Legal basis, policy framework
- Republic Act No. 9502 requires the State to protect public health and, when public interest or circumstances of extreme urgency so require, to adopt measures that promote and ensure access to affordable quality drugs and medicines (Section 2, RA No. 9502 as invoked in the whereas clauses).
- EO No. 104 (s. 2020) imposed MRP and/or MWP on 87 drug molecules or 133 drug formulas of selected drugs and medicines (whereas clauses).
- EO No. 104 created a Technical Working Group (TWG) composed of representatives from the Department of Health (DOH) and the Department of Trade and Industry (DTI) to review other drug prices through consultation (whereas clauses).
- RA No. 11223 (Universal Health Care Act) supports the strategy to improve access to affordable quality medicines and reduce out-of-pocket expenses (whereas clauses).
- The Order’s price regulation is implemented consistently with RA No. 9502 and related laws (Sections 4 and 7).
Scope: regulated drugs and price caps
- MRP and/or MWP price regulation under EO No. 104 is expanded to cover the 34 drug molecules or 71 drug formulas indicated in Annex A of EO No. 155 (Section 1).
- Price regulation applies to both the retail and wholesale channels for covered drugs and medicines (Section 1).
- The MRP labeling rules apply to all drug formulas or medicines brought under MRP through EO No. 104, including those covered by this Order’s expanded list through Annex A (Section 2).
Labeling requirement for MRP products
- Every manufacturer, importer, distributor, wholesaler, trader, or retailer of a drug/medicine intended for sale must display the retail price not to exceed the MRP (Section 2).
- The MRP must be labeled using the exact format preceded by the words “RETAIL PRICE NOT TO EXCEED” and “UNDER DRUG PRICE REGULATION” (Section 2).
- The required MRP label must be printed on a red strip and must be clearly printed on the label of:
- the immediate container of the drug/medicine; and
- the minimum pack offered for retail (Section 2).
- The labeling requirement applies to drug formulas or medicines under MRP through EO No. 104, including those covered by the expanded MRP list under this Order (Section 2).
Regulatory review cycle for MRPs and MWPs
- The list of medicines and their corresponding MRPs and/or MWPs covered by EO No. 104 and the additional list under EO No. 155 is subject to DOH review (Section 3).
- DOH must conduct the first review six (6) months after the effectivity of EO No. 155 (Section 3).
- DOH must conduct the review every 6 months thereafter (Section 3).
- Each review must be conducted by DOH in consultation with DTI (Section 3).
Measures to improve access to medicines
- The DOH, in consultation with relevant government agencies including the DTI and the Philippine Competition Commission, must study and propose measures to influence supply, demand, and expenditure on drugs and medicines (Section 4).
- The measures to be studied and proposed include mechanisms such as pooled procurement, price negotiation, and other mechanisms (Section 4).
- The study and proposed measures must be done in accordance with RA No. 9502 and other relevant laws and regulations (Section 4).
Implementing guidelines and agency support
- The DOH must formulate guidelines for the effective implementation of EO No. 155 when necessary (Section 5).
- The Presidential Communications Operations Office must provide necessary support and assistance to DOH for dissemination of information related to the Order (Section 6).
- All other government agencies and instrumentalities—including government-owned or-controlled corporations, government financial institutions, and state colleges and universities—must provide necessary support to DOH for:
- information dissemination; and
- enforcement and implementation (Section 6).
Violations, investigation, and administrative fines
- Violations of EO No. 155 are handled in accordance with RA No. 9502 and other related laws (Section 7).
- Under Section 19 of RA No. 9502, the Secretary of Health must investigate alleged violations involving MRP and/or MWP under EO No. 155 (Section 7).
- The Secretary of Health must impose administrative fines and penalties for violations (Section 7).
- The Secretary of Health must call upon and deputize government entities for assistance necessary to carry out the Order’s purposes (Section 7).
Transition for existing drug inventories
- Within a non-extendable period of ninety (90) days from the effectivity of EO No. 155, existing inventory stock must be disposed of at prevailing prices (Section 8).
- After the ninety-day transition period, MRP and/or MWP under EO No. 155 must be strictly implemented regardless of the status of existing stock (Section 8).
Separability and repeal of prior issuance
- If any part or provision of EO No. 155 is held unconstitutional or invalid, the remaining parts continue in full force and effect (Section 9).
- EO No. 821 (s. 2009) is repealed (Section 10).
- All executive issuances, orders, rules, and regulations, or parts thereof, inconsistent with EO No. 155 are revoked or modified accordingly (Section 10).