Transcript Zambia`s Porous Border - Medicines Transparency Alliance

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 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..
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