Preimplantation Diagnostics
The preimplantation genetic diagnosis ( PGD ) comprises the methods of cell biological and molecular genetic studies, which serve the decision as to whether a by in vitro fertilization generated embryo in the uterus to be implanted or not.
PGD has been available since the early 1990s and has been used in the conception of over 10,000 children worldwide. It is mainly used to detect hereditary diseases and chromosome abnormalities . It is also possible to choose the child's gender or certain hereditary characteristics. PGD can also be used to create a so-called “rescue baby”, which is suitable as a genetically compatible donor of stem cells for a sick sibling.
PGD is ethically and politically controversial because it raises fundamental questions about the value - and the admissibility of valuation - of developing life. In many countries, including most of the European countries, PGD is regulated by law and allowed for different applications. In Germany it is only permitted to prevent serious hereditary diseases, stillbirths or miscarriages, in Austria only to remedy hereditary infertility, and in Switzerland for both applications.
Concept and delimitation
Research in reproductive medicine |
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Prefertilization diagnosis : examination of the egg cell before fertilization Pre-implantation diagnosis : Prenatal diagnosis : |
Pre-implantation diagnosis is generally the genetic examination of an embryo created outside the body ( in vitro ) before it is implanted in the woman's uterus . Usually, three days after fertilization, if it consists of six to ten cells, one or two cells are removed from the embryo and examined for certain genetic defects (gene mutations). Preimplantation diagnosis usually also includes aneuploidy screening , in which the embryo is checked for the presence of excess chromosomes or the absence of chromosomes.
Pre-implantation diagnostics are to be distinguished from prefertilization diagnostics . With this method, the examinations take place before the cell nuclei of the egg cell and sperm are brought together, i.e. before the embryonic stage . This includes polar body diagnostics , an examination procedure on the egg cell, in which the genetic or chromosomal makeup of the polar body is used to determine the genetic material of the egg cell. It is to be further distinguished from prenatal diagnosis , the examination of the fetus in the uterus.
history
In 1990, the first child was born in Great Britain who had been sexually determined using PGD to prevent the occurrence of an X-linked hereditary disease . Two years later, the first child was born in whom PGD had ruled out a monogenic hereditary disease. While this technique was initially only used in individual cases and to detect a few hereditary diseases, the number of children born worldwide after PGD has already exceeded 10,000.
Areas of application
The more and more widespread use of PGD worldwide is due not least to an expansion of the range of indications . Today, PGD is not only used to detect around 200 hereditary diseases , but also for other purposes, such as increasing the success rate of in vitro fertilization , or for gender selection with or without a disease reference. The expansion of the indication can also be observed in relation to the range of indications in the case of prenatal diagnosis (PND); PGD is used to diagnose diseases that could also be examined in PND, but whose diagnosis is not common.
Screening for numerical chromosomal disorders (aneuploidy)
Today, aneuploidy screening is the most common indication for PGD. For around 15 years, this examination has been used more and more frequently in the context of PGD in infertile couples, mostly of an advanced age. Some have already suffered several miscarriages or several unsuccessful IVF cycles. The declared aim is to weed out embryos with numerical chromosomal disorders, which are considered to be the cause of the problems mentioned, in order to improve the success rate of IVF.
An aneuploidy examination as part of PGD not only increases the chance of having a healthy child, but also the chance of having a child at all. The natural union of egg and seed results in more rejects than offspring. A fertile couple in the prime of conception reach a pregnancy on average only in every fourth cycle of the woman, although fertilization always occurs. Experts estimate that more than four out of five fertilized egg cells never implant themselves in the uterus. The most important cause of these reproductive deficits are chromosomal disorders, so-called aneuploids: If the developing life has more than the correct number of 46 chromosomes or less in its cells, the chances of survival are almost zero. The aneuploidy screening is intended to ensure that only embryos with 46 chromosomes from a woman are used as part of the embryo transfer, so that the chance of a live birth increases.
PGD is also often offered to fertile women over the age of 35. Due to their advanced age, this target group is at an increased risk of having children with a chromosomal disorder such as trisomy 21 in particular .
Detection of genetic diseases
Another possible area of application of PGD is the detection of genetically determined, i.e. H. hereditary diseases that occur in families. PGD is also used less frequently as part of general risk prevention, namely to detect spontaneous new mutations in a family that has not been affected by genetic diseases.
Selection of immunocompatible embryos
PGD has also been carried out since 2001 with the aim of selecting an embryo that is immunologically compatible with a seriously ill sibling. In this context one speaks of HLA typing ( Human Lymphocyte Antigen ) or of the creation of a “savior” or “design baby”. HLA typing typically involves the following scenario: Parents have a child who suffers from a hereditary disease that makes blood formation difficult (e.g. Fanconi anemia , Diamond-Blackfan anemia , β- thalassemia ) or the immune system harms. A suitable blood stem cell donation can help the sick child effectively. Basically, siblings are the most likely to find an immunologically compatible donor. The probability that a naturally conceived sibling is immunocompatible, however, is 25%. IVF and PGD can significantly increase the probability of finding a suitable donor. According to immunogenetic criteria, an embryo is selected from the in vitro generated embryos that matches the diseased sibling. At the same time, in the same PGD procedure, it is excluded that the “rescue baby” is also a carrier for the same disease.
PGD to select an immunocompatible embryo is sometimes also used when the sibling to be cured suffers from a non-hereditary disease such as leukemia . In this case, PGD is carried out exclusively in the interests of the sick child.
Selection of sex without reference to illness
PGD is increasingly being carried out solely with the aim of selecting the sex of the embryo. This indication is usually referred to as “ social sexing ” or “family balancing”. In the USA as well as in Europe, the aim is to enable families to have a balanced relationship between girls and boys, so that no general preference for either gender can be observed. In other countries, on the other hand, the desire for male offspring is the main motivation for gender selection. In Europe, PGD is used in almost 2% of cases to select the gender without reference to disease. In the US, it is about 10% of all PID cycles.
Positive selection of a genetic anomaly
In the USA, PGD is occasionally offered to couples with a genetic anomaly who wish to have children with the same anomaly. Hereditary deafness , which can be detected using PGD, can be cited as an example . About 3% of IVF / PGD clinics in the US offer this type of diagnostics.
Procedure
In-vitro fertilization (IVF) is necessary in order to be able to perform PGD . The IVF procedure with PGD can be roughly divided into five steps:
- Hormone stimulation and egg retrieval
- extracorporeal (out of the body) fertilization
- Embryo biopsy (removal or splitting off of a cell from the embryo)
- genetic diagnostics
- Embryo transfer or cryopreservation
Steps three and four make up the PID in the narrower sense and are described in more detail here.
Trophectoderm and embryo biopsy
The embryo biopsy, i.e. the splitting off of one or two cells from an embryo, usually takes place on the third day after fertilization. At this point the embryo usually consists of six to ten cells and is surrounded by a protective covering ( zona pellucida ) . Approximately 70% of the 4-cell stage embryos reach the 8-cell stage.
According to a more recent method, the embryo is not biopsied until around the fifth or sixth day of development. At this stage of development, the embryo consists of an outer group of cells from which the placenta emerges ( trophoblast ) and the inner cell mass from which the embryo or fetus develops ( embryoblast ), and is known as a blastocyst . One therefore speaks of a blastocyst biopsy . In a blastocyst biopsy, several cells are usually removed from the trophoblast and examined genetically. The advantages and disadvantages of the blastocyst biopsy compared to the embryo biopsy performed on the third day have not yet been fully clarified. One advantage of the blastocyst biopsy is that more than two cells can be obtained and examined. The latest studies indicate that embryos on day three show a high rate of chromosomal maldistribution, which can still be rejected or repaired as the embryo continues to develop.
