AN ACT PROMULGATING A COMPREHENSIVE POLICY IN ADDRESSING THE NEEDS OF PERSONS WITH RARE DISEASE

Sixteenth Congress
Third Regular Session

Begun and held in Metro Manila, on Monday, the twenty-seventh day of July, two thousand fifteen.

REPUBLIC ACT No. 10747

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

SECTION 1. Short Title. — This Act shall be known as the “Rare Diseases Act of the Philippines”.

SECTION 2. Declaration of Policy. — It is the policy of the State to protect and promote the right to health of the people, including the right of persons suffering from rare diseases to survival and full and healthy development as individuals through access to timely health information and adequate medical care. In pursuit of such policy, the State shall institutionalize a system that is comprehensive, integrative and sustainable and will facilitate collaboration among government and nongovernment agencies and organizations at the national and local levels, private sector, professional health organizations, academic institutions, communities and families towards the provision of early and sustainable care of persons afflicted with rare disease. The State recognizes the crucial role of research in defining health programs and activities to address the needs of patients with rare disease. The State also recognizes that an effective public education program is vital in helping ensure the early diagnosis and treatment of rare disorders and in preventing those afflicted with them from being the subject of ridicule and stigmatization.

SECTION 3. Objectives. — The objectives of this Act are as follows:

ARTICLE II
DEFINITION OF TERMS

SECTION 4. Definitions. — For the purpose of this Act, the following terms shall be defined as follows:

ARTICLE III
IDENTIFICATION, REFERRAL, MANAGEMENT AND REGISTRATION OF PERSONS WITH RARE DISEASE

SECTION 5. Identification of Persons with Rare Disease. — The DOH, in coordination with the NIH, shall create a Rare Disease Registry. It shall endeavor to comply with set global standards, if applicable. All patients diagnosed with rare disease shall be included in this registry.

SECTION 6. Referral of Patients with Rare Disease. — Patients highly suspected of, or diagnosed with, rare disease shall be referred to a newborn screening continuity clinic identified by the DOH as referral centers for treatment of rare diseases under the National Comprehensive Newborn Screening System. For patients from remote areas, the Telegenetics Referral System will be utilized.

SECTION 7. Availability of Specialist for the Management of Persons with Rare Disease. — The DOH, with the assistance of the NIH, shall develop a system to train a sufficient number of medical specialists to diagnose and manage persons with rare disease.

SECTION 8. Management of Persons with Rare Disease. — The DOH, with the assistance of the NIH, shall provide persons with rare disease better access to a support system through the creation of a Rare Disease Management Program under the National Center for Disease Prevention and Control of the DOH.

SECTION 9. Registration of Persons with Rare Disease. — All healthcare practitioners and health institutions shall be required to report to the Rare Disease Registry diagnosed cases of rare disease and provide reports on the status of patients: Provided, That such reports shall be subject to guidelines issued by the NIH to protect the privacy of patients with rare disease.

ARTICLE IV
PERSONS WITH RARE DISEASE AS PERSONS WITH DISABILITIES (PWDs)

SECTION 10. Designation of Persons with Rare Disease as Persons with Disabilities (PWDs). — Persons with rare disease shall be considered as persons with disabilities (PWDs), in accordance with Republic Act No. 7277, as amended, or the Magna Carta for Disabled Persons.

SECTION 11. Rights and Privileges of Persons with Rare Disease. — The appropriate national government agency shall ensure that they are accorded the same rights and privileges as PWDs, to wit:

ARTICLE V
DESIGNATION OF RARE DISEASE, ORPHAN DRUG, AND ORPHAN PRODUCT STATUS

SECTION 12. The Rare Disease Technical Working Group (RDTWG). — The DOH shall convene the RDTWG which shall have the following roles and responsibilities:

SECTION 13. Designation of Rare Disease. — The DOH, upon recommendation of the RDTWG, shall have the authority to designate any disease that is recognized to rarely afflict the population of the country as a rare disease.

SECTION 14. Designation of Orphan Drug. — The DOH, motu proprio or upon application by any interested person, and with the recommendation of the RDTWG, may designate any drug or medicine indicated for use by patients afflicted with any of the rare diseases as an orphan drug. Within one hundred twenty (120) days from the effectivity of this Act, the DOH shall publish a list of orphan drugs for these rare diseases.

SECTION 15. Designation of Orphan Product. — The DOH, motu proprio or upon application by any interested person, and with the recommendation of the RDTWG, may designate any healthcare or nutritional product, other than a drug or medicine, including, but not limited to, diagnostic kits, medical devices and biological products, used primarily to prevent, diagnose, or alleviate the symptoms of rare diseases as an orphan product. Within one hundred twenty (120) days from the effectivity of this Act, the DOH shall publish a list of orphan products for these rare diseases.

SECTION 16. Permit for Restricted Use of an Orphan Drug/Orphan Product. — Any person may import any orphan drug/orphan product for compassionate use: Provided, That they secure a compassionate special permit from the Food and Drug Administration (FDA) in accordance with DOH Administrative Order No. 4, series of 1992, and any future guidelines that may be issued on the same.

Within thirty (30) days from receipt of the requirements, the FDA shall issue a permit for restricted use of an orphan drug/orphan product which shall be effective for a period of three (3) years, renewable for a period of three (3) years thereafter: Provided, That the FDA shall expedite the said permit in cases of emergency.

ARTICLE VI
IMPLEMENTATION

SECTION 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:

SECTION 18. Other Implementing Agencies. — The FDA, NIH, Department of the Interior and Local Government (DILG), Department of Education (DepED), DSWD, DOLE, Department of Science and Technology (DOST), and other relevant government agencies shall have the following tasks:

SECTION 19. Obligation of Healthcare Practitioners. — A healthcare practitioner who attends to a person with rare disease has the responsibility of informing the patient and their family of available resources and refer them to the nearest available specialist.

SECTION 20. Continuing Education and Training of Health Personnel. — The DOH and the NIH, together with health professional societies and academic healthcare institutions, shall:

ARTICLE VII
RESOURCE GENERATION AND FISCAL INCENTIVES

SECTION 21. Financial Assistance for Persons with Rare Disease. — A person with rare disease may avail of the following:

SECTION 22. Fiscal Incentives. – The following shall be exempted from all taxes and customs duties, as applicable, whether national or local:

ARTICLE VIII
FINAL PROVISIONS

SECTION 23. Implementing Rules and Regulations (IRR). — Within one hundred eighty (180) days from the effectivity of this Act, the DOH, in consultation with the NIH, shall issue the IRR of this Act.

SECTION 24. Repealing Clause. — All general and special laws, decrees, executive orders, proclamations and administrative regulations, or any part or parts thereof, which are inconsistent with this Act are hereby repealed or modified accordingly.

SECTION 25. Separability Clause. — If, for any reason or reasons, any part or provision of this Act shall be declared or held to be unconstitutional or invalid, other parts or provisions hereof which are not affected thereby shall continue to be in full force and effect.

SECTION 26. Effectivity. — This Act shall take effect fifteen (15) days after its publication in at least two (2) newspapers of general circulation.

Approved,

Senate Bill No. 2990, which was approved by the Senate on December 14, 2015, was adopted as an amendment to House Bill No. 5973 on December 15, 2015.

Approved: MAR 03 2016

(Sgd.) BENIGNO S. AQUINO, III
President of the Philippines