The Regulation of Genetic Testing and the Protection of Genetic and Medical Information in Singapore

In the decades since its independence in 1965, the transformation of Singapore’s economy and its transition to a relatively developed economy has also in like manner transformed its health care system, and of the demands made of it. The emergence and availability of new medical technologies has put into sharp focus many novel legal, ethical as well as social issues. This chapter looks at how Singapore has attempted to respond to issues thrown up by genetic testing and screening technologies. A particular focus of this chapter will be the tension between privacy concerns, and the imperatives of access for biomedical research, given that biomedical research has been championed by the Singapore government as one of the future leading sectors of the economy of Singapore. This chapter also examines Singapore’s approach to the question of “genetic exceptionalism:” Does genetic information possess special qualities or attributes that remove it from the realm of ordinary personal information, and which thereby demands special treatment and protection? In this context, the impact of the doctrine of genetic exceptionalism on industry (in this case the insurance industry) is examined.

Direct-to-Consumer Genetic Testing

The 1953 discovery of the DNA double-helical structure by James Watson, Francis Crick, Maurice Wilkins, and Rosalind Franklin, represented one of the most significant advances in the biomedical world (Watson and Crick 1953; Maddox 2003). Almost half a century after this landmark event, in February 2001, the initial draft sequences of the human genome were published (Lander et al., 2001; Venter et al., 2001) and, in April 2003, the International Human Genome Sequencing Consortium reported the completion of the Human Genome Project, a massive international collaborative endeavor that started in 1990 and is thought to represent the most ambitious undertaking in the history of biology (Collins et al., 2003; Thangadurai, 2004; National Human Genome Research Institute). The Human Genome Project provided a plethora of genetic and genomic information that significantly changed our perspectives on biomedical and social sciences. The sequencing of the first human genome was a 13-year, 2.7-billion-dollar effort that relied on the automated Sanger (dideoxy or chain termination) method, which was developed in 1977, around the same time as the Maxam-Gilbert (chemical) sequencing, and subsequently became the most frequently used approach for several decades (Sanger et al., 1975; Maxam & Gilbert, 1977; Sanger et al., 1977). The new generations of DNA sequencing technologies, known as next-generation (second generation) and next-next-generation (third generation) sequencing, which started to be commercialized in 2005, enabled the cost-effective sequencing of large chromosomal regions during progressively shorter time frames, and opened the possibility for new applications, such as the sequencing of single-cell genomes (Service, 2006; Blow, 2008; Morozova and Marra, 2008; Metzker, 2010).

Buddhism and Human Genetic Research

What the author is trying to do in this chapter is to explore how Buddhism, especially Theravada Buddhism as adopted in Thailand, responds to the advancements of human genetic research in the modern world. Buddhism has a certain number of doctrinal beliefs normally differing from those in the theistic tradition, making Buddhism respond to genetic research in a certain way. The way Buddhism responds to genetic research could be characterized as a kind of humanistic view. This kind of view is mainly based on human wisdom and rational investigation of the problem. Belief as normally understood in terms of religion plays a lesser role in Buddhist ethics. The following will show the positions of Buddhism on the problems raised by genetic research. As the concept of personhood plays the key role in the debates over human genetic research, the author will start with this point. As human genetic research raises so many issues that it is impossible to explore all of them, the chapter will then focus on some of these issues, namely human cloning and the use of embryonic stem cells in medical practice.

Human Biobanks

The chapter presents a careful comparative study on ethical and legal aspects of human biobanks both in Europe and elsewhere. The rapid expansion of human DNA sampling and data collection has taken place in the last few years, but the legal and ethical perception of this situation looks very different in European countries and beyond. The author focuses her attention on the European Union, especially in Estonia, where a population wide gene back has been established; moreover, she also discusses what is happening in Macedonia, a relatively neglected country in Eastern Europe, as well as Australia, India and Israel.

Biotechnological Patents and Morality

The chapter deals with ethical aspects of patent law and how the global patent regime helps or hinders the development of a developing country such as Thailand. More specifically, it discusses Article 27.3 of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which states that countries may exclude methods of medical treatment, plants and animals (but not micro-organisms) from patent protection. It also provides legal analysis on the issue of whether developing countries can maximize benefits from the TRIPS morality exception (Article 27.2) in dealing with biotechnological patenting.

