Transfers of Value to Healthcare Professionals

The Philippines

Supporting Healthcare Professionals (Transfers of Value)

Transfers of Value to Healthcare Professionals Stage

Bayer Philippines Inc. complies with the Government regulation regarding HCP Reporting signed under DOH Admin Order 2021-0036, Guidelines on Compliance with Section 35 (b) of RA No. 1123 (Universal Healthcare Act) (“Regulations”)

The Regulations require that All Drug, Medical Device, Biological and Medical Supplies Manufacturers to Submit Reports on Disclosure of Financial Relationships with Healthcare Providers and Healthcare Professionals to the DOH Website.

Scope

The Regulations shall apply to all FDA-licensed manufacturers, traders, repackers and distributor-importers and distributor-wholesalers of drug, medical device and biological products, including vaccines, and medical supplies registered with the FDA. 
 

Financial Relationships Coverage

  1. For health care providers, all sponsorship of events, research and educational grants, payment of services, space rentals or facility fees, and donations for patients, among other health care provider services arrangements. 
  2. For health care professionals, all donations, educational grants, research funding, sponsorships related to events, travel, and accommodation, registration fees, honoraria, support for continuing professional development (CPD), royalties, current or prospective ownership or investment interest, consultancy/speakership fees, among other health care professional services arrangements; and,
  3. Payments to drugstores for disease awareness partnership programs, training of drugstore pharmacists conducted by companies or training of drugstore pharmacists conducted by third parties on behalf of companies, or similar nature of financial relationships, shall be disclosed and reported.

Who needs to submit?

  • Manufacturers of drugs, medical devices, biological and medical supplies; 
  • Traders of drugs, medical devices, biological and medical supplies; 
  • Distributor-Importers of drug, medical device and biological products and medical supplies; 
  • Distributor-wholesalers of drug, medical device and biological products and medical supplies; 
  • Repacker of drug, medical device and biological products and medical supplies. 

Where to submit?

FDA Online Disclosure Report System that can be accessed online via https://odrs.fda.gov.ph. 

 

Reporting period coverage and deadline
 

Report Coverage Deadline for Updating in the FDA Online Disclosure Report System
1st half of the year Every 15th of July of the current year
2nd half of the year Every 15th of January of the succeeding year


Penalty

  • Failure to submit and update the Disclosure Reports on the part of the manufacturers, traders, repackers, distributor-importers and distributor-wholesalers shall constitute violation of the RA 11223 and its IRR. 
  • It shall be a basis or ground for the PHEC to investigate, process, and recommend to FDA to conduct inspection of the manufacturers, traders, repackers, distributor-importers, and distributor-wholesalers and check on the financial relationship with HCPs and report the findings. 
  • After due process, the FDA may institute penalty based on the provision of RA 9711 or as may be determined by the Secretary of Health in the exercise of powers under RA 11223 and other laws.