Generics Act of 1988 (R.A.

6675)

A Policy Analysis

Angelica Baes

PM 245

University of the Philippines – Open University

 Table of Contents

Problem 3

Policy alternatives 6

Analysis 8

Recommendation 12

Implementation 13

List of tables and figures

Figure 1 8

Table 1 9

Figure 2 12

References 15

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I. Problem

The Generics Act of 1988 or Republic Act 6675 was enacted as part of the policy of the
state to promote the use of generic drugs to ensure adequate supply of drugs with generic names
at the lowest possible cost (Generics Act, 1988). It was amended last 2008 by R.A. 9502 which
is also known as the Universally Accessible Cheaper and Quality Medicines Act. It endeavored
to strengthen R.A. 6675 by amending some of its provisions.

The following are the highlights of the amended law:

 Allows parallel importation of medicines

 Allows local generics firms to test, produce and register their generic versions of patented
drugs
 allows the government use of patented drugs when the public interest is at stake
 gives the President the power to set price ceilings on various drugs, upon the
recommendation of the secretary of health
 ensure the availability of affordable medicine by requiring drug outlets to carry a variety of
brands for each drug (Calica, 2008)

The origin of the Generics Act of 1988 can be attributed to the widespread corruption in
drug purchasing and distribution in the 1980s which led to the formulation of a national drug policy.
Individuals and groups who participated in the analysis of the drug situation at that time concluded
that majority of Filipinos cannot avail of drugs because of these four major reasons:

(1) Seventy percent of the population are below the poverty line.

(2) Drug prices are high due to cost factors pertinent to raw materials, advertising and
promotions and distribution.

(3) The absence or lack of drug outlets in many parts of the rural areas make drugs
physically inaccessible to many Filipinos.

(4) Some essential drugs are not available commercially (Yadao-Guno, 1991).

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 These problems shed light to the urgency of a lack of a comprehensive policy that would
regulate the drug industry in the Philippines. The years that followed resulted to the creation of a
national drug policy and later on, the Generics Act of 1988. Although R.A. 6675 has been in place
for 31 years, its effect is barely noticeable. Wong et al. (2016) cites the following as the main
reasons for this:

Lack of awareness or understanding of the law

Only 55 percent of the respondents were aware that the law requires generic names to be
written in prescriptions. Only 47 percent were aware that drugstores were required
to offer generic alternatives to consumers. However, when asked if they knew that they had the
right to choose between generic and branded medicines, 84 percent of consumers knew that they
had this right (Wong, et al.).

The results of the study show that consumers are aware that the Generics Act exists but
poorly understood that the law requires pharmacists to offer them generic alternatives when
purchasing branded medications. However, they understood that they had the right to choose
between the two alternatives.

Doctors’ lack of confidence

A focus group discussion conducted among private and public physicians revealed that
majority of them still prefer prescribing branded medications for the following reasons:

 Prior experiences of inconsistency, ineffectiveness or complete absence of

potency of generic drugs
 Distrust in FDA’s monitoring and regulatory practices of generic drugs available in
the market
 Imported generic drugs such as those from India and China are considered
spurious.
 Failure of generic drugs to alleviate patients’ condition will affect physician’s
reputation

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Weak implementation

Despite strengthening the Generics Act of 1988 through R.A. 9502, it is evident that many
doctors and distributors still do not abide by the law. This problem of implementation stems from
the fact that very few offenders have been given sanctions or penalties. It is up to the government
to follow through with the execution.

A stigma against generic drugs

Some consumers continue to believe that branded medicines are far better than
their generic counterparts. Doctors themselves may also not believe that generic drugs are
bioequivalent and bioavailable in the same degree as originator brands (Wong et al., 2016).

Physicians’ distrust of generic drugs and patients’ natural tendency to follow doctors’
prescription have naturally caused the proliferation of this misinformation among patients.

