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Health Law, Policy, and Ethics

Richard Taylor, PhD, MPH

Learning Objectives
Explain the scope of health law, policy, and ethics. Identify key legal principles that form the basis for public health law. Identify four types of law. Explain the differences between market and social justice. Illustrate the potential tensions between individual rights and the needs for society using public health examples. Discuss key principles that underlie the ethics of human research.

Principles that underlie public health and healthcare law in the U.S.
1. The U.S. Constitution is a fundamental document that governs the issues of public health and healthcare law. 2. Interstate Commerce Clause of the U.S. Constitution is the major source of federal authority in public health and health care. 3. US. Constitution grants individual rights (explicit and inferred)

Four Sources of Law

Constitutional law Legislative statutes Administrative regulations Judicial, case, common law

Characteristics of Market and Social Justice

Market Justice
Views health care as an economic good Assumes free market conditions for health services delivery Assumes that markets are more efficient in allocating resources equitably Production and distribution of health care determined by marketbased demand Medical care distribution based on peoples ability to pay Access to medical care viewed as an economic reward for personal effort and achievement

Social Justice
Views health care as a social resource Requires active government involvement in health services delivery Assumes that the government is more efficient in allocating health resources equitably Medical resources allocation determined by central planning Ability to pay inconsequential for receiving medical care Equal access to medical services viewed as a basic right

Implications of Market and Social Justice

Market Justice
Individual responsibility for health Benefits based on individual purchasing power Limited obligation to the collective good Emphasis on individual wellbeing Private solutions to social problems Rationing based on ability to pay

Social Justice
Collective responsibility for health Everyone is entitled to a basic package of services Strong obligation to the collective good Community well-being supersedes that of the individual Public solutions to social problems Planned rationing of health care

Principles of the Nuremberg Code

1. The voluntary consent of the human subject is absolutely essential 2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature. 3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.

Principles of the Nuremberg Code

4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. 5. No experiment should be conducted where there is a prior reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

Principles of the Nuremberg Code

7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. 8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. 10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Willowbrook Hepatitis Study

From 1963 through 1966, Willowbrook State School for mentally defective persons. Studies to understand the natural history of infectious hepatitis and to test the effects of gamma globulin in preventing or ameliorating the disease. Children were deliberately infected with the hepatitis virus Investigators defended the deliberate injection of these children During the course of these studies, Willowbrook closed its doors to new inmates, parents found that they were unable to admit their child to Willowbrook unless they agreed to his or her participation in the studies. This case caused a public outcry because of the perception that parents and their children were given little choice about whether or not to participate in research

Declaration of Helsinki
June 1964 in Helsinki, Finland First significant effort of the medical community to regulate research itself Developed the ten principles first stated in the Nuremberg Code More specifically addressed clinical research Relaxation of the conditions of consent

Tuskegee Syphilis Study

1932-1972 Tuskegee, Alabama USPHS Enrolled 399 poor African-American men with syphilis from Macon County, Alabama Followed natural progression of disease despite treatment availability in 1940s.

Belmont Report1979
Led to the development of Institutional Review Boards (IRBs) Defines the rights of research subjects incorporating basic ethical principles:
Respect for Persons Beneficence Justice