SIXTEENTH CONGRESS OF THE 
REPUBLIC OF THE PHILIPPINES 
Third Regular Session 
) 
) 
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"15 
GCT -7 P6 :35 
SENATE 
S. B. No. 2990 
." , "''';" 'lY'-iF 
PREPARED JOINTLY BY THE COMMITTEES ON HEALTH AND DEMOGRAPHY, 
SOCIAL JUSTICE, WELFARE AND RURAL DEVELOPMENT, WAYS AND MEANS, 
YOUTH AND FINANCE WITH SENATORS SANTIAGO, (P.) CAYETANO, LEGARDA, 
VILLAR, ANGARA, LAPID, POE, AND GUINGONA AS AUTHORS THEREOF 
"AN ACT PROMULGATING A COMPREHENSIVE POLICY IN ADDRESSING THE 
NEEDS OF PERSONS WITH RARE DISEASE" 
Be it enacted by the Senate and House of Representatives of the Philippines in 
Congress assembled: 
ARTICLE I 
GENERAL PROVISIONS 
1 
SECTION. 1. Short Title - This Act shall be known as the "Rare Diseases Act of 
2 
the Philippines." 
3 
SEC. 2. Declaration of Policy - It is the policy of the State to protect and 
4 
promote the right to health of the people, including the right of persons suffering from 
5 
rare diseases to survival and full and healthy development as individuals through 
6 
access to timely health information and adequate Medical Care. In pursuit of such 
7 
policy, the State shall institutionalize a system that is comprehensive, integrative and 
8 
sustainable and will facilitate collaboration among government and non-government 
9 
agencies and organizations at the national and local levels, private sector, professional 
10 
health organizations, academic institutions, communities and families towards the 
11 
provision of early and sustainable care of persons afflicted with rare disease. The State 
12 
recognizes the crucial role of research in defining health programs and activities to 
13 
address the needs of patients with rare disease. The State also recognizes that an 
14 
effective public education program is vital in helping ensure the early diagnosis and 
15 
treatment of rare disorders and in preventing those afflicted with them from being the 
16 
subject of ridicule and stigmatization. 
17 
SEC. 3. Objectives- The objectives of this Act are as follows: 
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1. Improve the access of patients diagnosed to have a rare disease or patients 
19 
highly suspected of having a rare disease to comprehensive Medical Care, 
20 
including drugs and other healthcare products to treat or otherwise, as well as 
21 
timely health information to help them cope with their condition by: 
22 
a. Establishing a comprehensive and sustainable health care system 
23 
integrated within the public health care delivery system for early and 
24 
sustainable care for patients suffering from rare diseases; 
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1 
b. Establishing and maintaining the Rare Disease Registry which shall 
2 
include data on rare diseases in the Philippines, patients afflicted with 
3 
rare diseases, and orphan drugs and products. 
This data shall be 
4 
utilized in formulating policies, identifying program interventions and 
5 
designing researches to address the needs of patients with rare 
6 
disease; 
7 
c. Integrating public educational and informational campaigns in the 
8 
current programs of the DOH to identify persons afflicted with rare 
9 
disease and help the public understand the special needs of such 
10 
persons; and 
11 
d. Facilitating the regular collaborative activities among stakeholders 
12 
regarding the realization of the objectives of this Act. 
13 
2. Provide regulatory and fiscal incentives to support research and development 
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studies on rare diseases and to facilitate the manufacture and importation of 
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affordable orphan drugs and orphan products. 
16 
ARTICLE II 
17 
DEFINITION OF TERMS 
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SEC. 4. Definitions - For the purpose of this Act, the following terms shall be 
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defined as follows: 
20 
a) Commercial Use refers to the selling of orphan drugs at profit. 
21 
b) Healthcare Practitioners refer to any doctor of medicine, dentist, nurse, 
22 
midwife, allied health professionals and other health care professionals duly 
23 
licensed by the Professional Regulatory Commission. 
24 
c) Healthcare Institutions refer to hospitals, health infirmaries, health centers, 
25 
lying-in centers or puericulture centers, whether public or private. 
26 
d) Medical Care refers to a comprehensive and professional care that 
27 
encompass correct diagnosis, treatment and prevention of rare diseases. 
28 
e) Medical Food refers to special milk formula devoid of offending amino acids, 
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organic acids or fatty acids, amino acid supplements, essential amino acid 
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mixtures, amino acid gels or juices, and low protein food products that are part of 
31 
the regimen for the medical treatment of patients with inherited metabolic 
32 
diseases. 