This policy analysis is for the government of the Philippines. This discussion analyzes the
weaknesses of R.A. 6675 so that our legislature and its implementing agencies may conduct
further amendments to the law and improve its execution.

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II. Policy Alternatives

R.A. 6675 is a good piece of legislation. As like many policies in the Philippines, it needs
reinforcement in some areas in order to create the change that we want it to. There is no need to
change the whole policy but perhaps a few modifications will increase its potential. The researcher
recommends the following alternatives to strengthen the Generics Act:

Consumer education

A qualitative study done in the United States revealed that barriers to the widespread use
of generic medication included beliefs about generic medications having lower safety and efficacy
as well as deep mistrust in the medical system (Wong et al., 2016).

Even physicians are doubtful of the effectiveness of generic drugs. They believe that
FDA’s weak regulatory practices have allowed drugs of poor quality to become available for public
consumption. This stigma among physicians worsens consumers’ perception of generic drugs.

Perhaps it is best to teach the public using social marketing strategies and consistent
education drives to remove the stigma on generic drugs. According to Magallon (2018), DOH
National Drug Policy Compliance Officer of the Department of Health Regional Field Office 6:

“Generics and branded medicines have the same active ingredient, the same
work of administration and the same dosage strength. They only have different
inactive ingredients, shape, color and packaging. When it comes to quality and
effectivity, they are the same.”

DOH’s “Generics Awareness Month” which is held annually in September pursuant to R.A.
6675 is also a good way to increase public awareness of availability of low cost, safe and essential
quality generic medicines (Department of Health, 2015).

Strict imposition of penalties

Comprehensive regulation on drugstores and proper implementation of penalties may

change the norm of disobedience to the law. The mystery shopper approach will make the
distributors aware that there is always someone monitoring their compliance (Wong et al., 2016).

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 The Department of Health, together with the Food and Drug Administration, may also
create a separate body that will only focus on doctor, pharmacy and distributor compliance to the
Generics Act. Non-compliance should immediately translate to sanction or penalties as provided
by law.

Bioequivalence tests

Bioequivalence is defined as two pharmaceutical products that are pharmaceutically

equivalent; their bio-availabilities after administration are in the same molar dose and are similar
to such a degree that their effects, with respect to both efficacy and safety, can be expected to be
essentially the same. It is considered the principal requirement for registering a generic drug and
it determines the identity of pharmaceutically equivalent drugs (Weinberg, 2009).

It is indeed expensive but conducting bioequivalence testing on generic drugs available in

the Philippine market will eliminate doubts with respect to their efficacy and safety. Branded and
generic medicines will finally be perceived as on a par with one another.

Proper regulation of generic drugs

Drug legislation is the basis of drug regulation, and defines the standards and
specifications to be applied. Regulatory tools, such as standards and guidelines, equip drug
regulatory authorities with the practical means of implementing this legislation (Ratanawijitrasin &
Wondemagegnehu, 2002).

Government resources such as people and finances should be utilized effectively. For
instance, employees hired for drug regulation should be skilled, incorruptible and well-paid since
they are dealing with big companies who may try to manipulate circumstances to benefit
themselves. With finances, the government can utilize fees and penalties collected from offenders
to cover the cost of regulatory services such as licensing, of establishments registration of
products, inspection, QC and control of promotion and advertising. This way, generic drug
regulation can be done without having to sacrifice a large part of the national budget. With clear
legislation, proper reinforcement and smarter financing mechanisms, the Generics Act will
embrace its full potential.

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III. Analysis

The Generics Act of 1988 was created as a result of the discovery of widespread
fraudulence in drug prescription and purchasing. At that time, policies that would regulate drug
manufacturing, purchasing and distribution were non-existent. Only R.A. 3720 or the Food, Drug
and Cosmetics Act of 1963 was in place but it had no stipulations regarding the regulation of
marketing and other practices of pharmaceutical companies. The Department of Health, under
the leadership of Dr. Alfredo Bengzon, then decided to initiate a national drug policy which also
included the generics policy (Co, 1998).