During an embryo biopsy, an opening is first created in the protective covering surrounding the embryo with the help of acid , laser light or by mechanical means. One or two cells are then removed from the embryo using a suction pipette . This cell extraction is not always successful: In about 5% of the biopsies, the split off cells perish and can no longer be genetically examined. As a result, the affected embryo can in principle no longer be used for reproductive purposes, because it cannot be determined whether or not it carries the genetic defect in question. In rare cases, the embryo dies directly as a result of the biopsy.
Recently, there have also been increasing indications that the splitting off of cells may reduce the embryo's ability to implant. The question of whether the split-off could have further negative effects on the development of the embryo or the child has not yet been clarified. According to more recent studies (as of 2010), PGD does not seem to influence the risk of severe malformations in newborns. Furthermore, PGD should at least not have any negative effects on the mental and psychomotor development of children in the first two years of life.
Genetic diagnostics
The examination of the genetic material of the split-off cell (s) is carried out, depending on the question, using different diagnostic methods and can take between 24 hours and four weeks, depending on the method. The FISH test, for example, tests for chromosomal aberrations , very serious changes in the genome. Individual genes are examined if the parents have a disposition to a genetic defect, i.e. if a certain hereditary disease occurs frequently in the family. The FISH technique is increasingly being replaced by Array-CGH (CGH: “comparative genomic hybridization”) and Next Generation Sequencing (NGS), which can also reveal smaller segmental chromosomal imbalances and random aneuploidies. In particular, NGS, as a cheaper and finer technique that can also recognize mosaics, will increasingly be used in laboratories equipped for this purpose.
The probability that the examination of the genome of an isolated cell leads to an interpretable result is around 90–95%. In 5–10% of the cases, no result is obtained due to technical problems.
Misdiagnosis
PGD is a difficult procedure to perform, not least because there are usually no more than two cells available for the test and the procedure cannot be repeated. Therefore, the risk of misdiagnosis should not be neglected. The probability that the test result is correct is around 90–95%. To check the result, it is recommended that all affected couples also perform PND during pregnancy.
The most common problems are false negative test results due to contamination with foreign DNA or due to the so-called "allelic dropout", i. H. the analysis of only one instead of both alleles . In the event of a false negative test result, the embryo is the carrier of the genetic defect, although the diagnosis does not say this.
Another problem is mosaicism , a mosaic being understood to mean an embryo that is made up of genetically different cells. It happens that the examined cells have a different genome than the remaining cells, which leads to a misdiagnosis. Mosaicism is relatively common and is due to errors in cell division.
Success rates of the individual process steps
The following table shows the average probability of the success of the individual process steps in the context of IVF / PGD, assuming that one of the parents suffers from an autosomal dominant hereditary disease ( heterozygous ) and a fresh cycle is carried out.
1. Egg cell | 1 | ||||||||
2. Egg cell capable of insemination | 0.8 | 1 | |||||||
3. impregnated egg cell | 0.56 | 0.7 | 1 | ||||||
4. Embryo at the 4-cell stage | 0.3 | 0.38 | 0.55 | 1 | |||||
5. Embryo at the 8-cell stage | 0.22 | 0.28 | 0.4 | 0.72 | 1 | ||||
6. Successful biopsy | 0.2 | 0.27 | 0.38 | 0.68 | 0.95 | 1 | |||
7. Successful diagnosis | 0.18 | 0.25 | 0.34 | 0.61 | 0.86 | 0.9 | 1 | ||
8. transferable embryo (without genetic defect) | 0.09 | 0.13 | 0.17 | 0.31 | 0.43 | 0.45 | 0.5 | 1 | |
9. Embryo after successful implantation | 0.02 | 0.02 | 0.03 | 0.05 | 0.06 | 0.07 | 0.08 | 0.15 | 1 |
10th birth | 0.01 | 0.02 | 0.03 | 0.04 | 0.05 | 0.06 | 0.07 | 0.13 | 0.85 |
Reading example : The probability that an impregnated egg cell of good quality (column 3) will develop into a transferable embryo (row 8) is 0.17 or 17%.
The probability that at least one transferable embryo will be obtained from a certain number of impregnated egg cells of good quality in IVF with PGD is:
Number of impregnated egg cells | 1 | 2 | 3 | 4th | 5 | 6th | 7th | 8th | 9 | 10 |
probability | 0.17 | 0.31 | 0.42 | 0.52 | 0.61 | 0.67 | 0.73 | 0.78 | 0.81 | 0.84 |
Ethical evaluation
Preimplantation diagnostics is the subject of controversy worldwide. In the question of whether and under what conditions PGD may be used, fundamental aspects of individual and social ethics are intertwined . This affects fundamental ideological decisions, such as the question of when it begins to be human.
The ethical controversy surrounding PGD is reflected in very different national legislations . PGD is completely banned in Italy , while the strict ban in Germany, Austria and Switzerland, for example, was relaxed somewhat in the 2010s. In contrast, there are far fewer legal restrictions in China , Great Britain , Israel , India and the USA . In the USA, a very liberal practice and a scientific-ethical debate, which is primarily concerned about restrictions on personal autonomy in the area of procreation , contrast with a very critical attitude of Christian-conservative circles. On the other hand, Judaism and Islam tend to be more open to the possibilities of modern reproductive medicine, even though controversial debates are conducted there too.
In many Asian countries there are fewer fundamental ethical reservations about PGD, although full approval is usually viewed critically. In India and China in particular, the gender selection made possible by PGD and the feared demographic effects play a central role in the discourse .
Rejection
PGD is generally rejected by the Catholic Church, groups critical of genetic engineering as well as individual women's organizations and some voices from philosophy and ethics. The arguments that play a role relate on the one hand to the procedure itself and its immediate effects:
- It is generally considered unnatural or contrary to Christian commandments to influence the process of human reproduction in any technical way. The beginning and end of human life are therefore withdrawn from human availability in a special way or should remain so.
- The intervention in reproduction implies the technical control over the female body and goes hand in hand with the degradation of the woman.
- To prevent embryos from developing for whatever reason is reprehensible. They are people like those who were born and have the same right to protection and recognition.
- It is even more reprehensible to make this recognition dependent on whether the embryos have certain characteristics or not, i.e. their chances of development, i. H. to make people's chances of development dependent on a kind of "quality test".
- Making appreciation and love for children dependent on their verified genetic traits is detrimental to natural family structures.
On the other hand, the arguments concern long-range effects of the procedure, which are to be feared due to its establishment and spread. These can relate to today's society that is indirectly affected, but in particular also to the social situation in the future:
- PGD is a eugenic procedure, with which decisions about the value or unworthiness of human life become socially acceptable.
- At the same time, this technology undermines the social recognition of sick and disabled people, whose life situation appears to be avoidable through PGD.
- As a result, PGD threatens to undermine the principle of equality for all people, which implicitly is essentially based on disregarding their genetic constitution and thus leading to a two-class society of tested and untested.
In sum, the categorical criticism sees PGD as an attack on the foundations of humane society in the course of its progressive mechanization and alienation from nature. PGD means an intervention in the human self-image in a serious way and with even more serious consequences in the future. It is an immediate disregard for the dignity of those who are weakest and in need of protection the most, and thus contributes to the general erosion of human dignity that will eventually affect everyone.
