Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices

On December 29th, 2022 the Philippines FDA (PFDA) issued an advisory reiteration concerning unethical business practices, specifically in regards to companies that sell/manufacture Prescription Pharmaceutical Products and Medical Devices (PPPMD) and their relationship/interaction with healthcare professionals (HCPs). The advisory is based off the Administrative Order (A.O.) No. 2015-0053, “Implementing Guidelines on the Promotion and Marketing of Prescription Pharmaceutical Products and Medical Devices.” 

PFDA Guidelines for Ethical Behavior Between PPPMDs and HCPs

The main purpose of the guidelines outlined in A.O. 2015-0053 are to ensure fair and reasonable marketing practices are utilized when promoting medical devices and pharmaceutical products, ultimately keeping the emphasis on patient rights and welfare. The provisions of the Administrative Order that the PFDA are as follows:  

Interactions Between PPPMDs and Health Care Professionals:  

• The foundation of the relationship between the PPPMD industry and HCPs must be patient welfare at all times. Ethics and transparency are crucial in encouraging healthcare practices revolving around patient need/well-being.  
• Accordingly, PPPMD companies must keep their contact with HCPs within accordance to (A.O.) No. 2015-0053, complying with all current laws and regulations.  

Promotional Information and Activities: 

• No PPPMD companies may utilize an HCP to promote a specific medical device or pharmaceutical product in an advertisement. This includes all media, such as print, online/social media, or television/radio advertising.  
• All marketing pertaining to medical devices or pharmaceutical products will be audited by the PFDA to ensure none of these provisions are disobeyed by a PPPMD. In the case that the PFDA finds an advertisement has violated the provisions, a number of penalties could be incurred, including a cease-and-desist order against the company or fines.  

• Education related items including grants or scholarships cannot be offered to an HCP in exchange for the recommendation or prescription of pharmaceutical products. 

Recreation and Entertainment:  

• Entertainment and recreational activities cannot be provided on behalf of an HCP from a PPPMD company, including vacations, tickets to theater/music performances or sporting events.  
• The aforementioned entertainment or recreational activities cannot be offered to an HCP regardless whether the PPPMD company has engaged the HCP for speaking/consulting purposes.  
• During scientific meetings, entertainment/recreational/social activities will not be paid for by a PPPMD company.  

• A PPPMD company is forbidden from paying the expenses incurred by family/guests of an HCP through travel or meals accumulated over the course of travel.  

Educational Items and Gifts:  

• Anything without direct effect on a patient or the work of an HCP is not permitted to be given by a PPPMD company to an HCP.  

Roles and Responsibilities:  

• A code of ethics for healthcare product promotion will be implemented by PPPMD companies to function in tandem with Administrative Order (A.O.) No. 2015-0053, engendering respect and ethical behavior between HCPs and PPPMD companies.  

These provisions laid forth by the FDA will be upheld by all stakeholders with the desired end result being the continued upholding of patient rights and welfare. Punishments for failing to follow these provisions include fines and more.