presented by deirdre dimancesco who department of ......anti-corruption meta ggm better access to...

1 Good Governance in the pharmaceutical sector

Ghana MeTA Forum, October 2014

Good Governance for Medicines

Presented by Deirdre Dimancesco

WHO Department of Essential Medicines and Health Products

TBS

November, 2014



Need for governance in the

pharmaceutical sector



Causes of inefficiency in health systems World Health Report 2010, Chapter 4

1. Medicines: underuse of generics and

higher than necessary prices for

medicines

6. Health-care services: inappropriate hospital

admissions and length of stay

2. Medicines: use of substandard and

counterfeit medicines

7. Health-care services: inappropriate hospital

size (low use of infrastructure)

3. Medicines: inappropriate

and ineffective use

8. Health-care services: medical errors and

suboptimal quality of care

4. Health-care products and services:

overuse or supply of equipment,

investigations and procedures

9. Health system leakages: waste,

corruption and fraud

5. Health workers: inappropriate or costly

staff mix, unmotivated workers

10. Health interventions: inefficient mix/

inappropriate level of strategies



Corruption



Registration



Selection



Procurement



Prescribing



Other examples

Inefficiencies

Corruption



What is governance

How decisions are made

How resources are managed

How public affairs are conducted.



Objectives of improving governance in the

pharmaceutical sector

To improve use of public, patient and donor funds

To improve public trust and confidence on the health

system

=> To improve health, health service delivery and access

to quality and affordable medicines



GGM and MeTA

Transparency

Participation

Accountability

Efficiency

Policy

Leadership

Ethics

Anti-corruption

Rule of law

Regulation

MeTA

GGM

Information

Better access to medicines

MoH

WHO

Multi-

Stakeholder



WHO Good Governance for Medicines

programme (GGM)

Specific objectives

– Raise awareness

– Increase transparency and accountability

– Promote individual and institutional efficiency and integrity

– Institutionalize good governance in pharmaceutical systems by

building national capacity, participation and leadership



Background of the WHO Good

Governance for Medicines Programme

Implemented

during 2004-2013

37 countries have

participated

Programme

supported by

Government of

Kuwait, BMZ,

Australia



Good Governance for Medicines

programme: a process

PHASE II

Development national GGM framework

PHASE III

Implementation national GGM programme

PHASE I

National transparency assessment

Clearance

MOH

GGM framework

officially

adopted

Assessment

report

GGM integrated

in MoH plan



National Transparency

Assessment

Assess transparency and vulnerability to corruption using the WHO Assessment Instrument

Looks at key functions such as: – Regulation: registration, licensing, inspection, promotion,

clinical trials

– Supply: selection, procurement, distribution

Elements evaluated: – Regulations and official documents

– Written procedures and decision-making processes

– Criteria for membership and conflict of interest policy for committees

– Appeals mechanisms and other monitoring systems

National assessment report

PHASE II PHASE I PHASE III

Assessment

report


Utrecht Summer School 2014

Findings from national assessments

Weaknesses and vulnerabilities

Most frequently identified areas most vulnerable to corruption:

– Registration

Widespread lack of access to information

Lack of formal criteria to guide selection of members of key

committees

Registration committees have a weak policy base and lack

adequate operational procedures

Conflict of interest policies lacking or poorly implemented


Utrecht Summer School 2014

Development of a GGM Framework

Based on the GGM Model Framework and through a consultative process

"Discipline-based approach"

– Aims to put into place policies, laws and procedures

– Attempts to prevent unethical and corrupt practices through fear of sanctions on reprehensible acts

"Values-based approach"

– Attempts to motivate ethical conduct of public servants

– Promotes institutional and individual integrity through promotion of ethical principles

The National GGM Framework is officially adopted


GGM framework

officially

adopted



Achievements

Improved medicines procurement practices

Revised pharmaceutical laws and regulations

Increased transparency in registration and licensing

Improved management of conflict of interest

More public information on medicines



Examples of country achievements Mongolia • Compliance with regulations on procurement and dispensing

• Public sector procurement based on, but not limited to, the EML

• Web-sites to make Information on drug registration publicly available

• Conflict of Interest declaration forms for members of medicines committees

Thailand • Group purchasing as a good tool to control drug prices

• Practice guidelines for medicines promotion

• Information database on Selection, Registration, Procurement, Drug Price

• Ethical framework, conflict of interest forms

Malaysia • Training of trainer workshops on: (1) GGM concept in the pharmaceutical

sector; (2) areas of vulnerability to corruption; (3) proposed counter-

measures and way forward; (4) techniques and skills to build culture of good

governance.

Macedonia • Guideline for public procurement in the health sector includes transparency

procedures, limited emergency procurement, open tenders




Facilitating factors for effective

implementation

High national priority to tackling corruption including tangible

support at highest political levels

Other programmes or processes already in place

Engagement of other ministries i.e. ministry of finance

Dedicated GGM management group comprising senior

stakeholder representatives

WHO technical support, benchmarking progress and sharing

lessons



The MeTA Hypothesis

Robust & relevant

information

collected

Information made

available to

relevant

stakeholders

Evidence-based

policies and

implementation

Multi-sector data

sharing and

analysis

Improved access to

medicines



MeTA process

Identifying challenges or

gaps

Setting priorities

Defining a baseline

Agreeing the process

Gathering data

Assessing data

Policy

dialogue

Disseminatio

n of data and

messages

Multi-stakeholder

dialogue

Evidence

based

policy

Advocacy

Voice

presented by deirdre dimancesco who department of ......anti-corruption meta ggm better access to...

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