Law Summary
Criteria for Setting Maximum Drug Retail Prices
- Focus on public health priorities targeting diseases with high morbidity and mortality.
- Addressed drugs with high international price differentials.
- Consideration of drugs with limited competition (lack of generics or market access).
- Drugs where innovator products are most expensive yet widely prescribed.
- Additional conditions under Section 19(2) of RA 9502 and other relevant parameters.
Stakeholder Consultation and Voluntary Price Reductions
- Inclusive consultation process involving stakeholders, academic institutions, and Advisory Council for Medicine Price Regulation.
- Pharmaceutical companies voluntarily reduced prices by at least 50% for sixteen (16) priority medicines.
- Additional 10%-50% price reduction commitments for twenty-two (22) other drugs outside the original list.
- Price reductions effective from August 15, 2009, fully implemented by September 15, 2009.
- Only five original drugs non-compliant with proposed MDRP rates.
Imposed Maximum Drug Retail Prices (MDRP)
- MDRPs prescribed for specific active ingredients and their pharmaceutical forms.
- Drugs covered include anti-hypertensive (e.g., Amlodipine), anti-cholesterol (e.g., Atorvastatin), antibiotics/antibacterials (e.g., Azithromycin), and anti-neoplastics/anti-cancer drugs (e.g., Cytarabine, Doxorubicin).
- Detailed ceiling prices listed per dosage strength and form.
Scope and Applicability
- Applies to all BFAD-registered medicines listed that are available in the market.
- Covers retail outlets, including drugstores, hospitals, HMOs, supermarkets, and similar establishments.
- Manufacturers, traders, and importers bear price differential costs arising from the Order.
- No entity may sell or demand payment exceeding MDRP.
- Extends to government agencies, offices, and instrumentalities for procurement, reimbursement, and drug dispensing.
- MDRP serves as price ceiling for procurement by national and local government units, government hospitals, Specialty Centers, Department of National Defense and Philippine National Police facilities, GOCCs, and government-funded entities like PCSO and PAGCOR.
- Sets ceiling for reimbursement by Philippine Health Insurance Corporation, Social Security System, Government Services Insurance System, and related entities.
Implementation Provisions
- Department of Health (DOH) tasked to establish policies and systems for full enforcement.
- Bureau of Food and Drugs (BFAD) mandated to fast-track registration processes for listed drugs (15 days upon application, with decision within 90 days).
- Government-owned media required to assist DOH in information dissemination concerning MDRP.
- All government agencies, including GOCCs and GFIs, must support implementation, enforcement, dissemination, and monitoring.
Violations and Circumvention
- Any actions that circumvent or violate the MDRP Order will be dealt with accordingly, though specific penalties or sanctions are not detailed in the Order.
Review Mechanism
- DOH to review the list of medicines and MDRPs three to six months after effectivity and thereafter as needed.
Transition Period
- From issuance to August 15, 2009 designated as transition to manage packaging, labeling, and disposition of inventory.
- Full and strict MDRP enforcement starts on August 15, 2009 regardless of inventory status.
Repealing Clause
- Revokes or modifies any prior executive issuances, orders, rules, or regulations inconsistent with this Order.
Effectivity
- Requires immediate publication in two newspapers of general circulation.
- Takes effect on August 15, 2009.
- Signed by the President and Executive Secretary on July 27, 2009.