Public Health & Medicine Policy

Public Health & Medicine
Policies
Rashid Mureed
Email:
rashid.Mureed@cepal.pk

Health Policy Defined
 Health policy refers to decisions, plans, and actions that are undertaken to
achieve specific health care goals within a society.
An explicit health policy can achieve several things: it defines a vision for
the future which in turn helps to establish targets and points of reference for
the short and medium term.
 Health policies are public policies or authoritative decisions that pertain to
health or influence the pursuit of health
 Health policies affect or influence groups or classes of individuals or
organizations
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2020
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ublic Health Policies

22 February 2020Public Health Policies
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Public vs. Private Policymaking
 Public Policy
 Policy that is established by the federal, state, and local levels of
government
 Private Policy
 Policy that is established by private organizations
 For example, AKUH Trust etc.
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2020

Forms of Health Policies
 There are four main forms of health policies:
 Laws/Regulations
 Operational Decisions
 Judicial Decisions
 Macro Policies
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2020

Laws/Regulations
 Formally recognized as binding or enforced by a controlling authority
 Regulations designed to guide the implementation of laws
 Organizations and agencies responsible for implementing laws
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2020

Operational Decisions
 Operational decisions are made by the executive branch of the government
as a part of the implementation of a law
 Normally these decisions consist of protocols and procedures that follow
the implementation of a new law
 These decisions tend to be less permanent than rules or regulations
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2020

Judicial Decisions
 These are policies that are created as a result of a decision made in the
court system
 Many judgments has been passed from various Courts in Pakistan related
to quality of products and healthcare system
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2020

Macro Policies
 Macro policies are broad and expansive and help shape a society’s
pursuit of health in fundamental ways
 Example
 DRAP regulation of pharmaceuticals
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2020

Categories of Public Health Policies
 Public health policies are grouped into two categories
 Allocative
 Regulatory
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2020

Allocative Policies
 Designed to provide net benefits to some distinct group of class of
individuals or organizations, at the expense of others(?), in order to
ensure that public objectives are met
 In general, allocative policies come in the form of subsidies
 Examples
 Federal Govt. aid to medical schools/colleges
 NGO’s
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2020

Regulatory Policies
 Policies designed to influence the actions, behaviors, and decisions
of others to ensure that public objectives are met
 Five main categories of regulatory policies
 Social regulations
 Quality controls on the provision of health services
 Market-entry decisions
 Rate or price-setting controls on health service providers
 Market-preserving controls
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2020

Social Regulations
 These regulations are established in order to achieve socially
desirable outcomes and to reduce socially undesirable outcomes
 Examples
 Environmental protection
 Childhood immunization requirements
 No smoking
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2020

Quality Controls
 These regulations are intended to ensure that health services
providers adhere to acceptable levels of quality in the services they
provide and that producers of health-related products meet safety
and efficacy standards
 Example
 DRAP regulation of pharmaceuticals
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2020

Market-entry Restrictions
 These regulations focus on licensing of practitioners and
organizations
 Example
 Certificate of Need programs
 New license for establishment of healthcare facility
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2020

Rate or Price-setting Controls
 These regulations are designed to control the prices of products or
healthcare services:
 Example
 The federal government’s control of the rates of product prices
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2020

Healthcare Costs Skyrocketed?
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 Demographic requires more care now
 Traditional fee services system encourage unnecessary tests
 Malpractices control cost pass to the patients
 Administrative cost add around 7% of the medicine cost of total spend
 Technological developments are expensive as are prescription drugs
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2020

Healthcare Reform Dilemma
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Assuring
Access
Preservin
g Quality
To
Ensure
all tasks
simultane
ously is
true
challenge
Controllin
g Cost
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2020

1. Legislation to ensure sustainability of
national Healthcare policies
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 Summary of key issues:
 Legislation are important, but administrative regulations, codes and
standards are useful instruments to manage the pharmaceutical sector.
 Wording of the law is important. There is a need to mandate what
governments are obliged to do.
 Political will is needed to enforce the rule of law.
 High profile legal action can serve as an effective deterrent to infringements
of healthcare-related law.
 Regulatory authority inspectors need adequate powers as well as training
and support to successfully implement laws and regulations.
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2020

