Dr Michael Axiak

The use of human stem cells for research purposes has been going on for some time now. It is important to state that there is nothing intrinsically wrong with stem cell research as such.  New opportunities in transplanting tissue that is histocompatible and not subject to rejection, is an exiting [exciting] field which can lead to substantially reducing much suffering and avoid immuno-suppressive treatment that is currently sustained by patients needing a transplant. In this regard adult stem cell research, which uses totipotent stem cells (immature cells which are capable of transformation into any specific cells of the body under the right chemical and physical conditions of growth) which are derived from adult human sources of so called haemopoetic tissue (bone marrow, spleen, lymph nodes – tissue which produces blood cells) and blood itself, does not offer any ethical difficulties. Research in this area is developing at a fast pace.

The ethical problems with stem cell research are reserved for so-called embryonic stem cell research. There are sources of embryonic stem cells that are available from cord blood (collected from a cut umbilical cord just after delivery) which do not present any problems. The problem arises, because stem cells are also available as tissue found in the embryo in the first few days of development. [this is not the problem – this is normal – so rewrite, possibly, as follows] Certain researchers are harvesting stem cells by the destruction of the human embryo. The problem arises when researchers harvest stem cells by the destruction of the human embryo. Stem cells are naturally available as tissue found in the embryo in the first few days of development. Unfortunately In fact these cells may only be obtained by the destruction of the embryo itself or by inhibiting the normal development of totipotent cells into an embryo. [do you mean destroying the products of IVF / nuclear transfer before a fully developed embryo is formed, e.g. at the zygote stage? – please make it clear to the reader] Some justify this as a necessary price to pay for research to proceed, others argue that spare embryos left over from ‘in vitro’, fertilization would die anyway, so it would be better to get some positive benefit out of them, before they become worthless. Whichever way one looks at this, two facts are indisputable. The first is, that human life is being used for research purposes and destroyed in the process. The second is, that human beings are being commodified on an increased scale and being rendered an object of financial and economic gain, the demand will increase the supply! Maybe you want further explanation here, as most would deny that the aim of research is financial and economic gain but would argue for a therapeutic one.

The ethical problems associated with the destruction of human embryos, obtained directly from reproductive technology (IVF) programmes, are not the only ones. Some countries have started the procedure of cloning human embryos first, so that iso-immune cells can be obtained which can be used in transplantation. That is, an individual’s cells are first cloned by nuclear transfer (transferring the cell nucleus [please explain to the reader what the donor cell is and that it is transferred to an ovum] as happens in reproductive cloning), and the resulting embryo is then destroyed to obtain cells that are histologically immunologically compatible with the cells of the donor, thereby obtaining good tissue for transplantation. Here the ethical and legal problems mentioned in the 1st Protocol on Human Cloning [not called first but Additional – somewhere in the references, must mention its proper title Additional Protocol on the Prohibition of Cloning of Human Beings] of the Bioethics Convention [this is its common  BUT incorrect term – somewhere there must be a reference to the full title of the Convention: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine – you can use the short term – Convention on Human Rights and Biomedicine – in the text or the Oviedo Convention]  of the Council of Europe CoE are still inherent. That is, Moreover there is a breach of the principles of Liberty, Individuality and Equality mentioned [encompassed] [I changed the word mentioned to addressed, because the convention on human rights DOES NOT actually have articles on individuality or equality although the principles are there in the rights and in non discrimination of those rights] in the European Convention of Human Rights [again, a reference to its full title: Convention for the Protection of Human Rights and Fundamental Freedoms which has been ratified by Malta and is now transposed into Maltese legislation  – in the European Convention Act] of the same Council of Europe CoE. Reproductive and therapeutic cloning both breach these principles, and the Protocol Bioethics Convention considers both in the same light, without distinguishing between them, and without even referring to the word cloning, in the relevant article, prohibits [It is mentioned in the introduction, although it does shy away from using ‘cloning’ in terms of humans] but to the voluntary reproduction creation [ this is the word used] of an individual with the same genetic material.

Other ethical problems that are encountered in human stem cell research are surely those of patenting and ownership. Do the harvested cells belong to the donors or to the researchers? Should they be patented at all? What about the rights of the sacrificed embryo, which is the human being from which the cells originally emanated? These considerations require profound and deep analysis. [ on a positive note maybe you should say that Maltese legislation prohibits the granting of patents for ‘processes for cloning the human body, processes for modifying the germ line genetic identity of the human body and uses of the human embryo for industrial or commercial purposes’]

Another problem with embryonic stem cell research, concerns cloning for therapeutic purposes used with derived [What do you mean by derived? From embryos, zygote or cord blood? Make it clear] embryonic stem cells. Cloning, contrary to what has been widely held, is not something new! Nature has been using it for thousands of years to reproduce lesser orders of animals and plants. As evolution progressed slowly, nature developed a different and better way for reproduction to take place, with better mix age of genes and physical features, thereby improving a particular species’ resistance to being wiped out by environmental change and improving the evolutionary profile of that particular species. The previous type of reproduction involving cloning was called ‘asexual’ while the newer revolutionary type was called ‘sexual’. In man, sexual reproduction needs no introduction! Asexual reproduction involving cloning also occurs naturally at a particular stage of human development ‘in utero’ when identical twins are produced.

