PERSPECTIVES IN PHARMACY - Laws Affecting the Pharmacy Practice

Legal Environment

• Highly regulated

• Issues with counterfeit drugs

• Wrong dispensing practices

• Dispensing without prescription

• Government Mediated Access Price (GMAP)

• Maximum Drug Retail Price (MDRP)

The Pharmacy Law

Title of the law RA 5921

RA 5921 (The Pharmacy Law)

• Standardization and regulation of pharmaceutical education

• Licensure examination

• Supervision, control, and regulation of the practice of pharmacy

• —

• Recognizes the vital role of pharmacists in healthcare

• Promotes safe, effective, and quality pharmaceutical products

• Ensures pharmacists’ services are integral to healthcare

June 23, 1969

When was RA 5921 (The Pharmacy Law) signed into law?

Ferdinand E. Marcos

Who signed RA 5921 (The Pharmacy Law) into law?

• Council of Pharmaceutical Education

• Board of Pharmacy (BOP)

Agencies responsible for the enforcement of RA 5921 (The Pharmacy Law)?

Philippine Pharmacy Act

Title of the law RA 10918

RA 10918 (The Philippine Pharmacy Act)

• Standardization and regulation of pharmacy education

• Administration of licensure examination

• Supervision and regulation of pharmacy practice

• Development of professional competence through CPD

• Integration of the pharmacy profession

By widening the role of pharmacies and pharmacists in healthcare delivery.

How does RA 10918 (The Philippine Pharmacy Act) strengthen the practice of pharmacy?

July 21, 2016

When did RA 10918 (The Philippine Pharmacy Act) lapse into law?

Benigno S. Aquino III (without the signature)

Who signed RA 10918 (The Philippine Pharmacy Act) into law?

Professional Regulatory Board of Pharmacy (PRBP)

Which agency enforces RA 10918 (The Philippine Pharmacy Act)?

PRC Modernization Act of 2000

Title of the law RA 8981

RA 8981 (PRC Modernization Act of 2000)

Basis for the creation of the Professional Regulatory Board of Pharmacy (PRBP)

December 5, 2000

When was RA 8981 (PRC Modernization Act of 2000) signed into law?

Joseph Ejercito Estrada

Who signed RA 8981 (PRC Modernization Act of 2000) into law?

Professional Regulation Commission (PRC)

Which agency reinforces RA 8981 (PRC Modernization Act of 2000)?

CPD Law of 2016

Title of the law RA 10912

RA 10912 (CPD Law of 2016)

• Creation of CPD Council

• Promote and upgrade professional practice

• Improve competence according to international standards

• Uplift general welfare and economic growth

July 21, 2016

When did RA 10912 (CPD Law of 2016) lapse into law?

Benigno S. Aquino III (without the signature)

Who signed RA 10912 (CPD Law of 2016) into law?

Food, Drug, and Cosmetic Act (FDA Act)

Title of the law RA 3720

June 22, 1963

When was RA 3720 (Food, Drug, and Cosmetic Act - FDA Act) signed into law?

RA 3720 (Food, Drug, and Cosmetics Act ; FDA Act)

• Protect and promote health rights of Filipinos

• Establish effective health products

Bureau of Food and Drugs

Which agency enforces RA 3720 (Food, Drug, and Cosmetics Act ; FDA Act)?

Food and Drug Administration Act of 2009

Title of the law RA 9711

RA 9711 (Food and Drug Administration Act of 2009)

• Expand and strengthen the regulatory capacity of the BFAD

• Establish adequate testing laboratories and field offices

• Upgrade equipment and human resources

August 18, 2009

When was RA 9711 (Food and Drug Administration Act of 2009) signed into law?

Gloria Macapagal-Arroyo

Who signed RA 9711 (Food and Drug Administration Act of 2009) into law?

Food and Drug Adimistration (FDA)

Which agency enforces RA 9711 (Food and Drug Administration Act of 2009)?

Act for Salt Iodization Nationwide (ASIN)

Title of the law RA 8172

RA 8172 (Act for Salt Iodization Nationwide - ASIN)

• Promote salt iodization nationwide

• Define food fortification and iodine deficiency disorder

• —

• Protect and promote health

• Maintain an effective food regulatory system

• Provide proper nutrition, especially for women and children

December 20, 1995

When was RA 8172 (Act for Salt Iodization Nationwide - ASIN) approved?

Fidel V. Ramos

Who approved RA 8172 (Act for Salt Iodization Nationwide - ASIN)?

