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