Legal issues and umbilical cord blood banking

Transcription

1 Legal issues and umbilical cord blood banking Prof Cameron Stewart THE CENTRE FOR VALUES, ETHICS & THE LAW IN MEDICINE THE CENTRE FOR HEALTH GOVERNANCE, LAW AND ETHICS

2 This study Empirical bioethics NHMRC funded - $400K Prospective Survey of consumers (4000+) Retrospective survey (2000+) Interviews (70+) Expert Legal Panel Workshop Conference Religious advice Jewish, Catholic, Protestant, Hindu, Islam, Buddhist Issues Paper 15+ publications/ JLM

3 What is cord blood?

4 What are stem cells?

5 Cures (not treats) Leukaemia Lymphoma bone marrow failure syndromes Haemoglobinopathies Immunodeficiencies Inborn errors of metabolisms.

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7 From waste to wonder Hasn t this happened before...? Resources value economy law - Oil - Burking - Enclosure What is the practice?

8 Your cord blood, your stem cells Autologous Transplantation

9 Someone else s stem cells, tissue compatible with you Allogenic transplantation

10 Public and private banking Public banking for allogenic use Private banking for autologous use Or is it really?

11 Status of the umbilicus and UCB mother/child Mother/child Seymour not one but not two Placenta and umbilicus as part of mother before birth R v King; R v Iby; the Finlay Report 2003 definition of GBH, Current 2010 inquiry into death of Zoe Ball?

12 Status of the umbilicus and UCB mother/child Born alive rule does it become part of the child after satisfying born alive rule? Does it matter when the placenta is released? Before or after clipping of umbilicus? Flow on issues for tort, eg negligent collection? Crime theft?

13 Research questions Should the placenta/umbilicus be considered in law to be part of the mother or child after birth? Alternatively, should the placenta/umbilicus not be considered to be part of either the mother or child after birth?

14 Who can consent to UCB banking? Mother on behalf of child (fiduciary model/trust model?) Mother on behalf of herself Father on behalf of child/himself Surrogate? Donors? Person paying for it? Eg Nanna?

15 Research questions Who is the most appropriate person to ask for consent to UCB banking and how should disputes about consent between parties be mediated?

16 Who is the UCB banking contract with? What rights does the child have? What rights do parents have and how are they held? Conflict between parties? Use for another person eg sibling? Fiduciary duties and UCB Contracts and Private UCB banking Trusts and UCB (contractual rights held on trust? Effect on doctrine of privity?) Fair trading laws TPA, FTA Contracts between UCB banks Glyka v New England Cord Blood Bank 2009 US Dit LEXIS 55608

17 Research questions Who is the most appropriate person to contract with for UCB banking? How are contractual rights held by the contracting parties? How do traditional contract doctrines apply to UCB banking contracts? How are they effected by fair trading legislation?

18 Informed consent in Australia Risks to child? Informed consent and UCB banking Does it apply to contracts regarding medical services which do not effect the body? Impact of medical records law?

19 Research Questions What is the appropriate level of information to provide donors about UCB banking? How relevant is the so-called doctrine of informed consent to UCB banking?

20 Property and UCB banking the res nullius rule Human tissue cannot be the subject of property Professor Loane Skene (2002; 2007) is a leading advocate of why property rights should not be recognised in human tissue. She states that following public policy issues justify the law s failure to recognise property rights (2004: 166): - emotional (a repugnance at people selling their bodies and body parts); - familial (stored genetic material should be available to blood relatives for their own testing, not subject to veto by one person); - pragmatic (the possible consequences of such a principle for hospitals and laboratories); - economic (undue fettering of teaching, research and commercialisation of biological inventions); and - social (maintenance of museum collections and educational institutions)

21 Res nullius and the labour theory of value Doodeward v Spence (1908) 6 CLR 406 Dobson v North Tyneside Health Authority [1997] 1 WLR 596 R v Kelly [1999] QB 621 Moore v Regents of University of California 793 P 2d 479 (Cal 1990) Greenberg v Miami Children s Hospital 264 F Supp 2d 1064 (2003) Washington University v Catalona 437 F Supp 2d 985 (2006)

22 Exceptions to the res nullius rule McStay v. Minister for Health and Children [2006] IEHC 238 Stevens v Yorkhill NHS Trust [2006] ScotCS CSOH 143 Caufield v Wong 2005 ABQB 290 Yearworth v North Bristol NHS Trust [2009] EWCA Civ 37 Bazley v Wesley Monash IVF Pty Ltd [2010] QSC118

23 Should UCB be treated as property? Research Questions If UCB is treated as property at what point does it become property? Is the proprietary nature of UCB dependant on the labour theory or is UCB able to be considered property on some other basis?

24 Conditional and directed donation Conditional vs directed donation private and public UCB banking Public conditional/directed donation arguments for? Against? Private conditional/directed donation arguments for? Against?

25 Research questions To what extent should private and public UCB banks allow donors to place directions and conditions on the storage of UCB?

26 Family law and s 79 FLA Property covered by legislation Family law and UCB banking Kennon v Spry (2008) wide scope to consider rights as property Marriage of Nash 2009 Wash App LEXIS 1272 contract for UCB/IVF stated that woman would control UCB/embryos on divorce later proceedings was agreed between parties to allow the court to settle the issue

27 Research Questions Would the Family Law Act definition of property include UCB so that banked UCB would be divisible between parties at the end of their relationships?

28 Tort law and UCB banking Property torts (trespass, detinue and conversion) and negligence Not effected by CLA Claims for failing to store UCB? Claims for negligent collection/transport/ storage?

29 Tort law and UCB banking Polsecuk v CBR Systems Inc 2006 US Dist LEXIS cord blood was property for the purpose of negligent carriage laws Christopher v Pharmastem Therapeutics 824 NYS 2d 761 (2006) refusal to collect blood because doctor was warned of patent infringement cause not struck out Wolfe v Virginia Birth Related Neurological Injury Compensation Board 580 SE 2d 467 (2003) failure to collect and store UCB give rise to adverse presumption that injury cuased by negligent birth

30 Research questions How might the law of negligence impact on the regulation of UCB banking? How might the property law torts impact on the regulation of UCB banking?

31 Succession issues (both human and corporate) and UCB banking Death and inheritance law - Bazley v Wesley Monash IVF Pty Ltd [2010] QSC118 Corporate insolvency contract? licensing?

32 Research Questions How might the law of succession impact on the regulation of UCB banking? How might the corporate insolvency of the bank impact on the regulation of UCB banking?

33 Research questions Therapeutic goods law and UCB banking How is the practice of UCB regulated by licensing of providers? How do the provisions regarding the licensing of products effect the practice of UCB banking

34 Public/private or public vs private banking? Benefits/detriments of public banking Benefits/detriments of private banking Scope for hybrid models

35 Research questions What does the Australian experience tell us about the arguments regarding the appropriate mix of public and private UCB banking?

36 Review of draft research questions Are these the sorts of questions that need answering? What other questions need to be asked? Intellectual property?

37 Where to from here? Issues paper Comments and discussion Final submission paper Conference Papers into monograph/special issue