law is a body of norms (or rules of conduct) of binding force and effect, specified and enforced by a recognised authority. Law is used to create rights and duties, which should be applied fairly and consistently throughout society

1. AhmedRefat 2021 1
Prof. AhmedRefat AG Refat
• Community Medicine Department FOM-ZU 2021

2. Topics
• Common terms
• Health Laws in the 10 Essential Public Health Services (Old & New )
• UN Rule of Law Principle & The right to health is a human right
• Public Health Police Power
• Objectives of PP in Public Health Laws to achieve:
• ** Characteristics of public health law
• Power of Policy and Laws…..Real examples
• Hierarchy of Laws
• ** Health policy
• The Power of Policy, Systems, and Environmental Change
• Role of laws in Health Impact Pyramid
• Evaluating health laws:
• Legal and public policy tools
• Real Example & Exercise : How to use different legal models.
• Legal Epidemiology
• Some Egyptians Public Health Regulations
• Some international laws and regulations
AhmedRefat 2021 2

3. Some Relevant Terms
1. Law
2. Policy
3. Rule
4. Legislation
5. Regulation
6. Statue
7. Treaty
8. Case law
9. Tort
10. Bill
11. Decree
12. Standard
13. Code of
conduct
14. Guideline
15. Executive
order
16. Common
law
17. Ordinance
18. ‫التعريفات‬ ‫اذكر‬
‫الشائعة‬
‫والمعلومة‬
19. ‫التعريفات‬ ‫اذكر‬
‫المعني‬ ‫المتطابقة‬
AhmedRefat 2021 3

4. Health Laws in
the 10 Essential Public Health Services
AhmedRefat 2021 4

5. Essential Public Health Services
• The Ten Essential Public Health Services
fall into three categories that define the core
functions of public health:
A. Assessment
B. Policy Development
C. Assurance
AhmedRefat 2021 5

6. Essential Public Health Services
1994
• B. Policy Development:
• ___3. Inform, educate, and empower people about
health issues.
• ___4. Mobilize community partnerships to identify and
solve health problems.
• ___5. Develop policies and plans that support
individual and community health efforts.
• C. Assurance:
• ___6. Enforce laws and regulations that protect
health and ensure safety.
AhmedRefat 2021 6

7. EPHS-6
Enforce laws and regulations that protect
health and ensure safety.
• Enforce Laws
• This is the first portion of the assurance
component.
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8. • EPHS#5 The revised language includes mention
of the role public health plays in both
developing and championing policies, plans, and
laws and using them to correct historical
injustices and afford a fair and just opportunity
for all people to achieve optimal health. It
acknowledges the importance of including
health in all policies and adds preparedness and
community resilience.
• It maintains mention of community health
improvement planning processes.
AhmedRefat 2021 8

9. Revised EPHS 2020
• Essential public health service #6 focuses on
legal and regulatory actions. The revised
language adds the concept of equity and
expands responsibilities around the legal and
regulatory functions of the public health
system to protect communities from unsafe
food and water, hazardous conditions, and
exposure-related diseases that can cause
health crises
AhmedRefat 2021 9

10. Revised EPHS 2020
• The revised framework moves language about
licensing and monitoring the quality of
healthcare services (like labs and nursing
homes) and licensing and credentialing the
healthcare workforce from the original EPHS
#8 to here.
AhmedRefat 2021 10

11. UN Rule of Law Principle
• For the United Nations (UN) system, the rule of law is a principle of governance in
which …….all persons, institutions and
entities, public and private, including the
State itself, are accountable to laws that
are: publicly propagated, equally
enforced and independently adjudicated,
and which are consistent with…
• international human rights norms and
standards.
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12. The right to health
Core obligations :
• ensure the right of access to health services
without discrimination;
• ensure access to food that is safe and
nutritionally adequate and to ensure freedom from
hunger;
• ensure access to basic shelter, housing and
sanitation, and an adequate supply of safe and
potable water;
• provide essential medicines, as defined by WHO
from time to time;
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13. The right to health
obligations of “comparable priority”.
In addition to the core obligations
above, there are a number of
obligations of “comparable
priority”. These include the
obligations to:
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14. The right to health
Obligations of “comparable priority”.
• ensure reproductive, prenatal and postnatal
maternal and child health care;
• provide immunization for priority diseases;
• prevent, treat and control epidemic and endemic
diseases;
• provide education about the major health
challenges facing the community;
• provide appropriate training for health personnel.
AhmedRefat 2021 14

