Reproductive technologies in developing countries

Are there any ethical concerns about reproductive technologies that are specific or unique to developing countries? Three ethical concerns often mentioned specifically in regard to developing countries are (1), the "overpopulation argument"; (2) the limited resources argument; and (3) the ethical problem of poorly trained practitioners offering their services to unsuspecting and uninformed infertile individuals or couples. Each argument is explored in some detail, with the conclusion that ethical problems do, in fact, exist but are not unique to developing countries. Nevertheless, the difficulties relating to reproductive technologies are likely to be greater in developing countries than in developed ones because of limited resources and a larger number of poor people residing there.     

FAIR TRADE INTERNATIONAL SURROGACY

Since the development of assisted reproductive technologies, infertile individuals have crossed borders to obtain treatments unavailable or unaffordable in their own country. Recent media coverage has focused on the outsourcing of surrogacy to developing countries, where the cost for surrogacy is significantly less than the equivalent cost in a more developed country. This paper discusses the ethical arguments against international surrogacy. The major opposition viewpoints can be broadly divided into arguments about welfare, commodification and exploitation.
It is argued that the only valid objection to international surrogacy is that surrogate mothers may be exploited by being given too little compensation. However, the possibility of exploitation is a weak argument for prohibition, as employment alternatives for potential surrogate mothers may be more exploitative or more harmful than surrogacy. It is concluded that international surrogacy must be regulated, and the proposed regulatory mechanism is termed Fair Trade Surrogacy. The guidelines of Fair Trade Surrogacy focus on minimizing potential harms to all parties and ensuring fair compensation for surrogate mothers.     

Bioethics, vulnerability, and protection

What makes individuals, groups, or even entire countries vulnerable? And why is vulnerability a concern in bioethics? A simple answer to both questions is that vulnerable individuals and groups are subject to exploitation, and exploitation is morally wrong. This analysis is limited to two areas. First is the context of multinational research, in which vulnerable people can be exploited even if they are not harmed, and harmed even if they are not exploited. The type of multinational research likely to raise the most ethical concerns is that in which the investigators or sponsors are from a powerful industrialised country or a giant pharmaceutical company and the research is conducted in a developing country. Second is the situation of women, who are made vulnerable in cultural settings or in entire countries in which they are oppressed and powerless. In the face of cultural values and practices, or governmental policies, these women suffer serious consequences for their health and even lives. Examples are provided, and it is suggested that in some cases vulnerable individuals can be harmed but not exploited. On the positive side, recent developments reveal a new awareness of exploitation and efforts to enhance the ability of developing countries to protect themselves and their citizens from exploitation at the hands of powerful sponsors of research. In addition, human rights principles are increasingly being used to monitor the actions (or inaction) of governments regarding women's reproductive rights and vulnerability with respect to HIV/AIDS, and to take remedial actions.     

REPRODUCTIVE TOURISM IN ARGENTINA: CLINIC ACCREDITATION AND ITS IMPLICATIONS FOR CONSUMERS,HEALTH PROFESSIONALS AND POLICY MAKERS

A subcategory of medical tourism, reproductive tourism has been the subject of much public and policy debate in recent years. Specific concerns include: the exploitation of individuals and communities, access to needed health care services, fair allocation of limited resources, and the quality and safety of services provided by private clinics. To date, the focus of attention has been on the thriving medical and reproductive tourism sectors in Asia and Eastern Europe; there has been much less consideration given to more recent ‘players’ in Latin America, notably fertility clinics in Chile, Brazil, Mexico and Argentina. In this paper, we examine the context‐specific ethical and policy implications of private Argentinean fertility clinics that market reproductive services via the internet. Whether or not one agrees that reproductive services should be made available as consumer goods, the fact is that they are provided as such by private clinics around the world. We argue that basic national regulatory mechanisms are required in countries such as Argentina that are marketing fertility services to local and international publics. Specifically, regular oversight of all fertility clinics is essential to ensure that consumer information is accurate and that marketed services are safe and effective. It is in the best interests of consumers, health professionals and policy makers that the reproductive tourism industry adopts safe and responsible medical practices.     

