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The Legal Implications of Preimplantation Genetic Diagnosis

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Biotech Innovations and Fundamental Rights

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Abstract

The object of this paper is to analyze: (1) the pertinent ethical arguments for and against Preimplantation Genetic Diagnosis (PGD); (2) the international rules which apply to PGD; and (3)the differing legal approaches and policies towards PGD in selected European States. Finally it will consider the consequences of those differing approaches in Europe towards PGD for a couple’s right to procreative autonomy and will try to establish if the UK’s legal model is the one which best serves the different interests and rights at stake.

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Notes

  1. 1.

    The term genetic disease refers to diseases that are related to defects in one or more genes. They are often classified in categories depending on the gross mechanism of causation. One such category is Menedlian or monogenic disorders. These comprise over 8000 known disease entities in humans. Many of these are rare and do not occur in all populations (in different populations, geneticists often talk of ‘disease heritages’). As a group, these diseases affect 2–4% of people of same age, but each distinct disease is relatively rare (up to 1:500but with the majority in the 1:100,000–1:10,000 range). Monogenic disorders are characterized by a predictable recurrence risk, and precise molecular diagnosis is available for many (though not all) of them. Their severity varies from lethal to fully treatable. A second large group of genetic diseases comprises those with a gross chromosomal background. Trisomy 21 is the most common example, but additionally this category includes numerous rarer types. The third major group of genetic diseases is that including complex disorders. Many of these are common, and they result in major health care costs, particularly late in life. This group of diseases is of major interest in the current debate because there while there are definite genetic risks there is also predictive uncertainty resulting from environmental factors and pure chance. See, J. Kere, Genetic Diagnostics — what can it predict?, I. Jónsdóttir (eds), Preimplantantion Genetic Diagnosis and Embryo Selection, Copenaghen, 2005, at 22.

  2. 2.

    Hans Galjaard, Report of the IBC on Pre-Implantation Genetic Diagnosis and Germ-Line Intervention, UNESCO Report, SHS-EST/02/CIB-9/2 (Rev. 3), Paris, 24 April 2003, available at: http://unesdoc.unesco.org/images/0013/001302/130248e.pdf.

  3. 3.

    C. Cavaghan, Defending the Genetic Supermarket: The Law and Ethics of Selecting the Next Generation, Abingdon, 2007, at 18.

  4. 4.

    J. Savulescu, Procreative Beneficence: Why We Should Select the Best Children, in Bioethics, 2005, at 12.

  5. 5.

    K. P. Herrisone, Procreative Beneficence and the Prospective Parent, in J Med Ethics., 2006, at 166.

  6. 6.

    S. J., Fasouliotis, & J. G. Schenker, Preimplantation Genetic Diagnosis Principles and Ethics, in Hum. Repr., 1998, at 2238.

  7. 7.

    J.R. Botkin, Ethical Issues and Practical Problems in Preimplantation Genetic Diagnosis, in J Law, Med Eth, 1998, at 17.

  8. 8.

    According to the Human Genetics Commission’s (HGC) report ‘Increasing options, informing choice: A report on preconception genetic testing and screening’, 04/2001, at 14 “one of the more substantial problems associated to preconception genetic testing and screening is the possibility that it may encourage negative eugenics, which the report defines as the “organised, deliberate discouragement or prevention of natural reproduction”.

  9. 9.

    For a criticism to this argument, see F. Siddiqui, Assessing the Ethicality of Pre-Implantation Genetic Diagnosis Beyond the Discourse of Eugenics, in PBJ, Vol. II, Issue 1, 2006, at 31.

  10. 10.

    J.S Freeman, Arguing along the Slippery Slope of Human Embryo Research, in J Med Philos, 1996, at 79.

  11. 11.

    T.S. Petersen, Just Diagnosis? Preimplantation Genetic Diagnosis and Injustices to Disabled People, in J Med Ethics, 2005, at 231.

  12. 12.

    ECHR, Judgement of 01.04.2010, no. 57813/00.

  13. 13.

    C. Campiglio, Il divieto di fecondazione eterologa all’esame della Corte europea dei diritti umani, in D.U.D.I., 2010, at 624.

  14. 14.

    ECHR, Judgement of 18.04.2006, no. 44362/04, § 66.

  15. 15.

    ECHR, Judgement of 8.7.2004, Application no.53924/00.

  16. 16.

    ECHR, Judgement of 10.4.2007, Application no. 6339/05.

  17. 17.

    Article 2 of the Oviedo Convention states “The interest and the well being of the human being shall prevail over the sole interest of science and society”.

  18. 18.

    Explanatory Report to the Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine (ETS 164), par. 18.

  19. 19.

    See, Council of Europe, Background Document on Preimplantation and Prenatal Genetic Testing. Clinical Situation, Legal Situation, CDBI/INF (2010) 6, 22 November 2010, at 4.

  20. 20.

