REGULATORY ASPECTS OF
     CRYOPRESERVATION
    AROUND THE WORLD:
GLOBAL VILLAGE OR DYSTOPIA?
      Dr David Mortimer, PhD...
Cryopreserving Reproductive Tissues
• Own use:
   • Convenience, e.g. during ART treatment
   • Fertility insurance, e.g. ...
How Long Can We Cryobank Reproductive Tissues?


  Theoretical limit (mouse embryos based on cumulative DNA damage
  from ...
Global village?
Regulatory Restrictions
• An exhaustive review of what is / what is not allowed is
    pointless (a “stamp collecting” exe...
What is a Dystopia?
Common definitions:
• “A state in which the conditions of life are extremely bad, as from deprivation ...
Where Do These Differences Come From?
• Beliefs: the psychological state in which an individual holds a
  proposition or p...
What Drives Human Nature?
• Biological imperatives: survival and reproduction.
• Social grouping: cooperation, hierarchy, ...
Monotheistic Religions and Assisted Reproduction
e.g. Christianity; Judaism; Islam

• Characterized by the existence of an...
Disclaimer . . .

• Roman Catholicism is used as an example solely because
  it has made the clearest statements regarding...
Roman Catholic Doctrine
• The principal focus of the Catholic Church’s interventions
  in the public arena is the protecti...
Dignitas Personae (2008) – General
• The dignity of a person must be recognized in every human
  being from conception to ...
Natural Embryonic Wastage

Some basic biology:
• The purpose of sexual reproduction (as opposed to asexual
  reproduction)...
Dignitas Personae (2008) – Embryo cryo
• Cryopreservation is incompatible with the respect owed to
 human embryos; it pres...
Dignitas Personae (2008) – Using frozen embryos
• Proposals to use these embryos for research or for the
  treatment of di...
Dignitas Personae (2008) – Freezing oocytes
• In order avoid the serious ethical problems posed by the
  freezing of embry...
Human Rights, Freedoms and Infertility
Men and women of full age, without any limitation due to
race, nationality or relig...
Ethics and ART




                 © Oozoa Biomedical Inc, April 2010
• The Religious Right maintains that only sexual activity open to reproduction is morally
    acceptable, and that violati...
Definitions . . .
Secular humanism: a humanist philosophy that espouses reason,
ethics, and justice, and specifically reje...
• Human ART has brought about a radical change in traditional perspectives about sexuality
 and reproduction.
• In the pas...
Fundamental Questions (1)
When does life begin?
• A biologist’s perspective: Life is a continuum, spanning generations,
  ...
Fundamental Questions (2)
What marks the coming into existence of a new person /
  individual?
• Intercourse?
• When the s...
Answers?

• There are no absolute answers (c.f. the “chicken and
 the egg” question).
• Acceptable answers will depend on ...
How Did Regulatory Differences Come About?
National – or state / provincial – differences
 or compromises in:
• Balance be...
Patients’ Response: Circumvent regulations
Cross-border reproductive care (“reproductive tourism”)




              52%*
...
The Future — How Might We Improve It?
Assumption: That those of us working in human ART are
concerned with helping their f...
Things That Scare the Public – Cloning
Lay Information Sources . . .
In The Mass Media . . .
Some False Perceptions . . .
Regulatory aspects of cryopreservation around the world global village or dystopia  alpha- mortimer_david_01.05.2010
Regulatory aspects of cryopreservation around the world global village or dystopia  alpha- mortimer_david_01.05.2010
Regulatory aspects of cryopreservation around the world global village or dystopia  alpha- mortimer_david_01.05.2010
Regulatory aspects of cryopreservation around the world global village or dystopia  alpha- mortimer_david_01.05.2010
Regulatory aspects of cryopreservation around the world global village or dystopia  alpha- mortimer_david_01.05.2010
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Regulatory aspects of cryopreservation around the world global village or dystopia alpha- mortimer_david_01.05.2010

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Regulatory aspects of cryopreservation around the world global village or dystopia alpha- mortimer_david_01.05.2010

