HEALTH LAWS

E.TAALA-BAYUBAY,M.D.

OBJECTIVETo Explain The Different Health Laws And

Policies1.Generic Law (RA 6675)2.Law On Counterfeit Drug (RA 8203)3.Cheap Medicine Law (RA 9502)4.Comprehensive Dangerous Drugs Act Of

2002 (RA 9165)5.Food, Drug And Cosmetic Act (RA 3720)

RA 6675An act to promote, require and ensure

production of an adequate supply, distribution, use of medicine identified by their generic name

Sec 1. Title: This act shall be known as the Generics act of 1988

SEC 2. STATEMENT OF POLICY

• To promote, encourage, and require the use of generic terminology in the importation, manufacture, distribution, marketing, advertising and promotion, prescription and dispensing of drugs.

• To ensure adequate supply of drugs with generic names at the lowest possible cost and endeavor to make them available for free to indigent patients

• To encourage the extensive use of drugs with generic names through a rational system of procurement and distribution

• To emphasize the scientific basis for the use of drugs, in order that health professionals may become more aware and cognizant of their therapeutic effectiveness.

• To promote drug safety by minimizing duplication of medication and or use of drugs with potentially adverse drug interactions.

SEC 3. DEFINITION OF TERMS

Generic nameThe identification of drugs by their scientifically/internationally recognized active ingredient or by their official generic name determined by the BFAD

• Active ingredientChemical component responsible for claimed therapeutic effect of the pharmaceutical product

Chemical namedescription of the chemical structure of the drug/ medicine serves as the complete identification of the compound

4- thia- 1- azabicyclo (3.2.0) heptane –2- carboxylic acid, 6-[(amino(4 hydroxyphenyl)acetyl] amino ] –3,3-dimethyl-7-oxo-Trihydrate[ 2s [2a,5a,6b(s*)]

Generic drugsdrugs not covered by patent protection labeled solely by their international non proprietary or generic name

Brand nameproprietary name given by the manufacturer

Generic nameamoxicillin

Brand nameAmoxil SKBSumoxil UnilabGlamox Glaxo

Generic drugsamoxicillin trihydrate DLI generics amoxicillin trihydrate San Marino

SEC 4. THE USE OF GENERIC TERMINOLOGY FOR ESSENTIAL DRUGS

AND PROMOTIONAL INCENTIVE

A. In the promotion of generic names for pharmaceutical products, special consideration shall be given to drugs and medicines which are included in the essential drug list…

B. The exclusive use of generic terminology for the manufacture, marketing and sales of drugs and medicines particularly those in the essential drug list shall be promoted through a system of incentives as the board of investment jointly with the DOH and other governmentt agencies authorized by law…

SEC 5 POSTING AND PUBLICATION

• THE DEPARTMENT OF HEALTH SHALL PUBLISH ANNUALLY IN AT LEAST TWO NEWSPAPER AND GENERAL CIRCULATION IN THE PHIL THE GENERIC NAMES AND THE CORRESPONDING BRAND NAMES UNDER WHICH THEY ARE MARKETED OF ALL DRUGS AND MEDICINES IN THE PHIL

SEC 6 WHO SHALL USE THE GENERIC TERMINOLOGY

• ALL GOVERNMENT HEALTH AGENCIES AND THEIR PERSONNEL SHALL USE THE GENERIC TERMINOLOGY IN ALL THEIR TRANSACTIONS RELATED TO PURCHASING, PRESCRIBING, DISPENSING, AND ADMINSTERING OF DRUGS AND MEDICINES

• ALL MEDICAL, DENTAL AND VETERINARY PRACTITIONERS INCLUDING PRIVATE PRACTITIONERS SHALL WRITE THE PRESCRIPTION USING GENERIC NAME

• THE BRAND NAME MAY BE INCLUDED IF SO DESIRED.

• 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.

• 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

• DRUG OUTLETS, INCLUDING DRUGSTORE, HOSPITAL AND NON HOSPTIAL PHARMACIES AND TRADITIONAL OUTLETS SUCH AS SUERMARKETAND STORE SHALL INFORM THE BUYER ABOUT ANY AND ALL OTHER DRUG PRODUCTS HAVING THE SAME GENERIC NAME TOGETHER WITH THEIR PRICES SO THAT THE BUYER MAY ADEQUATELY EXERCISE THEIR OPTION.

