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Health Law

Conférence IRFP du June 2012. Health Law. Approach. A large choice of topics Your pick as to preferred subjects Especially for part 4. Rapid outline of the Swiss regulation of chosen topics Class discussion about adequacy of the legal regime Benefits and drawbacks Corrective measures

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Health Law

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  1. Conférence IRFP du June 2012 Health Law

  2. Approach • A large choice of topics • Your pick as to preferred subjects • Especially for part 4. • Rapid outline of the Swiss regulation of chosen topics • Class discussion about adequacy of the legal regime • Benefits and drawbacks • Corrective measures • Practical impact. • Comparison with other countries Prof. Junod – EMBA - Health Law

  3. Topics for discussion 1. Duties of physicians 2. Liability of physicians 3. Duties of medicalscientists 4. Specialhealthsectors 5. Conclusion Prof. Junod – EMBA - Health Law

  4. Legal health concerns you have encountered • Is it legal? • Will I be sued? • Should I do it here or abroad? • Can I sign this? Is it binding? • Should I get an authorization? • Should I be covered by insurance? • How long must I keep this? • To whom can I show this? • Should I speak up about what I’ve seen? Prof. Junod – EMBA - Health Law

  5. Part 1: Duties of physicians Prof. Junod – EMBA - Health Law

  6. What are the main obligations of physicians? Towards patients • Duty of best effort in care – duty not to harm • Duty of confidentiality • Duty to inform • Duty to obtainprior consent Towardthird parties • Duty to bill correctly • Dutytowardscolleagues Prof. Junod – EMBA - Health Law

  7. More about the obligations of physicians Towardthird parties • Duty to bill correctly • Dutytowardscolleagues • Duty to maintainskills and knowledge base • Maintaininsurance • Duty to keepsome distance with the industry • Don’taccept money, kickbacks, bribes • Don’trestrainyourfreedom (publication, independence) • Disclose Prof. Junod – EMBA - Health Law

  8. What the law says Prof. Junod – EMBA - Health Law

  9. Part 4: LIABILITY of physicians Prof. Junod – EMBA - Health Law

  10. When is a physician liable? The following conditions must beproven by the patient • The physician has breachedherduties (seeabove) • Usuallyeither: • failure to obtainpriorinformed consent • failure to exercise the best standard of diligence • The patient incurred a damage, including moral harm • The damage was the consequence of the breach To escape liability, the physician must prove: • That shecommitted no fault. • In practice very hard Prof. Junod – EMBA - Health Law

  11. What is most contentious? • Difficult to prove a lack of diligence • Medical expertise necessary • Difficult to find experts, • Independent experts • Contradictory opinions among experts • Have to go back to the situation at the time of medical intervention • Difficult to prove a causal link • Medical expertise also necessary • What about previous medical conditions of the patient? • Influencing on the bad outcome or bad recovery Prof. Junod – EMBA - Health Law

  12. Of note • All involved parties may be sued together or separately • E.g., hospital, main doctor, anesthesiologist, nurses, • If cantonal hospital: same rules apply • Fault of the patient may lead to a reduction in damages granted. • Civil procedure quite lengthy. • 3 levels, including Federal Tribunal. • No specialized court. • Penal procedure even more. • But sometimes easier to have someone else gather evidence. Prof. Junod – EMBA - Health Law

  13. Which solution for patients? • Easier to prove lack of informed consent • Physician has the burden of proof • Must absolutely keep proper files • But patients’ hypothetical consent widely admitted • Taking into account previous conduct, severity of disease, relationship with physicians, age, activity level. Prof. Junod – EMBA - Health Law

  14. Product liability • A separate law with a more generous regime • Can be combined with the regime of the CO • Conditions • A product (broadly understood) • A producer (broadly understood) • A defect • A damage (to anything, but the product itself or others products of commercial use) • A causal link between the defect and the damage • The absence of liberating evidence • Statute of limitations: 3 & 10 years • Jurisdiction: includes where the damage was incurred Prof. Junod – EMBA - Health Law

  15. Part 3: DUTIES OF MEDICAL SCIENTISTS Prof. Junod – EMBA - Health Law

  16. What are the main obligations of scientists? Towardsclinicalsubjects • Duty to obtainpriorinformed consent of subjects • Duty to update their information as needed • Duty to offert the best level of care, within the requirements of the protocol • Duty to remove a subjectfrom the study if needed • Usually must arrange for insurancecoverage for patients. What about? • Information about outcomes • Placebo • Long-termaccess to investigationaltreatment Prof. Junod – EMBA - Health Law

  17. What are the main obligations of scientists? Towardsthird parties or society: • Duty to abide by the protocol • Duty to obtainapproval of researchethicscommittee • Duty to (have the sponsor) obtain an administrative authorization • Duty to fill the formsproperly • Duty to report adverse events • Duty to report (publish) the resultsfully and fairly • Usuallyinsurancecoverage for the physician Prof. Junod – EMBA - Health Law

  18. Part 4: SPECIAL HEALTh SECTORS Prof. Junod – EMBA - Health Law

  19. In the health sector, Switzerland regulates • Medical research in general (future global law in 2013) • Medical products (drugs and medical devices + blood products) • Transplantation / transplants • Embryonic stem cells, but not adult cells (except at the collection stage & if used for transplantation) • Medically assisted reproduction • Genetic analyses • Chemical products, including nanoproducts • Genetically modified products (food or non-food) • Experiments on animals Of course also social security Prof. Junod – EMBA - Health Law

  20. Common principles • Objectives pursued: dignity & health of humans, animals and the environment • Precaution principle • Prohibitions based on ethical norms • Duty of diligence • Subsidiarity principle • As little commercialization as possible • Prior autorisation: varying requirements based on risk level • Regular reporting • Sometimes transparency for the public Prof. Junod – EMBA - Health Law

  21. Part 5: CONCLUSION Prof. Junod – EMBA - Health Law

  22. Thank you ! Questions ? Source: 2010 New Yorkerhere Prof. Junod – EMBA - Health Law

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