Virginia Genetics Law and Policy

Virginia Genetics Law and Policy

Virginia Genetics Law and Policy

A White Paper

Virginia Advisory Board on

Ethical/Legal Issues Related to Genetics

As of April 30, 2004

James G. Hodge, Jr., J.D., LL.M.

Assistant Public Health Professor, Johns Hopkins Bloomberg School of Public Health;

Adjunct Professor of Law, Georgetown University Law Center;

Executive Director, Center for Law and the Public’s Health

With:

Erin C. Fuse Brown

J.D./M.P.H. Candidate, Georgetown University Law Center,

Johns Hopkins Bloomberg School of Public Health

Table of Contents

I. Preface...... 3

  1. Introduction/Executive Summary...... 3
  2. The Genetics Revolution – In Brief...... 8
  1. The Human Genome Project...... 8
  2. Genetic Testing and Research...... 9
  3. Genetics and Public Health...... 10
  4. Forensic Uses of DNA...... 11
  5. The Genetics Information Infrastructure...... 12
  6. Genetics and Ethics...... 13

IV. State Genetics Law and Policy…………………………………………………………15

  1. Early Genetic Policy...... 16
  2. Genetics Exceptionalism and Property Rights...... 20
  3. Following Dolly...... 21
  4. A Conservative Approach – The Michigan Alternative...... 22
  1. Virginia Genetics Laws and Policies – A Case Study...... 23
  1. Use of Genetic Tests and Information in Insurance...... 25
  2. Use of Genetic Tests and Information in Employment...... 26
  3. Use of Genetic Tests and Information in Family Law...... 27
  4. Genetic Information for Hereditary Conditions and Disorders...... 28
  5. Genetic Information in Criminal Law...... 32
  6. Genetic Information in Research and Technology...... 33

VI. Principal Findings and Conclusions…………………………………………………. 34

Appendix A. Table of Virginia Genetics Laws …………………………………………………37

Appendix B. Text of Virginia Genetics Statutes and Administrative Regulations …………….. 38

References ………………………………………………………………………………………50

I. Preface

This White Paper was prepared for the Virginia Advisory Board on Ethical/Legal Issues Related to Genetics to assess the legal and ethical issues relating to the collection and use of genetic information in the Commonwealth of Virginia. After briefly summarizing major developments in genetic technology, primary uses for genetic information, and some key ethical issues surrounding its use, the Paper explores ways various states have regulated the uses and exchange of genetic information. A Virginia genetics case study is included to demonstrate how current and prospective Virginia laws and policies facilitate the use of and protect genetic testing and information in various contexts. Principal findings highlight areas of coverage and gaps in Virginia state genetics laws compared with other states.

The Paper is based in part on my work and that of my colleagues, Professor Lawrence O. Gostin, Professor of Law, Georgetown University Law Center, and Cheye M. Calvo, Senior Genetics Policy Specialist (former), National Conference of State Legislatures (NCSL), from our project, Genetics Legislation: Syntax, Science, and Policy. This project was funded by the National Human Genome Research Institute of the National Institutes of Health (NIH).

II. Introduction/Executive Summary

Advancing human genetic technologies is a revolutionary objective in science, medicine, and public health for the 21st century. The Human Genome Project (HGP) has led to the successful identification of genes and the sequencing the chemical bases in human DNA. The number of genetic tests developed and used is rapidly expanding. In some cases, genetic tests or hasten diagnosis (e.g., prenatal diagnosis and newborn screening). In other cases, these tests allow for medical diagnosis where it was previously impossible (e.g., presymptomatic diagnosis or identification of unaffected carriers of a gene). These advances allow medical practitioners and researchers to more effectively assess the complex interactions between environment, behavior, and genetics that contribute to human conditions. Public health authorities can better identify appropriate populations to target for public health interventions. The ability to test and precisely compare genetic samples has also permanently altered forensic science. Forensic DNA tests allow law enforcement officials to better identify potential suspects and exonerate the innocent accused.

