Genetic Information and the Challenge to Privacy

Genetic screening and testing techniques provide a new and powerful diagnostic tool for the acquisition of predictive information. The potential value of such diagnostic techniques cannot be overstated. Genetic diagnostic tests pave the way for the development of gene therapy techniques which may provide remedies for diseases previously considered untreatable. There are clearly tremendous opportunities for improving the quality of life of those who suffer from genetic disorders as well as opportunities for biotechnology and pharmaceutical companies to swell their profits. A complex of pressures and tensions is currently developing around the use of genetic technology for therapeutic purposes in human beings. This paper considers only one element of this complex and dynamic situation, that of the regulatory climate surrounding the use of genetic screening in Europe. If, as many pharmaceutical companies concede, the key to the development of successful gene therapy products is the freedom to use genotyping and genetic screening without significant legal restriction, then the regulatory climate has a crucial significance for the future of this technology. It emerges, however, that there are other interests at stake apart from just those of the patients and the pharmaceutical companies. Insurance companies and employers are also highly interested in the acquisition and use of genetic information. There are arguments both for and against permitting such entities to use or request genetic testing and screening which shall be traversed in the body of the paper. However, the interest of insurance companies and employers in genetic information has stimulated a countercurrent of public pressure for restrictions on the use that can be made of genetic diagnostic information. In a number of countries, this pressure has generated enough concern to stimulate legislatures to seek to enact laws that curtail the use and acquisition of genetic information. This pattern has clearly emerged in the United States and there are strong indications that similar trends are developing in Europe. This article catalogues and critiques the laws and regulations currently affecting genetic screening and testing in Europe.     

Prevention for those who can pay: insurance reimbursement of genetic-based preventive interventions in the liminal state between health and disease

Clinical use of genetic testing to predict adult onset conditions allows individuals to minimize or circumvent disease when preventive medical interventions are available. Recent policy recommendations and changes expand patient access to information about asymptomatic genetic conditions and create mechanisms for expanded insurance coverage for genetic tests. The American College of Medical Genetics and Genomics (ACMG) recommends that laboratories provide incidental findings of medically actionable genetic variants after whole genome sequencing. The Patient Protection and Affordable Care Act (ACA) established mechanisms to mandate coverage for genetic tests, such as BRCA. The ACA and ACMG, however, do not address insurance coverage for preventive interventions. These policies equate access to testing as access to prevention, without exploring the accessibility and affordability of interventions. In reality, insurance coverage for preventive interventions in asymptomatic adults is variable given the US health insurance system''s focus on treatment. Health disparities will be exacerbated if only privileged segments of society can access preventive interventions, such as prophylactic surgeries, screenings, or medication. To ensure equitable access to interventions, federal or state legislatures should mandate insurance coverage for both predictive genetic testing and recommended follow-up interventions included in a list established by an expert panel or regulatory body.     

The FDA and genetic testing: improper tools for a difficult problem

The US Food and Drug Administration (FDA) has recently issued draft guidance on how it intends to regulate laboratory-developed tests, including genetic tests. This article argues that genetic tests differ from traditional targets of FDA regulation in both product as well as industry landscape, and that the FDA''s traditional tools are ill-suited for regulating this space. While existing regulatory gaps do create risks in genetic testing, the regulatory burden of the FDA''s proposal introduces new risks for both test providers and patients that may offset the benefits. Incremental expansion of current oversight outside of the FDA can mitigate many of the risks necessitating increased oversight while avoiding the creation of new ones that could undermine this industry.     

Passing it on: should health care professionals be permitted to disclose patients' genetic information to their reproductive partners?

This article considers whether Australian law should permit health care professionals to disclose patients' genetic information to their reproductive partners without the patients' consent. The issue is addressed with reference to four genetic disorders (Huntington Disease, Familial Adenomatous Polyposis, Multiple Endocrine Neoplasia Type 2A and Cystic Fibrosis) which illustrate differences in inheritance traits and availability of effective treatments. The article explores the familial nature of these disorders and the notion that genetic information has implications which extend beyond the individual patient to third parties such as reproductive partners. It addresses the opinions of legal academics and regulatory bodies regarding the potential amendment of Australian laws to permit such disclosure. Ultimately, it is submitted that the application of current laws regarding medical information to the needs of genetics is unlikely to generate adequate results. To allow for a more appropriate response to this debate, health care professionals' duties to patients should be qualified when it concerns reproductive partners.     

