SHAPING GENES:

Ethics, Law and Science of Using New Genetic Technology in Medicine and Agriculture

Darryl R. J. Macer, Ph.D. Eubios Ethics Institute 1990


Copyright1990, Darryl R. J. Macer. All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.

11. Human Reproduction


pp. 188-213 in Shaping Genes: Ethics, Law and Science of Using New Genetic Technology in Medicine and Agriculture, D.R.J. Macer (Eubios Ethics Institute, 1990).
Birth Control Policies

During the past decade media attention regarding human reproduction has focused on in vitro fertilisation (IVF), a technique which has resulted in the birth of around 20,000 children to infertile couples. The amount of media attention given to infertility aids is much greater than that given to the more important question of trying to control the excessive fertility of the human race. In the last decade this has affected several billion individuals. That does not mean that the problem is literally a hundred thousand times more important, but it does highlight the importance of birth control.

We have a situation in the world today that it is rapidly approaching overpopulation. The population rises at a rate of over 400,000 per day (Aitken & Lincoln 1986). There are thought to be 600 million couples of reproductive age in the developing countries, 80% of whom, do not use adequate means of birth control (W.H.O. 1984). The situation is such that if we do not decrease the birth rate now, we will have very serious overpopulation problems. Fortunately during the last two decades many steps have been taken which have slowed the rate down from what it was, but there is still much more effort required in many countries. Many other interrelated problems may confound the primary problem of overpopulation, such as pollution, lack of food, human selfishness, and the loss of densely populated and agriculturally important coastal land with urban sprawl and as the sea level rises.

In earlier times the infant mortality rate was very high, but now in most countries it is much lower. This means to replace the population not more than 2-3 children per couple are required, much lower than the possible reproductive potential of the average human couple. In order to manage the population, contraception is required. Most couples are concerned with contraception. An additional factor is that the increase in extramarital sex has meant that contraception is particularly important for all young people, in both industrial and developing countries, whether or not we agree with extramarital sex. There are many very harmful social problems as a result of high incidence of extramarital sex, but contraception is still desirable to avoid passing these problems to a new individual.

Methods of Birth Control

About 500 million people used contraception in 1988. The policy chosen depends on the country as to the method and acceptance. In China a one-child per couple policy is strongly encouraged. In Shanghai, couples may have to wait several years for a ticket for permission to have a child. If a second child is born, the penalty is three years average earnings, which is a policy which discriminates against those who are poor. Detailed studies of the one child policy actually suggest a better policy now may be to allow two-children with a gap between their births, as this will give a better population age structure in the future (Greenhalgh & Bongaarts 1987). The best policy however will depend on the time and country, what is essential is that birth control is used, and especially in the poorer developing countries. It is irresponsible stewardship not to use it.

Sterilisation is one method of contraception, being used by 130 million couples in the world in 1983, making it the most widespread form. The main type used is female sterilisation, even though it is more risky, and more expensive than female sterilisation. Vasectomy is used widely only in USA, United Kingdom, India and China. There are some countries with rapid birth rates that do not use sterilisation, such as Latin America and most of Africa. This is because of the objections to its use by the Roman Catholic church, and some politicians.

Unlike the development of most other products, which is regulated by the actions of the marketplace, the development of new contraceptives is influenced by other conflicting public policies. The combination of public policies and the complexity of evaluating their risks and benefits, has lead to slow development of new methods. Developed nations offer much more support for research to alleviate specific illnesses than for birth control (NRC 1990).

There have been very few developments in the methodology of contraception during the last two decades. In the USA there have been no new active ingredients in the birth control pill sold since the 1960's because of fears of legal costs if there is any adverse effect. The birth control pill, in old or new form, is not widely available in Japan because of the opinions of the Medical Association. In Europe three new ingredients have been introduced in the 1980's, which can be used at much lower dosage levels, and are in fact safer than old formulations. There is currently very little research into contraceptives which is due to a lack of commercial interest by pharmaceutical companies (Djerassi 1989). Companies do not do research if the potential risks of product liability and the costs of protecting against it are not balanced by a sufficient profit potential. The only way to change this is to change the system of liability payments that companies are vulnerable to. There is a need for more research, and new possibilities could include a new spermicide with antiviral properties (to avoid AIDS), a once-a-month pill as a menstrual inducer, and reliable ovulation predictors. More distant may be easily reversible and reliable male sterilisation, a male contraceptive pill and an antifertility vaccine.

Women in Finland, Sweden and ten other countries can have a contraceptive implanted under their skin of the upper arm which acts for five years. A West German company is marketing in forty countries an injectable contraceptive that protects for two months. China and Mexico manufacture one month injectable contraceptives. These countries are in marked contrast to the older methods used in the USA, which often fail. The high failure rate of older methods has the result of a higher incidence of unwanted pregnancies which leads to a high abortion rate. The actual amount could represent half of the annual three million abortions performed in the USA (NRC 1990).

Abortion is a very common method of contraception despite the greater ethical objection to it. In the world there are about 90 million births a year, and up to 60 million abortions, both legal and illegal (OTA 1988c). Abortion is the term used to describe the termination of pregnancy by any means before the fetus is sufficiently developed to survive (6 months by the best medical techniques). Abortion is a very sensitive ethical and political issue. It does need to be considered for extreme circumstances, with the view that we may have to make compromises in a world like ours, as discussed in the last chapter.

Abortion is the least preferable of birth control methods. Between contraception and abortion there is the technique of what has been called embryo arrest. The time periods that different methods of fertility control act on is summarised in figure 11-1. Contraception is definable as the prevention of conception. Some birth control methods currently called contraceptives can only act after fertilisation. Post-fertilisation interruption is a very common process that most women have experienced at some time, even though they may not be aware of it. Contragestion, is an abbreviation of contra-conception, and has been suggested as an appropriate term to use for describing the action of some agents, such as RU-486 (Baulieu 1989). Some make iImplantation impossible, such as Ovran and Eugynon-50. The IUD has been also thought to prevent implantation. It is a serious legal and ethical issue to decide whether agents acting several weeks after conception, such as RU-486, are abortive drugs or ones that cause embryo arrest. Probably not until the embryo is implanted, after 14 days, should we call the action abortion (Crystal-Kirk 1989), though it is still seen by some as unethical. The abortion laws in New Zealand, Libya, and West.i Germany, apply specifically only after implantation, 14 days, which is consistent with this thinking.


Figure 11-1: Methods of Fertility and Birth Control
The efficacy of the different treatments is represented at the time after ovulation shown in the figure. The thick lines indicate the time of maximal effect, and the light lines indicate whether accessory effects may occur (Adapted from Baulieu 1989).
Recently, the steroidal antiprogestin milepristone (RU-486) has been developed and this has been used widely as a menstrual inducer in France. It has a high affinity for the progesterone receptor. Prosgesterone is a hormone that isproduced in pregnant women and is necessary for the maintenance of pregnancy. The hormone binds to a receptor on the target cells, and it is this binding which is necessary to act as a signal. RU-486 prevents this binding, thus removing the influence of progesterone, allowing menstruation to occur, which will take with it the early embryo (Baulieu 1987). It will aid the induction of menstrual flow 6-8 weeks after the last menses like a spontaneous abortion in action. The treatmentconsists of three 200 milligram pills of RU-486, followed 48 hours later by a small amount of prostaglandin to induce menstrual flow. The procedure is successful in 99% of the cases, and its efficiency is being improved. However, it must be performed under medical supervision in accordance to the developed procedure, and is safe only in countries with well developed medicine.

This technique is very useful in countries where surgical experience is limited, as most women will be able to avoid any instrumental intervention, with concurrent reduction in the risk of infection or injury. However, due to intense pressure from anti-abortion lobbies the company has been slow to use it outside of France, and it was even removed from the French market until the government forced its introduction. It was developed at the end of the 1970's, but was only used for the public at the end of 1988. It was used by over 25,000 women in the first year of its use in France, in preference to surgery (Palca 1989). It is currently being used on over 1,000 women a week. A trial in the U.K. has found it safe (Guillebaud 1990), and it is likely that it will be used in 1991 in the U.K., as the company Roussel-Uclaf has applied for a license. The U.K. government will probably support the application, because not only is it medically efficient and safer, but also more convenient for the women, and cheaper for the government (it could save 10-15 million annually). After the U.K., Scandinavia would probably be the next country. The company will introduce the drug to countries were abortion is not very controversial.