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34 
f) Medical Specialist refers to a pediatrician (for patients 0-18) or adult physician 
35 
(>18 yo) adequately trained by experts in the field of inherited metabolic diseases 
36 
to diagnose and treat patients with rare diseases. 
37 
38 
g) National Comprehensive Newborn Screening System, refers to the Newborn 
39 
Screening (NBS) system established in RA 9288 that includes, but is not limited 
40 
to: i) education of relevant stakeholders; ii) collection, transport, biochemical 
41 
screening, and reporting on result of blood samples taken from newborns; iii) 
42 
tracking and confirmatory testing to ensure the accuracy of screening results; iv) 
43 
clinical evaluation and biochemistry/medical confirmation of follow-up results; v) 
44 
administration of drugs and/or medical and surgical management and/or dietary 
2 


1 
supplementation to counter adverse effects of the heritable conditions; and f) 
2 
monitoring and evaluation of the National Comprehensive Newborn Screening 
3 
System. 
4 
h) Newborn Screening Continuity Clinic refers to an ambulatory clinic based in a 
5 
secondary or tertiary hospital identified by the DOH to be part of the National 
6 
Comprehensive Newborn Screening System Treatment Network. It is equipped 
7 
to facilitate continuity of care of patients confirmed with conditions included in the 
8 
expanded newborn screening in its area of coverage. 
9 
i) Orphan Drug refers to any drug or medicine used to treat or alleviate the 
10 
symptoms of persons afflicted with a rare disease and declared as such by the 
11 
DOH upon recommendation of the National Institutes of Health (NIH). 
12 
13 
j) Orphan Product refers to any healthcare or nutritional product, other than a 
14 
drug or medicine, including but not limited to diagnostic kits, medical devices and 
15 
biological products, used to prevent, diagnose, or treat rare diseases and 
16 
declared as such by the DOH upon recommendation of the NIH. 
17 
k) Rare Disease refers to disorders such as inherited metabolic disorders and 
18 
other diseases with similar rare occurrence as recognized by the DOH upon 
19 
recommendation of the NIH but excluding catastrophic (i.e., life threatening, 
20 
seriously debilitating, or serious and chronic) forms of more frequently occurring 
21 
diseases. 
22 
I) Rare Disease Management Program refers to a comprehensive management 
23 
program encompassing the diagnosis, clinical management, genetic counseling 
24 
and drug research development for people with rare diseases. 
25 
m) Rare Disease Registry refers to the secure health information system, 
26 
including the electronic database system, relating to data on rare diseases, 
27 
persons with rare disease, and Orphan Drugs and Orphan Products. 
28 
n) Rare Diseases Technical Working Group (RDTWG) refers to the DOH 
29 
designated pool of experts on rare diseases, which shall include experts from the 
30 
National Institutes of Health, tasked with identifying rare diseases, Orphan Drugs 
31 
and Orphan Products. 
32 
0) Telegenetics Referral System refers to telehealth using a computer network 
33 
system that provides remote genetic clinical consultations to physicians in the 
34 
provinces for their patients. 
35 
ARTICLE III 
36 
IDENTIFICATION, REFERRAL, MANAGEMENT AND REGISTRATION OF 
37 
PERSONS WITH RARE DISEASE 
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39 
SEC. 5. Identification of Persons with Rare Disease. -
The DOH, in 
40 
coordination with the NIH, shall create a Rare Disease Registry. It shall endeavor to 
41 
comply with set global standards, if applicable. All patients diagnosed with rare disease 
42 
shall be included in this registry. 
43 
SEC. 6. Referral of Patients with Rare Disease - Patients highly suspected of, 
44 
or diagnosed with, rare disease shall be referred to a Newborn Screening Continuity 
45 
Clinic identified by the DOH as referral centers for treatment of rare diseases under the 
3 


1 
National Comprehensive Newborn Screening System. For patients from remote areas, 
2 
the Telegenetics Referral System will be utilized. 
3 
SEC. 7. Availability of Specialist for the Management of Persons with Rare 
4 
Disease -The DOH, with the assistance of NIH, shall develop a system to train a 
5 
sufficient number of Medical Specialists to diagnose and manage persons with rare 
6 
disease. 
7 
SEC. 8. Management of Persons with Rare Disease. The DOH, with the 
8 
assistance of the NIH, shall provide Persons with Rare Disease better access to a 
9 
support system through the creation of a Rare Disease Management Program under 
10 
the National Center for Disease Prevention and Control of the DOH. 
11 
SEC. 9. Registration of Persons with Rare Disease. All Healthcare 
12 
Practitioners and Health Institutions shall be required to report to the Rare Disease 
13 
Registry diagnosed cases of Rare Disease and provide reports on the status of patients; 
14 
Provided, That such reports shall be subject to guidelines issued by the NIH to protect 
15 
the privacy of patients with rare disease. 
