and recipient R2 and another between donor D2 and recipient R1. This is known as a crossed donation.”

According to the provisions of the law, crossed donations remain anonymous. Each donor accepts that an anonymous recipient will receive their kidney so that their family member can also be transplanted. This system resolves the incompatibility between the patient awaiting a transplant and a family member prepared to donate a kidney. According to the ABM, this procedure also provides medical advantages : accessibility to a larger number of grafts, quicker access to a graft, programming of the operation, and reduced time when the donated organ is held in cold storage prior to transplantation.

Moreover, the data show that the risk of rejection of the graft increases with the duration of the cold storage prior to transplantation.

The 2021 law relaxes the crossed donation system. Initially, crossed donations concerned 2 pairs of donors and recipients. Between living donors, the 2021 law now authorises the number of consecutive donors and recipients to increase from two to six. It also provides the possibility of including in a crossed donation procedure the use of an organ taken from a deceased person.

In practice, a chain of donations is initiated by a single donor (living or deceased) having no specific patient to receive the donation. This first graft initiates a series of donations among incompatible patient/donor pairs. The living donor associated with the patient receiving the kidney of the deceased donor may therefore in turn donate a kidney which will benefit a second patient/donor pair, and so on.

The graft collection operations, which previously had to be conducted at the same time in order to ensure equal chances of success, are now undertaken within a maximum 24-hour time lapse.

 

 

III. A few figures on kidney transplants

The ABM conducted an information and awareness campaign in 2021 “Kidney donations to family members, the solution is within us all”. In 2020, the year disturbed by the Covid 19 sanitary crisis, 2,595 transplants were performed, including 390 (15%) thanks to a living donor. Slightly over 42,000 people are currently living with a transplanted kidney.

III. What are the other changes introduced by the 2021 bioethics law ?

  • It extended the duty of information to all people aged over 16 years. It demands in particular that general practitioners (art. R.1211-50) must ensure that every patient is informed about the possibility of organ donation and its procedure, and asks school and preventive medicine doctors in higher education establishments (art. R.1211-51) to participate in the provision of information to pupils and students over 16 years of age on organ donation for transplant purposes and the procedure for giving consent.
  • It modified the procedures for the organisation of expert committees tasked with authorising organ collection by the Biomedicine Agency and their operating conditions (art. R.1231-5 to R.1231-8 CSP).
  • It has modified the conditions for the collection of haematopoietic stem cells from minors or adults subject to legal protection measures, for the benefit of the father and mother. This is known as a “bone marrow transplant”. The haematopoietic stem cells are produced by the bone marrow and are originally red corpuscles, white corpuscles and platelets. They are therefore collected for grafting purposes in order to combat blood diseases. Up till now, such collection was authorised from minors or protected adults, in the absence of any therapeutic solution, for the sole benefit of brothers and sisters or “exceptionally” for the benefit of cousins, uncles/aunts, nephews/nieces. The 2nd August 2021 law now extends the possibility of such collection for the benefit of the parents of the donor under certain conditions. In view of the vulnerability of the minor or protected adult and in order to avoid any conflicting interests, the decree organises the designation of an ad hoc administrator to represent the minor (art. R.1241-13 CSP) or protected adult (art. R.1241-8).

It remains difficult to evaluate the impact of the new provisions of the law. The data have not yet been published and we shall no doubt have to wait several years before knowing whether there is an upward trend of donations and transplants following the alleviations introduced by the bioethics law adopted in 2021.

An increase in the number of donations is desirable, as the level today is inadequate compared with the number of potential recipients, but these new measures call for caution, in particular on the delicate question of the gathering of consent.

 

organ donation

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2021 Bioethics law : Pre-natal diagnosis

2021 Bioethics law : Pre-natal diagnosis

by | July 19, 2024 | Bioethics Law

2021 Bioethics law : Pre-natal diagnosis

Table of contents

 

I.Diagnosis and screening, what is the difference ?

II. What changes were introduced by the 2021 bioethics law ?

III. PND and ethical questions

Pre-natal diagnosis or PND covers all the medical practices for detecting anomalies or malformations of a baby at the foetal or embryonic stage. According to article L2131-1 of the French health code “Pre-natal diagnosis refers to the medical practices, including obstetric and foetal ultrasound scans, aimed at the detection in utero of particularly serious conditions in the embryo or foetus.”

 

Pre-natal diagnosis is aimed at a triple objective :

  • Improvement of the medical treatment of children born with a health problem,
  • Preparation of parents socially and psychologically for the arrival of their baby with special needs, but also in certain cases,
  • Asserting the serious nature of certain pathologies in order to undertake a medically induced abortion, which is authorised in France up to the term of the pregnancy.

When a foetal anomaly is detected, it must be asserted by one of the multi-disciplinary pre-natal diagnosis centres (CPDPN), which are supervised and approved by the French Biomedicine Agency (ABM).

I. Diagnosis and screening, what is the difference ?

 

Pre-natal diagnosis is based on imagery examinations and biological dosages, but also more invasive examinations (amniocentesis). The first tests conducted during pregnancy are generally SCREENING tests (ultrasound scan, blood dosage based on a blood test from a sample of the mother’s blood), and indicate the need or otherwise to conduct a DIAGNOSIS, in general via an amniocentesis or sampling of chorial villus, examinations which involve a far from negligible risk of miscarriage ( 0.5% to 1%).

