CHAPTER 4
STRENGTHENING OF THE BUREAU OF FOOD AND DRUGS
SEC. 31. Strengthening of the Bureau of Food and Drugs (BFAD). –
(a) For a more effective and expeditious implementation of this Act, the Director or head of the Bureau of Food and Drugs shall be authorized to retain, without need of a separate approval from any government agency, and subject only to existing accounting and auditing rules and regulations, all the fees, fines, royalties and other charges, collected by the Bureau of Food and Drugs under this Act and other laws that it is mandated to administer based on the immediately prior year of operations, for use in its operations, like upgrading of its facilities, equipment outlay, human resource development and expansion, and the acquisition of the appropriate office space, among others, to improve the delivery of its services to the public. This amount, which shall be in addition to the annual budget of the Bureau of Food and Drugs, shall be deposited and maintained in a separate account or fund, which may be used or disbursed directly by the Director or head.
(b) After five (5) years from the coming into force of this Act, the Director or head of the Bureau of Food and Drugs shall, subject to the approval of the Secretary of the Department of Health, determine if the fees and charges, mentioned in Subsection (a) hereof, are sufficient to meet its budgetary requirements. If so, it shall retain all the fees and charges it shall collect under the same conditions indicated in said Subsection (a) but shall forthwith, cease to receive any funds from the annual budget of the National Government; if not, the provisions of Subsection (a) shall continue to apply until such time when the Director or head of the Bureau of Food and Drugs, subject to the approval of the Secretary of the Department of Health, certifies that the abovestated fees and charges the Bureau of Food and Drugs shall collect are enough to fund its operations.
(c) The Bureau of Food and Drugs shall submit a yearly performance report to the Quality Affordable Medicines Oversight Committee, as provided in Section 45 of this Act. The report shall itemize the use of such retained funds in the past year up to the present and the budgeted use of the same in the succeeding periods.
SEC. 32. Quality Assurance of Drugs. – The Bureau of Food and Drugs shall take the necessary steps to ensure that all drugs authorized for marketing in the country shall conform to international standards for the content, purity and quality of pharmaceutical products as established in the International Pharmacopoeia: Provided, That imported products in finished dosage forms, should be certified under the World Health Organization (WHO) certification scheme on the quality of pharmaceutical products moving in international commerce: Provided, further, That the registration for multisource pharmaceutical products should conform to the WHO guidelines on registration requirements to establish interchangeability.
CHAPTER 5
NON-DISCRIMINATORY CLAUSE
SEC. 33. Non-Discriminatory Clause. – It shall be unlawful for any retail drug outlet to refuse to carry either by sale or by consignment, or offer for sale drugs and medicines brought into the country, as allowed under Section 7 of this Act which amends Section 72.1 of the Intellectual Property Code of the Philippines or Republic Act No. 8293, by the government or authorized third party which have been previously approved for distribution or sale by the Bureau of Food and Drugs. For this purpose, the said products shall be displayed with equal prominence as all other products sold in the establishment.
SEC. 34. Refusal to Sell Drugs and Medicines. – No manufacturer, importer, trader, distributor, wholesaler shall withhold from sale or refuse to sell to a wholesaler or retailer any drug or medicine without good and sufficient reasons.
SEC. 35. Penalties. – Any person or entity who shall refuse to carry or sell drugs and medicines pursuant to the provisions of this Chapter shall be punished with a fine of not less than One hundred thousand pesos (Php100,000.00) but not more than Five hundred thousand pesos (Php500,000.00), at the discretion of the court. For the succeeding offense, the penalties shall not be less than Five hundred thousand pesos (Php500,000.00) but not more than One million pesos (Php1,000,000.00), at the discretion of the court, and suspension or revocation of its license to operate (LTO), business or professional license, as the case may be.
SEC. 36. Implementing Rules and Regulations on the Non-Discriminatory Clause. – Within one hundred twenty (120) days from the effectivity of this Act, the Department of Health, in consultation with the Department of Trade and Industry, shall promulgate the rules and regulations necessary to effectively implement the provisions of this Chapter.
CHAPTER 6
AMENDMENTS TO REPUBLIC ACT NO. 6675, OTHERWISE KNOWN
AS THE GENERICS ACT OF 1988
SEC. 37. Section 5 of Republic Act No. 6675, otherwise known as the Generics Act of 1988, is hereby amended to read as follows:
“SEC. 5. 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.”
SEC. 38. Section 6 of Republic Act No. 6675, otherwise known as the Generics Act of 1988, is hereby amended to read as follows:
“SEC. 6. Who Shall Use Generic Terminology. –
(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.
“(c) 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.
“(d) Drug outlets, including drugstores, hospital and non-hospital pharmacies and nontraditional 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. Within one (1) year after the approval of this Act, the drug outlets referred to herein shall post in conspicuous places in their establishments a list of drug products with the same generic name and their corresponding prices.
“(e) 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.”
SEC. 39. Section 8 of Republic Act No. 6675, otherwise known as the Generics Act of 1988, is hereby amended to read as follows:
“SEC. 8. 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.”
SEC. 40. Section 11 of Republic Act No. 6675, otherwise known as the Generics Act of 1988, is hereby amended to read as follows:
“SEC. 11. Education Drive. – The Department of Health jointly with the Philippine Information Agency and the Department of the Interior and Local Government shall conduct a continuous information campaign for the public and a continuing education and training for the medical and allied medical professions on drugs with generic names as an alternative of equal efficacy to the more expensive brand name drugs. Such educational campaign shall include information on the illnesses or symptoms which each generically named drug is supposed to cure or alleviate, as well as in contraindications. The Department of Health with the assistance of the Department of the Interior and Local Government and the Philippine Information Agency shall monitor the progress of the education drive, and shall submit regular reports to Congress.”
