Case Summary (G.R. No. 189218)
Petitioners
Named petitioners are officers of the PMA acting for physicians, dentists, and veterinarians of like persuasion who contend that selected statutory and regulatory provisions unconstitutionally restrict prescribing practices, improperly permit substitution by drug outlets, and subject practitioners to excessive or arbitrary penal sanctions.
Respondent
The public respondent is the Secretary of Health, who promulgated Administrative Order No. 62 to implement the Generics Act and later issued Administrative Order No. 76 to postpone the sanctioning phase. The DOH defends the statutory scheme as a valid public-health measure designed to institutionalize generic prescribing and ensure affordable access to therapeutically equivalent medicines.
Key Dates
- Administrative Order No. 62 dated March 9, 1989 (implementing rules).
- Full text of RA No. 6675 published March 15, 1989; law took effect March 30, 1989.
- Administrative Order No. 76 dated August 28, 1989 postponed the effective date of sanctions to January 1, 1990.
- Judicial decision rendered December 21, 1989.
Applicable Law
The court applied the 1987 Philippine Constitution (as the operative constitution at the time of decision) in assessing the constitutionality of RA No. 6675 and its implementing orders. The challenged statutory provisions include Section 6 (pars. (a) and (b)) and Section 12 (pars. (b), (c) and (d)) of the Generics Act; the administrative provisions attacked include Sections 4 and 7, Phase 3 of Administrative Order No. 62 and related provisions of Administrative Order No. 63.
Relief Sought and Issues Presented
Petitioners sought declaratory relief (treated by the Court as a petition for prohibition) that the identified statutory and administrative provisions are unconstitutional. Principal contentions alleged: (1) invalid class legislation and unequal treatment between government and private practitioners under Section 6; (2) unlawful delegation of therapeutic choice to drugstore personnel and improper substitution under Section 6(d) and Administrative Order No. 62; (3) impairment of the physician–patient contract and professional autonomy by prohibiting “No Substitution” prescriptions; and (4) unconstitutionally excessive fines and cruel or degrading sanctions under Section 12’s graduated penalties.
Procedural Posture
Although captioned as an action for declaratory relief (a remedy outside this Court’s original jurisdiction), the Court, considering the significant public interest, reframed and entertained the challenge as a petition for prohibition. The Court examined the law’s text, implementing rules, and the DOH’s explanations in resolving the constitutional challenges.
Court’s Interpretation of Section 6(a) and (b)
The Court rejected petitioners’ contention that Section 6 creates unequal treatment between government and private practitioners. It analyzed the provisions’ language and purpose: Section 6(a) prescribes the use of generic terminology in government health-agency transactions (purchasing, prescribing, dispensing, administering) and thus addresses government operations; Section 6(b) expressly governs “all medical, dental and veterinary practitioners, including private practitioners,” and permits inclusion of the brand name if desired. The Court concluded both government and private practitioners are governed by the same rule as to prescriptions and that petitioners’ claim of class legislation rests on a misreading of the statute.
Court’s Analysis on Substitution and the Role of Drug Outlets
The Court found that neither Section 6(d) of the Generics Act nor Administrative Order No. 62 authorizes pharmacists or sales personnel to unilaterally substitute prescribed medicines in derogation of professional competence. The statutory scheme requires drug outlets to inform buyers of all generically equivalent products and their prices and to post lists of equivalent products for transparency; Administrative Order No. 62 imposes duties on pharmacists to report and not to fill “violative prescriptions” (e.g., where the generic name is absent or illegible) and to fill but report “erroneous prescriptions.” Administrative Order No. 63 further prohibits drug outlets from favoring, suggesting, or imposing a particular brand. The Court emphasized that the drugstore attendant’s role is informational—facilitating the patient’s informed choice between brand-name and generic equivalents—rather than decisional expertise supplanting the prescriber.
Purpose and Public Policy Underlying the Generics Act
The Court detailed the legislative purposes as articulated in the Act and by the DOH: to promote and require generic terminology across procurement, prescription, dispensing and marketing; to ensure supply of affordable drugs and make them available to indigent patients; to encourage use of therapeutically equivalent generics through rational procurement and distribution; to emphasize scientific (active-ingredient) bases for drug use; and to promote drug safety by minimizing harmful duplication and interactions. The Court endorsed these aims as consonant with constitutional mandates to protect and promote the right to health and to make essential goods and health services available at affordable cost (citing Section 15, Article II, and Section 11, Article XIII of the 1987 Constitution).
On the “No Substitution” Prohibition and Contractual Arguments
The Court held that prohibiting “no substitution” instructions is a valid, reasonable regulation to prevent circumvention of the law and to preserve patient choice for less expensive but therapeutically equivalent drugs. The Court rejected the contention that the Act impairs any contractual oblig
...continue readingCase Syllabus (G.R. No. 189218)
Case Title, Citation and Date
- Full case citation: 259 Phil. 1005 EN BANC [ G.R. No. 88265. December 21, 1989 ] with the listing of petitioners and respondent exactly as provided in the source.
- Decision authored by Justice Grino-Aquino.
- Date of decision: December 21, 1989.
