Prospects for 3D bio-printers in medicine and research


Three-dimensional bio-printing appears to be a genuine revolution, and some even consider it as the next industrial revolution. Two major innovations in this field were published this month in the media. What is it about? What is at issue? What can it contribute?

The first innovation concerns 3D laser printing with human tissue (or bio-printing). In early February, 2016, Poietis, a start-up from Bordeaux, announced that it had developed human tissue using 3D laser printing “It consists of combining 3D printing technologic and cell biology to create biological tissue, layer by layer”, summarized Fabien Guillemot, ex-scientist at the National Health Institute and Medical Research (INSERM) and founder of this start-up company in 2014. This procedure of laser bio-printing allows living tissues to be printed in two stages: first the printing, then the maturation of the cells and of the matrix which surrounds them. This process of skin creation lasts approximately three weeks. “The laser has several advantages. For example by very high definition, it can reproduce the entirety of tissues with particularly high accuracy. It also ensures 95 – 100 % viability for the cells.”

This technique appears very promising for skin grafts, especially in treating serious burns, but equally for cosmetic research, especially since the European Union has outlawed test on animals since 2013. Poietis has developed its own 3D laser printer which will be functional in the next two years. It may take a decade before the skin grafts can be performed on humans.

The second innovation involves creating transplants by 3D bio-printing techniques: this past February 15, the scientific review “Nature Biotechnology revealed the development of a 3D bio-printer capable of recreating muscle, cartilage and even bones from human stem cells by a team of American researchers at the Wake Forest Institute. “This new printer of tissues and organs represents a genuine advance in our tissue replacement research for patients” declared Professor Anthony Atala, the director of the Institute. “We can make human-size stable tissues of any form. In continuing this development, this technology could be used in the future for printing living tissues and organs for surgical implants.”

This type of transplant is not new, but until now the implants were not well adapted to the receiving organism, principally due to problems in reestablishing vascularisation. The recent trials on mice have been conclusive. In the years to come, this technology could compensate for the growing shortage of organ donations. The production times (a few days to a few weeks according to the type of implant) are much shorter than the usual waiting time for an organ donation.

Many promising prospects are in view thanks to these new 3D printing technologies, but nevertheless they raise ethical questions. Fabien Guillemot responded by saying « We have a self-imposed limit of stopping at repairing tissues and not increasing or improving them”.

MAP-Surrogacy abroad, incoherencies in senatorial report


On February 17, 2016, members of the Senate Legal Commission, Yves Détraigne and Catherine Tasca presented an informational report on the consequences of having recourse to Medically Assisted Procreation (MAP) and to surrogacy abroad, practices which circumvent French law and lead to serious infringements on filiation rules and children’s rights.

This incoherent situation is created by « some couples to bring a child to life, by having recourse, abroad, to means which are unlawful in France (MAP with a donor for single women or for female ‘couples’, surrogacy for infertile male/female couples, or male ‘couples’), then requesting in France the recognition of filiations established abroad”.

The president of the Senate’s Legal Commission, Philippe Bas, launched this informational study in autumn, 2014, in view of decisions delivered at that time by the Court of Cassation on MAP and by the European Court for Human Rights on surrogacy, decisions which called into question the basic principles of filiation in French law. The solutions recommended by both rapporteurs are their own and not the ones of the Parliament nor of the Government, but nevertheless they aim at taking note of these reversals of jurisprudence, and are presented as a “fait accompli”. What was clearly unlawful could be provided an official and legal solution, no matter the fraud to the French law.

A summary of this report is provided below in the annex.

According to Alliance VITA event if the report deserves credit for trying to reinforce prohibition on surrogacy, it doesn’t end the serious legal incoherencies of these practices and perpetuates serious injustices for the children concerned:

  • For MAP, by allowing the adoption by female ‘couples’, the biological link will not be taken into account regarding child’s paternal origins; however for surrogacy, the biological link would remain the determining criterion, since the filiation would be impossible for the intended mother. Why should this biological link be essential in one case in not in the other?
  • The rapporteurs consider that, in the situations examined, MAP raises fewer ethical problems than surrogacy. Yet, the child undergoes a mistreatment regarding his origins which is equivalent in both cases, since the objective remains to intentionally delete one of the two filiations of origin: paternal filiation for MAP and maternal filiation for surrogacy. Furthermore, when practiced by people of the same sex, these techniques deprive the child of the beneficial contributions of sexual alterity. It’s much more necessary to take into account these two fundamental injustices, which go against the genuine interest of the child.
  • The report is making an illusive attempt to find a new legal coherence, which is obviously impossible since the vote in 2013 for the law on marriage and adoption for same-sex couples. This evolution of the legal framework leads to a dead end: on the one hand, it distorts the principles of the adoption and it makes official the “right to have a child”; on the other hand, it may well introduce new forms of discrimination between adult men and women, because it would de facto create the right for filiations for two women while refusing it for two men.