1985
-395 drug manufacturing companies in the Philippines
produced 90% of supply
-200 Filipino-owned drug companies shared 5% of the market
nationwide
-83% were branded drugs, some of which research found to
be ineffective, expensive and harmful

1986
-BFAD discovered that more than 200 drugs who were banned
outside the Philippines were still being sold in the country
-Proliferation of expensive drugs and the lack of independent
information on drug products resulted in improper use of these
drugs

1986-1988
-New administration took over the DOH and took notice of the
widespread corruption in drug prescription and purchasing
-No policies were in place to rectify the fraudulence that was
taking place
-New administrators endeavored to start utilizing DOH budget
efficiently

Figure 1. Timeline of the formulation of the country’s national drug policy which later led to the
creation of the Generics Act of 1988

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 The stakeholders in the Generics Act of 1988 are the Department of Health, the Congress
which includes both the Senate and the House of Representatives, the American Chamber of
Commerce (AmCham), the Philippine Medical Association (PMA), the Drug Association of the
Philippines (nAP), different academics and experts, the Philippine Drug Action Network (PDAN),
the CACP and the media (Co, 1991).

Below is a table of the corresponding interests of these stakeholders which was adapted
from an analysis conducted by Edna Co in 1998:

Stakeholder
DOH
Congress
American Chamber of Commerce
Philippine Medical Association
Drug Association of the Philippines
Academics and experts
Philippine Drug Action Network
Citizen’s Alliance for Consumer Protection
Interest
public service and the promotion of people's
health
search for and identification with a popular
policy
business and investment interests
technical, professional interests
economic and business interests
technical, professional integrity and
promotion of people's health
public service and promotion of people's
health
protection of consumers' rights

Table 1. RA 6675 stakeholders and corresponding interest

Ten to twelve years after the implementation, the Department of Health conducted an
evaluation of the Generics Act. The following are the milestones of the policy as well as the
issues encountered along the way.

Milestones
 Lowered the cost of drug therapy
For example, branded ampicillin capsules cost as much as 17% to 90% more for the 250
mg. and 45% to 88% more for the 500 mg. form than generic ampicillin (Yadao-Guno,
1991). This is according to a cost-benefit analysis conducted by the DOH.
 A wider selection of drugs
Consumers were given more alternatives with regards to pricing. They were able to
choose medications according to their capacity to purchase which in turn, increased
compliance to drug therapy.

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  Minimized medication errors
Utilization of a fixed generic terminology eliminates errors associated with duplication,
overdosage, irrational fixed dose combinations and serious drug interactions.
 Universally understood
A drug’s generic name contains an informative stem reflecting the pharmacological class
to which the drug belongs (Yadao-Guno, 1991).

Issues
 Drug manufacturers may have had less commitment to aiming for quality when producing
generic drugs as compared to branded ones since they are paid less for the latter.
 Branded products are easier to recall than generic drugs in case of undesirable drug
reactions since it is the sole responsibility of the pharmaceutical company who sells the
product.
 Branded products secretly build up psychological confidence if proven effective during
initial use. Generic drugs rarely enjoy this level of consumer trust.
 The exclusive use of generic product will result in the immediate disappearance from the
market of those products protected by lawful patent as the owners of such products will
not allow their products to be copied by generic manufacturers, i.e., the possible black
market for drugs (Yadao-Guno, 1991).

One of the most significant achievements of RA 6675 is perhaps the publication of the
Philippine National Drug Formulary which is a module detailing the generic drugs for procurement
and circulation by the government and modules for training medical practitioners on drug
formulary and the like (Co, 1998).

However, the Department of Health continued to experience roadblocks such as poor

distribution of the module because of limited copies. Doctors continued to prescribe branded
medication as a result of habit and old practices while consumers kept on purchasing brand-
names drugs because of the flooding of advertisements.