Two ethical concerns about the use of persuasive technology for vulnerable people

Persuasive technologies for health-related behaviour change give rise to ethical concerns. As of yet, no study has explicitly attended to ethical concerns arising with the design and use of these technologies for vulnerable people. This is striking because these technologies are designed to help people change their attitudes or behaviours, which is particularly valuable for vulnerable people. Vulnerability is a complex concept that is both an ontological condition of our humanity and highly context-specific. Using the Mackenzie, Rogers and Dodds’ taxonomy of vulnerability, this paper identifies (a) the wrongs or harms to which a person is vulnerable, (b) the source of this vulnerability, and (c) the safeguards needed in response. Two ethical concerns with the design of persuasive technology for vulnerable people are discussed: the concerns of taking into account users' interests and their autonomy.     

THE ETHICS OF UTERUS TRANSPLANTATION

Human uterus transplantation (UTx) is currently under investigation as a treatment for uterine infertility. Without a uterus transplant, the options available to women with uterine infertility are adoption or surrogacy; only the latter has the potential for a genetically related child. UTx will offer recipients the chance of having their own pregnancy. This procedure occurs at the intersection of two ethically contentious areas: assisted reproductive technologies (ART) and organ transplantation. In relation to organ transplantation, UTx lies with composite tissue transplants such as face and limb grafts, and shares some of the ethical concerns raised by these non‐life saving procedures. In relation to ART, UTx represents one more avenue by which a woman may seek to meet her reproductive goals, and as with other ART procedures, raises questions about the limits of reproductive autonomy. This paper explores the ethical issues raised by UTx with a focus on the potential gap between women's desires and aspirations about pregnancy and the likely functional outcomes of successful UTx.     

Ethical issues of infertility treatment in developing countries

¹ Correspondence address. Tel/Fax: +32-16-620767; E-mail: guido.pennings{at}ugent.be The provision of infertility treatment in developing countriesis controversial. Reports over the last decades have inculcatedin people from Western countries the belief that overpopulationis the major problem of developing countries. This paper willanalyse the different arguments advanced for and against providinginfertility treatment to resource-poor countries. There aretwo arguments in favour: reproductive autonomy and the hugeburden of infertility in these countries. Pronatalism, whichreigns in almost all developing countries, is to a great extentresponsible for the devastating effects of infertility. Thefive arguments against the application of infertility treatmentare overpopulation, prioritization of limited resources, preventionrather than cure, justice and equal access and risk of abuse.The importance of a person's reproductive autonomy demands thatefforts should be made to enable people to determine how manychildren to have. This is equally true in developing countries.However, given the enormous difficulties of resource-poor countriesto provide even the most basic goods, the contribution by societyshould be directed mostly at prevention and should depend ona strong cost reduction for assisted reproductive technology.     

Research Ethics: Beyond the Guidelines

There is international recognition of the need for sustainable research ethics committees to provide ethical review of human subjects research in developing countries, but many developing countries do not have such committees (often called 'IRBs'). Theoretical and practical uncertainties encountered by an IRB on the Caribbean island of Grenada offer insight into ethical review of research in developing countries. Theoretical uncertainties include questions about whether means of ensuring confidentiality and obtaining informed consent will be effective in local settings, and whether deviations from Western norms are justifiable. International guidelines are helpful in addressing these concerns, but are subject to interpretation. Guidelines are less helpful in practical areas like selecting members or chairs. They do not address what sort of procedures and paperwork will work in a developing country, or IRBs' relationships to governments that have no mandate for them. Experiences presented here show that IRBs in developing countries can sustainably adhere to international standards. Sustainability requires knowledge, personal commitment, and an official mandate to uphold international standards. Capacity building must therefore focus on educational programs to make developing country leaders knowledgeable about the value of international guidelines to their nations. Such knowledge is needed before people will become motivated to promote, implement, and uphold the guidelines. People in developing countries must help design bridges to help their nations put international standards into practice. The structure of such bridges may, of necessity, vary in different settings.     