SEC 7. PROVISION OF QUALITY

• IN ORDER TO ASSURE RESPONSIBILITY, OR DRUG QUALITY IN ALL INSTANCES, THE LABEL OF ALL DRUGS AND MEIDICINES SHALL HAVE THE FOLLOWING

• NAME AND COUNTRY OF MANUFACTURE• DATES OF MANUFACTURE AND

EXPIRATION• QUALITY OF SUCH SHALL BE DULY

CERITIFED BY THE DOH

SEC 8 REQUIRED PRODUCTION

• EVERY DRUG MANUFACTURING COMPANY SHALL BE REQUIRED TO PRODUCE, DISTRIBUTE AND MAKE AVAILABLE TO THE GENERAL PUBLIC THE MEDICINES IT PRODUCES IN THE FORM OF GENERIC DRUGS

SEC 9 RULES AND REGULATIONS

• SHALL BE IN ACCORDANCE WITH THE RULES AND REGULATIONS OF THE DOH

SEC 10 AUTHORITY TO IMPORT

• THE DOH IS AUTHORIZED TO IMPORT RAW MATERIALS OF WHICH THERE IS A SHORTAGE OF USE FOR FILIPINO OWNED AND CONTROLLED DRUG ESTABLISHMENT TO BE MARKETED AND SOLD UNDER GENERIC NOMENCLATURE

• THE PRESIDENT MAY AUTHORIZE THE IMPORTATION OF RAW MATERIALS TAX AND DUTY FREE

SEC 11 EDUCATION DRIVE

• THE DOH , DEPED, DILG, PUBLIC INFORMATION AGENCY SHALL CONDUCT A CONTINUOUS INFORMATION CAMPAIGN FOR PUBLIC AND CONTINUING EDUCATION AND TRAINING FOR MEDICAL AND ALLIED PROFESSIONS

SEC 12 PENALTY

• ANY PERSON VIOLATING SEC 6 A OR B SHALL SUFFER THE FF

• FIRST CONVICTION=REPRIMAND BY PRC• SECOND CONVICTION= 2-5000.00• 3RD CONVICTION= 5-10,000 AND

SUSPENSION OF LICENSE TO PRACTICE PROFESSION FOR 30 DAYS

• 4TH 10,000, SUSPENSION FOR ONE YEAR DEPENDING ON DISCRETION OF COURT

• THE DOH SECRETARY SHALL BE THE AUTHORITY TO IMPOSE ADMINISTRATIVE SANCTIONS SUCH AS SUSPENSION OR CANCELLATION OF LICENSE TO OPERATE OR RECOMMEND SUSPENSION TO PRACTICE TO THE PRC

APPROVAL DATE

• SEPT 13, 1988 (PRES CORAZON AQUINO)

RA 9502

• AMENDED 3 LAWS– INTELLECTUAL PROPERTY CODE RA

8293– GENERICS ACT OF 1988 RA 6675– PHARMACY LAW RA 5921

• APPROVAL DATE– JUNE 6, 2008 (PRES GLORIA

MACAPAGAL ARROYO)

RA 9502

• SEC 1 TITLE: – UNIVERSALLY ACCESSIBLE CHEAPER

AND QUALITY MEDICINE ACT OF 2008• SEC 2. DECLARATION OF POLICY:

– TO PROTECT PUBLIC HEALTH AND ADOPT MEASURES TO PROMOTE AND ENSURE ACCESS TO AFFORDABLE QUALITY DRUGS AND MEDICINES FOR ALL

• an effective competition policy in the supply and demand of quality affordable drugs and medicines is recognized by the State as a primary instrument.

• In the event that full competition is not effective, the State recognizes as a reserve instrument the regulation of prices of drugs and medicines, with clear accountability by the implementing authority as mandated in this Act, as one of the means to also promote and ensure access to quality affordable medicines.

SEC 4 DEFINITION OF TERMS

• "Compulsory License" is a license issued by the Director General of the Intellectual Property Office to exploit a patented invention without the permission of the patent holder, either by manufacture or through parallel importation

CHAPTER 2

• AMMENDMENTS TO INTELLECTUAL PROPERTY CODE OF THE PHIL– INVENTIVE STEPS– LIMITATION OF PATENT RIGHTS– GROUNDS FOR LICENSING

• SEC. 93. Grounds for Compulsory Licensing. - The Director General of the Intellectual Property Office may grant a license to exploit a patented invention, even without the agreement of the patent owner, in favor of any person who has shown his capability to exploit the invention, under any of the following circumstances:

• "93.1. National emergency or other circumstances of extreme urgency;

• "93.2. Where the public interest, in particular, national security, nutrition, health or the development of other vital sectors of the national economy as determined by the appropriate agency of the Government, so requires; or

• "93.3. Where a judicial or administrative body has determined that the manner of exploitation by the owner of the patent or his licensee is anti-competitive

• "93.4. In case of public non-commercial use of the patent by the patentee, without satisfactory reason;

• "93.5. If the patented invention is not being worked in the Philippines on a commercial scale, although capable of being worked, without satisfactory reason: Provided, That the importation of the patented article shall constitute working or using the patent; (Secs. 34, 34-A, 34-B, R.A. No. 165a) and

• "93.6. Where the demand for patented drugs and medicines is not being met to an adequate extent and on reasonable terms, as determined by the Secretary of the Department of Health."

