WHO Good Governance for Medicines programme Me TA

WHO Good Governance for Medicines programme Me. TA Launch Dr Guitelle Baghdadi-Sabeti Geneva, 21 May 2008 st 61 World Health Assembly Department of Medicines Policy and Standards

Corruption identified as the single greatest obstacle to economic and social development q US$ 3 trillion spent on health services annually q Global pharmaceutical market: > US$ 600 b q 10 to 25% procurement spending lost into corruption (including health sector) q Some countries report that 2/3 medicines supplies lost through corruption and fraud in hospitals q Low quality trials exaggerate the benefits of treatment by an average of 34% q Bribery of high officials in regulatory authorities has led to unsafe medicines circulating on the market resulting in deaths Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines 2

Unethical practices can be found throughout medicines chain & are very diverse R&D and clinical trials Evergreening R&D priorities Collusion Patent Fraud Manufacturing Overinvoicing Registration Falsification of safety/Efficacy data Thefts Cartels Pricing Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines 3 Unethical donations Procurement & import Unethical promotion Pressure Counterfeit/ substandards Selection Conflict of interest State/regulatory capture Bribery Tax evasion Distribution Promotion Inspection

Unethical practices can have significant impact on health systems q Health impact ì Unsafe medicines on the market ì Lack EM in health facilities ì Irrational use of medicines q Economical impact ì Pharma. expenditure low-income countries: § ì 10 -40% of public health budget § 20 -50% of total health care expenditures Poor most affected inequalities q Image and trust impact ì Reduces government capacity ì Reduces credibility of health profession ì Erodes public trust Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines 4

Numerous technical guidelines already exist… the challenge is to balance them with ethical practices Technical guidelines q GMP q GCP q Counterfeits q Manual on Marketing Authorization q WHO model list of EM q Good procurement practices q Ethical criteria q Etc… Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines 5 Ethical practices q Rule of law q Accountability q Transparency q Participation q Merit system q Evidence-based decisionmaking q Honesty q Efficiency and effectiveness q Etc…

WHO Good Governance for Medicines Programme q Goal ì To curb corruption in pharmaceutical sector systems through the application of transparent and accountable administrative procedures and the promotion of ethical practices among health professionals. q Specific objectives ì To increase the awareness of all stakeholders on the potential for corruption in the pharmaceutical sector and its impact on health systems functioning. ì To increase transparency and accountability in medicines regulatory systems and supply management systems. ì To build national capacity for good governance in medicines regulation and supply management systems. Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines 6

Good Governance for Medicines programme: a model process Clearance MOH PHASE III National transparency assessment Development national GGM framework Implementation national GGM programme Assessment report Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines 7 GGM framework officially adopted Communication plan

Efforts to address corruption need coordinated application of two basic strategies q "Discipline-based approach" (top-down) ì Laws, policies and procedures against corruption and for pharmacy practice with adequate punitive consequence for violation ì Attempts to prevent corrupt practices through fear of punishment q "Values-based approach" (bottom-up) ì Promotes institutional integrity through promotion moral values and ethical principles ì Attempts to motivate ethical conduct of public servant Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines 8

What could be the components of a national GGM Framework? 1. Ethical framework of moral values & ethical principles 5. Established anti-corruption legislation ì Justice/fairness 6. Whistle-blowing mechanism ì Truth 7. Sanctions on reprehensible acts ì Service to common good ì trusteeship 2. Code of conduct 3. Socialization programme 4. Promotion of Moral Leadership Values based approach Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines 9 8. Transparent and accountable regulations and administrative procedures 9. Collaboration with other GG & AC initiatives 10. Management, coordination and evaluation of GGM programme (Steering Committee & task force) Discipline based approach

Bottom-up approach in implementation of project and policy development Phase I (13 countries) Phase II (10 countries) Phase III (4 countries) Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines 10

PHASE III Progress in countries q Nb countries: ì 18 completed ì 9 currently on-going q Publications: ì 4 -country study: Laos, Malaysia, Philippines, Thailand ì 5 -country study: Bolivia, Cambodia, PNG, Mongolia, Indonesia (upcoming) ì Future: individual country reports Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines 11

PHASE III Progress in countries q National workshops: ì Share results assessment ì Consult on national GGM framework q National GGM Steering Group and/or Task Force q Consultation phase to finalize national GGM framework q Official adoption of national GGM framework Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines 12

PHASE III Progress in countries q Mongolia ì Official establishment of national GGM committee ì Regional technical groups (including training) ì Campaigns to promote awareness (educational material) q Philippines ì GGM pharmaceutical benchbook ì Awards system for local units q Thailand ì Workshops on GGM framework ì Newsletters, public communications (media, brochures, websites) ì Introduction in university curricula q Bolivia (waiting clearance Po. A by MOH) ì Develop national GGM programme (national and regional consultations) ì Orientation meeting for MOH staff ì Campaign for promoting awareness Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines 13

Key next steps for 2008 q Analyse experience from 4 phase III countries and further refine WHO global guidance q Establish system to collect learning in countries and facilitate communications b/w countries q Scale up to more countries q Publish more country assessment reports q Next Global Stakeholders Group in Alexandria q Explore collaboration with private sector q Raise funding for wider implementation of the programme Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines 14

"I never worry about action, but only inaction. " Winston CHURCHILL Department of Medicines Policy and Standards May 2008 – Good Governance for Medicines 15