Bi Regional Consultation on Good Governance

Transcription

1 Pharmaceutical Services Ministry of Health Malaysia GGM PROGRAMME IN MALAYSIA WHO Collaborating Centre For Regulatory Control of Pharmaceuticals Bi Regional Consultation on Good Governance 9 th November 2015 Member of Pharmaceutical Inspection Cooperation 1 Pharmaceutical Services Division Ministry of Health Malaysia Jalan Universiti Petaling Jaya MALAYSIA Tel : Fax : Website : MS ISO 9001:2000 Certified

2 Introduction to GGM GGM Program in Malaysia Future Plans Malaysian National Medicines Policy

3 Population (2014) Total Drug Expenditure (USD) (2014-Public only) 1 (2014-Public and Private) 2 HEALTH FACTS Million 0.68 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) Total number of registered drugs (2014) 4 20,599 Number of drugs in NEML (2014) 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

4 HEALTHCARE FACILITIES Ministry of Health Hospitals 1 Special Institutions 1 Primary Health Clinics ,784 Mobile Health Teams Mobile Clinics 2 Helicopter Bus Boat Flying Doctors Services 2 13 Private Health Care Facilities General Practitioners GPs 3 Community Pharmacists CPs 4 6,611 3,569

5 ORGANISATIONAL CHART MINISTRY OF HEALTH MALAYSIA INSTITUTE/STATE MEDICAL HEALTH DIRECTOR 5

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7 Vision, Mission VISI & MISI & Objective Vision Leading 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 7

8 Acts & Regulations 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

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10 OBJECTIVES GGM program introduced in 2004 Strengthen health system by promoting good governance in pharmaceutical sector Prevent corruption by identifying areas of vulnerability Increase transparency and accountability in all processes related to pharmaceutical sector Promote individual and institutional integrity 10

11 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

12 PHASE 1 National Transparency Assessment Launch and Promotion of GGM Program by WHO (2004) National Assessment of ethical practices Publication of National Transparency Assessment report by WHO (2006) PHASE II Development of National GGM Programme PHASE III Implementation of National GGM Programme 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. 12

13 Country assessment report in 2006 Laos Malaysia Philippines Thailand Registration Moderate Marginal Marginal Marginal Selection Marginal Moderate Marginal Marginal Procurement Marginal Marginal Minimal Marginal Extremely vulnerable Very vulnerable Moderately vulnerable Marginally vulnerable Minimally vulnerable

14 PHASE 1 National Transparency Assessment PHASE II Development of National GGM Programme PHASE III Implementation of National GGM Programme 1 st 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) 14

15 Guideline for MOH Members Dealing with Representatives of Suppliers and Pharmaceutical Company Guidelines for Giving and Receiving Gifts For Pharmaceutical Members of MOH 15

16 PHASE 1 National Transparency Assessment PHASE II Development of National GGM Programme PHASE III Implementation of National GGM Programme Publication of GGM Guidelines ( ) Development and Implementation of GGM Training Module ( ) National Transparency Assessment study on the Public Pharmaceutical Sector Inclusion of GGM in the National Medicines Policy (DUNas) 16

17 GGM TOT MODULE 1. The GGM Training of Trainers (TOT) Module 1. Facilitator s Handbook. 2. Module Duration 30mins 60mins 120mins 90mins 90mins 90mins Activity Lecture 1 : Introduction to GGM Malaysia Lecture 2 : Integrity in the Pharmaceutical sector Lecture 3 : GGM Guidelines in Malaysia Lecture 4 : GGM in Regulatory Pharmacy Lecture 5 : GGM in Enforcement Pharmacy Lecture 6 : GGM in Pharmacy Practice

18 GGM TOT Workshop Objectives i. 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.

19 GGM TOT Workshop Zone 4 : 6 MT 39 State Trainers Zone 2 : 5 MT State Trainers - 14 Zone 3 : 6 MT 22 Pharmacists Zone 1 : 6 MT 21 State Trainers Zone 5 : 6 MT 33 State Trainers 14 Master Trainers (MT) trained State Trainers across 5 Zones in Malaysia on a rotation basis. State Trainers : Upper and middle management level Pharmacists A Total of 129 Pharmacists were trained as State Trainers

20 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 stakeholders 20

21 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

22 Pharmaceutical Services Division Ministry of Health Malaysia Malaysian National Medicines Policy (MNMP) & Recent Developments

23 Introduction to MNMP 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

24 Steps 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 11 th October

25 Stakeholders Malaysian Pharmaceutical Society Malaysian Medical Association Professional Government agencies Ministry of Health Ministry of Defense Ministry of Science, Technology and Innovation Economic Planning Unit Public universities Federation of Malaysian Consumers Associations Malaysian Association of Traditional Indian Medicine Others Industries Pharmaceutical Association of Malaysia Malaysian Organization of Pharmaceutical Industries 25

26 Objectives of MNMP 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 26

27 Development of MNMP Workshop with stakeholders -Consultation and funding by WHO st Term MNMP ( ) 2012 Full-term review of MNMP nd Term MNMP ( ) 2014 Master Plan of Action for 2 nd Term Initiation of MNMP formulation 27

28 Recent development 2 nd term ( ) after five years of implementation ( ) The core supporting components of the 1 st term policy have been reorganized New components introduced into revised policy 28

29 Components of MNMP Supporting Components Main Components MNMP 2006 Quality, Safety and Efficacy of Drugs Drug Availability Drug Affordability Quality use of Drugs Human Resources Development Research & Development Technical Cooperation Management MNMP 2012 Governance in Medicines Quality, Safety and Efficacy of Medicines Access to Medicines Quality Use of Medicines Partnership and Collaboration for the Healthcare Industry 29