Perhaps the W.H.O. can introduce it more widely, as it could save many dangerous illegal abortions which cause the annual deaths of about 200,000 women worldwide. In some countries almost 50% of the maternal mortality is due to unsafe abortion. W.H.O. is also researching another drug, ZK98734, but it may not be as efficient. China has approved the use of RU-486, but since the French will not supply it, the drug may need to be synthesised in the countries that decide to use it. One of the limitations of the use of RU-486 is that it must be used with synthetic prostaglandin, made using genetic engineering. The unavailability of synthetic prostaglandin may keep the drug out of Canada and Australasia also. China is the only developing country with access to prostaglandin. The American Medical Association supports the trials and use of RU-486 in USA, despite the opposition from the pro-life movement.

There has been research aimed at developing vaccines to control fertility (Ada et al. 1985, Aitken & Paterson 1989), and this is one of the most urgent needs for medical research. The ideal vaccine should have a long lasting specific effect and should inhibit fertilisation as a contraceptive agent, rather than act as an embryo-arresting agent, or an abortificant. The immunological response induced by the vaccine should not elicit any cytotoxic response that might result in abnormal reproduction or damage. Long term contraception in female mice has been achieved by vaccination with antibodies to the sperm-binding proteins of the zona pellucidia, the membrane that surrounds growing oocytes and ovulated eggs. One of the proteins that sperm bind to has been sequenced, and a 16 amino acid sequence of this protein was synthesised as a peptide. This peptide was coupled to a carrier protein and injected into female mice. The mice made antibodies to this peptide, which were found to be an effective contraceptive. Repeated immunisation with this peptide resulted in long term infertility (Millar et al. 1989). The sequence of the equivalent human peptide is known, and is being tested. There are similar experiments underway in human embryo research.

Should We Use Contraception?

There has been a long history of contraception, there are prescriptions for contraceptive pastes in Egyptian medical papyri from 1850 B.C. Soranus of Ephesus (78-117 A.D.) wrote a detailed account of contraceptive methods, which he distinguished from abortive potions (Soranus I). The male sheath, or condom, was made in a linen version by Gabriel Fallopius (1523-1562), the discover of the fallopian tubes. Public interest in population control was widened by the essay in 1798 of Rev. T.R. Malthus, Essay on the Principle of Population as it affects the future Improvement of Society. The first birth control clinic was opened in Amsterdam in 1882, and in America in 1916 (Wilkinson 1988).

Many recent books on ethics do not consider contraception, except the Catholic theologians, as it already widely accepted. However, it was only widely accepted during the second half of the century. Contraception for medical reasons has long been permitted by many Christians, and by some Jews. It is not accepted by Jewish Rabbis generally, and recently they have been opposed to it as they are trying to build up the Jewish population (Jakobovits 1975). Jews consider the Biblical precept to "be fruitful and multiply" to mean that each couple should have at least one son and one daughter as a minimum duty.

This is an area where there is a major controversy in the Roman Catholic Church, whereas Protestant Churches in general support birth control through the use of contraceptives. The Catholic church and other religious groups who exert powerful control over the actions of many people, carry a huge responsibility for the failures to decrease the global population problem. We need to examine this case to decide which principle should be given priority when several apparently clash. There are several important ethical principles involved, stewardship of the earth and a high value of human life are common to a general perspective and a religious perspective. For those who hold religious beliefs, the commandments of God to mankind, recorded in the Bible for a Christian, are also important, and can be overriding to some believers. In the Bible, humans were told to be fruitful and multiply and reproduce (Gen. 1:28). All people would agree that the procreation of the new generation is necessary to replace the old, and is the basis of family structure and society. The old, who are wiser, train the young who replace them. However, the human race was also repeatedly told to take care of the world, and to be good stewards (Gen. 2:19).

The Humanae Vitae of 1968 (Pope Paul VI) has been used to maintain the Catholic teaching that every contraceptive act is intrinsically evil. It is based on the idea that intercourse is a single act with two aspects, the unitive and the procreative, which it claims are inseparable. Some Catholic theologians have since considered that contraception is intrinsically evil and others have considered that it is possible to dissent from the papal teaching on contraception (McCormack 1981). The major argument used by opponents of this view of the function of marriage and intercourse, is that the primary function of marriage is the unity of man and woman (Berry 1987). Only out of this primary function of marriage is that of procreation, Eve is not viewed as a baby-maker for Adam, but as an equal companion. No where in the Bible is contraception prohibited, despite the existence of the methods. However, it has been opposed since the time of St. Augustine.

Sterilisation is permitted by Catholics only if it is part of a procedure necessary for the treatment of a serious disease such as cancer. It is regarded more seriously than individual acts of contraception. The Roman Catholic church says only the periodic abstinence method can be used. However, even this abstinance can be argued as unnatural. All medical treatment is unnatural, but that does not make it wrong. We are not merely to follow the law of biological laws and rhythms as is suggested by the narrow interpretation of Catholic "natural law", it is in conflict with the responsibility of stewardship.

Some racial groups, or countries are very sensitive to the encouragement of birth control by what they see as the major world powers, however, fortunately most people do see that it is a real problem for everyone. It has worked in some countries such as Indonesia, but failed in others like Kenya. Some object because it may encourage promiscuity,an argument used by religious authorities, and some governments such as Japan, but abuse of a practice does not cancel its proper use.

There is another reason to allow birth control, as mentioned. This is the very high incidence of maternal mortality, connected with pregnancy, abortion, and child birth. In Africa, a woman has a 1-in-14 lifetime risk of maternal mortality (in developed countries the figure is between 1 in 4,000 to 10,000). The WHO is trying to tackle this problem, which on a per capita basis works out to cost about US$ 200 per maternal death saved. There needs to be more access to family planning clinics in developing countries. Some governments are against this, some for religious reasons. If they look at saving lives from illegal abortions, which are often the result of unavailable birth control, they may change their thinking. It also represents the usual problem of misdistribution of wealth.

We need to take responsibility for our actions, including reproduction. There is extreme over population in parts of the world, and even if we all slowed down today, the carry on effects will take another 50 years to stabilise, due to the great proportion of young people in the worlds age structure. It is an additive cause for much starvation and suffering, and a major cause for some of the pollution problems. When the earth is crowded, and so many resources used, we should not overfill it. There is a limit to the land. We need to control the desire to have many children, and what is more important allow choice to those who want birth control, and use reason and common sense, and the techniques that we have been given in our technology to practise sensible birth control.


Infertility

Is Infertility a Medically Treatable Disease?

There are many couples who are unable to have children. The proportion is approximately 10% (H.M.G. 1986, OTA 1988c). For the purposes of this discussion I will use the convention of calling them infertile. Physicians have developed methods to overcome infertility, with the motive of helping such couples have their own child. In some countries the assisted reproductive technologies such as IVF and AID are involved in close to 1% of the live births. The birth of children to infertile couples brings not only great human joy but a new human being. We should also recognise the frustration of couples who desire to have a family genetically related but are unable to achieve this on their own. In our society there are many prenatalistic ideas putting pressure on couples to have children, and there is a shortage of children for adoption (though this has not been aided by the racial selections in the procedure endorsed by some hospital boards). These medical treatments are the means of raising children for many couples who were not able to give birth to children. All methods for the procreation of children should always have the well being of the family in mind, though we should also enjoy the joys of parenthood.

We can't reject these techniques as "unnatural" because we would then be rejecting modern medicine as a whole, as every medical treatment is aimed to resist disease and suffering. Some critics such as Paul Ramsey or Leon Kass, argue that infertility is not a disease in a strict medical sense, and the physician who employs IVF to overcome infertility is merely treating the desire of the couple to bear a child. It is manufacture, not medicine in their view, however, it depends on our criteria of health, in the wider sense it is restoring a natural function of the human body. They are seen by many as another application of intelligence to overcome our adverse situation.

There has been a concern about the capacity of technology to change, not just the conditions of human existence, but its essential characteristics (O'Donovan 1984). What has occured with reproductive technologies is a revolution in our view of human reproduction (Jones 1987). The writings of twenty years ago were mainly against IVF, but now most writers see it as ethical for use by married couples. It is not a matter of being conformed to the world, but rather the value of hindsight and understanding upon a technology. There will always be techniques and ways to make us inhuman, what could show this more than war, rather we must look at the techniques with eyes of the 1990's.

In the United Nations Declaration of Human Rights, one of the "rights" is to raise a family. However , this refers not to infertility but is against compulsory sterilisation. A negative right not to be interfered with (e.g. the right to marry), does not entail a positive right (e.g. society must provide a spouse). An individuals' right to reproduce is not violated if fertility treatments are not made available. This question is important regarding the limits of public funds for some reproductive methods. Currently many countries offer support for married couples to use these techniques, but those involving ova or sperm or embryo donation are not financially supported in France or the USA. When health care budgets are stretched, the money will be spent on what are generally seen to be more urgent needs.