  1. 1. REGULATORY ASPECTS OF CRYOPRESERVATION AROUND THE WORLD: GLOBAL VILLAGE OR DYSTOPIA? Dr David Mortimer, PhD O oz Bi oa omedialI c nc Vancouver, BC, Canada
  2. 2. Cryopreserving Reproductive Tissues • Own use: • Convenience, e.g. during ART treatment • Fertility insurance, e.g. pre-vasectomy • Fertility preservation, e.g. pre-sterilizing therapy (chemo~ / radio~) • Use by others: • Donor gametes (spermatozoa and oocytes) • Donated embryos • Custom embryos, e.g. Abraham Center of Life (San Antonio, TX, USA) – now closed Spermatozoa Mature oocytes (MII) (semen / washed / SSR) Immature oocytes (for IVM) Testicular tissue Ovarian tissue Zygotes Embryos: cleavage stages, blastocysts © Oozoa Biomedical Inc, April 2010
  3. 3. How Long Can We Cryobank Reproductive Tissues? Theoretical limit (mouse embryos based on cumulative DNA damage from background radiation, extrapolated from in vitro experiments): ~2000 years Glenister et al., J. Reprod. Fertil., 70: 229-234, 1984 Practical limit: What are we allowed to do? © Oozoa Biomedical Inc, April 2010
  4. 4. Global village?
  5. 5. Regulatory Restrictions • An exhaustive review of what is / what is not allowed is pointless (a “stamp collecting” exercise) — each of us knows the regulations that affect our practice locally. Examples: • Italy: gametes only, no embryos • Switzerland: zygotes only, no embryos • Denmark: anything, but maximum 2 yrs storage • Australia: anything, maximum 10 years storage • UK: anything, for max 10 yrs unless frozen @ age <55 yrs, then up to 55 yrs (?) • Finland: unrestricted • Abu Dhabi: embryo cryo banned in mid-2008 – but with >10,000 embryos in cryostorage . . . © Oozoa Biomedical Inc, April 2010
  6. 6. What is a Dystopia? Common definitions: • “A state in which the conditions of life are extremely bad, as from deprivation or oppression or terror.” • “A society in which social and/or technological trends have contributed to a corrupted or degraded state.” • “A place where people lead dehumanized and often fearful lives, an imaginary place or state where everything is as bad as it possibly could be.” But from whose perspective? • General society / ethnic sub-groups? • Religious leaders: local, national &/or international? • Infertile couples? • What right(s) does / should Society have to dictate how people can reproduce? © Oozoa Biomedical Inc, April 2010
  7. 7. Where Do These Differences Come From? • Beliefs: the psychological state in which an individual holds a proposition or premise to be true. — primarily religious beliefs • Morals: motivation based on ideas of right and wrong. • Ethics: the philosophical study of moral values and rules. • Principles: a basic generalization that is accepted as true and that can be used as a basis for reasoning or conduct. • Cultural norms: “public opinion” • Politics: the activities and affairs involved in managing a state or a government; OR social relations involving intrigue to gain authority or power. © Oozoa Biomedical Inc, April 2010
  8. 8. What Drives Human Nature? • Biological imperatives: survival and reproduction. • Social grouping: cooperation, hierarchy, authority / power. • Fear of the unknown: • The need for explanation and understanding, creating our fundamentally inquisitive nature, learning through experience — and hence exploration and scientific investigation. • In the absence of understanding, gods have appeared in all human cultures and societies throughout history to explain existence as the result of “divine intervention”. • Fear of change: “comfort zones”, sense of insecurity, result in resistance to change = conservatism. © Oozoa Biomedical Inc, April 2010
  9. 9. Monotheistic Religions and Assisted Reproduction e.g. Christianity; Judaism; Islam • Characterized by the existence of an “intrinsic truth”. • Involve ethical principles and norms based upon God’s revelations made known to the believer through holy books. • Separating religious norms from national or local cultural determinants can be extremely difficult — and religious beliefs can exert strong influences on civil authorities and legislation. • Show widely variable attitudes towards assisted conception (not even considering PGD, stem cells, etc) — not just between the main religions, but also within them, e.g. Roman Catholic church, Anglican church, etc. © Oozoa Biomedical Inc, April 2010
  10. 10. Disclaimer . . . • Roman Catholicism is used as an example solely because it has made the clearest statements regarding the practice of assisted reproduction. • Only aim is to illustrate the disconnect between religious doctrine and individuals’ (patients) needs and actions, not to editorialize. • No intention to disrespect anyone’s beliefs or to offend — and apologize in advance for any inadvertent choice of words that might do so. © Oozoa Biomedical Inc, April 2010
