uk’s Legalisation of Mitochondrial Donation in ivf Treatment: A Challenge to the International Community or a Promotion of Life-saving Medical Innovation to Be Followed by Others?

in European Journal of Health Law
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Mitochondrial dna diseases are rare genetic disorders, which can have a devastating effect on the patients’ health and well-being. There is no cure for such diseases, although recent experiments suggest that there may be a way to prevent them by genetically altering the eggs or embryos through a procedure known as mitochondrial donation. However, such a procedure not only raises serious safety and ethical concerns, but legal challenges as well, since it involves germline gene modification, which until recently was not legal in the uk or elsewhere. In February 2015, the British Parliament amended the relevant legislation to allow such a procedure, making the uk the first state to openly challenge the global policy on germline gene modification. The article presents the scientific background to the procedure and discusses the regulatory challenges brought by the first case of its legalisation.

uk’s Legalisation of Mitochondrial Donation in ivf Treatment: A Challenge to the International Community or a Promotion of Life-saving Medical Innovation to Be Followed by Others?

in European Journal of Health Law

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References

1

Human Fertilization and Embryology Act 1990http://www.legislation.gov.uk/ukpga/1990/37/contents retrieved 23 April 2015.

2

Human Fertilization and Embryology Act 2008http://www.legislation.gov.uk/ukpga/2008/22/contents retrieved 23 April 2015.

7

See: P. Amato et al.‘Three-parent in vitro fertilization: gene replacement for the prevention of inherited mitochondrial diseases’Fertility and Sterility 101(1) (2014) 31-35 at 31; Wolf et al. supra note 5; J.P. Burgstaller et al. ‘Mitochondrial dna disease and developmental implications for reproductive strategies’ Molecular Human Reproduction 21(1) (2015) 11-22 at 11.

10

M. Tachibana et al.‘Mitochondrial gene replacement in primate offspring and embryonic stem cells’Nature 461(7262) (2009) 367-372 at 367. Generally heteroplasmy mutations are the cause of most frequent and severe mtDNA diseases. Supra note 7.

14

See: Amato et al.supra note 7; supra note 12 at 555.

15

P.F. Chinnery and G. Hudson‘Mitochondrial genetics’British Medical Bulletin 106(1) (2013) 135-159 at 141-142.

24

See: Burgstaller et al.supra note 7 at 12; Amato et al. supra note 7.

26

M. Araki and T. Ishii‘International regulatory landscape and integration of corrective genome editing into in vitro fertilization’Reproductive Biology and Endocrinology 12(1) (2014) 108.

29

Wolf et al.supra note 5.

30

Amato et al.supra note 7.

31

Wolf et al.supra note 5.

36

M. Tachibana et al.‘Towards germline gene therapy of inherited mitochondrial diseases’Nature 493 (7434) (2013) 627-631 at 630.

44

Mitochondria public consultation 2012http://www.hfea.gov.uk/9359.html retrieved 23 April 2015.

54

Burgstaller et al.supra note 7 at 14.

56

See: Amato et al.supra note 7 at 33-34; Wolf et al. supra note 5 at 74-75.

64

See e.g. G.E. Marchant and R.A. Lindor‘Prudent Precaution in Clinical Trials of Nanomedicines’Journal of Law Medicine and Ethics 40(4) (2012) 831-840 at 832.

67

Baylissupra note 52 at 533.

70

Ishiisupra note 52 at 154.

71

Baylissupra note 52 at 533.

73

Baylissupra note 52 at 533.

76

See: Baylissupra note 52 at 533; Ishii supra note 52 at 154.

84

As of April 201529 member states of the Council of Europe were parties to the Convention with 6 more member states signing but not ratifying it. Meanwhile the Convention is open for signature and accession not only to all 47 member states of the Council of Europe but to Australia Canada Holy See Japan Mexico the usa and the eu. A more detailed information on the participation is available at http://conventions.coe.int/Treaty/Commun/ChercheSig.asp?NT=164&CM=&DF=&CL=ENG retrieved 23 April 2015.

101

Baylissupra note 52 at 534.

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