Therefore, it is difficult to argue that a situation where genetic modification would allow the birth of a healthy child could be covered by the prohibition in article Again, an open question arises—in a situation where the main purpose of the modification is to remove from a particular embryo a particular mutation and the secondary goal is to transfer the modified gene to the next generations, is prohibiting such practices justified?
Referring to the Code of Medical Ethics Kodeks Etyki Lekarskiej , it should be pointed out that pursuant to article 51 par. Assuming that in most cases genetic modification will be done by a geneticist, not a doctor, the regulation of the code will not apply to the medical practitioner. In such cases, gene editing will be qualified as a medical experiment and will require, among others, the opinion of the bioethics commission. Summarizing this part of the considerations, it should be emphasized that it is extremely difficult to unequivocally indicate that Polish law prohibits gene editing of embryos and germline cells.
In Poland, no such modifications have been carried out. The question then arises as to whether a child or his or her parents will have claims to compensation and if so to whom, if gene therapy causes harm to the child or if it is not performed despite its availability.
At the beginning of the second part of the study, the following questions should be asked: who would be the patient in a situation where genetic modifications were made to reproductive cells and would such modifications be considered a medical procedure?
To answer these questions, the legal status of human germ cells and embryos should be determined. In many European legislations the term embryo is defined by law of medically assisted procreation. In some countries there is a debate as to whether it is possible to extend the concept of nasciturus to the embryo Cacace, In Polish law, the term embryo has been defined as a group of cells formed as a result of the extracorporeal connection of the female and male reproductive cells, from the end of the process of fusion of the germ cells karyogamy to implantation in the endometrium witch is a stage without legal personality.
After the implementation in the endometrium the embryo is considered to be a nasciturus and a potential human who has conditional legal capacity. The doctrine indicates that despite the lack of explicit statutory regulation in the field of compensation for damages, the embryo should be considered a nasciturus. In reference to cells of human origin, in the absence of explicit statutory regulation, it is postulated to consider them as the subject of law res with a very limited turnover.
Similarly, it should be pointed out that the issue of the status of human body parts in various European countries raises a lot of controversy. In Italian law, it can be indicated that the recognition of whether a given element can be protected by legal claims or by the protection of personal rights depends on the nature of the body parts and the purpose for which they were disconnected from the human body.
As De Cupis points out, parts detached from the human body, the disconnection of which is not associated with irreversible damage to the body, become movable goods that can be disposed of with certain restrictions arising from article 5 of codice civile Civil Code Regio Decreto 16 marzo , n.
It should be noted that things beni within the meaning of article c. According to this theory, parts of the human body become things when they become detached from the body.
As in Polish law, the Italian Civil Code uses the concept of nasciturus , guaranteeing, for example, rights related to inheritance, and the concept of embryo was specified in the Act on Medically Assisted Procreation Legge 19 febbraio , n 40, Norme in materia di procreazione medicalmente assistita l.
Initially, in Great Britain there was no doubt that the human body or even a human being could be the object of property, the best proof of which was slavery and feudal relations.
This view was maintained until the beginning of the 19th century, i. It should be noted that English positive law does not de facto determine the legal status of the human body, leaving the regulation to case-law. The general principle arising from common law is therefore the recognition that it has no property on the human body, but the development of medical science and commercialization of scientific research results have led the jurisprudence to create many exceptions to this principle.
Referring to the subject of reproductive cells, the courts often referred to exceptions to the rule of no property on human body. The admissibility of qualifying male semen as an object of property rights was indicated R v. Welsh RTR Under Polish law, all relations between the patient and healthcare service providers are regulated by civil law obligations Borysiak, This means, therefore, that in a situation where reproductive cells are genetically modified, the patient is the person from whom they originate.
Regarding this treatment, it should be pointed out that the therapeutic goal is reproductive cell therapy aimed at the treatment of infertility. Despite its title, the act does not apply to every infertility treatment. Gene modifications of reproductive cells would only be acceptable if the mutations held by these cells could not lead to the conception and birth of a child before the modification was applied. I am referring to the most serious diseases that cause infertility or a high risk of foetal death or spontaneous abortion.
