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Other topics in healthcare law and ethics

Joy WingfieldShort residential course

Session 10 September 13th 2006

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What topics?• Genetics and pharmacogenetics• Organisational and business ethics• Clinical trials in humans• Publication ethics• Biotechnological advances• Religious and cultural influences• Animal research• Global availability of medicines• Public health

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Genetics

• “The stuff of life” – media power• Genetic testing

– Pre-implantation, “saviour siblings”– Self-testing, reliability, risk and prediction– Effect on lifestyle, family and friends

• Genetic information– State interest– Individual and family interests– Other parties’ interests

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Pharmacogenetics

• Pharmacogenetic testing– Reliability, predictability, availability– Ethnicity, privacy, confidentiality– Counselling and support– Education and training needs– Scale of impact? Economics?– Prescribing requirement?– MUR requirement?

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Organisational ethics

• The culture – how we do things round here

• “Cues” and systems on how to think and how to behave

• Incentives, promotion, targets, budgets

• Conflicts of interest, stakeholders

• Feeling good about what you do

• Preserving professional judgement

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Let’s check your cynicism!

• In business, people will do anything to further their own interest

• Everyone working in hospital puts the patients’ interests first

• Financial gain is all that counts in business• Star ratings/tables are an honest reflection of

what happens in my organisation

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Business ethics

Exercise: describe the nature of the interests of these stakeholders– Patients– Customers– Employees– Owners/Investors– Suppliers– Competitors– Communities

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Ethics operates at all levels

• Individual behaviour and judgement• Managers reinforce or subvert culture

- Senior managers- Middle and junior managers- Pharmacists or not

• Board members set the organisational culture• Organisation creates an image to the outside

world

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Organisational issues

• Employment practice– fairness, trust, impartiality, transparency– hiring and firing, discipline– performance evaluation, rewards and penalties

• Not abusing obedience to authority• Diversity, cultural sensitivity• Use of corporate resources• Managing conflicts of interest• Managing group norms – “everyone’s doing it”

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Ethical systems

Formal• Leadership• Rules/policies• Reward systems• Selection criteria• Training• Decision processes

Informal• Norms• Heroes• Rituals• Myths/stories• Language

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Principles of human research

• Small risk compared with disease

• Disease is serious

• Knowledge gained has practical value

• No other way of gaining knowledge

• Patient gives valid consent

• Qualitative research?

• Research for the greater good?

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Research Ethics Committees

• Scientific merits• Subject dignity, rights, safety, wellbeing• Special licensing for

– Clinical trials– Gene therapy– Human embryology– Use of radioactive material– Animal experiments

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Pharmacists and Research

• Code of Ethics – says little• Therapeutic, clinical, biomedical• Sociological/non-clinical• Degree of intrusion

– Observation, interview, use of records, direct interference

• Methodology - qualitative or quantitative

• Subjects - children, mental disorder, dying

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Publication Ethics

• The purpose of publication– Enhance career, secure funding– Inform regulators, bias in data presentation– Promote product, persuade prescribers

• Suppression of information• Policy agreed with REC beforehand

– Recognition of role of participants

• Publication journals policy– What and when to publish

• Direct to consumer promotion

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New biotechnology

• The body as property

• Transplants, organ donation

• Use of stem cells– Therapeutic or cloning

• Brave New World surgery– Separation of conjoined twins– Limb transplants– Face transplants

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The body as property

• Who owns your body? Information about your body?

• Body parts, fluids and derivatives– Biochemical test material– Amputations, unwanted material– Sperm banks, stem cells, embryos

• Genetic information

• Commercial exploitation

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Some legal controls

• Human Fertilisation and Embryology Act 1990

• HFEA Authority – includes surrogacy, genetics

• Human Genetics Commission

• Human Tissue Act 2004

• Human Tissue Authority

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Religion and culture

• Pre-eminence of religious authority• Religious rites for burial, post mortem material• Religious routine and medication• Importance of family and patriarchal authority• Attitudes to understanding of disease• Status of women• Status of children and spiritual beliefs• ? ?

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Animal rights

• Should we eat animals? Animal welfare and husbandry

• Should we experiment on them? Which species? Under what conditions?

• Can they talk? Can they reason? Can they suffer? LD50, Draize test

• Essentially a utilitarian justification for animal experimentation

Peter Singer Practical Ethics … read on …

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Global availability of medicines

• Doing business– Culture: individualism

versus collectivism– Pay offs and bribes– Assumptions about

cultural homogeneity– Use of language:

straight talking

• Global inequality– Prices, suitability,

availability of drugs– Infant milk– Recruitment of health

professionals– Politics and human

rights

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Public health

• Patients or customers?• Consistency of messages – saturation• Nuffield Council inquiry

– Issues when designing measures to improve public health

– Individual choice, consent and solidarity– Criteria for allocation of resources– Perceptions of risk– Children, the poor and socially excluded

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The end is nigh!

• The quiz!

• The evaluation forms!

• The handing in of the keys!

• Who is having lunch?

• Safe journey