June 2012 Health Law Conférence IRFP du June 2012

June 2012

Health Law

Conférence IRFP du June 2012

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

June 2012Prof. Junod – EMBA - Health Law2


Topics for discussion

1. Duties of physicians

2. Liability of physicians

3. Duties of medical scientists

4. Special health sectors

5. Conclusion

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?


PART 1: DUTIES 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 obtain prior consent

Toward third parties•Duty to bill correctly•Duty towards colleagues


More about the obligations of physicians

Toward third parties•Duty to bill correctly•Duty towards colleagues•Duty to maintain skills and knowledge base•Maintain insurance•Duty to keep some distance with the industry

– Don’t accept money, kickbacks, bribes– Don’t restrain your freedom (publication, independence)– Disclose


What the law says


PART 4: LIABILITY OF PHYSICIANS


When is a physician liable?

The following conditions must be proven by the patient•The physician has breached her duties (see above)

– Usually either:• failure to obtain prior informed 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 she committed no fault.

– In practice very hard


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


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.


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.


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


PART 3: DUTIES OF MEDICAL SCIENTISTS


What are the main obligations of scientists?Towards clinical subjects•Duty to obtain prior informed 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 subject from the study if needed•Usually must arrange for insurance coverage for patients.

What about?•Information about outcomes•Placebo •Long-term access to investigational treatment


What are the main obligations of scientists?Towards third parties or society:•Duty to abide by the protocol•Duty to obtain approval of research ethics committee•Duty to (have the sponsor) obtain an administrative authorization•Duty to fill the forms properly •Duty to report adverse events•Duty to report (publish) the results fully and fairly•Usually insurance coverage for the physician


PART 4: SPECIAL HEALTH SECTORS


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


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


PART 5: CONCLUSION



Thank you !

Questions ?

Source: 2010 New Yorker here

Documents

June 2012 Health Law Conférence IRFP du June 2012