GGM PROGRAMME IN MALAYSIA
Bi Regional Consultation on Good Governance9th November 2015
Pharmaceutical Services DivisionMinistry of Health Malaysia
Jalan Universiti
46730 Petaling Jaya
MALAYSIA
Tel : 603-79682200 Fax : 603-79682222
Website : www.pharmacy.gov.my
Pharmaceutical Services
Ministry of Health Malaysia
WHO Collaborating Centre
For Regulatory Control of
Pharmaceuticals
Member of Pharmaceutical
Inspection Cooperation 1
MS ISO 9001:2000 Certified
Introduction to GGM
GGM Program in Malaysia
Future Plans
Malaysian National Medicines Policy
HEALTH FACTS 2015
Population (2014) 30.1 Million
Total Drug Expenditure (USD)
(2014-Public only)1
(2014-Public and Private) 20.68 Billion
1.84 Billion
GNP per capita (USD) (2014)
Value of drug budget spent per capita (USD)
(2014-Public and Private)
(2014-Public budget only) 3 20.6
Total number of registered drugs (2014) 4 20,599
Number of drugs in NEML (2014) 5 320
Number of drugs in MOH Formulary (2014)5 1,660
Number of Registered Pharmacists (2014) 6
Ratio of registered pharmacist to population (2014) 6
12,294
1:2,424
HEALTHCARE FACILITIES
Ministry of Health
Hospitals1
Special Institutions1
Primary Health Clinics1
132
9
3,784
Mobile Health Teams2 212
Mobile Clinics2
Helicopter
Bus
Boat
8
5
3
Flying Doctors Services2 13
Private Health Care Facilities
General Practitioners GPs3
Community Pharmacists CPs4
6,611
3,569
ORGANISATIONAL CHARTMINISTRY OF HEALTH MALAYSIA
5INSTITUTE/STATE MEDICAL HEALTH DIRECTOR
6
VISI & MISI
7
Vision, Mission & Objective
VisionLeading in quality medicine management through a competent workforce and appropriate science and technology, in partnership with stakeholders
Mission
Ensuring quality medicines for the nation
Objective
Ensuring all pharmaceutical and health products in the market are of quality, safe, efficacious, regulated according to relevant legislations and used rationally
8
Poison Act 1952 (Revised 1989) & Its regulations
Dangerous Drugs Act 1952 (Revised 1980) & its regulations
Sale of Drugs Act 1952 (Revised 1989) & its regulations
Registration of Pharmacists Act 1951 (Revised 1989) and its regulations
Medicines (Advertisement and sale) Act 1956 (Revised 1983) and its regulations
Control of Drugs and Cosmetics Regulations 1984
Acts & Regulations
9
OBJECTIVES
GGM program introduced in 2004
Strengthen health system by promoting
good governance in
pharmaceutical sector
Preventcorruption by
identifying areas of
vulnerability
Increase transparency
and accountability in all processes
related to pharmaceutical
sector
Promote individual and institutional
integrity
10
AREAS OF VULNERABILITY -regulatory and supply management functions
Medicines Registration
Licencing:
Manufacturers, Importers
Inspections
Medicines Promotion
Medicines Selection
Procurement
Control of Clinical Trials
Distribution
11
PHASE 1
National Transparency Assessment
PHASE II
Development of National GGM Programme
PHASE III
Implementation of National GGM Programme
12
Launch and Promotion of GGM Program by WHO
(2004)
National Assessment of ethical practices
Publication of National Transparency Assessment
report by WHO (2006)
Aim of study : • To assess level of transparency and potential vulnerability to corruption of the critical pharmaceutical sector functions.
• To provide a baseline to revise and adjust the laws and policies and to enable the monitoring of progress over time.
•To serve as a platform for developing a national GGM Framework.