There are various factors that contribute to infertility. Among women the three most common are problems in ovulation, blocked or scarred fallopian tubes, and endometriosis (the presence in the lower abdomen of tissue from the uterine lining). Among men most cases of infertility are due to abnormal or too few sperm. The causes include genetic factors, environmental pollution, drugs and smoking, and much is yet to be known. About twenty percent of cases of infertility in the USA are the result of infection with sexually transmitted diseases, which are often the result of sex outside of marriage. There are various ways to overcome infertility, including induction of ovulation, surgery, and AIH or AID, which may be used in 85% of cases. The use of IVF and GIFT may treat 10-15% of cases. Approximately only half of infertile couples can achieve a pregnancy, sometimes this is because they run out of money trying these techniques. They have to realise there is a point to stop. In 1987 in USA about US$1 billion was spent on medical care to cure infertility, about 7% was on IVF (OTA 1988c).

Methods Involving the Married Couple Only

There are several methods used to alleviate infertility. The oldest involving only the married couple as sources of gametes is artificial insemination (AIH), where semen of the husband is implanted into the wife. The oldest recorded case was in 1790. There was some ethical debate, but it is generally accepted as a legitimate medical technique by the majority of people including the majority of Christians (Dunstan 1975). The exception is the Roman Catholic church (Vatican 1987), rejecting any technology that would replace sexual intercourse between husband and wife, including artificial insemination and IVF. They reject them for the same reason as for contraception, that they separate the procreative and unitive aspects of intercourse. However, Catholic hospitals in several countries will continue to provide these services, as they do not accept that aspect of the Vatican policy.

The technique of IVF is of much more recent origin. Human IVF is an established clinical procedure in many countries. Attitudes have changed as it has been found that the babies born by use of IVF are normal and it has brought happiness to many families, so that now it is also generally accepted as a legitimate medical treatment. Because of much publicity this technique is well known, and over 20,000 babies have been born as a result of it.

There are several major phases in the technique of IVF (Edwards 1985). First the woman is treated with a stimulator of follicular growth, then the oocytes, or egg cells, are removed by aspiration and collected. The oocytes used to be collected by a technique called lapraroscopy, where the oocytes were aspirated from the follicles in the ovary. There has been increasing use of ultrasound scanning to guide the needle which can then go through the abdominal wall or the vagina, therefore avoiding the need for repeated operations (Sims 1988). Male semen is combined with the oocytes to fertilise the eggs, there is a high success rate, often 80%, for patients to fertilise the eggs. Usually about 10-12 embryos are produced, and these are grown to a multicell stage before implantation. Implantation is the most difficult stage. The two most important factors are maternal age and the number of embryos replanted. In the successful clinics, 3 embryos are normally replanted with the rest of the embryos being frozen, to be used for another attempt to produce a child (the first babies born from a frozen embryo are growing normally).

With the replacement of 3 embryos a 33% implantation rate is often obtained (Trounson & Wood 1984, Edwards 1985). The United Kingdom the Voluntary, or Interim, and now-called Statutory Licensing Authority, records the statistic from the IVF clinics. It reported that the overall pregnancy and live birth rates for 1986 for all IVF clinics in Britain were 9.9% for pregnancy and 8.6% for live birth, per stimulation cycle, and in 1987 this figure was 9% for live births. The figure per embryo transfer cycle is 12% live births, in 1987 (VLA 1989). Usually women have several cycles of treatment so the success rate is about 25% overall. There is a wide difference in the success rate between different clinics, depending on experience, and the selection criteria for mothers. There is still much room for improvement in the success rates of the technique, which requires further experimental research.

A recent alternative is gamete intrafallopian transfer (GIFT), in which the mother receives hormonal treatment to stimulate ovulation, and produce several ova. Some of these are then placed, together with a concentrated amount of a sperm, in her fallopian tubes. Fertilisation occurs normally, in the body. If it can be made to be safer than IVF for the mother then it should be used. GIFT is not applicable to all women requiring IVF, as at least one functioning fallopian tube is required, so it will not replace IVF totally. A new technique is called POST (peritoneal oocyte and sperm transfer). A mixture of eggs and sperm are placed at the end of the fallopian tube in the peritoneal cavity. VISPER (vaginal intra-peritoneal sperm transfer) is where the sperm is placed directly in the peritoneal cavity. They are simpler than IVF in the fertilisation and embryo transfer side, but the same hormonal manipulation of the women is needed. In practise the techniques are done in parallel in the same units (Sims 1988). GIFT has a higher success rate, of 19% live births per cycle, versus 10% live births per implantation using IVF, in 1987 in the United Kingdom. The multiple pregnancy rate is about 20% in both. The actual success rate of IVF is about the same as it was in 1985, though new clinics improve as they gain experience. The figures for the UK in 1988 showed that clinics varied considerably, with the highest live birth rate being 16.4%, with a mean success rate of 12.9%. However, some smaller clinics had no success at all, and the Interim Licensing Authority, soon to be replaced by a Statutory Licensing Authority, has threatened that it may withdraw the licenses of those clinics (ILA 1990).

In the United Kingdom there is a total of 42 IVF clinics, 38 offer GIFT, and about 32 clinics offer GIFT alone (VLA 1989, ILA 1990). There is a growing number of clinics offering GIFT alone, in March 1990 there were 45 unlicensed clinics only offering GIFT. Whichever technique is in the best clinical interests of the mother is used. A loophole in the U.K. Human Fertilisation and Embryology Bill is that clinics offering only GIFT might not need to be registered, and at a practical level, there may be insufficient staff to monitor their operation if registered. The MRC interprets the bill to include GIFT, as it is a procedure that involves "an egg in the process of fertilisation" (Braude et al. 1990). GIFT is cheaper than IVF as it does not require laboratory maintenance of gametes or embryos. However, it is considered more risky by some experts (Vines 1990). Because the techniques are similar, if IVF is going to be regulated, GIFT should also be regulated, and statistics collected for study of these techniques which are still at an early stage in refinement.

There are several reasons why GIFT should also be regulated by committee licensing. The maintenance of proper clinical standards is important, which can partly be measured by the statistical performance of each centre. The individual statistics need to be keep. In Australia and New Zealand most clinics offering IVF or GIFT send their annual results to a monitoring group, at the Australian National Perinatal Statistics Unit (PNSU 1990). It also shows the high variability between the performance rates of different clinics. There is a stronger need to monitor the incidence of multiple pregnancies in GIFT, as more eggs may be implanted, or not all the eggs were extracted so that some remain to add to the chances of multiple pregnancy when the egg and sperm are returned to the woman. There are many implications of multiple pregnancies, such as higher mortality rate, and social consequences for the family.

The claim that AIH or IVF are risky for the offspring, were important objections against the early use of these techniques. In hindsight, we can say that there is no significant additional risk of defect to children born as a result of IVF compared to those of normal conception (Edwards 1985). This was a valid objection to these techniques before their use, and some would consider that when they were first used they were unethical because of unknown risks. The spontaneous abortion rate after IVF and embryo transfer is not significantly different to that after natural reproduction, being about 40-60% at conception, and about 25% at two weeks gestation (Steer et al. 1989). There have been many multiple pregnancies as a result of IVF, but the reason for some has been the high number of embryos replanted. In a survey of the British IVF births up until 1987, out of 1092 deliveries, 249 were multiple births (23%), which compares to 1% for natural conceptions. The average birth weights were lower and there was a greater proportion of premature births because of this (MRC 1990). There is a slightly lower overall survival rate for babies born as a result of IVF because of the lower weight babies, due to the three times higher rate of multiple pregnancies. However, there has been no evidence that the procedure itself is harmful. If we control the incidence of multiple pregnancies than the procedure presents no known risks to the child.

Some regard IVF as "unnatural" because the embryo is conceived outside of the body. However, there is nothing intrinsically more unnatural in fertilisation in vitro than some other medical techniques. There may be other reasons to oppose IVF, such as its potential misuse, or the following arguments, but unnaturalness is not convincing.

The religious objections to masturbation used in these treatments are used only by a few conservatives, most theologians do not consider this important (BSR 1985). The motive behind the act of producing semen is procreative and so different to the acts that those claiming scriptural objection refer to. Religious taboos may be eased in the case of IVF, as it leads to cocreation of children. There are in fact social taboos on infertility which bring pressure and create problems for the couples seeking IVF treatment. The sexual taboos should not have a role in the assessment of these issues unless they are morally relevant. We should note that IVF for married couples is accepted in some Islamic countries, where there are clinics. It is also accepted by many Jews, and there are clinics in Israel, that will provide services to a broader group of infertile women.

