ESSENTIAL DRUGS in the Philippines Joselit Jose lito o Quin Quinitio itio,, 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 appropriate dosage forms.” – The use of essential drugs, WHO WHO,, 1990
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 appropriate dosage forms.” – The use of essential drugs, WHO 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 hour’s walk from the patient’s home that enable 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 t he 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 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)
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.”
KP’S 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)
KP’S 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
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
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)
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
5 PILLARS OF SARAH 1. Safety, Efficacy and Quality (SEQ) of medicines 2. A ffordability and Availability 3. R ational Drug Use 4. A ccountability, Transparency and Good Governance 5. Health Systems Support
SARAH Access Framework
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
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
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)
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
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
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
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)
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
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.
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 25
complete treatment regimens for the most common diseases: infections, hypertension, DM, asthma
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
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
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
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
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
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
2. AVAILABILITY AND AFFORDABILITY
EDPMS (http://uhmis4.doh.gov.ph/edpms)
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
DPRI
Highly Inefficient Public Sector Procurement
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
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
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
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
2. AVAILABILITY AND AFFORDABILITY h. TRIPS Flexibilities - Trade R elated 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)
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 Bayer ’s consent
Trips flexibilities 2. Compulsory licensing •
A govt. allows someone else to produce a patented drug without the consent of the patent owner
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
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
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)
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
3. RATIONAL USE OF MEDICINES (RUM)
3. RATIONAL USE OF MEDICINES (RUM)
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
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
3. RATIONAL USE OF MEDICINES (RUM)
3. RATIONAL USE OF MEDICINES (RUM)
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
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
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