Country assessment report in 2006
Laos Malaysia Philippines Thailand
Registration 5.6 6.8 6.8 7.0
Moderate Marginal Marginal Marginal
Selection 6.1 5.8 6.1 8.0
Marginal Moderate Marginal Marginal
Procurement 6.9 7.1 8.5 7.1
Marginal Marginal Minimal Marginal
0.0 ‐2.0 2.1 ‐4.1 4.1‐6.0 6.1‐8.0 8.1 – 10.0
Extremely vulnerable
Very vulnerable
Moderately vulnerable
Marginally vulnerable
Minimally vulnerable
PHASE 1
National Transparency Assessment
PHASE II
Development of National GGM Programme
PHASE III
Implementation of National GGM Programme
14
1st National GGM workshop
(Dec 2005)
1st draft of national GGM framework
Formation of GGM Committees :
GGM Steering Comm.(Sept 2006)
GGM Technical Comm. (Jan 2007)
Development of Ethical framework for Good Governance in Malaysia
(Nov 2009)
Guideline for MOH Members Dealing
with Representatives of Suppliers and
Pharmaceutical Company Guidelines for Giving and Receiving
Gifts For Pharmaceutical Members of
MOH15
PHASE 1
National Transparency Assessment
PHASE II
Development of National GGM Programme
PHASE III
Implementation of National GGM Programme
16
Publication of GGM Guidelines (2011-2012)
Development and Implementation of GGM Training
Module (2012-2013)
National Transparency Assessment study on the Public
Pharmaceutical Sector
Inclusion of GGM in the National Medicines Policy
(DUNas)
GGM TOT MODULE
1. The GGM Training of Trainers (TOT) Module
1. Facilitator’s Handbook.
2. Module
Duration Activity
30mins Lecture 1 : Introduction to GGM Malaysia
60mins Lecture 2 : Integrity in the Pharmaceutical sector
120mins Lecture 3 : GGM Guidelines in Malaysia
90mins Lecture 4 : GGM in Regulatory Pharmacy
90mins Lecture 5 : GGM in Enforcement Pharmacy
90mins Lecture 6 : GGM in Pharmacy Practice
GGM TOT Workshop
Objectivesi. To introduce the GGM concept into the
pharmaceutical system.
ii. To highlight the areas within the pharmaceutical system that are vulnerable to corruption.
iii. To propose counter-measures and the way forward to increase transparency and accountability continuously
iv. To equip pharmacists with techniques and skills to build a culture of good governance.
GGM TOT Workshop
Zone 1 :
6 MT
21 State Trainers
Zone 2 :
5 MT
State Trainers - 14
Zone 3 :
6 MT
22 Pharmacists
Zone 4 :
6 MT
39 State Trainers
Zone 5 :
6 MT
33 State Trainers
State Trainers : Upper and
middle management level
Pharmacists
A Total of 129 Pharmacists
were trained as State Trainers
14 Master Trainers (MT) trained
State Trainers across 5 Zones
in Malaysia on a rotation basis.
• Engage with other ministries to collaborate further on GGM initiatives –• Ministry of Finance
• Ministry of Education
• Malaysian Anti-Corruption Commission
• Institute of Integrity Malaysia
• Transparency International Malaysia, etc.
• Widen the GGM initiatives via the National Medicines Policy-• Private pharmaceutical industry
• Other stakeholders20
• To review the National GGM Framework
• To develop other relevant GGM Guidelines
• To conduct the National Transparency Assessment study on the public and private Pharmaceutical Sector
21
Malaysian
National Medicines Policy
(MNMP) &
Recent Developments
Pharmaceutical Services Division
Ministry of Health Malaysia
• A clear and official government statement that defines and prioritizes the medium-to long term-goals set by the government for the pharmaceutical sector
• A formal record of aspirations, aims, decisions and commitments of the government and all stakeholders in both public and private sectors to a common goal for the pharmaceutical sector
• Identifies strategies and provides a transparent framework for the coordinated implementation of these strategies by stakeholders in the public and private sectors
• Existing legislation can provide the executive power and legal framework to implement the NMP
• Presence of organizations in MOH to oversee, monitor and administer the legislation
• 40% initial existence of structural elements crucial for successful implementation of NMP
23
Introduction to MNMP
No single policy related to medicines
Stakeholders with different objectives
A single policy is deemed necessary to prioritize the goals set by the government
