Genetic Property Governance.

• Author: Simana, Shelly

TABLE OF CONTENTS INTRODUCTION I. CURRENT GENOME CONCEPTUALIZATION AND GOVERNANCE A. A Resource Supporting Property Rights of the Person from Whom It Was Extracted a. An Explicit Property Regime b. An Implicit Property Regime B. A Resource Available for Appropriation by Other Entities a. An Explicit Property Regime b. An Implicit Property Regime II. WHAT'S WRONG WITH THE CURRENT GENOME CONCEPTUALIZATION AND GOVERNANCE? A. Failure to Consider the Relationality of an Individual Genome a. Familial and Collective Aspects of an Individual Genome b. Individualistic Ideology and Absolute Conception of Ownership B. Exclusion of the "Economic" Features of an Individual Genome a. Genetic Material b. Genetic Information C. Lack of Explanatory Power III. GENETIC PROPERTY GOVERNANCE A. Genetic Property Governance--A Bird's Eye View B. Genetic Property Governance--A Closer Look a. Why a Property Regime? b. Common Property Regime c. A Liberal Conception of Property d. Legitimate Property Interests e. Appropriate Control C. What Difference Would Genetic Property Governance Make? CONCLUSION "It is more than likely that joint ownership, and not separate ownership, is the really archaic institution, and that the forms of property that will afford us instruction will be those that are associated with the rights of families and of groups of kindred."

--Henry Sumner Maine, 1906 (1)

INTRODUCTION

Henrietta Lacks died from cervical cancer in 1951, at the age of 31. (2) It was only in 1973 that Henrietta's family learned that doctors at the Johns Hopkins Hospital had taken samples of her cancerous cells and given them, without her knowledge, to Dr. George Gey, a prominent cancer researcher. (3) In Dr. Gey's lab, the cells, which came to be known as the "HeLa cells," were discovered to have an extraordinary capacity to survive and reproduce. For that reason, these cells have had a significant role in scientific research and, over the years, have contributed to enormous scientific breakthroughs, including the development of the polio vaccine and the study of cancer and the AIDS virus. (4)

Thus far, the family of Henrietta Lacks has not sued anyone for ownership of the HeLa cells and the genetic information retrieved from them. (5) However, at a news conference on October 4, 2021, seventy years after Henrietta's death, the Lacks family announced that they are suing a biotechnology company, Thermo Fisher Scientific, which has been accused of profiting from Henrietta's "stolen" cells (6) and "making a conscious choice to sell and mass produce the living tissue of Henrietta Lacks." (7)

The Lacks' lawsuit reflects an urgent and timely topic: the ownership of what I term an "individual genome"--genetic material and information extracted from a single person. It incites a burning question to which the law has yet to provide a clear answer: Who can claim to have ownership over an individual genome--is it the person from whom an individual genome was extracted or someone else?

By ownership, I mean authority--the normative power to determine to some degree what others may do with a resource--that is enforceable against the "whole world." (8) According to this definition, the institution of property offers different "configurations of entitlements that constitute the contents of an owner's rights vis-a-vis others, or a certain type of others, with respect to a given resource." (9)

Before going any further, two points of clarification are appropriate. First, when I refer to "genetic material" and "genetic information," I mean a variety of genetic materials and forms of genetic information. These include specimen (e.g., hair and saliva), DNA sample (e.g., extracted and purified DNA and an isolated gene), manipulated genetic material (e.g., cell line and synthetic DNA), and any information that can be derived or inferred from these genetic materials (e.g., information on single nucleotide polymorphism and chromosomes). (10)

Second, genetic material and genetic information are frequently inseparable; when someone collects the genetic material of another individual, they are also able to obtain the individual's genetic information from that material. That being the case, there are situations in which the physical form and the information embedded in it should not be treated as distinct matters. Therefore, for the purposes of this Article, I consider genetic material and genetic information to be a single resource and refer to them collectively as an "individual genome."

