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ESSENTIAL DRUGS

in the
Philippines
Joselito Quinitio, DDM

INTRODUCTION
Essential drugs are those that satisfy the health care needs of the
majority of the population; they should therefore be available at all
times in adequate amounts and in the appropriate dosage forms.
The use of essential drugs, WHO, 1990

Access to essential medicines pertains to the equitable and


sustainable availability and affordability of safe, efficacious and quality
medicines in a health facility or medicines outlet, within one hours
walk from the patients home that enable a health system to achieve
better health outcomes for its people. World Medicines Situation,
WHO, 2004

CURRENT SITUATION IN THE


PHILIPPINES
In the Philippines, about 3.84% of the Gross Domestic Product (GDP)
is spent on health care where 54.3% of health expenditures are paid
out of pocket (National Health Accounts, 2007)
65% of total out-of-pocket expenditures goes to medicines putting
more burden on the poorest quintile of the population (FIES, 2009)

CURRENT SITUATION IN THE


PHILIPPINES
2nd largest component of govt. expenditures in terms of payments
made through the National Health Insurance Program (NHIP) at
about 1/3 of all reimbursement made by PhilHealth in 2010
At least 30% of Filipinos lack regular and sustainable access to
essential medicines
In 2004, the World Medicines Situation Report identified the Philippines
as one of 64 countries worldwide with low to medium regular access
to essential medicines (WHO, 2004)
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CURRENT SITUATION IN THE


PHILIPPINES
Medicine prices in the Philippines have been historically high
compared to other countries
In 2006, a drug price survey by WHO and the Health Action
International revealed that Filipinos are among those who pay the
highest drug prices in Asia with innovator brands costing 16x more
and generic drugs costing 15x more when compared with
international reference prices

UNIVERSAL HEALTH CARE IN THE


PHILIPPINES
Universal Health Care (UHC) is the call and commitment of the
Philippine government to ensure that every Filipino has access to
quality and affordable health care
In 2011, the Kalusugan Pangkalahatan (KP) was launched by the
Aquino govt. to address the goal of the DOH to achieve UHC by 2016

KP is defined as the provision to every Filipino of the highest possible


quality of health care that is accessible, efficient, equitability distributed,
adequately funded, fairly financed, and appropriately used by an informed
and empowered public.

KPS 3 STRATEGIC THRUSTS


1. Achieve the health-related Millennium Development Goals
(MDGs) of improving maternal and child health and combating
priority infectious and non-communicable diseases
2. Provide financial risk protection through expansion in the
enrollment and benefit delivery of the National Health Insurance
Program (NHIP)

KPS 3 STRATEGIC THRUSTS


3. Improve access to quality health care which includes the
upgrading of public hospitals and health facilities, ensuring adequate
health human resources and securing the availability of essential drugs

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PHILIPPINE MEDICINES POLICY


In line with the govt. policy to deliver UHC by 2016, the Philippine
Medicines Policy (PMP) was adopted in 2011
PMP 2011 2016 is a comprehensive plan to ensure access to
essential medicines for all Filipino now and into the future

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PHILIPPINE MEDICINES POLICY


The overall responsibility for the management, monitoring and
evaluation of the PMP shall be the DOH-National Center for
Pharmaceutical Access and Management (DOH-NCPAM)

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SARAH MEDICINES ACCESS


FRAMEWORK
The SARAH Medicines Access Framework consists of the five
major pillars of the Philippine Medicines Policy
The 5 pillars cover all the components that are necessary to ensure
that essential and quality medicines are accessible and available to
achieve better health outcomes for all Filipinos especially the poor

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5 PILLARS OF SARAH
1.
2.
3.
4.
5.