Role of the National Nutrition Council (NNC) in RA 8172

Advisory board on salt iodization

Responsibilities of the Department of Health (DOH) in RA 8172

Undertakes the salt iodization program

Responsibilities of the Bureau of Food and Drugs (BFAD) in RA 8172

• Set and enforce standards for food-grade iodized salt

• Monitor compliance by manufacturers

Responsibilities of Local Government Units (LGUs) in RA 8172

• Check and monitor quality of food-grade salt

• Ensure proper iodization through health officers

Responsibilities of the Department of Trade and Industry (DTI) in RA 8172

Regulate and monitor trading of iodized salt

Responsibilities of the Department of Science and Technology (DOST) in RA 8172

Initiate and promote technology for salt iodization

Intellectual Property Code of the Philippines

Title of the law RA 8293

RA 8293 (Intellectual Property Code of the Philippines)

• Promote diffusion of knowledge for national development

• Streamline registration of patents, trademarks, and copyrights

• Enhance enforcement of intellectual property rights

June 6, 1997

When was RA 8293 (Intellectual Property Code of the Philippines) approved?

January 1, 1998

When did RA 8293 (Intellectual Property Code of the Philippines) took effect?

Intellectual Property Office (IPO)

Which agency is responsible for the enforcement of the RA 8293 (Intellectual Property Code of the Philippines)?

• Creation of the Intellectual Property Office (IPO)

• Law on Patents

• Law on Trademarks, Service Marks, and Trade Names

• Law on Copyright

What are the main components of the Intellectual Property Code of the Philippines?

Tobacco Regulation Act of 2003

Title of RA 9211

Secretary of the Department of Trade and Industry (DTI)

The chairman of the Inter-Agency Committee-Tobacco (IAC-Tobacco)

June 23, 2003

When was RA 9211 (Tobacco Regulation Act of 2003) approved?

Sen Juan Flavier

Authored the Traditional and Alternative Medicine Act (TAMA) of 1997

Traditional and Alternative Medicine Act (TAMA) of 1997

• It made herbal plants a priority in Philippine Traditional Medicine

• Encourage scientific research on traditional and alternative health care

• Promote safe and effective traditional health care modalities

• Develop skills training courses for traditional health care

• Formulate standards and guidelines for ethical practice

• Protect indigenous health resources from exploitation

• Lagundi

• Ulasimang Bato

• Bayabas

• Bawang

• Yerba Buena

• Sambong

• Ampalaya

• Niyug-niyogan

• Tsaang-gubat

• Akapulko

What are the 10 priority plants listed in the Traditional and Alternative Medicine Act (TAMA) of 1997?

Generics Act of 1988

Title of RA 6675

RA 6675 (Generics Act of 1988)

This RA’s purpose is to promote the production and acceptance of drugs identified by their generic names.

September 13, 1988

When was the RA 6675 (Generics Act of 1988) approved?

Expanded Senior Citizens Act of 2003

RA 9994

RA 9994 (Expanded Senior Citizens Act of 2003)

• Grants additional benefits and privileges to senior citizens

• Amends RA 7432

• Changes tax credit to deduction to gross profit

• Enforcement by Office for Senior Citizens Affair (OSCA)

• —

• Maximize contributions of senior citizens

• Assist and appreciate senior citizens in the community

• Establish beneficial programs for senior citizens and their families

• Create community-based health and rehabilitation programs

February 26, 2004

When was RA 9994 (Expanded Senior Citizens Act of 2003) approved?

Universally Accessible Cheaper and Quality Medicines Act of 2008

RA 9502

RA 9502 (Universally Accessible Cheaper and Quality Medicines Act of 2008)

• Cheaper and quality medicines

• Price control of several drugs

• Impose maximum retail prices on drugs

• Empower government to control prices of essential medicines

June 6, 2008

When was RA 9502 (Universally Accessible Cheaper and Quality Medicines Act of 2008) approved?

Gloria Macapagal-Arroyo

Who approved RA 9502 (Universally Accessible Cheaper and Quality Medicines Act of 2008)?

Consumer Act of the Philippines

RA 7394

RA 7394 (Consumer Act of the Philippines)

Protection against hazards, deceptive practices, and provision of consumer rights

April 13, 1992

When was the RA 7394 (Consumer Act of the Philippines) approved?

Corazon C. Aquino

Who signed RA 7394 (Consumer Act of the Philippines) into law?

Price Act

RA 7581

RA 7581 (Price Act)

Promote productivity, stabilize prices, and protect consumers

Corazon C. Aquino

Who signed RA 7581 (Price Act) into law?

RA 8203

What is the Republic Act number for the Special Law on Counterfeit Drugs?

September 4, 1996

When was RA 8203 (Special Law on Counterfeit Drugs) approved?

Counterfeit Drug

A drug that is mislabeled or contains incorrect ingredients

Comprehensive Dangerous Drugs Act of 2002

RA 9165

RA 9165 (Comprehensive Dangerous Drugs Act of 2002)

Its goal is to combat trafficking and use of dangerous drugs

Anti-Age Discrimination in Employment Act

RA 10911

July 21, 2016

When did RA 10911 (Anti-Age Discrimination in Employment Act) lapse into law?

No Shortchanging Act

RA 10909

July 21, 2016

When did RA 10909 (No Shortchanging Act) lapse into law?