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Israel: Recommendation to allow embryo cloning for research purposes

National Academy of Sciences: Cloning for the production of stem cells; The law in Israel does not refer to "therapeutic cloning" * The science committee will hold an urgent discussion on this cloning technology, after American scientists cloned a human embryo; The committee will discuss the need to define the type of experiments permitted in cloning and stem cell research

 By: Tamara Traubman, Haaretz

The Knesset's science committee will hold an urgent discussion tomorrow regarding the consequences and risks of cloning technology. The discussion was initiated by the chairman of the committee, MK Anat Maor (Maretz), after it was learned yesterday that American scientists tried to clone a human embryo.

Maor will raise the question in the discussion, if there is a need to apply laws or regulations that will define the type of experiments allowed and prohibited in cloning research and stem cell research. Stem cells are cells that can be extracted from embryos, and implanted in the body of patients who need new tissues.

Maor pointed out that the "Cloning Law", approved by the Knesset in 1998, explicitly prohibits the use of cloning as an alternative fertilization method. However, the law does not directly address the question of whether it is permissible to use cloning as a medical measure. In this type of cloning, known as "therapeutic cloning", an embryo is cloned and grown in the laboratory, until the stage where stem cells can be extracted from it to be used to cure patients. At this stage the embryo is 5-6 days old, and looks like a microscopic ball of about 200-100 cells. After the stem cells are extracted, the embryo is destroyed.

To answer the moral questions associated with cloning and embryonic stem cells, the Ministry of Science initiated the establishment of a national committee for bioethics. The committee is expected to begin its work next month, after the government approves its operating powers.

According to Prof. Hagit Maser-Yeron, chairman of the committee's preparation team and chief scientist at the Ministry of Science, the committee is supposed to determine what the state's policy is regarding cloning and stem cell research. According to her, today, in fact, there is no clear policy, and the researchers at the hospitals and universities act according to the approvals received from the institutions' internal committees.

In recent months, the "Helsinki Committee for Genetic Experiments on Humans" - a committee of the Ministry of Health that is supposed to supervise genetic experiments - has also begun to discuss the issue of stem cells. According to the ministry, the committee is at the beginning of its deliberations.


Israel: Recommendation to allow cloning of embryos for research purposes by Tamara Traubman
In 1998, the Knesset approved a law prohibiting human cloning. According to the law, it is forbidden to use cloning as a substitute for reproduction, that is, it is forbidden to clone a human embryo and grow it to maturity. However, the law does not directly refer to "therapeutic cloning", in which clones are transferred for the purpose of producing cells to be transplanted into humans, and its growth is stopped on the fifth or sixth day of its creation.

The law remains open to interpretation. Gali Ben Or from the Ministry of Justice, who supervised the preparation of the Cloning Law on behalf of the Ministry, says that according to her personal interpretation, cloning of human embryos is allowed in Israel. A committee established by the National Academy of Sciences, headed by Prof. Michel Rebel from the Weizmann Institute, submitted similar recommendations a few months ago. According to the committee's recommendation, it will be allowed to clone embryos and grow them up to the 14th day of their lives, and use them only for the purpose of producing stem cells. A committee of the Ministry of Health, which is supposed to decide on the matter, is still discussing the issue.

After the cloning of Dolly the sheep, then US President Bill Clinton banned the cloning of humans. This ban does not apply to American private companies, but only to scientists who use their research with public funds. In the US, the bill is now being formulated, which some scientists fear will impose a blanket ban on human cloning, including "therapeutic cloning".

In England, the law allows the cloning of human embryos for the purpose of producing cells for transplantation. Regulations that would allow similar cloning are in various stages of legislation in Australia, Canada, Sweden, France and Belgium. On the other hand, in Germany, Austria and Ireland there is a ban and public opposition to the implementation
Technology in humans.

Previous update on the subject: from 7/9/2001
Today, the recommendations of the Bioethics Advisory Committee of the National Academy of Sciences will be published, regarding the continuation of research in stem cells extracted from human embryos. Stem cells are featureless cells that only exist in very young embryos. The cells can be transferred to laboratory dishes and made to develop into any of the cell types in the body.

The research done so far on stem cells raises hope that in the future it will be possible to use them to regenerate damaged tissues and cure diseases such as Alzheimer's, cancer and diabetes. However, the production of the stem cells involves the destruction of embryos, so the research is accompanied by a fierce value debate.
The advisory committee included scientists, philosophers, jurists, doctors and halachic experts. Among them, Prof. Hermona Sorek, a biologist from the Hebrew University, the philosophers Prof. David Had from Jerusalem and Prof. Asa Kosher from Tel Aviv, the retired judge Shoshana Berman, Dr. Efrat Levi Lahad, a geneticist at Shaare Zedek Hospital, and Rabbi Dr. Mordechai Halperin .