Advocates
Proponents of PGD reject the arguments of the opponents:
- Religiously based reservations are generally rejected because they cannot claim to be generally binding in a liberal and secular society.
- This applies equally to the complementary secular arguments relating to a certain, presupposed concept of nature; Nobody has privileged knowledge of what human nature or, specifically, human reproduction is. Moreover, from such a nature, even if one knew what it was like, there was no obligation to preserve it; man also opposes many other natural conditions such as cold, illness or his inability to fly. What is more, it is unclear whether this human nature is something fixed and unchangeable, even unavailable, or whether it does not consist in the “perfectibilité” of man, i.e. H. his ability and his will to change and improve himself and to free himself from his natural entanglement.
- A ban on PGD would therefore considerably restrict people's freedom of choice. Every citizen is free to ethically reject PGD, but nobody has the right to impose this point of view on those who think differently. The state should not prescribe a certain ideological idea to its citizens.
- Further arguments for PGD include an alleged right to optimal starting conditions , according to which mothers have the right to give their children optimal starting conditions for life, as well as an alleged duty to optimize : the philosopher Julian Savulescu calls it a moral obligation of parents Provide children with the best possible starting conditions.
As a result, the feared social effects of PGD are also considered to be less threatening:
- Specifically, especially with reference to up to 20 years of experience in those countries in which PGD is used, actually recognizable signs of such developments, such as the de-solidarization of people with disabilities, are denied. In any case, it should be kept in mind that the feared tendencies, if they should really arise, are by no means uncorrectable. If necessary, countermeasures can still be given, but a general ban is by no means necessary.
- For example, it is stated in detail that PGD remains an exceptional investigation: it is only carried out after artificial insemination, and the assumption that PGD could be used on a large scale in the future, for example to get "optimal" offspring or to eradicate hereditary diseases ( eugenics ) , is therefore exaggerated.
- In the context of pre-implantation diagnosis, the embryos do experience special protection; During later pregnancy, however, an abortion is possible if, for example, a disability is found. Because the burden on the pregnant woman is much greater than before the embryo was implanted, the ban on PGD causes unnecessary suffering.
- It is also argued that a ban would only push the treatments abroad: Even if PGD is prohibited in one country, the couple who wish to have children are free to have PGD carried out abroad. It has been scientifically proven that so-called PGD tourism has increased due to the German PGD ban.
Ultimately, the key question of PGD remains what an embryo is - in vivo , in the womb, or in vitro , in the glass - and what can be done with it. Proponents of PGD do not see him as a complete person, but as a preliminary stage to it. This requires certain special forms of action - for example with respect - but under no circumstances does an embryo enjoy the inviolability of human dignity.
Individual points of contention
PGD and prenatal diagnosis or abortion
The view that the inviolability of the embryo in vivo has been factually refuted by the approval of PND and the termination of pregnancy and that it would be unjust to deviate from the in vitro embryo , is one of the main arguments in favor of the approval of PGD. Proponents of PGD argue that the PGD ban creates a drastic imbalance between PND and PGD and thus the protection of embryos (and fetuses) in vivo and in vitro . Incomprehensibly, the vital interests of an embryo only a few cells in size are valued more highly than that of a child who will soon be viable and not yet born. From this perspective, the approval of PGD is almost ethically necessary, as it could save women and couples the burden of a “pregnancy on trial”.
Opponents of PGD, on the other hand, fundamentally deny the comparability of the two situations, because in the case of PGD with seeing eyes a conflict situation is brought about, in contrast to the unintended emergency in the case of natural pregnancy.
Reproductive autonomy
As with conventional procreation and parenthood, which for many people is one of the essential goals of their life planning and self-development, in the opinion of PGD advocates, it must remain in the individual decision-making power of individuals or couples whether they use such a measure for themselves want or not. One of the key terms in the ethical debate about PGD is therefore that of the “ reproductive autonomy ” of individuals and couples, which is not permitted to intervene in a regulatory manner.
This is countered by the fact that parenting cannot be defined in terms of autonomous decision-making alone. Rather, this role implies responsibility, care and respect for the child's own growing personality, which in the event of a conflict has always been subject to the protection of the general public. In addition, the parents' reproductive autonomy and the decision they make are also based on social living conditions and have an effect on them. Reproduction is not just a matter of isolated individuals, rather society as a whole reproduces itself in it at the same time, which is why it cannot simply be indifferent to the reproductive process.
Legal situation in individual countries
In most European countries, PGD is legally permitted and clearly regulated. Italy is assuming an implicit ban on PGD, while PGD is not implemented in Ireland and Luxembourg for other reasons.
The following information about the legal situation in western countries can be presented in the following table:
country | Diagnosis of hereditary diseases | Aneuploidy screening | Selection of immunocompatible embryos | Gender selection | other reasons (e.g. selection of an anomaly) |
---|---|---|---|---|---|
Germany | |||||
Austria | |||||
Switzerland | |||||
Belgium | |||||
China | |||||
Denmark | |||||
France | |||||
India | |||||
Ireland | |||||
Israel | |||||
Italy | |||||
Japan | |||||
Luxembourg | |||||
Netherlands | |||||
Norway | |||||
Portugal | |||||
Sweden | |||||
Spain | |||||
South Africa | |||||
United Kingdom | |||||
United States |
Legend :: allowed (possibly with restrictions or not everywhere); : forbidden; No symbol: no regulation, legal situation unclear or not described below.
Countries with PGD prohibition
Italy
Before the Reproductive Medicine Act came into force in 2004, PGD was allowed and carried out in Italy at least in private clinics. Today it is considered forbidden based on the purpose article of the Reproductive Medicine Act. This article only allows reproductive medicine techniques to be used to cure a couple's infertility. Furthermore, according to further regulations, any intervention that aims to predict genetic characteristics by means of selection or other techniques is prohibited, as is the cryopreservation and the destruction of embryos.
Countries without legal regulation of PGD
Ireland
Ireland has no PGD or medically assisted procreation regime. Public health institutions offer neither one nor the other. There are individual IVF clinics on a private basis. PGD procedures, on the other hand, are not carried out, in particular because of the open question until recently as to whether and to what extent the constitutional protection of unborn babies also extends to embryos in vitro . In December 2009 the Supreme Court ruled that it was not. The Ministry of Health intends to present a proposal for the statutory regulation of reproductive medicine (including PGD) in the course of 2011.
Luxembourg
PGD is not regulated by law in Luxembourg. There is only one center for medically assisted reproduction. Its operating license specifies that PGD does not fall under the approved activities, which is why PGD cannot be carried out in Luxembourg.
Countries in which PGD is regulated and permitted by law
Germany
Legal position
In Germany, until the summer of 2010, the ban on PGD was derived from various provisions of the Act of December 13, 1990 on the Protection of Embryos (ESchG) (in particular from the ban on fertilizing an egg cell for a purpose other than bringing about a pregnancy, the ban the use of human embryos for a purpose other than their preservation and the prohibition on cloning human embryos).
On July 6, 2010, the Federal Court of Justice ruled that PGD intended after extracorporeal fertilization by means of blastocyst biopsy and subsequent examination of the pluripotent trophoblast cells removed for severe genetic damage was not a criminal offense under the Embryo Protection Act.
On July 7, 2011, the Bundestag approved a non-partisan bill with 326 votes, which prohibits PGD in principle, but allows it if a serious hereditary disease in the child or a death or miscarriage is probable due to the genetic makeup of the parents. A hereditary disease is “serious” if it differs significantly from other hereditary diseases due to the low life expectancy of the person affected or the severity of the clinical picture and poor treatability.