Introduced in France in 2013, non-invasive pre-natal diagnosis (NIPD) is a pre-natal screening technique, which enables the early detection of chromosome  anomalies in the foetus and in particular forms of trisomy 21, trisomy 13 and 18. From a simple blood test of the pregnant mother, the NIPD test analyses fragments of the foetus ADN, which circulate in the mother’s blood during pregnancy.

Free of charge since 2018, this test is undertaken by many mothers who are unaware that it is not compulsory. The High Authority for Health (HAS) recommends inclusion of the analysis of the free ADN circulating in the mother’s blood of chromosome 21 when the risk of trisomy 21 of the foetus is considered in regard to the mother’s age, the dosage of serum markers (PAPP-A, ß-HCG) or ultrasound scan measurement of nuchal clarity.

According to the DPN 2022 activity report by the ABM, the screening of aneuploidy (chromosome anomalies), including trisomy 21, remains the most frequent via various methods:

  • The screening of trisomy 21 by the mother’s serum markers (618 027 women tested in 2022, i.e. 85.5 % of births, compared with 629 688 women screened in 2021),
  • NIPD whose number has increased since 2021, reached 129 804 in 2022
  • Aneuploidy diagnosis by foetal karyotype, an invasive examination which consists in taking a sample to confirm the diagnosis of the screened anomaly. The reduction in 2022 is linked in particular to the increase in NIPD and diagnosis by chromosome analysis by ADN chip (CAAC), claimed to be more accurate than the karyotype test.

II. What changes were introduced by the 2021 bioethics law ?​

 

  1. Extension of PND to a genetic investigation of the parents in the event of a fortuitous discovery during the habitual examinations :

Whenever genetic information is discovered during a test without being specially targeted, it is used in the context of “foetal medicine”, previously known as pre-natal diagnosis. According to article L. 2131-1, VI 

“The pregnant mother is also informed that certain medical biology examinations for diagnostic purposes […] may reveal foetal genetic characteristics with no definite relationship with the initial indication of the examination and that, in such case, further investigations, in particular examinations of the genetic characteristics of each parent, may be conducted under the conditions of the device specified at article L. 1131-1.

  1. Changes introduced by the bioethics law on medically induced abortion (MIA)

The law does not substantially modify MIA but nevertheless introduces significant changes to the conditions in both substance and form.

  • Partial abortion of a multiple pregnancy

“Embryonic reduction” is the term used to describe the practice which consists in eliminating one or more foetuses in the context of a multiple pregnancy, even if they are in good health. The August 2021 bioethics law specifies that an “embryonic reduction” may be conducted before the end of the twelfth week of pregnancy if it “reduces the risks of a pregnancy where the multiple nature is a hazard for the health of the mother, the embryos or the foetuses” (art. L. 2213-1, II).

The conditions are less stringent than for a standard abortion in that the “hazard”, which is liable to affect the health of the mother as well as the embryos or the foetuses according to the age of the pregnancy, does not necessarily have to be serious.

  • Abortion for non emancipated minors

The law applies to MIA the provisions which exist for abortions for minors. Even in the event of refusal by the parents or a possible guardian, an MIA may be performed on a minor providing the pregnant minor is accompanied by an adult of her choice, as in the case of abortion.

  • Notification obligation by the doctor in the event of refusal to practice an MIA

The 2021 bioethics law added article L. 2213-4 specifying that “any doctor who refuses to practice an MIA must notify the pregnant mother without delay of the said refusal and immediately provide her with the details of practitioners liable to perform the procedure“.

  • Deletion of the cooling-off period

The law finally deletes the obligation to allow the pregnant mother a cooling-off period of at least one week before ending the pregnancy in the event of a high probability that the child to be born will be suffering from a particularly serious condition which is recognised as incurable at the moment of diagnosis.

 

 

III. PND and ethical questions​

In the field of pre-natal diagnosis, major progress now ensures better anticipation during pregnancy, of the possible need for the treatment of the child at birth, or even in utero. Nevertheless, as the diagnosis of an anomaly in the child to be born most often leads to an MIA, there is every reason for doubt.

Gradually PND combined with a proposed MIA has become the “good medical practice”. Trisomy has become emblematic : France holds the world record for its screening.

In the event of a chromosome anomaly, no treatment, or support are offered. In 2021, 1 861 “particularly serious assertions” were thus issued following a trisomy 21 diagnosis. According to the ABM report, in 2021, 97% of women who had received such an assertion from the CPDPN in view of an MIA for a foetal reason resorted to it.

In 2021, the UN committee for the rights of the handicapped criticised France for its systematic pre-natal screening policy for trisomy 21, which is demeaning for those suffering from handicap.

The growing technicality of pregnancy has generated a vicious circle where :

  • The medical profession feels obliged to screen anomalies in utero by constantly improving the PND tools ;
  • Parents expect ever more from technical progress in order to achieve a child with the least possible defects.

Among the expected progress, note the need to guarantee to future parents truly free consent by the development of all the measures necessary to facilitate the acceptance of a child for which a disease or a handicap has been detected, which is not the case today.