  11. 11. Roman Catholic Doctrine • The principal focus of the Catholic Church’s interventions in the public arena is the protection and promotion of the dignity of the person, drawing particular attention to principles which are not negotiable. • This includes the protection of life in all its stages, from the first moment of conception until natural death, and recognition and promotion of the natural structure of the family (as a union between a man and a woman based on marriage). • These principles are not truths of faith . . . they are inscribed in human nature itself and therefore they are common to all humanity. [“Natural law”] Pope Benedict XVI (2006) © Oozoa Biomedical Inc, April 2010
  12. 12. Dignitas Personae (2008) – General • The dignity of a person must be recognized in every human being from conception to natural death. • The body of a human being, from the very first stages of its existence, can never be reduced merely to a group of cells. • Thus the fruit of human generation, from the first moment of its existence, i.e. from the moment the zygote has formed, demands the unconditional respect that is morally due to the human being in his bodily and spiritual totality. . . . his rights as a person must be recognized, among which in the first place is the inviolable right of every innocent human being to life. But what about natural biological wastage? © Oozoa Biomedical Inc, April 2010
  13. 13. Natural Embryonic Wastage Some basic biology: • The purpose of sexual reproduction (as opposed to asexual reproduction) is to ensure genetic variability within the population. • However, meiosis, recombination and mitosis are imperfect processes, resulting in many errors. • At least 50% of all human embryos created naturally in vivo are genetically abnormal; only a very small proportion of these are not lost spontaneously. • This is nature (and not amenable to human – or religious – intervention); so how can “natural law” include the concept that all embryos have a right to life? © Oozoa Biomedical Inc, April 2010
  14. 14. Dignitas Personae (2008) – Embryo cryo • Cryopreservation is incompatible with the respect owed to human embryos; it presupposes their production in vitro; it exposes them to the serious risk of death or physical harm, since a high percentage does not survive the process of freezing and thawing; it deprives them at least temporarily of maternal reception and gestation; it places them in a situation in which they are susceptible to further offense and manipulation. • With regard to the large number of frozen embryos already in existence the question becomes: what to do with them? Some of those who pose this question do not grasp its ethical nature, motivated as they are by laws in some countries that require cryopreservation centers to empty their storage tanks periodically. © Oozoa Biomedical Inc, April 2010
  15. 15. Dignitas Personae (2008) – Using frozen embryos • Proposals to use these embryos for research or for the treatment of disease are obviously unacceptable because they treat the embryos as mere “biological material” and result in their destruction. • The proposal that these embryos could be put at the disposal of infertile couples as a treatment for infertility is not ethically acceptable for the same reasons which make artificial heterologous procreation illicit as well as any form of surrogate motherhood. © Oozoa Biomedical Inc, April 2010
  16. 16. Dignitas Personae (2008) – Freezing oocytes • In order avoid the serious ethical problems posed by the freezing of embryos, the freezing of oocytes has also been advanced in the area of techniques of in vitro fertilization. Once a sufficient number of oocytes has been obtained for a series of attempts at artificial procreation, only those which are to be transferred into the mother’s body are fertilized while the others are frozen for future fertilization and transfer should the initial attempts not succeed. • In this regard it needs to be stated that cryopreservation of oocytes for the purpose of being used in artificial procreation is to be considered morally unacceptable. © Oozoa Biomedical Inc, April 2010
  17. 17. Human Rights, Freedoms and Infertility Men and women of full age, without any limitation due to race, nationality or religion, have the right to marry and to found a family. Article 16.1: Universal Declaration of Human Rights, United Nations, 1948. Everyone has the right to freedom of thought, conscience and religion; this right includes freedom to change his religion or belief, and freedom, either alone or in community with others and in public or private, to manifest his religion or belief in teaching, practice, worship and observance. Article 18: Universal Declaration of Human Rights, United Nations, 1948. Infertility: a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse. WHO, 2009 (Zegers-Hochschild et al., Fertil. Steril., 92: 1520-4, 2009). © Oozoa Biomedical Inc, April 2010
