Redefining Counterfeit Medicines and Updating the Legal Framework to Address Falsified Medicines: A Qualitative Policy Review

Abstract

Background. The existence of counterfeit medicines has been a long-standing global public health concern. In the Philippines, Republic Act No. 8203 Section 3 provides a definition of counterfeit medicines, outlines prohibited acts, and states liabilities and penalties of concerned parties. The Philippine legal definiti on of counterfeit medicine needs to be aligned to what is widely accepted by the international community and to update its scope to prevent varied interpretations due to a mix in the categories of “counterfeit medicines.”

Objective. This qualitative narrative policy review aims to generate evidence on counterfeit and falsified medicines from grey literature and recent publications in order to propose recommendations for updating the legal framework to address specifically “falsified” medical products.

Methods. An online search was performed to identify relevant literature that discussed counterfeit medications. A review of narrative textual evidence from grey literature was conducted including extraction of data on the proliferation of fake, unregistered, and substandard medicines from published news articles and reports for the past six years. A review of published literature was also conducted to supplement findings from aforementioned reports and articles.

Results. Literature search revealed that the presence of counterfeit medicines remains prevalent in the country despite the enactment of RA 8203. Counterfeited products include over-the-counter medicines, prescription medicines, and vaccines. The classification of counterfeit medicines in grey literature, including news articles and FDA advisories, are aligned with the WHO definitions.

Conclusion. There is a clear need to update the regulatory framework on counterfeit medicines which would entail revisiting RA 8203 to amend the definition of counterfeit medicines and other related provisions in alignment with the WHO definitions.