15. Police Power :UK
English common law principles
mandating the
“ limitation of private rights
when needed for the
preservation of the common
good”.
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16. Police Power:USA
• In US constitutional law, police power is the
capacity of the states to regulate behavior and
enforce order within their territory for the
betterment of the health, safety, morals, and
general welfare of their inhabitants
• Police power is the right to protect the
country and its population from threats to the
public health and safety
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17. • Police powers of the states are an expression of
civil authority, i.e., the state's ability to control,
regulate, or prohibit non-criminal behavior.
• Health officials may use these powers
to compel treatment, prohibit or direct
a particular conduct, or detain and
isolate in a quasi-criminal nature.
Communicable disease laws are
enacted under the police power.
AhmedRefat 2021 17
Police Power

18. Public health police power
allows the states to pass and
enforce isolation and
quarantine, health, and
inspection laws to interrupt or
prevent the spread of disease.
AhmedRefat 2021 18
Public Health Police Power

19. Objectives of PP in Public Health Laws to
achieve:
• (1) promote the public health, morals, or
safety, and the general well-being of the
community;
• (2) enact and enforce laws for the promotion
of the general welfare;
• (3) regulate private rights in the public
interest; and
• (4) extend measures to all great public needs.
AhmedRefat 2021 19
Public Health Police Power

20. Power of Laws
• laws exert a powerful force on all the social
determinants of health.
• Well designed laws can help build strong health
systems, ensure safe and nutritious foods, evaluate and
approve safe and effective drugs and vaccines, create
healthier and safer workplaces, and improve the built
and natural environments.
• However, laws that are poorly designed, implemented,
or enforced can harm marginalised populations and
entrench stigma and discrimination
AhmedRefat 2021 20

21. **Public Health Law **
The study of the legal powers and duties
of the state to assure the conditions for
people to be healthy (….) and the
limitations on the power of the state to
constrain the autonomy, privacy, liberty
proprietary, or other legally protected
interests of individuals for the protection
or promotion of community health.
AhmedRefat 2021 21

22. ** Characteristics of public health law
• 1. Government — Public health is a special
responsibility of government, in collaboration
with partners in the community, business, the
media and academia.
• 2. Populations — Public health focuses on the
health of populations rather than individual
patients.
AhmedRefat 2021 22

23. Characteristics of public health law
• 3. Relationships — Public health addresses
the relationship between the state and the
population (or between the state and
individuals who place themselves or the
community at risk).
• 4. Services — Public health deals with the
provision of population-based services
grounded on the scientific methodologies of
public health (e.g. biostatistics and
epidemiology).
AhmedRefat 2021 23
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24. Characteristics of public health law
• 5. Power — Public health authorities possess
the power to regulate individuals and
businesses for the protection of the
community, rather than relying on a near
universal ethic of voluntarism
AhmedRefat 2021 24
,

25. Power of Policy and Laws
The power of policy is illustrated by the fact that……every one
of
the top 10 public health achievements
in the last century was facilitated by……..
some sort of policy action to influence
practice.
AhmedRefat 2021 25

26. Power of Policy and Laws
1. Vaccination, which has resulted in the control or
eradication of smallpox, poliomyelitis, measles,
rubella, tetanus, diphtheria, Haemophilus
influenzae type b, and other infectious diseases;
2. Motor-vehicle safety (through safer vehicles and
highways, use of safety belts, child safety seats, and
motorcycle helmets, and decreased drinking and
driving), which has resulted in significant reductions
in motor vehicle related deaths;
AhmedRefat 2021 26
,

27. Power of Policy and Laws
3.Safer workplace (particularly in mining, manufacturing,
construction, and transportation), which has resulted in
significant reductions in fatal occupational injuries;
4.Control of infectious diseases (from clean water and
improved sanitation, and antimicrobial therapy), which
has resulted in the reduction of typhoid, cholera,
tuberculosis, and sexually transmitted diseases;
5.Decline in deaths from coronary heart disease and
stroke
• (through risk factor modification such as smoking
cessation, blood pressure control, and early detection);
AhmedRefat 2021 27
,

28. Power of Policy and Laws
6. Safer and healthier foods (from decreases in microbial
contamination and increases in nutritional content),
which has eliminated nutritional efficiency diseases such
as rickets, goiter, and pellagra;
7. Healthier mothers and babies (through better hygiene
and nutrition), which has resulted in significant infant and
maternal mortality reductions;
8. Access to family planning and contraceptives, which
has resulted in smaller family size, fewer infant, child, and
maternal deaths, and fewer HIV and STDs;
AhmedRefat 2021 28
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29. Power of Policy and Laws
9. Fluoridation of drinking water, which has
reduced tooth decay and tooth loss.
10.Recognition of tobacco use as a health
hazard, which has reduced smoking related
deaths.
AhmedRefat 2021 29
,

