Predictive Testing in the Workplace-could the German Model Serve as a Blueprint for Uniform Legislation in the United States?

• Publication year: 2005

Eva Lorenz⁰

This Comment focuses on the problems associated with the use of employment-based genetic testing. Recently, the German National Ethics Council ("NEC") drafted a list of recommendations to regulate the use of predictive testing in the workplace. This problem of genetic testing is not limited to Germany—similar cases have been reported in the United States. The lack of a federal framework to regulate the use of genetic testing in the workplace creates uncertainty for employees and employers. Though it is likely that any federal framework will require amendments, the increased certainty associated with a uniform federal law will likely outweigh any shortcomings. This Comment analyzes the recommendations of the NEC as a possible blueprint for a uniform law in the United States.

"[O]nce a tool is developed there are considerable pressures for implementation."¹

I. Introduction

Imagine you are a thirty-six year old woman who always wanted to become a teacher. You have finished high school, graduated from college, passed all of the professional tests, and are now on the verge of getting a tenure track position to teach. Just one more test and you will be there. There is a problem, however, and it is that the final test is a physical examination, which is a requirement for public servants seeking tenure track positions. Part of the physical is a questionnaire that seeks information about family health history. You put down that your father has Huntington's disease ("HD", also called Huntington's chorea).² You pass your physical, but are still denied a teaching position by the state. Why? Because you have a high risk of carrying the Huntington's gene and therefore have a high likelihood of developing an incurable disease that may force you to seek early retirement.

While this sounds like a fictional story from George Orwell³ or Aldous Huxley,⁴ this was the reality faced by a young woman in Germany, and it could happen in any country where medicine has advanced enough to enable testing for inherited diseases. The fact that the young woman had a fifty percent chance of carrying a disease gene was deemed sufficient by a lower court in Germany to deny her a teaching position. The woman appealed, arguing that she has a fifty percent chance of being healthy and that questions regarding the health status of close relatives should not be part of a physical that seeks to determine whether she is fit to teach.⁵ The administrative court granted her relief and she was given a teaching position.

Despite the positive outcome for the plaintiff, some concerns remain. The language of the decision and the recommendations of the German National Ethics Council⁶ ("NEC") leave open what kind and how much information should be shared with third parties as part of pre-employment physicals.

This Comment presents a critical analysis of the NEC recommendations for the use of predictive testing in the workplace and their possible use as a blueprint for comparable legislation in the United States. A federal law would generate certainty regarding the use of predictive testing in the workplace by replacing the existing patchwork of laws and regulations. While many people already view genetic testing with suspicion, it is important to keep in mind that predictive testing can be useful in determining whether certain people are at an increased risk for exposure-related illnesses. A balance between the benefits of predictive testing in protecting workers from exposure hazards and the possible abuses of testing for discriminatory purposes is best achieved through a uniform law at the federal level that covers all employees and employers. Part II of this Comment is a primer on genetics and genetic testing. Part III provides a brief introduction to the NEC and analyzes the recommendations of the NEC dealing with the use of predictive testing in the workplace. The NEC recommendations are compared to existing legislation in the United States to determine whether the NEC proposal should serve as a template for uniform federal laws in the United States.⁷ While the United States does not have a national law regarding the use of genetic testing to determine employment eligibility, the Americans with Disabilities Act,⁸ state-based laws, and pending federal legislation indicate that there have been attempts to regulate genetic testing in this country. Part IV summarizes the existing case law, which demonstrates the need for a better legal framework, and will also reiterate the danger of using genetic testing as a discriminatory tool in the workplace. Part V analyzes the split in the minority community regarding access to genetic testing, which underscores the need for an in-depth debate on the future use of employment-based predictive testing in the United States.

