who-technical briefing seminar | october-november 2012 dr cécile macé 1 |1 | good governance for...

WHO-Technical Briefing Seminar | October-November 2012Dr Cécile Macé

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Good Governance for Medicines Programme

Dr Cécile MacéEMP/MPC

Good Governance for Medicines Programme

Dr Cécile MacéEMP/MPC


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Conflict of interest

Pressure

BriberyFalsificationsafety/

efficacy data

State Capture

Patent

R&D and clinical trials

Manufacturing

Pricing

Distribution

Registration

Selection

Procurement & import

Promotion

Inspection

Unethical practices can be found throughout medicines chain

Unethical practices can be found throughout medicines chain

Prescription

Dispensing

Pharmacovigilance

R&D priorities

Cartels

Unethicalpromotion

TheftsOver-

invoicing

Tax evasionCounterfeit/

substandard

CollusionUnethical donations


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Why a Good Governance for Medicines Programme?

Why a Good Governance for Medicines Programme?

To improve transparency, accountability, effective, efficient and ethical management of pharmaceutical systems

To improve the health service delivery to the population in countries through improved access to quality-assured medicines and rational use

To avoid wastage or misuse of public or donor funding in the pharmaceutical sector

To improve public trust and confidence on health system

To support countries to identify, prioritize and mitigate risks

To develop guidance to support countries in improving good governance in the pharmaceutical system


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WHO Good Governance for Medicines Programme:

WHO Good Governance for Medicines Programme:

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


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Good Governance for Medicines programme: a model process

Good Governance for Medicines programme: a model process

PHASE II

Developmentnational GGM

framework

PHASE III

Implementation national GGM programme

PHASE I

Nationaltransparencyassessment

Assessmentreport

GGM frameworkofficiallyadopted

GGM integrated

in MOH plan

ClearanceMOH


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Achievements in countriesAchievements in countriesIncreased awareness of impact of corruption in the

Pharmaceutical Sector and Importance of having Good Governance and Transparency

1.National Assessments done and published

2.GGM incorporated in National Health Agenda by nominating a task force and steering committee to work on framework

3.Increase in political will to implement GGM

4.Collaboration between various stakeholders (MoH, other ministries, anti-corruption commission, NGOs, private sector…)


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Achievements in countriesAchievements in countriesIncreased Transparency and Accountability in Medicine

Regulatory and Supply Systems

1.Various laws, regulations, SOPs created or reviewed/updated

2.Management of conflicts of interest put in place for various committees

3.Information publicly available to increase transparency

4.Whistle-blower protection bill passed, increase in number of corruption cases investigated

5.Increased accessibility of medicines at lower costs

6.Appeal mechanism put in place


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Achievements in countriesAchievements in countries

Increased promotion of individual and institutional integrity in the pharmaceutical sector

1.National GGM Framework developed, adopted and published

2.Creation of Code of conduct for people working in the public pharmaceutical sector

3.Continuous training workshops on ethical leadership and GGM at national and regional level

4.Continuous collaboration with other stakeholders

5.GGM included in the curricula of phamacy students


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Achievements in countriesAchievements in countries

Institutionalization of GGM

1.In Mongolia, the MoH has designated by law in 2010 the Drug Regulatory Agency to implement GGM

2.In Philippines, the GGM team in the MoH is having a specific budget to conduct activities

3.Still in progress in other countries…


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Common challenges faced in implementation

Common challenges faced in implementation

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

Political: instability, change in government

Managerial: lack staff, rotation, lack of financial resources

Structural: more difficult if basic systems not in place

Technical: integration in day to day affairs, new subject, access to legislation documents

Time: workload, other priorities; GGM not a priority


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Key observations and lessons learntKey observations and lessons learnt

1. Great interest in subject area

2. A dedicated and motivated national team to tackle the issue

3. Involvement of high-level and technical officials essential

4. Collaboration with key stakeholders

5. Promotion of integrity together with legislative reforms

6. Timeframe different between countries

7. Institutionalization needed for sustainability


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Thank you!

[email protected]://www.who.int/medicines/ggm/en/index.html

who-technical briefing seminar | october-november 2012 dr cécile macé 1 |1 | good governance for...

Documents

good governance

technical briefing seminar

pharmaceutical system

private sector slide

national health agenda

health systems

leadership slide

national capacity