30. Basic
Concepts
& Terms
AhmedRefat 2021 30

31. Law
Law is a body of norms (or
rules of conduct) of binding
force and effect, specified and
enforced by a recognized
authority.
AhmedRefat 2021 31

32. Why Laws
Law is used to create rights
and duties, which should be
applied fairly and
consistently throughout
society
AhmedRefat 2021 32

33. Functions of Laws
how the law shapes societal
interactions.
1. Establishing norms and standards in
domestic and international law
2. Resolving disputes at national and
international levels
3. Governing public and private institutions
AhmedRefat 2021 33

34. Health Laws
Health law is the area of law
concerned with the health of
individuals and populations,
the provision of health care
and the operation of the health
care system
AhmedRefat 2021 34

35. ** HealthLaws
how health laws are used include laws that:
• establish the basis for organizing, governing
and financing a country’s health system;
• protect the public and social nature of
healthcare;
• protect public health from communicable
diseases or other public health risks;
AhmedRefat 2021 35

36. HealthLaws
how health laws are used include laws that:
• regulate the operation of hospitals, clinics or other
health services;
• regulate the safety and efficacy of medicines and
medical devices;
• protect patient rights;
• address non-communicable disease risk factors (e.g.
smoking);
• regulate the collection and use of health information.
AhmedRefat 2021 36

37. ** Public Health Law
The study of the legal powers and duties
of the state to assure the conditions for
people to be healthy (….) and the
limitations on the power of the state to
constrain the autonomy, privacy, liberty
proprietary, or other legally protected
interests of individuals for the protection
or promotion of community health.
AhmedRefat 2021 37

38. Hierarchy of Laws
AhmedRefat 2021 38

39. Some relevant concepts and terms
Constitution
• Establishes the innate characteristics of the
country and its authority; outlines the rights and
responsibilities of its citizens –
as such it is the supreme law.
• * All other laws must adhere to the constitution.
• * The constitution should reflect and adhere to a
country‟s international obligations.
AhmedRefat 2021 39

40. Hierarchy of Laws
Aconstitution
is considered as the supreme law in a country to
which all other laws must adhere.
AhmedRefat 2021 40

41. Some relevant concepts and terms
Presidential
Decrees/Executive Orders
• Executive orders are legally-binding
directives to an executive agency by the
president or other executive acting within his
or her constitutional authority.
AhmedRefat 2021 41

42. Hierarchy of Laws
Astatuteis a law made by a
legislature to govern society, and its
authority is derived from the constitution
or founding document of a country, which
authorizes the legislature to enact it.
AhmedRefat 2021 42

43. Hierarchy of Laws
Regulations
• are issued under the authority of a statute by
a division of the government or by a special
body . They are sometimes referred to as
“delegated” legislation, and they provide
administrative and technical detail to carry out
the purpose of the statute.
•
AhmedRefat 2021 43

44. Regulations
• Regulations are not laws themselves, but are
legal directives written to explain how to
implement statutes or laws.
• Regulations are written by executive branch
agencies at several levels
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Hierarchy of Laws

45. Hierarchy of Laws
Procedures
• describe the required steps necessary to
complete a process, and are generally written
by an administrative body to ensure that the
law and regulations are applied consistently
and fairly to all parties
AhmedRefat 2021 45

46. Some relevant concepts and terms
CodesofConduct
• * A written set of rules, principles or standards
to govern the behavior of certain groups.
• * Enforcement of codes of conduct depends
on whether they are considered “soft” or “hard”
law. Codes of conduct are considered “soft law”
when they are not passed by a lawmaking body
and thus rely on voluntary compliance.
AhmedRefat 2021 46

47. Some relevant concepts and terms
Guidelines, Instructions, and
Policies
• * Terms such as “guidelines” and “instructions” are
uncertain in meaning and can result in ambiguity,
particularly with regard to enforceability.
* “Policies” are broad, informative
statements of intent regarding principles to
be followed, priority of programs.
AhmedRefat 2021 47

