The Concept of ‘The Generics Act’ (RA 6675) and Prescription Rules

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SUBJECT: The Concept of ‘The Generics Act’ (RA 6675) and Prescription Rules

I. Introduction

This memorandum provides an exhaustive analysis of Republic Act No. 6675, otherwise known as the Generics Act of 1988, and its intersection with prescription rules under Philippine law. The primary objective is to delineate the legal framework governing the promotion, prescription, and dispensing of generic drugs, and to clarify the applicability of prescription periods for violations thereof. Given that RA 6675 is a special law, its prescriptive period is governed by distinct rules under Act No. 3326, as amended. This research will cover the law’s key provisions, jurisprudential interpretations, and procedural nuances concerning the institution of criminal actions.

II. Statement of Facts

The scenario involves potential violations of RA 6675, typically arising from acts committed by pharmaceutical entities, medical practitioners, or drug dispensers. Common factual patterns include: (1) a physician’s persistent failure to write the generic name of a drug in all prescriptions in accordance with Section 6; (2) a drug establishment’s refusal to carry the generic equivalent of a branded drug as mandated by Section 10; (3) the dispensing by a pharmacist of a branded drug without offering the generic equivalent as required by Section 11; and (4) the use of deceptive or misleading packaging or labeling contrary to Section 13. The critical legal question is the timeframe within which the state must institute criminal proceedings for such violations before the right to prosecute is extinguished by prescription.

III. Statement of the Issue

The principal issue is: What is the applicable prescriptive period for violations of Republic Act No. 6675, the Generics Act of 1988, and how is this period computed under Philippine law?

IV. Applicable Laws and Jurisprudence

Republic Act No. 6675 (The Generics Act of 1988), particularly Sections 4, 6, 10, 11, 13, and 20.

Act No. 3326, entitled “An Act to Establish Periods of Prescription for Violations Penalized by Special Acts and Municipal Ordinances and to Provide When Prescription Shall Begin to Run,” as amended by RA 3763 and RA 4661.

Revised Penal Code, Article 90 (Prescription of crimes).

Relevant Jurisprudence:

People v. Pangilinan (G.R. No. 152662, September 24, 2002) clarified that for violations of special laws, the prescriptive period is governed by Act No. 3326, not the Revised Penal Code*.
Zaldivia v. Reyes, Jr.* (G.R. No. 102342, July 3, 1992) established the doctrine that for offenses under special acts where no specific prescriptive period is provided, the default under Act No. 3326 is 12 years for offenses punishable by imprisonment for more than 6 years.
Re: Problem of Delays in Cases Before the Sandiganbayan* (A.M. No. 00-8-05-SC, September 18, 2000) reiterated the computation rules under Act No. 3326.
People v. Dimaano (G.R. No. 168168, January 28, 2008) applied Act No. 3326 to violations of the Dangerous Drugs Act of 1972*, illustrating its application to special laws on public health.

V. Discussion of the Generics Act (RA 6675)

RA 6675 is a special law enacted to promote, require, and ensure the production of an adequate supply, distribution, use, and acceptance of drugs and medicines identified by their generic names. Its key mandates include:
Section 4*: Declares the state policy of promoting generic drug usage to ensure adequate supply of medicines at reasonable prices.
Section 6: Requires all government health agencies and their personnel to use generic names in all prescriptions. All medical, dental, and veterinary practitioners are mandated to write prescriptions using the generic name. The brand name* may be included if so desired.
Section 10: Obligates drug manufacturers, distributors, and traders to make available to the general public the generic equivalents* of all their branded drugs.
Section 11: Mandates any drug outlet or pharmacy to inform any buyer about any and all other drug products having the same generic name*, together with their corresponding prices, so the buyer may adequately exercise his option.
Section 13: Prohibits any misleading or deceptive packaging, promotion, or advertisement of a generic drug*.
Section 20: Provides the penalties for violations. Any person who shall violate any provision of this Act shall suffer the penalty of imprisonment for a period of not less than six (6) months but not more than one (1) year, or a fine of not less than One thousand pesos (P1,000.00) but not more than Five thousand pesos (P5,000.00), or both such imprisonment and fine*, at the discretion of the court.