    Art. 12 states: “Tests which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to a disease may be performed only for health purposes or for scientific research linked to health purposes, and subject to appropriate genetic counselling”.

  21. 21.

    I.R. Pavone, La Convenzione europea sulla biomedicina, Milano, 2009, at 203.

  22. 22.

    Explanatory Report to the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes, (CETS No. 203), par. 31.

  23. 23.

    A. Santosuosso, L’integrità della persona nell’ambito della medicina e della biologia: a proposito dell’art. 3 della Carta di Nizza, in Donne e Responsabilità, 8–9 2002, at 809.

  24. 24.

    Explanations relating to the Charter of Fundamental Rights, in Official Journal of the European Union, 14.12.2007, C303/17.

  25. 25.

    Council of the European Union, Directive on Cross-Border Health Care, 11 February 2011, 7056/11.

  26. 26.

    Gesetz zum Schutz von Embryonen vom 13. december 1990 (Embryonenschutzgesetz), entered into force on 1st January 1994, in I.D.H.L., nr. 42, 1991, at 60.

  27. 27.

    D. Birnbacher, La Convenzione europea di bioetica in Germania, in Bioetica, 2001, at632.

  28. 28.

    BGH, Decision of 6th July 2010 – 5 StR 386/09, in Neue Juristische Wochenschrift, 2010, 2672. A. Tuffs, Court allows Preimplantation Genetic Diagnosis in Germany, in BMJ, 2010, at 341.

  29. 29.

    N. Stafford, The German Parliament Considers Three Bills on Preimplantation Genetic Diagnosis, in BMJ, 2011, at 342.

  30. 30.

    Gesetz zum Regelung der Gentechnik vom 16. Dezember 1993 (entrata in vigore il 1.1.1995), in I.D.H.L., nr.46, 1995, at 42.

  31. 31.

    Norme in materia di procreazione medicalmente assistita, Law n. 40 of 10 February 2004, entered into force on 10 March 2004, in G.U. n. 45 of 24 February 2004. G. Benagiano, Legge 40/2004: le critiche di un conservatore, in Bioetica, 2004, at 220.

  32. 32.

    Judgment nr. 151/2009 of 8 May 2009; G. Benagiano, L. Gianaroli, The Italian Constitutional Court modifies Italian Legislation on Assisted Reproduction Technology, in Reprod Biomed Online, 2010 Mar; 20(3):398–402. Epub 2009 Dec11.

  33. 33.

    A. Milunski, J. Milunsky, Genetic Disordes and Fetus: Diagnosis, Prevention and Treatment, in Am J Hum Genet, 2005 November; at 896.

  34. 34.

    Section 73 (Selection of Embryos based on tissue type), foreseen by Act no.240 of 5th April 2004 amending the Act on Artificial Fertilisation.

  35. 35.

    L. Walin, Ambiguity of the Embryo Protection in the Human Rights and Biomedicine Convention: Experiences from the Nordic Countries, in E.J.H.L., 2007, at 131.

  36. 36.

    Law No. 56/1994 of 5 august 1994 on the use of biotechnology for medical purposes (amended by Law No.29 of 16 May 1997), in I.D.H.L., nr. 46, 1995, at 51–69.

  37. 37.

    J. H. Solbakk, The Bio-Politics of extending Pre-Implantation Genetic Diagnosis: A Norwegian Case History, in I. Jónsdóttir (eds), Preimplantation Genetic Diagnosis and Embryo Selection, Copenhagen, 2005.

  38. 38.

    Artificial Fertilisation Act 1996 no. 55, 29 May 1996.

  39. 39.

    Genetic Integrity Act. Swedish Code of Statutes no 2006:351 (18 May 2006), in International Digest of Health Legislation, 2007, 58, Swed. 07.005.

  40. 40.

    Art. 67–73 of the Loi relative à la procréation médicalement assistée et à la destination des embryons surrenuméraires et des gamètes, 6 Juillet 2007, see Pennings, Belgian Law on Medically Assisted Procreation and the Disposition of Supernumerary Embryos and Gametes, in E.J.H.L., 2007, at 251.

  41. 41.

    Loi n. 2004-498 du 6 août 2004 relative à la bioétique, in J.O. n. 182 du 7 août 2004 page 14040.

  42. 42.

