30 Commercialized assisted reproduction Filip Křepelka 30.1 Position of reproductive treatment in the economy Reproductive treatment contributes to an increasing number of newborns in developed countries (Mouzon et al. 2009). Many women and men are infertile when they wish to raise children in socioeconomic conditions they find appropriate. Only a small proportion of the population needs reproductive treatment in a particular year. Therefore, its impact on health care, which contributes up to 10% of the gross domestic product in the most developed countries (Pearson 2009), is minor. Reproductive treatment, however, is expensive. The costs of standard in vitro fertilization (IVF) exceed US$10,000 in most countries for most age groups (www.ivfcost.net, Table 2: Average IVF cost worldwide). Therefore, billions are spent on it worldwide, and a reproductive industry has emerged in many countries. 30.2 Commercialization of assisted reproduction Health care is generally based on a consensus of providers and patients. Certainly, the duty to treat in emergency situations, the obligation to care for all patients, mandatory vaccination and quarantines, and involuntary treatment of the insane, plus price and quality regulations, are examples of government interventions in the health care market. Reproductive treatment, however, is more commercialized than other areas of health care. Apart from measures against discrimination, no compulsion to treat is imposed on providers. Exclusively, people showing a desire to be treated are treated. Public reimbursement is limited, and many people pay the whole price for treatment out of their own pockets. Commercialization is apparent in deliveries of genetic materia! and services. Egg donation is a burdensome and risky procedure that cannot be expected without remuneration. Payments, however, are labeled as compensation for inconvenience, time lost, and related risk. Even sperm is usually not free. An excellent example of commercialization in reproductive medicine is surrogacy, in which the biological mother is paid for to become pregnant. Technologies related to reproductive medicine are also commercialized with patented pharmaceuticals and with licenses. Desperate women and men suffering from infertility can be misguided by inappropriate advertisements from the profit-oriented reproductive industry (Robertson 2007). 30.3 Divergent national policies toward reproductive treatment Many aspects of manipulation with eggs, sperm, and embryos outside the human body are controversial, including donation of gametes (anonymity, remuneration), use of gametes in altered conditions (duration of storage, withdrawal of consent, death of 364 | 30 Commercialized assisted reproduction donor), use of surplus material, specific patients (single mothers, same-sex couples, or older women), preimplantation diagnosis, and implantation of several embryos and subsequent partial abortion, in addition to surrogate pregnancy. Even IVF based on the egg of a wife and sperm from her husband and subsequent implantation of a resulting single embryo in the wife's uterus is considered objectionable. The Roman Catholic Church is the most prominent critic of this and other practices in assisted reproduction. National policies vary significantly, based on different religious, cultural, and political attitudes toward reproductive treatment in general and toward its various methods and specific groups of patients. Many nations do not find consensus on assisted reproduction or its aspects. As a consequence, there is often a lack of appropriate legislation or timely changes of applicable law. (For example, Italy switched in 2004 from a liberal stance to restrictions. Nevertheless, its restrictive "legge 40" faced referendum seeking its annulment in 2005 and was restricted by the constitutional court in 2009. Future victory of leftist parties can result in removal of restrictions.) Laws often do not address specific situations, and it is hard to legislate appropriately on quickly developing procedures of reproductive treatment even if there is consensus. Diverse attitudes toward various types of reproductive treatment based on an estimation of their benefits for both affected men and women and for society are reflected in different levels of government spending for various procedures. An absence of global consensus on assisted reproduction is apparent. There is no standardization with international treaties and little effort to adopt them in pertinent organizations such as the United Nations Educational, Scientific, and Cultural Organization and the World Health Organization. Nevertheless, these organizations organize in-depth studies of the issue, useful for comparison of political, social, economic, and legal conditions (Vayena, Rowe, and Griffin 2002). Diverging laws and various economic conditions result in variations in the availability of reproductive treatment. Reproductive tourism can solve problems for infertile women and men. I don't concur with suggestions (Mattoras 2005) to describe this movement as reproductive exile, because that implies an evaluation of restrictions, and reproductive tourists seek other services abroad due to restrictions in their home country. 30.4 International economic integration and assisted reproduction Liberalized trade in goods among the member states of the World Trade Organization is not applicable for assisted reproduction. Nevertheless, contemporary global economic integration based on voluminous trade contributes to establishment of an international marketplace where commercialized assisted reproduction is feasible. International migration is curtailed, but a short-term stay is sufficient for reproductive treatment. Reproductive tourists are generally welcomed as consumers of services that pump money into national economies. Similarly, people are usually encouraged to travel abroad. There are also no significant restrictions on transfer of moneys necessary for compensation of services purchased abroad. 30.5 Absence of effective restrictions on reproductive tourism | 365 Free exchange of knowledge seems to be similarly important as part of economic liberalization. Progress in developing procedures in reproductive medicine result from international cooperation. The purchasing power of women and men seeking infertility treatment is, however, a principal consideration. Many people cannot afford it. Three-fourths of the world's population lives in countries with a gross domestic product per capita and per year that is significantly lower than the costs of IVF. Advanced procedures of infertility treatment such as IVF are thus available primarily for people living in developed countries. 