SALMAH BAHRI, PhD., RPh. Director of Pharmacy Practice and Development Pharmaceutical Services Division Ministry of Health Malaysia NATION ONAL REGULATO TORY Y CONFEREN ENCE E 2013 7-9 May 2013 Ista tana Hotel l Kuala la Lumpur 1
• Background of DUNas 1 • DUNas 2013: Strategies for 2 Pharmacy Transformation • Tasks Ahead 3 2
BACKGROUND OF DUNas 3
A clear and official government statement that defines and prioritises 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 DUNas Ministry of Health (MOH) to oversee, monitor and administer the legislation 4
12 April 2013: DUNas II 2009: Approved by MOH DUNas Mid-term 14 June 2006: Review DUNas Approved by MOH 15-17 Oct. 2012 2000: DUNas Full-term Initiation of 11 October formulation Review 2006: DUNas I DUNas Approved by Cabinet 2001-2003: • Consultation & funding by WHO • MNMP workshops with stakeholders & policy makers 5
To reflect achievements and outcomes attained from strategies implemented Serves as platform to obtain input and consensus from all stakeholders on new propositions and strategies The intitial objectives of DUNAS were maintained Introductions of new strategies and revision of current strategies to fulfill the current needs of the country. 6
DUNas I (2006) DUNas II (2013) Quality, Safety and Quality, Safety and Efficacy of Core Components Efficacy of Drugs Medicines Drug Availability Access to Medicines Drug Affordability Quality Use of Drugs Quality Use of Medicines Human Resource Development Components Supporitng Partnership and Collaboration for Research and Development the Healthcare Industry Technical Co-operation Governance in Medicines Management of the National Medicines Policy 7
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 8
Strategies For Pharmacy Transformation 9
QUALITY, SAFETY & EFFICACY 10
Only safe, efficacious and quality medicines that meet approved standards and specifications shall be registered and made available for sale and use by the consumers in Malaysia 11
STRATEGIES Legislation & Regulations Pharmaceutical Quality Assurance Strengthened to ensure appropriate practices in development, production, importation, supply, • Post Marketing Surveillance marketing, sale and management (including • Management of Complaints prescribing, dispensing, administration and about Medicines disposal) of medicines Level of regulation shall be consistent with potential benefits and risks to the community • National Pharmaceutical Control Bureau • Regulating Premises that Supply Medicines • Effective Enforcement • Medicines Advertisement & Promotion • Counterfeit Medicines 12 12
Resp esponsible for or Ph Pharmaceuti tical l Regu egula latory Con ontrol ol in n Mala laysia • Collaborate with industry and • Licensing of manufacturers, other stakeholders to:- importers and wholesalers • strengthen regulatory • Registration of medicines framework & community engagement • Quality control of medicines • ensure enhanced • Good Laboratory Compliance communication and effective use of medicines by the • Post Marketing Surveillance consumers. Activities • Play a prominent role in • Control of medicines used in facilitating regional and clinical trials international harmonisation of technical requirements of registration of medicines 13
Regul egulatin ing Premises s that Sup upply Medi edicines • Only licensed manufacturers, importers and wholesalers shall handle registered medicines • The sale, supply and dispensing of medicines shall be carried out at premises regulated according to the appropriate legislations . Effect ctive Enf nforcement • Ensure all activities in the manufacture, import, supply or dispense medicines comply with legislations, regulations, guidelines and directives • Premises involved in these activities shall be inspected regularly to ensure compliance to existing regulatory requirements. 14
Med edicines Advertisement and and Pr Prom omotion All relevant stakeholders shall comply with existing legislations, guidelines and relevant codes of ethics for advertising and promotion Cou ounterfeit Medi edicines • An appropriate legal and technical framework for concurrent enforcement of laws and regulations by MOH together with other relevant authorities for market surveillance shall be enhanced to manage and control the problem of counterfeit medicines • Suitable security measures for authentication, traceability of counterfeit medicines and public education shall be implemented and enhanced. 15
Post Marketing Surveillance • Continuous monitoring on products available in the market to ensure products conform to standards and requirements • Necessary punitive action will be instituted on non- conforming products Management of Complaints about Medicines All complaints pertaining to medicines shall be investigated and appropriate action shall be taken in a timely manner 16
ACCESS TO MEDICINES 17
• 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 18
STRATEGIES 2. Affordability of 1. Availability of Medicines Medicines • Selection of Medicines National Pricing Reference for • Transparent & based on quality, safety, Malaysia efficacy, clinical effectiveness & cost • Transparency on Price effectiveness of treatment Information • Monitoring of Price Information • Tariffs and Duties • Supply of Medicines Financing of Medicines • Strengthen Medicines Supply Generic Medicines Policy Chain Network -TQM,GDP & ICT 19
National Medicines Formulary National National Drug Essential & Therapeutic Drug List Committee Selection of Traditional & Medicines Complementary Halal Medicines Medicines Formulary Life-saving & Orphan Medicines Formulary 20 20
National Medicines National Essential Drug List Formulary • National reference for domestic • National Essential Medicines List SELECTION • Developed by National Drug & medicines industry for : OF • Production, procurement, Therapeutic Committee MEDICINES • Standard reference for prescribing in distribution & utilisation • Research Malaysia • Teaching curriculum Traditional & Complementary National Drug & Medicines Formulary Therapeutic Committee • Shall be developed by an expert advisory Under MOH & represented by all • committee under MOH relevant stakeholders • Serves as a guide for use of registered TCM All local drug and therapeutic • by health providers Committee shall be established and function based on the Life-saving Medicines and Orphan guidelines developed by MOH Medicines Halal Medicines • To develop appropriate procedures for the accessibility of live-saving and orphan Strategic partnerships with the relevant medicines without jeopardising elements of authorities to make certified halal safety, quality & efficacy medicines available in Malaysia 21
Distribution & Storage of Procurement Medicines • Strengthen efficient, effective • Strengthen efficient & and transparent procurement economical distribution system to ensure adequate & network timely availability of Supply of • Storage, inventory control medicines Medicines and quality assurance to comply to GDP Medicines Supply in Emergency • Establish integrated ICT & Medicines Donations network for logistic, inventory and financial • Collaboration and coordination of transaction in all health all organisations to manage facilities national emergency situation Disposal of Medicines • WHO Guidelines on managing drug supplies in emergency • Disposal of medicines to be in situations and receiving donations accordance with prevailing laws and regulations 22
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