During the debates for the 2021 bioethics law, experts and MPs denounced the eugenics of the PND practices in France. In an Advice issued in 2022, the National Consultative Ethics Committee insisted on the need for “announcement ethics”, including three criteria :

  • Firstly, the plurality of options (information is of true ethical value when it enlightens, without dictating, a choice which remains open to different possible actions).
  • Then neutrality (calling for the greatest oratory caution when mentioning the possibility of an MIA,: “The simple fact of considering the possibility of an abortion can act as an incitement, insofar as, tacitly, the doctor judges the situation to be concerning”).
  • Finally, temporality (the time factor is part of the conditions for non constrained thought).

 

Conclusion 

Pre-natal diagnosis should be aimed exclusively at the medical treatment of the anomalies detected. Any policy in favour of support for the handicapped and medical research cannot today ignore consideration of the temptation for eugenics which is invading our society.

 

Further reading :

2021 Bioethics Law: Pre-implantation Genetic Diagnosis (PIGD)

2021 Bioethics Law: Pre-implantation Genetic Diagnosis (PIGD)

by | June 27, 2024 | Bioethics, Infertility

2021 Bioethics Law: Pre-implantation Genetic Diagnosis (PIGD)

Table of contents

 

I. What exactly is PIGD?

II. Resorting to PIGD in France in a few figures

III. The special case of a Double PIGD: PIGD-HLA, the so-called “double-hope baby” technique

IV. What are the stakes involved in PIGD?

I. What exactly is PIGD?

 

PIGD is a screening technique for embryos. This biological diagnosis is conducted in vitro prior to the possible transfer of the embryo into a uterus. It can enable the detection of genetic and chromosomic anomalies. PIGD involves de facto in vitro fertilization (IVF) in order to conceive the embryos, and therefore the collection and preservation of gametes beforehand (sperm and oocytes) from the parents. Resorting to an ART procedure (ovarian stimulation and puncture, IVF…) is inevitable.

This technique, which has been authorised since 1994, is conducted using cells drawn directly from the embryo, a few days after fertilization, before or after a freezing period. Despite this removal, the embryo will continue to develop.

In 2021, 305 babies were live-born (from 290 childbirths) following a PIGD procedure. To understand the growth in the number of cases of PIGD, there are now six times more than in 2007, when 50 babies were born following its use.

 

A. Who is concerned by PIGD?

In France, PIGD is used essentially in a context of personal or family antecedents. Its use by people who wish to become parents is authorised exceptionally under certain conditions:

  • When it is known that the couple (or the single woman applying for ART involving an anonymous sperm donation), due to family history, has a strong probability of giving birth to a child suffering from a particularly serious genetic disease which is recognised as incurable at the moment of diagnosis.
  • If the genetic anomaly or anomalies responsible for the disease have been identified previously and precisely, in one of the parents or one of their immediate ascendants (in the event of a seriously invalidating disease which is revealed late and which prematurely threatens life expectancy).
  • The diagnosis cannot have any purpose other than searching for the disease as well as the means of preventing and treating it.

In simple terms, although resorting to PIGD is authorised for a couple who have already had a child carrying a disease, the diagnosis may only be used to search for the presence or absence of that precise pathology in the embryos and not to look for any other indications.

 

B. What becomes of the embryos which have been subjected to PIGD?

If the embryo is free of the pathology concerned, it may be decided to implant it in the uterus or to freeze it for subsequent implantation. If the anomaly or anomalies are found on the embryo, it is destroyed or the couple or woman may agree to donate it for research.

 

C. Which are the indications for which PIGD is authorised and possible?

The Biomedicine Agency (ABM) provides a list of the indications which qualify for a pre-implantation genetic diagnosis in France. In 2021, a total of 403 different genetic diseases have benefited from diagnostic technique development with a view to PIGD. Obviously, this figure is increasing all the time, whenever new anomalies become detectable and identifiable. Among the pathologies most frequently sought, is mucoviscidosis, Huntington’s disease, X fragile syndrome, sickle-cell anaemia, certain muscular dystrophies etc.

II. Resorting to PIGD in France in a few figures

Each request for PIGD is examined by a multidisciplinary pre-natal diagnosis centre (CPDPN). 1366 requests were examined in 2021 (the latest figures available from the ABM). This figure is higher than for the previous years (in 2017, there were 1018. In 2015, 766).

In 2021, 869 requests were accepted. Therefore, slightly less than two thirds of requests (63.6%) nationally are recognised as being eligible for PIGD. This proportion, on the other hand, is decreasing regularly. Therefore, on average, there are more requests but less acceptable cases. There is also a strong disparity between the different centres. Nantes reports an acceptance rate of 81.2% whereas in Paris it is 52%.

III. The special case of a Double PIGD: PIGD-HLA, the so-called “double-hope baby” technique​

The designer-baby technique, sometimes known as the “double-hope baby” requires the generation of a very large number of embryos in vitro, followed by double screening. It consists in conducting a double diagnosis. First, to select the embryos which are exempt from the given pathology (suffered by a child of the couple). Then, among those embryos, a check is made to see whether or not they are immunologically compatible with the child already born. Whence the term HLA attached to PIGD. HLA signifies: “human leucocyte antigen” and contains a major part of the human immunity system.

