ADDITIONAL READINGS FOR DTI:

What is the Cheaper Medicines Act?

The Law intends to achieve better health outcomes for the Filipino people by assuring that
quality medicines are accessible and affordable to as many Filipinos especially the poor.    

There are a number of factors to be considered and a variety of issues and concerns to address
when facing the problem of access to medicines.  Among the major and critical issues include
those of rational drug use, public perception on generics, health professional behaviour on
prescribing and dispensing medicines, information asymmetry and exercising informed choice,
pricing, supply and distribution, and procurement systems’ transparency, respect for patent rights
vis-à-vis access by the poor, quality assurance, and many others.  This is the reason why the Law
too has many different interventions ready to address these critical and major issues.

Republic Act No. 9502 or THE CHEAPER MEDICINES ACT

AN ACT PROVIDING FOR CHEAPER AND QUALITY MEDICINES, AMENDING FOR THE
PURPOSE REPUBLIC ACT NO. 8293 OR THE INTELLECTUAL PROPERTY CODE,
REPUBLIC ACT NO. 6675 OR THE GENERICS ACT OF 1988, AND REPUBLIC ACT NO. 5921
OR THE PHARMACY LAW, AND FOR OTHER PURPOSES
CHAPTER 1
SECTION 1. Short Title . — This Act shall be known as the "Universally Accessible Cheaper and
Quality Medicines Act of 2008".
Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:
GENERAL PROVISIONS
SECTION 2. Declaration of Policy . — It is the policy of the State to protect public health and, when
the public interest or circumstances of extreme urgency so require, it shall adopt appropriate
measures to promote and ensure access to affordable quality drugs and medicines for all.
Pursuant to the attainment of this general policy, an effective competition policy in the supply and
demand of quality affordable drugs and medicines is recognized by the State as a primary
instrument. In the event that full competition is not effective, the State recognizes as a reserve
instrument the regulation of prices of drugs and medicines, with clear accountability by the
implementing authority as mandated in this Act, as one of the means to also promote and ensure
access to quality affordable medicines.
(a)
SECTION 3. Construction in Favor of Protection of Public Health . — All doubts in the
implementation and interpretation of the provisions of this Act, including its implementing rules
and regulations, shall be resolved in favor of protecting public health.

SECTION 4. Definition of Terms . — For purposes of this Act, the following terms are to mean as
follows:
“Compulsory License” is a license issued by the Director General of the Intellectual
Property Office to exploit a patented invention without the permission of the patent
holder, either by manufacture or through parallel importation;
“Drugs and medicines” refers to any chemical compound or biological substance, other
than food, intended for use in the treatment, prevention or diagnosis of disease in
humans or animals, including but not limited to:
any article recognized in the official United States Pharmacopoeia ‐National
Formulary (USP‐NF), official Homeopathic Pharmacopoeia of the United States,
Philippine Pharmacopoeia, Philippine National Drug Formulary, British
Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia, Indian
Pharmacopoeia, any national compendium or any supplement to any of them;
“Drug outlet” refers to drugstores, pharmacies, and any other business establishments
which sell drugs and medicines;
any article intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in humans or animals;
any article other than food intended to affect the structure or any function of the
human body or animals;
(e) “Importer” refers to any establishment that imports raw materials, active ingredients
and finished products for its own use or for distribution to other drug establishments or
other than food, intended to affect the structure or any function of the
human body;
in finished or ready‐to‐use dosage form; and
intended for use as a component of any of the articles specified in clauses
(i), (ii), (iii), and (iv);
herbal and/or traditional drugs which are articles of plant or animal origin used
in folk medicine which are:
“Essential drugs list or national drug formulary” refers to a list of drugs prepared and
periodically updated by the Department of Health on the basis of health conditions obtaining in the
Philippines as well as on internationally accepted criteria; recognized in the Philippine National Drug
Formulary; intended for use in the treatment or cure or mitigation of disease symptoms, injury or
body defects in humans; human body or animals; any article intended for use as a component of any
articles specified in clauses
(1), (2), and (3) not including devices or their components, parts, or accessories;
“Manufacture” includes any process or part of a process for making, altering, finishing,
packing, labeling, breaking or otherwise treating or adapting any drug with a view to its
sale and distribution, but does not include the compounding or dispensing of any drug
in the ordinary course of retail business;
“Manufacturer” refers to any establishment engaged in the operations involved in the
production of a drug with the end view of storage, distribution, or sale of the product;
“Multisource pharmaceutical products” refers to pharmaceutically equivalent or
pharmaceutically alternative products that may or may not be therapeutically equivalent.
“Retailer” refers to a licensed establishment carrying on the retail business of sale of
drugs and medicines to customers;
“Trader” refers to any licensed establishment which is a registered owner of a drug
product that procures the materials and packaging components, and provides the
production monographs, quality control standards and procedures, but subcontracts the
manufacture of such products to a licensed manufacturer;
“TRIPS Agreement” or Agreement on Trade‐Related Aspects of Intellectual Property
Rights refers to the international agreement administered by the WTO that sets down
minimum standards for many forms of intellectual property regulation; and
“Wholesaler” refers to a licensed establishment or drug outlet who acts as merchant,
broker or agent, who sells or distributes for resale or wholesale drugs and medicines.

