Transcript Pharmaceutical Act No 14 of 2004 Part IV 33. (2) provides for the

International
Medical Products
Anti-Counterfeiting
Taskforce
Map of Our Country
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.
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
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)
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.
Number of cases
Suspected
Confirmed
Imported / Domestic
Vital Medicines
2008
04
Nil
04
04
2007
Nil
Nil
Nil
Nil
2006
Nil
Nil
Nil
Nil
2005
Nil
Nil
Nil
Nil
How where these cases detected?
number of cases
Patients complaints
01
Health professionals reports
Nil
Enforcement/investigation work
Nil
Routine checks
02
Reported by affected manufacturer/importer
01
Other
Nil
Number of prosecutions,
convictions & pending cases
• Only two (2) cases prosected
• Two companies involved were successfully
prosecuted and convicted (fined) in 2008.
• One is still pending.
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