Nature of the Action and Court's Procedural Disposition
- The action was initially captioned as an action for declaratory relief filed by officers of the Philippine Medical Association on behalf of medical practitioners.
- The Supreme Court noted it does not exercise jurisdiction over actions for declaratory relief in the posture presented, but, given the public interest involved, treated the petition as a petition for prohibition.
- The petition was ultimately dismissed for lack of merit.
- Costs were assessed against the petitioners.
Parties and Standing
- Petitioners: Officers of the Philippine Medical Association (named individually in the caption) filing on behalf of their professional brethren of kindred persuasion.
- Respondent: Hon. Alfredo R. Bengzon, in his capacity as Secretary of the Department of Health.
- Petitioners alleged unconstitutionality of specific provisions of Republic Act No. 6675 (Generics Act of 1988) and implementatory Administrative Order No. 62 issued by the Secretary of Health.
Statutory and Regulatory Provisions Challenged (Quoted Text from Source)
- Generics Act of 1988 (Republic Act No. 6675), Section 6, Paragraphs (a) and (b):
- (a) "All government health agencies and their personnel as well as other government agencies shall use generic terminology or generic names in all transactions related to purchasing, prescribing, dispensing and administering of drugs and medicines."
- (b) "All medical, dental and veterinary practitioners, including private practitioners, shall write prescriptions using the generic name. The brand name may be included if so desired."
- Generics Act, Section 12, Paragraphs (b), (c) and (d):
- (b) "For the second conviction, the penalty of fine in the amount of not less than two thousand pesos (P2,000.00) but not exceeding five thousand pesos (P5,000.00) at the discretion of the court."
- (c) "For the third conviction, the penalty of fine in the amount of not less than five thousand pesos (P5,000.00) but not exceeding ten thousand pesos (P10,000.00) and suspension of his license to practice his profession for thirty (30) days at the discretion of the court."
- (d) "For the fourth and subsequent convictions, the penalty of fine of not less than ten thousand pesos (P10,000.00) and suspension of his license to practice his profession for one year or longer at the discretion of the court."
- Administrative Order No. 62, Series of 1989 dated March 9, 1989 — Sections 4 and 7, Phase 3 (quoted portions):
- Section 4. Violate, Erroneous and Impossible Prescriptions:
- 4.1 Violative Prescriptions:
- 4.1.1 Where the generic name is not written;
- 4.1.2 Where the generic name is not legible and a brand name which is legible is written;
- 4.1.3 Where the brand name is indicated and instructions added, such as the phrase No Substitution which tend to obstruct, hinder or prevent proper generic dispensing.
- 4.2 What to do with Violative Prescriptions. Violative Prescriptions shall not be filled. They shall be kept and reported by the pharmacist of the drug outlet or any other interested party to the nearest DOH Officer for appropriate action. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.
- 4.3 Erroneous Prescriptions:
- 4.3.1 When the brand name precedes the generic name.
- 4.3.2 Where the generic name is the one in parenthesis.
- 4.3.3 Where the brand name is not in parenthesis.
- 4.3.4 Where more than one drug product is prescribed in one prescription form.
- 4.4 What to do with erroneous prescriptions. Erroneous prescriptions shall be filled. Such prescriptions shall also be kept and reported by the pharmacist of the drug outlet or any other interested party to the nearest DOH Office for appropriate action.
- 4.1 Violative Prescriptions:
- Section 7. Timetable of Implementation. Implementation in three phases: Phase 1 Education Drive; Phase 2 Monitoring of Compliance; Phase 3 Implementation. "Beginning September 1, 1989 the DOH and the other relevant agencies of government shall monitor compliance with these Rules and Regulations and all violations shall be subject to the appropriate sanctions and penalties provided for under these Rules and Regulations and the Generics Act of 1988."
- Section 4. Violate, Erroneous and Impossible Prescriptions:
Legislative and Administrative Dates, Publication and Postponement of Penal Provisions
- Full text of Republic Act No. 6675 published on March 15, 1989 in two newspapers of general circulation.
- The law took effect on March 30, 1989, fifteen (15) days after publication, pursuant to Section 15 of the Act.
- Administrative Order No. 76 dated August 28, 1989 amended Section 7, Phase 3 of Administrative Order No. 62 by postponing to January 1, 1990 the effectivity of the sanctions and penalties for violations of Sections 6 and 12 of the Generics Act and Sections 4 and 7 of the Administrative Order.
Petitioners' Principal Contentions (as framed in the source)
- Petitioners challenged:
- Paragraphs (a) and (b), Section 6 of the Generics Act as unconstitutional, alleging unequal treatment between government physicians and private practitioners in the manner of prescribing generic drugs and characterizing such differential treatment as invalid class legislation.
- Paragraph (d), Section 6 — argued that drug outlets and salesgirls may "substitute the prescribed medicine with another medicine belonging to the same generic group," thereby transferring the physician's act of prescribing to the salesgirl at the drugstore counter and denying physicians the right to instruct "Dispense only as Prescribed."
- Section 12 paragraphs (b), (c) and (d) — alleged that the graduated penalties including fines and suspension of license violate the constitutional guarantee against excessive fines and cruel and degrading punishment.
- Petitioners alleged that