Power Point Ra 9502

Republic Act. No. 9502

Sec 1. Title: “ Universally Accessible Cheaper and Quality Medicines Act of 2008”

definition

An act providing for cheaper and quality medicines.

Amending for the purpose of the following: R.A. 8293- intellectual property

code R.A. 6675- generics act of 1978 R.A. 5921- pharmacy law.

Sec. 2. Declaration of Policy

It is the policy of the state to protect public health and, when the public interest or circumstances of extreme urgency so require, it shall adopt appropriate measures to promote and ensure access to affordable quality drugs and medicine for all.

Establishment of effective competition policy in the

supply and demand of quality affordable drugs and

medicines

Regulation of prices of drugs and medicines

Promote and ensure access to affordable

quality drugs and medicines

for all

Sec. 3

Construction in favor of protecting

public health

SEC 4: Definition of terms: Compulsory liscence- issued by the

director general of the intellectual Property office to exploit a patented invention without permission of the patent holder.

Drugs and medicines- refers to any chemical compound or biological substance, other than food, intended for use in the treatment, prevention, or diagnosis of disease in humans or animals.

Drug Outlet – refers to drug store, pharmacies, and any other business establishments which sells drugs and medicines.

Essential drugs list or national drug formulary. –refers to a list of drugs prepared and periodically updated by the department of health on the basis of health conditions obtaining in the philippines.

Manufacture – includes any process or part of a process of making, altering, finishing, packing, labeling , breaking or otherwise treating or adapting any drug with a view to its sale and distribution, but does not include the compounding or dispensing of any drug in ordinary course of retail bussiness.

Manufacturer- refers to any establishment engaged in the production of a drug with the end view of storage, distribution or sale of the product.

Retailer- refers to any licensed establishment carrying on the retail business of sale of drugs and medicines to costumers.

Trader- refers to any licenced establishment which is a registered owner of a drug product that procures the materials and packaging components, and provides the production monographs, quality control standards, and procedures, but subcontracts the manufacture of such products to a liscenced manufacturer.

TRIPS Agreement- Trade related Aspects of intellectual property rights.

- refers to international agreement administered by WTO that sets down minimum standards for many forms of intellectual property regulation

Chapter 3Drugs and Medicine Price Regulation

President of the Philippines

Secretary of DOH

Drugs and Medicines Price regulation Authority

Drugs and Medicines Price Monitoring and regulation Authority

Chapter 3Drugs and Medicine Price Regulation

Sec 17: Drugs and Medicine Price regulation Authority of the President of the Philippines

Chapter 3Drugs and Medicine Price Regulation

Sec 18: Drugs and Medicine Price Monitoring and Regulation Authority of the secretary of

the Department of HealthEstablish and initiate a system in price monitoring and regulation within 120 daysafter enactment of this act.

May create bodies or council from which advice maybe sought in the implementation of a drug or medicine price monitoring and regulation policy

Sec. 19: Functions Responsibilities of the Secretary of DOH

a. Recommend the maximum retail price of drugs and medicines subject to price regulation.

b. Include other drugs and medicine in the list subject to price regulation.

c. Power to cost containment and other measures

d. Other powers necessary to implement provisions of this chapter.

Sec 23: List of Drugs and Medicines Subject to price regulation

a. All drugs and medicines indicated in the treatment of chronic illnesses and life threatening conditions

b. Drugs and medicines indicated for prevention of diseases

c. Drugs and medicine indicated to prevent pregnancy

d. Anesthetic agentse. Intravenous fluidsf. Drugs and medicines included in the PNDF

Essential Drug listg. Other drugs and medicines which from time

to time is added by the DOH secretary to be in need of price regulation.

