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 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.

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 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..

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

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