    Art. L. 2131-4-1 of the Code de la Santé Publique introduced by art. 23.6 of Law n. 800 states that “Par dérogation aux dispositions prévues par le cinquième alinéa de l’article L. 2131-4, le diagnostic biologique effectué à partir de cellules prélevées sur l’embryon in vitro peut également être autorisé, à titre expérimental, lorsque les conditions suivantes sont réunies: le couple a donné naissance à un enfant atteint d’une maladie génétique entraînant la mort dès les premières années de la vie et reconnue comme incurable au moment du diagnostic; le pronostic vital de cet enfant peut être amélioré, de façon décisive, par l’application sur celui-ci d’une thérapeutique ne portant pas atteinte à l’intégrité du corps de l’enfant né du transfert de l’embryon in utero, conformément é l’article 16-3 du code civil; le diagnostic mentionné au premier alinéa a pour seuls objets de rechercher la maladie génétique ainsi que les moyens de la prévenir et de la traiter, d’une part, et de permettre l’application de la thérapeutique mentionnée au troisième alinéa, d’autre part. Les deux membres du couple expriment par écrit leur consentement à la réalisation du diagnostic. La réalisation du diagnostic est soumise à la délivrance d’une autorisation par l’Agence de la biomédecine, qui en rend compte dans son rapport public conformément à l’article L. 1418-1. Cette autorisation est subordonnée au respect des dispositions prévues au dernier alinéa de l’article L. 2141-3.”

  43. 43.

    Act. No. 227/2006 Col.: About stem cell research and related activities and about the change of some related acts.

  44. 44.

    Law on the Rights of the Patients (no 283-Ils).

  45. 45.

    Law 3305/05 for the Medically Assisted Reproduction.

  46. 46.

    Law n. 32/2006, of the 26thof July, concerning Medically Assisted Reproduction.

  47. 47.

    Health Care Act of Serbia (2005).

  48. 48.

    The Law on Treatment of Infertility and on Biomedical Assisted Procreation, 2000.

  49. 49.

    Human Fertilization and Embryology Act, of 1 November 1990, in I.D.H.L. 1991, nr. 42, at 350 ss. See, Klotzo, The Regulation of Embryo Research under the Human Fertilisation and Embryology Act, in D. Evans (eds) Conceiving the Embryo. Ethics, Law and Practice in Human Embryology, The Hague, 1996, at 303; A. Plomer, Beyond the HFE Act 1990: The Regulation of Stem Cell Research in the UK, in M.L.R., 2002, at 132.

  50. 50.

    R. Scott, The Uncertain Scope of Reproductive Autonomy in Preimplantation Genetic Diagnosis and Selective Abortion, in Med Law Rev, 2005, at 291.

  51. 51.

    Wet houdende regels inzake handelingen met geslachtscellen en embryo’s: Embrowet 2002.

  52. 52.

    E.C.A. Asscher, The Regulation of Preimplantation Genetic Diagnosis (PGD) in the Netherlands and the UK: a Comparative Study of the Regulatory Frameworks and Outcomes for PGD, in Clin Ethics, 3 2008, at 176.

  53. 53.

    Y. Verlinsky, A. Kuliev, Practical Preimplantation Genetic Diagnosis, London, 2005.

  54. 54.

    E. Aarden, I. Van Hoyweghen, R. Vos and K. Horstman, Providing Preimplantation Genetic Diagnosis in the United Kingdom, the Netherlands and Germany: a Comparative In-Depth Analysis of Health-Care Access, in Hum. Reprod., 24 (7) 2009 at 1542; S. Soin, Preimplantation Genetic Diagnosis (PGD) in Europe: Diversity of Legislation a Challenge to the Community and its Citizens, in Med Law, Jun; 26(2) 2007, at 309. Soin specifies in his paper that in order to standardize the application, performance and delivery of PGD in European countries, the European Society for Human Reproduction and Embryology (ESHRE) recently issued a number of guidelines and viewpoints, specifying technical requirements to laboratories, indicating best practices for diagnosis and counselling, and highlighting the need of cooperation between genetics and reproductive medicine.

  55. 55.

    http://www.hfea.gov.uk/cps/hfea/gen/pgd-screening.htm. Also Georgia commonly uses list of disorders for which PGD is accepted, listed in the code of practice to the law of 2000.

  56. 56.

    R. Scott, C. Williams, K. Ehrich, B. Farsides, The Appropriate Extent of Pre-Implantation Genetic Diagnosis: Health Professionals’ and Scientists’ Views on the Requirement for a ‘Significant Risk of a Serious Genetic Condition’, in Med Law Rev, 2007, at 320.

  57. 57.

    J.R. Botkin, Ethical Issues and Practical Problems in Preimplantation Genetic Diagnosis, in J Law, Med Eth, 16 1998, at 17.

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Authors and Affiliations

  1. Institute for International Legal Studies (ISGI) of the Italian National Research Council, Rome, Italy

    Ilja Richard Pavone (Researcher of International Law)

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Editors and Affiliations

  1. Department of Juridical Sciences, University of Ferrara, Italy

    Roberto Bin , Sara Lorenzon  & Nicola Lucchi ,  & 

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Pavone, I.R. (2012). The Legal Implications of Preimplantation Genetic Diagnosis. In: Bin, R., Lorenzon, S., Lucchi, N. (eds) Biotech Innovations and Fundamental Rights. Springer, Milano. https://doi.org/10.1007/978-88-470-2032-0_12

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