CHAPTER 3

• DRUGS AND MEDICINE PRICE REGULATION

• SEC 17– THE PRESIDENT SHALL HAVE THE

POWER TO IMPOSE MAXIMUM RETAIL PRICES OVER ANY OR ALL DRUGS AND MEDICINES ENUMERATED IN SEC 23

DOH

Power to Recommend the Maximum Retail Price of Drugs and Medicines Subject to Price Regulation

a) Retail prices of drugs and medicines that are subject to regulation in the Philippines and in other countries;

(b) The supply available in the market;(c) The cost to the manufacturer, importer,

trader, distributor, wholesaler or retailer

• No retailer shall sell drugs and medicines at a retail price exceeding the maximum retail price approved by the President of the Philippines

• Power to Include Other Drugs and Medicines in the List Subject to Price Regulation

• Power to Implement Cost-Containment and Other Measures

• The Secretary of the Department of Health shall have the power to implement any other measures that the government may avail of to effectively reduce the cost of drugs and medicines that shall include, but not limited to, competitive bidding, price volume negotiations, and other appropriate mechanisms that influence supply, demand and expenditures on drugs and medicines.

• Power to Impose Administrative Fines and Penalties

• Power to Deputize Government Entities • Other Powers Necessary to Implement

Provisions of this Chapter

• SEC 23– LIST OF DRUGS AND MEDICINE

SUBJECT TO PRICE REGULATION

• ALL DRUGS AND MEDICINE INDICATED FOR THE TREATMENT OF CHRONIC ILLNESS BUT NOT LIMITED TO ENDOCRINE DISEASES.– DM– GIT DISEASES – UROLOGIC DISORDER– BPH– CARDIOVASCULAR DIS (HPN)– PULMONARY DIS (PTB, ASTHMA)– AUTOIMMUNE DIS (SLE)– NEUROPSYCHIATRIC DIS– HIV– ORGAN TRANSPLANT– NEOPLASM

• Drugs and medicines indicated for prevention of diseases• Drugs and medicines indicated for prevention of

pregnancy• Anesthetic agents• Intravenous fluids• Drugs and medicines that are included in the Philippine

National Drug Formulary (PNDF) Essential Drug List; and• All other drugs and medicines which, from time to time,

the Secretary of the Department of Health determines to be in need of price regulation.

CHAPTER 4

• STRENGTHENING BFAD• THE BFAD SHALL TAKE THE NECESSARY

STEPS TO ENSURE THAT ALL DRUGS AUTHORIZED FOR MARKETING SHALL CONFORM TO INTERNATIONAL STANDARDS…

Sec 32. QUALITY ASSURANCE OF DRUGSThe 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 multi source pharmaceutical products should conform to the WHO guidelines on registration requirements to establish interchangeability.

CHAPTER 6

• AMMENDMENTS TO THE RA 6675 (GENERIC LAW)

• SEC 5– POSTING AND PUBLICATION– WHO SHALL USE THE GENERIC

TERMINOLOGY– REQUIRED PRODUCTION– EDUCATION DRIVE– PENALTY

AMMENDMENT

• SEC 6 "(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. 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. 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.

CHAPTER 7

• AMMENDMENTS TO RA 5921 (PHARMACY LAW)

• SEC 25– SALE OF MEDICINE,

PHARMACEUTICALS, DRUGS AND DEVICES

RA 5921

• STANDARDIZATION AND REGULATION OF PHARMACY PRACTICE AND EDUCATION

• NO DRUG SHALL BE COMPOUNDED, SOLD, RESOLD, DISPENSED, BE MADE AVAILABLE EXCEPT THROUGH A PRESCRIPTION DRUGSTORE OR HOSPITAL PHARMACY. OTC DRUGS CAN BE SOLD IN SUPERMARKETS, CONVENIENT STORE AND OTHER RETAIL ESTABLISHMENTS

• EVERY PHARMACY, DRUGSTORE, HOSPITAL PHARMACY SHALL BE UNDER THE PERSONNAL OF IMMEDIATE SUPERVISION OF A REGISTERED PHARMACIST

• Section 40. Penal provisions. Any person who shall violate any of the provisions of Sections twelve, twenty-four, twenty-five, twenty-six, twenty-seven and twenty-nine of this Act or any person who shall make false representation to procure a registration certificate as pharmacist for himself or for another; or any person who shall allow anyone in his employ who is not a registered pharmacist to engage in the practice of pharmacy; or any person who shall falsely display within the establishment the certificate of registration of a pharmacist who is not actually and regularly employed therein as such or to act as a dummy for any alien or an unqualified person for the purpose of opening and operating a retail drugstore; shall, upon conviction thereof, be sentenced to a fine of not less than one thousand pesos but not exceeding four thousand pesos or to an imprisonment of not less than six months and one day but not more than four years, in the discretion of the court.

• Section 23. Definition of practice of pharmacy. A person shall be deemed to be practicing pharmacy within the meaning of this Article, who shall, for fee, salary, percentage or other reward paid or given directly to himself or indirectly through another, prepare or manufacture, analyze, assay, preserve, store, distribute or sell any medicine, drug, chemicals, cosmetics, pharmaceuticals, devices or contrivances used in pursuance thereof; or render pharmaceutical service in any office or drug and cosmetic establishment where scientific, technological or professional knowledge of Pharmacy is applied; or engage in teaching scientific, technological or professional pharmacy subject in a college of pharmacy; or conduct or undertake scientific pharmaceutical research for biological and bacteriological testings and examinations.