16 
ARTICLE IV 
17 
PERSONS WITH RARE DISEASE AS PERSONS WITH DISABILITIES (PWDs) 
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SEC. 10. Designation of Persons with Rare Disease as Persons with 
19 
Disabilities (PWDs) - Persons with Rare Disease shall be considered as persons with 
20 
disabilities (PWDs), in accordance with Republic Act 7277, as amended, or the Magna 
21 
Carta for Disabled Persons. 
22 
SEC. 11. Rights and Privileges of Persons with Rare Disease. -
The 
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appropriate national government agency shall ensure that they are accorded the same 
24 
rights and privileges as PWDs, to wit: 
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a) The Department of Social Welfare and Development (DSWD) shall provide 
26 
assistance to persons with Rare Disease to ensure that their social welfare 
27 
and benefits are provided under Republic Act 7277, as amended, or the 
28 
Magna Carta for Disabled Persons, are granted; and 
29 
b) The Department of Labor and Employment (DOLE) shall adopt programs that 
30 
promote the availability of opportunities for work and employment of able-
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persons with Rare Disease. 
32 
ARTICLE V 
33 
DESIGNATION OF RARE DISEASE, ORPHAN DRUG, AND 
34 
ORPHAN PRODUCT STATUS 
35 
SEC. 12. The Rare Disease Technical Working Group (RDTWG) • The DOH 
36 
shall convene the RDTWG which shall have the following roles and responsibilities: 
37 
a) Determine what disorder or disease shall be considered as a Rare Disease, 
38 
and what are the Orphan Drugs and Products, and update the list periodically; 
39 
b) Formulate policies that shall regulate the approval and certification of Orphan 
40 
Drugs and Products; and 
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1 
c) Establish a system to ensure the regular updating of information, diagnosis 
2 
and treatment of Rare Diseases in order to provide for the comprehensive 
3 
health care of these patients. 
4 
SEC. 13. Designation of Rare Disease - The DOH, upon recommendation of 
5 
the RDTWG, shall have the authority to designate any disease that is recognized to 
6 
rarely afflict the population of the country as a Rare Disease. 
7 
SEC. 14. Designation of Orphan Drug -
The DOH, motu proprio or upon 
8 
application by any interested person, and with the recommendation of the RDTWG, may 
9 
designate any drug or medicine indicated for use by patients afflicted with any of the 
10 
Rare Diseases as an Orphan Drug. Within one hundred twenty (120) days from the 
11 
effectivity of this Act, the DOH shall publish a list of Orphan Drugs for these Rare 
12 
Diseases. 
13 
SEC. 15. Designation of Orphan Product - The DOH, motu proprio or upon 
14 
application by any interested person, and with the recommendation of the RDTWG, may 
15 
designate any healthcare or nutritional product, other than a drug or medicine, including 
16 
but not limited to diagnostic kits, medical devices and biological products, used primarily 
17 
to prevent, diagnose, or alleviate the symptoms of Rare Diseases as an Orphan 
18 
Product. Within one hundred twenty (120) days from the effectivity of this Act, the DOH 
19 
shall publish a list of Orphan Products for these Rare Diseases. 
20 
SEC. 16. Permit for Restricted Use of an Orphan Drug/Orphan Product - Any 
21 
person may import any Orphan Drug or Orphan Product for compassionate use, 
22 
Provided, That they secure a compassionate special permit from the FDA in accordance 
23 
with DOH Administrative Order No.4, series of 1992, and any future guidelines that 
24 
may be issued on the same. 
25 
26 
Within thirty (30) days from receipt of the reqUirements, the FDA shall issue a 
27 
permit for restricted use of an Orphan Drug/Orphan Product which shall be effective for 
28 
a period of three (3) years, renewable for period of three (3) years thereafter: Provided, 
29 
That the FDA shall expedite the said permit in cases of emergency. 