An intellectual property sharing initiative in agricultural biotechnology: development of broadly accessible technologies for plant transformation

The Public Intellectual Property Resource for Agriculture (PIPRA) was founded in 2004 by the Rockefeller Foundation in response to concerns that public investments in agricultural biotechnology benefiting developing countries were facing delays, high transaction costs and lack of access to important technologies due to intellectual property right (IPR) issues. From its inception, PIPRA has worked broadly to support a wide range of research in the public sector, in specialty and minor acreage crops as well as crops important to food security in developing countries. In this paper, we review PIPRA's work, discussing the failures, successes, and lessons learned during its years of operation. To address public sector's limited freedom-to-operate, or legal access to third-party rights, in the area of plant transformation, we describe PIPRA's patent 'pool' approach to develop open-access technologies for plant transformation which consolidate patent and tangible property rights in marker-free vector systems. The plant transformation system has been licensed and deployed for both commercial and humanitarian applications in the United States (US) and Africa, respectively.     

Ethics committees. Research ethics: beyond the guidelines

There is international recognition of the need for sustainable research ethics committees to provide ethical review of human subjects research in developing countries, but many developing countries do not have such committees (often called 'IRBs'). Theoretical and practical uncertainties encountered by an IRB on the Caribbean island of Grenada offer insight into ethical review of research in developing countries. Theoretical uncertainties include questions about whether means of ensuring confidentiality and obtaining informed consent will be effective in local settings, and whether deviations from Western norms are justifiable. International guidelines are helpful in addressing these concerns, but are subject to interpretation. Guidelines are less helpful in practical areas like selecting members or chairs. They do not address what sort of procedures and paperwork will work in a developing country, or IRBs' relationships to governments that have no mandate for them. Experiences presented here show that IRBs in developing countries can sustainably adhere to international standards. Sustainability requires knowledge, personal commitment, and an official mandate to uphold international standards. Capacity building must therefore focus on educational programs to make developing country leaders knowledgeable about the value of international guidelines to their nations. Such knowledge is needed before people will become motivated to promote, implement, and uphold their guidelines. People in developing countries must help design bridges to help their nations put international standards into practice. The structure of such bridges may, of necessity, very in different settings.     

Fostering molecular breeding in developing countries

Molecular breeding (MB) increases genetic gain per crop cycle, stacks favourable alleles at target loci and reduces the number of selection cycles. In the last decade, the private sector has benefitted immensely from MB, which demonstrates its efficacy. In contrast, MB adoption is still limited in the public sector, and it is hardly used in developing countries. Major bottlenecks in these countries include shortage of well-trained personnel, inadequate high-throughput capacity, poor phenotyping infrastructure, lack of information systems or adapted analysis tools or simply resource-limited breeding programmes. The emerging virtual platforms aided by the information and communication technology revolution will help to overcome some of these limitations by providing breeders with better access to genomic resources, advanced laboratory services and robust analytical and data management tools. Apart from some advanced national agricultural research systems (NARS), the implementation of large-scale molecular breeding programmes in developing countries will take time. However, the exponential development of genomic resources, including for less-studied crops, the ever-decreasing cost of marker technologies and the emergence of platforms for accessing MB tools and support services, plus the increasing public–private partnerships and needs-driven demand for improved varieties to counter the global food crisis, are all grounds to predict that MB will have a significant impact on crop breeding in developing countries. These predictions are supported by some preliminary successful examples presented in this paper.     

Assisted reproductive technologies: how to minimize the risks and complications in developing countries?

¹ Correspondence address. E-mail: petra.desutter{at}ugent.be In 2% of assisted reproductive techniques (ART) cycles complicationsoccur. Some are preventable, some are not. In this paper, wewill discuss risks and complications of the standard ‘Western’approach in ART today and point to some measures to be takenwhen implementing ART in developing countries, where resourcesand access to medical care may be limited. Ovarian hyperstimulationsyndrome (OHSS, and its thrombo-embolic complications) is responsiblefor the majority of cycle-related complications, followed bybleeding and infection at oocyte retrieval. ART pregnanciesare complicated by first-trimester bleeding more often thanspontaneous pregnancies, they are more often ectopic, but themajor complication is the very high incidence of multiple pregnancies,when more than one embryo is transferred. OHSS can be preventedby screening patients at risk and by using mild or no stimulation.Simple measures can minimize the risks of bleeding or infection.Obviously single embryo transfer is the only way to avoid multiplepregnancies, which have a highly increased risk for severe maternaland neonatal morbidity and mortality (mainly due to prematurity).Special attention should be given to pre-existing pathologies.Risk minimization of ART in developing countries is not onlymandatory from an economical but also an ethical point of view.     

