Generics Act of 1988

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Republic Act No. 6675, also known as the Generics Act of 1988, is an act to promote, require and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic name. R.A. 6675, which was signed into law on 13 September 1988, is a consolidation of Senate Bill No. 453 and House Bill No. 10900, which was finally passed by the Senate and the House of Representatives on 25 August 1988 and 31 August 1988, respectively.


Contents

Generic Name, Generic Drugs; Definition

Generic Name or Generic Terminology is defined as "the identification of drugs and medicines by their scientifically and internationally recognized active ingredients or by their official generic name as determined by the Bureau of Food and Drugs of the Department of Health."[1] "Generic Drugs" are drugs not covered by patent protection and which are labeled solely by their international non-proprietary or generic name.[2] An active ingredient is the chemical component responsible for the claimed therapeutic effect of the pharmaceutical product.[3] A chemical name is the description of the chemical structure of the drug or medicine and serves as the complete identification of a compound.[4]

Posting and publication

The Department of Health shall publish annually in acceptable means of public dissemination in at least two (2) newspapers of general circulation in the Philippines the generic names, and the corresponding brand names under which they are marketed, of all drugs and medicines available in the Philippines[5] A brand name is the proprietary name given by the manufacturer to distinguish its product from those of competitors.[6]

Compulsory use of generic terminology

  • 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.[7]
  • 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.[8]
  • Any organization or company involved in the manufacture, importation, repacking, marketing and/or distribution of drugs and medicines shall indicate prominently the generic name of the product. In the case of brand name products, the generic name shall appear prominently and immediately above the brand name in all product labels as well as in advertising and other promotional materials.[9] A drug establishment means any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs or medicines.[10]
  • Drug outlets, including drugstores, hospital and non-hospital pharmacies and non-traditional outlets such as supermarkets and stores, shall inform any buyer about any and all other drug products having the same generic name, together with their corresponding prices so that the buyer may adequately exercise, his option.[11] The term drug outlets means drugstores, pharmacies, and any other business establishments which sell drugs or medicines,[12] while a drug product means the finished product form that contains the active ingredients, generally but not necessarily in association with inactive ingredients.[13] Within one (1) year after approval of the Generics Act, drug outlets shall post in conspicuous places in their establishments, a list of drug products with the same generic name and their corresponding prices.[14]
  • There shall appear prominently on the label of a generic drug the following statement: "this product has the same therapeutic efficacy as any other generic product of the same name. Signed: BFAD."[15]

Essential Drugs List or National Drug Formulary

Essential Drugs List or National Drug Formulary is defined as "a list of drugs prepared and periodically updated by the Department of Health on the basis of health conditions obtaining in the Philippines as well as on internationally accepted criteria. It shall consist of a core list and a complementary list."[16]

  • A Core List is a list of drugs that meets the health care needs of the majority of the population.[17]
  • Complementary List is a list of alternative drugs used when there is no response to the core essential drug or when there is hypersensitivity reaction to the core essential drug or when for one reason or another, the core essential drug cannot be given.[18]

In the promotion of the generic names for pharmaceutical products, special consideration shall be given to drugs and medicines which are included in the Essential Drugs List to be prepared within one hundred eighty (180) days from approval of this Act and updated quarterly by the Department of Health on the basis of health conditions obtaining in the Philippines as well as on internationally accepted criteria.[19]

The exclusive use of generic terminology in the manufacture, marketing and sales of drugs and medicines, particularly those in the Essential Drugs List, shall be promoted through such a system of incentives as the Board of Investments jointly with the Department of Health and other government agencies as may be authorized by ljaw, shall promulgate in accordance with existing laws, within one hundred eighty (180) days after approval of the Generics Act.[20]


Label requirement

In order to assure responsibility for drug quality in all instances, the label of all drugs and medicines shall have the following: name and country of manufacture, dates of manufacture and expiration. The quality of such generically labeled drugs and medicines shall be duly certified by the Department of Health.[21]


Required Production

Subject to the rules and regulations promulgated by the Secretary of Health, every drug manufacturing company operating in the Philippines shall be required to produce, distribute and make widely available to the general public an unbranded generic counterpart of their branded product.[22]


Rules and Regulations

The implementation of the Generics Act shall be in accordance with the rules and regulations to be promulgated by the Department of Health. Rules and regulations with penal sanctions shall be promulgated within one hundred eighty (180) days after approval of the Generic Act and shall take effect fifteen (15) days after publication in the Official Gazette or in two (2) newspapers of general circulation.[23]


Authority to Import

Within three (3) years from the effectivity of the Generics Act, extendible by the President for another two (2) years and during periods of critical shortage and absolute necessity, the Department of Health is hereby authorized to import raw materials of which there is a shortage for the use of 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 that the imported raw materials are allocated fairly and efficiently among Filipino-owned or controlled drug establishments. He shall submit to the Office of the President and to Congress a quarterly report on the quantity, kind and value of the raw materials imported.[24]


Penalties for violations

The Generics Act provides for specific penalties for certain violations:

