Chapter 1

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  1. Definition of law
    Requirements for human conduct applying to all persons within their jurisdiction
  2. Factors courts commonly apply in reaching decisions
    • Fundamental notions of fairness
    • Custom or history involved
    • Command of a political entity
    • Best balance between conflicting societal interests
  3. Reason To Regulate Drugs
    •  Public goods
    •  Externalities
    •  Natural monopolies
    •  Information asymmetry
  4. Public Goods are
    •Necessary and beneficial commodities products that private entities will not supply because there is no incentive for a private entity to provide them.

    •Examples: Orphan drugs, vaccines, parks, highways
  5. Why do we consider Orphan drugs as public goods?
    • Drugs that the number of patients who need them is so small that it is not commercially feasible.
    • Government must step in to ensure their availability for those who need them.
  6. Whey do we consider Vaccines as public goods?
    • They benefit society as a whole by preventing epidemics, but because of acute reactions to them, they are
    • viewed as too risky by many individuals. 
    • Prevention of epidermics is a public good and government must regulate by requiring vaccinations.
  7. Whey do we consider Externality as public goods?
    • - When the production or consumption
    • of a good affects someone who does not fully consent to the effect
    • - When the costs of the good are not fully incorporated in the price of the good

    - Example: Indiscriminate use of antibiotics
  8. Whey do we consider Monopoly as public goods?
    • When the fixed costs (business expenses) of providing a good are high relative to the variable costs of producing the good.

    • Example: Patents and market exclusivity for new drugs
  9. Whey do we consider Information Asymmetry as public goods?
    • • When the consumer is uniformed about the true value of a good
    • •Consumers are unable to determine
    • the medications value even after using them
    • Government regulations require the provision of information and input by educated professionals into decisions about drug use
    • • Examples: Prescription only drugs;
    • written consumer information for certain drugs
  10. Limits of the law
    • •Certain human relationships, in families or religious groups
    • •De minimis violations (very minor violations)
    • •Protecting individual freedoms while preventing harm to others.
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Chapter 1

Chapter 1
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