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 Key barriers
 Lack of political will to maintain the expertise and adequate numbers of
qualified staff.
 Limited data on how laws are implemented, their effects and impact, and
how the law is broken.
 Corruption in some sectors has the potential to undermine regulatory and
enforcement efforts.
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2020

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 Key enablers
 Respect for the rule of law and body of law should support regulatory
agency functions. There should be effective enforcement of laws and
regulations.
 Training and support inspectors to gather the evidence required to facilitate
prosecution in the courts.
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 Steps to address barriers and enablers
 Greater collaboration between the legal and health sectors regarding
Healthcare law.
 Consider development of a regional taskforce to review national laws
relating to access to health facilities.
 Provide a forum to learn about sanctions that have been successful in the
Healthcare sector.
 How to monitor progress in implementation
 There should be routine monitoring and reporting on the staffing and
functions of regulatory agencies, and the outcomes of regulatory activities
including inspections.
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2020

2. Monitoring medicines use
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 Summary of key issues
 Medicines-related data are powerful and should be relevant to need. There
should be local level ownership and understanding of data. Start with
simple efficient systems and build on successes.
 Collecting and managing data requires a skill base. There is a need for
capacity building for data collection, analysis, interpretation and
presentation of results in formats suitable for feedback to decision makers
and other stakeholders.
 Medicines monitoring can be used to improve drug selection and
procurement, measure availability and affordability link to health outcomes
of therapy.
 Efficient and effective methods for monitoring are required with clear and
concise formats, agreed frequency of reporting, timeliness for decision
making, and feedback to stakeholders to facilitate the quality use of
medicines.
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 Key barriers
 Limited political and financial commitment to monitoring and a lack of
awareness of its value. There are few incentives to collect medicines-
related data.
 Limited workforce to undertake monitoring, data analysis and interpretation,
and limited budgets for training.
 Validity, relevance and usefulness of the data – timeliness of data provision
and analysis, lack of understanding of data limitations including the
representativeness of reports.
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 Key enablers
 Governments and other stakeholders need to ‘own’ the processes of
medicines monitoring, with clearly defined roles, responsibilities and
reporting cycles.
 Improved data quality with validated indicators is needed to assess
medicines affordability, availability and rational use. Reports and
presentations of key messages should be in simple formats for
dissemination to all stakeholders.
 Establish appropriate reporting cycles for health sectors based on available
resources.
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 Regular, routine use of medicines monitoring data derived from
standardized methods is needed to inform key stakeholders for clinical
practice, research, and to drive policy change.
 There needs to be regional sharing of medicines monitoring information
based on minimum data sets.
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2020

3. Consumer education and health
literacy
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 Patients are dependent on others (family, community, professionals, media)
for getting correct diagnosis and unbiased information.
 Health care should empower consumers to become health literate and
move beyond the paternalistic approach.
 Self-help can work – consumers can learn to understand medicine labels
and other basic concepts of over-the-counter medicines, in group sessions
with responsible media or peer-educators.
 The poor and older people are at special risk, but are more difficult to reach
with interventions and programs to develop health literacy.
 Social media and the internet are powerful channels of health and
medicines information and are widely accessible.
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 Key barriers
 Abundance of biased health and medicines information and promotion, and
relative lack of objective, understandable information on medicines and
their appropriate use.
 Key enablers
 Community-based organizations promoting appropriate use of medicines
and empowered, health literate consumers asking ‘WHY?’, and actively
seeking information on medicines.
 Access to unbiased information on medicines and health. Understanding
needs more than just good information – messages must be clear, simple,
objective and motivate for appropriate action
literacy
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2020

