LCSHD and Pharmaceuticals

1
Ethical Infrastructure for Good Governance in
Public Pharmaceutical Sector (GGM Project) MeTA
expert consultation meeting London, March 13,
2007 Dr. Guitelle Baghdadi Director of GGM
Project, WHO, Geneva Dr Eloy Anello WHO
Consultant
Department of Medicines Policy and Standards
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

3
Unethical practices can be found throughout
medicines chain are very diverse
RD and clinical trials
Patent
Manufacturing
Collusion
Registration
Evergreening
Bribery
Pricing
Fraud
Overinvoicing
Selection
Cartels
Procurement import
Falsification of safety/Efficacy data
Counterfeit/ substandards
Distribution
Promotion
Conflict of interest
Unethical donations
Inspection
Unethicalpromotion
State/regulatory capture
Pressure
Tax evasion
Thefts
4
Corruption identified as the single greatest
obstacle to economic and social development

• US 3 trillion spent on health services annually
• Global pharmaceutical market gt US 500b
• 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

5
Unethical practices can have significant impact
on the health system

• Health impact
• Lack EM ? increases morbidity mortality
• Unsafe medicines on the market
• Irrational use of medicines
• Economical impact
• Pharma. expenditure 20-50 of total health care
  expenditures (low-income countries)
• Poor most affected ? inequalities
• Image and trust impact
• Reduces government capacity
• Reduces credibility of health profession
• Erodes public trust

6
WHO Good Governance for Medicines Programme

• Goal
• Curb corruption in the pharmaceutical public
  sector through promotion of ethical practices in
  medicines regulation and procurement 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

7
Efforts to address corruption need coordinated
application of two basic strategies

• "Discipline-based approach" (top-down)
• Legislative reform establishes laws against
  corruption with adequate punitive consequence for
  violating the laws
• Policies and administrative procedures
• Attempts to prevent corrupt practices through
  control mechanisms and 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

8
Tackling corruption requires long-term strategy
and GGM implementation includes 3 main phases

• Phase 1
• National assessment of transparency
  vulnerability to corruption
• Phase 2
• Development of national ethical infrastructure
  based on consensus building
• Phase 3
• Socializing the national ethical infrastructure
  (ethical framework learned, internalized, applied
  and promoted by group of key MOH actors ?
  institutional culture)

9
Bottom-up approach in implementation of project
and policy development
Phase 1 (2 countries)
Phase 2 (5 countries)
Phase 3 (2 countries)
10
Good Governance for Medicines programme a model
process
11
Phase I assessment of transparency level
vulnerability to corruption

• Assessment of 5 key functions
• registration, promotion, inspection, selection
  procurement soon distribution
• Quantitative and qualitative information
• Structures and procedures (documents publicly
  available, decision making process, management of
  conflict of interest
• Perceptions on systemic application of procedures
• Identifies loopholes in the systems ?
  recommendations to increase transparency

12
Phase II development of national ethics
infrastructure based on consensus building

• Framework of moral values and ethical principles
• Code of conduct (CC)
• Mechanisms for whistle-blowing
• Sanction of reprehensible acts
• Coordination, management and evaluation
  programmes
• Tools for promotion and socialization of
  framework CC

13
Elements of an Ethical Framework

• Core moral values
• Ethical principles derived from moral values

14
Consensus among 9 Asian countries on core moral
values for promoting ethical practice (Panang,
Milaysia)

• Justice / Fairness
• Truth
• Service to the common good
• Fiduciary responsibility

15
Principles of Justice

• Equity in administering rewards and punishments
• Equality of rights and opportunities
• Participation in the consultative process in
  collective decision making
• Merit system in contracting personnel

16
Principles of Truth

• Transparency in decision making and resource
  management for public scrutiny
• Evidence based decision making
• Truthfulness in reporting facts
• Honesty in managing resources
• Safeguards for whistle-blowers

17
Principles of Service to the Common Good

• Consensus building regarding the common good
• Application of human development indicators
• Inclusiveness
• Spirit of service
• Respect for human dignity

18
Principles of Fiduciary Responsibility

• Legal and contract between government and public
  servant
• Moral imperative of responsible stewardship
• Efficient and effective service of the public
  interest
• Transparency regarding possible conflict of
  interests
• Recognition of merit and adequate renumeration

19
Phase III promting and socializing the
components of the Ethical Infrastructure

• A four stage process that facilitates the
  establishment of an institutional ethical
  infrstructure consisting of both top-down and
  bottom-up approaches
• Preparation for implementation of process
• Awarness / consciousness raising regarding issues
• Capacity building for implementing Ethical
  Infrastructure
• Sustained application of Ethical Infrastructure

20
The case of Bolivia

• Milestones of Phase I
• Transparency Assessment of Pharmaceutical Sector
  of MOH completed and results and recommendation
  processed with MOH personnel at National
  Workshops and meetings
• Technical Commision formed within the MOH to
  elaborate a National Ethical Framework and Code
  of Conduct
• Recommendations derived from Assessment formally
  presented to the Minister of Health and Vice
  MInister of Health
• MOH of Bolivia planning to publish the Assessment
  for distribution

21
Case of Bolivia

• Milestones of Phase II
• Elaboration and official presentation of the
  National Ethical Framework and Code of Ethics for
  the Good Governance of the Public Farmaceutical
  Sector
• Issuance of Miniserial Resolution by MHO
  offically approving the National Ethical
  Framework and Code of Conduct and mandating their
  promotion socialization at the National, State
  and Municipal levels of the MOH

22
Case of Bolivia

• Milestones of Phase III
• Stage one preparations have begun for the
  promotion of the ethical framework and code of
  ethics and for the application of the
  recommendations proposed in the Transparency
  Assessment
• Search for funding for Stage III of GGM Project
  in Bolivia