Subsequently, if a compatible healthy embryo has been conceived, it will then be implanted in the mother’s uterus. Once the child is born, stem cells will be taken from this “double-hope baby”, first from placenta blood or, later on, from its bone marrow, to be administered to the elder sick child. The probability of achieving a compatible healthy embryo is very low (around 10%). When this is combined with the habitual high failure rate experienced with ART, the chances of a successful pregnancy are therefore quite minimal.

Moreover, the progress achieved in the collection, storage and donation of umbilical cord blood provides an ethical means of meeting this type of therapeutic need, making the PIGD-HLA technique even more unacceptable. Nowadays, the probability of finding a compatible donor is increasing year by year thanks to the solidarity network woven by worldwide registers. Today, umbilical cord grafting is an operational practice and represents some 8% of the total grafts of haematopoietic stem cells in France (this proportion rises to 27% of grafts in children).

This technique poses serious ethical and moral problems. It considers the birth of a child, not as an end in itself, but as a means. The mere fact of rejecting healthy embryos (but which are not HLA compatible) shows that the child to come is not primarily desired for itself, but in fact for another. This technique can give parents false hope.

Moreover, it is difficult to imagine the psychological burden to be borne by the child regarding the role set for it: to be the saviour of its brother or sister. What impact could that have on the construction of the child’s personality? Knowing that it owes its very existence to the result of a screening process, whose aim is to save another, is far from innocuous. Added to this is the possibility that the bone marrow punctures will need to be repeated throughout its lifetime. What about if the therapeutic graft is a failure, what then becomes of the child, and the family with it?

Umut-Talha, the first French “medicine child”, was born in 2011, conceived in order to treat a sister suffering from beta-thalassemia, a genetic disease due to a haemoglobin anomaly. Since then, requests have always been extremely rare, a mere 38 between 2006 and 2014. Hôpital Béclère, the only hospital to have practiced PIGD-HLA, even discontinued the procedure in 2014 as the activity was considered too lengthy and arduous, both for the couples and for the medical teams involved. The technique is rarely proposed, rarely requested and rarely performed.

In the new bioethics law adopted by the French parliament in 2021, this measure was however maintained although some MPs sought to delete it. Certain conditions have even been relaxed. Indeed, the 2021 law no longer demands that all healthy embryos stored for a couple should be implanted before attempting any new IVF (article L 1231-4 of the public health code) in order to conduct a double PIGD, which was stipulated by the law previously.

IV. What are the stakes involved in PIGD?​

In certain nations, such as the United States, PIGD is already used for selecting embryos according to their sex, aesthetic criteria (eye colour) and even to choose embryos suffering from a handicap. A real market has developed around this eugenic “service”. Additionally, a survey has revealed that 3% of parents suffering from genetic deafness intentionally choose to resort to PIGD-IVF in order to select an embryo, also suffering from deafness. The parents wish to pass on their handicap as a heritage, for their child to share the same means of communication.

Currently in France, the context of PIGD is limited to hereditary anomalies only, which are particularly serious and incurable at the time of diagnosis. But the logic inherent in the technique is intimately dependent on embryo screening. Already, some people wish to obtain an extension of the indications, in particular to open up its potential to others who are not suffering from hereditary genetic diseases. In particular for PIGD-A (where A stands for aneuploidia, which means an abnormal number of chromosomes, which is the case in trisomy).

In France, strong pressure is being applied for ever more widespread screening. A slippery slope towards PIGD for EVERYTHING and for EVERYONE, against the backdrop of an increasing myth in the quest for the “perfect baby”. The slide is already well under way. First, these tests were authorised only to track very serious diseases. Then less serious. Then, simple predispositions.

When embryos are conceived in vitro, by IVF, in the context of an ART procedure for couples suffering from infertility, the embryos are in a way made available to biologists. Some people are pleading for these embryos to be screened prior to implantation. The mechanical and technicist logic is established. Since the technique is available, why not use it, and thus, avoid storing and implanting embryos which may be suffering from trisomy, for instance, since that condition would be detected subsequently during pregnancy, and could lead to a therapeutic abortion, which is more traumatic for both the pregnant woman and the medical staff.

Thus, the slide towards consensual technological eugenics has never been so relevant. The ethical stakes are immense: it constitutes a wilful breakdown towards a form of quality control of embryos, in the absence of any identified risk. For example, which trisomies would be eligible for the test? Which ones would pass through the selection screening?

Finally, PIGD is not a foolproof diagnosis. There is a risk of false positives as well as false negatives. There may also be cases of mosaic embryos, where cells coexist in a given embryo which give different diagnosis results.

Within this PIGD technique true stakes for humanity are being played out: the manner in which a society considers childbirth and childcare. And the consideration of human procreation, subject to ever increasing pressures from the technique, the market and the law of the survival of the fittest. That, in fact, of refusing to submit life to biotechnologies.