There is still objection to the separation of procreative and conjugal aspects of marriage, from the Roman Catholic church (Vatican 1987, Stagnolo et al. 1989). The view of the Roman Catholic church has been that aids to infertility involve the intrusion of a third party, the physicians and scientists, into the marriage as a means of solving the infertility problem. This was seen as a trepasses upon the covenant and exclusive relationship between the husband and wife, who are "one flesh", and also intruding into the parent-child relationship of the family. However, this is like the argument that medicine is unnatural, there is usually the involvement of a third party. The argument that children who are not born as a result of conjugal intercourse are deprived of "proper perfection" (Vatican 1987) has no scriptural, reasoned or scientific basis. This is not only an unscriptural doctrine but cruel, harmful and in my opinion a mistake which needs changing, as such statements affect the lives of many people, who look to religious authorities as sources of moral guidance. We can hope that theological intepretations consider new technology.

In Japan there has been a survey of the attitudes of Buddhist Priests towards new reproductive technology (Shirai 1990). Among the Japanese population in general, about 30% of the general population approve of IVF, and 55% disapproved, in a study at the end of 1985. A group of Buddhist priests and student priests was surveyed, from several different sects. About 43% of the respondents approved of IVF in the case of a married couple, and the major reason was the sympathy for the infertile couple. Only 22% disagreed with the procedure, the survey was conducted in early 1987. These figures suggest that the Buddhist monks are more accepting of the use of IVF, though it may also be a partial reflection of the growing acceptance of new technology within a society once it is used. The main objection to IVF was it is interfering with nature, which is the argument discussed in chapter 3. These attitude survey does not necessarily reflect much theological reflection, as there has been very little theological examination of this technology by Buddhist scholars.

In the simple case of the use of these techniques for a married couple, there is no relation to the "brave new world" situation. The use of these techniques supports the traditional family values. Human life needs an environment of love to flourish, and this love can be provided in the marriage to a child born in any way, and probably more so towards a child that involved much difficulty to be born. The procedure of IVF has raised the question about intercourse being not simply a biological event, but a symbolic human event expressing human love. A woman who is able to conceive does not necessarily mean that she is able to procreate. There may be problems in the conflicts of interest, but these are more important when extramarital gametes are used.

There are associated legal problems that require regulation. These include who has legal control over gametes and embryos, and who decides their fate. The primary authority should rest with the two gamete providers, who should agree to any disposition of the embryos. Agreements made by the gamete providers for the future disposition of the embryos should be enforceable to avoid problems arising from divorce cases. There has been an infamous case in the USA, called the Davis case, where the couple divorced. The woman wanted to use the frozen embryos to try to become pregnant, but the man wanted to prevent this. A Tennessee court supported the woman's claim, but it is being appealled. It is best to have these legal questions decided, and an agreement entered before starting IVF treatment. In light of past legal problems many clinics have developed detailed consent and instruction forms. However, it is not an objection to IVF itself, and is a manageable problem.

The moral status of the embryo is an important question, as some embryos may be discarded if not all are used in IVF. I considered the moral status of the human embryo in chapter 5. The conclusion was to support the use of human embryos in scientific research for important medical goals, and to improve the success rate of IVF. The technique involves making spare embryos, which may be used at a later time. There is a high level of embryo wastage associated with natural fertilisation, about 70%. There are large numbers of gametes unused, far more than is necessary for reproduction. The embryos are only 1-4 cells in size. If just one child is made from four embryos then we have the same situation as in nature, and in my opinion it does not matter if the figure is 20 to 1 at this stage of development. Rather than looking at the embryos wasted, we should focus on the utilisation of gametes that would otherwise have been unused, and more importantly, on the birth of a child that would not have been possible without using this technique.

Spare embryos can be frozen, and used for another attempt at embryo transfer, and this is routine in some clinics. To lower the risk of multiple pregnancy only three embryos are usually transferred per attempt. Freezing avoids wasting the embryos, and the survival rate for embryos is greater than for oocytes. It avoids the need for oocyte recovery from the mother before every attempt. It has not been found to be associated with any risks to the child. It does present several important ethical and legal issues, after the couple have a successful live birth, on the disposal of the frozen embryos (as well as the disposal of unused sperm and oocytes). The embryos may be used for a future attempt by the donor couple, or they may be donated, or discarded, or used for research prior to discarding. In practise most clinics follow the wishes of the parents.

There have been objections from the feminist movement, who claim that IVF is a failed technology (Arditti et al. 1988). Their opposition to reproductive technology is based on the hypotheses that it reinforces social attitudes concerning the imperative of biological parenthood (with the stereotype of women as child raisers); it increases the possibility of exploitation of women; there are possibilities such as sex selection (which is often based on a low value of female over male); the commercialisation of gametes, embryos and women, so they are viewed as commodities; and the experimental nature of the techniques. It is true that IVF has a low success rate, but it still is successful, what is imperative is that there is better counseling and prior knowledge of the low success rate, as many unsuccessful couples find it emotionally draining. It is very important that infertility is seen to be one factor in life, and the birth of children is not required to live a full life. This objection to IVF is more important than most of the philosophical arguments about the status of the human preembryo in relation to reproductive technology. The exploitation and commercialisation of these techniques are discussed in the following pages.

The objections from several feminist writers have however, highlighted the severe emotional stress that couples and especially women undergo when using these techniques (Frank & Vogel 1988). They also criticise the businesses that are making money out of offering this technology, such as surrogate mothering agencies. This may place increasing pressure on people to have children, whereas in the past they accepted their conditions. There is a certain peer pressure to use new reproductive technology if a couple is infertile, even if they would not have gone through the stress or financial cost, without this pressure to conform.

In an overpopulated world there is something incongruous about using all the ingenuity of modern medicine to create more children. However, it is not an ideal world. Most of us are free to adopt needy children, from our own country or others. If fertile couples don't chose adoption in addition to having their own, we can't enforce things on others, especially what we don't do ourselves (Jones 1985). "Infertile" couples may have to consider the option of adoption more than couples who are easily able to have children. There is a strong desire among couples who are unable to have children to use these techniques, but in one survey of patients involved in IVF programmes 70% of the couples using IVF would use adoption or AID/IVF using extramarital gametes, if those possibilities were available (Singer & Wells 1984). Unfortunately, there is a shortage of children available for adoption, unless international adoptions across cultures and races are accepted.

Should IVF be Publicly Funded

By todays standards IVF is not an inordinately expensive medical technique. As mentioned in the section discussing whether infertility is a disease, reproductive rights are involved. It is one thing to recognise the right to treatment, a liberty right; but another to recognise an entitlement right, the right to expect society to pay. Infertility treatment could be regarded in the same way as other medical therapy, and different countries provide national health schemes, and others do not. Some ask whether it should be included in the range of treatments subsidised from community medical resources. There does not seem to be any reason to single IVF out for harsher treatment than given to many medical treatments. We still treat lung cancer caused by over smoking, liver disease caused by alcohol abuse, or heart attacks caused by bad eating habits, on national health schemes, or under medical insurance schemes. In fact, one would favour the motives of IVF over some of the other treatments possible. IVF only benefits a small proportion of infertile couples. The real cost of the IVF and embryo transfer procedures alone per live birth is A$ 40,000 in Australia, and US$ 50,000 in the United States (Wagner & St. Clair 1989). There may be more cost effective ways to treat infertility, and further research is needed. About 15-25% of couples waiting for IVF, or failing IVF, have pregnancies before receiving treatment, or within two years of its discontinuation. Research may lead to better alternatives.

Nevertheless it does highlight the wrong in the world that we invest resources in order to help a few thousand childless homes get a genetically related baby, when we don't simultaneously invest the same resources to help the millions in developing countries be able to live, and overcome the tragically high rate of infant mortality. We also have to decide whether IVF is consistent with the ultimate aims of medicine, the restoration to health of those diseased and impaired. Some believe it is more towards the satisfaction of other needs, for which there is only a strong desire (Iglesias 1984), however, I do believe it is at least as worthy as many other medical treatments we readily accept.

