Good governance for medicines programme dr c cile mac emp mpc
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Good Governance for Medicines Programme Dr Cécile Macé EMP/MPC. Conflict of interest. Counterfeit/ substandard. Tax evasion. Pressure. Unethical donations. Collusion. Thefts. Over- invoicing. Bribery. Falsification safety/ efficacy data. State Capture. R&D and clinical trials.

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Good Governance for Medicines Programme Dr Cécile Macé EMP/MPC

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Good governance for medicines programme dr c cile mac emp mpc

Good Governance for Medicines ProgrammeDr Cécile MacéEMP/MPC


Unethical practices can be found throughout medicines chain

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

Manufacturing

R&D

priorities

Registration

Pricing

Selection

Procurement & import

Cartels

Distribution

Inspection

Prescription

Dispensing

Pharmacovigilance

Promotion

Unethical

promotion


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


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


Good governance for medicines programme a model process

Good Governance for Medicines programme: a model process

Clearance

MOH

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


Achievements in countries

Achievements in countries

Increased awareness of impact of corruption in the Pharmaceutical Sector and Importance of having Good Governance and Transparency

  • National Assessments done and published

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

  • Increase in political will to implement GGM

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


Achievements in countries1

Achievements in countries

Increased Transparency and Accountability in Medicine Regulatory and Supply Systems

  • Various laws, regulations, SOPs created or reviewed/updated

  • Management of conflicts of interest put in place for various committees

  • Information publicly available to increase transparency

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

  • Increased accessibility of medicines at lower costs

  • Appeal mechanism put in place


Achievements in countries2

Achievements in countries

Increased promotion of individual and institutional integrity in the pharmaceutical sector

  • National GGM Framework developed, adopted and published

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

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

  • Continuous collaboration with other stakeholders

  • GGM included in the curricula of phamacy students


Achievements in countries3

Achievements in countries

Institutionalization of GGM

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

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

  • Still in progress in other countries…


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


Key observations and lessons learnt

Key observations and lessons learnt

  • Great interest in subject area

  • A dedicated and motivated national team to tackle the issue

  • Involvement of high-level and technical officials essential

  • Collaboration with key stakeholders

  • Promotion of integrity together with legislative reforms

  • Timeframe different between countries

  • Institutionalization needed for sustainability


Good governance for medicines programme dr c cile mac emp mpc

Thank you!

[email protected]

http://www.who.int/medicines/ggm/en/index.html


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