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  1. 1. Why We Need A National Medicines Policy? DUNAS Ministry of Health Malaysia A clear and official government statement that defines and prioritises the medium-to long term-goals set by medium- term- the government for the pharmaceutical sectorNational Medicines Policy To present a formal record of aspirations, aims, decisions and commitments of the government and all of Malaysia stakeholders in both public and private sectors to a common goal for the pharmaceutical sector To identify strategies and consolidate efforts to meet the objectives of pharmaceutical sector To provide a transparent framework for coordinated implementation of strategies by stakeholders in the Pharmaceutical Services Division public and private sectors Ministry of Health Malaysia 2 Global Implementation Global Implementation DUNAS DUNAS Promoted by WHO since 1981 Based on the Essential Medicines Concept Until 2003, 98 out of 131countries that reported (75%) have official NMP • Countries with > 10 years NMP- 5 NMP- • Countries with < 10 years NMP- 93 NMP- • E.g. Australia – Official NMP in 2000 United Kingdom – In drafting stage 3 4 National Medicines Policy Situation in Malaysia of Malaysia DUNAS DUNAS Existing legislation can provide the Formulation of NMP initiated in 2000 executive power and legal framework for Developed through a systematic and MOH to implement the NMP consultative process • Assisted by WHO consultancy and funding Presence of organizations in MOH to • National MNMP Workshops with stakeholders oversee, monitor and administer the in 2001 & 2003 legislation Formalization of the MNMP as a government policy document Presence of structural elements crucial for Approved by JDPKK, MOH on 14 June 2006 successful implementation of NMP Submitted ‘Memorandum Jemaah Menteri’ for Menteri’ cabinet endorsement in July 2006 Approved by cabinet on 11 Oktober 2006 5 6
  2. 2. Objectives of NMP Components of NMP DUNAS DUNAS To improve health outcomes of Malaysians through: Core Components: Promoting equitable access to essential 1. Quality, Safety and Efficacy of medicines Drugs Ensuring availability of safe, effective and 2. Drug Availability affordable medicines of good quality 3. Drug Affordability Promoting quality use of medicines by 4. Quality Use of Drugs healthcare providers and consumers 7 8 Policy 1: DUNAS Quality, Safety And Efficacy Supporting Components.. Of Drugs*** Drugs*** 1. Human Resource Development 2. Research and Development Only safe, efficacious and quality 3. Technical Cooperation with Other drugs that meet approved Countries and International Agencies standards and specifications shall be registered and made available 4. Management of the National Medicines for sale and use in Malaysia Policy DUNAS 9 10 Policy 1: Policy 1: Quality, Safety And Efficacy Quality, Safety And Efficacy Of Drugs Of Drugs Issues addressed: Legislation and regulations Issues addressed: DCA Prescribing of drugs Licensing of Premises Inspection Manufacturers, Importers and Medicines advertisement and promotion Wholesalers Intellectual Property Rights Retail and dispensing outlets Counterfeit Drugs Direct selling of pharmaceuticalsDUNAS DUNAS 11 12
  3. 3. Policy 1: Policy 2: 2: Quality, Safety And Efficacy Drug Availability*** Availability*** Of Drugs Issues addressed: An efficient and integrated drug Pharmaceutical quality assurance management and supply network Drug Registration shall be maintained Inspection Quality Control Post- Marketing Surveillance Post-DUNAS DUNAS 13 14 Policy 2: 2: Policy 3: 3: Drug Availability*** Availability*** Drug Affordability*** Affordability*** Issues addressed: The pharmaceutical industry shall Selection of drugs be organized and regulated to • National Essential Drug List (NEDL) • Traditional Medicines create incentives and foster Supply competition in drug prices; • Procurement Appropriate financing mechanisms • Domestic Pharmaceutical Production shall be developed to ensure • Distribution, Storage and Disposal essential drugs needed for quality • Drug supply in emergency situations healthcare are affordable and drug donationsDUNAS DUNAS 15 16 Policy 3: 3: Policy 4: 4: Drug Affordability Quality Use of Drugs*** Drugs*** Issues addressed : Quality use of drugs by healthcare Price of Drugs providers and consumers shall be • Pricing Policy promoted; • Price Information Activities of the government, Generic Policies industry and media in support of Drug Financing informed and appropriate use of drugs by consumers shall be encouragedDUNAS DUNAS 17 18
  4. 4. Policy 4: 4: Policy 5: Quality Use of Drugs Human Resources Issues addressed : Development*** Development*** Education and Training Healthcare providers The human resource of the General public pharmaceutical sector shall be Drug Information planned and developed Drugs and Therapeutic Committees Standard Treatment Guidelines Prescribing and Dispensing Practices Issues addressed : Role of Pharmacists Planning Medicines Advertisements and Promotions Education and TrainingDUNAS DUNAS 19 20 Policy 6: Policy 7: Research And Technical Cooperations*** Cooperations*** Development*** Development*** Technical collaboration and Research in utilization, management and development co-operations in the implementation co- of medicines shall be enhanced and strengthening of relevant areas in the pharmaceutical sectors shall be established with Issues addressed : various stakeholders at the Drug Utilization and Management national, regional and Drug Research and Development international levelsDUNAS DUNAS 21 22 Policy 7: Technical Cooperations Policy 8: Management of The National Issues addressed : Medicines Policy Areas For Technical Co-operation Co- • Regulatory practices All stakeholders shall be • Drug accessibility committed to the successful • Quality use of drugs implementation of the MNMP • Training and human resources development • Drug research and developmentDUNAS DUNAS 23 24
  5. 5. Policy 8: A Successful DUNAS Management of The National Medicines Policy Implementation of MNMP Issues addressed: Requires national acceptance, acceptance, Every 3-year Master Action Plan recognition and commitment by 3- all stakeholders including the Monitoring every 3 years and highest political level in order to Evaluation every 6 years achieve the goals of the pharmaceutical sector in MalaysiaDUNAS 25 26 Thank You