2021 Bioethics Law: Assisted Reproductive Technology (ART)

2021 Bioethics Law: Assisted Reproductive Technology (ART)

by | April 26, 2024 | ART

2021 Bioethics Law: Assisted Reproductive Technology (ART)

Table of contents

 

I. The ART technique available without any medical indication

II. Self-preservation of gametes without any medical indication is also instituted

III. The impact on filiation

IV. Donor anonymity and the question of origins

V. Filiation of children born by surrogate motherhood abroad

VI. Techniques which remain prohibited

I. The ART technique available without any medical indication

Deletion of the requirement for a medical indication of confirmed infertility for the use of Assisted Reproductive Technology techniques represents a major change in the law. The choice of ART is simply conditional on the existence of a “parental project”.

Heralded as the “ART for all“, the law authorises and organises access to Assisted Reproductive Technology techniques for women, whether single or in a partnership. Article L2141-2 of the public health code now stipulates that “Assisted Reproductive Technology is intended to satisfy a parental project. Any partnership consisting of a man and a woman or two women or any single woman qualifies for Assisted Reproductive Technology”.

In its wording, the focus is on the “parental project”, placing the will of the individual or the couple at the heart of the process. The wording applicable since 2011 and which has therefore been repealed stipulated that: “Assisted Reproductive Technology is intended to correct the infertility of a couple or to avoid transmitting to the child or a member of the couple of a particularly serious disease. The pathological nature of the infertility must be diagnosed medically”.

The extension of ART with a third-party donor to single women or two-women couples has an undeniable effect of doing away with the father and the paternal lineage. A decree issued in September 2021 specifies age conditions for such access:

  • Ovocytes may be collected from the woman up to her 43rd birthday;
  • Sperm may be collected from the man up to his 60th birthday.

In the case of ART for a couple, the law maintains the requirement for prior consent of each member of the couple before resorting to Assisted Reproductive Technology. “Both members of the couple or the single woman must consent prior to the artificial insemination or transfer of embryos.”

The law has also done away with the prohibition of ART with a double donation of gametes, when a couple accepts a donation of both oocytes and sperm. In the previous version of the law, a couple could not accept such a double donation. The intention was to maintain as far as possible a genetic link between the child and at least one of its parents. In the event of double infertility, the couple could ask for the donation of an embryo.

II. Self-preservation of gametes without any medical indication is also instituted

According to the Agency of Biomedicine (ABM) in its brochure on the subject, “The purpose of self-preservation of gametes is to have them available if, later on, a child project should require ART (Assisted Reproductive Technology)”. The ABM also points out the role of individual will: The indication is not of a medical nature but is the result of the person’s choice. That is the novelty introduced by the 2021 bioethics law.”

The same decree in September 2021 determined the age criteria for such self-preservation:

  • Oocytes may be collected from women from their twenty-ninth till their thirty-seventh birthday;
  • Sperm may be collected from men between their twenty-ninth and their forty-fifth birthday
  • The collected gametes are preserved in centres which are approved for the purpose.
  • The law states that each year, the person having undertaken such preservation must indicate whether they wish to:
  1. Preserve them,
  2. Use them for ART,
  3. Make them available to persons waiting for a donation of gametes,
  4. Donate them for scientific research,
  5. Terminate their preservation.

It is important to note that for self-preservation of sperm, the man may consent for part of the sperm collected to be donated. In the absence of any response to reminders for 10 consecutive years, the gametes are destroyed. In the event of death, their preservation is terminated, unless the person whilst alive had consented to a donation or research. Although the costs of the procedure associated with the collection of gametes are covered by health insurance, their self-preservation incurs a charge of 40.5 euros per year.

The import and export of gametes or germinal tissues from the human body are subject to authorisation delivered by the Agency of Biomedicine. They are exclusively intended to allow the completion of a “parental project” through ART, at the exclusion of any commercial gain.

The question of export, combined with the destruction in the event of death, has recently given rise to complex cases of precedent.

III. The impact on filiation

Prior to the 2021 law, the ART techniques tended to imitate natural procreation, in order to guarantee for the child that its filiation is consistent with respect to the biological requirements for procreation (a mother and a father). In order to undertake ART with a donor, the candidate couple must certify their consent with a judge or a lawyer. This consent procedure underlines the difficulty with this type of procreation of ensuring that the child thus conceived will be cared for and brought up by a father and a mother to compensate for the existential lack of one of the biological parents.

Extending its availability to single women or to two-women couples necessarily impacts this model. The filiation becomes mainly based on the will, established by the existence of a “parental project”, instead of a link or a biological reality.

  1. In the context of a man and woman couple, the rules governing the establishment of filiation are unchanged. The maternal filiation is established with respect to the woman who gives birth to the child. If they are married, the paternal filiation is established on the presumption of paternity. If they are not married, it is established through voluntary recognition.
  2. In the case of a single woman, resorting to ART involves a third-party sperm donor. The filiation of the child is established with respect to the woman who gives birth and who is recognised as the mother. If the single mother subsequently marries a man, he may submit an application to adopt the child. The same applies if she marries a woman.
  3. In the case of a two-women couple, whether married, in a civil partnership or not: resorting to ART involves a third-party sperm donor. The filiation of the mother is established automatically to the woman who gives birth. A joint recognition in anticipation certified by a lawyer for the other woman enables the establishment of filiation.

