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16'h CONGRESS Of THE REPUBLIC 
OF THE PHILIPPINES 
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Second Regular Session 
SENATE 
S. B. NO. 2383 
Introduced by Senator Sonny M. Angara 
AN ACT PROMULGATING A COMPREHENSIVE POLICY IN ADDRESSING THE 
NEEDS OF PERSONS AFFLICTED BY RARE DISORDERS 
Explanatory Note 
A "rare disease" is any health condition resulting from genetic defects that rarely 
affect the general population. There are 6,000-8,000 rare diseases, also known as 
"orphan disorders" majority of which are genetic in origin and manifest at birth or 
early in childhood." Rare diseases are often chronic, progressive, degenerative, and 
life-threatening. 
With many rare diseases, a patient's quality of life is often compromised by the lack 
or loss of autonomy and high level pain, inflicting emotional strife as well on both the 
patient and their families. 
These diseases afflict a small number 'of people, as the Global Genes Project 
estimated that only 4 percent of the world population has a rare disease. With such a 
small population, pharmaceutical companies and other medical companies find it 
difficult to achieve the economies of scale that justify any targeted research or mass 
production of "orphan treatments or medicines." Such a situation makes treatment, 
often lile-Iong, costly and far beyond the reach of most Filipino patients. 
However, every Filipino should be provided access to proper healthcare, as 
enshrined in Section 15 Article 2 01 the 1987 Constitution which emphasizes that 
"[tlhe State shall protect and promote the right to health of the people and instill 
health consciousness among them". Section 11 Article 13 further provides that "[tlhe 
State shall adopt an integrated and comprehensive approach to health development 
which shall endeavor to make essential goods, health and other services available to 
all people at affordable cost." 
Furthermore, the United Nations Convention on the Rights of the Child, which the 
Philippines ratified on July 26, 1990, requires States Parties to "recognize the right of 
the child to the enjoyment of the highest attainable standard of health" (Art. 24[1]) 
and to "ensure the provision of necessary medical assistance and health care to all 
children" (Art. 24[2b]). 
Simply, it should be national policy that the state endeavors toward universal 
. healthcare, even for rare diseases. 
I EURORDI$-RARE DISEASES EUROPE: httpl!www,eulOrdlsorgiabollt l\lre (hse~ses 
1 NatlOlllll Orgalllzat!OO [01 Rllre DISOlder~ (US National Institutes of He~l[h): https.llwww l'lledlseases.on,l1are-dlse~se­
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Lately, facets of a true universal healthcare system were put in place-including 
mandatory health insurance coverage, assured long-term health financing through 
higher excise taxes on alcohol and tobacco products, and a nationwide health 
research system. 
The foregoing measure aims to build on these foundations, 
seeking to create a 
comprehensive and sustainable health system for rare diseases integrated into the 
existing public health care system. This will ensure the provision of early and 
sustainable care for patients suffering from rare diseases; relevant and well-
coordinated research and development initiatives across the appropriate government 
agencies and private sector proponents; and integration of the health care activities 
for informational program on rare diseases for the general public and health care 
practitioners. As a result, patients with rare diseases and their families will be 
afforded better access to adequate medical care, health information, and healthcare 
products needed to treat their condition. 
In recognition of our constitutional and international obligations to improve the health 
conditions of the people, the immediate enactment of this bill is earnestly sought. 


1 
16th CONGRESS OF THE REPUBLlC_ 
OF THE PHILIPPINES 
Second Regular Session 
SENATE 
S. BILL NO. 2383 
Introduced by Senator Sonny M. Angara 
'14 
AUG 27 P 4 :37 
AN ACT PROMULGATING A COMPREHENSIVE POLICY IN ADDRESSING THE 
NEEDS OF PERSONS AFFLICTED BY RARE DISORDERS 
Be it enected by the Senate and the House of Representatives of the Philippines in 
Congress assembled: 
ARTICLE 1 
GENERAL PROVISIONS 
2 
SECTION 1. Title - This Act shall be known as the "Rare Diseases Act of the 
3 
Philippines." 
4 
5 
Section 2. Declaration of Policy - It is the policy of the State to protect and 
6 
promote the right to health of the people, including the right of persons suffering from 
7 
rare diseases to survival and full and healthy development as individuals through 
8 
access to timely health information and adequate medical care. In pursuit of such 
9 
policy, the State shall institutionalize a system that is comprehensive, integrative and 
10 
sustainable and will facilitate collaboration among government and non-government 
11 
agencies and organizations at the national and local levels, private sector, 
12 
professional health organizations, academic institutions, communities and families 
13 
towards the provision of early and sustainable care of every person afflicted with rare 
14 
disorders. The state recognizes the crucial role of research in defining health 
15 
programs and activities to address the needs of patients with rare disorders. The 
16 
State also recognizes that an effective public education program is vital in helping 