In some countries IVF is performed for a high fee, but in others it is covered by national health systems. A recent international survey was conducted by (Gunning 1990). In France IVF is fully reimbursed by Social Security, as France has a pronatalist policy. Some patients have to pay laboratory charges (about FF 2,500). In Spain 14 of the 24 clinics are in public hospitals where treatment is available in the National Health Service, and in private clinics the women can claim on medical insurance. In Denmark there are six clinics offering IVF, five of them are in the National Health Service Hospitals and offer free treatment, under strict criteria. In Italy the state will reimburse the costs of IVF with gametes from the married couple, but in Sicily the government will also reimburse the costs of IVF using donated gametes. In Belgium the social security system will contribute to the cost. In Norway the state pays 90% of the cost, and IVF and AID may only be performed in authorised institutions included in the national or county health plans. In Canada, public health funding is on a provincial basis and Ontario is the only province which covers the cost of IVF. British Columbia has withdrawn financial support for IVF. In the Netherlands some funding is available from the Sick Funds Council, but it is still a matter of debate whether it will cover future IVF treatments. Private medical insurance will meet IVF costs for those not covered. In Switzerland IVF services can be performed at approved private institutions.

In Britain only two clinics offer free service under the National Health Service. The charges at the other clinics range from 250 to 2000 pounds. In Australia approximately half the costs are available on Medicare, so patients pay A$ 1-2,000. In the USA couples pay on medical insurance cover, and six states (Arkansas, Delaware, Hawaii, Maryland, Massachussetts & Texas) have mandated medical insurance cover. There is a varying degree of coverage under state Medicaid programs, with some cover for drugs, counseling and surgical procedures related to infertility treatment, but no direct funding of IVF (OTA 1988c). In West Germany medical insurance will pay. In Sweden patients must pay the costs (between US$ 3-4,500) (Gunning 1990).

Eligibility

In principle IVF and artificial insemination are accepted means to aid infertility to married partners, using semen or eggs within the marriage, by most Christians (Mahoney 1984), and also in some cases by Jews (Jakobovits 1975). The possible consequentual uses of human embryos, especially fears of genetic manipulation raise many additional moral concerns, which are a separate issue, are described later.

There is the question of whether prospective parents should be screened for their suitability to have children. Assisting single parents or homosexual couples to conceive a child may directly contribute to specific negative child-rearing conditions in most cultures. This may harm individuals and also the wider community. There has been some evidence that children from single-parent households do not do as well academically as children from two-parent households (Orentlicher 1989). However, this may reflect differences in income, education and other factors. Some other studies do not find differences in academic performance among children depending on the number of parents. Girls who have a single mother may be more independent and more achievement orientated (McGuire 1985). In some instances the child may be raised in a better environment than children in heterosexual families. There are also a large number of single parent families existing in Western countries, because of high divorce rates, and premarital pregnancy. What is important is that active intervention in bringing about the birth of a child is involved. Society can try to increase the number of ideal family situations by marriage counseling, and it is a backward, even if minor, step to use technology to generate unusual family situations. Normally people are not screened if they will be good parents, only if they commit child abuse are their children taken away. There might be cases where a heterosexual couple is "judged" to be unsuitable for nonmedical reasons for IVF, in which cases they should be told why, honestly, and then they can seek the services of another doctor.

The Council of Europe adhoc Committee on Bioethics prepares drafts for the European Committee of Ministers. It recommended that the techniques of artificial procreation should be restricted to heterosexual couples (Gunning 1990). People in Norway must sign a declaration that they are married. In Sweden the recipients must be married or cohabitants for more than two years. In South Australia IVF is allowed only for married couples, or for couples with at least five years of continuous cohabitation. However, in Spain the law makes reproductive services (IVF, GIFT, AIH, AID) open to any woman, whether married or not. In Israel an unmarried woman can receive IVF with her own fertilised ovum if a social worker in the clinic supports her application.

In the U.K. Human Fertilisation and Embryology Bill there is a conscience clause for the medical practitioners which states "No person who has a conscientious objection to participating in any activity governed by this Act shall be under any duty, however arising, to do so". The Bill makes reproductive services generally available for "the purpose of assisting women to carry children". On clinical indications alone, services are open to any women. However, the conscience clause allows doctors who have a genuine conscientious objection in the interests of the prospective child, to refuse services. The burden of proof for the objection still rests on the practitioner (Evans 1990). This still allows some selectivity, but it is likely that a sympathetic doctor may be found to provide the services. On the more sinister side, it may force the rejected women to use more expensive services than if there was an open policy.

The eligibility for using reproductive technologies is an important area of the law. While the resources are limited, they should be solely applied to benefit infertile married couples. For longterm de facto "married" couples, who wish to have a child by IVF, it would seem that they should be prepared to become legally married if they wish to use the involved procedures of IVF, and to raise children. There are IVF clinics practising in Egypt, Jordan, Kuwait and Saudi Arabia, and only their own gametes are being used. However, there is no legislation controlling IVF, and there may be many unofficial clinics. In West Germany, IVF can only be used for married couples, which is a contrast to the situation in the Netherlands where lesbian couples have used IVF and AID. In the USA, courts have ruled that it is not possible for clinics to refuse to consider applications for reproductive technology from unmarried couples, or single women. In the U.S. Constitutional tradition, there is a right to procreate and raise children according to individual preferences.

Fertile people may have a need for infertility treatments also. People who undergo radiation treatment, especially women, may want to store eggs for use after. Some chemotherapy agents also can cause mutations. Treatment for lymphoma can use gonadotrophin alkylating agents which cause premature ovarian failure in most women. Oocyte recovery would allow future pregnancy. A women in the twenties may want to store oocytes produced then, for implantation in the thirties when she wants to have a child, as older women have increased risks of chromosomal abnormality (Dawson & Singer 1990). Abnormalities can be screened for using genetic screening, but oocyte recovery when there is a more significant risk of mutation, and the case of possible absence of oocytes, is justifiable. It is a question of resources available, more than anything else, once we accept IVF as an ethical technique.


Table 11-1: International Comparisons of In Vitro Fertilisation in 1990
(Information from ANPU 1990, Gunning 1990, ILA 1990, Mori 1988)

Nation; Legislation; Embryo Research, Time Limit (days); Regulatory Body; Number of Clinics providing IVF; Treatment Cycles p.a.; (Live birth rate %);

Australia & New Zealand; Victoria 1984, and South Australia 1989 ; Surplus, (14); Standing Review & Advisory Com.; 25 (1988) and 3 in N.Z.; 9,191 (9.4)
Belgium; No; Yes (no restriction); No; 14; Unknown
Canada; No; Yes (no restriction); No; 13; 2000+
Denmark; Establishing National Bioethics Council; Moratorium on all research; No; 3; 900
France; Draft 1989; Surplus (7); National Com. licenses clinic; >100; 19000 (FIVNAT)
F.D.R.; Bill 1990; No (5 year prison); Yes; 51; 14,400 egg collections Italy; No; Yes (no restriction); No; 10+; Unknown
Japan ; No; -; No; <45(1986); 2008 (6%)
Netherlands ; No; Yes; No; 30; 2377
Norway ; Act No. 628 1987; No; No; 7; 3-4,000
Spain ; Law 35 1988; Surplus (14) ; National Commission; 24 (1989); 2500(1989)
Sweden ; IVF Act 1988; (14) ; No; -; -;
U.K. Up to 14 days Licensing Authority ; Human Fertilisation & Embryology Act 1990; Yes (14); Licensing Authority; 44(1987); 7043
U.S.A.; No Federal Legislation In some states yes.; In some states yes, no federal funding; No ; 200; 14619 (in 146 clinics)


The Use of Extramarital Gametes

Sometimes one member of a couple may be incapable of producing gametes which can lead to fertilisation, so that IVF or AIH will not work. The couple may not be infertile, but one may carry a genetic defect and so would not like to take the chance that the offspring also suffer from that genetic disease. If these couples do not consider adoption a possible option and still want to have children, then they may consider use of artificial insemination using donated semen (AID) or IVF where the egg, or sperm, may come from another person. In about 30% of infertile couples, the male alone is responsible for the couple's infertility.

The first documented human insemination using semen from a husband was performed by John Hunter in London in the 1770's. The oldest claimed case of medically assisted AID was in 1884, but it was seldom used until the later half of this century. The success rate per patient after three months is about 40%. In the United Kingdom about 1700 children a year are registered born as a result of AID (H.M.G. 1986), and they were legally regarded as illegitimate until the 1990 Human Fertilisation and Embryology Bill was passed. About one in 20 of the British population today, has a father other than the one named on the birth certificate. In the United States the number of children born by AID is measured in hundreds of thousands, and about 30,000 children are born annually (OTA 1988c).

