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Zambia’s Porous Borders & the Influx of Medicines

Zambia’s Porous Borders & the Influx of Medicines. Influx of Counterfeits . Counterfeit medicines have serious consequences such as: Erosion of public confidence in health-care systems Loss of public confidence and faith in the medicines and in the health care system

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Zambia’s Porous Borders & the Influx of Medicines

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  1. Zambia’s Porous Borders & the Influx of Medicines

  2. Influx of Counterfeits • Counterfeit medicines have serious consequences such as: • Erosion of public confidence in health-care systems • Loss of public confidence and faith in the medicines and in the health care system • Pharmaceutical companies may lose interest to invest in research and development and future innovation because the counterfeit product deprives them of significant amount of revenues. • Counterfeit medicines particularly affect the most disadvantaged people in poor countries • Emergence of drug resistant pathogens, bacteria, viruses, parasites. 

  3. Measures by Pharmaceutical Regulatory Authority (PRA) to combat counterfeit products • Registration of products for use on the Zambian market • Increased Post Marketing Surveillance (PMS) by the PRA Inspectorate • Formation of the Medical Drugs Task Force – MoU between the Ministry of Health PRA and the Ministry of Home Affairs (Zambia Police and Drug Enforcement Commission) signed on 18th November 2008 - combined teams of inspectors go to inspect outlets, to deter illegal traders form selling medicines of questionable quality to the public • PRA participated in the Regional operation to combat counterfeits -“Operation Zambezi” which was conducted in Zambia, Zimbabwe, Malawi and Swaziland in October 2009 • Introduction of the Pharmacovigilance Unit to monitor drug safety profiles and adverse drug reaction reports • Technical support for the establishment of the National Drug Quality Control Laboratory through the Drug Supply Budget Line - MOH..

  4. Challenges • Porous borders - Zambia is a landlocked country with eight neighbors and multiple ports of entry, not all ports are manned by PRA inspectors • Lack of adequate legislation prohibiting counterfeiting of drugs • Lack of a National Drug Quality Control Laboratory • Shortage of human resource at the Regulatory Authority resulting in weak enforcement of drug laws • Weak penal sanctions • Shortage or erratic supply of drugs • Lack of sophisticated equipment to inspect passenger luggage at the ports of entry • Sophistication in clandestine drug manufacture

  5. Way Forward • Develop, strengthen and promulgate appropriate legislation; need to review legislation and clearly define counterfeit, substandard, distribution channels, forfeiture, confiscation, destruction, sanctions/penalties, and designate ports of entry in new legislation • Support regional harmonization initiatives in the fight against counterfeits i.e. harmonized approach, harmonized legislation and harmonized sanctions • Develop and strengthen PRA’s capacity to combat counterfeit medical products by equipping it with latest technology • Establish/Operationalize the National Drug Quality Control Laboratory at the PRA

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