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International Medical Products Anti- Counterfeiting Taskforce

International Medical Products Anti- Counterfeiting Taskforce. Map of Our Country. Definition of counterfeit medical product used in our country.

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International Medical Products Anti- Counterfeiting Taskforce

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  1. International MedicalProducts Anti-Counterfeiting Taskforce

  2. Map of Our Country

  3. Definition of counterfeit medical product used in our country • 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.

  4. Our National Legislation • 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

  5. Penalties 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)

  6. National coordination 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.

  7. Number of cases How where these cases detected?

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

  9. Our proposals for action • 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

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