House report defines start of human life

Maltese law should define the beginning of human life as having taken place not later than the conception phase, precisely at the moment when the fertilisation of the ova is completed and the fusion (amphimixis) of the two pro-nuclei takes place to create a human cell that is genetically unique and capable of growing on its own, a parliamentary committee has said.

The Social Affairs Committee, in recommendations to Parliament on the use of biotechnology, genetic technology and assisted procreation, also says with regard to In-Vitro Fertilisation (IVF) that only the minimum number of ova necessary for success should be fertilised. Embryos created through IVF should be implanted in the womb of the woman from whom the ova are taken, as soon as the fertilisation process is complete.

On the storage of embryos the committee gives two choices.

It says that embryos should not be stored for future use except when, after fertilisation, the mother falls sick to an extent that endangers her and/or the embryo; or,

Embryos can be stored in conditions which do them no harm, for implantation in the mother within a reasonable time. Parents who opt to store embryos will be held responsible to do whatever is necessary within their competence for the embryos to be eventually implanted in the mother.

"Therefore, it should be considered a crime when parents opt to leave their children in the freezer without valid reason (death of the mother or disease of the womb which would instantly kill the embryo)."

The committee said that immediately the first human cell is created, this should be given proper protection as a human being. Such protection had to be given both to the embryo in the womb and outside. The responsibilities of the parties should be identified and penalties under criminal law should apply against all those who knowingly cause direct harm.

Use of genetic technology

On genetic research, the committee said use of technology should be allowed by law on condition that:

¤ such use respects the dignity and integrity of the human being;

¤ such research is not used for discrimination on the basis of genetics;

¤ such research is not used for genetic selection;

¤ any medical scientific intervention on a human being is made only for the benefit of that person;

¤ Such activities do not expose the human being to unreasonable risks;

¤ Where applicable, such intervention is accompanied by professional counselling;

¤ The individual concerned gives free and informed consent and where this is not possible, proper protection is given;

¤ No part of the human body is used for financial gain.

The committee said research on adult stem cells should be acceptable but the creation of embryos for research purposes should be prohibited.

Research on stem cells removed from a foetus after natural miscarriage should be permissible following consent form the parents.

Research on stem cells from the umbilical chord and the placenta should also be allowed.

As for genetic diagnosis, the committee said this should be allowed only for medical and forensic purposes. Genetic diagnosis on embryos should be allowed only when this could correct specific abnormalities of the embryo; when it is aimed only to benefit the embryo; when the benefit justifies the risks and when the parents gave their consent.

Pre-implantation diagnosis should not be allowed and pre-natal diagnosis should take place only as long as there is a remedy for the disease which is the reason of the test. Polar body biopsy should be acceptable in cases of serious illness.

On genetic therapy, the committee said the use of adult stem sells for therapeutic purposes is acceptable but the use of stem cells from embryos for therapeutic purposes should be limited to those stem cells removed after a natural miscarriage. Medical interventions on embryos should be acceptable only when they can correct specific abnormalities in the embryo; when they are aimed for the benefit of the embryo, when the benefit justifies the risks for the embryo and the mother, and there is the consent of the parents.

The committee said human cloning should be banned even when sought for the therapeutic treatment of another person.

Assisted procreation

The committee said assisted procreation should be allowed by law under the following conditions:

¤ Such technology respects human life and the human person throughout all the process;

¤ It is used only to treat infertility and the prevention of health problems in the future;

¤ It is not used for purposes of genetic selection;

¤ It does not expose the mother or the offspring to unreasonable risks.

First and foremost, technology for assisted procreation should protect the dignity and integrity of the future child by ensuring that it does not in any way threaten the future good health of the child.

The would-be parents should still be of child-bearing age, the committee said.

It did not take a decision on whether assisted procreation technology should be allowed only to married couples, but gave two options.

It said such technology should be used either only for as long as the eventual birth was to a heterosexual married couple or to a heterosexual couple which is in a stable relationship.

It said, however, that embryo donations to couples which are not the genetic parents should not be allowed.

Stored embryos facing destruction can be given for adoption under the relevant laws.

Procreation techniques should not be used for purposes of surrogate motherhood.

In the case of IVF, the committee said that only the minimum amount of ova necessary for success should be fertilised. All embryos created through IVF should be implanted in the womb of the woman from whom the ova are taken as soon as the fertilisation process is complete.

The committee then went on to give its options on the storage of embryos.

Protection to the parents

The committee said assisted procreation services should be given only after informed consent. Such services should include professional counselling before, during and after the process. The mother should be given the best possible treatment to protect her health.

The storage of gametes for personal use should be permissible only when there is a risk of infertility. When the person from whom gametes are removed dies, goes missing or withdraws consent, the gametes should not be used for artificial procreation.

The committee gave two options on the donation of gametes. It said the donation of gametes by third parties should not be legal; or such donations from third parties should be legal only when the receiving couple suffers from proven irreversible sterility; when there is serious risk of malformation or abnormality in the future baby; other options are not considered adequate; there is the consent of the couple; donor screening is possible for reasons of illnesses; no payment is made for such a donation; the number of children born from such donations is limited; a child born after artificial insemination using donor gametes can, at the proper age, have access to the identity of the donor; there will be no legal obligation (including obligations for maintenance) as a result of the donation; the donor will have no paternity rights.

Protection of society

The committee said interventions that tried to alter the human germ cell line should be unacceptable.

The human embryo should not be put in the uterus of another species, and vice versa. The fusion of the human gamete with that of another species should be prohibited.

Regulation

The committee suggested that the Bioethics Consultative Committee should become a statutory committee even if it does not assume a regulatory role. It should include representatives of the different disciplines involved and from society in general, including persons with disability.

The Department of Health or an authority so delegated should have the regulatory role, with the right and duty to monitor, inspect and assess practices and observance of regulations.

The use of genetic and assisted procreation technology should be practised not only by institutions and adequately qualified doctors but also others who are registered and licensed by the department/authority.

In other considerations, the committee observed that St Luke's Hospital currently does not provide full infertility and assisted procreation treatment. It recommended that the government should seriously consider ways how such treatments could be given from the state hospital.

It said efforts should be made to separate pregnant women and those seeking infertility treatment at hospital.

It also recommended a credit in the doctors' course on bioethics.

In other sections of its recommendations, the committee supported the call for abortion to be entrenched in the Constitution.

It recommended that Malta should sign and ratify the Oviedo Convention with reservations on euthanasia, the destruction of the embryo and embryo selection. While embryo selection should not be allowed, there was no objection to the selection of chromosomes before IVF fertilisation so that inherited disease related to the sex of the baby could be avoided, the committee said.

The recommendations were drawn up after the Social Affairs Committee held 25 sittings spread over eight months during which it heard the views of experts on bioethics, morality, philosophy, theology, medicine, genetics, human rights, public administration doctors, people who have undergone fertility treatment as well as constituted bodies among others.

The opposition did not participate in the last sitting after insisting that more time should be allowed before proceedings were concluded.

The recommendations were presented on behalf of the committee by its chairman, Clyde Puli (PN). He also presented two detailed documents where he discusses the current situation in Malta and abroad and the background to the recommendations made by the committee.

The documents, all in Maltese, can be viewed on http://parliament.gov.mt/information/Papers/Biotechnology.htm along with documents and reports presented to the committee and related documents and literature, such as statements by the bishops.