30.5 Absence of effective restrictions on reproductive tourism Countries with restrictive reproductive policies are incapable of preventing their citizens from seeking reproductive treatment abroad. Travelers' intentions can be easily hidden; even careful body searches and examinations of luggage would not likely reveal their true purpose for traveling. Return after successful treatment is also easy. Generally, a baby resulting from IVF cannot be distinguished from a child produced by traditional methods. Sanctions for participating in reproductive tourism would hardly be acceptable even with hypotheticaliy effective controls. Restrictions are based on the conviction that human dignity is compromised with assisted reproduction. However, a baby, no matter how it conceived, is no monster. No country could compel a woman who becomes pregnant thanks to reproductive treatment that is restricted in her home country to submit to abortion, especially it emphasizes protection of unborn children. Similarly, fines and imprisonment for women and men seeking restricted treatment abroad are hard to enforce and are thus usually not expected. However, Turkey recently introduced legislation permitting prosecution of parents using donated sperm or eggs for concealing biological ancestry (Telegraph 2010). Certainly, countries with restrictive policies can try to discourage reproductive tourism with campaigns highlighting safety problems, low efficacy, and adverse effects. Ultimately, people who agree with the restrictive policies of their home country would not seek treatment abroad. 30.6 Natural barriers to reproductive tourism Nevertheless, national restrictions are partially effective. First, transportation costs increase, especially if the treatment requires repeated attendance at a foreign reproductive center. Second, reproductive tourists often face a language barrier, and reproductive medicine requires a good understanding about the nature of the treatment. Third, trust in safety and quality of goods and services from abroad is a highly sensitive issue in reproductive treatment. Both reproductive centers and their clients are capable of surpassing these barriers. However, facilities face increased costs and are thus compelled to charge higher prices. As a result, demand decreases to some extent, although there are always infertile people with a strong desire for a child. 366 | 30 Commercialized assisted reproduction 30.7 Intellectual property and assisted reproduction The progress of reproductive treatment is based on a worldwide exchange of experience and knowledge. Nevertheless, such exchange is not free from an economic point of view. Certainly, basic knowledge can be found in textbooks, and experts find information in the professional literature. Similarly, patients can easily find numerous Web pages where aspects of infertility treatment are intensively debated. Modern pharmaceuticals administered to many infertile patients are patented. Their prices thus include royalties or profits for patent holders having a temporary monopoly on production. It is hard to estimate to what extent patenting of pharmaceuticals increases their prices. These costs vary significantly from one country to another due to other reasons. Patenting is harmonized globally with the multilateral conventions administered by the World Intellectual Property Organization. The World Trade Organization, meanwhile, has improved protections of inventions while making that a precondition for further liberalization of international trade. New pharmaceuticals are usually patented worldwide. On the contrary, most countries - the only significant exception is the United States -reject patenting of medical procedures, and attempts to collect royalties face resistance there also (DeBlasio 2004). Worldwide, physicians express their objections, as revealed in a statement of the World Medical Association (1999). In reality, patenting of medical procedures has little importance, at least as far as its consequences for reproductive treatment are concerned. Nevertheless, commerce in knowledge and technology is thus not excluded. Leading centers of reproductive medicine such as Australia's Sydney lVF make their organization, technology, and equipment available to other centers. An important aspect is reputation: Centers are expected to advertise such cooperation, which, understandably, is compensated. Information about costs and other conditions of such franchising is, however, not disclosed. Similarly, the quality of reproductive treatment is increased with widespread recourse to quality-management systems (ISO 9001). 30.8 Doing business in the reproductive industry The development of methods of reproductive treatment is connected with gynecology and obstetrics clinics at university hospitals and other major health care facilities. Special departments at these hospitals continue to progress in advanced infertility treatment. Nevertheless, reproductive care has been privatized significantly in many countries. Private clinics, managed by senior physicians who have acquired experience in university hospitals, specialize in assisted reproduction or offer the treatment together with other gynecological health care. Joint employment in these hospitals and private business is common, and many of these physicians are also university professors. In addition, these physicians and their colleagues often hold shares in the companies operating the centers. The economic success of assisted reproduction and expectations that the number of women and men facing infertility issues will increase attracts institutional investors. 30.9 Assisted reproduction in united Europe j 367 Takeovers and mergers in the industry are expected, suggested, and realized, and multinational providers emerge. 30.9 Assisted reproduction in united Europe Both assisted reproduction and antireproductive interventions show limits of consensus of European countries. Many European countries have liberal policies. Nevertheless, Germany and Italy impose significant restrictions on IVF, and various restrictions are also proposed in Poland (Brown 2010). The Council of Europe respects this lack of consensus. The Oviedo Convention on Human Rights and Biomedicine, which clarifies the fundamental rights for health care, avoids addressing controversial issues, and it condemns sex selection and the creation of embryos for research. In addition, the Council of Europe monitors the various policies of its member states. Similarly, the European Court for Human Rights refused to interpret the Convention for the Protection of Human Rights and Fundamental Freedoms against national legislation in many controversial issues. Regarding assisted reproduction, the court accepted, in Evans v. United Kingdom (2007), a ban on the use of embryos created with the sperm of a former partner who has withdrawn his consent. The recent judgment of S. H. and others v. Austria (2010), however, condemns the prohibition of the use of donated eggs and sperm as discrimination. This decision indicates possible future interventions against national restrictions in the name of individual liberty and equality. Liberalization of cross-border economic activities in 27 member states of the European Union makes reproductive tourism easier there than elsewhere. The free movement of services, including health care, is guaranteed. Border controls have ceased, and payments are largely uncontrolled. Socioeconomic cohesion and the harmonization of standards contribute to an improvement in the quality of health care. Directive 2004/23/EC of the European Union addresses the quality of tissues, including gametes (European Union 2004). Approaches toward abortions are similar. The European Union's Court of justice has underlined the economic nature of abortions while avoiding a decision on compliance of restrictions with fundamental rights. The European Court for Human Rights rejected for decades most complaints against both restrictive and liberal policies of European countries. This restraint has not evaporated in a recent judgment regarding A, B, C v. Ireland. Similarly, there is also antireproductive tourism in Europe: Women seeking abortion travel from countries with restrictions (i.e., Ireland and Poland) to natrons where it is allowed (United Kingdom). Few judgments of the Court of Justice deal accidentally with reproductive treatment (an embryo existing in vitro as a situation analogous to pregnancy protected by labor laws, patentability of biotechnological inventions). There is no judgment examining the different policies of member states toward reproductive treatment and their impact on internal markets. Nevertheless, it would be easy to apply economic freedoms of the European Union on any hypothetical restrictions of reproductive tourism. Reproductive care can be also affected when the Court of Justice requires reimbursement of treatment sought abroad under the same conditions as at home. The member states finance IVF to a limited extent. Differing prices and the ability of infertile women and men to move abroad make it feasible. 