Cheaper and Quality Medicines Act of 2008

Protect public health and promote access to affordable quality medicines.
Recognizes competition in drug supply as primary means.
Price regulation of drugs as a reserve instrument when competition is ineffective.

Includes terms such as “Compulsory License,” “Drug outlet,” "Drugs and medicines" (including chemical compounds, biological substances, and herbal/traditional drugs with defined criteria), “Essential drugs list,” "Importer," "Manufacturer," "Multisource pharmaceutical products," "Retailer," "Trader," "TRIPS Agreement," and "Wholesaler."

Non-patentable inventions related to drugs clarified, forbidding patents on minor modifications lacking efficacy enhancement.
Defines the inventive step for drug-related inventions excluding minor discoveries.
Limits on patent rights include use after market introduction worldwide, use for experimental or regulatory purposes, and use on vehicles temporarily entering the Philippines.
Government's ability to exploit inventions for public health, emergencies, anti-competitive practices, unsatisfactory use by patentee, or unmet demand.
Procedures on compulsory licensing, including special compulsory licenses for importation and export to countries lacking pharmaceutical capacity, following TRIPS Agreement.
Civil actions for infringement exclude uses allowed by this Act.
Trademark protection exceptions for patented or off-patent drug imports that are properly marked.

President may impose maximum retail prices on drugs based on DOH recommendation.
DOH tasked with price monitoring and recommended maximum retail price setting, considering international prices, market supply, costs (exchange rate, labor, transport), and other just factors.
DOH empowered to include new drugs for price regulation, implement cost-containment (e.g., competitive bidding), impose administrative fines (Php50,000 to Php5,000,000) for violations, and deputize government personnel.
Enforcement empowered to require production and submission of relevant documents.
Decisions of DOH on price regulation immediately effective but reviewable by Court of Appeals.
List of price-regulated drugs includes those for chronic and life-threatening diseases, preventive medicines (vaccines, contraceptives), anesthetics, IV fluids, essential drug list drugs, etc.
Illegal acts of price manipulation like hoarding and cartel formation penalized with imprisonment (5-15 years), fines (Php100,000 to Php10,000,000), and license revocation.
Maximum retail prices must be clearly displayed on drug labels and price lists provided across supply chains.
Local governments and DTI required to submit price monitoring reports; DOH and DTI to conduct independent price and income impact surveys.

BFAD Director authorized to retain collected fees and fines for operational use without separate approval.
BFAD to ensure drug quality conforms to international standards with WHO certifications.

Drug outlets must not refuse to carry or sell government or authorized third-party drugs legally approved for sale.
Refusal to sell drugs without good reason penalized with fines (Php100,000 to Php1,000,000) and possible license suspension or revocation.

Annual publication of generic and brand names of drugs required.
Mandatory use of generic names in government health agencies, prescribing, labeling, and retail.
Drug outlets must inform buyers of alternatives with same generic names and prices.
Drug manufacturers required to produce unbranded generic counterparts of branded drugs.
Continuous public education on generic drugs' therapeutic efficacy mandated.
Penalties defined for violations, including fines, license suspensions, and possible deportation for aliens.

Medicines except non-prescription drugs sold only through licensed prescription drugstores or hospital pharmacies.
Non-prescription drugs may be sold in original or small quantities through supermarkets and other retail outlets.
Manufacturers, importers, and wholesalers restricted to selling products only to licensed retail outlets or wholesalers.

A bipartisan committee composed of Senators and Representatives to oversee implementation.
Includes chairpersons from committees on Trade, Commerce, Health, and Demography.

Initial funds allocated for DOH operations (Php25 million) and oversight committee (Php5 million).
Future funding to be included in annual General Appropriations Act.

Separability clause ensures invalidity of any part does not affect the whole law.
Repealing clause nullifies inconsistent laws, decrees, and orders.
Effectivity 15 days after publication in two national newspapers.