1. International Medical Products Anti-CounterfeitingTaskforce

2. Map of Our Country

3. A counterfeit pharmaceutical product can be defined as a pharmaceutical product which is deliberately and fraudulently mislabeled with respect to identity and/or source. According to WHO. We have no specific legislation that has attempted to give a definition of counterfeit medical products. Definition of counterfeit medical product used in our country

4. There is no National Legislation specific on counterfeit medicinal products in Zambia. However, the Pharmaceutical Act No 14 of 2004 Part IV Section 33. (1) provides that – A person shall not manufacture, import, export, distribute or sell substandard, counterfeit or adulterated medicines or allied substances. The penal code sections 363 and 376 give provisions on counterfeit coins and counterfeiting trademark respectively Our National Legislation

5. Pharmaceutical Act No 14 of 2004 Part IV 33. (2) provides for the penalties as follows: A person who contravenes subsection (1) commits an offence and shall be liable upon conviction, to a fine of not less than three hundred thousand penalty units but not exceeding five hundred thousand penalty units or to imprisonment for a term of not less than five years but not exceeding ten years, or both. 1 penalty unit is = K180 Thus K 54 to 90 Million (12 – 20 thousand US dollars) Penalties

6. The MDTF is a grouping of ZP, PRA, DEC and MOH but does not address IPR protection It deals with the actual chemical composition $ quality aspects of the drugs and Help in the enforcement of the PRA Act Operation Zambezi (12 – 16 october 2009 in Lusaka) highlighted serious limitations of the MDTF. Efforts have since been made towards the formation of a National Steering Committee targeted at counterfeit medical products. National coordination

7. Number of cases SuspectedConfirmedImported / DomesticVital Medicines 200804Nil04 2007Nil 2006Nil 2005Nil How where these cases detected? number of cases Patients complaints 01 Health professionals reportsNil Enforcement/investigation workNil Routine checks02 Reported by affected manufacturer/importer01 OtherNil

8. Only two (2) cases prosected Two companies involved were successfully prosecuted and convicted (fined) in 2008. One is still pending. Number of prosecutions, convictions & pending cases

9. Establish a National Steering Committee on counterfeit medicinal products Fully equip and expand the National Pharmacovigilance Unit at PRA so as to effectively handle counterfeit medicinal products. Establish a fully fledged National Drug Quality Control Laboratory Increase capacity and staffing levels for inspectors Our proposals for action