There is no doubt, that the concept of serious illnesses has not been defined, and as Kleiderman et al. The situation would look differently if the occurrence of a genetic disease did not cause a foetus to die or its non-existence or cause the birth of a sick child. It is difficult to stipulate that such a treatment that affects the genotype is therapeutic for the patient who is a cell donor. Is it possible to indicate that in this regard the doctor performs a medical treatment for a future legal person, that is, the person who the child will become?
The answer to this question is not easy, although some proponents of the doctrine indicate that legal subjectivity is not a feature that determines the status of a patient. Traditionally, however, the subject of consideration was the legal nature of nasciturus , the embryo, and not the reproductive cells from which it would arise. Prenatal damage was directly defined in article 1 of the Polish civil code c. This regulation has made it possible for a child to claim damages for the damage that he or she has suffered before birth.
Using the language interpretation, it should be noted that art. In my opinion, there are no grounds for limiting the scope of article 1 c. I therefore accept that article 1 c. In her article, Wojtaszek aptly pointed out that legal subjectivity matters only when the claim is made and that compensation for preconception damage is subject to damage consisting in a health disorder. The author, referring to the views of Rezler, indicates that unlawfulness is a feature of a cause and may be a future violation of the legally protected interests of an entity that is to be created in the future.
The procedures of assisted procreation and genetic modification of human reproductive cells have shown, however, that it is possible to cause damage that will only become apparent after the birth of the child and that will not be damage done to the mother. This issue is not only related to genetic modification but also occurs in relation to mistakes in the in vitro procedure, e.
Another problem that can arise with regard to legal subjectivity is the argument of identity Soniewicka, It is difficult to indicate the possibility of pursuing claims showing the guilt of the doctor Article of the Polish Civil Code. It will also be difficult to indicate the causal relationship between the damage and the event.
When such a child develops malaria, it will be difficult to prove that the immediate cause was the modification, not the mosquito infection.
Such a relationship can be demonstrated in two cases: first, in a situation where the child has a high probability of contact with malaria, e. Even greater doubts may arise when the gene is not edited to cure the existing disease but to obtain a certain specific immunity.
Therefore, this case is about making a modification that has no therapeutic purpose and that is preventive. It is well known that a modification in the CCR5 gene a similar modification has just been carried out by He Jiankui causes resistance to HIV but increases the probability of becoming sick susceptibility to a virus with the West Nile fever. Undoubtedly, for the legality of such a medical experiment, a comparison of benefits and risks will be required.
However, the question remains open whether a child who is ill with West Nile fever will have a claim against the entity that made these modifications. As in the previous case, will we be able to indicate an adequate causal relationship between the event and the damage? Another problem is identifying the entity responsible for the damage. Fundamental in this respect is the problem of the responsibility of the parents who would agree to such a modification.
It seems unresolved whether pursuant to article c. These issues are directly related to the rights and obligations of future parents towards future children and the legal status of the human embryo and reproductive cells. There is no doubt that it can be problematic to justify blaming the parents the classic association of guilt in supervision. According to R. Scott there are very restrictive limitations to a duty of care toward an unborn child. First, it is doubtful whether there would be a legal basis for the consent of future parents.
Indeed, it cannot be said that by agreeing the parents would be making decisions that fall under parental authority, which would arise only if the child was born. Therefore, it would be possible to consider their responsibility only when the parental authority was also extended to the prenatal period.
Another important threat associated with gene editing is the right to privacy and autonomy. Many scientists indicate that children who were conceived from genetically modified cells or from embryos subjected to gene editing should be monitored for a long time Ishii and de Miguel Berian, Finally, a question arises about the time limits on this responsibility. According to art. If we make a genetic modification of a hereditary nature, will the children or grandchildren of the subject whose genome had been subjected to gene editing be able to make claims?
It seems that responsibility will always be limited by the sine qua non premise and an adequate causal relationship. At the current level of knowledge, we can indicate that the genome of each new generation will result not only from a single modification but also from subsequent modifications associated with environmental and associated changes that will naturally arise as a result of conception. In other words, it could open the door for unprecedented forms and practices of eugenics.