• Section 24. Prerequisite for the practice of pharmacy. No person shall engage in the practice of pharmacy in the Philippines unless he is at least twenty-one years of age, has satisfactorily passed the corresponding examination given by the Board of Pharmacy, and is a holder of a valid certificate of registration duly issued to him by said Board.

• Section 25. Sale of medicine, pharmaceuticals, drugs and devices. No medicine, pharmaceutical, or drug 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.

• Section 26. Markings and inhibition to the sale of drug samples. No sample of any drug, biological product, device or proprietary medicine, given or intended to be given for free to the physician and other qualified person by any manufacturer or distributor of its representative or detailman as part of its program or promotion, may be sold.

• The statement "Sample, not for sale" shall appear conspicuously on the container, package or carton of the drug or device to be given.

RA 9502CHAPTER 7 Section 43

DRUG MANUFACTURER

HOSPITALPHARMACY

DRUGSTORE WHOLESALER

PRESCRIPTION DRUG NON PRESCRIPTION DRUG

SUPERMARKET

CONVENIENCESTORE

OTHER RETAILOUTLET

RA 8203

• SEC 1 TITLE– SPECIAL LAW ON COUNTERFEIT DRUGS

• SEC 2. DECLARATION OF POLICY– TO PROTECT AND PROMOTE THE RIGHT

TO HEALTH OF THE PEOPLE AND INSTILL HEALTH CONSCIOUNESS AMONG THEM

– IN ORDER TO SAFEGUARD THE HEALTH OF THE PEOPLE, THE STATE SHALL PROVIDE FOR THEIR PROTECTION AGAINST COUNTERFIET DRUGS

SEC 3. DEFINITION OF TERMS

• DRUGS SHALL REFER TO ANY CHEMICAL COMPOUND OR BIOLOGICAL SUBSTANCE, OTHER THAN FOOD INTENDED FOR USE IN THE TREATMENT, PREVENTION OR DIAGNOSIS OF DISEASE IN MAN AND ANIMALS INCLUDING BUT NOT LIMITED TO

• ANY ARTICLE RECOGNIZED IN THE– US PHARMACOPOEIA- NATIONAL

FORMULARY– OFFICIAL HOMEOPATHIC

PHARMACOPOEIA OF THE US– PHIL NATIONAL DRUG FORMULARY – BRITISH PHARMACOPOIEA– NATIONAL COMPENDIUM OR ANY

SUPPLEMENT TO ANY OF THEM

• ANY ARTICLE INTENDED FOR USE IN THE DIAGNOSIS, CURE, MITIGATION , TREATMENT OR PREVENTION OF DISEASE IN MAN OR ANIMALS, ANY ARTICLE OTHER THAN FOOD INTENDED TO AFFECT THE STRUCTURE OR ANY FUNCTION OF THE BODY OF MAN OR ANIMALS

• ANY ARTICLE INTENDED FOR USE AS A COMPONENT OF ANY ARTICLES SPECIFIED ABOVE…

• HERBAL AND OR ALTERNATIVE DRUGS WHICH ARE ARTICLES OF PLANT OR ANIMAL ORIGIN USED IN FOLK MEDICINE– RECOGNIZED BY THE PNDF– INTENDED FOR USE IN THE TREATMENT…– OTHER THAN FOOD INTENDED TO AFFECT THE

STRUCTURE..– IN FINISHED OR READY TO USE DOSAGE FORM– INTENDED FOR USE AS A COMPONENT OF ANY

OF THE ARTICLES SPECIFIED IN CLAUSE A,B,C,D

WHAT ARE COUNTERFEIT DRUGS

• MEDICINAL PRODUCTS WITH THE CORRECT INGREDIENTS – BUT NOT IN AMOUNT PROVIDED– WRONG INGREDIENTS– WITHOUT THE ACTIVE INGREDIENTS– WITH SUFFICIENT QUANTITY OF THE

ACTIVE INGREDIENT• WHICH RESULTS IN THE REDUCTION IN THE

DRUG’S SAFETY, EFFICACY, QUALITY , STRENGTH OR PURITY.

