Reframing Property in the Age of Genetics

Transcription

1 in the Age of Genetics Prof. Nils Hoppe Centre for Ethics and Law in the Life Sciences Leibniz Universitaet Hannover 22 January 2013

2 Outline What s the problem? How has this played a role in my research? What have the courts done about it? Is there actually a property problem or are we just being squeamish about terminology? Property as a framework Fast-moving regulatory targets and abstract frameworks Delineation issues in property Practical consequences Reframing property? 2

3 Property as a governance framework has been treated as problematic in the life sciences context Some of the current research methodologies (such as biobanks) test the robustness of property frameworks by working with a mixture of assets (health data, genetic information, original cells, reprogrammed cells, the database itself) The nature of some of these assets challenge classic notions of property where is the exact delineation between tangible and intangible And most importantly: is any of this actually a problem? 3

4 How has property played a role in my work? PropEur Property Regulation in European Science, Ethics and Law IPR in the life sciences Tiss.EU Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union - an Evidence-Based Impact Analysis tissues and cells for therapy REBIRTH From Regenerative Biology to Reconstructive Therapy solid organ transplantation, exoregeneration StemBANCC Stem Cells for Drug Discovery stem cell lines, reprogramming, differentiation 4

5 In what type of context do we encounter property issues? Practically: where, within a project, human biological material is transferred (material transfer agreements); when data are transferred between research institutions; wherever intellectual property is brought into a project, developed alongside, or within a project. Academically: where issues of rights, entitlements play a role in project governance (for example in biobanking, etc) 5

6 Biobanks as a particularly relevant research context Eclectic mix of property issues: Samples (cells, tissue) from source to biobank for storage; Samples from biobank to researcher for research; Health data about source from clinician to biobank; Pseudonymised health data from biobank to researcher; Whole exome / whole genome sequencing; In stem cell banking: reprogramming / differentiation / cell lines; The database itself as a sui generis right; Subsequent availability of samples / data to source for health reasons (cf. incidental findings). 6

7 How courts approached property issues in the life sciences in the past Undifferentiated between tangible / intangible Generally with the mindset that it s problematic : Moore v Regents of the University of California (rewarding dishonesty) Greenberg v Miami Children s Hospital Research Institute (poor contract work) Washington University v Catalona (misunderstanding gift principles) Brüstle v Greenpeace (creating far-fetched legal fiction to be impermissive) BGHZ 124, 52 "Spermakonserve (creating even more far-fetched legal fiction to ensure availability of a remedy) More promising: R v Kelly (Lockean fruits of labour) Yearworth v North Bristol NHS Trust (Gratuitous bailment) 7

8 But why is property problematic in this context? Nagging feeling that we are dealing with terminological unease rather than a technical legal problem. If so could this be a non-issue? If property, as a framework, is flexible enough to encompass even difficult assets (embryos, solid organs, live animals, bodies) is it merely the connotation of property terminology that causes the problem? Are we making a sufficient difference between propertisation and commodification and commercialisation? 8

9 Property as a framework Björkman & Hansson (2006) 9

10 Property as a framework If a human cell line is a tangible, movable object then simply by having control over it, there is already a property interest Property, understood as an abstract governance framework, is capable of describing any interaction between actors in relation to objects Fast-moving regulatory target fallacy: abstract law means there is no such thing as a legal vacuum (at most, there might be a barely breathable legal atmosphere but never a vacuum) 10

11 Delineation issues in property Range of different property interests in biobanks Significance of the tangible cells (/immortal cell lines) as a target for pharmaceutical research; Significance of the tangible cells as a medium for information. Reprogramming and differentiation of stem cell lines technically creates new property. This facilitates Moore scenarios dishonest appropriation, invest artful work, disenfranchise source? How do we allow patients to follow or trace their property? With the advent of affordable whole exome sequencing and whole genome sequencing, many research contexts will look more at the information contained in a sample than at the sample s tangible characteristics 11

12 Delineation issues in property This means that a tangible biological sample is a carrier of information; the arrangement of the molecules is the significant value of the asset How is this different to the arrangement of letters or numbers on, for example, a magnetic storage medium Is this a chose in action analogy? Are there two discrete property entitlements: (1) in the storage medium and (2) in the information (value) contained/represented? What does this mean for the actors? 12