368 | 30 Commercialized assisted reproduction Zealous application of economic freedoms of the European Union by national courts can be seen in R. v. Human Fertilisation and Embryology Authority, ex parte Blood, which found a ban on sperm exportation from the United Kingdom incompatible with the principle of free movement of goods. 30.9.1 Case study: German patients in Czech centers Czech reproductive centers - both departments of university hospitals and private clinics - serve many Czech patients. Over the last two decades, increasing numbers of older women and men there have decided to have children, and thus, demand for reproductive treatment is increasing. Public financing of infertility treatments is considerable (up to four IVF cycles for women under 40 years of age). Nevertheless, there is also a significant foreign clientele, and many patients come from Germany. This exportation of reproductive care can be detected in Web sites for Czech reproductive-treatment facilities. German-language versions of such sites are available, the presence of German-speaking staff is identified, and certificates awarded by German institutions are publicized. Similar Italian and Russian versions of these Web sites indicate other important foreign clienteles. English, of course, omnipresent as the language of global communication, is also represented. Divergent policies among various nations is one explanation for cross-border migration for reproductive treatment. Certain procedures (anonymous donation of gametes, creation of embryos in excess) are prohibited in Germany, whereas Czechs, many of whom are not religious, generally support reproductive medicine. Disputed methods (i.e., anonymous donation, preimplantation genetic diagnosis, partial abortion) are allowed under certain conditions, while others {i.e., surrogate pregnancy) remain un-addressed due to little interest among Czech lawmakers. Assisted reproduction was unregulated in the Czech Republic for decades, but provisions addressing assisted reproduction were inserted in the national health care code in 2006. References Brown S. Poles apart: focus on reproduction. January 2010, 30-34. http://www.eshre.eu/01/ default.aspx?pageid=912. Accessed April 8, 2011. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine. Council of Europe Treaty Series 164 (the Oviedo Convention). DeBlasio SL. Patents on medical procedures and the physician profiteer. Findlaw. 2004. http:// library.findlaw.com/2004/Sep/19/133572.html. Accessed April 8, 2011. European Union. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Evans v. United Kingdom. ECHR judgment on complaint 6339/05. April 10, 2007. Kraske M, Ludwig Z. Die Babygrenze. Der Spiegel, 2005, 46. http://www.spiegel.de/spiegel/ print/d-43103148.html. Accessed April 8, 2011. Mattoras R. Reproductive exile versus reproductive tourism. Hum Reprod. 2005;20(12): 3571-3573. Mouzon J, Lancaster P, Nygren KG, et a!. World collaborative report on assisted reproductive technology, 2002. Hum Reprod. 2009;24(9):2310-2320. References 369 Pearson M. Disparities in health expenditures in OECD countries: why does the United States spend so much more than other countries? Written Statement to Senate Special Committee on Aging. 2009. http://www.oecd.Org/dataoecd/5/34/43800977.pdf. Accessed April 8, 2011. R. v Human Fertilisation and Embryology Authority, ex parte Blood. 1997 2 All ER 687 (Court of Appeal, United Kingdom). Robertson JA. Book review essay: Commerce and regulation in the reproductive treatment industry. Texas L Rev. 2007;85:665-702. http://www.utexas.edu/law/journals/tlr/assets/cur rent/Robertson.Proof.Final.pdf. Accessed April 8, 2011. S. H. and others v Austria. ECHR Judgment on complaint 57813/00. April 1, 2010. Shenfield F, Mouzon J, Pennings G, et al. Cross border reproductive care in six European countries, Hum Reprod. 2010:1-8. http://humrep.oxfordjournals.org/cgi/content/full/deq 057v1. Accessed April 8, 2011. Telegraph. Turkey bans trips abroad for artificial insemination. Telegraph (London), March 15, 2010. http://www.telegraph.co.uk/news/worldnews/europe/turkey/7450571/Turkey-bans' trips-abroad-for-artificial-insemination.html. Accessed April 8, 2011. Vayena E, Rowe P), Griffin PD, eds. Current practices and controversies in assisted reproduction (report). Medical, Ethical, and Social Aspects of Reproductive Treatment, World Health Organization Geneva, September 17-21, 2001. World Medical Association. Statement on patenting medical procedures, 51st Assembly of the World Medical Association, Tel Aviv, 1999. http://www.wma.net/en/ 30publications/10policies/m30/index.html. Accessed April 8, 2011. Ethical Dilemmas in Assisted Reproductive Technologies Edited by Joseph G. Schenker DE GRUYTER Editor Joseph C. Schenker MD, FRCOG, FACOG (Hon) Department of Obstetrics and Gynecology Hebrew University-Hadassah Medical Center Jerusalem, Israel ISBN 978-3-11-024020-7 e-ISBN 978-3-11-024021-4 Library of Congress Cataloging-in-Publication Data Ethical dilemmas in assisted reproductive technologies / edited by Joseph G. Schenker. p.; cm. Includes bibliographical references. ISBN 978-3-11-024020-7 (alk. paper) 1. Human reproductive technology—Moral and ethical aspects. 1. Schenker, Joseph G. [DNLM: 1. Reproductive Techniques, Assisted—ethics. 2. Bioetliical Issues. 3. Women's Rights. WQ 208] RG133.5.E8394 2011 176—dc22 2011002651 Bibliographic information published by the Deutsche Nationalbibliothek The Deutsche Nationalbibliothek lists this publication in the Deutsche Nationalbibliografie; detailed bibliographic data are available in the Internet at http://dnb.d-nb.de. © 2011 Walter cle Gruyter GmbH & Co. KG, Berlin/Boston. The publisher, together with the authors and editors, has taken great pains to ensure that all information presented in this work (programs, applications, amounts, dosages, etc.) reflects the standard of knowledge at the time of publication. Despite careful manuscript preparation and proof correction, errors can nevertheless occur. Authors, editors and publisher disclaim all responsibility and for any errors or omissions or liability for the results obtained from use of the information, or parts thereof, contained in this work. The citation of registered names, trade names, trademarks, etc. in this work does not imply, even in the absence of a specific statement, that such names are exempt from laws and regulations protecting trademarks etc. and therefore free for general use. Cover image: iStockphoto/Thinkstock Typesetting: Apex CoVantage Printing: Hubert & Co. GmbH & Co. KG, Gottingen © Printed on acid-free paper Printed in Germany www.degruyter.com