WHAT ARE COUNTERFEIT DRUGS

• A DRUG WHICH IS DELIBERATELY OR FRAUDULENTLY MISLABELED WITH RESPECT TO IDENTITY AND OR SOURCE OR WITH FAKE PACKAGING AND CAN APPLY TO BOTH BRANDED AND GENERIC PRODUCTS

WHAT ARE COUNTERFEIT DRUGS

• IT SHALL ALSO REFER TO• ANY PART OF THE DRUG BEARING THE

TRADEMARK WITHOUT AUTHORIZATION• DRUG REFILLED IN CONTAINERS BY

UNAUTHORIZED PERSONS IFTHE ORIGINAL LABEL IS USED

• UNREGISTERED IMPORTED PRODUCT EXCEPT IF IT IS FOR PERSONAL USE

• DRUG CONTAINING NO AMOUNT OF THE ACTIVE INGREDIENT OR LESS THAN 80% OF THE ACTIVE INGREDIENT

• SECTION 4: PROHIBITED ACTS• SECTION 5 : PARTIES LIABLE• SECTION 6: ADMINISTRATIVE

PROCEEDINGS• SECTION 7: ADMINSTRATIVE SANCTIONS• SECTION 8: PENALTIES• APPROVAL DATE: SEPT 4, 1996 (PRES

RAMOS)

PROHIBITED ACTS

• The manufacture, sale, or offering for sale, donation, distribution, trafficking,brokering, exportation, or importation or possession of counterfeit drugs

• Possession of any such counterfeit drugs

THE FF SHALL BE EXEMPTED FROM LIABILITY

1) presentation of sales invoices, official receipts or other legally acceptable documents evidencing his purchase thereof from a drugstore, distributor, manufacturer, hospital pharmacy or dispensary; or any other person or place duly licensed to sell and/or dispense drugs or medicines and indicating the batch and lot numbers, as well as the expiry dates of such drugs;

2) Presentation of certificates and other documents evidencing the importation or exportation of the counterfeit drugs found in his possession as required by existing laws, including those documents required in the preceding paragraph covering the commercial transactions involving counterfeit drugs.

• Furthermore, the amount or volume of counterfeit drugs held is such that it is not inconsistent with the averment that the same are for personal use, notwithstanding the presentation by the possessor of medical records and other similar documents accompanying and justifying the use of such drugs

• Q

PROHIBITED ACTS

Forging, counterfeiting, simulating or falsely representing, or without proper authority, using any mark, stamp, tag, label or other identification mark or device authorized or required by Republic Act No. 3720, as amended, and/or the regulations promulgated under this Act;

PROHIBITED ACTS

Photocopying, duplicating, altering, printing, transferring, obliterating or removing the approved label or any part thereof, lawfully belonging to another person, for the purpose of using such label or a part thereof on any counterfeit drug:

Provided, That if the person who committed any of the acts enumerated in this paragraph and the person who used the labels produced thereby are not one and the same person and the former had knowledge of the purpose for which the labels are intended, the former shall also be liable under this

PROHIBITED ACTS

Making, selling, or concealing any punch, dye, plate or any other equipment or instrument designed to print, imprint or reproduce the trademark, trade name or other identifying mark of another registered producer or any likeness thereof, any drug product or device or its container or label without authority from the legitimate owners of the trademark or trade name.

PENALTIES

A. imprisonment of not less than six (6) months and one (1) day; but not more than six (6) years for mere possession of counterfeit drugs as provided for in Section 4 (PROHIBITED ACTS)

B. imprisonment of six (6) years and one (1) day, but not more than ten (10) years or a fine of not less than One hundred thousand pesos (P100,000) but not more than Five hundred thousand pesos (P500,000) or both such imprisonment and fine at the discretion of the court in any other case mentioned in Section 4 hereof; or

c) imprisonment of not less than six (6) months and one (1) day, but not more than two (2) years and four (4) months if the counterfeit drug is intended for animals; or

• d) imprisonment of not less than six (6) years and one (1) day but not more than ten (10) years for any manufacturer, seller or distributor who shall conceal, substitute, dispose or destroy any drug as may have been segregated and sealed by the Bureau or who shall break, alter or tamper any mark or seal used by the Bureau to identify

• those segregated drugs as provided for under Section 6(a) of this Act. Any other person who breaks, alters or tampers any mark or seal used by the Bureau to identify the segregated drugs shall suffer the penalty of not less than six (6) months and one (1) day, but not more than six (6) years imprisonment; or

e) if, as a result of the use of the drug found to be counterfeit, the illness sought to be cured is aggravated or physical injury or suffering results there from, a punishment of imprisonment from twelve (12 years to fifteen (15) years and a fine ranging from One hundred thousand pesos (P100,000) to Five hundred thousand pesos (P500,000) shall be meted out; or

f) should a counterfeit drug be the proximate cause of death of a victim, who unknowingly purchased and took a counterfeit drug, the penalty of life imprisonment and a fine of Five hundred thousand pesos (P500,000) to Five million pesos (P5,000,000) shall be imposed.

RA 9165

• TITLE:▫COMPREHENSIVE DANGEROUS DRUGS ACT OF

2002• DECLARATION OF POLICY▫ TO SAFEGUARD THE INTEGRITY OF ITS

TERRITORY AND THE WELL BEING OF ITS CITIZENRY PARTICULARLY THE YOUTH FROM HARMFUL EFFECTS OF DANGEROUS DRUGS ON THEIR PHYSICAL AND MENTAL WELL BEING AND TO DEFEND THE SAME AGAINST ACTS OR OMISSIONS DETRIMENTAL TO THEIR DEVELOPEMNT AND PRESERVATION. THE STATE NEEDS TO ENHANCE THE LAWS AGAINST DANGEROUS DRUGS, IT BEING ONE OF THE MORE SEROUS SOCIAL ILLS.