Sec. 24: illegal acts of price manipulation

Sec. 25: Penalty for illegal Acts of Price Manipulation

It shall be unlawful for any manufacturer, importer, trader, distributor, wholesaler, retailer, or any person engaged in any method of disposition of drugs and medicines to engage in acts of price manipulation such as hoarding, profiteering, or illegal combination or forming cartel

Any person or entity who commits any act of illegal price manipulation of any drugs and medicines subject to price regulation shall suffer the penalty of imprisonment for a period of not less than 5 years nor more than 15 years or shall be imposed a fine of not less than 100,000 nor more than ten million pesos at the discretion of the court.

The court may also order the suspension or revocation of liscence to operate, proffesional or bussiness liscence.

Chapter 4

Strengthening of the Bureau of Foods and Drugs

Section 31: Strengthening of the Bureau of Food and Drugs

a) For more effective and expeditious implementation of this act, the director of the BFAD shall be authorized to retain all fees, fines, royalties and other charges collected under this act and other laws it is mandated to administer for use in its operation.

b) After 5 years from coming into the force of this act, the director of BFAD determines if the fees and charges are sufficient to meet its budgetary requirement.

c) BFAD shall submit a yearly performance report to the Quality Affordable Medicine Oversight committee itemizing the the use of retained funds .

Sec. 32: Quality Assurance of Drugs

BFAD shall take 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.

Chapter 6: Amendments to Republic Act 6675, otherwise known as the Generics Act of 1988

Sec 37: Amendments of section 5 of R.A. 6675sec5. Posting and Publication – the DOH shall publish annually in at least 2 newspapers of general circulation in the Philippines the generic names and corresponding brand names under which they are marketed, of all drugs and medicines available in the philippines.

Chapter 6: Amendments to Republic Act 6675, otherwise known as the Generics Act of 1988

Sec 38: Amendments of section 6 of R.A. 6675sec6. who shall use Generic Terminology

a) All government health agencies and their personnel.

b) All medical, Dental and veterinary personnel.c) Any organization involved in the manufacture,

importation, repacking, marketing and or distribution of drugs and medicines.

d) Drug outlets, including drugstores, hospitals and non hospital pharmacies, supermarket and store.

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.”

Chapter 6: Amendments to Republic Act 6675, otherwise known as the Generics Act of 1988

Sec 39: Amendments of section 8 of R.A. 6675

sec 8. Required Productionevery 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.

Chapter 6: Amendments to Republic Act 6675, otherwise known as the Generics Act of 1988

Sec 40: Amendments of section 11 of R.A. 6675

sec 11. Educational DriveThe 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

Sec. 12: Penalty

A) Violation of section 6a or 6b

a) All government health agencies and their personnel.

b) All medical, Dental and veterinary personnel.

Frequency of Offence

Monetary Penalty Non Monetary Penalty

First offence Reprimand and record in PRC

second offence P10,000.00 - P25,000.00

Third offence P25,000.00 – P50,000.00

Suspension of professional licence for 60 days

Fourth offenceAnd subsequent conviction

P 100,000 and above

Suspension of professional licence for 1 year or longer

Sec. 12: Penalty

B. Violation of section 6c, 6d, 7 or 8

-fine of Php100,000.00 or higher and suspension or revocation of LTO such drug establishment or drug outlet.

Provided, that its officers directly responsible for the violation:

fine of P40,000.00 and aboveand suspension or revocation of

license to practice profession, imprisonment of 6 months to 1 year or both fine and imprisonment

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.

CHAPTER 7 

AMENDMENTS TO REPUBLIC ACT NO. 5921, AS AMENDED, OTHERWISE KNOWN AS THE PHARMACY LAW

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

Composition:Quality Affordable Medicines Oversight Committee

5 members from the Senate(which includes the Chairperson of the Senate Committees on Trade and Commerce and Health and Demography)

5 members from the House of Representatives, (which includes the Chairperson of the House of Representatives Committees on Trade and Industry and Health)

SEC. 46. Appropriations

Department of HealthP25,000,000.00

Quality Affordable Medicines Oversight Committee P5,000,000.00