Where Are We With the Bioethics Legislation in France Today ?

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 The wording applicable since 2011 and which has therefore been repealed stipulated that: “Assisted Reproductive Technology is intended to correct the infertility of a couple or to avoid transmitting to the child or a member of the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.

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.