In Europe the situation varies between countries very widely. In France there are about 20 centres that are regulated by the Ministry of Health CEGOS sperm banks. They have developed a set of guidelines in the use of semen. Semen is obtained only from married fathers, with the approval of the spouses. There is a high demand for sperm, and a limit of 5 pregnancies per sperm donor (Jalbert et al. 1989). Anonymity of donors is guarantied, and only stable heterosexual couples are recipients. The recipient cannot chose a donor, and they must have a medical reason for using AID. There is no payment for sperm, though it has been shown that payment encourages more donations, but sufficient sperm is obtained from donations (Glover et al. 1989). More than 17,000 children have been born in France as a result of AID, and 0.25% of births in France are a result of CEGOS services. There are continuing followup studies, and the scheme has been running for fifteen years. There is a greater openness about infertility in France than in some other countries. In Denmark, AID is prohibited (Gunning 1990). West Germany discourages AID, and the new Bill prohibits egg or embryo donation.

In Sweden usually married donors are used, and when the child is 18 years old they can obtain the name of the sperm donor. Only married couples (or long term defacto couples) can use AID. When the law removing anonymity was introduced there was an initial drop in the number of sperm donors, but since then numbers have returned to an adequate level. The written consent of the woman's husband or cohabitant is required, and AID must be performed in a public hospital under specialist supervision. A couple may appeal to the National Board of Health and Welfare if their application for AID is refused. The doctor selects an appropriate sperm donor. Frozen sperm are prohibited from entering Sweden. However, many Swedish couples seek AID in countries where anonymity is guaranteed. The Swedish law prohibits the donation of eggs or embryos for IVF. In Bulgaria the written consent of the husband is required prior to AID, and only if the couple cannot have children with their own gametes or the husband suffers from a serious genetic disease. Donor sperm must be from donors between 18-40 years of age, and is screened for infectious diseases (Bulgaria 1987). In South Africa the written consent of the husband is also required, and only married couples can use AID.

In ethical terms I consider AID and embryo donation to be equivalent, the only difference being that the embryo is conceived in vitro in one case. In fact the embryo can even be fertilised in utero, using GIFT, or transferred after fertilisation by embryo flushing. The women can be inseminated with the semen of the infertile woman's husband, then after a brief incubation in vivo, the embryo(s) are flushed from her body and replanted in the infertile woman. The donor mother can be made to superovulate by hormonal treatment so more embryos are produced. The use of IVF may seem more preferable than flushing, as it means less involvement for the egg donor in the process, and IVF is a relatively efficient, safe technique.

The intrusion of a third party into the marriage is genetic as well as physical in these cases (Dunstan 1975). The involvement of a third party is the crucial objection to AID seen by many (O'Donovan 1984). The biological imbalance introduced into the parent-child relationship is an additional factor to the possible resultant stress between the husband and wife about the child (Snowden & Mitchell 1983). The asymmetrical genetic relationship of the child with the parents is a main concern. There is very little evidence of the actual results as the process has always been kept secret. It may have a close parallel to second marriages to which one partner may bring children of a previous marriage (Mahoney 1984), though the parent-child bond will be closer because both parents were involved in the pregnancy, birth and raising of the child. Since there are many instances of successful and loving marriages, in these categories, it seems acceptable for a stable marriage to use AID or IVF on this criteria. In fact, in France couples who have children by AID have only a 2% divorcerate, lower than the general population. However, in these situations the child exists, but AID involves deliberate conception of a child into an unusual family situation.

The considerations about the child are of paramount importance. A child needs a secure and loving environment to grow well. Children may also want to know their origins, and may have the right to know their biological parents. There has been one major study published that indicated that the majority of couples who used AID were very happy for the children that came as a result, and had no regrets. Both husbands and wives had found parenting rewarding and were happy with their children, after a long period. The children that knew that they had come from using AID were also happy (Snowden et al. 1983). In France studies so far have shown that children are not at any psychological disadvantage. Further studies should be done, such as the reactions of couples who use AID but do not have children, but their is much weight to social studies such as this if the answer is clearly positive. It is difficult to study as many doctors do not keep records of AID, and even if they do it is secret. It may be important to use criteria that something is morally wrong on grounds other than the consequences to which it will lead. The consequences vary with different marriage situations, and you can not tell necessarily which couple will make the best family situation.

A reason for objecting on religious grounds is that it may break the exclusive covenant relationship which God has established with each married couple. It is the closest of personal unions, which may mirror the union between Christ and His church. In this closest of personal unions, new human beings are brought into existence, as the fruit of God's creative love, and of the co-creative mutual love of husband and wife (Mahoney 1984). But it is an imperfect world, and not every family has great love shown in it. AID is not marriage infidelity, as it does not involve an intimate relation offending marital fidelity. However, AID is generally condemned by many Christians and Jews. This is in contrast to adoption which is considered ethical, except in Islamic countries. AID is grounds for divorce under Islamic law (Schenker 1985). There are IVF clinics in a variety of Islamic countries, and no gamete or embryo donation is permitted in these clinics, and there use is only for married couples.

The two sources of extramarital gametes that are commonly used are those donated by relatives or friends, or those from completely anonymous sources. Because of the risk of a conflict of attitude toward an offspring from an identifiable nonparental source, anonymous donations are prefered. In fact, recently in the United Kingdom the Voluntary Licensing Authority that licenses centres carrying out IVF and embryo research (set up after the M.R.C. report after the Warnock Committee report by the M.R.C.) made guidelines, which include that no more than 4 embryos should be replanted at one time and that donor gametes should be from anonymous sources. The reason given for anonymity was that this is best in the interests of the children. In fact it is probably more that it it is the best interests of the donors, who are often medical students, who have no connection with the parents. They would get a great shock to have a teenager coming to them 20 years later saying "Hello Father". The British Medical Association in 1970 recommended that the procedure remain anonymous. Also many Asian and Muslim mothers seek AID without telling the husbands, as it is not understood that the reason for infertility can also be the males fault!

In actual fact it is very difficult to conceal the fact, and will become much more difficult in years to come when genetic fingerprints of many people start to be recorded. In Sweden the child can find the identity of the genetic parents, like adopted children. In the U.K. the information of the identity and characteristics of the donors will be stored by the licensing authority for up to fifty years in some cases. Details can be divulged to the children concerned in limited circumstances (HMG 1990). The actual identity of the donors will not be disclosed, unless the Secretary of State for Health alters the information to be provided. This reflects the idea that the public opinion may change, as in the case of adoption (Evans 1990).

The issue of anonymity is very contentious, as some would say that if the parents do not tell their children that they are not their genetic parents, it is always going to be a deceitful relationship. Many children never know their origin. We need to question which is greater, the desire of the resultant child to know their genetic parents, or the desire of donors to retain anonymity. It is claimed that if donors know that they might be traced, they would not donate gametes and this would result in a shortage of donors, however as mentioned, in Sweden there are still sufficient donors. We need to change society's attitude to the importance of genetic ancestry. In 29 states of the USA there are AID laws that name the recipient and her husband as the legal parents, and that the sperm donor is not the legal father (Hummel & Talbert 1990). The legal definition of parents should be changed, as has been done in Britain. However, the U.K. Bill is still backward if it maintains the anonymity of donors despite the needs of the prospective children. It is currently unclear what information about gamete donors a child will be able to obtain. In the early stages of the Bill the wording was to release "non-identifying" information only, but in the Bill this phrase "non-identifying" has been removed, so potentially any information is releasible. Like adoption, when the child reaches a certain age they should have access to the records of who the biological parents were,though the legal parents are those who raised the child. In Britain adopted children only have direct access to who the birth mother was, and about 5% of the children have used this provision (Braude et al. 1990).

Besides the ethical argument that children should be able to know their roots, there are also medical reasons for regulation. This is especially so for semen donors, as there has been numerous accounts of the transmission of infectious diseases, such as HIV, ureaplasma, cytomegalovirus and herpes simplex virus. There is currently a lack of systematic screening of semen (Barratt & Cooke 1989), though some AID programs involve screening for many viruses (Hummel & Talbert 1990). It has been found that the same success rate is obtainable using frozen semen as with fresh semen (Scott et. al. 1990). In France there is some genetic screening of semen, and recipients, to avoid known serious genetic disease (Jalbert et al. 1989). The American Fertility Society 1990 guidelines (AFS 1990) recommend that fresh semen should no longer be used for donor insemination, and that all frozen specimens be quarantined for 180 days and that the donor be retested to ensure no antibodies to HIV are found, before releasing the specimen. They also recommend that each donor should be limited to 15 successful pregnancies, though less in smaller local areas. In South Africa the maximum number of children that one donor's sperm can be used for, is five.

