WHO Good Governance for Medicines programme - Zambia

13th ICDRA Meeting

Ms Esnat MwapeDirector General

Pharmaceutical Regulatory Authority of ZambiaBerne, Switzerland

19th September, 2008

Pharmaceutical Regulatory Authority, Zambia

Presentation outline

Geographical positionBackground: Brief overview of the Zambian pharmaceutical sectorGGM baseline assessmentResults of analysisWay forward & Next stepsRecommendations and conclusions

Pharmaceutical Regulatory Authority of Zambia

Zambia – History, Geography and Economy

Pharmaceutical Regulatory Authority of Zambia

Political independence : 1964Multipartyism: 1991Landlocked countryArea: 752,612sqkmPopulation: 11.2mlnpeople (2005)Copper is main export Poverty estimates: 70-73%Life expectancy: 37yearsLeast developed countryCorruption 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.

Pharmaceutical Regulatory Authority of 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.

Pharmaceutical Regulatory Authority of Zambia

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 PermitsNational Formulary Committee is responsible for selection of pharmaceutical products including the National Essential Medicines ListThe Formulary committee is multidisciplinary drawing its membersfrom medical, pharmaceutical, dental and allied health professionals. Members are drawn from both the public and private sectors

Pharmaceutical Regulatory Authority of Zambia

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 pharmaceuticalproducts for public sector useCooperating Partners support logistics management of antiretroviral medicines and are supporting capacity building initiatives in pharmaceutical management in public sector health institutionsProcurement and Supplies Unit of the MOH is responsible for the procurement of medicines for public sector using funds from Government and Cooperating PartnersMSL is responsible for Storage and Distribution at central levelChurches Health Association of Zambia is also involved in medicines supply and management as a complementary service to government system

Pharmaceutical Regulatory Authority of Zambia

Background information…(5)

Private pharmaceutical sector consists of Local Manufacturers, Importers/Wholesalers, and RetailersLocal manufacture contributes about 15% of all products available on the Zambian;Medicines are mainly imported from India, Africa, Europe, US, China and East AfricaMain buyer of medicines and allied products is government

Pharmaceutical Regulatory Authority of Zambia

Health Centre Kits $3.9 8%

Vital $4.5 9%

Essential $2.5 5%

Necessary $0.2 0%

Vaccines $8.1 17%

EPI Supplies $0.9 2%

Coartem $4.0 8%Malaria Supplies $5.0 10%

ARVs $11.0 24%

HIV Supplies $2.0 4%

TB & Leprosy $1.5 3%

Special Drugs $1.5 3%

Other Supplies $3.4 7%

MOH Estimated Drug and Supplies Needs, $48.5 Million

Traditional Essential

Drugs$11.1M

EPI$9M

Malaria$9M

HIVAnd TB$14.5M

Others$4.9M

HIV (& TB)Drugs & Supplies

Current 2005 Funding

$30 MillionCould Explodeto as much as

$300 Millionin coming years

HIV (& TB)Drugs & Supplies

Current 2005 Funding

$30 MillionCould Explodeto as much as

$300 Millionin coming years

(M. Huff-Rousselle, etal., 2007)

Corruption – Zambia’s experiences and challenges (1)

Anti Corruption Commission - established in 1980Corruption perceived to be quite rampant1991 – 2001, Government perceived to have no political will to fight corruption;2002 to date – Government to have strong political will to fight corruptionTask Force on corruption was createdBoth 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 agenciesRetention schemes for qualified staff;Transparent and effective budget and procurement systems

Pharmaceutical Regulatory Authority of Zambia

Zambia’s participation in GGM activities

Mid-2007 WHO (Geneva) invited Zambia’s participation in the GGM programmeNational assessors appointed and attended training organisedby the WHO in September, 2007African states included: Zambia, Egypt, Cameroun, Mozambique and EthiopiaAssessment conducted in November/December 2007Dissemination of findings at inter-regional workshop in JordanZambia hosted the second inter-regional meeting for assessors in April 2008Zambia held a national stakeholders meeting to disseminate results in July 2008 and established a GGM National Steering and Coordinating Committee.

Pharmaceutical Regulatory Authority of Zambia

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.

Pharmaceutical Regulatory Authority of Zambia

Areas of Assessed

Registration of medicinesPromotion of medicinesInspection of pharmaceutical establishmentsSelection of medicines Public Procurement of medicinesSupply and Distribution

Pharmaceutical Regulatory Authority of Zambia

General Findings (1)

Distribution scored highestSelection and promotion got the lowest scoresAlthough 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 PRAThe common unethical behaviors in medicines management were bribery, favouritism and conflict of interest

Pharmaceutical Regulatory Authority of Zambia

General Findings (2) Scoring

Area Totalindicators

Number ofKIs

Score Degree ofvulnerability

Registration 12 9 6.95 MarginalPromotion 8 12 5.13 HighInspection 8 11 8.03 Marginal

Selection 8 11 5.19 HighProcuremen

t11 15 6.68 Marginal

Distribution 12 11 9.57 Minimal

Total 59 69 6.92 Marginal

Pharmaceutical Regulatory Authority of Zambia

Vulnerability Vs Area assessed

02468

1012

PromotionSelec tion

ProcurementRegistr

ationInspectio

nDis tr ib

utionAverage

Area

Leve

l of V

ulna

rabi

lity

Series1

Pharmaceutical Regulatory Authority of Zambia

Conclusion

There is some level of vulnerability to Corruption in medicines supply system in Zambia

Pharmaceutical Regulatory Authority of Zambia

Patent

clinical trials

Manufacturing

Pricing

Distribution

Registration

Selection

Procurement & import

Promotion

Inspection

Conflict of interest

Counterfeit/Substandard

medicines

Tax evasion

Falsification of safety/Efficacy data

Bribery

State/regulatory capture

Overinvoicing

Pressure

Unethicalpromotion

Thefts

Fraud

Unethicaldonations

Perceived Common Unethical practices

Pharmaceutical Regulatory Authority of Zambia

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

Pharmaceutical Regulatory Authority of Zambia

Zambia Good Governance for Medicines programme -Roadmap

PHASE II

Developmentnational GGMFramework

In the process

PHASE III

Implementation national GGM Programme

PHASE I

Nationaltransparencyassessment

Nov/Dec 2007

Assessmentreport

GGM frameworkofficiallyadopted

Communicationplan

National GGM dissemination

workshopJuly 2008

Pharmaceutical Regulatory Authority of Zambia

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

Pharmaceutical Regulatory Authority of Zambia

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 public-private partnership to fight corruption.

Pharmaceutical Regulatory Authority of Zambia

Way forward

Establishment of a GGM National Steering and Coordinating Committee to over see the implementation of the GGM programmeCreate linkages between similar efforts such as MeTA to create and support an anti- corruption environment in pharma sectorDevelop the country GGM Implementation FrameworkImplementation and monitoring of GGM Implementation Framework

Pharmaceutical Regulatory Authority of Zambia

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”

Pharmaceutical Regulatory Authority of Zambia

Acknowledgements

MOH, Zambia and its Cooperating PartnersWHO and its partnersNational assessorsNational Stakeholders

Thank you for your attention…

Pharmaceutical Regulatory Authority of Zambia