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 Government valuing health literacy as a national priority that provides long-
term health benefits for the nation.
 Consumer education programs to improve health literacy – health
education begins in schools.
 Community organizations and peer networks can support appropriate use
of medicines.
 Develop and evaluate tools to measure steps towards health literacy.
literacy
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 Maternal mortality rate remains alarmingly high in many developing
countries.
 Family planning is still an unfinished agenda.
 Reproductive health supplies are commonly out of stock at service delivery
points.
 Key barriers
 Lack of policies and adequate funding to support reproductive health
programs.
 Weak bureaucracies limit the implementation of agreed policies in some
countries.
 Complex systems of funding, multiple procurement agencies, logistics
operators, and reproductive health service providers hamper efficient
service delivery.
 ‘Silo’ approaches and fragmented systems contribute to duplication and
4. Opportunities for policy access to
medicines Collaboration
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 Key enablers
 Improved information and supply management systems.
 Collaboration in providing reproductive health services and
commodities, and essential medicines, through national medicines
policies.
 A regional policy framework needs to be developed and requires
commitment and implementation.
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 Political will and action are needed to align reproductive health activities
with national medicines policies and to build partnerships and collaboration.
 Reproductive health commodity supply management systems need
strengthening and integration to ensure security of supply and avoid stock-
outs.
 Human resource development to support, implement and maintain
programs.
 Regular monitoring and reporting on reproductive health program specific
indicators.
 Regional sharing of monitoring information based on comparable minimum
data sets.
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2020

5. Medicines selection and essential
medicines lists
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 Countries may start with either standard treatment guidelines or an
essential medicines list – evolves over time, as capacity increases within
the country.
 Need evidence to support the review standard treatment guidelines and
expertise to review and interpret the evidence – capacity issues exist in
many countries.
 Evidence should be used to both add and remove medicines from the
essential medicines list.
 Essential medicines list strategies need to plan for balancing the needs for
acute and chronic health conditions.
 Levels of standard or specialized treatment guidelines may be developed
according to country-specific needs.
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 Key barriers
 Lack of expertise to evaluate the evidence on medicines for inclusion in
essential medicines lists.
 Conflict between vertical program treatment guidelines and national
treatment guidelines.
 No established processes for removing medicines from the essential
medicines list once they are included.
 Key enablers
 Official approval and endorsement of the essential medicines list (by
national departments of health/WHO).
 Stakeholder involvement in the process from the outset creates ownership
of the essential medicines list.
medicines lists
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 Countries with limited capacity may start with the WHO Essential Medicines
List.
 National therapeutic committees need to play a role in the development and
approval of all guidelines and medicines lists that are to be implemented in
the country.
 Training in essential medicines lists and standard treatment guidelines
should be included in undergraduate health sciences programs.
 Regional collaboration in capacity development may accelerate progress.
medicines lists
22 February
2020

6. Ensuring quality of medicines
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 Quality medicines are an essential component of a national medicines
policy – industry needs to have an active role in ensuring quality products
are manufactured.
 Existing WHO pre-qualification processes are limited in scope – there is a
role for inter-country cooperation and collaboration to share manufacturing
quality information with the possibility of harmonization of standards.
 Capacity of individual countries is different, making a simple solution
difficult.
 Regulators require the financial and human resources to follow up and
enforce standards
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2020

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 Key barriers
 With so many products in the market, regulatory authorities have limited
capacity to assure quality.
 Mistrust between manufacturers and regulators (policing not partnership
role).
 Key enablers
 Strengthen regulatory authorities and where appropriate make use of
existing quality assurance schemes, policies, standards, and share
experiences between countries.
 Develop stronger relationships between responsible manufacturers and
regulators.
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2020

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 Member states should work with WHO to initiate regional discussions on
regulatory collaborations.
 Individual governments should encourage inter-agency and industry
collaboration to assess needs and develop capacity.
 Regular country level monitoring and reporting on results of regulatory
activities including inspections and product testing.
 Regional sharing of information on quality assurance activities.
22 February
2020

8. Medicine supply and distribution
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 Quantification and forecasting Lack of reliable, good quality data
 Inventory management systems Varying accuracy
 Manual operations do not provide real-time data capture
 Computer systems require staff training
 Often there are no alternative systems for managing when computer
systems are down
 Poor data recording leads to inaccurate and unreliable data
 Donor and vertical disease programs (for HIV, tuberculosis and malaria)
often use separate reporting systems
 Often poor linkage between stock management, essential medicines lists
and standard treatment guidelines.
 Issues in supply chain infrastructure Often inadequate human and financial
resources to run programs, along with limited & poor storage conditions
 May be no effective donation policies or guidelines in place or where these
exist they are not enforced
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2020