Contents Preface xvii Author index xxi 1 The foundations and application of medical ethics.................................................1 Avraham Steinberg 1.1 Introduction....................................................................................................1 1.2 Historical background....................................................................................1 1.3 General ethical theories and principles...........................................................2 1.4 Modern medical ethics...................................................................................8 1.5 Conclusion...................................................................................................13 2 Legislation for assisted reproductive technologies................................................15 Bernard M. Dickens 2.1 Introduction..................................................................................................15 2.2 Legislation and regulations...........................................................................16 2.3 Legislative motivations..................................................................................18 2.4 Evidence-based legal policy.........................................................................20 2.5 The focus of legislation.................................................................................22 2.6 Human rights................................................................................................25 3 Reproductive rights as an integral part of women's rights....................................29 \ Giuseppe Benagiano, Sabina Carrara, and Vaientina Filippi < 3.1 Introduction..................................................................................................29 3.2 Granting women equal rights: the origin of discrimination...........................30 3.2.1 Cornerstones of women's rights.........................................................32 3.2.1.1 Dignity, body integrity, and freedom from violence.............32 ; 3.2.1.2 Equality and empowerment................................................34 ! 3.2.1.3 Full, unconditional access to health care services...............35 I 3.2.2 A right to treat infertility....................................................................36 i \ 4 Right to reproduce...............................................................................................43 Harpreet Kaur and Kamini A. Rao 4.1 Socioeconomic issues...................................................................................43 4.2 Religious issues.................................................................;..........................45 4.3 Legal and historical aspects..........................................................................45 4.4 Moral aspects...............................................................................................48 4.5 ART-related aspects.......................................................................................49 vi I Contents 5 Informed consent for treatment of fertility..................... Yosi Green 5.1 Introduction............................................................. 5.2 The right to experience parenthood and its standing 5.3 The informed-consent doctrine................................ 5.3.1 The doctrine and its nature........................... 5.3.2 Application of the doctrine to fertility treatments.................................................... 5.4 Mutual consent of spouses....................................... 5.4.1 Joint process................................................ 5.4.2 The good of the child and consideration of parental capability....................................... 5.5 Validity of the consent............................................. 5.5.1 Effect of the initial consent........................... 5.5.2 Withdrawal of patient consent...................... 5.5.3 Physician's withdrawal of consent................ 5.5.4 Consent after death...................................... 5.5 Conclusion.............................................................. 6 Specific ethical and legal aspects of ART practice in eastern European countries....................................... Jiri Dostai 6.1 Introduction.......................................................... 6.2 Situation in eastern European countries...............[. 6.2.1 Number of centers..................................... 6.2.2 Legal regulation of ART............................. 6.2.3 Coverage or reimbursement of ART........... 6.2.4 Marital status in ART................................. 6.2.5 The number of transferred embryos in ART 6.2.6 Cryopreservation....................................... 6.2.7 Posthumous ART........................................ 6.2.8 Gamete donation...................................... 6.2.9 Anonymity................................................. 6.2.10 Micromanipulation................................. 6.2.11 In vitro maturation of oocytes................. 6.2.12 Welfare of the child................................ 6.2.13 Multifetal-pregnancy reduction............... 6.2.14 Preimplantation genetic diagnosis........... 6.2.15 Surrogacy................................................ 6.2.16 Research on the embryo................<......... 6.2.18 Gamete intrafallopian transfer................. 6.2.19 The moral status of the embryo......,......... 6.3 Conclusions.......................................................... Contents | vi i 7 Sperm donation and sperm-bank management....................................................87 Dan Cong and Zheng Li 7.1 Introduction..................................................................................................87 7.2 Limiting the number of donor offspring.........................................................88 7.2.1 United States.....................................................................................88 7.2.2 United Kingdom...............................................................................88 7.3 Minimizing the risk of infection and genetic complications from sperm donors.......................................................................................89 7.4 Age requirements for sperm donors..............................................................89 7.5 Anonymity versus nonanonymity of sperm donors........................................90 7.5.1 Anonymous sperm donation.............................................................90 7.5.2 Nonanonymous sperm donation.......................................................91 7.6 Sperm-donor compensation..........................................................................92 7.7 Informed consent and counseling.................................................................93 7.8 Conclusions..................................................................................................93 8 Oocyte donation: medical and legal perspectives................................................95 Sarit Avraham and Daniel S. Seidman 8.1 Introduction: Indications for egg donation....................................................95 8.2 Preparation of donor and recipient...............................................................96 8.3 Outcome determining factors.......................................................................98 8.4 Obstetric and perinatal outcomes.................................................................98 8.5 Ethical