essential drugs in the philippines

ESSENTIAL DRUGS

in the

PhilippinesJoselito 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

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• “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 a health system to achieve better health outcomes for its people.” – World Medicines Situation, WHO, 2004

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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)

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• 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

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CURRENT SITUATION IN THE PHILIPPINES

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

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• 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.”

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Presenter

Presentation Notes

KP focuses on improving access to health care services and reducing poverty from catastrophic healthcare expenditures especially for the poor and most vulnerable population

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)

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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

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PHILIPPINE MEDICINES POLICY

• In line with the govt. policy to deliver UHC by 2016, the PhilippineMedicines 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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• 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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PHILIPPINE MEDICINES POLICY

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. Safety, Efficacy and Quality (SEQ) of medicines2. Affordability and Availability3. Rational Drug Use4. Accountability, Transparency and Good Governance5. Health Systems Support

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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

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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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Presenter

Presentation Notes

The FDA has a national database for gathering reports on adverse drug events in the country

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), goodstorage 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. Medicines Access Program (MAPs)2. Consignment3. Pricing policies4. TRIPS Flexibilities5. 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 diabetes2. 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 AFFORDABILITYVariants:

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

25 complete treatment regimens for the most common diseases: infections, hypertension, DM, asthma

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Presenter

Presentation Notes

ComPacks are pre-packaged medications that include complete doses of medicines for some of the most common diseases in the country. ComPack medicines comprise primarily generic drugs listed under the Essential Drug List whose price is significantly lower than that of the branded equivalents. Broadly, medicines included in the ComPack program have the following characteristics: 1) They help treat the leading causes of morbidity and mortality, 2) They adhere to clinical treatment guidelines, and 3) They are commonly-prescribed, fast-acting, and cost-effective. ComPacks are sourced from legitimate suppliers with valid Current Good Manufacturing Practice and a Certificate of Product Registration for the drugs included in the program. ComPacks are provided free of charge to PhilHealth’s Sponsored Program members and their dependents in PhilHealth-accredited health facilities, which receive quarterly supplies of the packs.

DOH COMPACK PROGRAM

• For out-patient care (to be interfaced with the PhilHealth Primary Care Benefit Packages)

• By 2013:To cover all RHUs nationwideTo include all PhilHealth sponsored members and indigenous people as

beneficiaries

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Cancer Medicines Access Porgram1. 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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• Other MAPs1. DOH Insulin Access Program2. Valsartan Access Program3. Geriatric Health Care Medicines Access Program4. Mental Health Care Medicines Access Program

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2. AVAILABILITY AND AFFORDABILITY

Presenter

Presentation Notes

The DOH Insulin Access Program, a program under the NCPAM MAP where partner pharmaceutical companies participate by providing access to affordable Insulin products through the consignment system, implementation of which was started in 2009. The DOH has concluded negotiations and discussion with Novartis Philippines having entered into a Memorandum of Understanding (MOU) dated May 28, 2009 under the MOU, Novartis will grant non-exclusive right to DOH market, promote and sell the Valsartan products under the mark "DOH Valsartan" in all DOH Hospitals and some Local Government Units (LGUs) pharmacies. Valsartan provides blood pressure (BP) reductions that last a full 24 hours greater with increasing baseline systolic BP and across diverse patients types and it is available at strengths of Valsartan 80 mg and Valsartan 160 mg film-coated tablets. This anti-hypertensive drug is still under patent until 2014 and has offered 50-60% cheaper compared to the prevailing market price.

• 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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Presenter

Presentation Notes

Policies must be followed to ensure transparency and competitiveness

• 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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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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Presenter

Presentation Notes

The current EDPMS is a computer-based solution with the functionalities to capture, process, store and generate reports on essential medicines prices and inventories from pharmaceutical companies. Furthermore, this will be able to monitor the point origin of medicines and the chain of custody from manufacturer to the dispensing pharmacy or drug outlets. Therefore, for the effective implementation and management of EDPMS, all stakeholders are directed to cooperate in providing relevant and timely information on essential medicines.

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

• 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

Presenter

Presentation Notes

The DPR is set at the Median or the 50th percentile across the range of prevailing tender prices of essential medicines. For medicines with less than four (4) manufacturers, the DPR may be set at the lowest winning bid price from a reputable supplier. Projected inflationary costs have already been considered in the calculation of the DPR. For innovator drugs approved for inclusion in the Philippine National Formulary, the price may be set by referencing with relevant international markets particularly those with similar income status (i.e. Thailand, India). It may also be informed by economic evaluations conducted in the Philippines used by the DOH to value their claimed clinical benefits and negotiate tender prices where an innovative pharmaceutical pro-duct has only one sole supplier

Highly Inefficient Public Sector Procurement

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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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g. Generics PolicyThe 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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• 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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Universally Accessible Cheaper & Quality Medicines Act of 2008 (RA 9502)

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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Presenter

Presentation Notes

Patents provide the patent owner with the legal means to prevent others from making, using or selling the new invention for a limited period of time, subject to a number of exceptions

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

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Trips flexibilities

Presenter

Presentation Notes

For example, in Mozambique 100 units of Bayer's ciprofloxacin (500mg) costs US$740, but in India Bayer sells the same drug for US$15 (owing to local generic competition). Mozambique can import the product from India without Bayer's consent.

2. Compulsory licensing• A govt. allows someone else to produce a patented drug without the

consent of the patent owner

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Trips flexibilities

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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• Basic tenets of RUM:1. Prescribing medicines only when these are necessary2. 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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• 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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• 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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Presenter

Presentation Notes

Summary of comparison of the AMR of selected organisms in 1993 and 2011

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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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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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4. ACCOUNTABILITY, TRANSPARENCY AND GOOD GOVERNANCE

Presenter

Presentation Notes

c. The government shall improve protocols for registration, selection, procurement, distribution and quality assurance of medicines to shorten time frames, reduce red tape, promote fair competition among suppliers and create an environment conducive to the improvement of medicines access.

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. Human resourcesb. Local research and developmentc. Medicines information systemd. Local govt. supporte. Public private partnerships

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Thank You for Listening.

essential drugs in the philippines

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