A complete ban received 260 votes in favor, a more restrictive compromise draft 58 votes. On September 23, 2011, the draft law on the approval of pre-implantation diagnostics (PräimpG) was adopted in the Federal Council. The law is published in Federal Law Gazette No. 58/2011 and has been in force since December 8, 2011. The tasks of the competent authority for the granting of the approval to carry out pre-implantation diagnostics as well as the composition, the internal procedural regulation, the appointment of the members, the duration of the membership and the financing of the ethics committee ( § 3 Abs. 1 Nr. 2 and § 4 Abs 1 and 4 of the Preimplantation Diagnostic Ordinance) is determined by state law.
Public discussion
The judgment of the Federal Court of Justice of 2010 criticized the Augsburg auxiliary bishop Anton Losinger and the Freiburg moral theologian Eberhard Schockenhoff . You are both members of the German Ethics Council . On the other hand, the President of the Evangelical Church in the Rhineland , Nikolaus Schneider , declared that he was in favor of PGD approval if there was a justified risk of the most serious hereditary diseases being passed on. The topic was debated at the CDU federal party conference in November; The most prominent opponents of PGD approval were Angela Merkel and Annette Schavan , who achieved a narrow majority at the party congress, while the ministers Ursula von der Leyen and Kristina Schröder were just inferior in support of PGD .
In a party-internal position paper, the FDP politician Ulrike Flach in 2010 advocates pre- implantation diagnostics to avoid serious hereditary diseases. Similar positions as the FDP represent the majorities of the SPD - and the Left Party - members of the Bundestag as well as some members of the Greens . Accordingly, a group motion by MPs Ulrike Flach (FDP), Peter Hintze (CDU) and 13 other MPs from all parliamentary groups calls for PGD to be released in the event of severe hereditary diseases in the parents. In contrast, a majority of members of the CDU / CSU advocate a general ban on pre-implantation diagnostics. A draft for a ban on pre-implantation diagnostics in the Genetic Diagnostics Act comes from the Bundestag member Patrick Sensburg .
In January 2011, the National Academy of Sciences Leopoldina, in a statement that it presented to the members of the Bundestag, advocated approval of PGD within narrow limits and under certain conditions. On March 8, 2011, the German Ethics Council published a statement on pre-implantation diagnostics containing contradicting recommendations: Thirteen of its 26 members vote in favor of PGD approval under strictly limited conditions, 11 in principle against it, one member of the Ethics Council abstained and Another recommended in a special vote the general approval of PGD for the determination of viable embryos.
On June 1, 2011, the German Medical Association approved the approval of pre-implantation diagnostics within narrow limits. PGD should therefore only be carried out for diseases for which a couple is known to have a high genetic risk.
Austria
In Austria, pre-implantation diagnostics were banned until 2015. According to Section 2 of the 2015 Law on Reproductive Medicine, passed in January 2015, pre-implantation diagnostics are now only permitted to remedy hereditary infertility. The law allows it if, after three or more uses of medically assisted procreation, no pregnancy could be brought about, at least three medically proven pregnancies ended spontaneously with a miscarriage or stillbirth of the child and this was most likely caused by the genetic disposition of the child , or due to the genetic disposition of at least one parent, there is a serious risk of miscarriage, stillbirth or a hereditary disease of the child.
Switzerland
In Switzerland, PGD was banned from the entry into force of the Reproductive Medicine Act of December 18, 1998 ( FMedG ) until it was amended in 2016. Article 5 paragraph 3 FMedG in the 1998 version prohibited the detachment of one or more cells from an embryo in vitro and their examination. The Federal Council's message on the law justified the ban with possible long-term risks for the diagnosed embryo, the risk of misdiagnosis, the hardly possible demarcation between permitted prevention and undesired selection, and with the fact that PGD has become an automatism between alleged genetic damage and the Rejection of the unborn life, which has no parallel in prenatal diagnosis.
Then the question of the approval of PGD was raised repeatedly in the Federal Assembly . In 2005, both chambers of parliament (with 92:63 and 24:18 votes respectively) approved a motion mandating the Federal Council to present a change in the law for the approval of PGD. In 2009 the government submitted a corresponding draft for public consultation . The PGD advocates criticized this as too restrictive because it stuck to the ban on cryopreservation of embryos and the rule that a maximum of three embryos may be developed per reproductive cycle ("rule of three").
On the basis of a revised draft from 2011, the Swiss voters approved a constitutional amendment on June 14, 2015 with 62% yes votes in a referendum, which should create the conditions for the approval of PGD. Article 119 paragraph 2 letter c of the Federal Constitution , which until then stipulated that “only as many human egg cells may be developed into embryos outside the woman's body as can be implanted immediately”, has been changed to: “... than for medical purposes assisted reproduction are necessary ". For the revision of the Ordinance on the Reproductive Medicine Act, the Department of the Interior presented a new draft of the implementing law (FMedV). From autumn 2017, pre-implantation diagnostics (PGD) should be permitted in Switzerland under certain conditions.
Based on this, the Federal Assembly decided to change the law, according to which PGD will be approved for couples who are carriers of serious hereditary diseases and for couples who cannot have children naturally. PGD remains prohibited for other indications. In all in vitro fertilizations with or without PGD, up to twelve embryos can be developed. The Evangelical People's Party held a referendum against this change in the law . In the referendum on June 5, 2016, 61% of those entitled to vote accepted the change in the law.
Belgium
The Belgian Reproductive Medicine Act from 2007 leaves it up to the individual centers to decide for which pathologically relevant indications they want to offer PGD (aneuploidy screenings, HLA typing, etc.). However, eugenic motives are also prohibited in Belgium; these are paraphrased as "designed for the selection or multiplication of non-pathological genetic properties". The law also forbids gender selection, except to prevent gender-related diseases. PGD is currently offered in seven centers.
Denmark
The Danish Reproductive Medicine Act of 1997 initially allows PGD in those cases in which the child is at a known and significantly increased risk of a serious hereditary disease. It is also allowed in the context of IVF indicated by infertility if a severe chromosomal abnormality can be determined or excluded. According to an amendment to the law from 2004, the “National Board of Health” can also allow HLA typing in individual cases if this enables the treatment of a sibling suffering from a life-threatening disease. So far, however, PGD has only been carried out in Denmark as part of research protocols.
France
France has regulated PGD since 1994 in the Public Health Code (Code de la santé publique). According to this, PGD may only be carried out if the affected couple would in all probability give birth to a child who would be affected by a particularly serious genetic disease that was incurable at the time of diagnosis. The legislature does not specify what is to be understood by such a disease, so it is left to the specialists at the pluridisciplinary PND centers (CPDPN) to specify this criterion. Furthermore, the law allows couples who know that there is a certain, late-manifesting, severe genetic burden in their family to perform PGD without having to find out whether they are carriers themselves.
The law only allows PGD with the aim of HLA typing in order to later have blood stem cells available for the treatment of a sick child that has already been born, only with individual approval from the competent national authority and for the time being only on a trial basis. However, aneuploidy screening is not permitted. In France, PGD is carried out in three centers.
