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1 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013 Good governance in the pharmaceutical sector Gilles Forte Deirdre Dimancesco.

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Presentation on theme: "1 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013 Good governance in the pharmaceutical sector Gilles Forte Deirdre Dimancesco."— Presentation transcript:

1 1 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013 Good governance in the pharmaceutical sector Gilles Forte Deirdre Dimancesco Cécile Macé Department of Essential Medicines and Health Products Side event at the 66 th WHA Good governance in the pharmaceutical sector Gilles Forte Deirdre Dimancesco Cécile Macé Department of Essential Medicines and Health Products Side event at the 66 th WHA

2 2 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013 Ten leading causes of inefficiency World Health Report 2010, Chapter 4 1. Medicines: underuse of generics and higher than necessary prices for medicines 6. Health-care services: inappropriate hospital admissions and length of stay 2. Medicines: use of substandard and counterfeit medicines 7. Health-care services: inappropriate hospital size (low use of infrastructure) 3. Medicines: inappropriate and ineffective use 8. Health-care services: medical errors and suboptimal quality of care 4. Health-care products and services: overuse or supply of equipment, investigations and procedures 9. Health system leakages: waste, corruption and fraud 5. Health workers: inappropriate or costly staff mix, unmotivated workers 10. Health interventions: inefficient mix/ inappropriate level of strategies

3 3 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013 Inefficiencies and unethical practices can occur throughout the medicines supply chain Promotion Conflict of interest Pressure Falsification safety/ efficacy data State Capture Bribery Patent R&D and clinical trials Manufacturing Inspection Distribution Registration Selection Procurement & import Pricing Prescription Dispensing Pharmacovigilance R&D priorities Cartels Thefts Over- invoicing Tax evasion Counterfeit/ substandard Collusion Unethical donations Unethical promotion High prices Waste Inappropriate use Losses

4 4 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013 Why improve good governance in the pharmaceutical sector To improve health, health service delivery and access to quality and affordable medicines To contribute to Universal Health Coverage, through reduced inefficiencies, unethical behavior and corruption To establish relevant structures and processes for efficient implementation of medicines policies and the enforcement of laws and regulations in countries To increase transparency, accountability and ethical management of pharmaceutical systems To improve public trust and confidence on the health system and prevent misuse of public, patients and donors funds

5 5 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013 Common elements of governance relevant to the pharmaceutical sector Transparency Accountability Participation Consensus Ethics Efficiency Information Rule of law Regulation Leadership Equity Efficacy Policy formulation & planning

6 6 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013 WHO contribution to good governance in the pharmaceutical sector Transparency Participation Accountability Efficiency Policy Leadership Ethics Anti-corruption Rule of law Regulation MeTA GGM Information Better access to medicines

7 7 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013 WHO Good Governance for Medicines programme (GGM) Goal To contribute to health systems strengthening and to prevent corruption by promoting good governance in the pharmaceutical sector Specific objectives –To raise awareness on the impact of corruption in the pharmaceutical sector and bring this to the national health policy agenda –To increase transparency and accountability in medicine regulatory and supply management systems –To promote individual and institutional integrity in the pharmaceutical sector –To institutionalize good governance in pharmaceutical systems by building national capacity and leadership

8 8 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013 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 Clearance MOH GGM framework officially adopted Assessment report GGM integrated in MoH plan

9 9 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013

10 10 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013 National Transparency Assessment Assesses transparency and vulnerability to corruption of pharmaceutical systems Looks at key functions such as: –Regulation: registration, licensing, inspection, promotion, clinical trials –Supply: selection, procurement, distribution Elements evaluated: –Regulations and official documents –Written procedures and decision-making processes –Committees, criteria for membership and conflict of interest policy –Appeals mechanisms and other monitoring systems PHASE II PHASE I PHASE III Assessment report

11 11 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013 Development of a GGM Framework "Discipline-based approach" –Aims to put into place laws, policies and procedures for the pharmaceutical sector and against corruption –Attempts to prevent unethical and corrupt practices through fear of sanctions on reprehensible acts "Values-based approach" –Attempts to motivate ethical conduct of public servants –Promotes institutional and individual integrity through promotion of ethical principles PHASE II PHASE I PHASE III GGM framework officially adopted

12 12 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013 Implementation of National GGM Programme 1.Increase of information publicly available (regulations, laws, procedures, inspection reports, procurement contracts and tenders, web-based platforms with procurement prices…) 2.Revision of policies and procedures; Operational guidelines developed; Appeal mechanisms put in place 3.Adoption of codes of conduct for people working in the pharmaceutical sector; Development and adoption of policies on conflicts of interest 4.Clarification of TORs and selection criteria for various committees 5.GGM fully institutionalized, funded by government budget and part of the anti-corruption national plan 6.Regular training sessions on ethical leadership and Good Governance at national and regional level 7.GGM included in the curricula of pharmacy students PHASE II PHASE I PHASE III GGM integrated in MoH plan

13 13 Good Governance in the pharmaceutical sector, WHA side event 20 May 2013 Next steps/Final words Develop methodologies for assessing good governance interventions and their impact on reducing inefficiencies and on improving access to quality and affordable medicines. Strengthen WHO support to countries for good governance in pharmaceutical and health systems as a contribution to the achievement of universal health coverage. Facilitate sharing of experiences among countries and explore synergies with other partners and sectors.


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