SEC. 41. Section 12 of Republic Act No. 6675, otherwise known as the Generics Act of 1988, is hereby amended to read as follows:
“SEC. 12. Penalty. – (A) Any person who shall violate Section 6(a) or 6(b) of this Act shall suffer the penalty graduated hereunder, viz:
“(a) for the first conviction, he shall suffer the penalty of reprimand which shall be officially recorded in the appropriate books of the Professional Regulation Commission.
“(b) for the second conviction, the penalty of fine in the amount of not less than Ten thousand pesos (Php10,000.00) but not exceeding Twenty-five thousand pesos (Php25,000.00), at the discretion of the court.
“(c) for the third conviction, the penalty of fine in the amount of not less than Twenty-five thousand pesos (Php25,000.00) but not exceeding Fifty thousand pesos (Php50,000.00) and suspension of his license to practice his profession for sixty (60) days at the discretion of the court.
“(d) for the fourth and subsequent convictions, the penalty of fine of not less than One hundred thousand pesos (Php100,000.00) and suspension of his license to practice his profession for one (1) year or longer at the discretion of the court.
“(B) Any juridical person who violates Sections 6(c), 6(d), 7 or 8 shall suffer the penalty of a fine of not less than One hundred thousand pesos (Php100,000.00) and suspension or revocation of license to operate such drug establishment or drug outlet at the discretion of the court: Provided, That its officers directly responsible for the violation shall suffer the penalty of fine of at least Forty thousand pesos (Php40,000.00) 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: and, a list of drug products with the same generic name and their corresponding prices.
Provided, further, That if the guilty party is an alien, he shall be ipso facto deported after service of sentence without need of further proceedings.
“(C) 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 for the violation of this Act.
“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.
“An administrative case may be instituted independently from the criminal case: Provided, That, 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.”
SEC. 42. Implementing Rules and Regulations to the Amendments to the Generics Act of 1988. – The Department of Health, in consultation with the appropriate government agencies, shall, within one hundred twenty (120) days from the effectivity of this Act, promulgate the rules and regulations necessary to effectively implement the provisions of this Act that relate to Republic Act No. 6675, or the Generics Act of 1988.
CHAPTER 7
AMENDMENTS TO REPUBLIC ACT NO. 5921, AS AMENDED,
OTHERWISE KNOWN AS THE PHARMACY LAW
SEC. 43. Section 25 of Republic Act No. 5921, as amended, otherwise known as the Pharmacy Law, is hereby amended to read as follows:
“SEC. 25. Sale of medicine, pharmaceuticals, drugs and devices. – No medicine, pharmaceutical, or drug, except for those which are non-prescription or over-the-counter, of whatever nature and kind or device shall be compounded, dispensed, sold or resold, or otherwise be made available to the consuming public except through a prescription drugstore or hospital pharmacy, duly established in accordance with the provisions of this Act. Non-prescription or over-the-counter drugs may be sold in their original packages, bottles, containers or in small quantities, not in their original containers to the consuming public through supermarkets, convenience stores and other retail establishments.
“Pharmaceutical, drug or biological manufacturing establishments, importers and wholesalers of drugs, medicines, or biologic products, shall not sell their products for re-sale except only to retail drug outlets, hospital pharmacies or to other drug wholesalers under the supervision of a registered pharmacist, and supermarkets, convenience stores, other retail establishments for over-the-counter drugs, duly licensed by the Bureau of Food and Drugs.”
SEC. 44. Implementing Rules and Regulations to the Amendments to the Pharmacy Law. – The Department of Health, in consultation with the appropriate government agencies, within one hundred twenty (120) days from the effectivity of this Act, shall promulgate the rules and regulations necessary to effectively implement the provisions of this Chapter.
CHAPTER 8
MISCELLANEOUS PROVISIONS
SEC. 45. Congressional Oversight Committee. – For the effective implementation of this Act, there shall be created a Congressional Oversight Committee, hereinafter referred to as the Quality Affordable Medicines Oversight Committee, to be composed of five (5) members from the Senate, which shall include the Chairpersons of the Senate Committees on Trade and Commerce and Health and Demography, and, five (5) members from the House of Representatives, which shall include the Chairpersons of the House of Representatives Committees on Trade and Industry and Health. The Quality Affordable Medicines Oversight Committee shall be jointly chaired by the Chairpersons of the Senate Committee on Trade and Commerce and the House of Representatives Committee on Trade and Industry. The Vice-Chair of the oversight committee shall be jointly held by the Chairpersons of the Senate Committee on Health and Demography and the House of Representatives Committee on Health.
SEC. 46. Appropriations. – For the initial implementation of this Act, the amount of Twenty-five million pesos (Php25,000,000.00), in addition to the budget of the Department of Health, shall be provided for the operations of the Office of the Secretary of the Department of Health. The Quality Affordable Medicines Oversight Committee shall be provided an initial budget of Five million pesos (Php5,000,000.00) to perform its functions as mandated under this Act. Thereafter, such sum as may be necessary for its continued implementation shall be included in the annual General Appropriations Act.
SEC. 47. Separability Clause. – Any portion or provision of this Act that may be declared unconstitutional or invalid shall not have the effect of nullifying other portions and provisions hereof as long as such remaining portion or provision can still subsist and be given effect in their entirety.
SEC. 48. Repealing Clause. – All laws, decrees, executive orders, proclamations and administrative regulations or parts thereof inconsistent herewith are hereby repealed or modified accordingly.
SEC. 49. Effectivity Clause. – This Act shall take effect fifteen (15) days after its publication in at least two (2) national papers of general circulation.