MNMP was approved by the Cabinet of Malaysia on 11th October 2006
24
Steps to MNMP
• Pharmaceutical Association of Malaysia
• Malaysian Organization of Pharmaceutical Industries
• Federation of Malaysian Consumers Associations
• Malaysian Association of Traditional Indian Medicine
• Ministry of Health
• Ministry of Defense
• Ministry of Science, Technology and Innovation
• Economic Planning Unit
• Public universities
• Malaysian Pharmaceutical Society
• Malaysian Medical Association Professional
Government agencies
IndustriesOthers
25
Stakeholders
26
To improve health outcomes of Malaysians through:
Promoting equitable access to essential medicines
Ensuring availability of safe, effective and affordable medicines of good quality
Promoting quality use of medicines by healthcare providers and consumers
Objectives of MNMP
2000
Initiation of MNMP formulation
2001-2003
-Workshop with stakeholders
-Consultation and funding by WHO 2006
1st Term MNMP (2007 –2011)
2012
Full-term review of
MNMP
27
Development of MNMP
2013
2nd Term MNMP
(2013 – 2017)
2014
Master Plan of Action for 2nd
Term
28
2nd term (2013-2017) after five years of implementation (2007-2011)
The core supporting components of the 1st
term policy have been reorganized
New components introduced into revised policy
Recent development
29
Quality, Safety and Efficacy of Drugs
Drug Availability
Drug Affordability
Quality use of Drugs
Human Resources Development
Research & Development
Management
Quality, Safety and Efficacy of Medicines
Access to Medicines
Quality Use of Medicines
Partnership and Collaboration for the Healthcare Industry
Governance in Medicines
Sup
po
rtin
g C
om
po
nen
tsM
ain
Co
mp
on
en
ts
MNMP 2006
Components of MNMP
Technical Cooperation
MNMP 2012
Malaysian National Medicines Policy
First edition (1st term) Revised 2012 (2nd term)
30
Master Plan of Action
31
Policy Statement
Aim
Strategy
Activity
• Implementation timeline
• Indicators• Targets
http://www.pharmacy.gov.my/v2/en/documents/
master-plan-action-malaysia-national-
medicines-policy-2nd-edition.html
Aim To ensure adequate, continuous and equitable access to quality, safe, effective and affordable medicines towards achieving optimal health outcomes
32
Policy 3: Access To Medicines
An efficient and integrated medicines management and supply network shall be maintained. The pharmaceutical
industry shall be organised and regulated to create incentives and foster competition in medicine prices. Appropriate
financing mechanisms shall be developed to ensure essential medicines needed for quality healthcare are affordable
Strategies
1. Availability of Medicines
1.1 Selection of Medicines
1.2 Supply of Medicines
2. Affordability of Medicines
2.1 National Pricing Reference for Medicines
2.2 Financing for Medicines
2.3 Generic Medicines Policy
33
Policy 3: Access To Medicines
34
1. Availability of Medicines
SUPPLY
SELECTION
• National Medicines Formulary (NMF)
• National Essential Medicines List (NEML)
• Drug and Therapeutic Committee
• Traditional and Complementary Medicines Formulary
• Live-saving Medicines and Orphan Medicines
• National PharmacoeconomicImplementation Road Map
• Halal Medicines
• Procurement
• Distribution and storage of medicines
• Disposal of medicines
• Medicines supply in emergency situations and medicines donations
35
• Guide for prescribing and providing healthcare professional with practical and authoritative information on the selection and clinical use of medicines
National Medicines Formulary
• National reference for domestic medicines industry as well as to the healthcare academia in their teaching curriculum
National Essential
Medicines List
• Responsible in the selection of medicines, ensuring availability and affordability for use by their healthcare providers
• Develop and coordinate in-house policies related to medicines by referring to and adopting the National Medicines Formulary and standard clinical practice
Drug and Therapeutic Committees
1. Availability of MedicinesSelection of Medicines
36
1. Availability of MedicinesNational Medicines Formulary
No. Activities Indicator Target / Timeline
1.