Newborn screening in the genomics era

Newborn screening (NBS) exists in every state for the purpose of testing newborns for genetic medical conditions that can be severe, may be treatable, and are often not clinically evident at birth. While almost all of the diseases screened for in newborns have underlying genetic causes, NBS in its current form is performed not by testing for genetic mutations, but by testing for biochemical markers that indicate a disorder. The potential use of whole-genome newborn screening (WG-NBS) as an alternative to the current biochemical testing utilized for NBS would dramatically expand the quantity and types of information parents could learn from screening and is likely to have many implications, both positive and negative. As whole-genome sequencing (WGS) becomes more economical, it probably will be used for the purposes of NBS. However, such an expansion of NBS would contradict many of the principles that have historically guided public health screening programs and, if implemented without sufficient preparation, could result in insufficient infrastructure to accommodate the health care and data management needs that would arise. This article will first look at the past and present of NBS, then the rise of whole genome sequencing, before considering the challenges of WG-NBS, and will end with some thoughts on the path forward.     

An exploration of the legal and socio-ethical implications of predictive genetic testing of children

This article explores the current position in relation to predictive genetic testing of children, highlighting some of the legal and socio-ethical issues and complexities that such testing presents. It evaluates the existing regulatory framework for predictive genetic testing of children in Australia, including the possible role of the Family Court in protecting children from inappropriate testing, and suggests that introducing a more interventionist approach would create its own difficulties. The article also considers a particular issue arising in the context of predictive genetic testing of children which the ALRC/AHEC inquiry canvassed concerning disclosure obligations to insurers. The article argues that creating an exception to established principles of disclosure would mitigate the impact of predictive genetic testing of children and would be consistent with international instruments which seek to protect against unfair genetic discrimination.     

Commercialization of genetic testing services: the FDA, market forces, and biological tarot cards

Many women fear being diagnosed with breast cancer, and rightfully so. Despite the capabilities of modern medicine, the cumulative lifetime risk of getting the disease has risen to one in eight and, despite decades of research, no cures exist. In this Article, the authors explore the commercialization of so-called breast cancer gene tests, based upon genetic alterations linked to the disease. Although the authors fully address this specific technology, they use what constitutes the seminal case of predictive genetic testing to analyze the adequacy of the existing regulatory framework. The authors conclude that the present regulatory system is inadequate and places a dangerous amount of reliance on primary care physicians. Their conclusion is grounded in the observation that most primary care physicians lack sufficient knowledge about this evolving investigative technology--which is highly subject to misinterpretation, and, though potentially helpful to some "high risk" patients, offers questionable clinical value for the general public. The authors set forth numerous proposals to promote both the quality and clinical value of predictive genetic testing so that it conforms to public health standards and can be properly integrated as a reliable component of medical care in specific situations.     

Natural Settings Trials — Improving the Introduction of Clinical Genetic Tests

Approaches to genetic testing differ in the research setting and the clinical setting. More data are needed to develop approaches that will best facilitate the use of new genetic tests in the clinical setting, especially settings where genetic testing has not been widely used, such as in primary care. Furthermore, data are needed to establish the clinical utility of new genetic tests in the general practice setting. Natural setting trials are proposed as a strategy to develop this information. While natural setting trials are clinical research studies and will expose participants to some degree of risk, the risks are different, and arguably less than the risks those same individuals would otherwise face if the test went directly into clinical practice. Ultimately, clinical practice and safety of new genetic tests can be improved by adding the evaluation provided by natural setting trials.     

The most personal information of all: an appraisal of genetic privacy in the shadow of the Human Genome Project

The advent of genetics and genetic testing has given rise to unique problems for the family. The discovery of a predisposition to a genetic condition in one individual also reveals information about the genetic make-up and potential risks of family members. There is, therefore, potential for conflict over access to and control of such information. Traditionally the duty of confidentiality owed by a health care professional to a patient has provided an appropriate means by which personal health information has been kept secured. It is not clear, however, that the problems which surrounds genetic information in the familial milieu can be adequately dealt with using confidentiality. This article examines these problems and argues for the value of an appeal to the concept of privacy in seeking to resolve some of the more intractable issues.     

Direct‐to‐Consumer Genetic Testing,Gamete Donation,and the Law

Once thousands of dollars, direct‐to‐consumer (DTC) genetic testing has become affordable and readily accessible in recent years. The technology can reveal a wealth of information to consumers: health risks, ancestry composition, and connections to genetic matches through relative databases. However, the law has not yet regulated many aspects of this new technology. This article analyzes how the law should regulate DTC genetic testing within the context of gamete donation. It will argue that gamete donors’ privacy interests warrant state regulation of DTC genetic testing kits and their associated genetic relative databases. It will also explore how state regulation should balance the competing interests of gamete donors and of donor‐conceived individuals.     