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ARTICLE VI 
31 
IMPLEMENTATION 
SEC. 17. Lead Agency -
The DOH shall be the lead agency in the 
implementation of this Act. For purposes of achieving the objectives of this Act, the 
DOH shall: 
32 
a) Establish the RDTWG as defined in Sec. 4(n); 
33 
b) Coordinate with the NIH for the technical assistance in the implementation of 
34 
this Act; 
35 
c) Coordinate with all government and non-government agencies that are 
36 
involved in the implementation of this Act; 
37 
d) Support the activities of the Newborn Screening Continuity Clinics and 
38 
designate referral centers in strategic locations in the country for the timely 
39 
and sustainable medical management of persons with Rare Disease; 
40 
41 
e) Organize a pool of Medical Specialists who will be responsible in the 
42 
diagnosis and management of persons afflicted with Rare Disease and their 
43 
families; 
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1 
f) With the assistance of the NIH and other government agencies, professional 
2 
societies and non-government organizations, conduct culturally sensitive 
3 
public educational and information campaigns on the nature of Rare 
4 
Diseases, identify persons with Rare Disease and help the general public 
5 
understand the special needs of afflicted persons and their right against 
6 
ridicule and discrimination; 
7 
8 
g) Develop the implementing rules and regulations for the implementation of this 
9 
Act within one hundred eighty (180) days from the enactment of this Act; and 
10 
h) Allot budget for the implementation of this Act. 
11 
SEC. 18. Other implementing agencies - The FDA, NIH, Department of Interior 
12 
and Local Government (DILG), Department of Education (DepEd), DSWD, DOLE, 
13 
Department of Science and Technology (DOST), and other relevant government 
14 
agencies shall have the following tasks: 
15 
16 
17 
18 
19 
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24 
25 
26 
27 
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a) 
b) 
c) 
d) 
e) 
FDA shall ensure that Medical Foods, Orphan Drugs and Products are 
permitted in the country for purposes of treating Rare Diseases and shall 
develop a system that addresses emergency cases, as they may arise; 
NIH shall provide technical assistance to the DOH in the implementation 
of this Act; 
DILG, DepEd, DSWD and DOLE shall ensure that persons with Rare 
Disease are given the opportunity to be productive members of society 
and that they are given the same rights and benefits as PWDs; 
DOST shall provide mechanisms to further research for a beUer 
understanding of Rare Diseases in the country and develop low cost 
Medical Foods and Orphan Products for the patients; and 
All 
other relevant government agencies shall assist in 
the full 
implementation of this Act. 
29 
SEC. 19. Obligation of Healthcare Practitioners - A Healthcare Practitioner 
30 
who attends to a person with Rare Disease has the responsibility of informing the 
31 
patients and their families of available resources and refer them to the nearest available 
32 
specialist. 
33 
34 
35 
SEC. 20. Continuing Education and Training of Health Personnel. - The DOH 
36 
and the NIH, together with health professional societies and academic Healthcare 
37 
Institutions, shall: 
38 
a) 
Conduct continuing education, information, and training programs for 
39 
Healthcare Practitioners on the identification and referral of persons with 
40 
Rare Disease for medical management; and 
41 
b) 
Educate Healthcare Practitioners on the importance of reporting cases to 
42 
the Rare Disease Registry. 
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1 
ARTICLE VII 
2 
RESOURCE GENERATON AND FISCAL INCENTIVES 
3 
SEC. 21. Financial Assistance for Persons with Rare Disease - A person 
4 
with Rare Disease may avail of the following: 
5 
6 
7 
8 
a) 
b) 
Basic benefit package from the Philippine Health Insurance Corporation, 
which shall be provided in accordance with its guidelines; and 
Medical assistance as provided in Section 8 of Republic Act No. 10351 or 
the Sin Tax Reform Act of 2012. 
9 
SEC. 22. Fiscal Incentives - The following shall be exempted from all taxes and 
10 
customs duties, as applicable, whether national or local: 
11 
12 
13 
a) 
Donations intended for researches on Rare Diseases, maintenance of the 
Rare Disease Registry, or for purchase of Orphan Drugs or Orphan 
Products for use solely by patients with Rare Diseases; and 
14 
15 
b) 
Orphan Drugs and Orphan Products for use solely by patients with Rare 
Diseases, as certified by the FDA. 
16 
ARTICLE VIII 
17 
FINAL PROVISIONS 
18 
SEC. 23. Implementing Rules and Regulations - Within one hundred eighty 
19 
(180) days from effectivity of this Act, the DOH, in consultation with the NIH, shall issue 
20 
the implementing rules and regulations of this Act. 
21 
SEC. 24. Repealing Clause - All general and special laws, decrees, executive 
22 
orders, proclamations and administrative regulations, or any parts thereof, which are 
23 
inconsistent with this Act are hereby repealed or modified accordingly. 
24 
SEC. 25. Separability - If, for any reason or reasons, any part of provisions of 
25 
this Act shall be declared or held to be unconstitutional or invalid, other provision or 
26 
provisions hereof which are not affected thereby shall continue to be in full force and 
27 
effect. 
28 
SEC. 26. Effectivity - This Act shall take effect fifteen (15) days after its 
29 
publication in at least two (2) newspapers of general circulation. 
30 
Approved, 
7