ASEAN and Philippines:

Regulatory Challenges and

Opportunities Moving Forward

Maria Kathrina D. Olivarez, RPh. MSc.

Disclaimer: The views expressed in this paper/presentation are the views of the author and do not necessarily reflect the views
or policies of the Asian Development Bank (ADB), or its Board of Governors, or the governments they represent. ADB does not
guarantee the accuracy of the data included in this paper and accepts no responsibility for any consequence of their use.
Terminology used may not necessarily be consistent with ADB official terms.
 Questions to be discussed

1. What are the 3 pilars of ASEAN?

2. How does the region benefit from the AEC?
3. What are Free Trade Agreements, ACCSQ and PPWG?
4. How can the ASEAN overcome the regulatory challenges
in the region?
5. What are the opportunities in ASEAN?
6. What are the 9 indicators and core functions of Phil. FDA?
7. What are FDA strategies and key priorities?
8. Why do we need to invest?
9. How can we do it?
 ASEAN Members

Countries have different

capacity to regulate
medicines.
 AEC Blueprint—Four Pillars and Core Elements
Single Market and • Free flow of goods
Production Base • Free flow of services
• Free flow of investment
• Freer flow of capital
• Free flow of skilled labor ASEAN ASEAN
• Priority integration sectors
Economic Political-
• Food, agriculture, and forestry
Community Security
Competitive • Competition policy
Economic Region • Consumer protection Community
• Intellectual property rights
• Infrastructure development
• Taxation
• E-commerce ASEAN Socio-
Equitable • SME development Cultural
Economic • Initiative for ASEAN Integration Community
Development
Integration into • Coherent approach toward external
Global Economy economic relations
• Enhanced participation in global
supply networks
 ASEAN Free Trade Agreement
lower tariffs at 0-5% range

ASEAN Trade in Goods 2016 “ASEAN Economic

Country Export Import Community (AEC)
Intra- USD USD
ASEAN 276,218,711,506.76 239,794,176,232.46
is VERY RELEVANT
because it is an
Philippines USD USD IMPORTANT part of the
8,400,632,626.00 22,494,822,539.00
Economic Integration.”
 “Regulation
Pharmaceuticals
is part of the Economic
Community in ASEAN.”

Facilitate the Objectives

ASEAN Consultative Committee on
Standards and Quality (ACCSQ)
ACCSQ Pharmaceutical Product
Working Group (PPWG)
of the Free Trade Area (FTA)
Implement the Mutual
Recognition Agreement (MRA)
Create a Transparent Regulatory Process
Standardize Regulation Requirements
Remove the Need for Duplicate Studies
 Insufficient
Regulatory
Knowledge
and Capacity
Fragmented
Budget National
Limitations Regulatory
Requirements

Regulatory
Challenges
Lack of
Regulatory
Resource
Science and
Constrains
Policy
Innovation
Registration
of Health
Products and
Information
Technology
Opportunities in the ASEAN Region
“Professionals will be given an opportunity to practice in neighboring countries “Scale-up business
through harmonization of standards, qualifications and certification system.” operations and increase
economic revenue.”
“Reduces opportunities for
corruption by limiting direct
interactions with clients
through customs electronic
modernization.”

“Availability of job opportunities for

the workers with better and fair wages
and opportunity to learn new skills.”
“Institutional reforms will
benefit the SMEs, the so-called
backbone of developing economies to
capture the needs of rapidly expanding
middle class families.”
 FDA Philippines

Mission: To guarantee the safety, quality, purity,

efficacy, of products in order to
protect and promote the right to health of
the general public.

Vision: The Food and Drug

Administration to be an INTERNATIONALLY
RECOGNIZED
CENTER OF EXCELLENCE in health
Product regulation by 2026.
 FDA Philippines’s roles
FDA is responsible for protecting the public health
by ensuring the safety, efficacy, and security of human and
veterinary drugs, biological products, and medical devices;
and by ensuring the safety of our nation's food supply,
cosmetics, and products that emit radiation.

FDA is also responsible for advancing the public

health by helping to speed innovations that make
medical products more effective, safer, and affordable
and by helping the public get the accurate, science
based information they need to use medical products
and foods to maintain and improve their health.
 FDA Philippines – 9 Functions

• 01 - NATIONAL REGULATORY SYSTEM

• 02 - REGISTRATION AND MARKETING AUTHORIZATION
• 03 - PHARMACOVIGILANCE
• 04 - MARKET SURVEILLANCE AND CONTROL
• 05 - LICENSING PREMISES
• 06 - REGULATORY INSPECTION AND ENFORCEMENT
• 07 - LABORATORY ACCESS AND TESTING
• 08 - CLINICAL TRIAL
• 09 - LOT RELEASE
STAKEHOLDER PROFILE 03 CLASSIFIED BASED ON LOCATION:
45,874 total establishments as of 25 Nov. 2016