The expansion of genetic technology and uses has led to the proliferation of genetic information. A genetics information infrastructure is developing in which genetic information (often individually-identifiable) is acquired, used, stored, and transmitted to support diagnosis, research, treatment, surveillance, reproductive counseling, and other functions. One form of genetics information gathering, criminal DNA data banking, has become prominent as federal and state governments collect and store hundreds of thousands of DNA samples for criminal investigatory purposes. Additional examples of mass genetic data collection are found in the fields of medical services, human subject research, and public health.

These data collections contribute to ongoing national legal and ethical debates about whom and under what circumstances genetic information may be acquired, used, or disclosed. Individuals profess a strong need to control data uses to protect the privacy and security of their identifiable genetic information. These data are among the most sensitive types of health information. Individuals and members of some societal groups (e.g., religious, ethnic, or other vulnerable populations) are concerned that the sharing of genetics information with third parties will lead to discrimination. Discrimination can occur among health, life, disability, and long-term care insurers who are able to use genetic testing to choose who they serve. Employers may attempt to use genetic testing results to discriminate in hiring or promotions based on a health condition or other genetic trait. Conversely, public health authorities, researchers, law enforcers, private insurers, and employers profess needs to access genetic information to meet communal goals, protect persons from potential or actual harms, prevent unwarranted actions, or satisfy other, arguably justifiable bases.

Balancing individual privacy and communal or other justifiable grounds for sharing genetic information is not easy. Attempts to reach this balance are further complicated by differing views on “genetics exceptionalism.” Many law- and policy-makers view genetics information as “exceptional” relative to other health information. They suggest that genetic information is uniquely predictive, different, or more personal and thus deserves special privacy or other protections. Others posit that genetic information is no different than other health data, and thus it should be treated similarly to all health data concerning legal protections.

Differences on how to protect the privacy of genetic information have led to a wide array of legal responses. Genetics policy first became prominent through state newborn screening programs in the 1960s and the sickle cell trait anti-discrimination movement of the 1970s. State legislators and executive agencies have been highly active since 1990 in developing genetics-specific law and policy relative to their federal counterparts. The HGP led to early efforts among a few individual state legislators (e.g., California, Wisconsin) to develop comprehensive genetics-specific privacy and anti-discrimination legislation. Other states soon followed. Some (e.g., Colorado, Oregon) gave individuals property rights to genetic information and DNA samples. In the mid-1990s, many states employed broader definitions of genetic information to widen legal protections. In several states, however, legislatures took no action on genetic-specific protections in part due to political pressure from interest groups, health and life insurers, and employers.

Animal cloning in 1997 renewed the efforts of many state legislatures regarding genetics- related privacy and anti-discrimination protections. Some states passed moratoriums on human cloning. Additional privacy and anti-discrimination measures were also passed. Michigan used a deliberative process to shape its genetics legislation. A special genetics policy commission made up of experts in the fields of law, policy, and genetics was created to craft recommendations for legislation. After months of public hearings and deliberations, the commission proposed a wide range of new laws that were based on a more conservative approach than had been seen in other states. The Michigan prototype has been subsequently used in other states as they increasingly build on others’ experiences to thoughtfully develop genetics laws and policies that match their states’ values and political environments.

To examine the extent of state genetics laws and policies in Virginia, this White Paper includes a case study that evaluates genetic laws and policies in the Commonwealth as of April, 2004. This study summarizes Virginia’s statutes, administrative regulations, pending bills, and jurisprudence relating to the use of genetic information and testing in key legal areas, including: insurance, employment, family, prevention and treatment of hereditary and congenital disorders, criminal, and genetic research and technology. Appendix A provides a table that summarizes Virginia’s current statutes, administrative regulations, case law, and pending legislation relating to genetic policy. Appendix B contains the actual text of the relevant sections of statutes and regulations discussed in the case study and listed in the table. Principal findings as to how Virginia genetics laws differ or are consistent with other state genetics laws include:

  • Insurance. Virginia differs from many states in that it forbids discrimination on the basis of genetic testing or information in health insurance but not in disability or life insurance.
  • Employment. Virginia forbids genetic discrimination on the basis of genetic testing status or information. Life, disability, and long-term care insurance as employment benefits are excluded from the genetic discrimination provisions.
  • Privacy. In each context in which genetic information may be held, from health insurance to criminal DNA banks, genetic information is protected with affirmative assurances of confidentiality, descriptions of privacy procedures, as well as bans on disclosure without informed consent. In areas such as insurance or criminal law where discrimination is a special concern, criminal penalties may be assigned for infringements of genetic privacy.
  • Family Law. Virginia’s genetics policies are consistent with other states regarding paternity testing, but lag in the area of adoption and assisted reproductive technology. Virginia’s policies to maintain and make accessible genetic information of biological parents to adopted children or children of reproductive technology are narrower than provisions in some states.
  • Genetic Screening. Virginia maintains robust screening, reporting, and treatment provisions for genetic diseases and disorders for pregnant women, newborns, and children. The development of new screening tests, however, may outpace existing policies.
  • Criminal Law. Virginia maintains a DNA bank for convicted and incarcerated felons like other states, although its polices are more far-reaching than in some other states. For example, Virginia requires DNA to be collected for those merely arrested on suspicion of committing a felony prior to conviction. As well, juveniles older than 14 years are subject to the same DNA sampling provisions as adults.
  • Genetic Research and Technology. Virginia is among a minority of states that has passed laws banning human reproductive cloning. Despite this ban, Virginia encourages other types of genetic research and engineering, including non-reproductive cloning.

III. The Genetics Revolution – In Brief

A. The Human Genome Project

The Human Genome Project (HGP) is an international enterprise principally funded by the U.S. federal government and the British research charity, Wellcome Trust.[1] Federal funding was coordinated between the Department of Energy (DOE) and the National Institutes of Health (NIH) starting in 1990.[2] The HGP has now met its two main scientific goals. It has identified the approximately 30,000 genes[3] (links of base pairs that usually contain information for making a specific protein[4]) in human DNA. And in April 2003,[5] the Project led to the successful sequencing of the approximately 3.1 billion[6] chemical bases that make up human DNA. Sequencing information will promote better understanding of how genetic material interacts to produce certain characteristics and allow researchers studying a particular trait to quickly retrieve data about relevant sections of DNA.[7]

Through the HGP, researchers will be able to advance understanding in several avenues of study, such as the origin of humans, efficacy of medical treatments, and genetic causes of diseases and disorders.[8] Additional aims of the HGP include sharing information regarding its scientific discoveries through public databases, developing better sequencing technologies and tools for data analysis, and examining the ethical, legal, and social implications (through the Ethical, Legal, and Social Implications (ELSI) Program).[9] Project researchers have also evaluated the genetic material of non-human organisms.[10] These efforts aid in the improvement of genetic research technology and better understanding of human gene function through comparisons to non-human models.

B. Genetic Testing and Research

Genetic tests involve an examination of chromosomes, DNA molecules, or gene products (such as proteins) for evidence of certain mutated sequences.[11] Genetic tests can: (1) confirm a diagnosis for a symptomatic individual; (2) assist with presymptomatic diagnosis or assessment of the risk of development of adult-onset disorders. Better knowledge of the causes of disease may lead to more effective drugs and gene therapy techniques; [12] (3) identify unaffected carriers of one copy of a gene for a disease where two copies are needed for the disease to be expressed; (4) aid in prenatal diagnosis and newborn screening; and (5) be used in forensic and identity evaluations.[13] Hundreds of genetic tests already exist, and many more are in various stages of development.[14]

Despite great potential, certain technical limitations inhibit the prediction of genetic disease in individuals. A genetic test may not be able to identify every mutation of a gene and thus may not recognize an abnormality.[15] Furthermore, different mutations in a gene have different effects. Finally, genetic tests do not measure the complex interactions between genes and environment that contribute to almost all diseases. This restricts the ability to test for major causes of mortality such as cancer and heart disease.[16]