A Philosophical Exploration of the Concept of ‘Property’ in Genetics and Databanking

The chapter criticizes arguments purporting to show that the human body could be made available in the market as property and those arguing that the concept of property could be applicable to the human bodily parts or human DNA. The author argues that the genetic information contained in matter such as DNA cannot be taken for granted as classifiable as property. There are three reasons: DNA is too personal to be commodified; DNA is of familial nature; and commercialization of DNA runs the risk of exploitation of the disadvantaged. Moreover, ethics should venture to clarify interests and stakes in the debate, with sympathy for the vulnerable rather than executing the rationales of powerful groups in economy and society.

Beyond Informed Consent

This chapter affirms the continuing relevance of requiring informed consent for health research in a context consisting of evolving genetic research methodologies and non-paradigmatic ways by which human beings become subjects of genetic research. The chapter also recognizes the special status of genetic materials and genetic data as subjects of research, as well as the different ways in which genetic materials and genetic data may be “owned.” Different senses of ownership necessitate variable ways of implementing informed consent and these have to be clarified and carefully matched. Taking into account the specific interests expressed by human participants in human tissue research,the authors can see that these can be best promoted by a kind of oversight function delegated to ethics committees. The idea of a “one-time” or absolute consent given at the time of recruitment sounds appealing in that it minimizes inconveniences to many stakeholders, including researchers and human subjects. However, there remain valid reasons to be wary lest the system allow some types of research (or use of human research materials) that subjects would disapprove of unless sufficient pertinent information could be provided at the moment of recruitment. Thus the authors present an option for something close to “one-time” or absolute consent with safety nets in the form of oversight functions “delegated” to oversight ethics committees. The exercise of oversight function should involve flexibility to negotiate specific instructions given by the subject(s), such as those that may have something to do with uses that could have a particular religious or cultural significance.

The Applications of Omics Technologies and the Challenges of Ethics in Nutritional Sciences

During the past two decades, there have been numerous developments in the genetic and genomic technologies enabling us to understand complex biological systems in an integrative manner through holistic approaches in research. Since the sequencing of the human genome, efforts are made to identify the number of the genes and their functions. The tools for determining the functionality of the genes are just beginning to appear. Initially the methodologies to identify functionality of the genes were largely based on comparative studies between model organisms. The very high number of genes with unknown functions demanded the need to develop new methods and technologies that may be helpful in assigning functions to the identified genes. Advancements in computing techniques and software opened the door for new technologies to be able to take an applied approach by studying biomolecules needed for proper functioning of the cell and take a holistic approach in biomedical research. Besides genomics, several other technologies are developed in the last decade that take an ‘omics’ approach, i.e., an integrated approach in the study of cell function. It is hoped that the applied integrative omics approaches may be helpful in establishing cause and effect relationships between genotype and phenotype. These ‘omics’ approaches include the integration of genomics, proteomics, transcriptomics, metabolomics and other omic technologies to do the non-targeted studies of biomolecules involved in the proper functioning of the cells and their responses to environmental changes. The applications of these technologies have been also utilized in the field of nutrition for studies on how nutrients and other metabolites effect the proper functioning of the cell. With these emerging techniques to understand the molecular functioning of the body, it is envisaged that they might be helpful to give personalized medical care and dietary advice to people based on their individual genotypes in the future. Whilst nutritional genomics is a rapidly growing field in the nutritional sciences focusing on the diet-gene relationships, there is an increasing understanding that other technologies will also be crucial in understanding the whole biological processes involved in metabolism of food. In this chapter I wish to outline the use of contemporary technologies that are involved in establishing the intricate linkages between diet and the genes, and the ethical challenges they raise in their applications.

The Value of Life of the Embryo Observed from Two Different Lenses

The chapter deals with moral deliberation over the status of the embryo, observed from two perspectives, namely the inner context of physical and biological composition including the argument of potentiality as a driving force of development, and the external context within lived and experienced practices in which an embryo is inevitably embedded. Both components are integral parts of what constitutes the life of the embryo, and therefore any separated observation is biased and does not fulfill the demands of the universal truth. Hence, the usual argument that focuses exclusively on the embryo itself, whether the embryo deserves moral right as a result of its potentiality for autonomy, is misguided.

Genetic Testing and Protection of Genetic Privacy

Progress in the field of biomedical science has made it possible to obtain greater knowledge of the human genome and the nature of genetic disorders. Thanks to these advances, doctors now have the tools to diagnose certain disorders, and to carry out genetic tests to determine increased risks of developing other illnesses and of passing them on to future generations. In addition to the classic single gene disorders (like hemophilia and sickle cell anaemia), susceptibility genes are also being identified for genetically complex diseases, including many types of cancer, Alzheimer‘s disease, diabetes and other illnesses (House of Lords, 2009, p. 8). We can look toward a future where genetic test results are an important part of every healthy person’s medical file.