Safety, Efficacy and Quality (SEQ) of medicines


Affordability and Availability
Rational Drug Use
Accountability, Transparency and Good Governance
Health Systems Support

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SARAH Access Framework


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1. SAFETY, EFFICACY AND


QUALITY (SEQ)
Includes all policies and strategies by the govt. to assure the safety,
efficacy and quality of essential medicines along the supply chain and at
all levels of care
Manufacture, packaging, procurement, import, export, distribution,
supply and sale of drugs, product promotion and advertising and
clinical trials strict adherence to standards of safety, efficacy and
quality

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1. SAFETY, EFFICACY AND


QUALITY (SEQ)
Food and Drug Administration (FDA) lead agency that develops
and implements regulations concerning safety, efficacy and quality of
drugs
Formerly was called Bureau of Food and Drugs (BFAD)
Enforces the laws and regulations concerning the drug regulatory
system involving all parties in the drug supply chain

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1. SAFETY, EFFICACY AND


QUALITY (SEQ)
FDA programs to ensure safety of drugs:
a. National Pharmacovigilance Program a system of reporting and
surveillance of adverse drug reactions, drug alerts or any event which brings
into question the safety, efficacy and quality of drugs (vaccines, medicines,
contrast media, herbal products and food supplements)

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1. SAFETY, EFFICACY AND


QUALITY (SEQ)
b. Combating counterfeit medicines
Counterfeit medicines medicinal products which are deliberately and
fraudulently mislabeled with respect to identity and/or source sold under a
product name without proper authorization
Coordination among govt. agencies such as Bureau of Customs. Philippine
Post Office, NBI, PNP, etc. and private sector to combat counterfeit
medicines
FDA is also tasked with educating the public on the dangers of using
counterfeit medicines
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1. SAFETY, EFFICACY AND


QUALITY (SEQ)
The FDA also enforces compliance of drug manufacturers and
distributors to Current Good Manufacturing Practices (cGMP), good
storage and distribution practices (GDP, GSP)
FDA also regularly conducts inspections of manufacturing plants and
health care facilities in relation to medicines quality assurance

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2. AVAILABILITY AND
AFFORDABILITY
The goal is to ensure the continuous availability of essential medicines
in the health care system at prices that are within reach of patients,
consumers and the govt.
Govt. programs to improve availability and affordability
1.
2.
3.
4.
5.

Medicines Access Program (MAPs)


Consignment
Pricing policies
TRIPS Flexibilities
Use of traditional and alternative medicines
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2. AVAILABILITY AND
AFFORDABILITY
Medicines Access Programs (MAPs) since 2011, DOH has
pursued free medicines access programs to the poor as a strategy
toward UHC
Priority Areas:
1. Outpatient drugs for common infections, hypertension and diabetes
2. Inpatient drugs for some catastrophic diseases such as breast cancer,
childhood acute lymphocytic leukemia (ALL)

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2. AVAILABILITY AND
AFFORDABILITY
MAPs for out-patient care:
a. Botika ng Barangay (BnB) a drug outlet with special license to operate
from the FDA to improve access to essential medicines especially by the
poor
Can be managed by community organization, NGO and/or LGU with a
trained operator and visiting pharmacist

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2. AVAILABILITY AND
AFFORDABILITY
Variants:
a. Botika Para sa Taumbayan a partenership with the Civil Service
Commission
b. Botika ng Manggagawa a partnership with the Philippine Government
Employees Association
c. Health Plus Outlet a partnership with the National Pharmaceutical
Foundation
d. Botika Binhi a partnership with the Kabalikat ng Botika Binhi, Inc.

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2. AVAILABILITY AND
AFFORDABILITY
MAPs for outpatient care:
DOH COMPLETE TREATMENT PACKAGES (COMPACKS)
Free drug access program for poor families covered by the Pantawid Pamilya
Pinoy Program (4Ps) introduced in 2011
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hypertension, DM, asthma

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DOH COMPACK PROGRAM


For out-patient care (to be interfaced with the PhilHealth Primary
Care Benefit Packages)
By 2013:
To cover all RHUs nationwide
To include all PhilHealth sponsored members and indigenous people as
beneficiaries

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Cancer Medicines Access


Porgram
1. Breast Cancer Medicines Access Program (BCMAP)
1,356 patients enrolled in 6 DOH hospitals

2. Acute Lymphocytic Leukemia in Children (ALLMAP)


867 patients enrolled in 14 DOH hospitals

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2. AVAILABILITY AND
AFFORDABILITY
Other MAPs
1.
2.
3.
4.

