04 ensuring access to safe, affordable and quality essential medicines - dr. edelina padilla-dela...

8/14/2019 04 Ensuring Access to Safe, Affordable and Quality Essential Medicines - Dr. Edelina Padilla-Dela Paz

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Ensuring Access to Safe, Affordable

and Quality Essential Medicines

Edelina Padilla-Dela Paz, M.D.College of Medicine

University of the Philippines Manila

February 2, 2010


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Health is a basic human right.

Access to medicines is a basic part of

primary health care.

*International Covenant on Economic, Social and Cultural Rights

**Declaration of Alma Ata


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It is the responsibility of the state to ensure thatthe people have access to quality health care.

1987 Philippine Constitution

ARTICLE XIII

Section 11. The State shall adopt an integratedand comprehensive approach to healthdevelopment which shall endeavor to make

essential goods, health and other social servicesavailable to all the people at affordable cost.


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1987 Philippine Constitution

ARTICLE XIII

Section 12. The State shall establish andmaintain an effective food and drug

regulatory system and undertake appropriate

health, manpower development, and

research, responsive to the country's health

needs and problems.


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In the Philippines, access to

medicines is an economicprivilege.


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What the lowest-paid government worker will

have to spend for a 4 week course of omeprazole

for peptic ulcer disease

70% of monthly income for the innovator

brand

14.5% for a generic product

Health Action Information Network , Medicine Prices and Availability Survey in the Philippines, 2009

Medicines are expensive and

unaffordable, especially for the poor.


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Comparison to International Reference

PricesMedicine

(Generic name)All formulations below

are as cap/tab

Type of Drug/

Indication

Number of times more

expensive than international

reference prices*

Originator brand

product

Lowest priced

generic product

Diclofenac50 mg

Pain reliever 105.32 23.46

Metronidazole

500 mgAntibiotic 74.37 22.39

Omeprazole

20 mgFor peptic ulcer

disease71.43 14.65

*In private pharmacies surveyed in the HAIN Medicine Prices and Availability Survey, 2009


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% Availability*

Private sectorOriginator brand products 48.1

Private sector

Generic products61.1

Public sectorGeneric products

31.0

*availability of 30 selected essential medicines in HAIN Medicine Prices and Availability

Survey, 2009; Botika ng Barangay outlets not included in public sector survey

Medicines have low availability,

especially in the public sector.


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Top 10 Therapeutic Classes in the Philippines in

Terms of Counting Units SoldTherapeutic Classes Indications % Share

Infant Formulas Nutrition Supplement 22.63

Electrolyte Solution Over 100 mL Fluid and Electrolyte Replacement 13.34

Standard Solution Over 100 mL Fluid and Electrolyte Replacement 10.93

Other General Nutrients Nutrition Supplement 5.23

Vitamin C Including Mineral

CombinationsVitamin Supplement 4.23

Non-narcotic Analgesics Pain Relief 3.99

Expectorants Cough 2.87

Multivitamins Without Minerals Vitamin Supplement 2.73

Multivitamins + Minerals Vitamin Supplement 2.59

Tonics Vitamin Supplement 2.45

Others -- 29.01

Philippine Pharmaceutical Industry Fact Book, 2008


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Questions of drug quality persist, in

part due to the limitations of the

Food and Drug Administration.


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Why?


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From manufacturing to distribution to retail,

the drug industry in the Philippines is an

oligopoly.


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MercuryDrug Store (80%)

*

*owns 70% of InterphilFrom Health Policy Notes

Department of Health, 2008 and

Sabangan, AR, GMANews.tv Special Report, 2009


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Sixteen of the top 20 drug companies in

the Philippines are multinational firms with

combined sales of P58.23 billion in 2007,nearly eight times more than the

Philippines P7.39 billion GDP in 2008.

