GENERICS AWARENESS MONTH

DOH, FDA: Generic medicines are safe and effective

Medicines play an important role in people’s lives as these help fight illnesses or to keep people from getting sick. When purchasing medicines, consumers have two options: branded or generics.

People tend to wonder if generic medicines have the same quality and effectiveness as their brand-name equivalents, since generic drugs cost less.

Department of Health (DOH) undersecretary Maria Rosario Vergeire said “there is not much of a difference” between the two types of medicines.

“There is not much of a difference between the generic and brand-name drugs. The generic version usually differs in some characteristics such as color, flavorings, and other inactive ingredients from the brand-name drugs,” Vergeire told Manila Bulletin.

Why is there a difference between generics and brand-name medicines in terms of cost?

“In terms of costs, pharmaceutical companies put a tremendous amount of effort into the research and development of a new medication. During this process, the new drugs are put under patent protection, which gives the sponsor’s investment protection and sole right to sell these drugs while the patent is still in effect,” Vergeire explained.

“Once the patent protection dissolves, other manufacturers will be allowed to sell generic versions of these drugs under a generic name.

This will allow such to sell drugs at a cheaper price,” she added.

Food and Drug Administration (FDA) director-general Rolando Enrique Domingo said that generic medicines are also effective and safe, just like brand-name drugs.

“Generic (medicines) approved by the FDA are safe, effective, and of good quality. They are more affordable than their branded counterparts, making drug regimens easier to comply with,” he told Manila Bulletin.

“They have exactly the same content and active ingredients. Only the brand is not the same,” he added.

Vergeire shared the same view. “While there are differences in its physical forms, generic drugs can not affect performance characteristics, safety, or effectiveness established by the branded drug,” she said. “There may be instances, however, where the inactive ingredients are significant in the care of a particular patient,” she said, pointing out that generic medicines must meet certain standards to earn FDA’s approval for public consumption.

“The Philippine FDA has its own assessment unit, which oversees the assurance of the drugs’ quality, safety, and effectiveness,” said the DOH official.

“Offhand, the DOH also has its unit, (the) Health Technology Assessment

Council, which mandates ‘technology appraisals by determining their clinical and economic values in the Philippine healthcare system, with the aim to improve overall health outcomes and ensure fairness, equity, and sustainability of coverage.”

Vergeire said that the public has the “liberty” to choose between brand-name medicines and their generic counterparts. “The Department of Health would like to emphasize that the public has the liberty to choose their medication, whether branded or otherwise, appropriate to their clinical care and financial capacity,” she reiterated. “Drugs and medications have been approved and assured of their safety, effectiveness, and quality through rigorous review and process under the Philippine FDA and other concerned units, as may be provided.”

There is not much of a difference between the generic and brandname drugs. The generic version usually differs in some characteristics such as color, flavorings, and other inactive ingredients from the brand-name drugs. — DOH UNDERSECRETARY MARIA ROSARIO VERGEIRE