DOH Insulin Access Program


Valsartan Access Program
Geriatric Health Care Medicines Access Program
Mental Health Care Medicines Access Program

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2. AVAILABILITY AND
AFFORDABILITY
Medicine consignment system by the DOH allows government
health facilities to deliver essential medicines to patients at no cost to
the government
The consignment system must comply with systems and guidelines set
forth by the DOH and the Government Procurement Policy Board

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2. AVAILABILITY AND
AFFORDABILITY
Pricing Policy for Medicines
To ensure that essential medicines are affordable, the government
shall undertake the following measures:
a. Price Advisory Council monitors drug prices and recommends policy options
for fair and rational pricing of medicines
b. Voluntary Drug Price Reduction the govt. shall negotiate with the industry to
voluntarily reduce prices particularly for medicines included in the Essential
Drug List or the Philippine National Formulary

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2. AVAILABILITY AND
AFFORDABILITY
c. Medicines Price Board created to set and negotiate for fair and transparent
prices of all drugs in the national formulary
d. Electronic Essential Drug Price Monitoring System (e-EDPMS) and Drug Price
Reference Index (DPRI)
EDPMS is a computer-based monitoring system for the collecting,
submitting, processing and analyzing prices and inventories of drugs

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2. AVAILABILITY AND
AFFORDABILITY

EDPMS (http://uhmis4.doh.gov.ph/edpms)

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2. AVAILABILITY AND
AFFORDABILITY
Drug Price Reference Index (DPRI)
1. Lists the ceiling prices of essential medicines for government bidding and
procurement set by the DOH for all DOH Retained Hospitals and Regional
Offices
2. Aims to improve the efficiency and good governance in the pricing and
procurement of medicines in the public sector through establishing a
transparent and publicly available reference price for medicines
3. Helps guide PhilHealth in setting reimbursement caps for medicines both for
inpatient and outpatient services

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DPRI
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Highly Inefficient Public


Sector Procurement

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2. AVAILABILITY AND
AFFORDABILITY
e. Special discounts for medicines for seniors and PWDs
f. Tax incentives such as lower taxes for pharmaceutical companies or
exemption from taxes, tariffs or duties on life-saving medicines to
lower cost for patients

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2. AVAILABILITY AND
AFFORDABILITY
g. Generics Policy
The primary instrument recognized by the govt. to reduce prices of medicines
is effective competition and the active promotion, adoption and use of
generics
Generic medicines health products that have the same quality and efficacy as
branded innovator drugs but give patients more choice because of their lower
price

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Generics law of 1988 (ra 6675)


Promotes, encourages and require the use of generic terminology in
the importation, manufacture, distribution, marketing, advertising and
promotion, prescription and dispensing of drugs
Ensures the adequate supply of drugs with generic names at the
lowest possible cost and endeavor to make them available for free to
indigent patients
Encourages the extensive use of drugs with generic names through a
rational system of procurement and distribution
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Universally Accessible Cheaper &


Quality Medicines Act of 2008 (RA 9502)
Gave the govt. instruments to ensure the affordability of drugs to
patients and consumers
Power to set maximum retail prices of drugs sold in the Philippines as
a consumer protection pillar
Power to invoke TRIPS flexibilities particularly for public health
emergencies and other situations as deemed necessary by the
Secretary of Health
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2. AVAILABILITY AND
AFFORDABILITY
h. TRIPS Flexibilities - Trade Related Aspects of Intellectual
Property Rights
TRIPS is a comprehensive global (WTO) agreement in the field of
intellectual property and covers a wide range of subjects; patents for
pharmaceutical products are only part of the agreement
The TRIPS agreement provides flexibility for governments to change the
protection for patented products in order to meet social goals (e.g. health
crises, national emergencies)