RA 9165

• SECTION 2– DECLARATION OF POLICY– THE GOVT SHALL PURSUE AND UNRELENTING

CAMPAIGN AGAINST THE TRAFFICKING AND USE OF DANGEROUS DRUGS AND OTHER SIMILAR SUBSTANCES THROUGH AN INTEGRATED SYSTEM OF PLANNING, IMPLEMENTATION AND ENFORCEMENT OF ANTI DRUG ABUSE POLICIES, PROGRAMS AND PROJECTS. THE GOVT SHALL AIM TO ACHIEVE A BALANCE IN THE NATIONAL DRUG CONTROL PROGRAM SO THAT PEOPLE WITH LEGITIMATE MEDICAL NEEDS ARE NOT PREVENTED FROM BEING TREATED WITH ADEQUATE AMOUNTS OF APPROPRIATE MEDICATIONS WHICH INCLUDE THE USE OF DANGEROUS DRUGS.

• ARTICLE 2– UNLAWFUL ACTS AND PENALTIES

• ARTICLE 3– DANGEROUS DRUGS TEST AND RECORD

REQUIREMENTS• ARTICLE 4

– PARTICIPATION OF STUDENTS, TEACHERS, FAMILY AND SCHOOL AUTHORITIES

UNLAWFUL ACTS AND PENALTIES

• Importation of Dangerous Drugs and/or Controlled Precursors and Essential Chemicals

• penalty of life imprisonment to death and a ranging from Five hundred thousand pesos (P500,000.00) to Ten million pesos (P10,000,000.00) shall be imposed upon any person, who, unless authorized by law, shall import or bring into the Philippines any dangerous drug, regardless of the quantity and purity involved, including any and all species of opium poppy or any part thereof or substances derived there from even for floral, decorative and culinary purposes.

• The penalty of imprisonment ranging from twelve (12) years and one (1) day to twenty (20) years and a fine ranging from One hundred thousand pesos (P100,000.00) to Five hundred thousand pesos (P500,000.00) shall be imposed upon any person, who, unless authorized by law, shall import any controlled precursor and essential chemical

• The maximum penalty provided for under this Section shall be imposed upon any person, who, unless authorized under this Act, shall import or bring into the Philippines any dangerous drug and/or controlled precursor and essential chemical through the use of a diplomatic passport, diplomatic facilities or any other means involving his/her official status intended to facilitate the unlawful entry of the same. In addition, the diplomatic passport shall be confiscated and canceled.

• The maximum penalty provided for under this Section shall be imposed upon any person, who organizes, manages or acts as a "financier" of any of the illegal activities prescribed in this Section.

• The penalty of twelve (12) years and one (1) day to twenty (20) years of imprisonment and a fine ranging from One hundred thousand pesos (P100,000.00) to Five hundred thousand pesos (P500,000.00) shall be imposed upon any person, who acts as a "protector/coddler" of any violator of the provisions under this Section.

• Section 5. Sale, Trading, Administration, Dispensation, Delivery, Distribution and Transportation of Dangerous Drugs and/or Controlled Precursors and Essential Chemicals. -

• The penalty of life imprisonment to death and a fine ranging from Five hundred thousand pesos (P500,000.00) to Ten million pesos (P10,000,000.00) shall be imposed upon any person, who, unless authorized by law, shall sell, trade, administer, dispense, deliver, give away to another, distribute dispatch in transit or transport any dangerous drug, including any and all species of opium poppy regardless of the quantity and purity involved, or shall act as a broker in any of such transactions.

• The penalty of imprisonment ranging from twelve (12) years and one (1) day to twenty (20) years and a fine ranging from One hundred thousand pesos (P100,000.00) to Five hundred thousand pesos (P500,000.00) shall be imposed upon any person, who, unless authorized by law, shall sell, trade, administer, dispense, deliver, give away to another, distribute, dispatch in transit or transport any controlled precursor and essential chemical, or shall act as a broker in such transactions.

• If the sale, trading, administration, dispensation, delivery, distribution or transportation of any dangerous drug and/or controlled precursor and essential chemical transpires within one hundred (100) meters from the school, the maximum penalty shall be imposed in every case.

• For drug pushers who use minors or mentally incapacitated individuals as runners, couriers and messengers, or in any other capacity directly connected to the dangerous drugs and/or controlled precursors and essential chemical trade, the maximum penalty shall be imposed in every case.

• If the victim of the offense is a minor or a mentally incapacitated individual, or should a dangerous drug and/or a controlled precursor and essential chemical involved in any offense herein provided be the proximate cause of death of a victim thereof, the maximum penalty provided for under this Section shall be imposed.