Man’s fixation with cloning, that is producing an individual whose genes are practically identical to another human being, can be brought about by two processes. One involving the splitting of a developing embryo by the passage of an electrical impulse through that embryo. The other involves the transference of an entire nucleus between one cell and another. [ as noted earlier, make it clear that this is the transfer of a somatic nucleus into an ovum] This is called nuclear transfer. Once a human being has been cloned successfully and this is now proceeding in several countries of the world, he or she might be implanted into a uterus to develop till birth and allowed to be born naturally. This is termed ‘reproductive cloning’. Otherwise the cloned embryo is allowed to develop for a few hours or days inside a dish in a laboratory where it is then cannibalised for its body parts including the much sought after ‘embryonic stem cells’. This is termed ‘therapeutic cloning’, funnily enough.

Probably our obsession with cloning stems from the fact that a duplication of our genetic heritage conjures up profound perceptions or images of our immortality, which is far from the truth, as a particular personal life is not only composed of a genetic component but also of a developmental environmental experience recorded in that particular psyche. Therefore, two identical twins are not the same human beings. They are different human beings with the same genetic code. What fundamental human rights are breached by the act of cloning? Without going into the problem of the wholesale wilful destruction of human embryos for research and other purposes involved in therapeutic cloning, which opens a chapter in its own right, I will now focus lightly on the legal problems concerned with reproductive cloning.

The very act of reproducing or trying to reproduce another human being, either living or dead, breaches the right of every human being of being unique and irreproducible. This breach applies to both the original and the copied clone. Cloning therefore breaches the fundamental right of every human being to his personal freedom and liberty. It also breaches his fundamental right to equality in that every human being has an equal right to free personal development devoid of any shackles to past or present physical or mental predeterminations.

Legal instrumentation in a pan-European context, which concerns cloning is found within the remits of two institutions. The Council of Europe and the European Union. The former institution has adopted the Bioethics Convention of Oviedo, [you mention Oviedo here but not before – do not confuse the reader – have both the same] which contains a first with a specific protocol on cloning, as mentioned above, which in effect outlaws both types of cloning. [ONLY for those who are signatories to the Convention] The European Union has adopted the Charter of Fundamental Rights which in effect, in one of the first couple of articles it contains, explicitly forbids reproductive cloning [this is INCORRECT as the wording used is much less strong, in fact it is rather wishy washy – in no way does it explicitly forbid it – only talks about respect of the integrity of the person – so I suggest quoting the exact wording as follows] in article three, the right to integrity of the person, it indicates that the following must be respected: ‘prohibition of the reproductive cloning of human beings’. Therapeutic cloning is not addressed in this charter. This charter will form part of the EU Constitution when the latter instrument is adopted by the EU. [ Until then it is NOT legally binding] In the USA, reproductive cloning is forbidden, and President Bush has wisely forbidden the use of public federal funding for research in therapeutic cloning. The EU is still debating the use of EU funding for therapeutic cloning in specific countries. Since our accession to the EU, Malta has consistently voted ‘no’ to the use of EU funding for therapeutic cloning during the ministerial council meetings of the EU particularly so because it objects to the use of the procedure and also because it objects to any use of the funds which Malta pays into the EU coffers, being used to fund these procedures in other countries where it is allowed. Many countries also have their own national legislation on cloning procedures. For example Germany has very tight restrictions while the UK has a very liberal legal formulation allowing therapeutic cloning to proceed under the control of research ethics committees. [events have overtaken us, with a vote being taken at Parliament fro funding FP7 research – maybe the author should comment]

Incidentally, Malta has no national legislation on the subject.[bar the abortion law which would prohibit use of embryos for stem cells – therapeutic or research and the patents law] It has not signed the Bioethics Convention at all, nor any of its protocols including the one on cloning. It is only bound by the declaration in the Charter of Fundamental Rights not to allow reproductive cloning. [NO NO this is not legally binding as yet! Malta is only bound by the Convention for the Protection of Human Rights and Fundamental Freedoms incorporated into the Maltese European Convention Act, which does not mention cloning at all. All else is fair game barring the arguing in a potential court-case of banning the procedure due to our obligations from our own criminal [you mean the abortion law?] law and those from our national commitment to the European Convention of Human Rights! Incidentally, the Court of Appeal in the Human Rights Court in Strasbourg has decided not to consider the fundamental rights included in the European Convention, as extended to children who are not yet born, although it does not prevent individual European countries from extending this right to children in utero if they so desire. [In Malta, there is some legislation that gives rights to unborn children – mainly Civil Law but also in the latest Domestic Violence Act.] Like many other issues in bioethics, Malta is still in its pre-embryonic stage or as a foreigner observed to me, in the Wild West and some effort is needed to remedy the situation soon!

COMMENTS

Red Text                     comments, suggestions

Blue Text                    actual replacement – sometimes this is only a comma

Highlighted Text         to highlight what I am commenting on

Scored Text                 to be removed

References

  1. Conventions, Charters, Laws, are to be given their full name, if not in the text, in a footnote. Those uninitiated must be aware of the differences between:
  2. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine – and its Protocols – binding only to signatories
  3. Convention for the Protection of Human Rights and Fundamental Freedoms – legally binding in Malta as the European Convention Act
  4. Charter of Fundamental Rights of the European Union – not legally binding in the EU
  5. Not to be biased, all relevant Maltese legislation should be mentioned – SEE comments in text.
  6. It would have been more user friendly to describe the meaning of the terms, reproductive cloning, therapeutic cloning, nuclear transfer, all at the beginning as done for the stem cells)
  7. However I respect the author’s style – so I have only commented where it is necessary for accuracy.