Legal issues and umbilical cord blood banking

Legal issues and umbilical cord blood banking

THE CENTRE FOR VALUES, ETHICS & THE LAW IN MEDICINE THE CENTRE FOR HEALTH GOVERNANCE, LAW AND ETHICS

This study

› 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

Cures (not treats)

› Lymphoma

› bone marrow failure syndromes

› Haemoglobinopathies

› Immunodeficiencies

From waste to wonder

› Resources – value – economy – law

- Oil

- Burking

- Enclosure

Autologous Transplantation

Allogenic transplantation

Public and private banking

› Private banking for autologous use

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?

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?

Research questions

mother or child after birth?

› Alternatively, should the placenta/umbilicus not be considered to be part of either the mother or child after birth?

Who can consent to UCB banking?

› Mother on behalf of herself

› Father on behalf of child/himself › Surrogate?

› Donors?

Research questions

banking and how should disputes about consent between parties be mediated?

Contracts and Private UCB banking

› 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

› 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

Research questions

banking?

› How are contractual rights held by the contracting parties?

› How do traditional contract doctrines apply to UCB banking contracts?

‘Informed consent’ and UCB banking

› Risks to child?

› Does it apply to contracts regarding medical services which do not effect the body?

Research Questions

banking?

› How relevant is the so-called doctrine of informed consent to UCB banking?

Property and UCB banking – the res nullius rule

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

Res nullius and the labour theory of value

› 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)

Exceptions to the res nullius rule

› 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

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?

Conditional and directed donation

› Public conditional/directed donation – arguments for? Against? › Private conditional/directed donation – arguments for? Against?

Research questions

Family law and UCB banking

› ‘Property’ covered by legislation

› 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

Research Questions

banked UCB would be divisible between parties at the end of their relationships?

Tort law and UCB banking

› Not effected by CLA

› Claims for failing to store UCB?

Tort law and UCB banking

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

Research questions

banking?

› How might the property law torts impact on the regulation of UCB banking?

Succession issues (both human and corporate) and UCB banking

› Death and inheritance law - Bazley v Wesley Monash IVF Pty Ltd [2010] QSC118

Research Questions

banking?

› How might the corporate insolvency of the bank impact on the regulation of UCB banking?

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

Public/private or public vs private banking?

› Benefits/detriments of private banking › Scope for hybrid models

Research questions

Review of draft research

questions

› Are these the sorts of questions that need answering?

Where to from here?

› Issues paper

› Comments and discussion

› Final submission paper › Conference