• The maximum penalty provided for under this Section shall be imposed upon any person who organizes, manages or acts as a "financier" of any of the illegal activities prescribed in this Section.

• The penalty of twelve (12) years and one (1) day to twenty (20) years of imprisonment and a fine ranging from One hundred thousand pesos (P100,000.00) to Five hundred thousand pesos (P500,000.00) shall be imposed upon any person, who acts as a "protector/coddler" of any violator of the provisions under this Section.

• Section 6. Maintenance of a Den, Dive or Resort. - The penalty of life imprisonment to death and a fine ranging from Five hundred thousand pesos (P500,000.00) to Ten million pesos (P10,000,000.00) shall be imposed upon any person or group of persons who shall maintain a den, dive or resort where any dangerous drug is used or sold in any form.

• Section 18. Unnecessary Prescription of Dangerous Drugs. – The penalty of imprisonment ranging from twelve (12) years and one (1) day to twenty (20) years and a fine ranging from One hundred thousand pesos (P100,000.00) to Five hundred thousand pesos (P500,000.00) and the additional penalty of the revocation of his/her license to practice shall be imposed upon the practitioner, who shall prescribe any dangerous drug to any person whose physical or physiological condition does not require the use or in the dosage prescribed therein, as determined by the Board in consultation with recognized competent experts who are authorized representatives of professional organizations of practitioners, particularly those who are involved in the care of persons with severe pain.

• Section 19. Unlawful Prescription of Dangerous Drugs. – The penalty of life imprisonment to death and a fine ranging from Five hundred thousand pesos (P500,000.00) to Ten million pesos (P10,000,000.00) shall be imposed upon any person, who, unless authorized by law, shall make or issue a prescription or any other writing purporting to be a prescription for any dangerous drug.

• ARTICLE 5– PROMOTION OF DRUG FREE WORKPLACE

• ARTICLE 6– PARTICIPATION OF PRIVATE AND LABOR

SECTORS• ARTICLE 7

– PARTICIPATION OF LGU• ARTICLE 8

– PROGRAM FOR THE TREATMENT AND REHAB OF DRUG DEPENDENTS

• ARTICLE 9– DANGEROUS DRUGS BOARD AND

PDEA

RA 3720

• TITLE– FOOD , DRUG AND COSMETIC ACT

• DECLARATION OF POLICY– TO ENSURE SAFE AND GOOD QUALITY

OF FOOD, DRUG AND COSMETIC AND TO REGULATE THE PRODUCTION , SALE AND TRAFFIC OF THE SAME TO PROTECT THE HEALTH OF THE PEOPLE

• (a) Establish standards and quality measures for food, drug, and cosmetic.

• (b) Adopt measures to insure pure and safe supply of food, drug, and cosmetic in the country.

• CHAPTER 3– CREATION OF THE FDA

• CHAPTER 4– BOARD OF FOOD DRUG AND INSPECTION

• CHAPTER 6– PROHIBITED ACTS

• CHAPTER 7– DEFINITIONS AND STANDARDS

• CHAPTER 10– CERTIFICATION OF DRUG CONTAINING

PENICILLIN, STREPTOMYCIN, CHLORTETRACYCLINE, CHLORAMPHENICOL, BACITRACIN

• CHAPTER 8– BOARD OF FOOD DRUG AND

INSPECTION• CHAPTER 9

• CHAPTER 10– COSMETICS

• CHAPTER 11– PENALTIES

• Section 4. To carry out the provisions of this Act, there is hereby created an office to be called the Food and Drug Administration in the Department of Health. Said Administration shall be under the Office of the Secretary and shall have the following functions, powers and duties:

(a) To administer and supervise the implementation of this Act and of the rules and regulations issued pursuant to the same.

(b) To provide for the collection of samples of food, drug and cosmetic.

(c) To analyze and inspect food, drug and cosmetic in connection with the implementation of this Act.

(d) To establish analytical data to serve as basis for the preparation of food, drug and cosmetic standards, and to recommend standards of identity, purity, quality and fill of container.

(e) To issue certificate of compliance with technical requirements to serve as basis for the issuance of license and spot-check for compliance with regulations regarding operation of food, drug and cosmetic manufacturers and establishments.

(f) To levy, assess and collect fees for inspection, analysis and testing of products and materials submitted in compliance with the provisions of this Act.

(g) To certify batches of anti-biotic and anti-biotic preparations in compliance with the provisions of this Act.

TWO DIVISIONS OF THE BFAD

• (a) Inspection and Licensing Division, which shall have charge of the inspection of food, drug, and cosmetic establishments engaged in their manufacture and sale.

• (b) Laboratory Division, which shall conduct all the tests, analyses and trials of products covered by this Act.

PROHIBITED ACTS

• (a) The manufacture, sale, offering for sale or transfer of any food, drug, device or cosmetic that is adulterated or misbranded.

• (b) The adulteration or misbranding of any food, drug, device, or cosmetic.

