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WHO Good Governance for Medicines programme Making the Invisible Visible Conference University of Brighton (Falmer Campus) 17 December 2010 Dr Guitelle Baghdadi-Sabeti. Department of Essential Medicines and Pharmaceutical Policies. What is corruption?.

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WHO Good Governance for Medicines programme Making the Invisible Visible Conference

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Who good governance for medicines programme making the invisible visible conference

WHO Good Governance for Medicines programme

Making the Invisible Visible Conference

University of Brighton (Falmer Campus)

17 December 2010

Dr Guitelle Baghdadi-Sabeti

Department of Essential Medicines and Pharmaceutical Policies


What is corruption

What is corruption?

"The abuse of entrusted power for personal gain"

Transparency International


Who good governance for medicines programme making the invisible visible conference

Conflict of interest

Counterfeit/

substandard

Tax evasion

Pressure

Unethical

donations

Collusion

Thefts

Over-

invoicing

Bribery

Falsificationsafety/

efficacy data

State Capture

R&D and clinical trials

Unethical practices can be found throughout medicines chain

Patent

R&D

priorities

Manufacturing

Unlawful

appropriation

royalties

Registration

Pricing

Selection

Procurement & import

Cartels

Distribution

Inspection

Prescription

Dispensing

Pharmacovigilance

Promotion

Unethical

promotion


Corruption identified as the single greatest obstacle to economic and social development

Corruption identified as the single greatest obstacle to economic and social development

"Corruption is a worldwide problem, existing in both high- and low-income countries… no country should feel offended and restrained to talk about it".

Dr H. Hogerzeil, Director, WHO

  • Health and pharmaceutical sectors attractive targets

    • US$ 5.3 trillion spent on health services annually

    • Global pharmaceutical market: > US$ 750b

  • No global estimate on financial losses, but:

    • 10 to 25% procurement spending lost into corruption

    • Some countries report losses:

      • 2/3 medicines supplies lost in hospitals

      • 10% national expenditures on health care

  • Countries with higher indices for corruption have higher infant mortality rates


Who good governance for medicines programme making the invisible visible conference

Health impact

Unsafe medicines on the market

Lack EM in health facilities

Irrational use of medicines

Economical impact

Waste limited public/donor funding

Not stable environment

Not easy to conduct business

Image and trust impact

Erodes public trust

Reduces credibility of health profession

Unethical practices can have significant impact on health systems


Who good governance for medicines programme an innovative initiative

WHO Good Governance for Medicines Programme: an innovative initiative

  • Goal

    • To contribute to health systems strengthening and 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


Numerous technical guidelines already exist the challenge is to balance them with ethical practices

Numerous technical guidelines already exist… the challenge is to balance them with ethical practices

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…


Ggm started as a pilot project in 2004 and is now a global programme

GGM started as a pilot project in 2004 and is now a global programme


Good governance for medicines programme a model process

Clearance

MOH

Good Governance for Medicines programme: a model process

PHASE II

Development

national GGM

framework

PHASE I

National

transparency

assessment

PHASE III

Implementation

national GGM

programme

Assessmentreport

GGM

integrated

in MOH plan

GGM framework

officially

adopted


Who good governance for medicines programme making the invisible visible conference

Working draft

PHASE II

PHASE III

PHASE I

Bottom-up approach in policy development lead to the 'GGM technical package'


Summary quantitative findings

PHASE I

PHASE II

PHASE III

Summary quantitative findings


Summary qualitative findings

PHASE I

PHASE II

PHASE III

Summary qualitative findings


Efforts to address corruption need coordinated application of two basic strategies

PHASE I

PHASE II

PHASE III

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


Ggm frameworks effective only if translated into action some preliminary achievements

PHASE I

PHASE II

PHASE III

GGM frameworks effective only if translated into action: some preliminary achievements

  • Lower costs for quality medicines procurement

  • National pharmaceutical laws, regulations and procedures revised

  • Web-based pharmaceutical activities (registration, licensing) and information

  • Conflict of interest policies developed and implemented

  • Integrity and Leadership training programmes for health officials

  • Good governance introduced in University curriculum

  • Communications and advocacy campaigns

  • Culture of transparency is emerging in institutions


Countries efforts focus on moving from phase i to phase iii

Countries efforts focus on moving from phase I to phase III

Phase I (12 countries)

Phase II (12 countries)

Phase III (7 countries)


Current monitoring mechanisms measuring outputs and milestones

Current monitoring mechanisms: measuring outputs and milestones


Common challenges faced in implementation

Common challenges faced in implementation

  • Cultural and behavioural: resistance to change, passive attitude or tolerance

  • Political: instability, delays

  • Managerial: lack staff, rotation

  • Technical: integration in day to day affairs, new subject

  • Time: workload, other priorities

  • Lack of resources: human and financial


Lessons learnt to date great interest in subject area

Lessons learnt to date: great interest in subject area

  • National "champions" that are persistent and dedicated

  • Political will and technical support

  • Strong collaboration with all stakeholders

  • GGM is integrated into existing structures and committees.

  • Time-frame for implementation adapted to each country's context

  • Effective communication within the MOH and by the government

  • Government's willingness to institutionalize the GGM

  • Integrity is promoted together with legislative reforms


Priorities for 2010 2012

Priorities for 2010 - 2012

  • Identify best practices in phase III countries

  • Monitoring and evaluation

  • Integrate corruption on the health agenda (global & countries)

  • Institutionalization of the GGM

  • Communications strategy

  • Training phase III and GGM resources

  • Fundraising


Who good governance for medicines programme making the invisible visible conference

"I never worry about action, but only inaction."

Winston CHURCHILL


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