1 
ensure the early diagnosis and treatment of rare diseases and in preventing those 
2 
afflicted with them from being the subject of ridicule and stigmatization. The State 
3 
further recognizes the leading role of the Department of Health in implementing the 
4 
Rare Disease Program, overseeing the provision of care, and working with the other 
5 
government agencies, the private sector and non-governmental organizations, in 
6 
designing and implementing programs, including research & development activities 
7 
on rare diseases, for the benefit of those afflicted with them. 
8 
9 
Section 3. Objectives - The objectives of this Act are as follows: 
10 
1) Ensure that every patient diagnosed to have a rare disease or patients highly 
11 
suspected of having a rare disease has access to comprehensive medical care, 
12 
including drugs and other healthcare products to treat or otherwise, as well as timely 
13 
health information, to help them Gope with their condition; 
14 
15 
2) Establish a comprehensive and sustainable health care system integrated within 
16 
the public health care delivery system that will ensure the provision of early and 
17 
sustainable care for patients suffering from rare diseases; 
18 
19 
3) Design and maintain the Rare Disease Registry which shall include data on rare 
20 
diseases in the Philippines, patients afflicted with rare diseases, and orphan drugs 
21 
and products. This data shall be utilized in formulating policies, identifying program 
22 
interventions and designing researches that will eventually address the needs of 
23 
patients with rare disease; 
24 
25 
4) Integrate public educational and informational campaigns in the current programs 
26 
of the DOH to identify persons afflicted with rare disease and help the public 
27 
understand the special needs of such persons; 
28 


1 
2 
3 
4 
5 
6 
7 
5) Facilitate the re(Jular collaborative activities among stakeholders regarding the 
realization of the objectives of this Bill; 
(, 
6) Provide regulatory and fiscal incentives to support research and development 
activities on rare diseases and the manufacturing of affordable orphan drugs or 
orphan products or the importation of these; and 
8 
7) Institutionalize a financial incentive system for agencies involved in clinical 
g 
researches, patient care, medical information management, and other similar 
10 
activities for the benefit of persons afflicted with a rare disease. 
11 
12 
13 
ARTICLE 2 
14 
DEFINITION OF TERMS 
15 
·16 
Section 4. Definitions - Under this Act, the following terms shall have the 
17 
meanings respectively given to them below: 
18 
1) Healthcare practitioners means any doctor of medicine, dentist, nurse, midwife, 
19 
allied health professionals and other health care professionals duly licensed by the 
20 
Professional Regulatory Commission. 
21 
22 
2)Healthcare institutions means hospitals, health infirmaries, health centers, lying-in 
23 
centers or puericulture centers, whether public or private. 
24 
25 
3)Medica/ care means any method used by a health care practitioner to prevent, 
26 
diagnose, and remove the symptoms and cause of a disease. 
27 


1 
4) Medical Food are food products specifically formulated for the dietary 
2 
management of specific inherited metabolic disorders. These are prescribed by 
3 
physicians with special training in the care of patients with rare disorders to provide 
4 
the necessary nutrition and treatmen1 that is essential for the survival of these 
5 
patients. 
6 
7 
5)National Comprehensive Newborn Screening System, as established by RA 
8 
9288,is the existing network of medical specialists, nurses, laboratories and hospitals 
9 
screening and treating these genetie diseases, many of which are also rare 
10 
disorders. 
11 
12 
6)Newborn Screening Continuity Clinic refers to an ambulatory clinic based in a 
13 
tertiary hospital identified by the DOH to be part of the National Comprehensive 
14 
Newborn Screening System Treatment Network. It is equipped to facilitate continuity 
15 
of care of patients confirmed with conditions included in the expanded newborn 
16 
screening in its area of coverage. 
17 
18 
7) NIH means the National Institutes of Health. 
19 
20 
8) Orphan Drug means any drug or medicine used to treat or alleviate the symptoms 
21 
of persons afflicted with a rare disease and declared as such by the Department of 
22 
Health upon recommendation of the National Institutes of Health. 
23 
24 
9) Orphan Product means any healthcare or nutritional product, other than a drug or 
25 
medicine, including but not limited to diagnostic kits, medical devices and biological 
26 
products, used to prevent, diagnose, or treat rare diseases and declared as such by 
27 
the Department of Health upon recommendation of the National Institutes of Health. 
28 