aspects..............................................................................................99 8.6 Legislation..................................................................................................101 8.6.1 The new Israeli legislation...............................................................104 8.7 Summary....................................................................................................107 9 Egg donation: ethical considerations and regulatory context.......................................................................................111 Anna C. Mastroianni and Luigi Mastroianni jr. 9.1 Introduction................................................................................................111 9.2 The regulatory context................................................................................111 9.3 Donating eggs............................................................................................112 9.3.1 Informed consent............................................................................112 9.3.2 Meeting demand: remuneration and other programs.......................113 9.3.2.1 Financial compensa tion....................................................113 9.3.2.2 Egg-sharing programs.......................................................114 9.3.3 Other obligations............................................................................115 9.4 Use of donated eggs...................................................................................115 9.4.1 Informed consent............................................................................115 9.4.2 Nontraditional patients and access to donated eggs........................115 9.4.3 Age.................................................................................................116 9.5 Donor identity and disclosure.....................................................................116 9.6 Conclusions................................................................................................118 viii Contents 10 Medical, ethical, and legal aspects of fetal reduction............................................................................... Mark I. Evans and David W. Britt 10.1 History................................................................................ 10.2 Ethical issues...................................................................... 10.2.1 Moral compromise................................................ 10.3 Legal issues......................................................................... 10.3.1 Recommendations................................................. 10.4 Summary............................................................................ 10.5 Acknowledgments.............................................................. 11 Fertility treatments in human immunodeficiency virus (HIV) infected patients........................................................ Karen Olshtain-Pops and Shlomo Maayan 11.1 Introduction....................................................................... 11.2 HIV and the male genital tract............................................ 11.3 HIV and the female genital tract......................................... 11.4 Assisted reproductive technologies in HIV-positive patients 11.5 Semen processing............................................................... 11.6 Viral testing of spermatozoa................................................ 11.7 Success rates...................................................................... 11.8 Summary............................................................................ 12 Pregnancies in perimenopause and beyond.................................. Yoel Shufaro and Joseph G. Schenker 12.1 Medical aspects and considerations................................... 12.1.1 Fertility fecundity and abortions............................ 12.1.2 Pregnancy-associated physiological changes......... 12.1.3 Obstetrical and intrapartum complications............ 12.1.4 Maternal mortality................................................. 12.1.5 Neonatal outcome................................................ 12.2 Oocyte-donation programs................................................. 12.3 Ethical aspects.................................................................... 12.3.1 The issue of choice................................................ 12.3.2 The welfare of the child......................................... 12.4 Coping with the medical risks............................................ 12.5 Legislation, regulation, and religion aspects....................... 12.6 Summary............................................................................ 13 Legal control of surrogacy - international perspectives............... K. Svitnev 13.1 Introduction...................................................................... 13.2 S u rrogacy -def i n iti o n........................................................ Contents | ix 13.3 Surrogacy -history..................................................................................149 13.4 Legal control of surrogacy - international perspectives...........................................................................................150 13.4.1 Prohibition of Surrogacy by legislation......................................150 13.4.2 Counties - surrogacy no prohibited by law...............................151 13.4.3 Surrogacy in China...................................................................152 13.4.4 Non commercial surrogacy.......................................................152 13.4.5 Greece Law..............................................................................152 13.4.6 South Africa..............................................................................153 13.5 Commercial surrogacy...........................................................................153 13.5.1 Former Countries of the Soviet Union.......................................153 13.5.2 India.........................................................................................154 13.5.3 Surrogacy in USA......................................................................154 13.5.4 Surrogacy in Russia...................................................................155 13.6 Russian Public Opinion..........................................................................158 13.7 Surrogacy in Islamic Countries...............................................................158 13.8 Cross-border Surrogacy..........................................................................159 13.9 Conclusions...........................................................................................161 14 Preimplantation genetic diagnosis in assisted reproduction: medical, ethical, and legal aspects...................................................................165 Anver Kuliev 14.1 Introduction...........................................................................................165 14.2 Biopsy methods for preimplantation genetic diagnosis...........................166 14.2.1 Polar-body biopsy.....................................................................166 14.2.2 Embryo biopsy..........................................................................167 14.3 Chromosomal aneuploidies in preimplantation development.................................................................167 14.4 Chromosomal rearrangements................................................................169 14.5 Impact of PGD on IVF outcome.............................................................170 14.6 Conclusion.............................................................................................172 15 Preimplantation genetic diagnosis of late-onset diseases..................................175 Zoltän Papp, Tibor Värkonyi, and Valeria Väradi 15.1 Introduction...........................................................................................175 15.2 Embryo selection....................................................................................177 15.3 Huntington's disease..............................................................................178 15.4 Cardiovascular disorders........................................................................180 15.5 Alzheimer's disease................................................................................181 15.6 Genetic testing for cancer.......................................................................181 15.7 Breast cancer......................................