WHO Good Governance for Medicines programme Technical Briefing Seminar 19 November 2009, Geneva Dr Guitelle Baghdadi-Sabeti Department of Essential Medicines

WHO Good Governance for Medicines programme

Technical Briefing Seminar 19 November 2009, Geneva

Dr Guitelle Baghdadi-Sabeti

Department of Essential Medicines and Pharmaceutical Policies

Department of Essential Medicines and Pharmaceutical Policies November 2009 – Good Governance for Medicines 2

Pharmaceutical sectors is a great target to corruption and unethical practices

Conflict of interest

Pressure

BriberyFalsificationsafety/

efficacy data

State Capture

Patent

R&D and clinical trials

Manufacturing

Pricing

Distribution

Registration

Selection

Procurement & import

Promotion

Inspection

Prescription

Dispensing

Pharmacovigilance

R&D priorities

Cartels

Unethicalpromotion

TheftsOver-

invoicing

Unlawful appropriation

royalties

Tax evasionCounterfeit/substandard

CollusionUnethical donations


What is the impact?

Health impact Lack EM in health facilities Unsafe medicines on the market Irrational use of medicines

Economical impact Waste limited public funding Not stable business environment Poor most affected

Image and trust impact Erodes public trust Reduces credibility of health

profession


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 Essential Medicines and Pharmaceutical PoliciesNovember 2009 – Good Governance for Medicines 5

WHO Good Governance for Medicines Programme: an innovative initiative

Goal

To strengthen pharmaceutical systems by promoting transparency and integrity.

Specific objectives

To increase awareness of all stakeholders on the potential for unethical practices in the pharmaceutical sector and its impact.

To increase transparency and accountability in medicines regulatory and supply management systems.

To build national capacity for good governance in medicines regulation and supply management systems.


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

0

10

20

30

2004 2005 2006 2007 2008

Number of countries

4

8

11

22

26


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 Strategic Plan of Action

ClearanceMOH


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

PHASE II PHASE IIIPHASE I


Common strengths and weaknesses in supply chain

PHASE IIPHASE I PHASE III

Common strengths Areas of improvement

Selection - Use of nal essential medicines lists

- Clear criteria for selection process

- Committees (multi-discipl. Experts)

- Update and dissemination

- Consultation with stakeholders

- Conflict of interest policy

- Selection criteria for members & TOR

Procurement - Formal systems in place

- Written procedures

- Well-established tender committees

- Conflict of interest policy

- Audit results publicly available

- Bribery in tender process

- TOR for committee and members

Distribution - Shelving

- Inventory

- Independent audits

- Coding government medicines

- Gift-giving needed for port-clearing

- Security management (all levels)

- Computerization

- Performance monitoring & evaluation

- Leakages


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 results

Strengthening systems by increasing transparency and accountability

Increased number of hospitals with best practices in drugs procurement (Thailand)

Amendment of laws, regulations and procedures (COI in Mongolia) Web-based procedures and information (Malaysia, Mongolia,

Thailand)

Promoting awareness (public & health professionals) Dissemination of information & social marketing Critical thinking and discussions

Building capacity (managers and public policy makers) Technical training programme Leadership training programme GGM in University Curriculum


Countries efforts focus on moving from phase I to phase III

Phase I (7 countries)

Phase II (13 countries)

Phase III (6 countries)


Key observations and lessons learnt

1. Great interest in subject area

2. Preventive and constructive approach appealing

3. Assessment can be educational

4. Involvement of high-level and technical officials essential for sustainability

5. Collaboration with key stakeholders extremely valuable

6. Some countries need more time than others

7. Cross-fertilization between countries best learning platform

Department of Essential Medicines and Pharmaceutical PoliciesNovember 2009 – Good Governance for Medicines 14Department of Medicines Policy and StandardsSeptember 2007 – Good Governance for Medicines 14

"Corruption is a powerful force, but it is not inevitable or unavoidable. Diminishing its

impact restores diverted resources to their intended purpose, bringing better health,

nutrition and education to victims of corruption around the world, and with them,

opportunity and hope."

Transparency International


Thank you!

Documents

WHO Good Governance for Medicines programme Technical Briefing Seminar 19 November 2009, Geneva Dr Guitelle Baghdadi-Sabeti Department of Essential Medicines