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?
Dr David Mortimer, PhD
O oz Bi
oa omedialI
c nc
Vancouver, BC, Canada

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

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?


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 . . .

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?

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.

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.

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.


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.


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)

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?


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?


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.


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.


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.


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).


Ethics and ART


• 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.

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.


• 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.

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 . . .


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?

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.


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.

Patients’ Response: Circumvent regulations
Cross-border reproductive care (“reproductive tourism”)

52%*

* of reported European oocyte donation cycles © Oozoa Biomedical Inc, April 2010

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.

Things That Scare the Public – Cloning

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