Netherlands
The main basis of the Dutch regulation on PGD is the law on special medical procedures from 1997. According to this, PGD can generally be indicated if the couple has an individually increased risk of offspring with a serious hereditary disease. What can be regarded as a "serious hereditary disease" is not further defined and is therefore left to the center. If PGD is to be carried out for a hereditary disease for which this has never been done in the Netherlands before, a non-governmental, interdisciplinary expert commission from the fields of medicine and ethics is first asked for an opinion. PGD with the aim of HLA typing for a sick sibling is prohibited. The Embryo Act of 2002 prohibits the selection of embryos based on their gender, unless this prevents the transmission of a serious sex-linked hereditary disease. Further legislation stipulates that initially only one center may carry out PGD and that a maximum of one additional license may be granted. The numerical assessment of the genetic material to rule out aneuploidies has so far only been allowed in the Netherlands as part of research projects that are being carried out in four centers.
Norway
The Norwegian Biotechnology Application Act came into force in 2004. It allowed PGD for preventing sex-linked disease transmission. Since 2008, PGD has also been permitted for monogenetic or chromosomal hereditary diseases, provided that one or both partners are sick or are carriers and there is a high risk of passing the disease on to the child. PGD is also allowed for HLA typing to select an immunocompatible embryo. In addition, Norway has introduced a new authority that decides on each individual case.
Portugal
The Portuguese Reproductive Medicine Act from 2006 also regulates PGD. It prohibits them from being used for gender selection (other than to prevent a sex-linked genetic disease) and their use in multifactorial diseases where the predictive value of the test is very low. Otherwise PGD is permissible, provided that it is not about improving the non-medical properties of the embryo. That means PGD is approved for both communicable severe genetic diseases and aneuploidy screenings. The law also states that the risk of transmission to offspring must be high, and a National Council on Medically Assisted Reproduction must have classified the disease to be diagnosed as severe. PID is also expressly permitted in connection with HLA typing. In spring 2009 the Portuguese Constitutional Court confirmed the constitutionality of the statutory IVF and PID regulation.
Sweden
The Swedish law from 2006 on “genetisk integritet” also regulates PGD. This is permissible if the man or woman is a carrier of a serious monogenic or chromosomal hereditary disease, which means that the child is at high risk of a genetic disease or damage. Special reasons and, based on this, an individual approval from the health authority are necessary for performing PGD with HLA typing with the aim of later donating blood stem cells for a seriously ill sibling.
Spain
The Spanish law on reproductive medicine from 2006 allows PGD to detect serious genetic diseases that occur early and, according to the current state of science, cannot be treated after birth. Second, it may also be used to detect other impairments that can affect the viability of the embryos. The centers themselves assess whether the indication to perform PGD is given in an individual case. The permissible implementation of PGD with HLA typing for therapeutic purposes for third parties, however, is subject to individual approval by the authority, whereby the positive opinion of the National Commission for Assisted Reproduction is also required. From the public side (Sistema Nacional de Salud) the PID is only offered in Seville. The numerous other clinics that offer IVF procedures with PGD are private facilities. PGD has been offered in Spain for many years and many couples from other countries who travel to Spain just to have PGD are treated.
United Kingdom
The British legislation ("Human Fertilization and Embryology Act, HFE-Act", 1990) contains since 2008 provisions on the admissibility of PGD. The responsible national authority ( HFEA ) first gives the centers a general license to carry out PGD. As a result, it issues a type approval for each new indication. If it has approved PGD for a specific genetic trait in a specific case, other centers can also carry out PGD for this trait. With this in mind, the UK has a list of acceptable indications. The law allows aneuploidy screening and PGD for the selection of immunocompatible embryos, but forbids the choice of sex without disease reference ("social sexing"). PGD is carried out in nine centers in the UK.
United States of America
There are no federal rules on PGD in the United States. Very few states have a ban on this; in all other countries, PGD is handled very liberally. A published survey of the American IVF clinics showed that almost three quarters of the IVF clinics also offer PGD. Social sexing is legal in many states in the United States, and today around 10% of all PGD is done with this goal.
literature
- German Fanconi Anemia Help e. V .: Adam: Lifesaver from the retort - reference to a television film about pre-implantation diagnosis In: Wolfram Ebell, Lynn Frohnmaye, German Fanconi anemia help: Fanconi anemia: A manual for parents, patients and their doctors. German Fanconi Anemia Help, Unna 2005, ISBN 978-3-00-015621-2 , pp. 341–342, fanconi.de (PDF).
- German Reference Center for Ethics in the Biosciences / Scientific Department (Ed.): Dossier Preimplantation Diagnostics. Central national and international legal guidelines and agreements as well as statements by national and international institutions.
- Lone Frank : My wonderful genome. A self-experiment in the age of personal genetic research. (Translated from the English by Ursel Schäfer) Hanser, Munich 2011, ISBN 978-3-446-42687-0 .
- Carl Friedrich Gethmann (Ed.): Law and Ethics in Preimplantation Diagnostics. Fink, Munich 2010, ISBN 978-3-7705-5088-3 .
- Torsten Hartleb: Protection of fundamental rights in the Petri dish. Duncker & Humblot, Berlin 2006, ISBN 978-3-428-12267-7 .
- Norbert Hoerster: Ethics of embryo protection. A legal philosophical essay. Reclam, Stuttgart 2002, ISBN 978-3-15-018186-7 .
- Andreas Kuhlmann: At the limits of our way of life. Texts on bioethics and anthropology . Campus, Frankfurt a. M. 2011, ISBN 978-3-593-39515-9 .
- Charikleia Z. Latsiou: Preimplantation Diagnostics. Comparative law and bioethical issues. Duncker & Humblot, Berlin 2008, ISBN 978-3-428-12690-3 .
- Daniela Reitz: Desired children. Preimplantation diagnostics from the perspective of ethics of principles and feminist ethics , Edition Ethik Volume 8, Edition Ruprecht, Göttingen 2011, ISBN 978-3-7675-7139-6 .
- Marcel Reuter: The decision of the BGH on pre-implantation diagnostics and its effects on legislation. In: StudZR Heidelberg e. V .: StudZR 3/2010. Hüthig Jehle Rehm, Heidelberg 2010, ISBN 978-3-8114-7738-4 , pp. 535-551, ( Google books ).
- Bernhard Schlink : The dignity in vitro . In: Der Spiegel . No. 25 , 2011 ( online essay on the debate in the Bundestag on pre-implantation diagnostics).
- Jana Thiel, Eberhard Passarge: Preimplantation Diagnosis - An Analysis from a Medical, Genetic, Legal and Ethical Perspective. Wiku, Duisburg / Cologne 2009, ISBN 978-3-86553-302-9 .
- Katja Weiske: History and Ethics of Preimplantation Diagnostics (PGD). 1st edition, Kontur-Verlag, Fredersdorf 2013, ISBN 978-3-944998-00-8 . * Mirjam Zimmermann, Ruben Zimmermann: Report: Preimplantationsdiagnostik: Chance oder Errweg? The German Medical Association and reproductive medicine. In: Zeitschrift für Evangelische Ethik (ZEE) No. 45, 2001, pp. 47–57.
Criticism:
- Elmar Brähler (Ed.): From the family tree to the stem cell. Reproductive medicine, prenatal diagnostics and human raw material. Psychosozial-Verlag, Giessen 2002, ISBN 978-3-89806-134-6 .
- Jürgen Habermas : The future of human nature. On the way to a liberal eugenics? Suhrkamp, Frankfurt a. M. 2001, ISBN 978-3-518-29344-7 .
- Hille Haker : The main thing is healthy ?: Ethical questions in prenatal and pre-implantation diagnostics - the current debate. Kösel, Munich 2011, ISBN 978-3-466-36871-6 .