Especially, among scientific and medical-professional bodies, academies, and societies, the view is gaining ground that the existing bans should be lifted and that reproductive gene editing should be allowed for therapeutic purposes as soon as the technology is safe for clinical application. How should these proposals be viewed from a human rights perspective? Interestingly, in most of the reports, articles, and manifestos that advocate a regulatory pathway approach to HGGE, human rights are equally invoked.
This suggests that conflicting views on the meaning of human rights and human dignity are at the heart of current legal-ethical debates on HGGE.
As such, HGGE indeed touches on the normative foundations of human rights law. It is widely recognized that the meaning of human rights and their underlying principles may evolve over time. Similarly, the meaning of human rights and human dignity for the issue of human germline editing is not set in stone and may evolve over time.
This is also recognized by bioethics committees of both the Council of Europe and UNESCO, when they emphasize the vital importance of a public debate on this matter.
In this article, I have aimed to contribute to that debate by addressing three human rights concerns about the recent proposals for a regulatory pathway approach to reproductive gene editing. First, I have discussed the distinction that many of these proposals make between human germline editing for therapeutic and nontherapeutic purposes. According to this line of thought, using genetic modification for enhancement purposes would conflict with human rights law, whereas using this technology to prevent serious diseases and conditions would not.
Although the medical boundary between healing and enhancing can indeed be recognized in the human rights frameworks for the regulation of biomedical technologies, I have argued that the medical boundary will be much harder to maintain in case of HGGE than PGD.
Hence, once the ban on HGGE is lifted, it will be hard to prevent the practice from gradually sliding down toward more eugenic applications. Second, I have focused on the view and concept of human rights that underlie the recent proposals to go from prohibition to regulation of heritable gene editing.
Some authors have argued that editing the human germline is tantamount to editing human nature and that this would therefore disrupt the foundation of human rights. Existing human rights approaches, as laid down in international law documents from the Council of Europe and UNESCO, address concerns at the level of the individual, society, and humanity.
The recent proposals, however, only take into account the individual and societal dimensions of human rights discourse. References to humanity, humankind, human dignity, or the idea of the human genome as heritage of humanity are conspicuously absent. If human dignity is mentioned, it is reduced to a principle that only protects individual freedoms and rights. In other words, the collective dimension of human dignity is ignored.
For a proper debate on the meaning of human rights for heritable genome editing, both sides need to be taken into account. A careful balance needs to be found between, on the one hand, the health and rights of prospective parents and their future offspring and, on the other hand, the long-term interests of society, future generations, and humankind. Third, I have argued that this dismissal of the collective dimensions of human rights discourse also has repercussions for the public deliberation on this matter.
Once the issue is framed as one concerning exclusively the health and rights of those directly involved, vital questions are lost from view. Questions such as: what kind of lives do we wish for future generations?
And: how can we protect our humanity in an increasingly technological and data-obsessed society? Moreover, the way in which the issue is reframed, with a strong focus on medical standards such as safety and the medical boundary between healing and enhancing, bolsters the tendency to leave the discussion and governance to the scientific community itself. From this perspective, democratic interests appear to be at stake as well. The other way around, scientists take the place of citizens when their voice becomes decisive in the governance of highly controversial technologies that may have a lasting impact on no less than the future of humankind.
For a brief overview of these patent wars, see Ana Nordberg et al. D 12 Many scientists also regard nuclear genome transfer as germline genetic modification e. Guido de Wert et al. Rinie van Est et al. Also see Nuffield Council, supra note 38, at — I No. Health L. Greenpeace e. V , EU:C, sub Previously art. Annelien Bredenoord et al. According to the Dutch minister of Health, this has to do with the Dutch ban on creating embryos for research purposes.
See Art. See for example the title of the article in Nature in which the news on the licences is shared Callaway, supra note David Baltimore et al. See the title of Baltimore et al. The UK Nuffield Council on Bioethics takes a different stance and rejects the medical boundary between healing and enhancing as a useful red line. This will be discussed in further detail in Section V.
See, e. UK , application no. Edward Lanphier et al. However, according to the Nuffield Council, concerns about function creep and slippery slopes can be countered through reliable regulation see Nuffield Council, supra note 38, at 53— Mary Joy et al. For this expression, and for an elaborate discussion of this issue, see Eric T. Juengst et al. Law Biosci. International Bioethics Committee, supra note 68, sub Explanatory Report Oviedo Convention, supra note 57, sub Also see International Bioethics Committee, supra note 68, sub Especially see box 3.
