Law Summary
Declaration of Policy
- Protects and promotes the right to health, specifically for persons with rare diseases.
- Guarantees access to timely health information and adequate medical care.
- Instituted a comprehensive, integrative, and sustainable system involving government, nongovernment, private sectors, professionals, and communities.
- Emphasizes research and public education to ensure early diagnosis and reduce stigma.
Objectives
- Improve access to comprehensive medical care, drugs, and health information for patients with rare diseases.
- Establish a healthcare system integrated within the public system for early and continuous care.
- Maintain a Rare Disease Registry for data collection and policy formulation.
- Integrate public education campaigns within DOH programs.
- Facilitate collaboration among stakeholders.
- Provide regulatory and fiscal incentives to support research and development and facilitate affordable orphan drugs and products.
Definitions
- Clear definitions for terms such as commercial use, healthcare practitioners/institutions, medical care/food, medical specialists, newborn screening system, orphan drugs/products, rare diseases, registries, and telegenetics referral system.
Identification, Referral, Management and Registration
- DOH to create and maintain a Rare Disease Registry compliant with global standards.
- Referral of patients to newborn screening continuity clinics or via telegenetics for remote areas.
- Development of training for medical specialists to diagnose and manage rare diseases.
- Establishment of a Rare Disease Management Program under DOH.
- Mandatory reporting by healthcare practitioners and institutions to the registry with privacy guidelines.
Persons with Rare Disease as Persons with Disabilities (PWDs)
- Designated as PWDs under the Magna Carta for Disabled Persons.
- Agreed rights and privileges, including social welfare benefits (DSWD) and employment opportunities (DOLE).
Designation of Rare Disease, Orphan Drug, and Orphan Product Status
- Formation of Rare Disease Technical Working Group (RDTWG) under DOH.
- RDTWG to identify and classify rare diseases, orphan drugs, and orphan products, update lists, and regulate certifications.
- DOH empowered to designate diseases, drugs, and products based on RDTWG recommendations.
- Publication of orphan drugs and products list within 120 days of the Act’s effectivity.
- Compassionate special permit from FDA required for importation of orphan drugs/products for compassionate use.
Implementation
- DOH as lead implementing agency responsible for coordination, specialist training, referral centers, public education, and budget allotment.
- Role of FDA, NIH, DILG, DepED, DSWD, DOLE, DOST, and other agencies defined for support and enforcement.
- Healthcare practitioners must inform and refer persons with rare diseases appropriately.
- Continuing education and training for healthcare workers on rare diseases identification and registry reporting.
Resource Generation and Fiscal Incentives
- Patients eligible for benefits under PhilHealth and medical assistance under sin tax revenues.
- Exemptions from taxes and customs duties for donations, orphan drugs, and products used solely by patients with rare diseases.
Final Provisions
- IRR to be issued by DOH within 180 days from effectivity.
- Repealing clause removing inconsistent laws or regulations.
- Separability clause for invalid provisions.
- Law takes effect 15 days after publication in two newspapers of general circulation.