In the event of non-presentation of the lawyer-certified recognition in anticipation when registering the birth, the second woman can only be mentioned as a mother in civil records at the request of the Public Prosecutor, and only the woman having given birth will have parental authority over the child. The French National Assembly did not accept the proposal by the Senate for recognition via the already available channel of adoption. Currently, birth certificates can therefore mention two women as mothers of the child.

IV. Donor anonymity and the question of origins

The law also has a section concerning access to origins for children conceived through donated gametes. It puts an end to the anonymity of donors, the principle established in the first bioethics law in 1994 and registered under article 16-8 of the civil code. This anonymity concerned the identity and so-called “non-identifying” data. These are identified in the public health code:

  1. Their age at the moment of the donation
  2. Their general state as they describe themselves at the moment of the donation, with respect to their perceived general state, psychological state and in terms of physical activity;
  3. Their physical characteristics, in particular their height and weight at the moment of the donation, skin colour, natural hair colour and colour of their eyes;
  4. Their family and professional situation, consisting merely of their marital status, their number of children, their educational level and their socio-professional status;
  5. Their country of birth;
  6. The motivations for their donation, in their own hand.

This anonymity was required at the time as a corollary for the free of charge donation, and was considered as a condition for the development of ART techniques. With the passage of time, the anonymity has been unable to withstand research into their origins by children conceived through such techniques, once they became adults. This research has brought to light an intrinsic paradox in ART.

On the one hand, the biological and genetic links are kept under wraps in the “legal fiction” (a term employed by jurists) of the filiation of the child conceived by ART. On the other hand, the importance for the child to know its origins, the importance of its biological heritage cannot be denied, quite apart from any medical questions. A genetic lineage, is also a family history.

Moreover, the right to know one’s origins “as far as is possible” is recognised for the child by article 7 of the United Nations International Convention of Children’s Rights, which convention has been ratified by France.

Henceforth, those born through ART may, on reaching adulthood and at their request, apply for access to the identity of their donor (name at birth, first names, sex, date and place of birth) as well as their non-identifying data. A Commission (CAPADD) has been created to deal with requests for access by those born through ART to the data of their third-party donors. It comes under the authority of the Health Minister and is presided over by a judiciary magistrate. These procedures have been made available since 1st September 2022.

As indicated on the Health Ministry web site: “As from 1st September 2022, those who wish to donate their gametes or offer their embryos will have to expressly consent to the communication of their identity and their non-identifying data. In the event of refusal, they will not be able to proceed with their donation. Such consent shall be collected by the doctor at the donation centre and will be retained by the centre. As soon as the donation is used, the donation will not be revocable.

For adults born from donations made prior to 1st September 2022, the right of access will be subject to the consent of the donor for the communication of their identity and non-identifying data, which was not a prerequisite for donations prior to that date.

The effect of this reform will not be immediate: the first children born in 2023 who so request will have access to their origins only from 2041, without having any right for any relation with the donor. For children born under the regime of the previous law, they may submit a request and receive the information if the donor, once located and contacted, so accepts.

V. The filiation of children born by surrogate motherhood abroad

Surrogate motherhood remains prohibited as a principle in France, by a law dated 1994 relative to respect for the human body. An article in the civil code establishes that “Any convention concerning the procreation or gestation on behalf of another is invalid.” The 2021 bioethics law and the debates which went with it have not deleted this prohibition.

Some French nationals nevertheless decide to resort to such practice – which exploits a woman’s body and makes the child the subject of a contract, separated at birth from the person within whom their life took form – abroad, in certain nations where such practice is tolerated. This is how certain requests have been made in France for the transcription of birth certificates. These sleeping partners of surrogate motherhood have forced French law to evolve over the last years.

The court of appeals finally authorised the full transcription of the birth certificate of a child born through surrogate motherhood abroad subject to the facts declared on the certificate being compliant with the foreign law. In other words: to declare as mother the sleeping partner of the surrogate motherhood, who had not carried or given birth to the child, and to delete from the birth certificate the mother who truly carried and gave birth to the child in question.

The claims by sleeping partners referred up to the European Court of Human Rights. Their decision went against France, which did not appeal the decision thus signalling a lack of political will to truly combat surrogate motherhood.

But through the latest revision of the bioethics law, this subject is covered in an amendment which cancels and unifies the precedent. The civil code has been supplemented in order to specify that the recognition of filiation abroad must be “considered with respect to French law”, which still prohibits surrogate motherhood conventions (Civil code 16-7) and which, apart from the exceptions which it determines, attaches the maternal filiation to the woman giving birth and does not allow, except through adoption, the establishment of a double paternal filiation.

VI. Techniques which remain prohibited

Despite the requests for amendments submitted during consideration of the law, certain techniques remain prohibited:

  • Post-mortem ART (after the death of one or both members of the couple, for whom gametes or embryos have been cryopreserved),
  • The so-called ROPA method (“Reception of the oocyte by the partner”) where the oocyte of one is collected, fertilized in vitro by a third-party donor before being implanted in the uterus of the other woman.
2021 Bioethics Law: Research on the Human Embryo and Stem Cells

2021 Bioethics Law: Research on the Human Embryo and Stem Cells

by | April 26, 2024 | Human embryo research

The question of research on the human embryo started to emerge essentially for reasons associated with the existence of a stock of so-called “supernumerary” embryos. These supernumerary embryos were conceived in the context of medically assisted procreation (ART), and subsequently abandoned by the couples who produced them.

