Other topics in healthcare law and ethics

1. Other topics in healthcare law and ethics Joy Wingfield Short residential course Session 10 September 13th 2006

2. 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

3. 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

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

5. 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

6. 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

7. Business ethics Exercise: describe the nature of the interests of these stakeholders • Patients • Customers • Employees • Owners/Investors • Suppliers • Competitors • Communities

8. 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

9. 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”

10. Formal Leadership Rules/policies Reward systems Selection criteria Training Decision processes Informal Norms Heroes Rituals Myths/stories Language Ethical systems

11. 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?

12. 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

13. 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

14. 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

15. 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

16. 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

17. Some legal controls • Human Fertilisation and Embryology Act 1990 • HFEA Authority – includes surrogacy, genetics • Human Genetics Commission • Human Tissue Act 2004 • Human Tissue Authority

18. 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 • ? ?

19. 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 …

20. 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 Global availability of medicines

21. 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

22. The end is nigh! • The quiz! • The evaluation forms! • The handing in of the keys! • Who is having lunch? • Safe journey