1 
10) Rare Disease means disorders such as Gaucher Disease, Maple Syrup Urine 
2 
Disease, Pompe Disease, Galactosemia, Phenylketonuria, Methylmalonic Acidemia, 
3 
Urea Cycle Defects, Hurler Syndrome, Hunter Syndrome and other diseases with 
4 
similar rare occurrence as recognized by the Department of Health upon 
5 
recommendation of the National Institdtes of Health. For the avoidance of doubt, it 
6 
does not include catastrophic (i.e .. life threatening, seriously debilitating, or serious 
7 
and chronic) forms of more frequently occurring diseases. 
8 
9 
11) Rare Disease F?egistry means the secure health information system, including 
10 
the electronic database system, relating to data on rare diseases, persons afflicted 
11 
with rare diseases, and orphan drugs and orphan product. 
12 
'13 
12) RDTWG means Rare Diseases Technical Working Group, a DOH designated 
14 
pool of experts on rare diseases tasked with identifying rare diseases, drugs and 
15 
products. 
16 
17 
13) Te/egenetles F?eferra/ System refers to a computer network system that provides 
18 
remote genetic clinical consultations to physicians in the provinces for their patients 
19 
20 
ARTICLE 3 
21 
RARE DISORDERS 
22 
23 
Section5. Obligation of health care practitioners - Health care practitioners 
24 
who attend to a person with rare disorders are obligated to the following: 
25 
1) To give the patient and their family substantial information about the 
26 
significance of diagnosis and management and the rights of the affected 
27 
individual to benefits of persons with disability; 
28 
, 


1 
2) To ensure that the afflicted person is referred to Newborn Screening 
2 
Continuity 
3 
Clinics identified by the Depa(lment of Health (DOH) as referral centers for 
4 
treating rare diseases; and 
5 
6 
Section 6. Designation of persons with rare diseases as persons with 
7 
disabilities -
Individuals with rare disease shall be included among those with 
8 
disabilities and enjoy the same rights under the Magna Carta for disabled persons as 
9 
mandated in Republic Act 9442. 
10 
11 
1) The Department of Labor and. Employment shall ensure that abled persons 
12 
with rare disease are given opportunity for work and employment to become 
13 
productive members of the society. 
14 
15 
2) The Department of Social Welfare and Development shall provide 
16 
assistance to person with rare disease to ensure that their social welfare and 
17 
benefits are provided as mandated in the Magna Carta for disabled persons 
18 
19 
ARTICLE 4 
20 
IDENTIFICATION, REFERRAL AND MANAGEMENT OF PERSON WITH RARE 
21 
DISORDERS 
22 
23 
Section 7. Continuing Education and Training of Health personnel -The 
24 
Department of Health and the National Institutes of Health in collaboration with 
25 
health professional societies and academic health institutions shall: 
26 


1 
2 
3 
4 
1) Conduct continuing education, information and training programs for health 
personnel on the identification and referral of persons with rare disorders for 
medical management; and 
5 
2) Educate health personnel on the importance of reporting of any cases of 
6 
orphan disorders for the Rare Disease Registry 
7 
8 
Section 8. Public Information about rare disorders -The Department of 
9 
Health with the assistance of the NIH and other government agencies, professional 
10 
societies and non-government organizations shall conduct culturally sensitive public 
11 
educational and information campaigns on the nature of rare diseases, identify 
12 
persons afflicted with rare disease and help the general public understand the special 
13 
needs of the afflicted persons and be- spared for being the subject of ridicule and 
14 
discrimination. 
15 
16 
Section 9. Referral of patients with rare disease-
Patients highly 
17 
suspected of or diagnosed with rare disease shall be referred to a Newborn 
18 
Screening Continuity Clinic identified by the DOH as referral centers for treatment of 
19 
rare diseases under the National Comprehensive Newborn Screening System. 
20 
21 
22 
23 
24 
25 
26 
27 
1) Timely reterral ensures that the afflicted person receives the adequate care 
of his/her condition and referral of the person afflicted and her/his families to a 
metabolic specialist, geneticist or genetic counselor for genetic counseling. 
2) In the absence of a medical specialist in the area, the Newborn Screening 
Continuity Clinic shall coordinate with the National Institutes of Health (NIH) 
for co-management of the patient with a specialist. 


