Conf rence irfp du june 2012
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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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Conf rence irfp du june 2012

Conférence IRFP du June 2012

Health Law


Approach

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


Topics for discussion

Topics for discussion

1. Duties of physicians

2. Liability of physicians

3. Duties of medicalscientists

4. Specialhealthsectors

5. Conclusion

Prof. Junod – EMBA - Health Law


Legal health concerns you have encountered

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


Part 1 duties of physicians

Part 1: Duties of physicians

Prof. Junod – EMBA - Health Law


What are the main obligations of physicians

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


More about the obligations of physicians

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


What the law says

What the law says

Prof. Junod – EMBA - Health Law


Part 4 liability of physicians

Part 4: LIABILITY of physicians

Prof. Junod – EMBA - Health Law


When is a physician liable

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


What is most contentious

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


Of note

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


Which solution for patients

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


Product liability

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


Part 3 duties of medical scientists

Part 3: DUTIES OF MEDICAL SCIENTISTS

Prof. Junod – EMBA - Health Law


What are the main obligations of scientists

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


What are the main obligations of scientists1

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


Part 4 special health sectors

Part 4: SPECIAL HEALTh SECTORS

Prof. Junod – EMBA - Health Law


In the health sector switzerland regulates

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


Common principles

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


Part 5 conclusion

Part 5: CONCLUSION

Prof. Junod – EMBA - Health Law


Thank you

Thank you !

Questions ?

Source: 2010 New Yorkerhere

Prof. Junod – EMBA - Health Law


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