Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1694840519452.pdf (Malta)
IT-TLETTAX-IL LEĠIŻLATURA P.L.

1578 Dokument imqiegħed fuq il-Mejda tal-Kamra tad-Deputati fis-Seduta Numru 106 tat-30 ta’ April 2018 mill-Onor.

Godfrey Farrugia, MP.


___________________________ Raymond Scicluna Skrivan tal-Kamra Scicluna Ray at Parlament-MT From: Sent: To: Subject: Godfrey Farrugia <farrugiagodfrey@gmail.com> 30 April 2018 20:03 Scicluna Ray at Parlament-MT Karta fuq il-mejda tal-kamra TheMALTAINDEPENDENTonSUNDAY The Embryonic Human Being http:/ /I ilene two rk.eu/the-e m b ryo n i c-hum an-being/ 23.4.2018.

It might seem obvious to some but not to others, that the life of a human individual begins at conception.
Academic research in this field has been very enlightening and it can be neither disregarded nor refuted, unless one consciously decides to dwell in a convenient cloud of unknowing.

Alternatively, one could admit that scientific studies point to conception as the moment of inception of human life, but still maintain that the reproductive "rights" they advocate for override the right to life of the unborn.
We will attempt to remove certain obfuscations related to this issue by presenting real scientific evidence concerning conception and human beings in order to do away with pseudoscience.

This clarification is both important and crucial, because an unnecessary grey area has been conveniently created.

The scientific evidence available confirms that any negative action taken vis-a-vis the fertilized ovum from the moment of conception is an action directed against a human individual.
This logically goes against the Hippocratic Oath in the medical field and many fundamental values of humanity.

It is hoped that the scientific evidence presented here will encourage the defence of the unborn from the instant of conception to the moment of birth, in all aspects of legislation and policies.

This would include the provision for clear definitions referring to the unborn child and the avoidance of vague terminology to avoid subjective interpretation that may lead to abuse.
The scientific literature that will be presented supports the definition of an embryo in the Embryo Protection Act (Cap.

524 of the Laws of Malta), which is quite accurate and cannot be considered outdated.
This definition states: "embryo" means the human organism that results from the fertilisation of a human egg cell by a human sperm cell which is capable of developing and shall further include each totipotent cell removed from a human embryo or otherwise produced, that is assumed to be able to divide and to develop as a human being under the appropriate conditions".

A quick glance at some pivotal statements by heavyweight authors and researchers in this field is in order.
The following are taken from very recent editions of medical text books on human embryology and reproduction and peer-reviewed scientific literature: • "Human development begins atfertilization, when a sperm ji1ses with an oocyte to form a single cell, the zygote (one cell embryo).

This highly specialized, totipotent eel!

(capable of giving rise to any cell type) marks the 1 !

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beginning of each of us as a unique individual."


(The Developing Human: Clinically Oriented Embtyology, Saunders 20 16).

• "[The zygote], formed by the union of an oocyte and a sperm, is the beginning of a new human being. "

(Before We Are Born: Essentials of Embryology.

Saunders, 2008).
Saunders, 2008).

• "Although life is a continuous process, fertilization ... is a critical landmark because, under ordinary circumstances, a new genetically distinct human organism is formed when the chromosomes of the male and female pronuclei blend in the oocyte."

(Human Embryology and Teratology.

Wiley-Liss, 2001).

• "Human pregnancy begins with the fitsion of an egg and a sperm within the female reproductive tract. "

(Human Embryology and Developmental Biology.

Elsevier, Saunders, 2014).


• "Representing the 60 trillion cells that build a human body, a sperm and an egg meet, recognize each other, andji.1se to form a new generation a,{ life."

(The immunoglobulin superfamily protein Izumo is required for a spenn to fuse with eggs.

Inoue N. eta!.

Nature, 2005).

• "The seminal question in modern developmental biology is the origins of new life arising from the unification of sperm and egg."
(Gene expression during the oocyte-to-embryo transition in mammals, Evsikov AV, Marin de Evsikova C. Molecular Reproduction and Development, 2009).