<...................................................182 15.8 Genetic counseling................................................................................185 15.9 Conclusion............................................................................................185 x Contents 16 Bioethics of human embryonic stem ceils and cloning for stem cells: an Israeli perspective........................................................ Michel Revel 16.1 The scientific and medical aspects................................................ 16.2 Ethical issues related to human embryo stem cells........................ 16.2.1 Pluralism of moral views on the preimplantation embryo 16.2.2 Potentiality of human preimplantation embryo............... 16.2.3 Persona! status of the embryo.......................................... 16.2.4 Therapeutic aims of human ES cells................................ 16.2.5 Pluralism of decisions on human ES cell production and research in various countries........................................... 16.2.6 A case study: ethical regulations on human ES ceil research in Israel............................................................. 16.3 Ethical views on cloning to obtain autologous ES cells................. 16.3.1 Bioethical arguments...................................................... 16.3.2 National and international resolutions............................ 16.3.3 Case study: regulations in Israel regarding cloning for ES cells....................................................................... 17 The future of human embryonic stem cell research: medical, legal, and ethical perspectives......................................... Outi Hovatta and Kenny A. Rodriguez-Waliberg 17.1 introduction: Human embryonic stem cell research............. 17.2 The first possible clinical applications of cells differentiated from hESC........................................................................... 17.3 Challenges in clinical treatment using hESC-derived cells ... 17.3.1 Microbial contamination....................................... 17.3.2 GMP and EU tissues and cells directive................. 17.3.3 Immunogenicity..................................................... 17.3.4 Tumorigenicity....................................................... 17.4 iPS cells versus hESC........................................................... 17.5 Legal and ethical aspects of hESC research.......................... 17.6 Conclusions........................................................................ 18 Preservation of fertility in children with cancer: medical, ethical, and legal aspects.......................................................... Cinny Ryan 18.1 Introduction.................................................................. 18.2 Population at risk.......................................................... 18.3 Medical and surgical options for fertility preservation.... 18.4 The ethical propriety of fertility-preservation options..... 18.5 Autonomy, justice, and treating pediatric patients.......... 18.6 Ethical and legal issues with unused tissue and gametes Contents XI 18.7 Posthumous reproduction.......................................................................215 18.8 Conclusion.............................................................................................216 19 Fertility preservation for cancer patients: a review of current options and their advantages and disadvantages..................................219 Shauna Reinblatt, Barnis Ata, Einat Shalom-Paz, Seang Lin Tan, and Hananel Holzer 19.1 Introduction...........................................................................................219 19.2 Cancer and fertility preservation.............................................................219 19.3 Current options for fertility preservation.................................................220 19.4 Medical options: CnRH agonists............................................................220 19.5 Surgical options: ovarian transposition and cryopreservation of ovarian cortical tissue.........................................................................221 19.5.1 Ovarian transposition................................................................221 19.5.2 Cryopreservation of ovarian cortical tissue.................................222 19.6 ART: in vitro fertilization and in vitro maturation....................................223 19.6.1 Embryo and oocyte cryopreservation after ovarian stimulation....................................................................223 19.6.1.1 Embryo cryopreservation..........................................223 19.6.1.2 Oocyte cryopreservation...........................................224 19.6.2 Embryo and oocyte cryopreservation without prior ovarian Stimulation................................................................................225 19.6.3 IVM embryo cryopreservation...................................................226 19.6-4 IVM-oocyte vitrifi cation............................................................226 19.6.5 Fertility preservation: the McGill experience.............................227 19.7 Conclusion............................................................................................227 20 Sexual orientation and use of assisted reproductive technology: social and psychological issues.........................................................................233 Rachel G. Riskind 20.1 introduction..........................................................................................233 20.2 A note about terminology.....................................................................233 20.3 Routes to parenthood among nonheterosexual adults...........................234 20.4 Legal issues surrounding sexual orientation and family formation.........234 20.5 Sexual orientation and incidence of parenthood...................................235 20.6 Sexual orientation and plans for parenthood.........................................235 20.7 Studies of sexual orientation and plans for parenthood.........................236 20.8 Outcomes for children of lesbians and gay men...................................237 20.9 Relationships with peers.......................................................................237 20.10 Child behavior problems......................................................................238 20.11 Gender development............................................................................238 20.12 Conclusions and future directions........................................................239 20.13 Assisted reproduction among nonheterosexual adults...........................239 20.14 Barriers to ART use by nonheterosexual adults..................................... 