International Medical Products Anti-CounterfeitingTaskforce

IMPACTs Legislative Principles Document: Feedback from Tanzania Legal Officer cum Investigator Tanzania Food and Drugs Authority (TFDA)

MAP OF TANZANIA

It is manufactured under a name which belongs to another medicine. It is an imitation of, or substitute for another medicine, resembles another medicine likely to deceive or bears upon its label or container the name of another medicine unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other medicine. The label or container bears the name of an individual or company purporting to be a manufacturer of the medicine; which individual or company is fictitious or does not exist. It has been substitute wholly or in part by another medicinal substance; It purports to be it is a product of manufacturer of whom it is not truly product. Definition of Counterfeit Medical Product in Tanzania

The Tanzania Food, Drugs and Cosmetics Act No.1 of 2003 The Merchandise Act (R.E, 2002) as ammended in 2008 The Penal Code Cap16 (R.E, 2002) National Legislation

Upon conviction as per Tanzania Food, Drugs and Cosmetics Act No.1, 2003; –Fine of not less than TZS 5 million (About 3,850 USD) –Imprisonment of not less than 2 years –Both fine and imprisonment –Disposal of counterfeit medical products at the owner`s cost Other Legislations could be used when deemed necessary Other Penalties

Fair Competition Commission under the Ministry of Industries, Trade and Marketing is responsible for combating counterfeit products Combating counterfeit medical products –Joint Task Force has been established since 2007 drawing members from Tanzania Food and Drugs Authority The Tanzania Police Force Fair Competition Commission Tanzania Revenue Authority (Customs Department) National coordination

Medical Stores Department (MSD) Presidents Office Pharmaceutical Services Unit (PSU) under the Ministry of Health and Social Welfare The Taskforce has conducted two successful operations between 2008 and 2009 Operation Mamba

Number of cases SuspectedConfirmedImported / DomesticVital Medicines ALL1(Duo cotecxin) ALL1 (Cialis) ALL ALL- How were these cases detected? number of cases Patients complaints ( ) 2 (Gentrisone and Vicks Kingo Lozenges) Health professionals reports1 (Cialis) Enforcement/investigation work9 Routine checks ( )2 Reported by affected manufacturer/importer ( )1 (Celestamine), 2008 Other

2008: 44 cases following Operation Mamba –Prosecution:05 –Conviction:01 –Pending:10 –Administrative Action taken: 28 Number of prosecutions, convictions & pending cases

Need to harmonize definition at global level Review national legislation to improve penalties against counterfeiters WHO/IMPACT to support establishment of national taskforces to carry out joint operations with members drawn from; –Medicines regulatory authority –The Police –Customs –Other law enforcers Proposals for action

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