However, in the final analysis it is impossible to enforce regulations on AID as it can be self-administered. In 1979 the Council of Europe recommended that all non-medical performance of AID should be unlawful, but the member states of the Council did not accept this for reasons relating to the practicality of such a law. It is not possible to regulate, and even if it may be detected during childhood by DNA Fingerprinting, it is undesirable to make the child "illegal" in some way.

It may be more balanced to use both egg and sperm from outside of the marriage, making the separation between genetic and social parenthood more fully. Donated embryos may be used, it is generally considered that any "spare" embryos made during the process of IVF, or donated egg and sperm, remain the property of the donors. The responsibility of safe medical practise is the responsibility of the medical staff. The doctor used to be the major selector of donors, but with the existence of large sperm banks the parents can increasingly chose the donor's characteristics, usually to match those of the husband or possibly with eugenic aims. There needs to be control over the number of times the same donor is used, so that there is a low chance of unwitting incestuous marriages. Some believe that the procedure is best left under the control of doctors, but it is very open to personal abuse.

There are commercial sperm banks operating in the USA, which has long been tolerated but is widely considered to be unethical. In the U.K. payment to gamete donors is prohibited, as is payment by the recipients to donors (HMG 1990). There has been a study conducted in Paris which showed that payment encourages donation (Glover et al. 1989), but there should still be adequate supplies of semen without this.

In the case of some dissatisfaction with the procedure's results, such that the parents have a disabled child or multiple births, providing the procedures have been explained to the parents and followed, there should not be grounds for lawsuits against the doctors, as has already occured in some cases. These techniques do not appear to have significant risks attached, monitoring them is the only way to investigate their safety.

There does need to be some regulating laws, but it is a case for situation ethics. There are widely variant laws in different countries, which is a consequence of the difficult issues involved. Society's attitudes to the use of donor gametes affects the legal controls, and if society grows to be more openly favourable to AID it will make regulation easier. It is impossible to prevent some abuse as AID requires no sophisticated technology, so it is best to allow it in a regulated way.

Surrogacy

Biomedical technology has made it possible for over a dozen new modes of reproduction. A child can have up to three types of mothers (genetic, gestational and social) and up to two types of fathers (genetic and social). It is possible to separate both genetic and social parenthood from physiological parenthood, as in the case of womb-leasing, or surrogate mothers. There already are children born, at least 500 in the USA alone, and reintroduced with their genetic parents, who will become the social parents, after birth from surrogate mothers. There are laws in Britain, and some other countries including Bulgaria and some states of the United States, which say that if the surrogate decides to keep the baby than no contract that she has signed can prevent her doing so. Carrying a baby to birth is the primary legal right to being a parent of the baby. In other countries, such as Greece, the Netherlands, Portugal, and Czechoslovakia, and thirty states of the United States, the preconception intent of the parents governs who are the legal parents of the child born (Andrews 1988). It is doubtful whether surrogacy should itself be illegal, as it seems strange to make the birth of a child illegal (Glover et al. 1989). However, it should still be strongly discouraged.

There are psychological and emotional factors which require careful scrutiny. Surrogacy in terms of financial gain is morally wrong to most people, and commercial surrogacy is illegal in Britain. In Australia the National Bioethics Consultative Committee recommended in August 1990 that surrogacy should be permissible in certain circumstances. In the state of Queensland surrogacy is legally prohibited, but the committee considers the factors that it is impossible to prevent it occuring and it is better to regulate the practise. It is still developing the working guidelines, and would make all surrogacy contracts unenforceable.

Surrogacy could lead to the situation where wealthy couples do not have to have the experience of pregnancy but let other women, who need money, have the troubles of pregnancy. There is a real danger that it would lead to the exploitation of poorer women. In the United States there are many surrogacy agencies, which involve commercial payments. A list of these agencies can be found in an appendix by a book by Evans (1989), that considers some of the excesses of reproductive technology in modern medicine. The total fee of most agencies is over US$20,000, up to half of which may be an agency fee. It is not the same as adoption, as adoption is finding a home for a child that exists that does not have a home, it is serving the child's interests. In surrogacy, or AID, the child is not being adopted, it is being created as a product to satisfy the desire of the parents. It is not done for the best of the child, but for the sake of the parents. It is a very short distance from the situation where children are viewed as consumer products, to add to the nice car and home. This is a concern seen especially in these treatments for infertility that involve multiple parties, and start to use people as means, and involve financial costs. It may also be considered desirable by some women who consider pregnancy to be an obstacle to their careers, in this case it seems unlikely they would provide a proper living environment for children anyway. There are both physical and emotional risks in having a pregnancy, and it is generally viewed as unacceptable because of the possible harm to the mother. I would view commercial surrogacy as unethical and something to be legislated against.

However, the offer of physiological motherhood by a sister or friend to a childless couple, could be treated as a generous offer (like the arguments used in allowing tissue donation). It is a novel concept, but novelty is not an indication of moral wrongness (Mahoney 1984). In this case it requires more careful examination, and might not cause many problems in the best case. In the U.K. however, no surrogacy is currently recommended with close relatives (VLA 1989). The legal concepts of mother and father have been changed in the U.K. so that the women who carries the child is to be the mother and her husband is to be treated as the father, unless it is shown that he did not consent to his wife's treatment (HMG 1990). This legal clarity is not seen in many countries.

A fear from many feminist writers is that the new technology is another control over women's lives at a new level (Arditti et al. 1988, Klein 1989). However, there have always been dangers of exploiting the fact that women carry the fetus, and any new technology involving reproduction is going to involve them. While contraception has freed women of the need to have so many pregnancies, techniques for relief of infertility are usually sort at the wishes of both members of the couple. There is a certain attitude that women have to have a child to please their husbands, but this is certainly nothing new. If anything women should be pleased with the development of safe contraceptives, and there will be some experimentation while any new drug is developed. Certainly western countries should not use the third world as a testing ground for drugs because of stricter laws in their own country, but that applies to all people who are victims of unethical trials. The only technique which is particularly prone to exploitation of poorer women is that of surrogacy, which in fact is accepted more in the so-called liberal USA, than in traditional countries in Europe.

Avoid Risks of Harm to Children

It is improbable that ectogenesis, the growth of the fetus outside the human body will ever be possible for the whole period of fetal life. It may be useful in the case of an immunological rejection of the fetus by the mother, so there is a case for development of emergency procedures, but the use of immunorepressive drug therapy is a safer procedure to consider. Although ectogenesis is scientifically far away, as the problem of imitating the placenta is very difficult to overcome, it is not impossible. There is research in this area, one of the medical uses is to help babies from premature births develop (babies born at 6 months have been raised, which otherwise would have died). However, the unknown affects of total embryonic development outside the body, on the growing individual is too great an experiment to ever justify. In the more general application of alleviating discomfort of pregnancy, the similar principle used to the case of financially paid surrogacy could be used, that if the parents are not prepared to experience pregnancy they may not be prepared to make the necessary sacrifices during the child's life.

Edwards (1984) has suggested that making identical human twins could be of value as twin transfers give higher rates of implantation than single transfers. When it is only possible to obtain a single embryo from collecting eggs, it would increase the chances of a pregnancy if that embryo was split. Animal studies would suggest that making 2-4 embryos from one, would present no extra harm to the babies born. Skills in human embryo manipulation are improving, and preimplantation genetic biopsy is possible. It has probably been technically possible for several years. The efficiency of IVF could be increased by about 50% if this could be used, on the basis of current animal studies (Wood 1988). Most of the main IVF clinics have purchased micromanipulators by 1989, this sort of splitting is technically possible in a growing number of clinics. The Council of Europe (1986) has recommended that even the creation of identical twins after IVF by embryo splitting, which would appear to present little harm in view of the limited animal studies done, should be forbidden. It might be too hasty to introduce a law which would ban embryo splitting. The question of genetic manipulation is considered in the following chapters.

The work with embryonic stem (ES) cells on humans is more dubious, however, if conducted within the time and developmental limits for human embryo experimentation there is some case for it. In this case chimeras could be made by mixing cells from several sources, like those made in mice for over twenty years. If we are prepared to justify some human embryo experiments for their scientific or medical benefit, then this class could also be reviewed by the regulatory authorities, in light of the fact that genetic manipulation can yield much scientific information, and the major interest in the roles of genes in development. We could imagine some longterm extrapolation to use for corrective germline gene therapy on humans, however these experiments could only be justifiable by use of what seems now to be unethical trials, which the first subjects would be. The affects of being a chimera are unknown, and if it is found acceptable to use germline gene therapy, an alternative may be better. It may be best to wait until other techniques are developed.