239 xii Contents 20.15 Donor-insemination decisions............. 20.16 Recommendations for clinical practice 20.17 Conclusion.......................................... 21 Access to fertility treatment by lesbian couples...... Simon Marina, Fernando Marina, and David Marina 21.1 Introduction................................................. 21.2 Legal changes.............................................. 21.3 Ass i sted rep rod ucti on.................................. 21.4 Being a lesbian and a mother...................... 21.5 Donor anonymity....................................... 21.6 Ethical assessment...................................... 21.7 A Child with two mothers........................... 22 ART practice and tourism.................................................................. Marc/a C. inborn and Pasquale Patrizio 22 A Introduction........................................................................... 22.2 Background and methods...................................................... 22.3 Major findings....................................................................... 22.3.1 The United Arab Emirates......................................... 22.3.1.1 Reproductive travel to the UAE............... 22.3.7.2 Reproductive travel from the UAE........... 22.3.1.3 Reproductive travel to and from the UAE 22.3.2 The East Coast of the United States.......................... 22.4 Conclusion............................................................................ 23 A savior child conceived by PCD/HLA: medical and ethical aspects.......................................................................... Edwin C. Hui 23.1 Introduction.......................................................................... 23.2 Medical indications and social acceptance of PGD............... 23.2.1 Chromosomal abnormalities.................................... 23.2.2 Monogenic diseases................................................. 23.2.3 Adult-onset diseases and cancer-predisposing genes 23.2.4 Creating a "savior child".......................................... 23.3 Other possible applications of PGD: savior embryos, gender selection, and designer babies................................... 23.3.1 Savior embryos........................................................ 23.3.2 Gender selection..................................................... 23.3.3 Designer babies....................................................... 23.4 Legislation and professional guidelines for the uses of PGD/HLA.......................................................................... 23.5 Ethical considerations............................................................ Contents J xiii 23.5.1 Embryo wastage........................................................................275 23.5.2 Moral status of the human embryo............................................275 23.5.3 Harm of embryo biopsy............................................................277 23.5.4 The condition of absolute medical necessity.............................277 23.5.5 PCD SC and family ethics.........................................................279 23.5.6 Weli-being of the savior child...................................................281 23.5.7 PGD, parental interests and public access.................................283 24 Posthumous reproduction: ethical and iegal perspectives................................289 Bethany Spielman 24.1 Introduction...........................................................................................289 24.2 The source..............................................................................................290 24.2.1 What counts as consent?..........................................................290 24.2.2 Coercion..................................................................................291 24.2.3 Minors as sources.....................................................................292 24.3 Requesters of retrieval............................................................................293 24.4 Reproductive partners............................................................................294 24.5 Children.................................................................................................295 24.6 Summary................................................................................................295 25 Human reproductive cloning: ethical perspectives...........................................297 David A. Jensen 25.1 Introduction...........................................................................■...............297 25.2 The potential value of HRC.....................................................................297 25.3 Ethical concerns with HRC.....................................................................301 25.4 HRC and the value of our unique genetic make-up................................306 25.5 Conclusion.............................................................................................307 26 ART practice - religious views..........................................................................309 Joseph C. Schenker 26.1 introduction............................................................................................309 26.2 Thejewishiaw.......................................................................................310 26.2.1 Torah.........................................................................................310 26.2.2 TheMishnah.............................................................................311 26.2.3 The Talmud...............................................................................311 26.2.4 Post-Talmudic codes.................................................................311 26.2.5 Responsa..................................................................................311 26.2.6 Orthodox Judaism.....................................................................312 26.2.7 Reform Judaism.........................................................................312 26.2.8 Conservative.............................................................................313 26.3 Christian denominations.........................................................................314 26.3.1 Roman Catholic Church............................................................314 26.3.2 Anglican Church.......................................................................315 xiv Contents 26.3.3 The Protestant Church............................................. 26.3.4 Eastern Orthodox Church........................................ 26.4 Hinduism............................................................................. 26.5 Buddhism............................................................................. 27 A Catholic ethical perspective on human reproductive technology................................................................. Norman Ford 27.1 Catholic position on respect for the human embryo............. 27.1.1 Biblical perspective................................................. 27.1.2 Christian tradition................................................... 