• "Fertilization-the fusion of gametes (sperm cell and oocyte I egg) to produce a new organism- is the culmination of a multitude of intricately regulated cellular processes.

"(Fertilization.

Marcello MR et a!.

Advances in Experimental Medicine & Biology, 2013).
• "The oocyte-to-embryo transition refers to the process whereby afidly grown, relatively quiescent oocyte undergoes maturation, fertilization, and is converted into a developmentally active, mitotically (a method of cell division, in which the nucleus divides into daughter nuclei, each containing the same number of chromosomes as the parent nucleus) dividing embryo.

arguably one of the most dramatic transitions in biology."

(The oocyte-to-embryo transition.


Robertson S., Lin R. Advances in Experimental Medicine & Biology, 2013).

II!

"Fertilization occurs when sperm and egg recognize each other and fuse to form a new, genetically distinct organism."

(Juno is the egg Izumo receptor and is essential for mammalian fertilization.

Bianchi E. et al.

Nature, 2014).

• "Mammalian life begins with a cell-eel/fusion event, i.e.

the fusion of the spermatozoid(spenn cell) with the oocyte" (State of the art in cell-cell fusion.
Willkomm L., Bloch W. Methods in Molecular Biology, 2015).

• "New parents anticipate their job begins at birth.

Little do they know they have been exerting control within the baby'sjirst cell since fertilization."

(Parental Control Begins at the Beginning.

Chu D. Genetics, 2016).

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From the above it transpires that the immediate result of a sperm-egg fusion is a unicellular totipotent embryo.
The fact that this embryo (the zygote) is a new cell type that is qualitatively different from its precursors (the gametes) and that, being a new organism, behaves in a very distinct way is an objective, verifiable piece of data that is scientifically evident.

Without the influence of any external factors, the zygote sets a process in motion whereby, within minutes, other sperm are not allowed to attach themselves to its surface.
This new organism, having characteristics that are different from mere cells, hence immediately embarks on a process of self-directed maturation.

The Merriam Webster dictionary defines an organism as: "(1) a complex structure of interdependent and subordinate elements whose relations and properties are largely determined by their fimction in the whole and (2) an individual constituted to carry on the activities of life by means of organs separate in fimction but mutually dependent: a living being. "
Rather than being a mere collection of cells or human parts, human beings (which are by nature organisms) have a characteristic molecular composition and a specific way of behaving, aptly carrying out the activities of life in a coordinated fashion.

Unlike other human cells which may assemble to form certain tissues or structures, the one-cell stage embryo that is the zygote, has the inner capacity to develop into a fully unified human body.

This capacity, known as totipotency, is unique to the zygote. ''
2 ~ Some may react by saying that even stem cells and tumours exhibit these characteristics, but this is far from the truth because, unlike embryos, these are not organisms, and neither do they exhibit the kind of interactions seen within an embryo which ensure its survival and development.

It is an empirically proven fact that the embryo fashions itself and independently directs its development.
It is incorrect to apply the term "totipotent" to any cell apart from the zygote, presuming that such cells can undergo an embryonic process leading to the formation of all the body components independently.

Indeed, totipotency, or the ability to initiate an integrated developmental sequence, distinguishes a single-cell embryo from all other cell types.
Consequently, embryos of all species are clearly organisms from the time of sperm-egg fusion onward, independent of the specific developmental mechanisms they employ.
In a study which observes embryos at a later stage ("Self-Organization of the Human Embryo in the Absence of Maternal Tissues", 2016), the author states: "Together, our results indicate that the critical re-modelling events at this stage of human development are embryo autonomous, highlighting the remarkable and unanticipated self-organizing properties of human embryos."
Now we have scientific proof that the immediate result of a human egg-sperm fusion is a unique and autonomous human being with full developmental characteristics, meaning that human life is a continuum which begins at a specific point.

Consequently, any practice or event which harms or terminates life at any point throughout the entire continuum, harms or terminates a human being.
A glance at embryo freezing ( cryopreservation) Embryo cryopreservation (embryo freezing) is a practice which may very easily subject human embryos to inappropriate and dangerous conditions.