We are referring here to a very particular type of research, since it involves a human being at the very beginning of its life. To consider a human embryo as a research material like any other, thus poses serious ethical questions.

 

Table of contents:

I. Chronology of the laws regulating research on the human embryo

II. Definitions and different types of research

III. Specific framework regulating research on the human embryo

IV. Specific framework regulating research on embryonic stem cells

V. Specific framework regulating research on induced pluripotent stem cells

VI. What becomes of the so-called “supernumerary” embryos?

I. Chronology of the laws regulating research on the human embryo

The law regulating this research is ever changing at each revision of the bioethics law.

  • 1994: Total prohibition of research on the human embryo
  • 2004: Prohibition with dispensations for 5 years and subject to conditions
  • 2011: Prohibition with dispensations with no time limit and subject to conditions
  • 2013: Deletion of the prohibition principle
  • 2021: Relaxation of many of the conditions

The first bioethics laws in 1994 logically introduced a total prohibition of all research on the human embryo. This rule had been asserted in line with the consequences of article 16 of the French Civil Code which establishes that “The law establishes the primacy of the person, and prohibits any assault on its dignity and guarantees the respect of the human being from the very beginning of its life”.

In fact, such prohibition established the recognition of the embryo as belonging to humanity, which already forbids it from being considered as a mere material for experimentation, but also recognises its human destiny. Consequently, destined to live and die like all human beings. This is what led the legislator to state that embryos could only be conceived in vitro with a view to being implanted in the mother’s uterus (in the context of medically assisted procreation).

The destiny of an embryo from a couple who no longer wished to foster it would therefore be limited to one of two options: live (by being donated to another couple) and failing that, to die (its preservation being terminated).

That is also the reason why it is prohibited to create embryos specifically for research.

The humanity of the embryo was reasserted by the legislator in the 2004 and 2011 bioethics laws even if the prohibition on research was already diminished by temporary dispensation exceptions. Since 2013, the principle of prohibition of research on the human embryo has been deleted. Finally, in 2021, the bioethics law considerably reduced the protection due to the human embryo by facilitating its availability and its exploitation.

Currently in France, some 80 teams of research scientists are authorised to conduct such research. Around twenty research programmes are being conducted on human embryonic stem cells (hESC), and 8 research programmes have been authorised on the human embryo. (Of those 8, only 2 are subsequent to the 2021 law.)

II. Definitions and different types of research

 

It should be noted that prior to 2021, embryonic stem cells were subject to the same legal restrictions as embryos, which was logical, since they are taken from embryos. But the law dated 2nd August 2021 afforded them a specific legal framework, considerably facilitating their access and relaxing the measures governing the research protocols.

It is now possible to distinguish several types of research within that legal framework:

  • Research on the human embryo as such
  • Research on embryonic stem cells, taken from a human embryo
  • Research on “induced” pluripotent stem cells, so-called IPS.

Note that within these different categories:

  • The human embryo is always obtained by ART. The embryos may be made available for research in 2 cases: either because they are no longer part of any “parental project”, to use the official term, or because following embryonic selection (following a preimplantation diagnosis), it is decided not to implant them.
  • Human embryonic stem cells (hESC). These cells are sourced directly from the embryo and are taken at a very early stage of its development. These cells are of particular interest for research scientists and industry because they have the ability to multiply ad infinitum and also to specialise into most types of cells of the human organism (this is known as pluripotency).
  • When a human embryo is subject to research or used as a source of cells in the context of a research programme, it is invariably destroyed.
  • IPS (Induced Pluripotent Stem cells): these are stem cells induced artificially from differentiated adult cells, into which four pluripotent genes are introduced. This manipulation – known as “reprogramming” – gives them an ability to differentiate into any type of cells and to multiply ad infinitum. All the cells which proliferate may be used to generate IPS cells. Those most commonly used are blood and skin cells.

Now that the different types of research and cells have been clarified, we shall explain the specific legal framework surrounding each type. Since the 2021 Bioethics Law, this is the current situation:

III. Specific framework regulating research on the human embryo

 

A. The research is subject to authorisation from the French Biomedicine Agency

B. So-called “scientific” conditions:

  • 2021 Law: “Scientific pertinence must be established”. This criterion is rather vague, and is often relaxed. Without being scientifically necessary, the research must not be whimsical.
  • 2021 Law: Requirement for a “medical purpose or aiming to improve knowledge of human biology”.

This criterion has constantly been relaxed over the years.

 

In 2004, the research had to enable “major therapeutic progress”. (Which could not be achieved by alternative methods); in 2011, the law merely required the research to allow “major medical progress” (a relaxation intended to facilitate fundamental research).

In 2013, the research on the human embryo had to have a simple “medical purpose”. Now, this may simply be an aim to improve the knowledge of human biology, which is extremely vast and fails to guarantee respect for ethical criteria.

  • 2021: The law merely demands that “in the current state of scientific knowledge, the research cannot be conducted without resorting to human embryos”

When the dispensation regime extended research to the human embryo, it was conditional on a demonstration of the absence of any alternative method of comparable effectiveness. This criterion has since been relaxed. Already in 2013, the law had deleted the intention of the preference for alternative methods.

