In its statement from November 23rd see module Opinion of the Ethics Council on the PGD Regulation from November 23rd , the National Ethics Council criticised that the organisational and procedural aspects of the PGD centres and the corresponding ethics committees are ill-defined and to some extent are for the countries to decide upon, so that uniformity, transparency and monitoring possibilities cannot be insured by the lawmaker.
After a long debate, the German Federal Council eventually agreed to the draft regulation on February 1st , however it required an amendment of the regulation: The German Federal Council demanded that the PGD centres are authorised separately and thus limited to a smaller number. The regulation came to force twelve months after it was passed in order to give the federal states enough time for the establishment of the necessary structures.
Since , five ethics committees for preimplantation diagnostics have been set up across Germany. Since no PGD center is currently being considered in Saxony-Anhalt, the federal state has decided not to set up an ethics committee.
The prohibition of PDG remains valid. In some cases it is possible to test for serious hereditary illnesses with help of PDG embryos before their insertion in the uterus. An exception to the prohibition is granted if the genetic disposition of a parent causes a risk of death or miscarriage or a risk of a serious, non-treatable hereditary illness for the new-born that adds the risk of serious brain damage or severe pain or thanks to which the child would only survive with intensive medical care.
It shall be possible to test embryos for their viability even after three unsuccessful IVF trials or three miscarriages. PDG as assistance for the production of a so-called saviour sibling see module Saviour Siblings remains prohibited. Since then, the analysis of the genetic material of reproductive cells and their selection to influence the sex or other characteristics of the child are permitted in order to identify chromosomal properties that may inhibit the development capacity of the embryo to be created, or if there is no other way of avoiding the risk of transmitting a predisposition for a serious disease.
The law states as a condition that it is probable that the serious disease will occur before the age of 50 and that no effective or expedient therapy is available for combating it.
A selection of embryos based on their gender or other physical characteristics independent of a medical condition as well as the generation of so-called saviour siblings see module Saviour Siblings remains prohibited.
The number of embryos that may be created per IVF cycle has been increased from three to twelve. The freezing and storage of embryos is also permitted. The couples for whom PGD would be an option decide independently after detailed consultation whether they would like to carry out the examination. There is a duty to provide advice on the part of the doctors. PGD and the involved embryo selection are generally permitted in licensed centres. The reasons for requesting PGD include serious genetic disorders, chromosomal disorders and the suitability as a tissue donor for a living affected sibling see module Saviour Siblings under certain conditions.
A selection in terms of the embryo's sex is strictly regulated: According to the guidancenote 10 of the Code of Practice 9th Edition, see module Legal Regulation of PGD in Great Britain published by the Human Fertilisation and Embryology Authority HFEA , such a selection is allowed to be carried out only in cases where there is a medical indication of a risk for a sex-related hereditary disease.
The regulations of PGD stated therein were amended several times by bioethics laws, most recently in July According to these laws, PGD is only permitted in order to prevent serious genetic diseases which are considered untreatable or incurable at the moment of the diagnosis.
It may not be applied if the anomaly responsible for the specific disease has not been clearly diagnosed beforehand in one parent or a direct relative. Furthermore, the diagnosis may be applied for the selection of a saviour sibling see module Saviour Siblings.
The diagnosis may only be conducted in an institution specially accredited for this purpose. It does not provide for a legal ban on PGD. Sex selection of embryos is prohibited.
Click on the button below to see examples of the vast number of conditions that PGD may be used to detect. In Victoria, PGD is permitted in order to prevent a genetic abnormality or disease in the embryo. The Victorian Assisted Reproductive Authority VARTA does not oversee PGD generally, unless PGD is intended for sex-selection, or is being carried out for a reason other than a potential risk of transmitting a genetic condition if the participants were to conceive naturally.
In these instances, an application must to be made to the Victorian Patient Review Panel for approval. The Patient Review Panel, and the Victorian Civil and Administrative Tribunal on appeal , have held that sex selection for family balancing focuses on the needs of the parents and the existing children, rather than focusing on the welfare of the future child.
The assessment should consider the limits that these factors impose on the extent to which a person can engage in activities or participate in life situations. PGD may be used to select the sex of a child for medical reasons to avoid a sex-linked disorder for example a disorder linked to the X chromosome such as heomophilia, a bleeding disorder.
The laws governing PGD to screen for such disorders are described above. PGD may however, also be used for sex-selection for non-medical reasons. A poll of Australians showed that they overwhelmingly opposed sex-selection for non-medical social reasons. The strong opposition usually reflects concern about sex discrimination, population gender imbalance for example, too many males in a particular population and the best interests of the child. Despite this knowledge, they wish to have offspring, but only if they can be sure that their child will not also have the disease.