What is the early working or Bolar provision and how does it help bring down prices of
medicines?

This allows development, testing, and experimental work for the registration of a generic
medicine to take place during the patent period of the innovator product.  Such development,
testing, and experimental work may last from 6 months to 2 years. Thus, this allows generic
counterparts to be readily available and marketed the day after the patent expires instead of 2
years after.  In contrast, without Bolar provision, a company may only apply for registration after
the patent expires, in which case, the effective life of the patent is extended subject to the time it
takes to complete said registration processes (usually 6 months to two years).  By exerting the
early workings provision for patented medicines, generic competition is facilitated and cheaper
yet quality counterparts for expensive innovators become available earlier in the market.

Who are involved in the implementation of the Cheaper Medicines Act?

 The Secretary of Health has special powers to be able to make informed decisions and
ensure the full implementation of the Law.  Such influence extends even to the Local
Government Units where the DOH shall actively engage in meaningful partnerships to
ensure the Law is followed.
 The DOH is the main implementing and monitoring agency for Cheaper Medicines Act
but this is not a sole responsibility of the Department.  DTI, IPO, FDA, PhilHealth, PITC,
PITC Pharma Inc. are all collectively working together to get the intent of the Law done. 
Moreover, the Secretary can deputize any other government agency for any purpose
related to the implementation and apt enforcement of the Law and its IRR.
 Private Sector participation, partnerships, and advice are encouraged and sought in terms
of monitoring implementation, building capacity, and reporting violations of the Law and
its IRR.

What is parallel importation and how does it bring down the prices of medicines?

Parallel importation (Sec. 7), as applied to the local setting, is when a patented drug is brought
into the country by Government or any private third party even without the consent of the patent
holder as long as any of the 2 condition is met:

a.  It has been introduced in the Philippines by the patent holder, or

b.  It has been introduced anywhere in the world by the patent owner.

It allows for an importer to “shop around” for a good price for a patented product, bring this into
the country and sell it to a more competitive and affordable price than the prevailing price of the
same patented product sourced locally from the innovator company.
Example:  a drug sold here at 45 pesos per tablet and sold at 8 pesos in another country, an
importer may now bring the quality cheaper medicine in the country and sell it cheaper for our
countrymen.

What is e-EDPMS?

The e-EDPMS- refers to Electronic Essential Drug Price Monitoring System which was created
by the DOH to support the establishment of an efficient and effective system and procedures for
collecting price and inventories of essential drugs and other drugs stated in RA 9502.

The intent is for the DOH and DTI to monitor essential drug prices as well as stocks of
medicines in the local market and detect practices such as overpricing and non-compliance to
efforts of the DOH to regulate excessive price of drugs such as the GMAP & the MDRP. It also
aims to educate consumers on prevailing market prices of essential drugs to enable them to make
informed choices.

What are Generic Drugs?

•   Generic Drugs is a drug which is produced and distributed without patent protection.

•   Generic Drugs is a copy of original/innovator.  Has the same active ingredient and quality but
costs less

•   More generic drugs in the market brings down the costs of drugs due to more competition ex.
Norvasc (Php 44) to Php 8 for Bezam, Php 11 for Pharex, Php 17 for Unilab.

•  Generic Drugs  are available once the patent protections afforded to the original developer
have expired.