WHO Good Governance for Medicines programme - Zambia 13 th ICDRA Meeting Ms Esnat Mwape Director General Berne, Switzerland 19 th September, 2008 Pharmaceutical Regulatory Authority, Zambia
Presentation outline Geographical position Background: Brief overview of the Zambian pharmaceutical sector GGM baseline assessment Results of analysis Way forward & Next steps Recommendations and conclusions
Zambia History, Geography and Economy Political independence : 1964 Multipartyism: 1991 Landlocked country Area: 752,612sqkm Population: 11.2mlnpeople (2005) Copper is main export Poverty estimates: 70-73% Life expectancy: 37years Least developed country Corruption Perception Index (2007): 2.6 Victoria Falls in Livingstone
Background information (1) Pharmaceutical business is regulated under the Pharmaceutical Act of 2004. The National Drug Policy provides policy direction for implementation of activities to improve the pharmaceutical sector. Pharmaceutical Act of 2004 establishes and mandates the PRA to regulate the pharmaceutical business in Zambia.
Background information (2) WHO provides support to the Essential Medicines Programme in Zambia including Traditional activities in the areas of Policy, Access, Regulatory, Rational Use and Monitoring. WHO GGM Initiative is a project to support government strengthen policy and operational management of essential medicines.
Background information (3) PRA is responsible for Registration of medicines, Inspections & Licensing of pharmaceutical establishments, Control of advertising and promotion of medicines, Issue of Import and Export licenses and Permits National Formulary Committee is responsible for selection of pharmaceutical products including the National Essential Medicines List The Formulary committee is multidisciplinary drawing its members from medical, pharmaceutical, dental and allied health professionals. Members are drawn from both the public and private sectors
Background Info (4) Ministry of Health (MOH) and its directorates through the Drug Supply Budget Line and in liaison with the Medical Stores Ltd (MSL) is responsible for forecasting and quantification of pharmaceutical products for public sector use Cooperating Partners support logistics management of antiretroviral medicines and are supporting capacity building initiatives in pharmaceutical management in public sector health institutions Procurement and Supplies Unit of the MOH is responsible for the procurement of medicines for public sector using funds from Government and Cooperating Partners MSL is responsible for Storage and Distribution at central level Churches Health Association of Zambia is also involved in medicines supply and management as a complementary service to government system
Background information (5) Private pharmaceutical sector consists of Local Manufacturers, Importers/Wholesalers, and Retailers Local manufacture contributes about 15% of all products available on the Zambian; Medicines are mainly imported from India, Africa, Europe, US, China and East Africa Main buyer of medicines and allied products is government
MOH Estimated Drug and Supplies Needs, $48.5 Million Other Supplies $3.4 7% Health Centre Kits $3.9 8% Special Drugs $1.5 3% HIV (& TB) Drugs & Supplies Current 2005 Funding $30 Million Could Explode to as much as $300 Million in coming years TB & Leprosy $1.5 3% HIV Supplies $2.0 4% HIV And TB $14.5M Others $4.9M Traditional Essential Drugs $11.1M Vital $4.5 9% Essential $2.5 5% Necessary $0.2 0% ARVs $11.0 24% EPI $9M Vaccines $8.1 17% Malaria $9M EPI Supplies $0.9 2% Malaria Supplies $5.0 10% (M. Huff-Rousselle, etal., 2007) Coartem $4.0 8%
Corruption Zambia s experiences and challenges (1) Anti Corruption Commission - established in 1980 Corruption perceived to be quite rampant 1991 2001, Government perceived to have no political will to fight corruption; 2002 to date Government to have strong political will to fight corruption Task Force on corruption was created Both private and public sector endeavours to be effective, transparent and accountable; Grand corruption, political corruption, petty corruption, nepotism; Corruption in procurement and budget mismanagement are common.