But having a child free of the disease means that that child is likely to lose a parent to the disease while still dependent on them. Some ethicists have questioned whether helping to have a child when the parent may die prematurely is a responsible act, and some physicians or programmes may refuse to offer such services Towner and Loewy, Yet a plausible case exists that such actions are ethical.
People in this situation have as strong an interest in reproduction as other people receiving infertility services. The fact of a shortened life span makes reproduction for that person all the more acute and pressing, and is the only chance for her partner to reproduce with her. In addition, the child in question could not otherwise be born but with this risk. The psychological trauma of dealing with the death or illness of a parent does not make a life so full of suffering or without clear benefit that one is harming the child by enabling her birth.
As a result, one cannot persuasively condemn parents and the physicians who help them who reproduce in those circumstances as causing unnecessary or undue suffering for their children. Without a stem cell transplant, the first child is likely to die. If no sibling exists, parents might conceive coitally and hope to have a child who is a suitable match.
Although rare, some parents might undergo prenatal diagnosis and abort if the fetus is not a good match, or even carry the fetus to term and give up the child for adoption Auerbach, Yet this distinction should not matter morally Pennings et al.
Although helping an existing child is a motivating factor in having an additional child, such a reason alone is not likely to make the parents ignore the needs of the new child. With stem cells available from umbilical cord blood no further intrusions on the new child will occur. Its birth might save the life of an existing, loved child, which would only increase its specialness.
If the stem cell transplant fails, the parents will have a surviving child to love. This limitation might be a prudent step to ensure that expanded uses of PGD occur slowly, but may not be entirely justifiable in terms of the principles that underlie allowing PGD for Mendelian disorders or other conditions.
Whether or not the embryo itself is at risk for the disease for which stem cells are sought, screening for closeness of HLA match for an existing sick child serves a substantial family need and is not abusive or commodifying of resulting children Robertson et al. The HFEA limitation should be reconsidered, and should not be followed in other jurisdictions facing the issue. A controversial use of PGD is for nonmedical sex selection—to serve parental interests in having a healthy child of a particular gender.
Because PGD for gender selection requires karyotyping only the sex chromosomes, it is more easily done than karyotyping for other aneuploidies or than single gene mutational analysis.
Requests for PGD for gender selection have come from two different groups. One is from people who wish to select the sex of their first born child. The second group is from people who already have a child of one gender and wish to have a child of the opposite gender. In many cases those requests are made after a family has had two or more children of the same gender, with no greater preference for males than for females. In either case PGD for nonmedical gender selection is highly controversial, because gender selection itself seems to be a less compelling reason for selection of embryos for transfer.
If sex selection for first children were carried out on a large scale, it could lead to great disparities in the sex ratio of the population, as has occurred in China and India Sen, ; Eckholm, Since PGD is unlikely to be widely practised, however, its use for the first child is only marginally likely to contribute to those disparities. As middle and upper classes in those cultures expand and have the means to obtain PGD, such demand could grow.
The use of PGD to select the sex of second or subsequent children is much less susceptible to a charge of sexism if used to choose a gender opposite to that of an existing child or children. It may not be per se sexist to wish to have a child or children of each gender, particularly if one has two or more children of the same sex.
Some feminists, however, would argue that any attention to the gender of offspring is inherently sexist, particularly when social attitudes and expectations play such an important role in constructing sex role expectations and behaviours.
Desiring the different rearing experiences that one has with boys and girls does not mean that the parents, who have already had children of one sex, are sexists or likely to devalue one or the other sex American Society of Reproductive Medicine, Based on this analysis the case is not strong for allowing PGD for the first child, but may be acceptable for gender variety in a family.
With regard to the first child, one may be promoting or entrenching sexist social mores. One could also argue that creating embryos to choose the gender of the first child is not a strong enough reason to show special respect for embryos. If PGD is not permitted, pregnancy and abortion might occur instead. The case for PGD for gender variety is stronger because the risk of sexism is lessened. A couple would be selecting the sex of a second or subsequent children for variety in rearing experiences, and not out of a belief that one sex is privileged over another.
Sex selection in that case would occur without running the risks of entrenching sexism and hurting women American Society of Reproductive Medicine, But is the desire for gender variety in children, even if not inherently sexist, a strong enough reason to justify creating and discarding embryos on that basis? The answer depends on how strong an interest that is. Aside from anecdotal evidence, it is unclear how many parents are in that situation and how strong the desire for gender variety is.
