Section 4. Definitions.— For the purpose of this Act, the following terms shall be defined as follows:
Commercial use refers to the selling of orphan drugs at profit.
Healthcare Practitioner refers to any doctor of medicine, dentist, nurse, midwife, allied health professional and other healthcare professional duly licensed by the Professional Regulatory Commission.
Healthcare institutions refer to hospitals, health infirmaries, health centers, lying-in centers or puericulture centers, whether public or private.
Medical care refers to a comprehensive and professional care that encompasses correct diagnosis, treatment and prevention of rare diseases.
Medical food refers to special milk formula devoid of offending amino acids, organic acids or fatty acids, amino acid supplements, essential amino acid mixtures, amino acid gels or juices, and low protein food products that are part of the regimen for the medical treatment of patients with inherited metabolic diseases.
Medical specialist refers to a pediatrician for patients zero to eighteen (0–18) years old or adult physician for above eighteen (18) years old adequately trained by experts in the field of inherited metabolic diseases to diagnose and treat patients with rare diseases.
National Comprehensive Newborn Screening System refers to the Newborn Screening (NBS) system established in Republic Act No. 9288 that includes, but is not limited to: 9. education of relevant stakeholders; (ii) collection, transport, biochemical screening, and reporting on result of blood samples taken from newborns; (iii) tracking and confirmatory testing to ensure the accuracy of screening results; (iv) clinical evaluation and biochemistry/medical confirmation of follow-up results; 22. administration of drugs and/or medical and surgical management and/or dietary supplementation to counter adverse effects of the heritable conditions; and (vi) monitoring and evaluation of the National Comprehensive Newborn Screening System.
Newborn screening continuity clinic refers to an ambulatory clinic based in a secondary or tertiary hospital identified by the DOH to be part of the National Comprehensive Newborn Screening System Treatment Network. It is equipped to facilitate continuity of care of patients confirmed with conditions included in the expanded newborn screening in its area of coverage.
Orphan drug refers to any drug or medicine used to treat or alleviate the symptoms of persons afflicted with a rare disease and declared as such by the DOH upon recommendation of the National Institutes of Health (NIH).
Orphan product refers to any healthcare or nutritional product, other than a drug or medicine, including, but not limited to, diagnostic kits, medical devices and biological products, used to prevent, diagnose, or treat rare diseases and declared as such by the DOH upon recommendation of the NIH.
Rare disease refers to disorders such as inherited metabolic disorders and other diseases with similar rare occurrence as recognized by the DOH upon recommendation of the NIH but excluding catastrophic (i.e., life threatening, seriously debilitating, or serious and chronic) forms of more frequently occurring diseases.
Rare Disease Management Program refers to a comprehensive management program encompassing the diagnosis, clinical management, genetic counseling and drug research development for people with rare diseases.
Rare Disease Registry refers to the secure health information system, including the electronic database system, relating to data on rare diseases, persons with rare disease, and orphan drugs and orphan products.
Rare Diseases Technical Working Group (RDTWG) refers to the DOH designated pool of experts on rare diseases, which shall include experts from the NIH, tasked with identifying rare diseases, orphan drugs and orphan products.
Telegenetics Referral System refers to telehealth using a computer network system that provides remote genetic clinical consultations to physicians in the provinces for their patients.