48. Policies
aren’t laws, exactly, but are
more like guides.
They may influence how laws
are applied, or they may help
you to understand the laws
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49. ** Health policy
Health policy, refers to „decisions,
plans, and actions that are
undertaken to achieve specific
health care goals within a society‟
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50. ** Health policy
The WHO states that ‘an explicit health policy can
achieve several things:
1. it defines a vision for the future which in turn helps
2. to establish targets and points of reference for the
short and medium term.
3. It outlines priorities and the expected roles of
different groups;
4. it builds consensus and informs people‟
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51. **Policy
• The term “policy” is used in different senses related to
governance:
 General state policy – the political principles and direction
set by a government, which forms the basis of its
administration;
 Legislative policy – a statement of the political purpose to be
achieved with a new law, the way the purpose is to be
achieved and a set of instructions for the professional
legislative drafters who will draft a bill; and
 Administrative policy – statements and guidelines issued by
an authority regarding the way it intends to administer its
duties and exercise its discretion.
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52. Regulations …..Rules ….Laws
• Regulations and rules are pretty close to the
same thing. A regulation is a bit more formal
than a rule – it prescribes the required conduct or
action exactly
• Rules are used by agencies to “fill in the gaps” of
legislation. They implement, interpret, apply or
enforce a state or federal law or court decision. A
rule is adopted by an agency; a statute is a law
that is passed by the state Legislature.
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53. Bill ….Act….Law….Statue…Ordinance
• An Act is a law also; it is a bill which has
passed through the various federal or state
legislative steps required for it and which has
become law.
• Ordinances are laws created by local
“legislatures”, like city and county
governments.
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54. Some relevant concepts and terms
International Laws
• * Trans-border agreements that have
different impacts on the country‟s law,
depending on the treaty language and the
way a country‟s constitution manages them.
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55. Some relevant concepts and terms
Treaties
are agreements between two or more countries,
entered into after negotiation. Their purpose is to
create international rules or standards by which the
involved parties agree to abide. Much of international
law has been written and enforced through treaties.
Treaties have been used to end wars, foster trade
and promote human and civil rights, among other
goals.
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56. Treaties
• Certain international institutions have law-
making power. WHO has adopted two major
treaties under its Constitution:
1. the Framework Convention on Tobacco
Control (adopted under Article 19)
2. and the International Health Regulations
treaty (adopted under Article 21).18
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57. Common law or Case law
• Case law is law made by judges, who sit in
courts
• In making case law, judges apply relevant
statutes, regulations, and prior case law to the
factual situation.
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58. Common law or Case law
• Common law is not a level of hierarchy
per se, nor is it law on a particular
subject.
• Common law is law made by the courts,
not by the legislature.
• It consists of the judgments of courts,
and is also referred to as case law.
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59. Common law or Case law
This can be a judgment to interpret the wording
of statute law, to protect the principles of
natural justice, to fill a gap in the law, or to deal
with an unforeseen situation not covered by
statute.
The common law consists of written
decisions and the judgments may be cited
in subsequent litigation.
AhmedRefat 2021 59

60. Indirect regulation
Legal process/claim
Tort Litigation
Tort Liability
• indirect regulation
• (e.g., : tort litigation in tobacco); and
• Tort liability lawsuit brought by overweight
adults or children against fast-food chain.
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61. The Two
fundamental
tools for PH
issues
AhmedRefat 2021 61

62. Two fundamental tools
• Two fundamental tools that assist states in
the task of protecting people from threats to
health, preventing disease, and striving for
healthy populations, are
1.public health law and
2. public health policy.
AhmedRefat 2021 62

63. Health Impact Pyramid
AhmedRefat 2021
63

64. Context Changing
• Near the base of the pyramid, the section
labeled “Changing the Context to Make Default
Decisions Health”
• is achieved through “policy, systems and
environmental changes, “
• which includes modifying the environment to
make healthy choices practical and available to
all community members, as well as influencing
policy and legislation.
AhmedRefat 2021 64

65. Context Changing
By changing laws
and shaping landscape around us,
a big and sustainable impact can be
made, often with fewer resources
than one-time programmatic
interventions with limited reach.
AhmedRefat 2021 65

66. Evaluating health laws
1. Health laws must be evidence-based
2. Health laws must promote equity
3. Health laws must engage sectors beyond
health
4. Health laws must be supported by good
governance
AhmedRefat 2021 66

67. Health laws must be supported
by good governance
• transparency and openness;
• community engagement and inclusive
participation;
• monitoring and evaluation systems;
• honesty, non-corruption, and stewardship;
and
• accountability at all levels, from legislating,
through implementation, to enforcement.
AhmedRefat 2021 67

