RARE DISEASES ACT OF THE PHILIPPINES
Download as PDF
Download as Word
Collections
Create new Collection
Overview
Full Text
Details
Case
Agency Issuance Number
Published Date
RARE DISEASES ACT OF THE PHILIPPINES
Republic Act No. 10747
March 3, 2016
Case Overview and Summary
Summary of the Rare Diseases Act of the PhilippinesObjectives and Policy (Sections 2-3):
- Protect the right to health of persons with rare diseases by providing access to timely information and medical care.
- Establish a comprehensive system for early and sustainable care of persons with rare diseases.
- Maintain a Rare Disease Registry for data on rare diseases, patients, and orphan drugs/products.
- Integrate public education campaigns to identify persons with rare diseases and promote understanding.
- Facilitate collaboration among stakeholders to address the needs of persons with rare diseases.
- Provide incentives to support research and development of orphan drugs and products.
Definitions (Section 4):
- Defines key terms such as "rare disease", "orphan drug", "orphan product", "medical care", "medical food", "medical specialist", "newborn screening system", "newborn screening continuity clinic", "Rare Disease Registry", "Rare Diseases Technical Working Group (RDTWG)", and "Telegenetics Referral System".
Identification, Referral, Management, and Registration (Sections 5-9):
- DOH to create a Rare Disease Registry for patients diagnosed with rare diseases.
- Patients suspected or diagnosed with rare diseases to be referred to newborn screening continuity clinics or through the Telegenetics Referral System.
- DOH to develop a system to train medical specialists for diagnosing and managing persons with rare diseases.
- DOH to provide a Rare Disease Management Program for support and care.
- Healthcare practitioners and institutions to report diagnosed cases to the Rare Disease Registry.
Persons with Rare Diseases as Persons with Disabilities (PWDs) (Sections 10-11):
- Persons with rare diseases to be considered as PWDs under the Magna Carta for Disabled Persons.
- DSWD to provide social welfare and benefits to persons with rare diseases as PWDs.
- DOLE to adopt programs promoting employment opportunities for able persons with rare diseases.
Designation of Rare Disease, Orphan Drug, and Orphan Product Status (Sections 12-16):
- RDTWG to determine rare diseases, orphan drugs, and orphan products, and update the lists periodically.
- DOH to designate rare diseases upon recommendation of RDTWG.
- DOH to designate orphan drugs and orphan products upon recommendation of RDTWG, and publish lists within 120 days.
- Permits for restricted use of orphan drugs/products for compassionate use to be issued by FDA within 30 days.
Implementation (Sections 17-20):
- DOH as the lead agency for implementation.
- Other implementing agencies (FDA, NIH, DILG, DepED, DSWD, DOLE, DOST) to assist in specific tasks.
- Healthcare practitioners to inform patients about resources and refer them to specialists.
- DOH, NIH, and healthcare institutions to conduct education and training programs for health personnel.
Resource Generation and Fiscal Incentives (Sections 21-22):
- Persons with rare diseases may avail of PhilHealth basic benefit package and medical assistance from Sin Tax Reform Act.
- Donations for research, registry maintenance, or purchase of orphan drugs/products, and orphan drugs/products for patients with rare diseases to be exempted from taxes and customs duties.
Final Provisions (Sections 23-26):
- DOH to issue implementing rules and regulations within 180 days.
- Repealing and separability clauses.
- Effectivity 15 days after publication in at least two newspapers of general circulation.
Amends
n/a
Amended by
n/a
Tags
Statutes
Republic Acts
rare diseases
orphan drugs
orphan products
medical care
healthcare
persons with disabilities
registry
newborn screening
incentives
research
public education
Law
RARE DISEASES ACT OF THE PHILIPPINES
Republic Act No. 10747
•March 3, 2016
Republic of the PhilippinesCONGRESS OF THE PHILIPPINESMetro Manila
Sixteenth CongressThird 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 IGENERAL 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,...
Login to see full content
Amends
n/a
Amended by
n/a