- Regine Kollek : Preimplantation Diagnostics. Embryo Selection, Female Autonomy, and Law. 2nd edition, Francke, Tübingen / Basel 2002, ISBN 978-3-7720-2621-8 .
- Elmar Mayer: Preimplantation Genetic Diagnosis. Critical consideration of the influence of modern medical-genetic technology on early human beings and our society. Tectum, Marburg 2006, ISBN 978-3-8288-9147-0 .
- Ralph Weimann : Bioethics in a secularized society. Ethical problems of PGD. Schöningh, Paderborn 2015, ISBN 978-3-506-78274-8 .
Web links
- Embryo Protection Act . (PDF; 40 kB) Federal Ministry of Justice (Germany)
- Federal Court of Justice: "Judgment of July 6, 2010 in the criminal case for a violation of the Embryo Protection Act" (5 StR 386/09) (PDF; 122 kB)
- Legal regulations of PGD in Germany and abroad . German reference center for ethics in the life sciences
Individual evidence
- ↑ on this, for example, M. Montag et al .: Polar body biopsy. In: DK Gardner, A. Weissmann, CM Howles, Z. Shoham (Eds.): Textbook of Assisted Reproductive Techniques. London 2009, pp. 371-379. (Source cited from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 9)
- ↑ The text of this section is taken in whole or in part from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and the amendment to the Reproductive Medicine Act, pp. 10-11. According to Art. 5 Para. 1 let. c of the Swiss Copyright Act as a report by an authority does not affect copyright protection.
- ↑ AH Handyside et al .: Pregnancies from biopsied human preimplantation embryos sexed by y-specific DNA amplification. In: Nature. 1990, No. 344, pp. 768-770. (Source cited from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 9)
- ↑ AH Handyside et al .: Birth of a normal girl after in vitro fertilization and preimplantation diagnostic testing for cystic fibrosis. In: The New England Journal of Medicine . 1992, No. 327, pp. 905-909. (Source cited from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 9)
- ↑ JL Simpson: Preimplantation genetic diagnosis at 20 years. In: Prenatal Diagnosis. 2010, Volume 30, pp. 682-695. Exact figures on this are not available because “PGD children” are not systematically registered. (Source cited from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 9)
- ↑ The text of this section is taken in whole or in part from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, pp. 9-10. According to Art. 5 Para. 1 let. c of the Swiss Copyright Act as a report by an authority does not affect copyright protection.
- ↑ The Preimplantation Genetic Diagnosis International Society (PGDIS), Guidelines for good practice in PGD: program requirements and laboratory quality assurance. In: Reproductive BioMedicine Online. No. 16, 2008, pp. 134-147. (Source cited from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 9)
- ^ "First, PGD testing of adult-onset disorders (Huntington disease, familial predispositions to cancer, polycystic kidney disease, etc) appears to be more widespread than is the case for prenatal diagnosis. Second, testing may be requested and performed for relatively less severe or less predictable diseases: a quarter of the centers offer PGD for CMT disease, which is not a common prenatal diagnosis. "A. Corveleyn et al .: Provision and quality assurance of preimplantation genetic diagnosis in Europe. In: European Journal of Human Genetics . 2008, No. 16, pp. 290-299; here p. 297. (Quotation and source from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and the amendment to the Reproductive Medicine Act, p. 10)
- ↑ The text of this section is taken in whole or in part from the explanatory report of June 28, 2011 of the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and the amendment to the Reproductive Medicine Act, pp. 15-21. According to Art. 5 Para. 1 let. c of the Swiss Copyright Act as a report by an authority does not affect copyright protection.
- ^ V. Goossens et al .: ESHRE PGD Consortium data collection IX: cycles from January to December 2006 with pregnancy follow-up to October 2007. In: Human Reproduction. 2009, No. 24, p. 1786 ff. (Source from the explanatory report of June 28, 2011 of the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and the amendment to the Reproductive Medicine Act, p. 9)
- ↑ S. Munné: Preimplantation genetic diagnosis for infertility (PGS). In: DK Gardner, A. Weissmann, CM Howles, Z. Shoham (Eds.): Textbook of Assisted Reproductive Techniques. London 2009, p. 403 ff. (Source from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and the amendment to the Reproductive Medicine Act, p. 9)
- ↑ Die Zeit July 11, 2013 (Wissen, p. 33)
- ^ BC Heng: Advanced maternal age as an indication for preimplantation genetic diagnosis (PGD) - the need for more judicious application in clinically assisted reproduction. In: Prenatal Diagnosis. 2006, No. 26, pp. 1051-1053. PGD is supposed to separate those embryos that have an abnormal set of chromosomes. (Source cited from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 9)
- ^ Y. Verlinsky et al .: Preimplantation genetic diagnosis for Fanconi anemia combined with HLA matching. In: JAMA. 2001, Volume 285, pp. 3130 ff .; M. Bellavia et al .: Preimplantation genetic diagnosis (PGD) for HLA typing: bases for setting up an open international collaboration when PGD is not available. In: Fertility and Sterility. 2010, No. 94, p. 1129 ff. (Source from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and the amendment to the Reproductive Medicine Act, p. 20)
- ↑ A. Malpani, et al .: Preimplantation sex selection for family balancing in India. In: Human Reproduction. 2002, Volume 17, pp. 517-523. (Source cited from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 9)
- ^ V. Goossens et al .: ESHRE PGD Consortium data collection VI: cycles from January to December 2006 with pregnancy follow-up to October 2007. In: Human Reproduction . 2009, Volume 24, pp. 1786-1810. (Source cited from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 9)
- ^ A b S. Baruch, D. Kaufman, KL Hudson: Genetic testing of embryos: practices and perspectives of US in vitro fertilization clinics. In: Fertility and sterility. Volume 89, number 5, May 2008, pp. 1053-1058, doi: 10.1016 / j.fertnstert.2007.05.048 , PMID 17628552 . (Source cited from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 9)
- ^ On the whole, see JL Simpson: Preimplantation genetic diagnosis at 20 years. In: Prenatal Diagnosis. 2010, Volume 30, pp. 682-695. (Source citation from the explanatory report of June 28, 2011 of the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 11)
- ↑ The text above and below is taken in whole or in part from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and the amendment to the Reproductive Medicine Act, pp. 11-14. According to Art. 5 Para. 1 let. c of the Swiss Copyright Act as a report by an authority does not affect copyright protection.
- ↑ a b A. R. Thornhill, AH Handyside: Human embryo biopsy procedures. In: DK Gardner, A. Weissmann, CM Howles, Z. Shoham (Eds.): Textbook of Assisted Reproductive Techniques. London 2009, pp. 191-205. (Source cited from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 12)
- ↑ Andreas Hehr, Helmut Frister, Sabine Fondel, Susann Krauß, Christine Zuehlke, Yorck Hellenbroich, Ute Hehr, Gabriele Gillessen-Kaesbach: Preimplantation diagnostics. (PDF) In: Medgen. Springer-Verlag, December 2, 2014, accessed on November 11, 2018 .