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IV. Recommendation

The researcher has the following recommendations to further improve R.A. 6675 or the
Generics Act of 1988:

 The start of a successful policy is a clear legislation. The Philippine government should
consider revising our drug laws and create a more comprehensive policy which covers all
activities involved in generic drugs regulation. This policy should be reviewed and updated
regularly to ensure is adaptability to changing times.
 The Food and Drug Administration should be empowered as the highest authority in
generic drugs regulation. They should also be held accountable for any lapses in their
duty. The agency shall have a clear mission and vision so that their objectives may be
attained.
 The FDA should come up with a clear set of standards and guidelines of the agency’s
regulatory practices. These standards are to be followed consistently and applied to all
generic drugs, whether manufactured inside or outside the country.
 These standards and guidelines are to be communicated to the stakeholders and the
general public to ensure transparency and public awareness.
 The regulatory processes of the FDA should be monitored and audited by another
government agency or an external regulatory body to ensure that the quality of generic
drugs is kept at a maximum. Checks and balances are crucial to measure and improve
the performance of an agency.
 The FDA should empower employees involved in the regulation of generic drugs with
developmental programs and access to the latest updates in the pharmaceutical industry.
They must also be incorruptible individuals since they will be subject to coercion of
stakeholders who have vested interests.
 Smarter financing mechanisms must be employed for the continuity of this policy. For
example, strict imposition of fines and penalties will allow the policy to be self-sufficient as
the fees collected will be used to improve drug quality control laboratories and equipment.

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V. Implementation Plan

To improve the Generics Act of 1988, the researcher adopted the implementation
strategy for effective drug regulation of the World Health Organization in 2002.

Figure 2. Effective drug regulation strategy of WHO

Administrative components are input factors that allow for the functioning of drug
regulation, including policy, legislation and regulations, organizational structures, human and
financial resources and mechanisms for planning, monitoring and evaluation (Ratanawijitrasin &
Wondemagegnehu, 2002).

Regulatory functions include licensing of persons, premises and practices, inspection of

pharmaceutical establishments, product assessment and registration, QC, control of drug
promotion and advertising and monitoring of ADR (Ratanawijitrasin & Wondemagegnehu, 2002).

Technical elements concern the existence and the type of standards, norms, guidelines,
specifications and procedures (Ratanawijitrasin & Wondemagegnehu, 2002).

The level of regulation indicates the level at which the various regulatory functions are
undertaken. The political structures of a country determine the overall governance of drug
regulation (Ratanawijitrasin & Wondemagegnehu, 2002).

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 Along with this implementation plan, the following strategies will also be applied to
maximize the potential of the Generics Act:

Social marketing

E-pharmamarketing is an activity of a pharmaceutical company aimed to promote and sell

its products and build a relationship with the customer or selected groups of recipients, conducted
via the Internet (Armstrong & Kotler, 2012). It can be helpful in communicating all necessary
information about pharmaceutical products but also promote pro-health actions in the field of
promotion and prevention (Akhtar et al, 2015).

This strategy may be adopted by the government to promote the use of generic drugs to
the general public. Additionally, Wong et al. (2016), suggests tapping on generic “believers” to
encourage the skeptics. Their study showed that the odds of purchasing generic alternatives
among individuals who are influenced by friends and relatives in their medical decisions are higher
compared to those who are not influenced.

Mystery shopper approach

The Market Research Society (“MRS”) defines mystery shopping or ‘mystery customer
research’ as: “The use of individuals trained to experience and measure any customer service
process, by acting as potential customers and in some way reporting back on their experience in
a detailed and objective way.” The validity of the mystery shopper technique hinges on the
employee believing that the observer is in fact a real customer, not an “undercover” evaluator
(Devi & Reddy, 2016).