CLASSIFIED PER CENTER

19%
North Luzon
01 CDRR CFRR CCRR CDRRHR
19%
CENTER FOR DRUG
REGULATION AND
RESEARCH
CENTER FOR FOOD
REGULATION AND
RESEARCH
CENTER FOR COSMETIC
REGULATION AND
RESEARCH
CENTER FOR DEVICE
REGULATION
RADIATION HEALTH AND
South Luzon 33%
RESEARCH NCR

75% 16% 5% 4% 14%

Visayas

CLASSIFIED BASED ON SUPPLY CHAIN

02 5% 10%
West Mindanao East
MANUFACTURER Mindanao
RETAILER DISTRIBUTOR
(Trader) (Processor)

12% 64% 24%

 FDA Philippines
STRATEGY ROADMAP
Sustained Stakeholder/Taxpayer Value
Revenue
Growth Productivity Strategy Revenue Growth Strategy
Improve Cost Increase Asset Enhance Expand Revenue
Structure Utilisation Customer Value Opportunities

Customer Value
Productivity
Proposition
Improvement
Price Quality Availability Selection Function Service Partnership Brand
Production Service Attributes Relationship Image

Operational Operations Management Customer Management Regulatory and Social

Innovative Processes
Excellence Processes Processes Processes
Processes that improve
Processes that produce and Processes that enhance Processes that create new
communities and the
deliver services customer value services
environment

Customer Human Capital Information Capital Organizational Capital

Intimacy
Skills
Training + Systems
Databases + Skills / Training
Knowledge
Knowledge Networks Teamwork
 FDA Philippines- Key Priorities

MIS and Organizational Strengthen Facility Upgrade Smart Strengthen

Operational Reform & Enforcement & Improvement Regulation Public
System Development (including Information &
Laboratory) Service
 ADB Support for National Regulatory Authorities

ADB can Provide

National Regulatory Technical
Assistance
Authorities have
important public In Myanmar, ADB
supported ADB can develop
health roles: information system Investment Case
Protecting people in the NRA on Regulatory
from low standard In the Philippines, System
and counterfeit ADB supported Strengthening
medicine policies
In GMS, ADB
Ensuring efficacy supported capacity
development
R • Brief Introduction of ASEAN – https://www.youtube.com/watch?v=WAnfj8v5acM
• Introduction to ASEAN AEC – http://asean.org/asean-economic-community/
•
E •
Regulatory Rapporteur – Vol 13, No 3, March 2016 and – www.topra.org
Regulatory Rapporteur – Vol 14, No 7/8, July/August 2017 – www.topra.org
• Meeting Report: 4th Pharmaceutical Product Working Group (PPWG) Meeting 27-28 July 2017, Bangkok, Thailand
•
F Moving Across Borders: The Philippines and the ASEAN Economic Community – 2016 Investment Guide by R.G. Manabat
& Co. (KPMG in the Philippines)
• Medicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia
•
E •
ADB Operational Plan for Health 2015-2020
ADBI Working Paper Series: The ASEAN Economic Community: Progress, Challenges, and Prospects (No. 440) by Siow
Yue Chia, October 2013
•
R •
ADB and National Medicines Regulatory Strengthening by Dr. Douglas Ball and Dr. Susann Roth, November 2015
ASEAN Economic Community Blueprint 2025, Jakarta: ASEAN Secretariat, November 2015
• Pharmaceutical Regulation in the Philippines and the Impact of ASEAN Harmonization by Wenzel C. Asprec, FDA
•
E •
Celebrating ASEAN: 50 Years of Evolution and Progress, Jakarta, ASEAN Secretariat, July 2017
Drug Approval System of the Philippines, April 2016, APEC Harmonization Center
• A Health Impact Assessment Framework for Special Economic Zones in the Greater Mekong Subregion, May 2018, ADB
•
N •
Issues and Challenges on ASEAN 2015 by Pattama
Global Health Initiative Investments and Health Systems Strengthening: A Content Analysis of Global Fund Investments
by Ashley E Warren, Kaspar Wyss, George Shakarishvili, Rifat Atun and Don de Savigny, 2013
•
C Strengthening Health Products Regulatory Systems to Enhance Access to Quality Health Products in the Asia-Pacific by
John C. W. Lim
• Philippine Health Agenda 2016-2022
•
E •
Philippines Health System Review Vol. 1 No. 2 2011
FDA Business Plan 2013
• Philippine FDA 5-Year Development Plan

S
Salamat DANKE
terima kasih

Khob khun ka

Cam On Rat Nhieu