- ↑ LK Shahine et al .: Preimplantation genetic diagnosis does not increase pregnancy rates in patients at risk for aneuploidy. In: Fertility and Sterility. 2006, vol. 85, pp. 51-56 / Bruce Goldman: The First Cut. In: Nature . 2007, Volume 445, pp. 479-480. Furthermore P. Miny, Ch. De Geyter, W. Holzgreve: New possibilities of prenatal genetic diagnostics including pre- implantation diagnostics. In: Therapeutic review. 2006, Volume 63, p. 707. (Source from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and the amendment to the Reproductive Medicine Act, p. 12)
- ↑ I. Libaers et al .: Report on a consecutive series of 581 children born after blastomere biopsy for preimplantation genetic diagnosis. In: Human Reproduction. 2010, Volume 25, pp. 275-282; JL Simpson: Children born after preimplantation genetic diagnosis show no increase in congenital anomalies. In: Human Reproduction. 2010, Volume 25, pp. 6-8. (Source cited from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 12)
- ↑ J. Nekkebroeck et al .: Mental and psychomotor development of two-year-old children born after preimplantation genetic diagnosis / screening. In: Human reproduction. 2008, pp. 1-7. Likewise: I. Barnejee et al .: Health of children conceived after preimplantation genetic diagnosis: a preliminary outcome study. In: Reproductive BioMedicine Online. 2008, Volume 16, pp. 376-381 and A. Sutcliffe et al .: Health of children conceived after preimplantation genetic diagnosis: a preliminary outcome study. In: Reproductive Biomedicine Online. 2008, Volume 16, pp. 376-381. In contrast, V. Touliatou et al .: Multidisciplinary medical evaluation of children younger than 7.5 years born after preimplantation genetic diagnosis for monogenetic diseases are skeptical. In: Pediatrics. 2008, Volume 121, p. 102. (Source from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and the amendment to the Reproductive Medicine Act, p. 12)
- ^ Y. Yaron et al .: Genetic analysis of the embryo. in: DK Gardner, A. Weissmann, CM Howles, Z. Shoham (Eds.): Textbook of Assisted Reproductive Techniques. London 2009, pp. 403-416. (Source cited from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 12)
- ↑ K. Sueoka: Preimplantation genetic diagnosis: an update on current technologies and ethical considerations. In: Reproductive medicine and biology. Volume 15, number 2, 04 2016, pp. 69-75, doi : 10.1007 / s12522-015-0224-6 , PMID 29259423 , PMC 5715849 (free full text) (review).
- ↑ J. Murken: Prenatal diagnostics . In: J. Murken, T. Grimm, E. Holinski-Felder (Ed.): Humangenetik . Stuttgart 2006, p. 386 ff. (Source from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 12)
- ^ S. Baruch, D. Kaufman, KL Hudson: Genetic testing of embryos: practices and perspectives of US in vitro fertilization clinics. In: Fertility and sterility. Volume 89, number 5, May 2008, pp. 1053-1058, doi: 10.1016 / j.fertnstert.2007.05.048 , PMID 17628552 . (Sources from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 21)
- ↑ J. Murken: Prenatal diagnostics. iIn: J. Murken, T. Grimm, E. Holinski-Felder (Eds.): Humangenetik. Stuttgart 2006. (Source from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 21)
- ↑ A. Kuliev et al .: Place of Preimplantation Diagnosis in Genetic Practice. In: American Journal of Medical Genetics. 2005, Volume 134A, pp. 105-110. (Sources from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 21)
- ↑ S. Ziebe et al .: Fish analysis for chromosomes 13, 16, 18, 22, X and Y in all blastomeres of IVF pre-embryos from 144 randomly selected donated human oocytes and impact on pre-embryo morphology . In: Human Reproduction. 2003, Volume 18, pp. 2575-2581. (Sources from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 21)
- ↑ E. Vanneste et al .: Chromosome instability is common in human cleavage-stage embryos . In: Nature Medicine . 2009, Volume 15, pp. 577-583. (Sources from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 21)
- ↑ The text of this section is taken in whole or in part from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and the amendment of the Reproductive Medicine Act, p. 21. This text is subject to Art. 5 Para . c of the Swiss Copyright Act as a report by an authority does not affect copyright protection.
- ↑ The text of this section is taken in whole or in part from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and the amendment of the Reproductive Medicine Act, p. 102. According to Art. 5 Para. 1 let . c of the Swiss Copyright Act as a report by an authority does not affect copyright protection.
- ↑ Unless otherwise noted, the information in this table is based on a survey of various reproductive physicians in Switzerland in 2007. See also M. Vandervorst et al .: Succesfull preimplantation genetic diagnosis is related to the number of available cumulus -oocyte complexes. In: Human Reproduction. Volume 13, 1998, pp. 3169-3176. (Sources from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 21)
- ↑ AD Handyside: Human embryo biopsy for preimplantation genetic diagnosis. In: DK Gardner et al .: Textbook of Assisted Reproductive Techniques. London 2004, pp. 191-199. (Sources from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 21)
- ↑ J. Murken: Prenatal diagnostics . In: J. Murken, T. Grimm, E. Holinski-Felder (Ed.): Humangenetik . Stuttgart 2006, p. 386 ff. (Citation from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 21)
- ↑ In the case of an autosomal dominant inheritance, the probability that a child is heterozygous for the defect allele is 50% (premise: one parent is sick (heterozygous)).
- ↑ probability = 1 - b n ; a = 0.17 (corresponds to the probability with which an impregnated egg cell of good quality will develop into a transferable embryo); b = 1-a (opposite probability).
- ↑ The text of this section is taken in whole or in part from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and the amendment of the Reproductive Medicine Act, pp. 22-24 and 35 ff. This text is subject to Art. 5 para. 1 let. c of the Swiss Copyright Act as a report by an authority does not affect copyright protection.
- ↑ John A Robertson: Ethics and the future of preimplantation genetic diagnostics. in: Reproductive BioMedicine. 2005, Volume 10, Supplement 1, pp. 97-101.
-
^ Bernard Dickens, Gamal I Serour: Assisted Reproduction Developments in the Islamic World. In: International Journal of Gynecology and Obstetrics. Volume 74, pp. 187-193, 2001.
NEK-CNE, Research on Embryonic Stem Cells, Opinion No. 3/2002, pp. 40-41. - ↑ T. El-Toukhy, C. Williams, P. Braude: The ethics of preimplantation genetic diagnosis. In: The Obstetrician & Gynecologist. Volume 10, No. 1, pp. 49-54, January 2008.
- ↑ Cf. the encyclical Evangelium vitae John Paul II of March 19, 1995, since then repeatedly affirmed. (Sources from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 21)
- ↑ Basel appeal against genetic engineering , “Check und weg” (September 14, 2010) ( Memento of March 4, 2016 in the Internet Archive ) (PDF; 672 kB) (source from the [explanatory report of June 28, 2011] by the Swiss Federal Office for health amending Art. 119 BV and amending the Reproductive Medicine Act, p. 21)
- ↑ For example Jürgen Habermas : The future of human nature. On the way to a liberal eugenics? Frankfurt / Main: Suhrkamp, 4th edition, 2002. (Source from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and the amendment to the Reproductive Medicine Act, p. 21)
- ↑ This view is e.g. B. the Swiss disability organization insieme : "PGD creates a high risk of stigmatization for people with disabilities by encouraging the myth that a child made to measure is feasible." Basic ethical statements on biomedicine ( Memento from February 1, 2012 in Internet Archive ) (PDF; 273 kB) (September 16, 2010). (Sources from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 21)
- ↑ Kurt Bayertz : The Idea of Human Dignity: Problems and Paradoxes. In: Archive for Legal and Social Philosophy, Vol. 81 (1995), pp. 465–481. (Sources from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 21)
- ↑ a b For approval of pre-implantation diagnostics within extended limits. GDS, 2011 ( Memento from March 4, 2011 in the Internet Archive ) (PDF; 119 kB)
- ↑ Ethics of Enhancement of Human Beings. ( Memento from April 23, 2013 in the Internet Archive ) (PDF; 810 kB)
- ↑ FAZ : Artificial fertilization - embryo selection remains limited , accessed on May 12, 2010.
