MANILA, Philippines — While investigations are ongoing into a local drug company’s alleged prescriptions for an incentive marketing scheme for doctors, the Department of Health (DOH) and Food and Drug Administration (FDA) have reminded pharmaceutical firms that they are required to regularly disclose their “financial relationships” with hospitals and physicians.
An announcement issued by FDA director general Dr. Samuel Zacate on April 26 and made public by the DOH on Tuesday reiterated to FDA-registered manufacturers, traders, repackers, distributor-importers, and distributor-wholesalers of drugs, medical devices and biological products — including vaccines, and medical supplies registered with the FDA — that they are mandated “to collect and track all financial relationships with healthcare providers and healthcare professionals and report these to the DOH, through the FDA.”
READ: Bell-Kenz Pharma admits giving incentives to doctors
Under DOH Administrative Order No. 2021-0036, the updated disclosure reports must be submitted twice a year: before July 15 for the first half of the current year and by Jan. 15 of the following year for the second half.
Financial relationships were defined as including “all donations, educational grants, research funding, sponsorships related to events, travel, and accommodation, registration fees, honoraria, support for continuing professional development, royalties, current or prospective ownership or investment interest, consultancy/speakership fees, among other healthcare professional services arrangements.”
READ: Drug firm in Senate probe denies ‘pyramiding’ accusations
Disciplinary action
Violators face an investigation, with the penalties to be determined by either the FDA or DOH secretary.
Based on the FDA’s database, Bell-Kenz Pharma Inc., which is the subject of an investigation being conducted by the DOH, FDA, Philippine Medical Association, Professional Regulatory Commission, and the Senate, has a license to operate as a drug wholesaler (until July 6, 2024), drugstore (July 31, 2024), and drug trader (until Sept. 28, 2025).
During a Senate hearing on Tuesday, Bell-Kenz chair and CEO Dr. Luis Raymond Go said that 50 of their shareholders were doctors, mostly cardiologists like him, and some connected to the state-run Philippine Heart Center.
He admitted that the company had been “incentivizing” doctors to prescribe their medicines by paying for their trips abroad for “continued medical education” or providing them with medical equipment.