AR Sabangan, GMANews.tv Special Report, 2009Philippine Pharmaceutical Industry Factbook, 2008


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How the dominant drug companies

increase the cost of medicines

Pharmaceutical patent system

Transfer pricing

Advertising and drug promotions


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Pharmaceutical Patent System

Adopts WTO-TRIPS

Patent essentially grants the patent

holder a monopoly for 20 years Patent holders and supportive

governments justify high prices as a

way to recoup investments inresearch and development


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Industry estimates for R&D on each

new drug range from $350-500

million, while independent estimatesrange from $30-160 million

Revenues from a single patented

drug can reach over $1 billion in a

year

Third World Network, 2001


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Evergreening refers to ways used by

patent holders to extend their

monopoly by filing patentapplications on their product shortly

before the expiration of the original

patent


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Evergreening applications are filed

for different isomeric forms,

derivatives, dosing route, biologicaltargets, etc. for the same molecule


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The Cheaper Medicines Act contains

provisions that intend to prevent

evergreening, and is being tested incurrent patent lawsuits in the

country (e.g. Unilab vs. Pfizer over

atorvastatin)


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In the 2001 Doha Round, WTO

allowed flexibilities in TRIPS largely

due to the clamor of countrymembers, particularly from Africa,

who had become even more severely

marginalized as a result of WTOpolicies


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Country members can override existing

patents in the interest of public health

Since then, such moves have been metwith opposition and lawsuits from

companies and their supportive

governments (e.g. Sanofi Aventis vs.Thailand over clopidogrel)


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Transfer Pricing

Parent companies export raw materials

to their subsidiaries

A study in Pakistan on transfer pricingfound that parent companies export at

rates as high as 300-700 times the price

of the raw materials in the open market

Third World Network, 2001


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Average Manufacturer/Trader

Cost Structure

% of totalcost

1. Cost of goods manufactured and sold 49.2%

2. Operating and selling expenses 40.5%3. Corporate tax 3.3%

4. Net profits 7.0%

Drug Advertising and Promotions

Philippine Pharmaceutical Industry Factbook, 2003


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Average Manufacturer/Trader Cost

Structure% of Total

Cost

2. Operating and selling expenses 40.5

2.1 General management costs 6.4

2.2 Selling costs (including meetings, seminars,

conferences)

17.25

2.3 Advertising and promotion (including

sponsorships and special conferences)

11.53

2.4 Research and development (clinical trials etc.) 0.612.5 Royalties 0.7

2.6 Interest and bank changes 1

2.7 Other operating and selling expenses 3.01

Philippine Pharmaceutical Industry Factbook, 2003


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Drug Promotion and Advertising

Big, aggressive campaigns virtually

ensure market dominance and brand

premium

In a four week monitoring period, of the

10 most frequently aired drug-related TV

ads, 8 were from a single company(Unilab)

Health Action Information Network, 2009


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Drug promotion and advertising to

the public and to healthprofessionals contribute to

widespread irrational drug use.


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Top 10 Therapeutic Classes in the Philippines in

Terms of Counting Units SoldTherapeutic Classes Indications % Share

Infant Formulas Nutrition Supplement 22.63

Electrolyte Solution Over 100 mL Fluid and Electrolyte Replacement 13.34

Standard Solution Over 100 mL Fluid and Electrolyte Replacement 10.93

Other General Nutrients Nutrition Supplement 5.23

Vitamin C Including Mineral

CombinationsVitamin Supplement 4.23

Non-narcotic Analgesics Pain Relief 3.99

Expectorants Cough 2.87

Multivitamins Without Minerals Vitamin Supplement 2.73

Multivitamins + Minerals Vitamin Supplement 2.59

Tonics Vitamin Supplement 2.45

Others -- 29.01



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Top 10 Prescription Drugs based on Value

Rank Prescription Brand Company Indication

1 Norvasc Pfizer Hypertension

2 Ventolin GSK Asthma

3 Plavix Sanofi-Aventis Thrombosis

4 Augmentin GSK Infection5 Neobloc GX International Hypertension

6 Lipitor Pfizer Hyper-

Cholesterolemia

7 Tazocin Infection Infection8 Zegen United American-Unilab Infection

9 Plendil ER AstraZeneca Hypertension

10 Seretide GSK Asthma



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Not reflective of first-line

treatments in accordance with

scientific guidelines

Top 10 Prescription Drugs based on Value


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Stunted Local Industry

Almost wholly dependent on imports

95% of raw materials are imported

No manufacturer of activepharmaceutical ingredients in the

country

Research and development ofinnovations very limited



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Food and Drug Administration

In 2006:

Ratio of Food and Drug Regulation

Officers to number of establishments1: 202

Ratio of evaluators to registered

products 1:1,513


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Government Programs and

Policies through the Years


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Philippine National Drug Policy,