- ↑ Giovanni Maio : What respect do we owe the embryo? Embryonic stem cell research from a medical ethical perspective . In: German Medical Weekly , 2002; 127 (4), pp. 160-163. See meanwhile: Ders .: Why the embryo needs protection of dignity and not just respect. The example of reproductive medicine . In: Journal of Medical Ethics , 2009, 55; 1, pp. 90-95. (Sources from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 21)
- ↑ Swiss National Ethics Commission (NEK-CNE), Preimplantation Diagnostics, Opinion No. 10/2005, p. 5. (source from the explanatory report of June 28, 2011 of the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and the amendment of the Reproductive Medicine Act, p. 21)
- ↑ H. Haker: Ethics of genetic early diagnosis . mentis, Paderborn 2002, in particular p. 224 ff. (Source from the explanatory report of June 28, 2011 of the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and the amendment of the Reproductive Medicine Act, p. 21)
- ↑ H. Haker: Ethics of genetic early diagnosis . mentis, Paderborn 2002, pp. 186 ff., as well as fundamentally: J. Robertson, Children of choice: freedom and the new reproductive technologies. Princeton: Princeton University Press, 1994. (Source from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and the amendment to the Reproductive Medicine Act, p. 21)
- ↑ H. Haker: Ethics of genetic early diagnosis . mentis, Paderborn 2002, especially pp. 61-100 and 245-302. (Sources from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 21)
- ↑ The text of this section is taken in whole or in part from the explanatory report of June 28, 2011 of the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and the amendment of the Reproductive Medicine Act, pp. 35-36 and 63 ff. This text is subject to Art. 5 para. 1 let. c of the Swiss Copyright Act as a report by an authority does not affect copyright protection.
- ↑ Provision on pre-implantation diagnostics in the Reproductive Medicine Act 2015. In: RIS. Federal Chancellery, accessed on September 26, 2017 .
- ↑ The text of this section comes in whole or in part from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and the amendment to the Reproductive Medicine Act, p. 63.
- ^ Judgment of the Supreme Court of December 15, 2009, Roche -v- Roche & ors, [2009] IESC 82
- ↑ The text of this section is taken in whole or in part from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and the amendment to the Reproductive Medicine Act, pp. 64–65.
- ↑ a b c The text of this section is taken in whole or in part from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and the amendment to the Reproductive Medicine Act, p. 65.
- ↑ See also: II. Legal aspects. In: German Reference Center for Ethics in the Biosciences: In Focus - Preimplantation Diagnostics. Retrieved February 26, 2011 .
- ^ Judgment: genetic testing on embryos is not a criminal offense. In: Focus Online. Retrieved July 6, 2010 .
- ↑ Reuters: Federal Court of Justice allows genetic tests on embryos
- ↑ Printed matter 17/5451 (PDF; 205 kB) bundestag.de
- ↑ Printed matter 17/5450 (PDF; 245 kB)
- ↑ bundestag.de
- ↑ The Bundestag allows genetic testing of embryos . Spiegel Online , July 7, 2011
- ↑ Federal Council: Federal Council accepts the law on pre-implantation diagnostics ( Memento of September 30, 2011 in the Internet Archive )
- ↑ November 21, 2011: Law regulating pre-implantation diagnostics (Preimplantation Diagnostics Act - PräimpG) from No. 58 of November 24, 2011, p. 2228; see also: buzer.de
- ↑ for example through the law on the approval of centers and on the establishment of the ethics committee for preimplantation diagnostics in North Rhine-Westphalia (Preimplantation Diagnostics Act North Rhine-Westphalia - PIDG NRW) of July 4, 2014.
- ↑ bistum-augsburg.de of July 7, 2010
- ↑ Islam belongs to Germany in a different way . In: Die Welt , October 12, 2010; interview
- ^ Spiegel: Chancellor wants to ban genetic tests on embryos
- ↑ Badische Zeitung: Preimplantation diagnosis: conscience instead of factionalism
- ↑ Ulrike Flach, Peter Hintze: Bill. (PDF; 44 kB) Draft of a law regulating pre-implantation diagnostics. December 20, 2010, archived from the original on January 3, 2011 ; Retrieved March 17, 2011 .
- ^ Opinion: Preimplantation Diagnosis (PGD) - Effects of a limited approval in Germany
- ↑ See the summary of these votes in the press release. (PDF; 89 kB) German Ethics Council presents position on pre-implantation diagnostics. March 8, 2011, archived from the original on September 24, 2015 ; Retrieved March 9, 2011 . , the opinion itself German Ethics Council: Opinion. (PDF; 620 kB) Preimplantation Diagnostics. March 8, 2011, archived from the original on April 9, 2011 ; Retrieved March 9, 2011 .
- ↑ Doctors' day for embryo genetic tests within narrow limits
- ↑ Explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 64.
- ↑ " National Council passes law on reproduction ", Kurier , January 21, 2015
- ↑ Reproductive Medicine Law Amendment Act 2015 , Parliament of the Republic of Austria
- ↑ Preliminary official final results: Federal Decree of December 12, 2014 on the amendment of the constitutional provision on reproductive medicine and genetic engineering in the human sector , accessed June 14, 2015
- ↑ Federal Office of Public Health (BAG): Revision of the Ordinance on the Reproductive Medicine Act ( Memento from November 26, 2017 in the Internet Archive ). On: bag.admin.ch ; last accessed on June 9, 2017.
- ↑ Explanations of the Federal Council ( Memento of December 6, 2015 in the Internet Archive ) (PDF) on the vote of June 14, 2015
- ↑ Markus Hofmann: Reproductive Medicine: A yes with many open questions , NZZ, June 14, 2015
- ↑ Switzerland says yes to pre-implantation diagnostics ( memento from June 26, 2018 in the Internet Archive ), Der Bund, June 6, 2016
- ↑ The text of this section is taken in whole or in part from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and the amendment to the Reproductive Medicine Act, pp. 65–66.
- ↑ The text of this section comes in whole or in part from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and the amendment of the Reproductive Medicine Act, p. 66.
- ↑ a b c The text of this section is taken in whole or in part from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and the amendment to the Reproductive Medicine Act, p. 67.
- ↑ Acórdão do Tribunal Constitucional n. ° 101/2009
- ↑ a b c The text of this section comes in whole or in part from the explanatory report of June 28, 2011 of the Swiss Federal Office of Public Health on the amendment of Art. 119 BV and the amendment to the Reproductive Medicine Act, p. 68.
- ↑ hfea.gov.uk ( Memento of July 8, 2011 in the Internet Archive ) (source from the [explanatory report of June 28, 2011] of the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and the amendment to the Reproductive Medicine Act, p. 68)
- ^ S. Baruch, D. Kaufman, KL Hudson: Genetic testing of embryos: practices and perspectives of US in vitro fertilization clinics. In: Fertility and sterility. Volume 89, number 5, May 2008, pp. 1053-1058, doi: 10.1016 / j.fertnstert.2007.05.048 , PMID 17628552 . (Source cited from the explanatory report of June 28, 2011 by the Swiss Federal Office of Public Health on the amendment to Art. 119 BV and on the amendment to the Reproductive Medicine Act, p. 67)