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Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices
Published on: January 13th, 2023
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.
Reporting Violations to the PFDA
In addition, the FDA has set up points of contact to report violations of this advisory, which are listed below:
- CDRR – (02) 8809-5596
- CDRRHR – (02) 8857-1900 loc. 8301
Understanding Medical Device Advertising Requirements
It is important to note that all medical device advertising in the Philippines has to be approved by either the Ad Standards Council or the PFDA, dependent on the content of the ad. The requirements for these advertisements can be found here. More information on the requirements for advertising medical devices and pharmaceutical products in the Philippines can be found on the Asia Actual website here.
Additionally, across Asia, several different countries have rules/regulations in regard to medical device advertising and how it must get approved. For more information on the requirements for getting medical device advertising approved in in Thailand, the Philippines, Indonesia, Vietnam, Malaysia, Singapore, Korea, China, Hong Kong, Taiwan, and Japan, check this article on the Asia Actual website here.
Grow With Us
Please contact us if you have questions regarding the new regulations and/or are interested in registering your product in the Philippines. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.
Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.