C. Special measures:

  • Their development in vitro is terminated no later than the fourteenth day of growth.
  • The conception of embryos is possible only in the context of ART (medically assisted procreation). It is prohibited to conceive embryos for the sole purpose of donating them to research.
  • The embryos on which research has been conducted cannot be transferred for gestation purposes. They are destroyed.
  • Free of charge: The embryos are given up without any financial compensation. The supply of embryos for financial gain is prohibited.
  • Consent: (of the couple, surviving member or woman).
  • It must be reiterated within 3 months and is revocable providing no research has taken place. Since the 2021 law: The information on the other possibilities authorised by the law is no longer mandatory (donation to a couple, termination of preservation etc.)
  • Anonymity: No information liable to identify the embryo originating couple can be communicated to the research team.
  • The article specifying that “The creation of transgender or chimerical embryos is prohibited” was deleted by the 2021 law.

Concerning transgender (genetically modified) embryos, this article is replaced by: “The in vitro conception of human embryos by the fusion of gametes or constitution by cloning of human embryos for research purposes is prohibited”. (L.2151-2 and Art.18 Oviedo convention). The wording has therefore changed. The words “by the fusion of gametes” (which corresponds quite simply to the natural fertilisation phenomenon, between an oocyte and a sperm) have been introduced.

As a result, “embryos” created by other procedures are not concerned by this prohibition. This opening is intended in particular to avoid preventing research on “embryo models”.

For “chimera” (mixed embryos between human and other species), the 2021 law states that: “The modification of a human embryo by the addition of cells coming from other species is prohibited”. The converse is therefore no longer prohibited: It is possible to integrate human cells (in particular embryonic cells, but also IPS cells) within embryos of other species.

IV. Specific context of research on human embryonic stem cells (hESC)

This research is subject to declaration to the French Agency of Biomedicine (ABM).

The Managing Director of the ABM may oppose the declaration.

A. Special measures

  • The hESC must derive from embryos resulting from an authorised research protocol or an hESC subject to an importation authorisation.
  • The gametes obtained by hESC (i.e. by the transformation of the hESC into oocytes or sperm) can under no circumstances be used to fertilise another gamete, obtained through the same process or from a donation.
  • Special case. If the protocol concerned is aimed at the differentiation of the hESC into gametes, the obtention of embryonic development models or the insertion of hESC in an animal embryo for the purpose of a transfer to an animal, the ABM Managing Director may oppose it, on the public advice of the ABM orientation council. In the absence of opposition by the Managing Director of the agency, the execution of the research protocol may begin.

 

B. So-called “scientific” conditions

  • The “scientific pertinence must be established”
  • The research must be part of a “medical purpose or for the improvement of knowledge of human biology”. This extremely broad criterion is therefore not very restrictive.

 

Conscience clause:

Whether for the purpose of research or for the exploitation of embryos or embryonic cells: “No research worker, engineer, technician or research assistant whatsoever, no doctor or medical assistant can be obliged to participate in any way in the research on human embryos or embryonic stem cells authorised in application of article L2151-5”.

V. Specific context of research on induced pluripotent stem cells (IPS)

Such research is subject to a declaration to the Agency of Biomedicine.

If the protocol concerned is aimed at the differentiation into gametes, the obtention of embryonic development models or the insertion into an animal embryo with the intention of a transfer to an animal, such specific research is subject to a declaration to the ABM.

The IPS cells, which do not involve sacrificing human embryos for their development, have often been put forward as a possible alternative to the use of embryonic cells. In reality, these two types of cells are not identical, in particular because IPS cells retain a “trace” of the changes introduced during reprogramming. Therefore, when protocols are conducted using IPS cells, quite often these protocols result in the use of hESC, which are recognised as being the “norm” against which results should be compared.

Research scientists refer to hESC as a “gold standard”. Among the ethical challenges inherent in IPS cells, is the consent by the person who donated the cells, in particular concerning the future usage which could be attributed to these specific cells, inasmuch as their differentiation into gametes or their insertion into an animal embryo (chimera) are not prohibited by the Bioethics Law.

VI. What becomes of the so-called “supernumerary” embryos?

Both members of the couple or the single woman whose embryos are preserved are consulted each year to know whether they wish to retain their “parental project”. If they confirm in writing the retention of their parental project, the preservation of their embryos is maintained. If they no longer have any “parental project”, both members of the couple or the single woman may consent (three months decision period):

  • For the embryo or embryos to be donated to another couple or another woman;
  • For the embryos to be donated to research;
  • For the cells derived from such embryos to be part of a cellular therapy preparation or an innovative therapy medicine for exclusively therapeutic purposes;
  • For their in vitro development to be terminated, (ending of cryogenic preservation) which leads to their destruction.

The absence of consent revocation within 3 months is considered as confirmation. For research or the derivation of cells for a cellular therapy preparation, the consent is revocable as long as the embryo is still intact. Their in vitro development is terminated and they are therefore destroyed:

  • In the absence of any response for at least five years, from the date when the said consent was confirmed;
  • In the event of disagreement between the members of the couple;
  • In the event of death of one or both members of the couple, in the absence of consent for them to be donated to other couples or for research.