Currently, genetic information about employees in this country is protected to some degree through a mixture of case law, state-based legislation, and federal statutes. However, a uniform federal framework is necessary to minimize the abuses and uncertainties that are possible under the current system, and the proposal by the NEC may provide some guidance for the establishment of such a federal framework. While attempts at establishing such a framework may evoke opposition from groups that fear possible discriminatory uses, the increased certainty associated with uniform federal rules as well as the possibility of covering all employees lend support to establishing such a framework at the federal level to replace the existing patchwork of laws and statutes. This Comment, therefore, uses the comparison with the NEC recommendations to point out how a federal law regulating genetic testing in the workplace could be structured for use in the United States in order to increase the certainty associated with the use of predictive testing in the workplace.

II. Primer on Genes and Genetic Testing

Before analyzing the recommendations by the National Ethics Council of Germany,⁹ a short introduction to genetic testing is helpful. The following paragraphs explain and highlight the basics of genetic testing, its current applications, and some of its weaknesses.¹⁰

DNA, short for deoxyribonucleic acid, is the carrier of genetic information, and its content determines such things as the physical appearance of the person, as well as what diseases a person may have inherited from his or her parents. The physical appearance and the effects of any inherited diseases, referred to as the phenotype, are differentiated from the genetic make up of a person called genotype.¹¹ DNA is transcribed into messenger ribonucleic acid ("mRNA").¹² RNA is closely related to DNA in its chemical composition. mRNA is translated into proteins, such as enzymes, that regulate all biological processes in mammals and are therefore crucial for biological functions, such as metabolism, growth, and healing. Since changes in the DNA, called mutations,¹³ translate into changes in the proteins that may affect the function of enzymes, much of modern day medicine is intent on discovering the underlying mutations that cause diseases ranging from asthma to cystic fibrosis ("CF").

Some diseases, such as cystic fibrosis¹⁴ or Huntington's chorea, can be linked to mutations in a single gene. Other diseases, called complex diseases, which include asthma or heart disease, are believed to be caused by a number of genetic changes as well as environmental influences. Determining the genetic causes for complex diseases is still in the initial stages and disease prevention is currently limited to identifying risk factors for the development of such diseases. Merely knowing that mutations in only one gene underlie a specific disease does not mean that physicians or genetic counselors can answer all the questions a person may have regarding disease severity, age of onset or life expectancy. This lack of conclusive information regarding the resulting phenotype is based on differences in penetrance.¹⁵ In some genes, such as the cystic fibrosis Transmembrane Reporter ("CFTR"), a large number of mutations throughout the gene have been identified that cause phenotypes ranging from a very mild form of CF that may go unnoticed until adulthood, to severe forms, in which the disease manifests itself in early childhood.¹⁶ In Huntington's chorea, penetrance of the disease phenotype is based on a number of trinucleotide repeats.¹⁷ Such repeats are present throughout the human genome and can range from three bases to five or more bases being repeated. The mutations in Huntington's chorea are limited to a stretch of nucleotide repeats that even in healthy adults differ in lengths. The fact that even healthy individuals display a variability in the number of repeats makes the job of the genetic counselor all the more difficult, since the initial diagnosis with Huntington's is often followed by questions from the tested individual related to age of onset and disease severity.¹⁸ For Huntington's, less than thirty repeats do not precipitate the development of the disease, while affected individuals have more than thirty-six repeats.¹⁹

The autosomal dominant nature of the disease explains why every person who has more than thirty-six CAG repeats develops Huntington's chorea.²⁰ In the inheritance of disease traits, autosomal dominant means that one copy of the mutation or disease-causing gene is sufficient to exhibit disease traits.²¹ In terms of inheritance, autosomal dominant diseases are inherited with fifty percent likelihood by the children (sons and daughters) of an affected parent.²² Therefore, the autosomal dominant nature of Huntington's chorea means that the teacher described in the Introduction has a fifty percent chance of inheriting the disease.²³ Testing for disease-associated mutations has become more efficient and affordable as genotyping techniques advance.²⁴ Usually, genetic testing involves using small amounts of blood to extract the DNA for polymerase...