13 Delineation issues in property Original source is the possessor of the cells, transfers possession to the researcher Researcher is interested in both the tangible cells as well as the information they may contain Who has an entitlement to the information? Is there an entitlement (or is it a res communis)? WES/WGS plus epigenetic data means that the information is utterly unique ultimately personal? Should we ask patients / research participants to transfer rights in both the cells and the information? Is seeking consent for genetic analysis sufficient to give rise to a transfer of an entitlement in the information? 13

14 Reframing property? How does our understanding of how property works hold up in the context of innovative biomedical research? Is property sufficiently abstract to permit the governance of unexpected developments? I think it is what needs to be reframed is how the users view property. Creating new instances of property in the same asset (tangible cells / intangible information) has more potential for exploitation than the application of property to human cells per se. As the tangible molecule is no longer of any interest, the original possessory entitlement in the molecule should sublimate to an entitlement in the information the molecules represent. 14

15 And what is all of this worth? The ultimate aim of the norms applied in this context should be to give equitable effect to each actor s rights. Resynchronising medical ethics and medical law means deploying norms to protect individuals autonomy. Current views of property tend to give protection to downstream uses of cells and information and exclude the original source. 15

16 And what is all of this worth? Property itself is not problematic the application of established ways of using these norms to new challenges without adaptation is problematic. Biomedical research is developing in a way which means that information is what it s all about cells are poor mediums for information, they will be replaced by other chemical or physical means of storing information once the data has been extracted. This means that we may have to reframe our thinking about property molecules are letters in the alphabet as well as tangible chemical connections. 16

17 1. Lenk, C; Hoppe, N; Beier, K; Wiesemann, C. (Eds.) (2011) Human Tissue Research. Oxford: OUP. 2. Kaye, J.; Stranger, M. (Eds.) (2009) Principles and Practice in Biobank Research. Aldershot: Ashgate. 3. Quigley, M. (in press) Property in Human Biomaterials: Separating Persons & Things? Oxford Journal of Legal Studies. DOI: /ojls/gqs Hoppe, N. (2009) Bioequity Property and the Human Body. Farnham: Ashgate. 5. Lenk, C; Hoppe, N; Andorno, R. (Eds.) (2007) Ethics and Law of Intellectual Property Current Problems in Politics, Science and Technology. Aldershot: Ashgate. 6. Björkman, B; Hansson, SO (2006) Bodily rights and property rights. J Med Ethics 32: Moore v Regents of the University of California 51 Cal. 3d 120, 271 Cal. Rptr. 146, 793 P.2d 479, cert. denied 499 U.S. 936 (1991) Greenberg v Miami Children s Hospital Research Institute 264 F. Supp. 2d 1064 (S.D. Fla. 2003) Washington University v Catalona 437 F.Supp.2d 985 (2006) Brüstle v Greenpeace C-34/10 BGHZ 124, 52 "Spermakonserve R v Kelly (1998) 3 All ER 741 Yearworth v North Bristol NHS Trust [2009] EWCA Civ 37 17

18 Database Directive For the purposes of this Directive, 'database` shall mean a collection of independent works, data or other materials arranged in a systematic or methodical way and individually accessible by electronic or other means. (Art. 1(2) EU Database Directive 96/9/EC) 18

19 Yearworth per Lord Judge CJ at para. 28 In his classic essay on "Ownership" (Oxford Essays in Jurisprudence, OUP, 1961, Chapter V) Professor Honoré identified 11 standard incidents of ownership but stressed that not all of them had to be present for ownership to arise. He suggested that the second incident was "the right to use" and he added, at p.116, that: "The right (liberty) to use at one's discretion has rightly been recognised as a cardinal feature of ownership and the fact that certain limitations on use also fall within the standard incidents of ownership does not detract from its importance " We have no doubt that, in deciding whether sperm is capable of being owned for the purpose which we have identified, part of our enquiry must be into the existence or otherwise of a nexus between the incident of ownership most strongly demonstrated by the facts of the case (surely here, the right, albeit limited, of the men to use the sperm) and the nature of the damage consequent upon the breach of the duty of care (here, their inability to use it notwithstanding that this was the specific purpose for which it was generated). 19

20 CELLS Centre for Ethics and Law in the Life Sciences Leibniz Universität Hannover Am Klagesmarkt Hannover Germany CELLS is a joint research centre of Hannover Medical School and Leibniz Universitaet Hannover 20