1 
2 
3) Establish a system in collaboration with local government unit and 
3 
agencies that will ensure that the afflicted person receives sustainable 
4 
medical management of the disease. 
5 
6 
4) Reports the case to NIH for its inclusion to the Rare Disease Registry. 
7 
8 
Section 10. Availability of specialist for the management of afflicted 
9 
person with rare disorders - The DOH with the assistance of NIH shall ensure the 
10 
availability of a medical specialist for the management of persons afflicted with rare 
11 
diseases 
12 
13 
ARTICLE 5 
14 
DESIGNATION OF RARE DISEASE, ORPHAN DRUG, 
15 
AND ORPHAN PRODUCT STATUS 
16 
Section 11. The Rare Disease Technical Working Group - The Department 
17 
of Health shall convene the Rare Diseases Technical Working Group (RDTWG) 
18 
which shall have the following roles and responsibilities: 
19 
1) Designate diseases that are 'rare diseases' 
20 
21 
22 
2) Designate orphan drugs and products corresponding to the rare diseases 
23 
3) Formulate policies that shall regulate the approval and certification of 
24 
orphan drugs and products 
25 


1 
2 
3 
4 
4) Establish a system to ensure the regular updating of information, diagnosis 
and treatment of rare disorders in order to provide for the comprehensive 
health care of these patients. 
5 
Section 12. Designation of Rare Disease· The Department of Health, upon 
6 
recommendation of the NIH and RDTWG, shall have the authority to designate any 
7 
disease that is recognized to rarely afflict the population of the country. 
8 
9 
Section 13. Designation of Orphan Drug -
The Department of Health, 
10 
motuproprio or upon application by any interested person, may designate any drug or 
11 
medicine indicated for use by patients afflicted with any of the rare diseases as an 
12 
orphan drug; provided, that there is no existing drug or medicine in the Philippines 
13 
that can provide the same or superior alternative therapy. Within one hundred twenty 
14 
days from the effectivity of this Act, the DOH shall publish a list of orphan drugs for 
15 
these rare diseases. 
16 
17 
Section14. Designation of Orphan Product· The Department of Health, 
18 
motuproprio or upon application by any interested person, may designate any 
19 
healthcare or nutritional product, other than a drug or medicine, including but not 
20 
limited to diagnostic kits, medical devices and biological products, used primarily to 
21 
prevent, diagnose, or alleviate the symptoms of rare diseases as an orphan product; 
22 
provided, that there is no existing product in the Philippines that can provide the 
23 
same or superior results, as certified by the Food and Drug Administration. Any 
24 
healthcare or nutritional product, other than a drug or medicine, including but not 
25 
limited to diagnostic kits, medical devices and biological products, used primarily to 
26 
prevent, diagnose, or alleviate the symptoms of rare diseases are hereby considered 
27 
as orphan products. Within one hundred twenty days from the effectivity of this Act, 


1 
the Department of Health shall publish a list of orphan products for these rare 
2 
diseases. 
3 
4 
Section 15. Permit for Restricted Use of an Orphan Drug/Orphan 
5 
Product - Any person may import any orphan drug or orphan product without need of 
6 
obtaining a Certificate of Product Registration; provided, that he first secures a 
7 
Permit for Use of an Orphan Drug/Orphan Product from the Food and Drug 
8 
Administration (FDA) within thirty days from receipt of requirements issued by the 
9 
FDA. 
10 
11 
The Permit for Use of an Orphan Drug/Orphan Product shall be effective for a 
12 
period of three years, renewable for periods of three years thereafter. 
13 
14 
Section 16. The Rare Disease Registry - All patients diagnosed with a rare 
15 
disease shall be included in this national database for rare disease case registries. 
'16 
17 
18 
19 
20 
21 
22 
23 
24 
25 
26 
27 
28 
1) All health care practitioners and health institutions shall be required to 
report to the Rare Disease Registry of the National Institutes of Health 
diagnosed cases of rare diseases and provide reports on status of patients; 
provided, that such reports shall be subject to guidelines issued by the 
National Institutes of Health to' protect the privacy of patients afflicted with 
rare diseases. 
2) Health practitioners and health institutions shall inform patients afflicted 
with rare diseases of relevant orphan drugs and orphan products in the Rare 
Disease Registry. 