Human Rights Alta Charo, Germline Engineering , supra note , at — Alta Charo, Germline Engineering , supra note , at Sheila Jasanoff, J. See Donna Dickenson, Me Medicine vs. See Report Highlights , p. Also see National Academies, supra note 98, at — and — ECtHR, Apr. Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide.
Sign In or Create an Account. Sign In. Advanced Search. Search Menu. Article Navigation. Close mobile search navigation Article Navigation. Volume 7. Article Contents Abstract. The germline gene editing science race. Legal approaches to human germline editing. From prohibition to regulation of HGGE? The blurring boundary between treatment and enhancement. Individual and collective dimensions of human rights law. From human rights to self-regulation by the scientific community?
Rewriting the human genome, rewriting human rights law? Department of Legal Theory. Corresponding author: E-mail: b. Oxford Academic. Google Scholar. Revision received:. Select Format Select format. Permissions Icon Permissions. Download citation. Received : 20 February Accepted : 03 May Published : 14 May Anyone you share the following link with will be able to read this content:.
Sorry, a shareable link is not currently available for this article. Provided by the Springer Nature SharedIt content-sharing initiative. Skip to main content. Search all BMC articles Search. Download PDF.
Abstract Human genome-editing is banned by guidelines, laws and regulations in most countries. Current laws and regulations of genome-editing in different countries Human genome-editing is largely forbidden by laws or guidelines even in countries permissive to human embryonic stem cell research [ 4 ]. The sentence of genome-editing babies in China Current Chinese laws are insufficient to deal with new challenges posed by new expertise and technologies.
Conclusion Human genome-editing technology is a two-sided sword. Availability of data and materials Not applicable. References 1. Article Google Scholar 4. Article Google Scholar 5. Google Scholar 6. Article Google Scholar 7. Acknowledgements The author would like to thank the comments and advices of reviewers in improving the quality of the article. Ethics declarations Ethics approval and consent to participate Not applicable. Consent for publication The author agreed the publication of this manuscript.
Competing interests The author declares that she has no competing interests. About this article. European Molecular Biology Organization Reports 8 , — Gordon, E. Nondisease genetic testing: Reporting of muscle SNPs shows effects on self-concept and health orientation scales. European Journal of Human Genetics 13 , — doi Grobet, L. A deletion in the bovine myostatin gene causes the double-muscled phenotype in cattle.
Nature Genetics 17 , link to article. Marteau, T. Effects of genetic screening on perceptions of health: A pilot study. Journal of Medical Genetics 29 , 24—26 McPherron, A. Regulation of skeletal muscle mass in mice by a new TGF-beta superfamily member.
Nature , 83—90 doi Tang, Y. Genetic enhancement of learning and memory in mice. Nature , 63—69 doi Taylor, C. Long-term impact of Huntington disease linkage testing. American Journal of Medical Genetics 70 , — Wei, F. Genetic enhancement of inflammatory pain by forebrain NR2B overexpression. Nature Neurosci ence 4 , — doi Well, D. Gene doping: The hype and the reality.
British Journal of Pharmacology , — doi Woolridge, E. The health orientation scale: A measure of feeling about sickle cell trait. Social Biology 35 , — Bioethics in Genetics.
Genetic Inequality: Human Genetic Engineering. Questionable Prognostic Value of Genetic Testing. Human Subjects and Diagnostic Genetic Testing.
Prenatal Screen Detects Fetal Abnormalities. Legislative Landmarks of Forensics: California v. Greenwood and Shed DNA. Calculation of Complex Disease Risk.
Gene Therapy. Personalized Medicine: Hope or Hype? Pharmacogenetics, Personalized Medicine, and Race. Pharmacogenomics and Personalized Medicine.
Medical Careers: Genetic Screening and Diagnostics. Citation: Simmons, D. Nature Education 1 1 As genetics allows us to turn the tide on human disease, it's also granting the power to engineer desirable traits into humans. What limits should we create as this technology develops?
0コメント