Corruption Zambia s experiences and challenges (2) Government with support from CPs introduced PSRP whose priorities included: Rightsizing ministries and other government agencies Retention schemes for qualified staff; Transparent and effective budget and procurement systems
Zambia s participation in GGM activities Mid-2007 WHO (Geneva) invited Zambia s participation in the GGM programme National assessors appointed and attended training organised by the WHO in September, 2007 African states included: Zambia, Egypt, Cameroun, Mozambique and Ethiopia Assessment conducted in November/December 2007 Dissemination of findings at inter-regional workshop in Jordan Zambia hosted the second inter-regional meeting for assessors in April 2008 Zambia held a national stakeholders meeting to disseminate results in July 2008 and established a GGM National Steering and Coordinating Committee.
Why did Zambia choose to participate in the programme? Goals of the programme were in line with the government vision and policy in its fight against corruption; Recognised need to improve transparency and accountability in the pharmaceutical sector; Need for sensitisation and increased awareness on the potential for corruption in the pharmaceutical Sector; Need to build capacity for implementation of good governance principles at all levels.
Areas of Assessed Registration of medicines Promotion of medicines Inspection of pharmaceutical establishments Selection of medicines Public Procurement of medicines Supply and Distribution
General Findings (1) Distribution scored highest Selection and promotion got the lowest scores Although current regulations have provisions on control of medicines promotion, many key informants believed that very little was being done in this area A number of regulations and guidelines related to registration and inspections were being developed by PRA; Although some key informants indicated that there were COI forms available, copies were not made available to the assessors except at PRA The common unethical behaviors in medicines management were bribery, favouritism and conflict of interest
General Findings (2) Scoring Area Total indicators Number of KIs Score Degree of vulnerability Registration 12 9 6.95 Marginal Promotion 8 12 5.13 High Inspection 8 11 8.03 Marginal Selection 8 11 5.19 High Procuremen t 11 15 6.68 Marginal Distribution 12 11 9.57 Minimal Total 59 69 6.92 Marginal
Vulnerability Vs Area assessed 12 10 8 6 4 2 0 Level of V ulnarability Promotion Selection P rocureme nt Registration Inspection Distribution Average Area Series1
Conclusion There is some level of vulnerability to Corruption in medicines supply system in Zambia
Perceived Common Unethical practices clinical trials Patent Falsification of safety/efficacy data Manufacturing Conflict of interest Registration Pricing Fraud Selection Bribery Procurement & import Overinvoicing Counterfeit/ Substandard medicines Unethical donations State/regulatory capture Unethical promotion Distribution Promotion Thefts Pressure Tax evasion Inspection
Unethical practices can have significant impact on health systems Health impact Unsafe medicines on the market Lack of availability of essential medicines in public health facilities Irrational use of medicines Economical impact Pharma. expenditure in low-income countries: 15% of public health budget Poor most affected inequalities Image and trust impact Reduces government capacity Reduces credibility of health profession Erodes public trust in the public healthcare delivery system
Zambia Good Governance for Medicines programme - Roadmap National GGM dissemination workshop July 2008 PHASE I National transparency assessment Nov/Dec 2007 PHASE II Development national GGM Framework In the process PHASE III Implementation national GGM Programme Assessment report GGM framework officially adopted Communication plan
Our Strategies include "Discipline-based approach" (top-down) Laws, policies and procedures against corruption and for pharmacy practice with adequate punitive consequence for violation Attempts to prevent corrupt practices through fear of punishment "Values-based approach" (bottom-up) Promote institutional integrity through promotion moral values and ethical principles Attempts to motivate ethical conduct of public servant
Recommendations (General) Establish and implement codes of conduct to include: conflict of interest, confidentiality, gifts, etc; Enforcement of anticorruption laws; Transparency and access to information; Protection of whistleblowers; Improve management systems; Improve Inter-institutional collaboration and cooperation; Provide guidelines to define and underpin PPPs so as to prevent and fight corruption Improve publicprivate partnership to fight corruption.
Way forward Establishment of a GGM National Steering and Coordinating Committee to over see the implementation of the GGM programme Create linkages between similar efforts such as MeTA to create and support an anti- corruption environment in pharma sector Develop the country GGM Implementation Framework Implementation and monitoring of GGM Implementation Framework
In conclusion 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 the victims of corruption around the world and with them, opportunity and hope Transparency international ZERO TOLERANCE ON CORRUPTION
Acknowledgements MOH, Zambia and its Cooperating Partners WHO and its partners National assessors National Stakeholders Thank you for your attention