27.1.3 Embryo defined....................................................... 27.1.4 Catholic Christian teaching..................................... 27.1.5 A person from conception....................................... 27.1.6 Ethics and destructive research on human embryos................................................. 27.1.7 Morality and personalized natural law.................... 27.1.8 Secular ethics and the human embryo................... 27.1.9 Challenge to find ethical alternatives..................... 27.2 Catholic ethics, marriage, and reproductive technology...... 27.2.1 Catholic Christian position on children of the marriage union............................................ 27.2.2 Assisted insemination............................................. 27.2.3 Rights of children and natural parents.................... 27.2.4 Donor gametes...................................................... 27.2.5 Surrogacy............................................................... 27.2.6 Access to ART by single women and lesbians........ 27.2.7 Human reproductive cloning................................. 27.3 Conclusion.......................................................................... 28 Islamic laws and reproduction...................................................... Carnal I. Serour 28.1 Islamic laws....................................................................... 28.2 Reproduction in Islam....................................................... 28.3 ART and Islam................................................................... 28.4 Islam and various ART practices........................................ 28.5 Surrogacy.......................................................................... 28.6 Multifetal pregnancy reduction.......................................... 28.7 Pregnancy in postmenopause............................................ 28.8 Sex selection..................................................................... 28.9 Cryopreservation............................................................... 28.10 Embryo implantation following husband's death................ 28.11 Embryo research................................................................ 28.12 Gene therapy.................................................................... Contents | xv 28.13 Cloning................................................................................................339 28.14 ART practices in different Muslim countries..........................................339 29 Jewish law (halakha) and reproduction............................................................343 Joseph C. Schenker 29.1 Introduction..........................................................................................343 29.2 Homosexuality.....................................................................................344 29.3 Lesbianism...........................................................................................344 29.4 Evaluation of the infertile couple...................................................'■......345 29.5 The laws of niddah...............................................................................345 29.6 Infertility treatment...............................................................................346 29.7 The beginning of human life.................................................................348 29.8 Artificial insemination by husband........................................................350 29.9 Artificial insemination by donor............................................................350 29.10 Oocyte donation..................................................................................351 29.11 Surrogacy.............................................................................................352 29.11.1 Legalizing surrogacy in Israel................................................353 29.11.2 The state-appointed permission committee...........................353 29.11.2.1 Guidelines set by the committee for surrogacy.....................................................353 29.11.2.2 Expenses...........................................................354 29.11.2.3 Legal status of the newborn...............................354 29.11.2.4 Surrogate mother's withdrawal from the agreement...........................................354 29.11.2.5 Legal rights of the surrogate mother...................355 29.11.2.6 Enforcement of the law......................................355 29.11.2.7 Right to privacy.................................................355 29.11.2.8 Illegal financing.................................................355 29.11.2.9 Legal adoption..................................................355 29.12 Fetal reduction.....................................................................................356 29.13 Gender preselection.............................................................................357 29.14 Cryop reservation..................................................................................357 29.15 Posthumous reproduction.....................................................................358 29.16 Cloning............................................................'•...................................359 29.17 Preembryo research..............................................................................360 30 Commercialized assisted reproduction.............................................................363 Filip Krepelka 30.1 Position of reproductive treatment in the economy....................................363 30.2 Commercialization of assisted reproduction..............................................363 30.3 Divergent national policies toward reproductive treatment........................363 30.4 International economic integration and assisted reproduction....................364 30.5 Absence of effective restrictions on reproductive tourism...........................365 xvi Contents 30.6 Natural barriers to reproductive tourism.............................. 30.7 Intellectual property and assisted reproduction.................... 30.8 Doing business in the reproductive industry....................... 30.9 Assisted reproduction in united Europe............................... 30.9.1 Case study: German patients in Czech centers.......... 31 The intersection between economic and ethical aspects of ART Ceorgina M. Chambers 31.1 Introduction.................................................................... 31.2 A framework for economic and ethical aspects of ART.... 31.3 Distributive justice and funding of ART........................... 31.3.1 International differences in funding.................... 31.3.2 Provision of ART in developing countries........... 31.3.3 Morally challenging funding decisions............... 31.4 The cost of ART treatment.....................................,.......... 31.4.1 Treatment costs.................................................. 31.4.2 The costs of multiple births................................ 31.4.3 Valuing ART treatment from an economic perspective............... 31.5 The affordability of ART treatment and its implications........................... 31.5.1 Affordability and utilization...................................................... 31.5.2 Affordability and clinical practice............................................. 31.5.2.1 It makes economic as well as clinical sense to reduce multiple-births 31.6 Conclusion...................................