VI. Prescription Rules for Special Laws

For crimes punishable under special laws (like RA 6675), the rules on prescription are governed by Act No. 3326, as amended, not by Article 90 of the Revised Penal Code. The fundamental principles are:

Determination of Period: Under Section 1 of Act No. 3326, if the special law does not provide its own prescriptive period, the default periods are:

For offenses punishable only by a fine or imprisonment* for not more than one month: 1 year.
For offenses punishable by imprisonment* for more than one month, but not more than one year: 2 years.
For offenses punishable by imprisonment* for more than one year, but less than three years: 4 years.
For offenses punishable by imprisonment* for three years or more, but less than six years: 6 years.
For offenses punishable by imprisonment* for six years or more: 12 years.

Commencement of Period: Under Section 2, the prescription shall begin to run from the day of the commission of the violation, or if the violation be not known at the time, from the discovery thereof and the institution of judicial proceedings for its investigation and punishment. The prescription is interrupted by the filing of the complaint or information in court.

VII. Application and Comparative Analysis

Applying Act No. 3326 to RA 6675: Section 20 of RA 6675 prescribes a penalty of imprisonment of six months to one year, and/or a fine. Under the classification in Act No. 3326, this falls under “imprisonment for more than one month, but not more than one year.” Therefore, the applicable prescriptive period is two (2) years from the day of the commission of the violation, or from its discovery if unknown at the time.

Aspect	Violations of RA 6675 (The Generics Act)	Crimes under the Revised Penal Code (e.g., Theft)
Governing Law on Prescription	Act No. 3326, as amended (A special law on prescription).	Article 90 of the Revised Penal Code.
Nature of Offense	Malum prohibitum; the act is punishable because it is prohibited by statute.	Malum in se; the act is inherently evil or wrongful.
Determination of Period	Based on the length of imprisonment prescribed by the special law, using the graduated scale in Act No. 3326.	Based on the severity of the penalty prescribed by the Revised Penal Code (e.g., afflictive, correctional, light penalties).
Specific Prescriptive Period	Two (2) years, as the penalty is imprisonment of 6 months to 1 year.	Varies; e.g., theft prescribes in 10 years if the penalty is prision mayor (6 yrs, 1 day to 12 years).
Commencement of Period	From the day of commission, or from discovery if the violation was not known.	From the day on which the crime is discovered by the offended party, the authorities, or their agents.
Effect of Filing Complaint	The filing of the complaint or information in court interrupts the running of the prescriptive period.	The filing of the complaint or information in court interrupts the period of prescription.

VIII. Potential Legal Complications

Determining the “Day of Commission”: For continuing violations (e.g., a drugstore’s ongoing refusal to offer generic equivalents), the prescriptive period may only begin upon the cessation of the unlawful act.

Date of Discovery: If the violation was concealed or not apparent, the prosecution must clearly allege and prove the date of discovery to justify a later commencement of the prescriptive period.

Interruption by Preliminary Investigation: Jurisprudence (Zaldivia) holds that the period is interrupted only by judicial proceedings, not by the conduct of a preliminary investigation by the prosecutor. The complaint or information must be filed in court within the prescriptive period.

Violations by Corporations: While RA 6675 penalizes “any person,” which includes juridical entities under the Revised Penal Code, the computation of prescription remains the same.

IX. Conclusion

The prescriptive period for violations of Republic Act No. 6675, the Generics Act of 1988, is two (2) years. This is derived from the application of Act No. 3326, Section 1, to the penalty of imprisonment for six months to one year prescribed under Section 20 of RA 6675. The period begins to run from the day the violation is committed, or from its discovery if it was unknown at the time. To effectively prosecute such violations, law enforcement agencies and the Department of Health must ensure that criminal complaints are filed in court within this two-year window to prevent the extinguishment of criminal liability by prescription.

X. Recommendations

Prosecutors and investigators handling RA 6675 cases should immediately ascertain the exact date of the alleged violation or its discovery to confirm that the two-year prescriptive period has not lapsed.

In drafting complaints or informations, it is prudent to specifically allege the date of discovery of the violation if relying on that to commence the running of prescription.

Regulatory bodies like the Food and Drug Administration and the Department of Health should implement robust monitoring and documentation systems to ensure violations are discovered and acted upon promptly, well within the prescriptive period.

For legislative consideration, amending RA 6675 to explicitly state its own prescriptive period could eliminate any potential ambiguity, though current jurisprudence provides a clear rule.