Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 1

Corruption, a major barrier to access to medicines

WHO/UNICEF Technical Briefing Seminar21 September 2006

Dr Guitelle BaghdadiWorld Health Organization, Geneva

Department of Medicines Policy and Standards

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 2

Corruption requires two parties: the corrupter and the corruptee

"Whose is the greater blame?

She who sins for pay or he who pays for sin?"

Sor Juana Inés de la Cruz

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 3

Overview

WHO Good Governance for Medicines project

A few questions…

Corruption in the pharmaceutical sector

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 4

Overview

WHO Good Governance for Medicines project

A few questions…

Corruption in the pharmaceutical sector

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 5

Corruption identified as the single greatest obstacle to economic and social development

US$ 3 trillion spent on health services annually

Pharmaceutical expenditure: 20 to 50% of total health expenditure (dev. countries)

10 to 25% procurement spending lost into corruption (including health sector)

Some countries report that 2/3 medicines supplies lost through corruption and fraud in hospitals

Affects also donor community: GFATM suspended or terminated grant agreement because of corruption concerns

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 6

Patent

R&D and clinical trials

Manufacturing

Pricing

Distribution

Registration

Selection

Procurement & import

Promotion

Inspection

Conflict of interest

Evergreening

Counterfeit/substandards

Tax evasion

Falsification of safety/Efficacy data

Bribery

State/regulatory capture

Overinvoicing

Pressure

Unethicalpromotion

Thefts

FraudCartels

Collusion

Unethicaldonations

Potential unethical practices could be found throughout medicines chain

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 7

Unethical practices can have significant impact on the health system

Economical impact Pharma. expenditure low-income

countries: 10-40% of public health budget 20-50% of total health care

expenditures Poor most affected inequalities

Health impact Lack EM increases morbidity & mortality Unsafe medicines on the market Irrational use of medicines

Image and trust impact Reduces government capacity Reduces credibility of health profession Erodes public trust

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 8

Efforts to address corruption need application of two basic strategies: "discipline" & "values"

"Discipline approach" (top-down)

Legislative reform: establishes laws against corruption with adequate punitive consequence for violating the laws

Attempts to prevent corrupt practices through fear of punishment

"Values approach" (bottom-up)

Promotes institutional integrity through promotion moral values and ethical principles

Attempts to motivate ethical conduct of public servant

Coordinated application of both strategies

required for significant impact

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 9

Overview

A few questions…

Corruption in the pharmaceutical sector

WHO Good Governance for Medicines project

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 10

Good governance for medicines regulation and procurement

Goal

Curb corruption in the pharmaceutical public sector through promotion of ethical practices in medicines regulation and procurement by health professionals and the application of transparent administrative procedures

Objectives

Increase awareness on potential for corruption and impact on health systems functioning

Increase transparency and accountability in medicines regulatory authorities and procurement systems

Build capacity for good governance

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 11

Implemented in countries with a 3-step approach

Phase I:

National assessment of transparency & vulnerability to corruption

Phase II:

Development of national ethical framework based on consensus building

Phase III:

Socializing the national ethical framework through reflection meetings and training national officials on good governance.

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 12

Phase 1 (3 countries)

Phase 2 (4 countries)

Bottom-up approach in implementation of project and policy development

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 13

Assessment tool: measures transparency in the public pharmaceutical sector & vulnerability to corruption: diagnostic tool recommendations

Evaluation indicators (questionnaires)

Collect information and perceptions (interviews)

Analyse information collected:

rough quantificationnarrative description

(report)

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 14

Phase II: development of national ethics infrastructure based on consensus building

1. Framework of moral values and ethical principles

2. Code of conduct (CC)

3. Mechanisms for whistle-blowing

4. Control of reprehensible acts

5. Coordination, management and evaluation programmes

6. Tools for promotion and socialization of framework & CC

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 15

Phase II: development of national ethics infrastructure based on consensus building

1. Framework of moral values and ethical principles

2. Code of conduct (CC)

3. Mechanisms for whistle-blowing

4. Control of reprehensible acts

5. Coordination, management and evaluation programmes

6. Tools for promotion and socialization of framework & CC

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 16

Focus on consolidating on-going efforts in countries and possibly add few new ones

Phase 1 (4 countries)

Phase 2 (4 countries)

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 17

Overview

WHO Good Governance for Medicines project

Corruption in the pharmaceutical sector

A few questions…

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 18

A few questions for reflection…

1. Do you believe that corruption exists in your country? Isolated cases or permissive culture?

2. What are the most common forms?

3. What are the possible causes?

4. What makes the pharmaceutical sector so vulnerable to corruption?

5. What do you think needs to be done to tackle corruption in the pharmaceutical sector on the long run?

Department of Medicines Policy and StandardsApril 2006 – Corruption, barrier to access to medicines 19

"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