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Trips flexibilities
1. Parallel importation of patented drugs
Parallel imports are imports of a patented or trademarked product
from a country where it is already marketed.
Mozambique 100 units of ciprofloxacin (Bayer) costs US$740
India 100 units of ciprofloxacin (Bayer) costs US$15
Mozambique can import the product from India without Bayers consent

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Trips flexibilities
2. Compulsory licensing
A govt. allows someone else to produce a patented drug without the
consent of the patent owner

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2. AVAILABILITY AND
AFFORDABILITY
i.

Use of Traditional and Alternative Medicines


Traditional and alternative medicines approved by the DOH give patients
wider choices to low cost and effective treatment while providing a local
source of livelihood and income to local manufacturers

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3. RATIONAL USE OF MEDICINES


(RUM)
RUM is the condition where patients receive medicines appropriate for
their clinical needs, in doses that meet their individual requirements, for
an adequate period of time and at the lowest possible cost to them and
their communities WHO
The goal of RUM is to promote quality use of drugs in the public and
private sectors using cost-effective and rational treatments that will
result in the best health outcomes for patients

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3. RATIONAL USE OF MEDICINES


(RUM)
Basic tenets of RUM:
1. Prescribing medicines only when these are necessary
2. Prescribing medicines appropriately (correct dosage and proper length of
time)
3. Considering the benefits of administering medicines in relation to the risks
involved (risk benefit)

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3. RATIONAL USE OF MEDICINES


(RUM)
The key strategy under RUM is the development and implementation
of a Philippine National Drug Formulary (PNDF) (Essential Drug
List of the Philippines)
The PNDF is a list of essential medicines deemed important to
address the primary health care needs of Filipinos
It is the basis of all government procurement of medicines and
reimbursement of drugs of PhilHealth
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3. RATIONAL USE OF MEDICINES


(RUM)

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3. RATIONAL USE OF MEDICINES


(RUM)

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3. RATIONAL USE OF MEDICINES


(RUM)
Movement to combat AMR (anti-microbial resistance) by raising
awareness on the growing threats of AMR, promoting the responsible
use of antibiotics and preventing the spread of infections
AMR is simply the ability of microbes, to grow in the presence of a
chemical, or a drug, that would normally kill it or inhibit its growth

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3. RATIONAL USE OF MEDICINES


(RUM)
The DOH established the Antimicrobial Resistance Surveillance Program
(ARSP) in 1988 to determine the current status and developing trends
of AMR

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3. RATIONAL USE OF MEDICINES


(RUM)

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3. RATIONAL USE OF MEDICINES


(RUM)

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4. ACCOUNTABILITY, TRANSPARENCY
AND GOOD GOVERNANCE
The goal is to institutionalize transparency, accountability and good
governance along the registration, regulation, selection, procurement
and management of medicines in the health sector
These measures shall be pursued through the following mechanisms:
a. Access to information there shall be transparent data and information
sharing among all the agencies, manufacturers, retailers, service providers
and consumer groups with regard to medicine prices, drug registration
status, status of regulatory compliance and other critical transactions,
decisions and processes with regard to medicines
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4. ACCOUNTABILITY, TRANSPARENCY
AND GOOD GOVERNANCE
b. Managing conflicts of interests the DOH shall provide a clear criteria in
the selection and appointment of members to decision making committees
(Formulary Executive Council, Bids and Awards Committees, Drug
Therapeutic Committees)
c. Efficient, transparent and accountable processes
d. Standards of good governance a rewards and incentives system shall be
developed and implemented for Good Governance in Medicines

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5. HEALTH SYSTEMS SUPPORT


The goal is to ensure that there is adequate health systems support
from the govt. and all stakeholders to ensure the effective
implementation of the PMP in the following areas:
a.
b.
c.
d.
e.

Human resources
Local research and development
Medicines information system
Local govt. support
Public private partnerships

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Thank You for Listening.

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