THE ROAD to the generic drugs acceptability is strewn with a number of obstructions.
According to the Bureau of Food and Drugs (BFAD), barely 40 percent of consumers comply with the Generics Act.
The Generics Act or Republic Act 6675 is “an act to promote, require and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic names.” It was enacted to provide the masses with access to cheap and quality medicines.
As a result, drugs remain unaffordable to the general masses. According to the Department of Health (DOH) Pharma 50 primer, drugs in the Philippines are 30 to 40 per cent more expensive than in those of other Asian countries.
Generally, branded drugs are more expensive than generic ones because of the research and development done by the manufacturer. Other factors include the promotion of the drug in the market, high costs of importation of raw materials and poor drug price control measures by the government, causing the manufacturers to set their own prices.
Although the generic product is cheaper, it does not mean that it is ineffective. “Generic drugs can be bioequivalent to the innovator. Generics could even be better than the branded. As long as manufacturers follow good manufacturing practices and set high standards,” Faculty of Pharmacy biopharmaceutics and pharmacokinetics professor Jovencio Apostol said.
Bioequivalent drug products are pharmaceutical equivalents whose rate and extent of absorption do not show a significant difference when administered in the body at the same dose and therapeutic level. The BFAD requires all drugs to undergo bioavailability studies to ensure consistency, effectiveness, safety, and bioequivalence.
The Pharmacy Division of the University of Santo Tomas Hospital (USTH) sells branded drugs. Since it is a hospital pharmacy, it follows a bidding system done yearly by the Pharmacy and Therapeutics Committee (P&TC). Thus, medicines are cheaper compared to drugs sold in drugstores outside (e.g. Moxillin 500 mg by United American Pharmaceuticals, Inc. (UAP) is only P6.50 while at Mercury Drug Laong Laan is P14.00).
USTH doctors prefer prescribing the generic although they sometimes indicate the brand in the prescription. This implies that they try to comply with the Generics Act.
According to the BFAD, most physicians are not supportive of the Generic Drugs Act and insist on prescribing branded drugs.
The increasing public ignorance causes consumers to prefer for branded drugs.
“ I think the Act did not succeed because cost of the drugs are still high and patients favor the branded especially the over-the-counter (OTC) drugs,” USTH senior pharmacist Junie Clemente said.
Other obstacles of the Generic Drugs Act include poor manufacturing utilization among local generic manufacturers, the government’s lack of funds for information campaigns, and the public’s mentality that cheap means poor quality.
Threat
Poorly implemented as it is, the Generics Drug Act faces a new threat.
The Medical Bill of 2002 authored by Senator Tessie Oreta seeks to authorize physicians to dispense drugs, usurping in the process the job of the pharmacist. Under the bill, “a doctor may now dispense drugs for treatment and mitigation of diseases and illnesses regardless of the nature of the treatment administered, prescribed or recommended”.
The provision alarmed the pharmacy sector since dispensing is the basic responsibility of the pharmacist. The UST Faculty of Pharmacy has already submitted a position paper to the Philippine Association of Colleges of Pharmacy (PACOP) opposing the bill. (See sidebar)
The Federation of Junior Chapters of the Philippine Pharmaceutical Association (FJCPPha) says only pharmacists have exclusive expertise on drugs and there are subjects physicians are apparently not familiar enough like drug interactions in the body.
But supporters of the bill say doctors should be given the right to dispense medicines since a large part of the country does not have access to drugstores.
“It (the power to dispense) will give convenience to the patient, because after his check-up, andiyan na iyang gamot and since we are in the business of selling drugs, pabor sa amin iyon,” Merck medical representative (Med rep) Joseph Allen Ciabal said. Fellow Med reps Karen Domingo and Celeste Jimenez of Pfizer agree. They said that their product is guaranteed sold since the patient will no longer go to a pharmacy.
However, Pharmacy senior Ban Joseph Ang said, “pharmacists are needed to check and balance the doctors’ prescription, the pharmacist checks if the prescription written by the doctor is erroneous or impossible.” “This may endanger the life of the patient,” he added.
The proposed Medical Act contradicts the Generics Law in general. The doctor dispenses himself the medicine he writes in the prescription, this does not allow the patient to choose a medicine that fits his budget.
It also opposes the Administrative Orders no. 62 and no. 63 which provide that “dispensing is the act by a validly registered pharmacist of filling a prescription or doctor’s order on the patient’s chart.”
The bill has already been approved in the House of Representatives, but is still subject to debate in the Senate. The Philippine Pharmaceutical Association has already voiced its opposition.
Pharmacy and medicine are two different things that however boil down to efficient health care management. If the proposed Medical Act will only endanger the patient in the long run, measures must be taken. The quality and cost effectiveness of the generic drug is clear, as long as there is no significant difference in its rate of absorption and clinical efficacy. By ensuring bioequivalence, quality assurance, and proper enforcement, healthcare costs may no longer burden the already desolate pockets of Juan dela Cruz. Brix Gil M. Bayuga