The question of ownership of an individual genome has been the subject of much debate and theorizing in the academic literature and beyond. By and large, the existing approaches to this question can be divided into two streams holding fundamentally different normative conceptions of genetic material and information and advancing competing legal interests. (11)

The first approach calls for legal recognition of the ownership interests of the person from whom an individual genome was extracted, (12) This approach has diverse theoretical underpinnings. Some scholars use property law to "assuage anxieties about misuse and exploitation." (13) Under property law, they claim, a person holds a "right to possession and use of his DNA, free from the interference of others." (14) Hence, a person has a monopoly over their individual genome, and other entities are excluded "from taking, using, receiving, selling, or otherwise misusing" it. (15) Other scholars reflect on the importance of self-ownership, (16) while pointing out that property law mirrors the sentiments society attaches to a specific thing; things deemed "ours" or recognized as personal and meaningful should therefore receive special protection. (17) Finally, several scholars touch on the connection to identity, (18) asserting that "no other individual or entity has a clearer or more justifiable claim over the [genetic] information than the person to whom it pertains." (19) An individual genome plays "a role in self-identity and may contain indications about one's present and future self.... Like a right to control the use of one's likeness, a right to control the use of one's genetic material ... arises without the specific intent or perhaps innovation of the rights holder." (20)

This approach is not merely theoretical; it has permeated state and federal laws and court decisions in the United States in the last 30 years. (21) Various states recognize genetic material and/or genetic information as a person's private property. (22) Alaska's Genetic Privacy Act, for instance, recognizes a DNA sample and the results of DNA analyses as "the exclusive property of the person sampled or analyzed." (23) Courts have adopted a similar perspective. In one case, a person was sued for conspiring to take and test the genetic material of another. (24) The court found that the person from whom the genetic material was extracted had property rights over his genetic information (and not over his genetic material). In another case, a person sued a direct-to-consumer (DTC) genetic testing company for making his DNA ancestry tests available online. (25) The court acknowledged that he had property rights over his genetic information.

The second approach implies that the ownership interests of other entities--but not those of the person from whom an individual genome was extracted--should be legally recognized. (26) Similar to the first approach, scholars use different theoretical grounds to justify their views. Different scholars raise the importance of innovation and scientific research and emphasize on researchers' crucial role in advancing scientific knowledge. (27) They assert that we must minimize roadblocks to research and have simple and inexpensive access to an individual genome. In "the new era of biomedical technology," they insist, "it is critically important for the law to facilitate tissue transactions efficiently." (28) Several scholars argue for the valuelessness of an individual genome in its natural state (i.e., its unaltered form), noting that this resource becomes valuable only after we have done something with it; people themselves only inhabit their bodies and have not done anything to create an individual genome. (29) Other scholars explain that an individual genome does not have value in isolation; its value comes "from being part of the larger collection." (30)

This second approach has also been heavily utilized across legislative and judicial institutions in the United States. (31) For many years, courts and legislatures have refused to assign property rights to the person from whom an individual genome was extracted while simultaneously legally recognizing--explicitly or implicitly--the ownership interests of other entities. For example, a de facto property regime has emerged through laws that enable different entities to exert extensive control over genetic material and/or information. (32) In addition, in several cases, the courts deemed--again explicitly or implicitly--that genetic material and/or information could be the property of other entities, such as researchers and law enforcement officials. (33)

The existing approaches have notable features in common. First, both protect rights that are proprietary in nature, (34) and situate an individual genome in a "zone" of liberty-rights and exclusivity. (35) Such rights boil down to the notion of exclusive rights, implying that third parties must "keep their hands off" an individual genome. Second, these approaches advocate "sole ownership" over an individual genome. (36) That is, they advance the perception of a single owner with unqualified dominion over an individual genome (37) and assume that multiple stakeholders cannot hold property rights over it. These approaches differ, however, in terms of the locus of decision-making authority over what happens with an individual genome. While the first approach designates the person from whom an individual genome was...