MeTA WHO Launch- Good Governance for Medicines programme

Publication date: 2008

Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines * WHO Good Governance for Medicines programme MeTA Launch Dr Guitelle Baghdadi-Sabeti Geneva, 21 May 2008 61st World Health Assembly Department of Medicines Policy and Standards Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines * Corruption identified as the single greatest obstacle to economic and social development US$ 3 trillion spent on health services annually Global pharmaceutical market: > US$ 600b 10 to 25% procurement spending lost into corruption (including health sector) Some countries report that 2/3 medicines supplies lost through corruption and fraud in hospitals Low quality trials exaggerate the benefits of treatment by an average of 34% Bribery of high officials in regulatory authorities has led to unsafe medicines circulating on the market resulting in deaths Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines * Patent R&D and clinical trials Manufacturing Pricing Distribution Registration Selection Procurement & import Promotion Inspection Conflict of interest Evergreening Counterfeit/ substandards Tax evasion Falsification of safety/Efficacy data Bribery State/regulatory capture Overinvoicing Pressure Unethical promotion Thefts Fraud Cartels Collusion Unethical donations Unethical practices can be found throughout medicines chain & are very diverse R&D priorities Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines * Unethical practices can have significant impact on health systems Health impact Unsafe medicines on the market Lack EM in health facilities Irrational use of medicines Economical impact Pharma. expenditure low-income countries: 10-40% of public health budget 20-50% of total health care expenditures Poor most affected  inequalities Image and trust impact Reduces government capacity Reduces credibility of health profession Erodes public trust Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines * Numerous technical guidelines already exist… the challenge is to balance them with ethical practices Technical guidelines Rule of law Accountability Transparency Participation Merit system Evidence-based decision-making Honesty Efficiency and effectiveness Etc… GMP GCP Counterfeits Manual on Marketing Authorization WHO model list of EM Good procurement practices Ethical criteria Etc… Ethical practices Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines * WHO Good Governance for Medicines Programme Goal To curb corruption in pharmaceutical sector systems through the application of transparent and accountable administrative procedures and the promotion of ethical practices among health professionals. Specific objectives To increase the awareness of all stakeholders on the potential for corruption in the pharmaceutical sector and its impact on health systems functioning. To increase transparency and accountability in medicines regulatory systems and supply management systems. To build national capacity for good governance in medicines regulation and supply management systems. Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines * Good Governance for Medicines programme: a model process PHASE II Development national GGM framework PHASE III Implementation national GGM programme PHASE I National transparency assessment Assessment report GGM framework officially adopted Communication plan Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines * Efforts to address corruption need coordinated application of two basic strategies "Discipline-based approach" (top-down) Laws, policies and procedures against corruption and for pharmacy practice with adequate punitive consequence for violation Attempts to prevent corrupt practices through fear of punishment "Values-based approach" (bottom-up) Promotes institutional integrity through promotion moral values and ethical principles Attempts to motivate ethical conduct of public servant Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines * What could be the components of a national GGM Framework? Ethical framework of moral values & ethical principles Justice/fairness Truth Service to common good trusteeship Code of conduct Socialization programme Promotion of Moral Leadership Established anti-corruption legislation Whistle-blowing mechanism Sanctions on reprehensible acts Transparent and accountable regulations and administrative procedures Collaboration with other GG & AC initiatives Management, coordination and evaluation of GGM programme (Steering Committee & task force) Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines * Bottom-up approach in implementation of project and policy development Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines * Nb countries: 18 completed 9 currently on-going Publications: 4-country study: Laos, Malaysia, Philippines, Thailand 5-country study: Bolivia, Cambodia, PNG, Mongolia, Indonesia (upcoming) Future: individual country reports Progress in countries Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines * National workshops: Share results assessment Consult on national GGM framework National GGM Steering Group and/or Task Force Consultation phase to finalize national GGM framework Official adoption of national GGM framework Progress in countries Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines * Mongolia Official establishment of national GGM committee Regional technical groups (including training) Campaigns to promote awareness (educational material) Philippines GGM pharmaceutical benchbook Awards system for local units Thailand Workshops on GGM framework Newsletters, public communications (media, brochures, websites) Introduction in university curricula Bolivia (waiting clearance PoA by MOH) Develop national GGM programme (national and regional consultations) Orientation meeting for MOH staff Campaign for promoting awareness Progress in countries Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines * Key next steps for 2008 Analyse experience from 4 phase III countries and further refine WHO global guidance Establish system to collect learning in countries and facilitate communications b/w countries Scale up to more countries Publish more country assessment reports Next Global Stakeholders Group in Alexandria Explore collaboration with private sector Raise funding for wider implementation of the programme Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines * "I never worry about action, but only inaction." Winston CHURCHILL * * Fraud and abuse in health sector cost US$ 12 – 23 billion annually in the United States Informal payments account for 56% of total health expenditure in Russian Federation 5 per cent of health budget lost through corruption in Cambodia * * * * * Work plan for 2008. *

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