Regulatory beneficiaries and informal agency policymaking

Administrative agencies frequently use guidance documents to set policy broadly and prospectively in areas ranging from Department of Education Title IX enforcement to Food and Drug Administration regulation of direct-to- consumer pharmaceutical advertising. In form, these guidances often closely resemble the policies agencies issue in ordinary notice-and-comment rulemaking. However, guidances are generally developed with little public participation and are often immune from judicial review. Nonetheless, guidances can prompt significant changes in behavior from those the agencies regulate. A number of commentators have guardedly defended the current state of affairs. Though guidances lack some important procedural safeguards, they can help agencies supervise low-level employees and supply valuable information to regulated entities regarding how an agency will implement a program. Thus far, however, the debate has largely ignored the distinct and substantial interests of regulatory beneficiaries--those who expect to benefit from government regulation of others. Regulatory beneficiaries include, among others, pharmaceutical consumers, environmental users, and workers seeking safe workplaces. When agencies make policy informally, regulatory beneficiaries suffer distinctive losses to their ability to participate in the agency's decision and to invoke judicial review. This Article argues that considering the interests of regulatory beneficiaries strengthens the case for procedural reform. The Article then assesses some possible solutions.     

Privacy and intra-familiy communication of genetic information.

The new knowledge (and predictions) created by DNA tests and the family nature of genetic information has already lead to a new problem: the intra-familiar communication of genetic data. This raises questions such as the following. Is there a duty to inform in cases when treatment is possible and the patient does not permit disclosure of genetic results to relatives? Is there an obligation to warn or merely an authorization (that could be used or not)? Could privacy protection be maintain as an individual interest but with some justified violations? A balance needs to be establishes between the interest of privacy and the need to disclose secret information.     

Coming soon to the "genetic supermarket" near you

Recent medical studies have indicated that synthesized human growth hormone (hGH) may cosmetically enhance short, but otherwise perfectly healthy, individuals by adding inches to their final predicted height. In this note, Curtis Kin examines the legal and ethical implications of such a discovery, arguing that nontherapeutic hGH treatment is likely the first of many biotechnology and gene therapy enhancements that may be available to the public in a "genetic supermarket" of enhancement products. Mr. Kin finds that the current regulatory framework for biotechnology and gene therapy inadequately regulates unapproved uses of hGH and fails to address properly its implications for a genetic "race to perfection." He proposes changes to the current regulatory framework that will enforce a strict distinction between therapeutic and enhancement applications of biotechnology and gene therapy. These changes in the law, Mr. Kin reasons, will help to solve the social and ethical problems posed by these emerging developments in technology.     

Genetic technologies and the regulation of reproductive decision-making in Australia

This article provides a critical analysis of the current Australian regulatory landscape at the interface between genetics and reproductive decision-making. The authors argue that a comparative analysis with other countries and international law and a contextual examination of the way law regulates concepts such as disease and health, abnormality and normality is necessary before we can develop appropriate policy and legislative responses in this area. Specific genetic testing technologies are considered including prenatal genetic testing, preimplantation genetic diagnosis and inheritable genetic modification. An increasing number of members of the Australian community are using genetic testing technologies when they decide to have a baby. The authors argue that as concepts of disease and health vary among members of the community and the potential to test for traits other than illness increases, a new tension arises between an ethic of individual choice and a role for government in regulating reproductive decision-making.     

Entrepreneurial Regulatory Legal Strategy: The Case of Cannabis

This article develops the concepts of regulatory legal strategy, a resource-based view of government agencies, and regulatory entrepreneurship. These ideas are explored through a case study of the limited (if any) access that legal cannabis-related businesses have to the banking system due to the clash between federal law and laws in those states that have legalized some uses of cannabis. This article argues that regulators’ entrepreneurial regulatory legal strategies can have a material impact on regulated entities and give them a competitive advantage. To demonstrate, this article claims that regulators’ adoption of permissive regulatory legal strategies has facilitated access of some cannabis-related businesses to the banking system. Conversely, if regulators adopted obstructive regulatory strategies, this would act as a constraint on such access in the future, even if Congress resolves the federalism issue largely responsible for the current limitations these businesses face.     

Governing Genetic Databases: Challenges Facing Research Regulation and Practice

This paper reports on the initial findings of an interdisciplinary research project on the governance of human genetic databases in England and Wales. The number of biosample and information collections has expanded, yet considerable legal uncertainty surrounds their definition, collection, storage, management, and use which could inhibit research and clinical practice, while failing to protect the rights and interests of all stakeholders. We report some initial findings from the legal research and identify major challenges associated with defining 'genetic databases'. We identify a wide range of relevant instruments and regulatory actors, and suggest that none adequately addresses the challenges posed by contemporary research techniques or the'corporeal'and'informational'materials used in the genetic databases context. This preliminary analysis seriously questions the efficacy of the current regulatory framework and concludes that developing an appropriate governance framework for the creation, maintenance, and use of genetic databases requires the bringing together of legal analysis with good quality empirical evidence.     

