Healthcare costs are continually increasing. In 2020, the country’s health spending reached Php 895.88 billion, 12.6 percent higher compared with 2019’s health spending at Php 795.64 billion. Out of the available health care financing schemes, government schemes and compulsory contributions had the highest share at 45.7 percent of total health spending in 2020. This is followed by household-out-of-pocket payment (OOP) at 44.7 percent, and voluntary health care payment at 9.6 percent. Among health care providers, most of the spending was on hospitals (43.8%), followed by pharmacies (28.2%), and providers of preventive care (9.0%).
Drug cost is a substantial expenditure in healthcare. The Philippine pharmaceutical market in 2017 is valued at Php 176 billion. About 62 percent of the pharmaceutical products being supplied in the Philippine market are imported and only 38 percent are manufactured in the country.
Generic drugs comprise 76 percent of the total market sales in 2016 while the rest comes from the sale of originator drugs. Generic drugs are copies of the original or innovator drug with the same active ingredient. They become available once patent protections of the original developer have expired.
In line with the mandate of the Food and Drug Administration (FDA) of ensuring the availability of safe, efficacious, and quality pharmaceutical products in the Philippines, the concept of bioavailability/bioequivalence to all stakeholders was introduced through Administrative Order No. 67 s. 1989: Revised Rules and regulations on Registrations of Pharmaceutical Products and Bureau Circular No. 01 s. 1997: Enforcement of the Requirement for Bioavailability Studies for Registration of Products Included in the List B (Prime) under Administrative Order No. 67 s. 1989. The Food and Drug Administration (FDA) requires evidence of bioequivalence through the conduct of bioavailability and bioequivalence studies. The list of products requiring bioequivalence studies for marketing authorization is found in FDA Circular No. 2013-014.
Bioavailability refers to the extent and rate to which a drug, from a specified dosage, reaches the bloodstream in an active, or free-drug form (in contrast to the amount of drug entering the non-circulating part of a tissue). In bioavailability studies, the concentration of the drug in the plasma or blood is measured after the drug is administered and its bioavailability is measured over time. On the other hand, bioequivalence means the absence of a significant difference in the rate and extent to which the active ingredient of drug products being compared becomes available in the circulation when administered at the same dose under similar conditions.
Two drug products containing the same active pharmaceutical ingredient (API) are considered bioequivalent if they are pharmaceutically equivalent such that the rate and extent of absorption after administration under the same conditions are within acceptable pre-defined limits. Demonstration of interchangeability between generic medicines and innovator products implies that one can be prescribed or substituted in place of the other. Additionally, the demonstration of bioequivalence of all generic medicines with the same innovator product also means that generic medicines can also be substituted with one another.
One of the most important benefits of generic medicines is their cost. This results in lower health expenditure which would allow for increased spending on other medical services and personal needs. Lower costs of medicines improve treatment adherence, clinical outcomes, and quality of life.
In the Philippines, however, generic drugs are sold four times higher than the international reference prices, and branded innovator products are sold up to 22 times higher, especially in private hospitals and pharmacies according to the Department of Health in 2019. This situation is persistent even ten years ago as shown in the 2009 report from Health Action Information Network where generic drugs are generally sold three times higher than international reference prices and branded innovator products are sold almost 30 times higher.
To control these prices, it is important to achieve effective competition between generic medicines and originator brands. Discussion on medicine prices and availability issues with other agencies concerned with trade and welfare should be done to allow further investigation on the procurement of high-priced medicines and subsequently, create and enforce regulations. After all, access to medicine is a basic human right, and the high prices of medicine are violations of that right.
The misconception of the quality of generic medicines is a barrier to their wide usage. In a study on knowledge, perceptions, attitudes, and practices of physicians regarding generic medicines, results revealed knowledge gaps on the therapeutic equivalence of generic medicines and the generic law’s provision on substitution in dispensing. Physicians have a negative perception of the quality of generic medicines and they also believe that pharmacists should consult physicians when dispensing generic alternatives. It was also found in the study that they have low or even non-compliance to generic prescribing.
A physician’s stance against prescribing generic drugs can inevitably lead to consumers being biased against choosing generic medications. Physicians are the most significant influencer in the generic use of consumers. Therefore, it is important that there is continuing education and information on the generics law and the quality and benefit of generic medicines.
Gaps in the knowledge on quality, safety, and efficacy of generic medicines may be improved by patient-provider communication. In a cohort study, only 4.8 percent of the study population switched back from taking generics to branded medicines. Implementing systems to further increase the awareness of consumers will encourage the use of generic medicines.
Access to medicines is a human right. Everyone has the right to health care, including the right to safe, effective medicines. Several advancements have been made by the regulatory authorities, pharmaceutical industry, and academia in the assessment and conduct of bioequivalence studies for generic medicines that would assure the quality, safety, and efficacy of interchangeable and affordable drugs. There must be continuing attempts not only in the development of more efficient approaches to assess bioequivalence but also in improving affordability, accessibility, and knowledge gaps in generic medicines.