IPOPHL lauds FDA’s haul of P28 million fake medicines and other violative health products under ‘Oplan Katharos’

IPOPHL lauds FDA’s haul of P28 million fake medicines and other violative health products under ‘Oplan Katharos’

November 22, 2024

The Intellectual Property Office of the Philippines (IPOPHL) lauded the Food and Drug Administration (FDA) for intercepting about P28 million worth of counterfeit medicines and health devices under its rigorous “Oplan Katharos” initiative.

Of the P28 million recorded as of September 2024, counterfeit drugs accounted for the bulk with a value of P21.9 million. Food products followed, estimated at P5.2 million. The haul value for cosmetics and household or urban and hazardous substances stood above P711,000 while health devices ran to over P142,000.

Launched in November 2023, “Oplan Katharos” is a comprehensive FDA-led initiative focused on the detection, seizure, storage and responsible disposal of counterfeit, unregistered and non-compliant health products.

IPOPHL Director General Rowel S. Barba highlighted the significance of the FDA’s operations over the past year, particularly the success under Oplan Katharos.

“Through coordinated operations and strict enforcement, FDA agents have seized a range of illicit items that threaten the safety of Filipino consumers. Each seizure represents a victory in our mission to ensure that only genuine and safe products are traded in the Philippine market,” Barba said.

IPOPHL, the acting chair of the National Committee on Intellectual Property Rights (NCIPR)—a multi-agency coalition of 15 government offices, including the FDA—is intensifying its role in fighting counterfeiting and upholding intellectual property (IP) laws across the country.

“The FDA assures that traders and manufacturers of fake medicines will be prosecuted to the full extent of the law,” FDA Director General Samuel A. Zacate said.

Addressing allegations as source

IPOPHL and the FDA aim to address the longstanding allegation, particularly that from the United States Trade Representative (USTR), which suggests the Philippines may be a producer of counterfeit medicines. However, in the report the USTR used as basis for the claim, the Organization for Economic Cooperation and Development (OECD) and the European Union IP Office (EUIPO) only referred to countries like the Philippines as “provenance economies.” The term tags a country as either a source or a transit point for fake medicines, acknowledging the challenge in distinguishing between the two.

Moreover, the OECD and EUIPO report, which used data from 2017 to 2019, have noted that seizure operation reporting, in which the Philippines has been transparent, could underestimate or overestimate its ranking.

“We will continue to work with IPOPHL and the NCIPR with hopes of finally uncovering the truth and possibly putting an end to the accusations that damage the country’s reputation,” Zacate added.

For his part, Pharmaceutical Security Institute (PSI) Regional Director for Asia Pacific Ramesh Raj Kishore said working with IPOPHL has showcased how the Philippine government has established an “excellent partnership” with various stakeholders to disrupt criminal networks and raise public awareness in avoiding counterfeit medicines.

“From pharmaceutical manufacturers to retailers, all must work in concert with law enforcement agencies in order to detect and prevent the integrity of the supply chain from being corrupted,” Kishore said.

Not a source

Founded in 2002 by security directors from 14 major pharmaceutical companies, the PSI is a non-profit organization that aims to protect public health by sharing information and taking action against pharmaceutical counterfeiting. It has 37 pharmaceutical manufacturer-members from various nations.

Since their MOU, the IPOPHL and PSI have successfully exchanged intelligence that have yielded positive results, especially when diverting large volumes of counterfeit pharmaceuticals seized in Philippine ports.

“In PSI’s Open-Source Intelligence Report, there has been no evidence to suggest that counterfeit medicines are manufactured in the Philippines but rather detained in transit and/or upon import,” Kishore said.

He added that the PSI commits to continuing its partnership with the Philippine government, sharing vital intelligence, resources and expertise to help develop robust regulatory frameworks that ensure only legitimate pharmaceutical products reach the market.

The Philippines this week is celebrating National Consciousness Week Against Counterfeit Medicines (NCWACM) which takes place every third week of November.

The event aims to raise awareness on the dangers of counterfeit medicines and the need to control their spread in the Philippines. # # # (Janina Lim, Information Officer III)