1 
ARTICLE 6 
2 
IMPLEMENTATION 
3 
4 
Section 17. Lead Agency - The Department of Health shall be the lead 
5 
agency in the implementation of this Act. 
For the purposes of achieving the 
6 
objectives of this act, the DOH shall: 
7 
8 
1) Establish the Technical Working group for the Rare Diseases; 
9 
10 
2) Develop the implementing rules and regulation for the implementation of 
11 
this Bill within one hundred eighty (180) days from the enactment of the Law; 
12 
13 
3) Coordinate with the National Institutes of Health for the technical 
14 
assistance in the implementation of the Act; 
15 
16 
4) Coordinate with all government and non-government agencies that will be 
17 
involved in the implementation of the Act; 
18 
19 
5) Designate referral centers in strategic location in the country for the timely 
20 
and sustainable medical managernent of persons afflicted with rare disorders; 
21 
22 
6) Organize a pool of medical specialists who will be responsible in the 
23 
diagnosis and management of persons afflicted with rare disorders and their 
24 
families; and 
25 
26 
7) Allot budget for the implementation of the law. 
27 


1 
Section 18. Other implementing agencies - The Food and Drug Administration, 
2 
NIH, Department of Interior and Local Government (DILG), Department of Education 
3 
(DepEd), Department of Social and Welfare Development (DSWD), Department of 
4 
Labor and Employment (DOLE) and the Department of Science and Technology 
5 
(DOST) shall each perform the mandated task in this Bill. 
6 
7 
1) Food and Drug Administration shall ensure that medical foods, orphan 
8 
drugs and products are permitted in the country for the purposes of treating 
9 
rare diseases; 
10 
11 
2) NIH shall provide the technical assistance to the DOH in the 
12 
implementation of this Act. 
'13 
14 
3) DILG, DspEd, DSWD and DOLE shall ensure that persons with rare 
15 
diseases are given the opportunity to be productive members of the society 
16 
and that they are given the same rights and benefits as persons with 
17 
disability. 
18 
19 
4) DOST shall provide mechanisms to further research for a better 
20 
understanding of rare diseases in the country. DOST shall develop low cost 
21 
medical foods and products for the patients. 
22 
23 
24 
25 
ARTICLE 7 
26 
RESOURCE GENERATON AND INCENTIVES FOR RARE DISEASES FUNDING 
27 


1 
Section 19. Source of funds for maintaining medical management of 
2 
persons afflicted with rare diseases· The Department of Health shall ensure the 
3 
establishment of a system that will facilitate the qualification of afflicted person as 
4 
one of the beneficiaries of the services for sustainable compliance to the medical 
5 
management of the rare disease: 
6 
7 
1) The Philippine Health Insurance Corporation shall include the cost of 
8 
treatment of rare disease in the benefit package. 
9 
10 
11 
12 
2) Provisions from the Sin Taxes collection shall be directed to cover the 
cost of care for patients with rare diseases 
13 
Section 20. Fiscal Incentives - The following shall be exempted from all 
14 
taxes, whether national or local: 
15 
16 
17 
18 
19 
20 
21 
22 
23 
24 
25 
26 
1) Donations to the 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 
2) Orphan Drugs and Orphan Products for use solely by patients with rare 
diseases, as certified by the Food and Drug Administration. 
In addition, Orphan Drugs and Orphan Products for donation solely to 
patients afflicted with rare diseases or institutions, as certified by the National 
Institutes of Health, shall be exempt from payments of all tariffs and duties. 


1 
ARTICLE 8 
2 
FINAL PROVISIONS 
3 
4 
Section 21. Implementing Rules and Regulations - Within one hundred 
5 
twenty days from effectivity of this Act, the Department of Health, in consultation with 
6 
the National Institutes of Health, shall issue the implementing rules and regulations to 
7 
this Act. 
8 
9 
Section 22. Repealing Clause - All general and special laws, decrees, 
10 
executive orders, proclamations and administrative regulations, or any parts thereof, 
11 
which are inconsistent with this Act are hereby repealed or modified accordingly. 
12 
Section 23. Separability -
If, for any reason or reasons, any part of 
13 
provisions of this Act shall be declared or held to be unconstitutional or invalid, other 
14 
provision or provisions hereof which are not affected thereby shall continue to be in 
15 
full force and effect. 
16 
17 
Section 24. Effectivity - This Act shall take effect fifteen (15) days after its 
18 
publication in at least two (2) newspapers of general circulation. 
19 
20 
Approved,