Section 6 of RA 6675 as amended by RA 9502 states that:

“Drug outlets, including drugstores,

hospital and nonhospital pharmacies and nontraditional outlets such as supermarkets and stores,
shall inform any buyer about any and all other drug products having
the same generic name together with their corresponding prices so that the buyer
may adequately exercise his option...the drug outlets referred to herein shall post in conspicuous
places in their establishments a list of drug products with the same generic name and their
corresponding prices...” (Wong et al., 2016)

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 To evaluate compliance of doctors and pharmacies, the government agencies tasked with
evaluating the Generics Act may consider hiring people to act as patients or consumers. Doctors’
prescriptions are enough to prove compliance. For pharmacies, however, it would involve people
acting as consumers to check for the presence and placement of generic menu cards and whether
the pharmacist will recommend a generic alternative to the buyer. Through this, pharmacies will
be obliged to always be on their toes, thus, maintaining compliance to the law.

Adapt new regulatory strategies

Rago & Santoso (2008) has this to say about regulation of drug quality: “all medicines
must meet three criteria: be of good quality, safe and effective”.

To achieve this, the Philippine Food and Drug administration should adapt and strictly
follow these WHO perspectives on drug regulation:

• Licensing of the manufacture, import, export, distribution, promotion and advertising of

medicines

• Assessing the safety, efficacy and quality of medicines, and issuing marketing authorization for
individual products

• Inspecting and surveillance of manufacturers, importers, wholesalers and dispensers of

medicines

• Controlling and monitoring the quality of medicines on the market

• Controlling promotion and advertising of medicines

• Monitoring safety of marketed medicines including collecting and analyzing adverse reaction
reports

• Providing independent information on medicines to professionals and the public (WHO, 2003)

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References

Calica, A. (2008, April 30). Congress ratifies cheap medicine law. Retrieved May 9, 2019, from
https://www.philstar.com/headlines/2008/04/30/59092/congress-ratifies-cheap-medicine-law

Co, E. A. (1998, October). Management of Policy Formulation: The Generics Act of 1988.
Retrieved May 16, 2019, from
http://lynchlibrary.pssc.org.ph:8081/bitstream/handle/0/3869/10_Management of Policy
Formulation.pdf?sequence=1&isAllowed=y

Department of Health. (2015). Generics Awareness Month: "Tatlong Dekada: Generics, Abot
Kamay... Abot Kaya!" Retrieved May 12, 2019, from https://mmmhmc.doh.gov.ph/job-
vacancies/53-awareness-months/149-generics-awareness-month

Devi, S., & Reddy, A. (2016). A Conceptual Study of Mystery Shopping as an Ancillary Method
for Customer Surveys. Retrieved May 15, 2019, from
https://globaljournals.org/GJMBR_Volume16/2-A-Conceptual-Study-of-Mystery.pdf

Lena, P. (2018, September 10). DOH cites advantages of generic medicines. Retrieved from
https://www.pna.gov.ph/articles/1047471

Ratanawijitrasin, S., & Wondemagegnehu, E. (2002). Effective drug regulation: A multi-country

study. Retrieved May 13, 2019, from
https://apps.who.int/medicinedocs/pdf/s2300e/s2300e.pdf

Weinberg, M. A. (2009, June 18). How Is the Quality of a Generic Drug Evaluated? Retrieved May
13, 2019, from https://www.uspharmacist.com/article/how-is-the-quality-of-a-generic-drug-
evaluated

Wong, J. Q., Baclay, R. M., Duque, R. G., Roque, P. S., Serrano, G. T., Tumlos, J. A., . . . Cochon,
K. (2016, February). How effective has the Generics Act been? Retrieved May 13, 2019, from
https://pidswebs.pids.gov.ph/CDN/PUBLICATIONS/pidspn1606.pdf

Yadao-Guno, C. (1991, October). The Generics Act of 1988: Policy Formulation and
Implementation Under Pressure. Retrieved May 16, 2019, from
http://lynchlibrary.pssc.org.ph:8081/bitstream/handle/0/4168/10_The Generics Act of
1988.pdf?sequence=1&isAllowed=y

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