Population aging and international development: addressing competing claims of distributive justice

To date, bioethics and health policy scholarship has given little consideration to questions of aging and intergenerational justice in the developing world. Demographic changes are precipitating rapid population aging in developing nations, however, and ethical issues regarding older people's claim to scarce healthcare resources must be addressed. This paper posits that the traditional arguments about generational justice and age-based rationing of healthcare resources, which were developed primarily in more industrialized nations, fail to adequately address the unique challenges facing older persons in developing nations. Existing philosophical approaches to age-based resource allocation underemphasize the importance of older persons for developing countries and fail to adequately consider the rights and interests of older persons in these settings. Ultimately, the paper concludes that the most appropriate framework for thinking about generational justice in developing nations is a rights-based approach that allows for the interests of all age groups, including the oldest, to be considered in the determination of health resource allocation.     

False perceptions and common misunderstandings surrounding the subject of infertility in developing countries

¹ Correspondence address. E-mail: willem.ombelet{at}telenet.be ^{Although the consequences of the problem of childlessness aremore pronounced in developing countries when compared with Westernsocieties, local health care providers and international organizationspay little attention on this issue. The limited budgets forreproductive health care are mostly restricted to family planningand mother care. The most common misunderstanding is the ‘overpopulation-issue’.It is generally believed that the expected growth of the worldpopulation puts a real burden on the issue of infertility treatmentin resource-poor countries, although recent UN reports clearlyshow that in most developing countries the fertility rate isdropping significantly and will fall below the threshold of2.0 by 2050. It seems that the expected population growth indeveloping countries in the next decades is rather due to populationageing and not to high fertility rates. Another important issuesurrounding infertility in developing countries is the so-called‘limited resources argument’. Because the problemof childlessness is a major health problem in most developingcountries, a re-arrangement of the global reproductive healthcare budget should be requested from local governments and internationalorganizations taking into account the urgent need for a go-togetherof more successful family-planning policies and affordable simplifiedART methods.}     

The prospect for international regulatory interventions in embryo transfer and reproductive technologies in the next century

Historically, international regulatory interventions in the area of animal reproductive technologies have focused on the need for mitigation against the dissemination of diseases with the movement of genetics and germplasm across international borders. The continued globalization of agriculture under the Sanitary/Phytosanitary (SPS) Agreement of the World Trade Organization (WTO) ensures that disease considerations arising from third and fourth generation reproductive technologies such as in vitro fertilized embryos, transgenics and xenotransplantation will continue to give rise to animal health regulatory measures. Furthermore, in the aftermath of the raising of the public consciousness and the ensuing consumer confidence crisis concerning animal husbandry and livestock production practices following the Bovine Spongiform Encephalopathy outbreak, evolving societal values are expected to expand regulatory considerations to address veterinary public health and ethical concerns. Consequently, it is expected that the role of the International Embryo Transfer Society in fostering meaningful dialogue and profiling of the research necessary to provide for appropriate science based regulation development will increase in importance.     

The non-human primate oocyte and embryo as a model for women, or is it vice versa?

The role of the non-human primate (NHP) oocyte and embryo in translational research is considered here including both in vitro activities directly involving oocytes or embryos as well as animal studies that impact reproductive function. Reasons to consider NHPs as animal research models along with their limitations are summarized. A case is made that in limited instances, such as in the development and application of the assisted reproductive technologies or in the study of embryonic stem cells, the human oocyte and embryo have acted as models for the monkey. The development of strategies for the preservation of fertility is used as an example of ongoing research in the non-human primate that cannot be conducted in women for ethical reasons. In animal studies, monitoring reproductive potential, responses to embryonic stem cell transplantation, along with translational research in the field of contraceptive development for women are considered as subjects that benefit from the availability of a NHP model.