Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 2005-0001)
The State's primary policy is to protect and promote the right to health of the people and instill health consciousness among them, as stated in Section 15, Article II of the 1987 Constitution.
The Department of Health through the Bureau of Food and Drugs (BFAD) is mandated to ensure the safety, efficacy, and good quality of pharmaceutical products applied for registration.
No, the Department of Health and BFAD do not have the legal authority, resources, or competence to pass upon intellectual property matters.
Republic Act No. 8293, known as the Intellectual Property Code of the Philippines, governs intellectual property rights such as patents and trade secrets.
Applicants must execute a notarized affidavit of undertaking stating that if it is finally decided that they have no intellectual property rights over the product, the issued Certificate of Product Registration (CPR) will be cancelled or revoked, and they agree to indemnify BFAD against any third-party claims.
New applications for CPR must be posted on the BFAD website for a period of at least thirty (30) days from the filing of the application.
BFAD must respond in writing that intellectual property matters are beyond its legal mandate and that the proper recourse is with the Intellectual Property Office (IPO) or a competent court of law.
No, filing such notification or posting the application on the website shall not cause suspension, delay, or adverse effect on processing unless BFAD is restrained or enjoined by the IPO or competent court.
Annotations linking the effectivity of the CPR to the patent expiration date or any similar intellectual property-related restrictions shall be considered superfluous and not countenanced by BFAD.
Administrative Order No. 170, series of 2004, along with other inconsistent issuances, is repealed and replaced by this Order.