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 Key barriers
 Inadequate, untrained and inexperienced workforce and limited financial
resources.
 Lack of clearly articulated guidelines on ordering and supply management
along with fragmented supply and distribution systems.
 Key enablers
 Essential medicines lists and standard treatment guidelines to guide the
management of the supply and distribution system.
 Adequate financial and human resources and strengthening of existing
supply systems.
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 Develop and use consensus-based supply chain management guidelines
and standard operating procedures for every step of the supply and
distribution chain.
 Integrate and harmonize supply and distribution systems – recognise the
importance of resilient supply chain systems as part of a functioning
healthcare system.
 Core indicators of supply chain management should be used to measure
performance of the system at regular intervals.
22 February
2020

9. Generic medicines policies
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 Generic medicines are usually well established with respect to efficacy and
safety and are a key strategy used by governments to contain medicines
costs and improve affordable access to medicines.
 Key barriers
 Mistrust in the quality of generic medicine products – bioequivalence may
not be assessed.
 Lack of appropriately skilled inspectors and monitoring to ensure the quality
of generic medicine products.
 Poor acceptance by consumers and health professionals due to quality
concerns and misconceptions.
 Failure to fully implement generic substitution policies and guidelines.
 Interplay between innovator and generic medicines sponsors, creates
potential for conflicts of interest and opportunities for corruption
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2020

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 Key barriers
 Mistrust in the quality of generic medicine products – bioequivalence may
not be assessed.
 Lack of appropriately skilled inspectors and monitoring to ensure the quality
of generic medicine products.
 Poor acceptance by consumers and health professionals due to quality
concerns and misconceptions.
 Failure to fully implement generic substitution policies and guidelines.
 Interplay between innovator and generic medicines sponsors, governments
and healthcare professionals creates potential for conflicts of interest and
opportunities for corruption
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2020

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 Key enablers – the four Cs
 Coordinate the implementation of generic medicines policies including
procurement, retail price controls, and reference pricing to support the
uptake of generic medicines.
 Communication – regulators to make clear statements about the
procedures involved in approving generic medicines and promote trust in
the quality of generics to the community.
 Commitment to procedures and infrastructure to demonstrate, evaluate
and promote bioequivalence and maintain product quality to build
confidence in generic medicines.
 Community trust – educate public/consumers and health professionals to
support understanding and confidence in generic medicines, and allow
informed choices by consumers.
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2020

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 Integrate generic medicines policies within the broader framework of
national medicines policies and make active efforts to promote confidence
in their quality and use.
 Regular reporting on monitoring for the quality, price and use of generic
medicines.
 Assess changes in consumer and healthcare professional attitudes to
generic medicines.
22 February
2020

9. Antimicrobial resistance and rational
use of antibiotics
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 Antibiotic resistance is a growing but ‘invisible’ problem and it is a global
issue requiring immediate action.
 Contributors to antimicrobial resistance include: self-medication with
antibiotics, combined courses of treatment due to poor knowledge and
costs.
 Poor use of antimicrobials based on patient demand not clinical need.
 Poor use of up-to-date treatment guidelines, which are lacking altogether in
some countries.
 Inappropriate availability of antibiotics and use of sub-standard products.
 Widespread use in animals for food production.
 Global trade and travel that facilitate cross-border transfer of resistance
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2020

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 Key barriers
 Complexity – the dynamics of resistance, lack of knowledge and
surveillance, misguided expectations, economic incentives in health
systems and unregulated access in many settings.
 Overcrowding in hospitals, poor infection control practices, the lack of
reliable diagnostic tools and laboratory facilities mean infections may not be
correctly identified and treated.
 Time pressures when it is easier to prescribe an antibiotic than explain why
it is not needed
use of antibiotics
22 February
2020