The important point would be never to risk harm to a baby being born. There is probably little risk to the mother. This is the reason why abnormal embryos detected by IVF are never implanted back into a mother the child may be disabled as a result of the manipulation. There also has to be questions asked about the limits of using gametes from parents who are extremely infertile. The children will also inherit the defect, and be infertile, using special technology will propagate the disorder. There has to be a limit to the extent to which people want their children to be genetically related. It may be better to implant embryos from donated, fertile donors, of normally reproducing parents, if the patients still want to bear a child. The same argument that says that procreation is not the primary purpose of marriage and argues for the use of contraception, can also argue against types of treatment for infertility, especially those requiring excessive manipulation to achieve fertilisation.


Changing Family Structure

The case of separating genetic parenthood from social parenthood, is highlighted more in the use of egg and sperm to have a child in an extramarital relationship. The institution of marriage and a heterosexual family do continue to provide the most favourable circumstances for the loving environment needed to nurture a new human life. There are examples of longterm homosexual partnerships, which are loving towards each other. Some lesbian couples have children by the use of IVF. The legal right to procreate is held by individuals, not by couples, but this is not the same as a right to have offspring by any means. Sexual intercourse outside is grounds for divorce. Multiple marriages are illegal in most countries, as is consumer surrogacy. The use of AID by unmarried women should not be condoned, despite the ease in our society of women having children outside of marriage. As previously mentioned, society should not encourage this type of single parent family.

There have been major differences between the ages at which people get married, and the size of the family living together. There are similarities and differences across cultural and religious boundaries. For example the Japanese family group is often three generational with a senior married couple and a junior married couple, and the unmarried offspring of both, which is similar to that of the Basque region of Spain. The average age of marriage varies, for instance in China last century it was about 17 years for women, but in Japan it was 24 years generally. There were wide regional variations. The Chinese used to marry early, but during the last three decades the government has tried to delay marriage for about ten years, which can be a major influence on the family size. In China only female infanticide was practised, and all males were welcome, but in Japan the number of males was also controlled by infanticide or abortion. Also in Japan, marriage at later age has also been used in the past to control the number of children in poorer economic conditions. In Western Europe fertility was controlled by a combination of late marriage and celibacy (Hanley & Wolf 1985).

Adoption has been practised in many ways. For instance in one study of a certain social class in northern Taiwan it was found that between 1906-1915 70% of the girls born were given out in adoption as prospective daughters-in-law to the home of their future parents (of these about 45% actually married the son of the family). Children living together as brother and sister often develop mutual sexual aversion, they had a higher divorce rate and a lower birth rate than "adult" marriages. To test the sexual attractiveness the couple were encouraged to try out before marriage, the proof of which was pregnancy, hence there was a high premarital pregnancy rate (Sa 1985).

Multiple marriages have been observed in a number of cultures, for a variety of reasons. Polygamy was common in most of the world, usually one man with several wives, though sometimes such as in some Himalayan societies a man shares his wife with a brother, who has a second wife also. In Eskimo culture a man will share his wife with business associates as a sign of hospitality. However, in those societies it was not the exclusive form of marriage and many men lived in monogamy because of a limited number of women and limited finance. There were several advantages for the male: the economic contributions of the many wives to household wealth, sexual companionship, and increased social status to the head of a large household. In societies where there is low regard for unmarried women it is also an advantage for the women, and they could share household labours with other wives. Usually one wife is senior, but not always, and often the wives had separate living room with their children. In Islam the number of simultaneous wives is limited to four, and while it was easy for a male to divorce, the detailed laws of inheritance led to a centralised family. In the Mormon church, the practise of polygamy was limited to an elite group, usually about 10% of the males last century. Although it was made illegal in the USA, there are some isolated groups still practising it. The children of the lower ranked wives, or concubines, were given equal status to those of the senior wife in cultures such as Biblical Jews and the Chinese. In Tokugawa period in Japan between 1500-1800 it was found that some of the daughters of upper class Bannerman (Samurai class) decided to become second or third wives of the same socioeconomic class, prefering this class than to have to marry downwards in social status (Yamamura 1985). In developing countries polygamy is increasingly becoming unfeasible because of economic changes, urbinisation and mass education. There is a general prestige given to Western ways and to the feminist movement.

The divorce rate also greatly varied. It varied in the time period of countries, for instance in Japan in Tokugawa in 1500-1800 it was 5-6% (Yamamura 1985), whereas in one study in another city, of Takayama during 1700-1800 the rate was 25%. In some countries it is very liberal, so that often couples can be remarried again, such as among the Bemba of Zambia, to countries where it is illegal such as in the Republic of Ireland.

One of the common grounds for ending marriage has been sterility, the failure of the marriage to produce children. In Jewish religious teaching after 5 years if there are no children it is grounds for divorce (Jakobovits 1959). In other countries the fertility is assessed more specifically in terms of whether any sons are born, the sexist thinking behind this is still prevalent in much of the world. In the New Testament of the Bible there is no such teaching, and the marriage was not seen as solely a procreative partnership but concentrated much more on the companionship offered.

There have been many changes to family structure in the past century, all over the world, and the process continues. Some of the change is for the good and other for the worse. This partly depends on what the family structure was like, or is like. Much more of the world is accepting a similar concept of marriage, of an ideal family being a heterosexual couple in a monogamous marriage for life. This concept is found in many countries under many religious systems, particularly that of the Christian belief. However, in the Muslim world several wives are still accepted in many countries, and even more in some African countries.

Family structure and the status of the family has often varied during history, even in the same culture. During reformation Europe it is estimated that 20 percent of women were spinsters and 20 percent widows, and that up to half the children died before the age of five (Ozmont 1983). The Reformers believed that the medieval church enforced virginity on unwilling youths, with exaggerated clerical ideals of virginity and celibacy. The church also had arbitrarily controlled the permissibility of marriages, which the Protestants saw as wrong. The model of the ideal was to be a monogamous marriage with the wife at home with the children, but studies suggest their was often little genuine affection between spouses, and between children and parents. However, marriage stabilised both individuals and society as a whole.

During the last century, there have been major changes in Europe, and these are still to fully spread throughout the world. The major introductions have been the rise of the divorce rates, which means that the family is no longer as stable as it is, and the availability of contraception to control the number of children. With contraception there are fewer children, which means that the mothers could have more time to start to pursue alternative vocations instead of being tied to the home, and the father was no longer the sole bread winner so lost some of the paternalistic authority. It also meant that there was less danger from extramarital sex so that this could become less risky and more common. There have been some major drawbacks of this change, the principle one being the loss of family stability with many spouses being left to look after children alone. While there has been increased options for women to pursue other roles, and increasing acceptance of single parents or homosexual couples, and the ability to sever some very unhappy marriages, the high divorce rate is not a gain. Humanity may continue to change its social structure, and develop ideas which are universally seen as good, such as lack or race or sexual discrimination, but not all the changes are for the good.

The new reproductive technologies can alter family structure, but compared to what we have already done, they should not be seen as so major. Even the increased life expectancy must have a major effect. The genetic and social parents may be separated, but they have previously been separated when children were adopted, which has occured for millenia, since the practise of leaving babies on the doorsteps of houses or in the market square of Greek towns. Children could also be bought as slaves, for a long period. What is more distinct is that new technologies plan for the births of new children, whereas these examples consider looking after an existing child. However, we then have only to look at the Bible to see a few examples of slaves having children for their masters who were infertile. The idea of surrogacy has a longer history than the hightened concern of recent interest. There have been 500 births from commercial surrogacy arrangements in the USA in the last decade, and despite its legal rejection in Britain and some other countries, it is still accepted in many US states. The new technology has made it more sophisticated, and perhaps more ethical as it does not involve "adultery" itself, but the wider issue has been faced in the past. Rich women have had the chance of letting their slaves bear children for them in the past, though they are not their genetic children. The idea of genetic relationship seems to be very important to our thinking in 1990, given the success of adoption in recent decades, this idea should be weakening.

In conclusion, under some situations I would support the use of AID or embryo donation, they lead to a positive affirmation of the family. They should be used only when the physicians are sure that the child will have a loving environment in which to grow. There should be no commercial sale of gametes. The children should be told of their origin, but whether they should be given the identity of the donor, is a very difficult question. I think that children have some right to know their genetic parents if they want, but that we should encourage the priority of social parenthood over other contributions. I do not support the use of surrogacy in general, but in exceptional circumstances there may be reasons to consider it, as when the surrogate mother is related or a friend of the couple, and if the situation is judged that it will not lead to any future conflicts over the child (it should have no commercial operation).


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