9th October 2017

64thSession of

the Regional Committee

for the Eastern Mediterranean

Islamabad, Pakistan9–12 October 2017

Good Governance

for Medicines Program in the East Mediterranean Region

Presentation Outline

The need for Good Governance for Medicines

WHO Good Governance for Medicines Program – GGM

Status of implementation of GGM in the East Mediterranean Region and the results

Low Access to Medicines…

Only

45%of 30 essential

medicines

surveyed in 40

developing countries

have shown

availability

Wastage and corruption

…despite high % of spending

20-60%of MoH recurrent health

budget is spent on medicines

60-70%of out of pocket expense

on medicines

3/10leading causes of health system inefficiencies are

medicines related

2/3 of scarce medicine

supplies in hospitals are “lost” to theft and

corruption

R&D

Manufacturing

Procurement and supply

Distribution

Prescribing

Dispensing

Pharmaceutical Supply Chain

Use

Inefficiencies Malpractices

WHO GGM Programmesupporting policy-makers & managers in 37 countries

To contribute to health systems strengthening by reducing/preventing vulnerability to corruption in the pharmaceutical sector.

Specific objectives

To increase transparency and accountability in medicine regulatory and supply management systems

To promote individual and institutional integrity in pharmaceutical sector

To institutionalize good governance in pharmaceutical systems by building national capacity and leadership

WHO Good Governance for Medicines programme

PHASE II

Development

national GGM

framework

PHASE III

Implementation

national GGM

programme

PHASE I

National

transparency

assessment

MOHClearance

GGM framework

officiallyadopted

Assessmentreport

GGM integrated

in MoH plan

Regulatory Functions: Registration / Licensing / Inspection / Promotion / Clinical Trials

Supply Chain Functions: Selection / Procurement / Distribution

GGM Implementation in EMR

PHASE II

Development

national GGM

framework

PHASE III

Implementation

national GGM

programme

PHASE I

National

transparency

assessment

MOHClearance

1. Bahrain

2. Iraq

3. Morocco

4. Yemen

1. Afghanistan

2. Egypt

3. Iran

4. Kuwait

5. Pakistan

6. Palestine

7. Tunisia

8. Sudan

1. Iran

2. Jordan

3. Lebanon

4. Oman

Since 2007 – 16 countries – Financially supported by Kuwait

Summary of Assessment Scores in EMR Countries

Vulnerability Level

1 MS is yet to report GGM assessment results;

Summary Findings – areas for improvement

RegistrationConflict of interest policy

Committee composition & TOR

LicensingConflict of interest policy

Written guidelines for assessing applications for a license

InspectionConflict of interest policy

Appeals mechanisms

PromotionComplete provisions to cover all

Establish monitoring committee

Clinical trialsConflict of interest policy

Clinical trials inspection system

SelectionConflict of interest policy

Selection criteria for members

ProcurementConflict of interest policy

Audit results publicly available

Distribution

SOPs for stock management system at each level of distribution

Systematic and orderly shelving of products in warehouses

A glimpse of achievements

Iran regulations on drug promotion introduced, declaration of conflict of interest forms developed for Legal Commissions, Drug Selection committee and Clinical trials committee, platform of the National Inspection Organization (Ombudsman)

Jordan developed Conflict of Interest guidelines, have introduced stronger sanctions against unethical marketing of pharmaceuticals and have adopted a code of conduct for pharmacists

Lebanon developed a new code for medicinal drug promotion, members of all committees have to sign Conflict of Interest forms and guidelines and first ever “requirements for clinical trials” have been adopted

Oman established a steering committee headed by the Minister of health to implement GGM related reforms after adopting the GGM framework

1. Iran

2. Jordan

3. Lebanon

4. Oman

Impact of Good Governance for Medicines Programme

In EMR MSs impact is yet to be assessed. The program has brought more transparency, new instruments have been developed and more efficiency is being achieved.

The programme in Thailand has resulted in the development of:

•A Regional Group Purchasing Strategy

•A Monopoly Drug Management Policy

•A Compulsory Licensing Law

•A Corruption Control Mechanism

•Socialization (A Whistle Brower Protection)

•Integration of 3 Health Security Schemes

11

Impact in Thailand

Item Pack Unit

Price USD(pre-GGM)

Price USD(Post-GGM)

% CostReduction

Diclofenac tab 25 mg

500 3.2 1.7 47

Medroxyprogesterone amp 50 mg/ml (3 ml)

1 0.48 0.4 16

Ranitidine tab 150 mg

500 6.0 5.3 12

Salbutamol sol 0.5 % (20 ml)

1 2.8 2.6 7

Regional Group Purchasing

Key Messages

1. Good Governance in Medicines is essential for addressing inefficiencies and malpractices

2. The Program needs to be strengthened and expanded in the region

3. We seek Member States guidance and support