Form National Medicines
Formulary (NMF) revision
committee (temporary
committee)
Committee
formed
Committee
formed by 2015
2.Development of guideline for
inclusion of medicines into
the NMF
Guideline
developed
Guideline
developed by
2016
3. Establish NMF 1st draft NMF draftedNMF draft ready
by 2017
37
1. Availability of MedicinesNational Essential Medicines List
No. Activities Indicator Target / Timeline
1.Periodic multisectoral
discussions to revise and
update NEML every 2-3 years
Number of
revisions done
2 times
(2014 and 2017)
2.Publication of 4th edition of
NEML
NEML 4th edition
published
NEML ready to be
used by 2014
3.Conduct NEML awareness to
stakeholders
Number of
sessions
organized
50 sessions
(follow DUNas
target)
38
• Developed by an expert advisory committee
• Guide for the use of registered traditional and complementary medicines by healthcare providers.
TCM Formulary
• Appropriate procedures to enhance accessibility of life saving products and orphan medicines without compromising safety, quality and efficacy
Life-saving Medicine and
Orphan Medicines
• Strategic partnerships with the relevant authorities to make certified halal medicines available in Malaysia.
HalalMedicines
1. Availability of Medicines1.1 Selection of Medicines
39
No. Activities Indicator Target / Timeline
1.Establish a framework and
process of TCM Formulary
Framework
established
Framework ready
by 2017
1. Availability of MedicinesTCM Formulary
40
1. Availability of MedicinesHalal Medicines
No. Activities Indicator Target / Timeline
1.To review the Drug Registration
Guidance Document (Use of
Halal Logo)
Revision of Drug
Registration
Guidance
Document
Document revised
by 2014
2.
Awareness on MS2424: 2012
Halal Pharmaceutical-General
Guideline and MS1900:QMS
from Islamic Perspective to the
industry stakeholders
Number /
percentage of
pharmaceutical
manufacturer
exposed to
MS2424: 2012 and
MS1900
100%
3.To create a list of Halal certified
medicines with regular updates
List of Halal
certified
medicines made
available
List of halal
certified
medicines made
available by 2015
41
• An efficient, effective and transparent procurement system shall be strengthened to ensure adequate and timely availability of medicines.
Procurement
• Distribution network strengthened to ensure timely distribution of quality medicines to end users.
• Storage, inventory control and QA throughout the supply chain network shall comply with GDP requirements
• The ICT network for logistics, inventory and financial transactions shall be established and integrated in all healthcare facilities.
Distribution and Storage of Medicines
• Shall be done in accordance with existing regulations and guidelines
Disposal of Medicines
• All organizations shall collaborate and be coordinated to manage national emergency situations
• Ensure timely supplies of these medicines without compromising safety, quality and efficacy.
Medicines Supply in Emergency
Situations and Medicines Donations
1. Availability of Medicines1.2 Supply of Medicines
42
Affordability of Medicines
National Pricing Reference for
Medicines
Financing for
Medicines
Generic Medicines
Policy
• Reliable, affordable & sustainable mechanism
• Cost-containment measures
• Ensure poor & under-privileged are not deprived of access to essential medicines
• Foster healthy competition in medicines pricing
• Guide the use and procurement of medicines
• Transparency on price information
• Monitoring of price information
• Tariffs &duties
43
2. Affordability of MedicinesMonitoring for Price Information
No. Activities IndicatorTarget / Timeline
1.
To compare medicine
wholesale price at local
market with International
Reference Price MSH/WHO
Annual Price
Analysis &
Comparison
report
Once per year
2.To collaborate with WHO in
the creation of an ASEAN
price database
ASEAN price
database
developed
2015
44
• Prescribing in generic International Non-proprietary Name (INN)
• Procurement of all medicines by generic INN shall be promoted
• In selection for procurement, priority shall be given to domestically manufactured medicines
• All dispensed medicines shall be labelled prominently with the generic INN name of the medicine with or without the brand name
• A list of interchangeable and non-interchangeable medicines shall be made available
• Generic substitution shall be permitted and legislated for all interchangeable medicines
• Appropriate incentives to promote the use of generic medicines and their production in the country shall be introduced
2. Affordability of Medicines2.3 Generic Medicines Policy
45
2. Affordability of Medicines2.3 Generic Medicines Policy
No. Activities IndicatorTarget / Timeline
1.Survey on writing prescription in
generic
(for government setting)
Survey completed Yes
2.
