Intramuros, Manila—Does the quality of generic drugs inferior to their branded counterparts? Or are generic drugs just as good as their brand named duplicates?
The assumption that branded drugs are superior when compared to generic medicines has been the subject of debate since the early 1990’s. A common misconception in the Philippines is that generic medicine fare poorer in performance and efficacy compared to branded medicine. Thus, leading to a stale growth of sales and reputation.
What reasons led to this misinterpretation? Before answering this question, what first are generic drugs exactly?
WHAT ARE GENERIC DRUGS?
The World Health Organization (n.d.) defines generic drugs as pharmaceutical products meant to be identical to an innovator’s product, that is developed outside of the innovator’s license and sold after the patent’s expiry date and other restricted rights.
Medicine student Ruth Misa (personal communication, 2014) adds that, “generics and branded drugs are exactly the same when it comes to effects, longevity, side effects and use.”
In other words, generic medicines are the exactly the same as branded drugs. Both of these drugs offer the same safety, quality, and effectiveness.
HOW ARE GENERIC AND BRANDED DRUGS MANUFACTURED?
Both generic and branded drugs are manufactured the same way, due to both having the same active ingredients. Doctor Lyria Reina states that, “the mode of action and the indication (of both drugs in factories) are all the same,” referring to the manufacturing of generic and branded medicines.
Contrary to popular belief, generic and branded medicines are not made in different factories, the quality of the latter better than the former. As a requirement, all medicines are to be manufactured in factories must reach specific quality standards.
The Bureau of Food and Drug administration (BFAD) of the Philippines will not allow these factories to manufacture drugs if they do not meet these standards (Ocampo, n.d.).
THE DIFFERENCE OF BRANDED AND GENERIC DRUGS
The price of branded medicines are higher than that of generic ones because more money is allotted for advertising and marketing even though the manufacturing processes are the same (Gonzales, 2014).
On the other hand, the prices of generic drugs, as Student Ruth Misa of the Far Eastern University (personal communication, 2014) says, “Are much cheaper than branded drugs because, as the patency expires in a branded product, commercial expenditure also lessens.”
As previously mentioned, both generic and branded medicine have the same active ingredients. These active ingredients allow both medicines to have the same safety, quality, and effectiveness. However, both medicines do not have the same inactive ingredients.
Since trademark laws do not permit generic medicines to have the same appearance as its branded counterparts, the former does not have the right to duplicate the look of the latter. This is where inactive ingredients in medicines come in.
These inactive ingredients generate the generic drug’s appearance in order to differ with its branded counterpart (Misa, personal communication 2014). Despite being inactive, the improper application of these said ingredients may result into it being active and harmfully alter the medicine’s effect (Misa, personal communication 2014).
GENERIC DRUGS ACT OF 1988 (REPUBLIC ACT NO. 6675)
Generic medicines have been made to be affordable and efficient since the implementation of the Generic Drugs Act of 1988—a law that ensures generic medicine to be sold at the cheapest available cost and be free of charge to poverty-stricken patients.
The violation of the said law might result into, “an administrative case on the Professional Regulatory Commission, that might cause suspension or revocation of our license and pay some amount of money,” says doctor of medicine student Crispin Bautista of Our Lady of Fatima University.
GENERIC DRUG’S PERCEPTION IN PH
Despite the law’s attempt to boost generic medicine, approval of generic drug prescription and sales has been slow (Bennett et al., 1997).
The sales by value of it are only about 5% mostly due to the low public perception of buyers and sellers to generic medicine (Batangan, n.d.). Additionally, a 1999 survey revealed that only 34% contained generic drugs in the 91% of sick respondents that were given prescriptions by physicians (Wong et al., 2014).
According to Wong (2014), this presented a trend that more physicians prefer to write the brand name of medicines only and a lessened practice of generic prescription.
When asked why this is the case, Doctor Reina elaborates that, “Generic drugs undergo lesser researches and tests. We cannot say that is has poor quality because the mode of action and the indication were all the same, however, its component (of inactive ingredients) may be of lower quality…”
She also adds, “Physicians want to give the best cure for their patient, which is maybe why they prescribe (further) proven drugs so as not to delay the course of treatment” (personal, communication, 2014).
The case of inactive ingredients and lesser research and tests of generic drugs may be the possible cause as to why it is harshly perceived in the Philippines.
Doctor Reina (personal communication, 2014) says, “Branded medicines undergo intensive researches and tests and, because of that, its effectiveness are (are seen as) well defined and proven,” as opposed to generic drugs.
A survey conducted by (RB, 1991) showed that 70% of the physicians, the respondents, are opposed to the Generics Drug Act of 1988. A greater number of physicians believe that the BFAD is incapable of assuring the quality of the medicine.
Doctor Reina (personal communication, 2014) states that the Philippine economy may to be to blame. She says:
“There are a lot of steps to prove the quality of a certain drug and it needs a lot of resources. Our economy’s budget for this cannot accommodate all the tests needed for all the drug. Though all drugs were certainly tested and proven to be safe, not all of them had undergone further intensive tests that can improve its effectiveness.”
Another reason might be rooted in the law’s implementation of BFAD. Crispin Bautista (personal communication, 2014) explains that:
“(the BFAD) doesn’t have the power to manipulate the manufacturers to have a standard formulation of chemicals for the generic ones and assure us that a pill is of the same potency as the branded medication.”
To improve general perception and dispensing of generic drugs, a long-term approach would be necessary in its promotion in the Philippines (Bennett et al., 1997).
al., J. Q. (2014). The Prevalence of Philippine Prescribing, Dispensing, and Use Behavior in Relation, to Generic Drugs and their Risk Factors. Makati City : Philippine Institute for Development Studies.
Batangan, D. B. (n.d.). Medicine prices, availability, affordability and price components. Quezon City : Institute of of Philippine Culture, Ateneo de Manial University.
Gonzales, E. (2014, July 29). Generic drugs vs branded drugs. Retrieved from http://www.mb.com.ph: http://www.mb.com.ph/generic-drugs-vs-branded-drugs/
Ocampo, R. D. (n.d.). Generic vs Branded: What Are Generic Medicines? Retrieved from http://www.raindeocampo.com: http://www.raindeocampo.com/2014/06/15/generic-vs-branded-what-are-generic-medicines/
RB, D. (1991). The new Philippine Generic Drugs Act: a physician’s viewpoint. Manila: Clinical Epidemiology Unit, University of the Philippines.
Sara Bennett, J. D. (1997). PUBLIC-PRIVATE ROLES IN THE PHARMACEUTICAL SECTOR: Implications for equitable access and rational drug use. World Health Organization.