The committee's report recommends two sources for the production of embryonic stem cells: one is frozen embryos, created as part of in vitro fertilization treatments but not implanted in the uterus; The other is genetic duplication (cloning) of human embryos.

The cloning proposed by the committee is called "medical cloning". In this procedure, the DNA is transferred from a mature cell to an egg whose nucleus has been removed. The nucleus of the egg contains almost all its DNA. The implantation of the new DNA in the egg may allow the growth of an embryo that is genetically almost completely identical to the person from which the adult cell was taken.

According to the committee's report, it should be allowed to clone embryos for medical research purposes only. The committee's recommendations allow the extraction of stem cells from the embryos grown in this way, but prohibit the continuation of the growth of the embryo beyond 14 days. Cloning cannot be used as a treatment for fertility problems or as a means of reproducing humans.

In the 30-page report, the committee refers at length to the ethical limitations that must be imposed on stem cell research. The committee calls on the Ministries of Health and Justice to draft new regulations that will conform to the report's recommendations, and if necessary, amend the existing ones.

Although some consider medical cloning an immoral act, the report states that "from a medical point of view, this research has the most potential." For example, if a patient needs a bone marrow transplant today, he must hope that a genetically suitable donor will be found. But if scientists can take a cell from his body, and fuse it with an egg, a cloned embryo will be created, from which stem cells can be extracted and turned into bone marrow cells in the laboratory. These cells will perfectly match the patient, since it is a replication of cells taken from his body.

The research on stem cells is mostly done on cells from mice. Researchers were able to extract stem cells from human embryos for the first time only two years ago, and scientific knowledge about them is still scarce. To date, scientists have succeeded in cloning animal embryos and producing stem cells from them, but as far as is known, no one has tried to reproduce this process in humans.

In the "Cloning Law", which was enacted about two years ago and prohibits the cloning of humans, there is no reference to the possibility of medical cloning, so the issue is subject to different interpretations. "The jurists who sit on the committee determined that medical cloning does not go against the existing regulations," says Prof. Michel Rebel, a biologist from the Weizmann Institute and chairman of the committee. Gali Ben Or, who accompanied the process of preparing the cloning law on behalf of the Ministry of Justice, also gave a similar interpretation to the law in the past.

Dr. Binyamin Raubinoff, who studies embryonic stem cells at Hadassah Ein Kerem Hospital, said that this is an "advanced report". Prof. Yosef Itzkovitz of Rambam Hospital, who is also involved in fetal stem cell research, welcomed the new report, saying that it will "enable research and development similar to that carried out in other advanced countries, such as the United Kingdom (which recently enacted a law allowing the cloning of human embryos, XNUMX)".

Although several laboratories in Israel have been researching stem cells from human embryos for more than two years, this is the first time that a national team of experts examines the ethical aspects of the research. The Ministry of Health, in fact, does not currently have regulations that determine under what limitations research on stem cells taken from human embryos must be conducted.

The committee recommends using embryos created as part of in vitro fertilization treatments as the main source for producing embryonic stem cells. All the embryonic stem cells that have been created to date have been produced from this source. In these treatments, a larger number of embryos is usually created than the one that is implanted in the uterus in the end, and the remaining embryos are not used after the end of the treatment. The committee members condition the use of these embryos on the condition that the doctors make sure that the couple has completed their family planning, that the couple is aware of the options before them (for example, to continue keeping the embryo frozen, or to destroy it without donating it to scientific research), and that the couple has given their consent to the donation of the embryos.

In any case, the report states, there must be "a clear separation between the medical staff, responsible for the in vitro fertilization treatment, and the medical and scientific teams that will be involved in the research". Naama Wichner of the International Center for Health, Law and Ethics at the University of Haifa compares this requirement to the separation practiced today in organ donation, where one medical team determines brain death, and another team implants the organ in the patient's body.

"In the case of embryo donation, this is even more important," Wichner says. "It is a system with a lot of options for applying pressure." In contrast to the one-time relationship created between the medical system and the family of the deceased, to which they apply for organ donation, couples undergoing fertility treatments may need a continuous relationship with the doctors. "It is impossible for a situation to arise in which the parents feel that the doctor will be angry if they refuse to donate embryos to his research," Wichner says.

Although the report states that the study will only use the embryos that remain after the end of the fertilization treatments, it does not specify a minimum period of time after which the doctors will be allowed to request the embryos from the couple. According to Wichner, a situation may arise where the couple believes they have finished family planning, but after a few years they will want to have another child. In such a case, to the extent that the couple donated the embryos from the previous series of treatments, the woman will have to go through the entire fertilization route again, which involves suffering. "Maximum flexibility should be allowed," Wichner says, "so that no one feels bound by a decision they made in the past."

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