***

Main proposals of the informational report

Firstly, the report explains how national laws are being circumvented by people who resort to MAP or surrogacy practices abroad. The report then suggests adjustments to French legislation, trying to reconcile the need for pragmatic answers and the defense of ethical principles.

* On MAP

The report recalls the current existing legal framework in French law: medically-assisted procreation is only authorized for couples consisting of a man and a woman, of an age to procreate and who have been medically diagnosed with infertility.

The May 17, 2013 law, authorizing marriage and adoption for same-sex couples, now makes it possible for a woman to adopt the child of her female partner. Operating a reversal of jurisprudence, the Court of Cassation then delivered two statements on September 22, 2014: having recourse to MAP abroad “is not an obstacle to pronouncing adoption by the female partner of the child’s mother […], as long as the legal requirements for adoption are respected and as the adoption is in the child’s interest”.

The report considers that this position of the Court of Cassation’s gives “a satisfactory balance”. It mentions the following two consequences:

  • One should no longer oppose this type of adoption, on the one hand because in France the filiations are established “without controlling the conditions of the child’s conception”, and on the other hand, because MAP “does not raise the same ethical questions as surrogacy
  • However MAP should not be open to same-sex couples, because if a medical diagnosis of infertility and sexual alterity are no longer required, it would completely upset the French conception of MAP by paving the way to a “right to having a child” and to a “reproduction for personal convenience”.

* On Surrogacy

The report emphasizes the absolute unlawfulness of this practice on French territory, the connected criminal punishment, thus making it impossible in France to establish the ensuing filiations. But following the decision of the European Court of Human Rights (ECHR) on June 26, 2014, condemning France for refusing to recognize the biological and paternal filiations, the Court of Cassation reversed its jurisprudence with two decisions on July 3, 2015. The State Council also validated the January 25, 2013 circular from the Justice Ministry facilitating the granting of certificates of nationality.

The report considers that certain clarifications are necessary and specifies that in the current debates, two false ideas have circulated: on the one hand, the children born from surrogacy are not “phantoms of the Republic” since they can live in France without any difficulty thanks to the foreign civil act; and on the other hand, the establishment of a purported “ethical surrogacy” would not diminish the numbers of those having recourse to the foreign “business” of surrogacy, as shown by the example in Great Britain. Indeed, the majority of those seeking commercial surrogacy abroad are British, even though the country has legalized “non-commercial” surrogacy for the past 30 years.

The report recommends :

  • strengthening prohibition on surrogacy by reinforcing the criminal punishment for those having recourse to this practice, and by initiating international negotiations so that foreign countries authorizing this practice forbid French people to have access to it on their territory.
  • strictly adhering to the ECHR requirements by “explicitly authorizing the child, and only the child (even if this action is exercised by his parents on his behalf), to establish filiations in a strict respect of the French legal requirements”, that is to say only the child’s paternal biological filiation.
  • to refuse, however, establishing filial relationships with the intended relative (that is the intended mother) so as not to contradict French civil law whereby the mother is the child-bearer.
  • to forbid any actions of later adoption of the partner’s child, in order to establish intended filiation.
  • to facilitate family life “by allowing the intended parent to receive a delegation of life-long parental authority.

Do twin pregnancies constitute a public health problem?


According to a study published early February 2016 in the Population and Development Review, the twinning rate almost doubled in developed countries over the last four decades.

Two main factors account for this phenomenon according to the study:

1° The expansion of medically-assisted reproduction (MAR), which has known a strong development during this period. As well as ovarian stimulation, in-vitro fertilization (IVF) techniques often go with the placement of multiple embryos, a procedure which carries the risk of multiple pregnancies. When the MAR started, obtaining twin pregnancies was seen as a success; whereas nowadays, a low rate of twin pregnancies has become a good criterion as to evaluate the MAR center’s performances.

2° Delayed childbearing, as older women tend to have twins more frequently: if fertility lowers after 35 years old, paradoxically poly-ovulation is more frequent. Indeed, if the risk of multiple births is lower when the mother is 20 years old, it reaches its maximum at the age of 37 (15 births out of 1000). Age increases the level of FSH, the hormone which stimulates follicles and the liberation of ovocytes. Moreover, another factor linked to age could be that the older ovocyte is more fragile and divides more readily at an early stage after fertilization, multiplying the possibility of developing identical twins.

