GENERICS ACT OF 1988

Case Overview and Summary

Summary of the Generics Act of 1988 (Republic Act No. 6675)

Policy and Objectives (Section 2):
- Promote, encourage and require the use of generic terminology for drugs
- Ensure adequate supply of generic drugs at lowest cost, and make them available for free to indigent patients
- Encourage extensive use of generic drugs through a rational procurement and distribution system
- Emphasize the scientific basis for drug use to increase awareness of therapeutic effectiveness
- Promote drug safety by minimizing duplication and adverse drug interactions

Definitions (Section 3):
- Generic Name/Terminology: Identification of drugs by their scientifically recognized active ingredients or official generic name
- Active Ingredient: Chemical component responsible for the claimed therapeutic effect
- Chemical Name: Description of the chemical structure of the drug
- Drug Product: Finished product form containing active ingredients
- Drug Establishment: Organization involved in manufacture, importation, repacking, and/or distribution of drugs
- Drug Outlets: Drugstores, pharmacies, and establishments that sell drugs
- Essential Drugs List/National Drug Formulary: List of drugs prepared and updated by the Department of Health based on health conditions in the Philippines and international criteria, consisting of a core list and a complementary list
- Core List: Drugs that meet the health care needs of the majority of the population
- Complementary List: Alternative drugs used when there is no response to the core essential drug, hypersensitivity reaction, or when the core essential drug cannot be given
- Brand Name: Proprietary name given by the manufacturer to distinguish its product
- Generic Drugs: Drugs not covered by patent protection and labeled solely by their international non-proprietary or generic name

Use of Generic Terminology and Incentives (Section 4):
- Special consideration shall be given to drugs in the Essential Drugs List for the promotion of generic names
- The Board of Investments, jointly with the Department of Health and other agencies, shall promulgate a system of incentives for the exclusive use of generic terminology in the manufacture, marketing, and sales of drugs, particularly those in the Essential Drugs List, within 180 days after approval of the Act

Posting and Publication (Section 5):
- The Department of Health shall publish annually in at least two newspapers of general circulation the generic names and corresponding brand names of all drugs available in the Philippines

Use of Generic Terminology (Section 6):
- All government health agencies, personnel, and other government agencies shall use generic terminology in all transactions related to purchasing, prescribing, dispensing, and administering drugs
- All medical, dental, and veterinary practitioners, including private practitioners, shall write prescriptions using the generic name (brand name may be included if desired)
- Organizations or companies involved in the manufacture, importation, repacking, marketing, and/or distribution of drugs shall prominently indicate the generic name on product labels, advertising, and promotional materials
- Drug outlets shall inform buyers about other drug products with the same generic name and their corresponding prices, and shall post a list of such products and prices in conspicuous places within one year after approval of the Act

Quality, Manufacturer's Identity, and Responsibility (Section 7):
- Drug labels shall include the name and country of manufacture, dates of manufacture and expiration, and the quality of generically labeled drugs shall be certified by the Department of Health

Required Production (Section 8):
- Every drug manufacturing company operating in the Philippines shall be required to produce, distribute, and make available to the general public the medicine it produces in the form of generic drugs, subject to rules and regulations promulgated by the Secretary of Health

Rules and Regulations (Section 9):
- The implementation of the Act shall be in accordance with rules and regulations promulgated by the Department of Health, including rules with penal sanctions, within 180 days after approval of the Act and effective 15 days after publication

Authority to Import (Section 10):
- Within three years from the effectivity of the Act (extendible by the President for another two years) and during periods of critical shortage and absolute necessity, the Department of Health is authorized to import raw materials for use by Filipino-owned or controlled drug establishments to be marketed and sold exclusively under generic nomenclature
- The President may authorize the importation of raw materials tax and duty-free
- The Secretary of Health shall ensure fair and efficient allocation of imported raw materials among Filipino-owned or controlled drug establishments and submit quarterly reports to the Office of the President and Congress

Education Drive (Section 11):
- The Department of Health, jointly with the Department of Education, Culture and Sports, Philippine Information Agency, and the Department of Local Government, shall conduct a continuous information campaign for the public and continuing education and training for medical and allied medical professions on generic drugs as an alternative to more expensive brand name drugs
- The education campaign shall include information on illnesses or symptoms cured or alleviated by each generically named drug, as well as contraindications
- The Department of Health, with the assistance of the Department of Local Government and the Philippine Information Agency, shall monitor the progress of the education drive and submit regular reports to Congress

Penalties (Section 12):
- Violation of Section 6(a) or 6(b) by any person shall result in penalties ranging from reprimand (first conviction) to fines of P2,000 to P10,000 and suspension of license to practice profession for up to one year or longer (subsequent convictions)
- Violation of Section 6(c), 6(d), 7 or 8 by any juridical person shall result in a fine of P5,000 to P10,000 and suspension or revocation of license to operate the drug establishment or drug outlet, and its officers directly responsible shall suffer penalties of fine, suspension or revocation of license to practice profession, and imprisonment of six months to one year or both fine and imprisonment (if the guilty party is an alien, deportation after service of sentence)
- The Secretary of Health shall have the authority to impose administrative sanctions such as suspension or cancellation of license to operate or recommend suspension of license to practice profession to the Professional Regulation Commission for violation of the Act

Separability Clause (Section 13):
- If any provision of the Act is declared invalid, the remainder shall remain in force and effect

Repealing Clause (Section 14):
- Provisions of any law, executive order, presidential decree or other issuances inconsistent with the Act are repealed or modified accordingly

Effectivity (Section 15):
- The Act shall take effect 15 days after its complete publication in the Official Gazette or two newspapers of general circulation