We will refer to studies originating from countries where there are decades of experience in this field.
The following is an excerpt from the conclusions of a study published in the periodical Fertility and Sterility of the American Society for Reproductive Medicine ("The Social Implications of Embryo Cryopreservation"): "Embryo cryopreservation has been increasingly used to improve the cost-effectiveness of in vitro fertilization (IVF) and expand the options available to infertile couples, yet its widespread adoption has occurred more rapidly than our ability to study the social consequences for the couples and health professionals involved.
For maintaining cryopreserved embryos, the existing literature is fragmented and incompletely explores the effects on an infertile couple's psychosocial health and personal relationships, their family planning strategies, or their preferences for the disposition of the embryos.

Managing unclaimed embryos .continues to create challenges for assisted reproduction professionals.

We currently lack a thorough understanding of the numerous social implications of cryopreservation.
Major areas for fitture research include the impact of stored embryos on couples' fertility intentions and psychosocial health, factors that affect couples' decisions about embryo disposition, strategies to minimize unclaimed embryos, and the consequences of oocyte/ovarian cryopreservation.

Should this concern, voiced in 2005, seem somewhat outdated (though it is not), more recent literature is available.
In a specialized textbook titled Principles of Oocyte and Embryo Donation (2013) the authors reported: "Although recipients approach their donor oocyte treatment with a desire to cryopreserve embryos for attempts at creating a genetic sibling in the future, most only return to use their cryopreserved embryos afier ftdling their original fi·esh transfer.

In fact, the results of a study which is referred to in the same publication ("Fate of Cryopreserved Donor Embryos".

Knopman et al.
Knopman et al.

2009) are as follows: 3 I ' I I " ; ' ' ' Analysed were 829 fresh donor embryo transfer cycles peiformed during the study period of 112000-1212004; 444 recipients delivered a viable irifant(s) following afresh transfer.

Of these successfitl women, 177 (40%) had supernumerary embryos cryopreserved; however, only 3 7 (21 %) returned for a donorfi'ozen embryo transfer by August 2009.
In contrast, of the 385 women who failed their fresh attempt, 128 (33 %) had supernumerary embryos Clyopreserved and Ill or 87 % returned for a donor frozen embryo transfer by August 2009.

Overall, only 49% of the recipients with supernumerary cryopreserved embryos returned to use their embryos by August 2009.

Calculations revealed that at the time of the study's conclusion, approximately 222 embryos remained in storage without a disposition.
Furthermore, the authors aver: Despite the desire to cryopreserve supernumerary embryos at the time of the fresh donor oocyte transfer, more often than not, patients do not return to use their surplus embryos.

Analysts estimate that as of 2003, over 400,000 embryos from all sources remained in storage jcLCilities in the United States.

As the number of IVF procedures has only grown over the past decade, we speculate that this number has nearly doubled.

But what happens to these "extra" embryos?


Reference to a qualitative interview study of 58 couples ("Parents' Conceptualization of their Frozen Embryos Complicates the Disposition Decision".

Nachyigal et al.2005) clearly indicates what fate they usually have: "At the time of the interview, 42 (72 %) of the couples had neither made a decision nor were in the process of making a decision regarding their embryo disposition.
Of the 16 who had made a decision regarding embryo disposition, 7 had donated their embryos to research/science, 5 had their embryos destroyed, 2 donated their embryos to another couple, and 2 used them for another attempt at pregnancy."

Another country where there are decades of experience in cryopreservation is the UK.
In 2011 Lord Alton of Liverpool asked Her Majesty's Government (in Parliament): " ..... whether they now collect data on how many human embryos have heen (I) created, (2) frnzen, (3) destroyed, (4) implanted, and (5) experimented upon, since the passage of the Human Fertilisation and Embryology Act 1990; if so, what are those figures; and, !fnot, whether they will instruct the Human Fertilisation and Embryology Authority to refine their collection of data so that it provides fit!
I disclosure under each of those categories.

[HL4176]" The answer is, at least in our view, quite disconcerting, and it does not look good for embryos: ...

