who good governance for medicines programme making the invisible visible conference university of...

WHO Good Governance for Medicines programme

Making the Invisible Visible ConferenceUniversity of Brighton (Falmer Campus)

17 December 2010

Dr Guitelle Baghdadi-Sabeti

Department of Essential Medicines and Pharmaceutical Policies

Department of Essential Medicines and Pharmaceutical PoliciesGood Governance for Medicines 2

"The abuse of entrusted power for personal gain"

Transparency International

What is corruption?


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

Unethical practices can be found throughout medicines chain


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

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 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

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

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


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

0

5

10

15

20

25

30

35

2004 2006 2008 2010

Number ofcountries


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


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

PHASE II PHASE IIIPHASE I

Working draft


Summary quantitative findings

PHASE IIPHASE I PHASE III


Common strengths Areas of improvement

Registration - Written procedures for applications

- Operational committees

- Conflict of interest policy

- Committee composition & TOR

Promotion - Provisions exist (major variations)

- No DTCA for prescription-only med.

- Complete provisions to cover all

- Establish responsible unit

Inspection - Inspection report required

- Reports subject to internal review


- Appeals mechanisms

Selection - Clear criteria for selection process

- Committees (multi-discipl. Experts)


- Selection criteria for members

Procurement - Written procedures

- Well-established tender committees


- Audit results publicly available

Summary qualitative findings



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

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

Phase I (12 countries)

Phase II (12 countries)

Phase III (7 countries)


Current monitoring mechanisms: measuring outputs and milestones


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

1. National "champions" that are persistent and dedicated

2. Political will and technical support

3. Strong collaboration with all stakeholders

4. GGM is integrated into existing structures and committees.

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

6. Effective communication within the MOH and by the government

7. Government's willingness to institutionalize the GGM

8. Integrity is promoted together with legislative reforms


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


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

Winston CHURCHILL

who good governance for medicines programme making the invisible visible conference university of...

Documents

medicines programme

medicines chain slide

health impact unsafe

pharmaceutical systems

health systems

impact of corruption

global pharmaceutical

health services