Scientists, policymakers, ethicists, and the public are concerned about legal and ethical issues relating to genetic testing. Some of these concerns include the difficulty interpreting genetic information for genes that do not necessarily result in disease, testing for diseases without a cure or against the person’s wishes, deciding when tests should be administered for adult-onset disorders like Alzheimer’s, deciding how much choice an individual should have in taking a test when that information could affect family members or potential offspring, and determining to whom the tests results may be released. Additional questions arise as to quality assurance and accuracy of testing. While genetic tests provide many benefits, they also provoke concerns about how, when, and why the tests should be performed.

C. Genetics and Public Health

Genetics testing and information may impact public health goals of preventing and treating diseases in the population in many ways. First, understanding the role genes play in contributing to diseases helps parse out environmental, behavioral, and genetic influences on diseases.[17] With this knowledge, public health professionals can shape their assessment, policy development, and assurance techniques more effectively. Environmental risk assessments, for example, benefit from new means to evaluate health damage caused by exposure to radiation or toxins.[18] Second, public health professionals promote the use of genetic tests and services where inexpensive and effective treatments are available to advance the collective health of the population.[19] Third, public health officials conduct population research to evaluate the clinical validity and utility of genetic testing.[20] Fourth, genetic information aids in targeted screening efforts by helping public health officials identify which groups should be screened.[21] Finally, public health officials help disseminate information about the role of genetics in health to medical professionals and the public.[22] Public health professionals are essential to translating the capabilities of genetic tests into better population-wide health through their ability to promote research, treatment, and education about the interaction between environment, behavior, and genes.

Multiple legal and ethical issues must be considered before a public health strategy using genetic tests and information is implemented. For example, what, if any, tests should be part of screening programs (mandatory or routine) and why? If screening is targeted to a certain population group, how can public health officials ensure that the group is not stigmatized by the connection to the disease? In addition, how should public health professionals evaluate risk when they determine how to allocate scarce testing resources? Should they focus research and prevention efforts on genetic diseases that impact the public at large or illnesses that disproportionately affect certain population groups? And what differences exist in the roles for federal and state public health agencies? Important questions regarding privacy, discussed below, also must be confronted.

D. Forensic Uses of DNA

Forensic uses of genetic tests involve identification of individuals based on organism tissues. States are forming a national criminal DNA data bank similar to the one developed by the Federal Bureau of Investigations (FBI), known as CODIS,[23] which contains hundreds of thousands of genetic profiles from convicted offenders.[24] Every state legally requires convicted sex offenders to submit a blood sample for genetic analysis. Others states (like Virginia – see infra Section VI) test all convicted felons, including juveniles. Louisiana passed legislation that forces those arrested on mere suspicion of felony sex offenses to submit to DNA testing.[25]

Unlike genetic tests for medical and public health purposes, forensic DNA tests generally examine regions of DNA that do not reveal information about an individual’s personal characteristics or probability of disease. The term “forensic” is most often used in the criminal setting where DNA tests allow investigators to identify potential suspects or to exonerate the innocent accused. But the forensic uses of DNA extend into other areas, such as identification of catastrophe victims or family relationships, such as paternity, between individuals.[26] In addition, it can aid in matching organ donors and recipients who need transplants.[27]

Technological and testing improvements have advanced to allow almost any type of organic matter (including sweat, hair, and degraded blood) to be used to perform a genetic analysis.[28] Hand-held devices are in process of development that would allow law enforcers to rapidly evaluate DNA samples at the scene of a criminal investigation.[29] This technology may help relieve backlogs of requested tests at laboratories. Still, significant technological limitations compromise the ability to identify specific individuals. Existing tests involve matching only four to five regions of DNA for the purposes of identification.[30] There is a remote chance that two or more suspected individuals will have the same DNA in those regions.[31] As well, certain population groups have more frequent occurrences of specific patterns of DNA than others.[32]