Rationale for Price Regulation on Drugs and Medicines
- Recognition that high drug prices contribute significantly to out-of-pocket health costs that push Filipinos into poverty and impede access to proper medical treatment.
- Expensive medicines contribute to increased morbidity and mortality rates.
- There is a need to update and revisit existing policies to improve the affordability and availability of medicines.
- Department of Health (DOH) proposed regulating retail prices on 122 drug molecules or 205 drug formulas.
Price Regulation Measures Imposed
- Maximum Retail Price (MRP) and/or Maximum Wholesale Price (MWP) are imposed on select drugs based on:
a. Addressing major public health priorities (leading causes of illness and death).
b. High price differences compared to international prices.
c. Limited market competition or lack of generic alternatives.
d. Innovator drugs that are both expensive and frequently prescribed or dispensed. - The Order imposes prices on 86 drug molecules (133 formulas) initially; remaining 36 molecules (72 formulas) to be reviewed within 30 days by a DOH-DTI technical group.
Scope and Coverage of Price Regulation
- Applicable to all currently FDA-registered drugs specifically listed in the Order.
- MRPs apply to public and private retail outlets including drugstores, hospitals, pharmacies, health maintenance organizations, supermarkets, etc.
- MWPs apply to manufacturers, wholesalers, traders, and distributors.
- No entity may sell, reimburse, or demand payment exceeding the MRP or MWP.
Periodic Review of Regulated Drugs and Prices
- DOH, in consultation with the Department of Trade and Industry (DTI), will review the list and prices of drugs subject to MRPs and MWPs within six months of the Order’s effectivity and every six months thereafter.
Additional Measures to Improve Medicine Access
- DOH, with other agencies including DTI and the Philippine Competition Commission, will study and propose mechanisms to influence drug supply, demand, and expenditure.
- Example measures include pooled procurement and price negotiations in line with RA 9502 and other laws.
Implementation and Institutional Support
- DOH tasked to formulate implementing guidelines for effective enforcement.
- Presidential Communications Operations Office mandated to assist in information dissemination about the Order.
- All government agencies, government-owned or controlled corporations (GOCCs), financial institutions, and state universities are directed to support enforcement and dissemination.
Penalties and Legal Consequences
- Violations of the Order will be dealt with pursuant to RA 9502 and other related laws, ensuring legal accountability.
Transition Period
- A non-extendable 90-day period allowed for disposal of existing inventory at prevailing prices.
- After this, MRPs and MWPs must be strictly enforced regardless of stock status.
Legal Provisions for Continuity and Conflict
- A separability clause ensures that if any part is declared unconstitutional or invalid, other provisions remain effective.
- The Order repeals or modifies all inconsistent executive issuances, orders, rules, or regulations.
Effectivity Clause
- The Order takes effect upon complete publication either in a newspaper of general circulation or the Official Gazette.