If it is a strong one, e. However, more evidence of the strength of the need would help in reaching a final conclusion Robertson, Subsequently, it found that preconception gender selection would be acceptable for purposes of gender variety but not for the first child American Society of Reproductive Medicine, Focusing only on the sexism and gender discrimination issue, the Chair of the Ethics Committee, in a widely publicized letter, found that PGD for gender balancing would be acceptable Kolata, When the full committee considered the matter, it concluded that it had not yet received enough evidence that the need for gender variety was so important in families that it justified creating and destroying embryos for that purpose Robertson, In the future if such evidence was forthcoming then PGD for gender variety might also be acceptable.
What might constitute such evidence? One source would be families with two or more children of one sex who would have another child only if they could be sure that it would be a child of the sex opposite of existing children.
Given the legitimacy of wanting to raise children of both genders, reasonable people might find that this need outweighs the symbolic costs of creating and destroying embryos for that purpose. Selection in that case could enable a couple to have a child that they would not otherwise have had, a goal served in other cases of embryo screening. A variation on this need might come from families that had suffered the death of a child and wanted to have another child of that sex.
Another arguably acceptable use of PGD for gender variety has been reported in India, where an IVF programme in Bombay is now providing PGD to select male offspring as the second child of couples who have already had a daughter Malpani et al. Because of the importance of a male heir in India, those couples might have resorted to abortion if pregnant with a female fetus even though illegal for that purpose. In that setting PGD for sex selection for gender variety appears to be justified.
Other controversial uses of PGD would arise if genetic tests for nonmedical traits such as hearing, sexual orientation, height, beauty, intelligence, or other factors became available Kass, ; Fukuyama, ; Stock, Untangling the inherited basis of phenotypic traits strongly influenced by learning and environment will not be simple, and such tests, with a few exceptions, are unlikely to be available, if at all, for some time to come.
One potential would be tests for GJB2 mutations, which are the largest known contributor to inherited deafness Nance and Pandya, If such a test is available, people with a family history of deafness might request PGD to screen out embryos with the mutation, in order to increase their chances of having a hearing child.
Because hearing is clearly beneficial to a child, a major ethical concern with this practice would be the prejudice to the deaf community that it might cause. For such screening to be acceptable, it is essential that it not be offered in ways that denigrated the deaf or lessened respect for them. The reverse situation—a deaf couple wants PGD to screen out embryos that do not have the GJB2 mutations—could also arise.
Here the ethical issue is whether having a deaf instead of a hearing child would have hurt that child. Others, however, strongly disagree Anstey, Similar issues would arise if a genetic test for sexual orientation became available. A main ethical concern would be whether use of the test to avoid offspring with homosexual orientation would increase discrimination or antipathy toward gays.
Much would depend on the precise circumstances of use and the characteristics of people seeking the test. Some people would strongly urge that selection for hearing ability, sexual orientation, or other traits should never be permissible Fukuyama, ; Kass, Reinforcing their concern is the fear that such uses of PGD will inevitably lead to more drastic efforts at selection and alteration of offspring traits.
Although PGD acts negatively by screening out embryos, it accepts the principle that parents might rightfully exercise control over the genomes of offspring. Although it is useful to identify the ethical issues that such uses would potentially raise, it is too soon to reach definitive judgements about whether these uses, if ever feasible, would or should be permitted.
Such tests are too far off in the future to make informed judgements about them now. Until they are closer to practical reality, they should not be an important factor in determining the acceptability of more feasible uses. Legitimate concerns about potential misuse of embryo screening and selection make it essential that a sustained public debate about these issues occurs as technical progress continues.
Some of the discomfort that surrounds new uses of PGD stems from a sense in many countries that there is no effective oversight of its development and use. Additional uses of PGD may occur only if the HFEA is satisfied that the uses are within statutory guidelines and the programme is qualified to undertake the work.
In addition, the HFEA uses a public consultation process to assess public attitudes and draw up guidelines for new uses, as demonstrated in its consultation process for whether PGD was acceptable for HLA matching of embryos with existing sick children Human Fertilisation and Embryology Authority, The situation in the United States is quite different. No agency exists at the state or federal level that plays a role comparable with that of the HFEA.
Congress exercises some control by refusing to fund research or use of PGD, but this often means that the activity escapes meaningful external review in the private sector. A few States have laws restricting embryo research, but several of them have been struck down as unconstitutionally vague or intrusive on reproductive rights, and the others are vulnerable to the same charges.
State malpractice and tort law will apply, but those restrictions provide little oversight of the ethical acceptability of new procedures. How PGD is used and for what indications is thus left largely to the discretion of providers offering those services and the patients who seek it.
With PGD, the need for a new agency or more explicit public controls may be less pressing than initially thought.
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