30 Malaysian National Medicines Policy First edition (1 st term) Revised 2012 (2 nd term) 30

31 Master Plan of Action Policy Statement Aim master-plan-action-malaysia-nationalmedicines-policy-2nd-edition.html Strategy Implementation timeline Indicators Targets Activity 31

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 Aim To ensure adequate, continuous and equitable access to quality, safe, effective and affordable medicines towards achieving optimal health outcomes 32

33 Policy 3: Access To Medicines 1. Availability of Medicines 1.1 Selection of Medicines 1.2 Supply of Medicines Strategies 2. Affordability of Medicines 2.1 National Pricing Reference for Medicines 2.2 Financing for Medicines 2.3 Generic Medicines Policy 33

34 1. Availability of Medicines 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 Pharmacoeconomic Implementation Road Map SELECTION SUPPLY Procurement Distribution and storage of medicines Disposal of medicines Medicines supply in emergency situations and medicines donations Halal Medicines 34

35 1. Availability of Medicines Selection of Medicines National Medicines Formulary Guide for prescribing and providing healthcare professional with practical and authoritative information on the selection and clinical use of medicines National Essential Medicines List National reference for domestic medicines industry as well as to the healthcare academia in their teaching curriculum Drug and Therapeutic Committees 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 35

36 1. Availability of Medicines National Medicines Formulary No. Activities Indicator Target / Timeline 1. Form National Medicines Formulary (NMF) revision committee (temporary committee) Committee formed Committee formed by Development of guideline for inclusion of medicines into the NMF Guideline developed Guideline developed by Establish NMF 1st draft NMF drafted NMF draft ready by

37 1. Availability of Medicines National 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 Conduct NEML awareness to stakeholders Number of sessions organized 50 sessions (follow DUNas target) 37

38 1. Availability of Medicines 1.1 Selection of Medicines TCM Formulary Developed by an expert advisory committee Guide for the use of registered traditional and complementary medicines by healthcare providers. Life-saving Medicine and Orphan Medicines Appropriate procedures to enhance accessibility of life saving products and orphan medicines without compromising safety, quality and efficacy Halal Medicines Strategic partnerships with the relevant authorities to make certified halal medicines available in Malaysia. 38

39 1. Availability of Medicines TCM Formulary No. Activities Indicator Target / Timeline 1. Establish a framework and process of TCM Formulary Framework established Framework ready by

40 1. Availability of Medicines Halal 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 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 MS % 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

41 1. Availability of Medicines 1.2 Supply of Medicines Procurement An efficient, effective and transparent procurement system shall be strengthened to ensure adequate and timely availability of medicines. Distribution and Storage of Medicines 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. Disposal of Medicines Medicines Supply in Emergency Situations and Medicines Donations Shall be done in accordance with existing regulations and guidelines All organizations shall collaborate and be coordinated to manage national emergency situations Ensure timely supplies of these medicines without compromising safety, quality and efficacy. 41

42 Affordability of Medicines Reliable, affordable & sustainable mechanism Generic Medicines Policy Foster healthy competition in medicines pricing Guide the use and procurement of medicines Costcontainment measures Ensure poor & underprivileged are not deprived of access to essential medicines Financing for Medicines National Pricing Reference for Medicines Transparency on price information Monitoring of price information Tariffs & duties 42

43 2. Affordability of Medicines Monitoring for Price Information No. Activities Indicator Target / 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

44 2. Affordability of Medicines 2.3 Generic Medicines Policy 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 44

45 2. Affordability of Medicines 2.3 Generic Medicines Policy No. Activities Indicator Target / 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 timeline Yes 4. Generic substitution except for non-interchangeable medicine to be enforced in new pharmacy law Provision in law to allow for generic substitution Yes 45

46 Management of MNMP Steering Committee Advise Health Minister, authorize plans, decide the direction Implementation Committee Monitor and review the development of the implementation Technical Committees Plan, identify and monitor the implementation done by the working committee Component 1 Governance in Medicines Component 2 Quality, Safety & Efficacy of Medicines Component 3 Access of Medicines Component 4 Quality Use of Medicines Component 5 Partnership & Collaboration for the Healthcare Industry Working Committees Implement plan of action 46

47 Management of MNMP How to monitor? Data collection *WHO recommended indicators Indicators from the Master Plan of Action Implementation status reports *Source: 47

48 Monitoring of WHO Indicators Background Indicators 24 indicators Structural Indicators 48 indicators Process Indicators 26 indicators Outcome Indicators 7 indicators 48

49 Background 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 Source: Department of Statistics and Ministry of Health,

50 Structural Indicators 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

51 Process 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

52 Outcome 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

53 Policy 2: Access to Medicines WHO Outcome Indicator 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/ / / Source: Pharmaceutical Services Division 53

54 Successful Implementation of MNMP 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 54

55 THANK YOU Pharmaceutical Services Division Ministry of Health Malaysia 55

56 PHARMACY Planning for Change 56

57 Objectives of Pharmaceutical Policy Keeping Costs Affordable To patient and to the health system Improving Equitable Access Available to the poor Encouraging Appropriate Use Necessary, safe, effective, properly taken, avoid wastage 57

58 Policy Focus Regulation Enforcement Selection Financing Manufacturing Procurement Distribution Financing Pricing Payment system Good medicines available and accessible in a system that uses resources efficiently Rational use Education 58

59 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