  18. 18. Ethics and ART © Oozoa Biomedical Inc, April 2010
  19. 19. • The Religious Right maintains that only sexual activity open to reproduction is morally acceptable, and that violating this imperative violates God’s will. • Religious progressives and secular humanists deny these positions, arguing instead that the moral quality of sex is determined by how its participants treat each other. • Religious progressives (but not secular humanists) continue to believe that religion has some authority in ethics. • This paper shows why no such arguments are successful, and concludes that any compelling case against the Religious Right sexual ethic and in support of a humane one must be based in secular ethics.
  20. 20. Definitions . . . Secular humanism: a humanist philosophy that espouses reason, ethics, and justice, and specifically rejects the supernatural and religious dogma. Secular ethics: a branch of moral philosophy in which ethics is based solely on human faculties such as logic, reason or moral intuition, and not derived from purported supernatural revelation or guidance. © Oozoa Biomedical Inc, April 2010
  21. 21. • Human ART has brought about a radical change in traditional perspectives about sexuality and reproduction. • In the past, the field was surrounded by an aura of mystery, which allowed religion to grasp the subject firmly. • An explosion of knowledge, and a new capacity to control all aspects of human reproduction are beginning to modify attitudes, so that the arenas of sexuality and reproduction are apparently undergoing a process of rapid secularization. • Religious solutions to reproductive problems are becoming obsolete and possibly dangerous, since they no longer adequately fulfill the needs of humanity in our modern era.
  22. 22. Fundamental Questions (1) When does life begin? • A biologist’s perspective: Life is a continuum, spanning generations, with gametes carrying the necessary information from one to the next. Evolution vs creationism / intelligent design: ? OR . . . © Oozoa Biomedical Inc, April 2010
  23. 23. Fundamental Questions (2) What marks the coming into existence of a new person / individual? • Intercourse? • When the spermatozoon enters the oocyte? [fertilization] • When the pronuclei form? [the zygote] • When the pronuclei break down, allowing the paternal & maternal chromosomes to intermingle? [syngamy] • First cleavage? • Implantation? • Neural crest formation? (or closure?) • Fetal heartbeat? • When a fetus can survive premature birth? • Birth of the baby? © Oozoa Biomedical Inc, April 2010
  24. 24. Answers? • There are no absolute answers (c.f. the “chicken and the egg” question). • Acceptable answers will depend on the individual’s, or organization’s, perspective – and also, probably, upon their intent. • The real question is whether anyone has the right to impose their beliefs upon anyone else. © Oozoa Biomedical Inc, April 2010
  25. 25. How Did Regulatory Differences Come About? National – or state / provincial – differences or compromises in: • Balance between traditional religion, religious progressives, and secular humanism. • Degree of segregation between church and state – or lack thereof. • Social attitudes towards needing to have children. • Recognition / acceptance of self-determination (or lack thereof). • Education of the population in biology / science. • Political expediency? • But certainly very little to do with Science or Medicine. © Oozoa Biomedical Inc, April 2010
  26. 26. Patients’ Response: Circumvent regulations Cross-border reproductive care (“reproductive tourism”) 52%* * of reported European oocyte donation cycles © Oozoa Biomedical Inc, April 2010
  27. 27. The Future — How Might We Improve It? Assumption: That those of us working in human ART are concerned with helping their fellow man (and woman) meet the fundamental human need for having children. What should we, as practising reproductive biologists, do? • Maintain strict ethical standards, respecting others’ rights and opinions. • Communicate: do not be secretive, as this only engenders fear in the public (“mad scientists”). • Avoid unnecessary controversy – and hence the risk of backlash. • Educate the public: improve their understanding of biology — and of biologists. © Oozoa Biomedical Inc, April 2010
  28. 28. Things That Scare the Public – Cloning
  29. 29. Lay Information Sources . . .
  30. 30. In The Mass Media . . .
  31. 31. Some False Perceptions . . .

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