Section 12Sec./Art. 12

The Rare Disease Technical Working Group (RDTWG). The DOH shall convene the RDTWG which shall have the following roles and responsibilities:

(a) Determine what disorder or disease shall be considered as a rare disease, and what are the orphan drugs and orphan products, and update the list periodically;

(b) Formulate policies that shall regulate the approval and certification of orphan drugs and orphan products; and

(c) Establish a system to ensure the regular updating of information, diagnosis and treatment of rare diseases in order to provide for the comprehensive healthcare of these patients.