The increase of multiple births continues, especially in France, the United States and the United Kingdom, and gives rise to public health problems. Indeed, these pregnancies present more risks, as much for the baby as for the mother. The biggest risk, often associated with induced deliveries, is premature babies with a higher infant mortality rate. Concerning the mother, there is a higher risk for gestational diabetes and postnatal depression.

The MAR centers lean more and more their recommendations towards single embryo transfer, and to retry in case of failure, after having frozen the other embryos.

CRISPR-Cas9 and genetically modified humans: France must urgently address the issue


Genetically modifying the human genome has become rather simple, accessible, fast and inexpensive with the CRISPR-Cas9 technique, and promises extraordinary leaps in research and genetic therapy.

But the ethical issues raised are important and France must urgently address them. In spite of certain moratorium requests addressed to the international community, a red line has just been crossed: on February 1, the United Kingdom authorized a scientist to genetically modify human embryos, which will later be destroyed. Although these techniques are not yet perfectly operational, they are advancing at vertiginous speed and promise the possibility in the future of creating genetically modified infants, with serious risks of eugenic and scientific abuse. Modifying the genome of an embryo also concerns the future descendants by these modifications transmissible from one generation to the next, in a definitive manner with unpredictable consequences.

Although France ratified the Oviedo* convention, this subject must imperatively be addressed by the scientific, academic, and ethical authorities in France: at issue is the protection against abuses identified by UNESCO “putting the inherent and equal dignity of all humans in danger, thus giving rise anew to eugenics, disguised as fulfilling a desire for a better life”.

On February 9, 2016, Alliance VITA wrote to Mr. Jean-Claude AMEISEN in order that the National Ethics Consultation Committee that he presides, reflect on this issue of major importance. France must assume its position as an ethical reference against all merchandising of the body and in favor of respecting human dignity.

>> For further information: Alliance VITA Notexpert

* The Oviedo convention, in Article 13, specifies that “an procedure with intent to modify the human genome can only be undertaken for preventive, diagnostic or therapeutic reasons, and only if it does not have intend to introduce modification in the genome of any descendants.”

Netherlands: official report against extending euthanasia


In The Netherlands, a report studying individuals who « are tired of living » has just been submitted to the government, concluding that euthanasia should not be extended to this type of situation.

The debate in The Netherlands is currently focused of cases of individuals who are “tired of living” and on the possibility to accord their request to put an end to their life, and to provide the means. The terms « voltooid leven » (life has ended) or « Klaar met leven » (finished with life), are the new key words used to expand the law on euthanasia whose ultimate objective is to make a pill available in an anonymous manner to whoever wishes to put an end to his life.

The doctors have presently allowed euthanasia to be practiced in cases which fulfill the 2002 law criteria on euthanasia. In July 2014, the Health and Justice Ministers set up “a commission of wise counselors” directed by Dr. Paul Schnabel, to study public issues and legal possibilities to enlarge this practice by relinquishing to the requests of individuals who consider their lives to be finished and who want to die.

In its report, this commission judged that the term « life has ended” is a very personal conclusion from individuals who consider that their life no longer has perspectives and who have developed a constant desire to die. Numerous factors can lead to this situation: corporal, psychic, cognitive, psycho-social, and existential.

Therefore, different cases can be described:

  1. those who fit the current law with intolerable suffering due to an essentially underlying medical condition;
  2. those on the borderlines where it is less clear whether the suffering has an essentially medical origin;
  3. those where there is no medical cause;
  4. those without suffering.

The report studies each of these situations. It seems that the number of individuals who esteem that their “life is finished” is rather feeble. This is even truer for cases with a medical origin.

This report also reveals that the viewpoint of legitimacy for assisted suicide for cases of “life being finished” depends on the autonomy approach: either individualist or relational. From the government and society’s point of view, it’s important to weigh the consequences for society if the law is potentially expanded.

This report underlines numerous possibilities to avoid having the impression that “life is finished”: preparation for accepting old-age, assistance for the elderly, improving their autonomy, fighting against loneliness, answering to spiritual needs, careful to give a sense to their existence, reevaluation of life’s value at an advanced age, etc.

The commission considers this to be a question of life and death, and that it is not reasonable to extend the current guidelines. Nevertheless, the fact that such a debate could be held demonstrates the serious consequences for the mentality on euthanasia.