  • For (a) all government health agencies and their personnel as well as other government agencies, who fails to use generic terminology or generic names in all transactions related to purchasing, prescribing, dispensing and administering of drugs and medicines;[25] and (b) all medical, dental and veterinary practitioners, including private practitioners, who fails to write prescriptions using the generic name,[26] the following penalties shall be imposed:[27]
  • Second conviction, fine of not less than Ten Thousand Pesos (PhP10,000) but not exceeding Twenty-Five Thousand Pesos (PhP25,000), at the discretion of the court.[28]
  • Third conviction, fine of not less than Twenty-Five Thousand Pesos (PhP25,000) but not exceeding Fifty Thousand Pesos (PhP50,000), and suspension of his license to practice his profession for sixty (60) days at the discretion of the court.[29]
  • Fourth and subsequent convictions, fine of not less than One Hundred Thousand Pesos (PhP100,000) and suspension of his license to practice his profession for one (1) year or longer at the discretion of the court.[30]
  • For certain juridical persons: (a) Any organization or company involved in the manufacture, importation, repacking, marketing and/or distribution of drugs and medicines who fails to indicate prominently the generic name of the product, as discussed above;[31] (b) Failure of drug outlets, including drugstores, hospital and non-hospital pharmacies and non-traditional outlets such as supermarkets and stores, to inform any buyer about any and all other drug products having the same generic name, together with their corresponding prices, as discussed above;[32] (c) Those who violate the label requirements[33] and the required production,[34] the following penalties shall be imposed:[35]
  • Fine of not less than Five Thousand Pesos (PhP5,000) nor more than One Hundred Thousand Pesos (PhP100,000), and suspension or revocation of license to operate such drug establishment or drug outlet, at the discretion of the court.[36]
  • The officers directly responsible for the violation shall be penalized with a fine of at least Forty Thousand Pesos (PhP40,000), and suspension or revocation of license to practice profession, if applicable, and by imprisonment of not less than six (6) months nor more than one (1) year or both fine and imprisonment at the discretion of the Court.[37]

Common to all the foregoing violations: If the guilty party is an alien, he shall be ipso facto deported after service of sentence without need of further proceedings.[38]

  • 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, as the case may be.[39] The administrative sanctions that shall be imposed by the Secretary of the Department of Health shall be in a graduated manner in accordance with Section 12.A.[40] An administrative case may be instituted independently from the criminal case. The dismissal of the criminal case or the withdrawal of the same shall in no instance be a ground for the dismissal of the administrative case.[41]


References

  1. Republic Act No. 6675, Sec. 3(1)
  2. Republic Act No. 6675, Sec. 3(11)
  3. Republic Act No. 6675, Sec. 3(2)
  4. Republic Act No. 6675, Sec. 3(3)
  5. Republic Act No. 6675, Sec. 5, as amended by Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 37
  6. Republic Act No. 6675, Sec. 3(10)
  7. Republic Act No. 6675, Sec. 6(a)
  8. Republic Act No. 6675, Sec. 6(b)
  9. Republic Act No. 6675, Sec. 6(c)
  10. Republic Act No. 6675, Sec. 3(5)
  11. Republic Act No. 6675, Sec. 6(d)
  12. Republic Act No. 6675, Sec. 3(6)
  13. Republic Act No. 6675, Sec. 3(4)
  14. Republic Act No. 6675, Sec. 6
  15. Republic Act No. 6675, Sec. 6(e), as amended by Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 38
  16. Republic Act No. 6675, Sec. 3(7)
  17. Republic Act No. 6675, Sec. 3(8)
  18. Republic Act No. 6675, Sec. 3(9)
  19. Republic Act No. 6675, Sec. 4(a)
  20. Republic Act No. 6675, Sec. 4(a)
  21. Republic Act No. 6675, Sec. 7
  22. Republic Act No. 6675, Sec. 8, as amended by Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 39. The original language reads: "Subject to the rules and regulations promulgated by the Secretary of Health, 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."
  23. Republic Act No. 6675, Sec. 9
  24. Republic Act No. 6675, Sec. 10
  25. Republic Act No. 6675, Sec. 6(a)
  26. Republic Act No. 6675, Sec. 6(b)
  27. Republic Act No. 6675, Sec. 12(a)
  28. Prior to the amendment by Sec. 41 of Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, this provision provides a penalty of Two Thousand Pesos (PhP2,000) but not exceeding Five Thousand Pesos (PhP5,000).
  29. Prior to the amendment by Sec. 41 of Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, this provision provides a penalty of Five Thousand Pesos (PhP5,000) but not exceeding Ten Thousand Pesos (PhP10,000), and suspension of his license to practice his profession for thirty (30) days at the discretion of the court.
  30. Prior to the amendment by Sec. 41 of Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, this provision provides a fine of not less than Ten Thousand Pesos (PhP10,000) and suspension of his license to practice his profession for one (1) year or longer at the discretion of the court.
  31. Republic Act No. 6675, Sec. 6(c)
  32. Republic Act No. 6675, Sec. 6(d)
  33. Republic Act No. 6675, Sec. 7
  34. Republic Act No. 6675, Sec. 8
  35. Republic Act No. 6675, Sec. 12(b)
  36. Prior to the amendment by Sec. 41 of Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, this provision provides a fine of not less than Five Thousand Pesos (PhP5,000) nor more than Ten Thousand Pesos (PhP10,000).
  37. Prior to the amendment by Sec. 41 of Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, this provision provides a fine and suspension or revocation of license to practice profession, if applicable, and by imprisonment of not less than six (6) months nor more than one (1) year, or both.
  38. Republic Act No. 6675, Sec. 12(c)
  39. Republic Act No. 6675, Sec. 12(d)
  40. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 41
  41. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 41
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