The Human Fertilisation and Embryology Authority (HFEA) has advised that the data it holds in relation to human embryos that have been created, frozen, destroyed and implanted are set out in the following table.
It does not hold data in relation to embtyos experimented upon ..... Embryos Frozen Embryos Discarded Implanted Embryos stored for the patients use Embryos stored for donation Embryos stored for research Embryos reported on the Treatment form as being discarded Embryos reported on the Gamete Movement form as being removed from storage and discarded Emb1yos transferred Gestational observed 23,480 4 Embryos created 3,546,818 ; ' • · ! '

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'' 839,325 2,071 5,876 1,691,090 1,388,443 235,480 HFEA Human Embryo Data-Cyclesjrom 1 August 1991 to 31 December 2011 Source: Human Fertilisation and Embryology Authority Effectiveness, usefulness and benefit of embryo freezing All this being said, is embryo freezing as effective and useful as was previously perceived?
A study published this year by the Yale School of Public Health and co-authors in China found an insignificant difference in life birth rates between IVF with fresh embryos and the cryopreservation method.

The study, titled "Transfer of Fresh Versus Frozen Embryos in Ovulatory Women", is a multicentre, randomized, controlled trial and was published in the New England Journal of Medicine.
It concluded that: "The live-birth rate did not differ significantly between fresh-embryo transfer and frozen-embryo transfer among ovulatory women with infertility, but frozen-embryo transfer resulted in a lower risk of the ovarian hyperstimulation syndrome (0.7% vs 2%),,There were also no significant between-group differences in the rates of implantation, birth weight, clinical pregnancy, overall pregnancy loss, and ongoing pregnancy,, The risks of obstetrical and neonatal complications and other adverse outcomes did not differ significantly between the two groups .... Our previous trial involving women with the polycystic ovary syndrome, which used a protocol that was nearly identical to that used in the present trial, showed favourable effect of frozen-embryo transfer on the rate of live birth.
The reason for the discrepant results in these two populations is uncertain".

Not even experts from major health institutions are certain about the effectiveness, usefulness and benefits of embryo-freezing.

Hence, putting human beings in harm's way despite the fact that the "benefits" there might be, as indicated in this study, are less and less promising, is highly questionable.
In another study (Comparison of Pregnancy Rate between Fresh Embryo Transfers and Frozen Thawed Embryo Transfers Following ICSI Treatment) published in the International Journal of Reproductive BioMedicine in 2016, results were quite similar: "There was no significant difference between biochemical pregnancy rate, gestational sac, andfoetal heart activity in fresh ETand FETcycles."
It is true that the authors of this study say that " ... the embtyos are able to be stored for subsequent ART {Assisted Reproductive Technology]".

Nevertheless, the aforementioned potential harm, namely the discarding and destroying of embryos, that goes hand in hand with cryopreservation, indeed remains.

Given the nature of this practice and the statistics available, it is clear that what is at stake is the life of a human individual.
Stunting the embryo's growth or disposing of it as a result of a production that has exceeded demand is tantamount to destroying human life.

Jean Pierre F ava Dip., B.Sc.

(Hons.

), M.Sc.

H.Sc.

Health Scientist :Maureen L. Co ndic.

Ph.D. is an Associate Professor, Neurobiology and Anatomy University of Utah, School of Medicine.

Since her appointment at the University of Utah in 1997, Dr. Condie's primary research focus has been the development and regeneration of the nervous system.
in 1999, she was awarded the Basil O'Connor Young Investigator Award for her studies of peripheral nervous system development.

In 2002, she was named a 5 t '' f. I ,, " ' , ., :McKnight Neuroscience of Brain Disorders Investigator, in recognition of her research in the field of spinal cord :repair and regeneration.

Her current research involves the control of human stem cell potency and differentiation.

In addition to her scientific research, Dr. Condie teaches both graduate and medical students.
:Her teaching focuses primarily on embryonic development, and she is Director for Human embryology in the .

University of Utah, School of Medicine's curriculum.

Dr. Condie has a strong commitment to public education 'and science literacy.

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