68. ** MODELS OF LEGAL
INTERVENTION
AhmedRefat 2021 68

69. Legal and public policy tools
1. Taxation, incentives, and spending
2. Changing the informational environment
3. Changing the built/physical environment
4. Changing the natural environment
5. Direct regulation
6. Indirect regulation
7. Deregulation
AhmedRefat 2021 69

70. Model 1: The power to tax and spend
Taxation, incentives, and spending
Tax relief can be offered for health-
producing activities such as medical
services, child care, and charitable
contributions.
At the same time, tax burdens can be
placed on the sale of hazardous products
such as cigarettes, alcoholic beverages,
and firearms.
AhmedRefat 2021 70

71. Model 2: The power to alter the
informational environment
• health education campaigns (e.g. safe driving,
.. nutritious diets);
• labelling requirements (e.g. instructions for
safe use, disclosure of contents, and health
warnings); and
• bans or limits on advertising harmful products
(e.g. cigarettes, firearms, or even high-fat
foods).
AhmedRefat 2021 71

72. • political and social speech (which deserve
rigorous legal protection)
• and commercial speech. The former is
necessary for a vibrant democracy, while the
latter is purchased and seeks primarily to sell
products for a profit
AhmedRefat 2021 72
Model 2: The power to alter the
informational environment

73. Model 3: The power to alter the built
environment
• Public health has a long history in designing
the built environment to reduce injury (e.g.
workplace safety, traffic calming, and fire
codes), infectious diseases (e.g. sanitation,
zoning, and housing codes), and
environmentally associated harms
(e.g. lead paint and toxic emissions).
AhmedRefat 2021 73

74. Model 3: The power to alter the built
environment
• Encouraging more active lifestyles
(walking, biking, and playing);
• Improving nutrition
(fruits, vegetables, and avoidance of high-fat, high-
caloric foods);
• decreasing use of harmful products
(cigarettes and alcoholic beverages);
• reducing violence
• (domestic abuse, street crime, and firearm use);
and increasing social interactions
(helping neighbours and building social capital)
AhmedRefat 2021 74

75. Model 4: The power to alter the
socio-economic environment
• people of low SES experience material disadvantage
(e.g. food, shelter, and health care); toxic physical
environments (e.g. poor conditions at home, work,
and community); psychosocial stressors (e.g.
financial or occupational insecurity and lack of
control); and social contexts that influence risk
behaviours.
• Society can work to try to alleviate each of these
determinants of morbidity and premature mortality.
AhmedRefat 2021 75

76. Model 5: Direct regulation of persons,
professionals and businesses
• Regulation of individual behaviour (e.g. use of
seatbelts and motorcycle helmets) reduces
injuries and deaths. Licences and permits enable
government to monitor and control the standards
and practices of professionals and institutions
(e.g. doctors, hospitals, and nursing homes).
• Finally, inspection and regulation of businesses
helps to assure humane conditions of work,
reduction in toxic emissions, and safer consumer
products.
AhmedRefat 2021 76

77. Model 6: Indirect regulation through
the tor t system
Civil litigation can redress many different kinds of
public health harms: environmental damage (e.g.
air pollution or groundwater contamination);
exposure to toxic substances (e.g. pesticides,
radiation, or chemicals); hazardous products (e.g.
tobacco or firearms); and defective consumer
products (e.g. children’s toys, recreational
equipment, or household goods).
AhmedRefat 2021 77

78. Model 7: Deregulation: Law as a
barrier to health
Sometimes laws are harmful to the public’s health
and stand as an obstacle to effective action.
In such cases, the best remedy is deregulation.
Politicians may urge superficially popular policies
that have unintended health consequences. Consider
laws that punish exchanges or pharmacy sales of
syringes and needles.
Restricting access to sterile drug injection
equipment can fuel the transmission of HIV
infection.
AhmedRefat 2021 78

79. LegalEpidemiology
• “ the scientific study and deployment of law
as a factor in the cause, distribution, and
prevention of disease and injury in a
population.
• Legal epidemiology is a transdisciplinary field
that relies on the collaborative efforts to
develop, implement, and evaluate the effects
of law.
AhmedRefat 2021 79

80. Legal Epidemiology
public health law has
focused on “what law says,”
and legal epidemiology
focuses on “what law does”
.
AhmedRefat 2021 80

81. LegalEpidemiology
• ” . Legal epidemiology supports the idea that
laws and legal practices can be studied using
theory and sound scientific methods, similar
to other social phenomenon that are
important to population health.
AhmedRefat 2021 81