Economic incentives for the self-regulation of the release of price-sensitive information

Companies, as primary disseminators of information, and financial institutions, as major recipients, have economic incentives to self-regulate the transmission and usage of price-sensitive information. These include increased (lost) reputation costs and adverse share price penalties arising from poor management of information disclosure. The economic motivation for self-regulation is seen as conceptually linked to but distinct from legislative changes. Self-regulation has the strong support of economic efficiency arguments, whereas recent additional new legislative changes do not. This article examines a major corporate and institutional response to the new regulatory climate—to internalize part of the regulatory process during their regular relationship communications. Relationships between the case companies and institutions already exist for transaction purposes. They are used as a convenient and low-cost means to pursue self-regulation and to avoid errors of price-sensitive information release. This self-regulatory process is illustrated using case material. It is clear from the response pattern presented that the development of a self-regulatory framework by the parties has been an iterative one. The corporate and institutional systems that have been evolving seem to be significantly influenced by the regulatory trends. The regulatory changes appear to have played a role in increasing market costs incurred by those companies with poor stock market communication practices. The article ends by arguing that new proposals to change in the formal regulatory system should recognize that further legislation is unlikely to improve the poor prosecution record. Nevertheless, legislative changes can combine with and buttress the self-regulation process to create an effective regulatory system.     

State legislative approaches to regulating the use of genetic information

As genetic testing becomes more prevalent and the uses for genetic information multiply, we are likely to witness more demand for comprehensive state legislation on the order of the Oregon law regulating the procedures for obtaining and using genetic information. In addition, the United States Senate has expressed an interest in the subject. The Senate Labor and Human Resources Committee reportedly agreed on August 2, 1995 to include in a health insurance reform bill (S. 1028) language prohibiting health plans from using genetic information when determining eligibility, continuation, enrollment, or contribution requirements. 4 BNA's Health Law Rep. at 1218 (Aug. 10, 1995). Insurance companies continue to maintain that genetic test results are simply another factor that should rightfully be used during underwriting, much as age, medical history, and physical examinations are routinely used today. Right to privacy advocates argue that genetic testing provides employers and insurance companies with too much information and offers a great potential for discrimination. As more states wrestle with this issue, these competing interests are likely to be debated in public forums throughout the country.     

Workplace drug testing in Europe

Not much information is available on workplace drug testing (WDT) in Europe. There is no specific legislation and there are no generally accepted guidelines. Many companies establish a drug policy with little or no provisions for drug testing. Often, testing is performed on-site by occupational physicians, with little or no quality control, no systematic confirmation of positives, no chain of custody and no adulteration testing. In some parts of Europe, e.g. in the United Kingdom and some Scandinavian countries, WDT is increasing in importance, but it is not as widespread as in USA. The most frequently performed tests are amphetamines, cannabinoids, cocaine, opiates and alcohol. The percentage of positives is variable, but seems to decrease with the years following the introduction of WDT. Cannabis is the drug that is most frequently found.Recently, the European Workplace Drug Testing Society (EWDTS) was founded, with the aims to ensure that WDT in Europe is performed to a defined quality standard and in a legally secured way and to provide an independent forum for all aspects of WDT.A working group in the United Kingdom has recently finalised the United Kingdom laboratory guidelines for legally defensible WDT and discussions are under way with the EWDTS to establish common guidelines.Many efforts will be needed to establish WDT as an accepted part of a company policy on drugs: establishing and maintaining the confidence in the results of the laboratory, establishing the legal status of WDT, preserving the privacy and rights of the employees, proving the cost-effectiveness of WDT in a European context, finding a balance between strict guidelines and enough flexibility to tailor testing to the changing needs. It is hoped that the exchange of experience between different countries will contribute to reaching these goals.     

Genetics,parenting, and children's rights in the twenty-first century

Not only do genetic traits sometimes translate into physical and mental illnesses, they may also manifest themselves as tendencies towards certain behaviours. This discovery has led to the misinterpretation and misapplication of genetic information, and has been directed to unforeseen uses, from criminal defence to genetic racism. The issue is especially sensitive when deciding if and when parents should have access to the genetic information of their children. The author begins with an overview of the principles of behavioural genetics and types of behaviour currently under study. Next, the social and psychological risks associated with genetic testing are presented, along with guidelines necessary to distinguish between testing which is therapeutic and that which is non-therapeutic. The distinction is a crucial one, as the author proposes a therapeutic-benefit test, advocating testing only where an effective intervention is available. Finally, the author concludes that legislation is the more appropriate medium for defining the extent of parental rights once intervention is allowed rather than leaving physicians to decide on a case-by-case basis.