1987 (revised in 1992)

P people empowerment

Q quality assurance

R rational drug use

S self-reliance

T targeted procurement


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Philippine National Drug Policy, 1987

Generics Act of 1988 as one of theinitial manifestations

Implementation delayed for twoyears

Initial vigilance in monitoring the

implementation waned with changesin DOH administration


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Local Government Code 1991

Devolution of health care delivery at

the primary level to local

government units Created new problem of provision of

drugs by LGUs


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Botika ng Barangay

European Commission study onfunctionality, monitoring and cost of the

BnB program:

Low turnover and lack of up to date

prescription registers indicate not only that

economic viability is often still low but that

there is also little control and informationon dispensing behavior.

EC-HSPSP, 2009


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P100 Program

Provision of full course or one month

treatment course for 100 pesos or less

Issues of sustainability

3rd

Medicines Transparency Alliance Forum, 2010


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Maximum Drug Retail Price

Since August 2009, maximum prices of 5

medicines were mandated to be pegged

at 50% the price of the originator brand

Prices of 16 other medicines were

voluntary reduced by companies (as the

Government Mediated Access Price orGMAP)


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Maximum Drug Retail Price

Does not make medicines more affordablefor the poor

Determining a fair price based on actual

cost is very difficult due to the opaque drugindustry

Experiences with price control in othercountries, notably in the EU, illustrates that it

is most effective in the context of universalhealth insurance coverage or universalhealth care systems*

*Medicines Transparency Alliance Forum, 2010


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Challenges on the way forward


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Challenges

Government must play a dominant role

in ensuring access to safe, affordable,

and quality medicines for all Filipinos,

especially the poor

h ll


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Challenge: Providing medicines,

especially to the poor, for free

Remove VAT on medicines

Centralized procurement at theprovincial government level to providefor medicines up to the barangay level

Government health facilities and localgovernment units must increase budget

allocations to provide medicines at theprimary level and in hospitals

h ll d d


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Challenge: Providing medicines

especially to the poor for free

Philhealth coverage of medicines must

be increased and include outpatient

drugs

Universal coverage under Philhealth can

eventually support a more sophisticated

price control system

h ll d lf li i


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Challenge: Towards self-reliance in

drug production

Government must support local drug

manufacturers through tax exemptions,

technical assistance, loans, discounts or

exemptions from regulatory fees

Develop local capacity to produce raw

materials, eventually including activepharmaceutical ingredients

Ch ll T d lf li i


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Challenge: Towards self-reliance in

drug production

Production of certain drug types can

eventually be restricted to local

manufacturers only

Challenge: Promoting accurate


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Challenge: Promoting accurate,

objective drug information to the

public and to health professionals Develop a wide-reaching information

system at the level of the

consumers/general public and at the

level of health professionals

Challenge: Promoting accurate


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Challenge: Promoting accurate,

objective drug information to the

public and to health professionals Ban drug and food supplement

advertising to the public

Ban promotional materials and drug

samples

Restrict drug sponsorship of seminars,conventions and ban drug company-

sponsored recreational activities

Challenge: A strong regulatory body


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Challenge: A strong regulatory body

than can ensure the quality of all

medicines in the country Strengthen and scale up the FDA by

increasing its budget, human resources,

equipment, and technical capacity

Streamline number of registered drugsand develop more stringent regulations

for the registration of new ones inconsideration of available number ofproducts for a drug

Challenge S pport research and


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Challenge: Support research and

development of herbal medicine as a

mainstream treatment Increase research on curative potential of

herbal medicines

Strongly promote the use of scientifically

validated herbal medicine


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These changes in the pharmaceutical

systems must be accompanied by

complementary changes in the health

care system and the education system of

health professionals.


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The need of Filipinos for efficacious and

affordable medicines can only be met

when a strong national health care

system is in place and under a

government whose policies are in the

best interest of its people.

Council for Health and Development, 2008


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Access to medicines is a right.

At the same time, a primary perspective ofgovernment should be the promotion of

good health and prevention of illness,through the attainment of optimaleconomic and social conditions, such

that the people will need only theminimum amount of medicines.

04 ensuring access to safe, affordable and quality essential medicines - dr. edelina padilla-dela...

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