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 Key enablers
 Government recognition of antibiotic ‘crisis’ and commitment to action and
resources including regulation of all actors in the supply chain including
quality assurance and sanctions.
 A prescriber ethos: ‘my individual behaviour impacts groups and systems
around me’.
 Communication material and processes that engage people emotionally in
the issue.
 Restricting access and therefore use of antibiotics by making them
prescription-only medicines.
use of antibiotics
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2020

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 Build partnerships and strengthen collaboration to make antibiotic
resistance visible, and connect the enablers in a resourced national
antibiotics policy platform to the national medicines policy.
 Training in antimicrobial resistance in undergraduate and continuing health
professional education programs to promote rational prescribing and
dispensing of antibiotics – link research projects and training.
 Policy platform for monitoring, evaluation (outcomes and impacts) and
course corrections
use of antibiotics
22 February
2020

10. Advertising and promotion
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 WHO ethical criteria are still relevant – the challenge is to embed an ethical
issues into the behaviors of pharmaceutical industry and health
professionals
 Country regulations (based on WHO code) need to be enforced, breaches
of codes and standards need to be appropriately penalized and publicized
to facilitate deterrence.
 The unregulated internet marketing of medicines poses challenges for
regulators and law enforcement – consumer education should discourage
online purchase of medicines.
 The boundaries of medicines advertising need to be well defined and the
limitations of pre-clearance of advertising material recognized.
 Promote transparency of medicines industry payments to health
professionals
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2020

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 Key barriers
 Increasing outlets for medicines advertising (TV, online).
 Monitoring advertising is a large and difficult task, especially for monitoring
evidence for claims made – regulations are difficult to enforce and penalties
need to be easily applied.
 Industry opposition to regulation of advertising and promotion of medicines.
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2020

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 Key enablers
 Develop ethical frameworks and monitoring of medicine advertising
compliance.
 Work with regulators and law enforcement agencies (Interpol for internet
activities).
 Use regulations rather than legislation – inform the public about violations
and sanctions.
 Strengthen pre-approval process for medicine advertising – increase
powers to enforce laws and regulations.
 Provide independent, objective information to health professionals and
consumers
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2020

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 Monitor medicines industry-sponsored activities including continuing
medical education, advocate for independent education arrangements, and
track complaints and sanctions applied.
 Development and regular reporting on indicators relating to regulation and
advertising.
 Monitor the processes of self-regulation to ensure standards are adequate
and appropriate independent mechanisms are in place to manage
breaches.
22 February
2020

WORLD HEALTH ASSEMBLY
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 To show effective leadership and ownership of the process of establishing
robust national or sub national health policies and strategies, basing that
process on broad and continuous consultation
 To base their national or sub national health policies, strategies and plans
on the
overarching goals of people-centred primary care and health in all policies
 To ensure that national or sub national health policies should be realistic
with respect to available resources and the capacities of staff and
institutions
 To ensure that national health policies, strategies and plans are integrated
with
disease or life-cycle programs, and are linked to the country’s overall
development and political ageda; 22 February
2020

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 To regularly monitor, review and adjust their national or sub national
health policies, strategies and plans with a view to developing
evidence-based responses to evolving challenges and
opportunities,
 To strengthen their institutional capacity, as appropriate, in
harmonizing and aligning donor programs with the national policies
 to promote the empowerment of all stakeholders, including civil
society and communities, the private sector, health professionals
and academics, to participate actively and efficiently in policy
dialogue
WORLD HEALTH ASSEMBLY
22 February
2020

Formulation and monitoring of comprehensive
national policies
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 National medicine policies
 Information and planning
 Access to essential medicines
 Transparency and good governance
 Intellectual property rights
 New global funding mechanisms
 Comprehensive supply systems
22 February
2020

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 Controlled drugs system
 Quality standards
 Prequalification system for tenders
 Pharmacovigilance
 Combating counterfeit medicines
 Rational use of medicines
Formulation and monitoring of comprehensive
national policies
22 February
2020

22 February 2020Public Health Policies
58

Public Health & Medicine Policy

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