• (c) The refusal to permit entry or inspection as authorized by Section twenty-seven hereof or to allow samples to be collected.

• (d) The giving of a guaranty or undertaking referred to in Section twelve (b) hereof which guaranty or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person residing in the Philippines from whom he received in good faith the food, drug, device, or cosmetic or the giving of a guaranty or undertaking referred to in Section twelve (b) which guaranty or undertaking is false.

• (e) Forging, counterfeiting, simulating, or falsely representing or without proper authority using any mark, stamp, tag label, or other identification device authorized or required by regulations promulgated under the provisions of this Act.

• (f) The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the Department or to the courts when relevant in any judicial proceeding under this Act, any information acquired under authority of Section nine, or concerning any method or process which as a trade secret is entitled to protection.

• (g) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) and results in such article being adulterated or misbranded.

• (h) The use, on the labeling of any drug or in any advertising relating to such drug, of any representation or suggestion that an application with respect to such drug is effective under Section twenty-one hereof, or that such drug complies with the provisions of such section.

• (I) The use, in labeling, advertising or other sales promotion of any reference to any report or analysis furnished in compliance with Section twenty-six hereof.

Food and Drug Administration has warned against fake "Tamiflu" sold through the Internet. FDA stressed that such medicines can lead to side-effects and other health

problems instead of curing swine flu. Buying antiviral medication online from an unfamiliar company can put health of people in danger. Such fake medicines available online are not checked by anybody hence these can contain undesirable substances.  

• Section 12. (a) Any person who violates any of the provisions of Section eleven hereof shall, upon conviction, be subject to imprisonment of not less than six months and one day, but not more than five years, or a fine of not less than one thousand pesos, or both such imprisonment and fine, in the discretion of the Court.

• Approved: June 22, 1963

BFAD gets more teeth, is renamed FDA

• MANILA, Philippines—A law granting more regulatory muscle to the Bureau of Food and Drugs (BFAD) and renaming it as the Food and Drugs Administration (FDA) was enacted Tuesday.

• President Gloria Macapagal-Arroyo signed Republic Act 9711, or the Food and Drugs Administration Act of 2009, before lawmakers and government officials in Malacañang.

• The law boosts the regulatory capacity of the FDA by mandating the establishment of adequate testing laboratories and field offices, upgrading its equipment and personnel, and authorizing the agency to retain income.

• In essence, it complements the Cheaper Medicines Law, according to Health Secretary Francisco Duque III.

RA 9711

• Section 1. The Bureau of Food and Drugs (BFAD) is hereby renamed the Food and Drug Administration (FDA).

• Section 2. This Act shall be known as the "Food and Drug Administration (FDA) Act of 2009".

• Section 4. This Act has the following objectives:• (a) To enhance and strengthen the administrative

and technical capacity of the FDA in the regulation of establishments and products under its jurisdiction;

• (b) To ensure the FDA's monitoring and regulatory coverage over establishments and products under its jurisdiction; and

• (c) To provide coherence in the FDA's regulatory system for establishments and products under its jurisdiction.

• (j) The manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement, or sponsorship of any health product which, although requiring registration, is not registered. with the FDA pursuant to this Act.

• Section 11. Section 12, subsection (a) of Republic Act No, 3720, as amended, is hereby further amended to read as follows:

• "SEC. 12. (a) Any person who violates any of the provisions of Section eleven hereof shall, upon conviction, suffer the penalty of imprisonment ranging from one (1) year but not more than ten (10) years or a fine of not less than Fifty thousand pesos (P50,000.00) but not more than Five hundred thousand pesos (P500,000.00), or both, at the discretion of the court:

• Provided, That if the offender is a manufacturer, importer or distributor of any health product, the penalty of at least five (5) years imprisonment but not more than ten (10) years and a fine of at least Five hundred thousand pesos (P500,000.00) but not more than Five million pesos (P5,000,000.00) shall be imposed Provided, further, That an additional fine of one percent (1%) of the economic value/cost of the violative product or violation, or One thousand pesos (P1,000.00), whichever is higher, shall be imposed for each day of continuing violation: Provided, finally, That health products found in violation of the provisions of this Act and other relevant laws, rules and regulations may be seized and held in custody pending proceedings, without hearing or court order, when the director-general has reasonable cause to believe from facts found by him/her or an authorized officer or employee of the FDA that such health products may cause injury or prejudice to the consuming public.

• 'Health products' means food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents and household/urban hazardous substances and/or a combination of and/or a derivative thereof.

• It shall also refer to products that may have an effect on health which require regulations as determined by the FDA.

• Approved: AUG 18 2009 (PRES. GLORIA MACAPAGAL ARROYO)

REFERENCES

1. Generic law (Republic Act no. 6675)2. Law on Counterfeit drug (RA 8203)3. Cheap Medicine law (RA 9502)4. COMPREHENSIVE DANGEROUS DRUGS

ACT OF 2002 (RA 9165)5. FOOD , DRUG AND COSMETIC ACT

(RA3720)