Generic Medicine Awareness
Program (GMAP) nationwide
i) Healthcare providers
ii) Consumers
No. of seminars organised
Number of CME conducted
1 seminar each
state
3.
Carry out a study on generic
labelling practice among GPs,
retail pharmacy, hospitals and
community clinics
Survey findings are
available by timelineYes
4.
Generic substitution except for
non-interchangeable medicine to
be enforced in new pharmacy
law
Provision in law to allow
for generic substitutionYes
Steering CommitteeAdvise Health Minister, authorize plans, decide the direction
Implementation CommitteeMonitor and review the development of the implementation
Technical CommitteesPlan, identify and monitor the implementation done by the working committee
Component 1Governance
inMedicines
Component 2Quality,
Safety & Efficacy of Medicines
Component 3Access
ofMedicines
Component 4Quality Use
ofMedicines
Component 5Partnership &
Collaboration for theHealthcare Industry
Management of MNMP
46
Working CommitteesImplement plan of action
47
Data collection
● *WHO recommended indicators
● Indicators from the Master Plan of Action
● Implementation status reports
Management of MNMPHow to monitor?
*Source:
http://apps.who.int/medicinedocs/pdf/whozip14e/whozip14e.pdf
48
Background Indicators
• 24 indicators
Structural Indicators
• 48 indicators
Process Indicators
• 26 indicators
Outcome Indicators
• 7 indicators
Monitoring of WHO Indicators
• Quantitative data
• Data on the demographic, economic, health and pharmaceutical contexts
• E.g.
– Total population
– Life expectancy, infant mortality rate
– Total number of prescribers, pharmacists
– Total drug expenditure
49
Background Indicators
Source: Department of Statistics and Ministry of Health, 2014
• Qualitative information to assess the pharmaceutical system’s capacity to achieve its policy objectives
• Check key structure/ systems/ mechanisms to implement the policy exist in the country
• E.g.
– Is there an official drug policy document updated in the past 10 years?
– Are drugs usually procured in the public sector through competitive tender?
– Are drug prices regulated in the private sector?
50
Structural Indicators
• Quantitative information on the processes by which a national drug policy is implemented
• Assess the degree to which activities necessary to attain the objectives are carried out and progress over time
• E.g.
– Number of drug outlets in violation out of those inspected
– Average time between order and delivery from central stores to remote facilities
– Amount spent on public education campaigns on drug use
51
Process Indicators
• Measure the results achieved and the changes that can be attributed to the implementation of the MNMP
• Assess the effects of implementing MNMP on QSE, availability, affordability, QUM
• E.g.
– Number of drugs/ batches that failed quality control testing
52
Outcome Indicators
Policy 2: Access to Medicines
53Source: Pharmaceutical Services Division
WHO Outcome
Indicator
2012 2013 2014
Value % Value % Value %
OT 1
Number of drugs
from a basket of
drugs available in
a sample of
remote health
facilities, out of
total number of
drugs in the same
basket (%)
195/
200
97.
5
195/
20097.5 198/2
00
99
54
Requires national acceptance, recognition and commitment by all stakeholders including the highest political level in
order to achieve the goals of the
pharmaceutical sector in Malaysia
Successful Implementation of MNMP
THANK YOU
55
Pharmaceutical Services Division
Ministry of Health Malaysia
56
PHARMACYPlanning for Change
Improving Equitable AccessAvailable to the poor
Keeping Costs Affordable
To patient and to the health system
Encouraging Appropriate Use
Necessary, safe, effective, properly taken,
avoid wastage
57
Objectives of Pharmaceutical Policy
Good medicines available and accessible in a system that uses resources efficiently
RegulationEnforcement
Selection
FinancingManufacturingProcurementDistribution
FinancingPricing
Payment system
Rational useEducation
58
Policy Focus
WAY FORWARD
• Establishment of formulary, reimbursable list, benefits package acceptable to practitioners, patients, financing body
• Setting up price monitoring system
• Forecasting realistic drug budgets
• Determining quantum of co-payment for prescriptions (if to be implemented)
• ICT development
• Engaging all stakeholders during planning process
59