Law Summary
Objectives
- To establish guidelines enabling more effective and efficient implementation of EDPMS.
Scope
- Applies to all DOH bureaus, attached agencies, regional and local government units, health facilities (government and private), drug establishments and outlets, and other data beneficiaries subject to compliance rules.
Definition of Key Terms
- Drug Distributor Exporter: Exports raw materials/ingredients/products outside the country.
- Drug Distributor Importer: Imports raw materials/ingredients/products for local wholesale.
- Drug Distributor Wholesaler: Procures products from local licensed establishments for local wholesale distribution.
- Drug Establishment: Entities involved in manufacture, import, export, sale, distribution, promotion, or use of drug products.
- Drug Outlets: Drugstores, pharmacies, hospital pharmacies dispensing drugs.
- EDPMS: Computer-based system capturing, processing, storing, and reporting essential drug prices.
- Erroneous Submission: Incomplete or incorrect data upload to the system.
- GMAP: Voluntary price reduction scheme under Advisory Council Resolution.
- Manufacturer: Engaged in drug product production, excludes prescription compounding in pharmacies.
- Manufacturer Trader: Registered owner of drug product subcontracting manufacture to licensed manufacturers.
- MDRP: Maximum retail price ceiling per Executive Order No. 821.
General Guidelines
- Medicines uploaded are those addressing leading morbidity/mortality causes.
- Medicines listed in the Philippine National Formulary (PNF) and primary health care formularies.
- Includes drugs under mandatory and voluntary pricing schemes (MRP and GMAP).
- EDPMS data enables consumer informed choice and guides DOH/PhilHealth pricing and health programs.
- Data analyzed and randomly validated regularly (quarterly).
- Partnerships with academic and research institutions for external validation.
- Blacklisting for non-compliance limited to one year, lifted upon compliance.
Specific Guidelines: Uploading
- Single-branch drug outlets upload prices/inventory annually based on geographical clusters.
- Multi-branch outlets and hospital pharmacies upload quarterly.
- Manufacturers and manufacturer traders upload selling price quarterly; toll manufacturers exempt.
- Distributors, importers, exporters, wholesalers upload purchase price, selling price, and inventory quarterly.
- Data must reflect latest transactions prior to uploading month.
- Certificate of Compliance required for participation in government drug tenders.
- Public price data confined to final retail selling prices.
User Access and Permissions
- Full access granted only to Secretary of Health/designated officials and Pharmaceutical Division (PD).
- PD defines authorized users, access levels, issues usernames/passwords.
- Access granted to PhilHealth, procuring entities, DOH management, and others upon assessment.
Certificates of Compliance
- Issued by PD and Regional Offices to drug establishments/outlets wishing to participate in government procurement.
Monitoring and Review
- Monitoring team from PD, KMITS, Regional Offices oversees compliance and system performance.
- Regular or spot monitoring authorized.
- Annual stakeholder program implementation review conducted.
- Funding for EDPMS operations incorporated into local health system development.
Roles and Responsibilities
- Pharmaceutical Division: Lead office managing EDPMS, policy recommendation, software provision, data analysis, violation investigation, issuance of compliance certificates, monitoring.
- FDA: Investigate and prosecute violations, impose administrative fines, suspend/revoke licenses, issue warnings, submit non-compliance reports.
- Bids and Awards Committees and Procurement Service: Require compliance certificates for procurement eligibility.
- DOH Regional Offices: Issue compliance certificates, train users, monitor compliance, submit non-compliance reports to FDA.
- KMITS: Provide technical support, conduct training, monitor system.
- Office for Health Regulation: Develop and enforce policies, resolve issues, support capacity building.
- Drug Establishments and Outlets: Comply with procedures, attend training, register users, report issues.
Administrative Sanctions
- Sanctions for erroneous submission or failure to submit data, unless involving illegal price manipulation.
- Sanctions escalate from written warnings to fines ranging from P10,000 to P1,000,000, product recalls and license suspension/revocation.
- Additional daily fine for continuing violations after notice.
- License suspension duration capped at one year.
- Fees and fines collected accrue to FDA.
- Blacklisting lifted upon compliance for one year post-blacklisting.
Repealing Clause
- AO 2016-0009 and inconsistent provisions repealed, amended or modified accordingly.
Separability Clause
- Invalid provisions declared by courts shall not affect validity of the rest.
Effectivity
- Order takes effect 15 days after publication in official gazette and a newspaper of general circulation.