IMPACT - Regional Meeting on Combating Counterfeit Medical Products
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IMPACT - Regional Meeting on Combating Counterfeit Medical Products 9-10 November 2009, Kempton Park South Africa. WHO Survey on situation of counterfeit medicines in SADC Tanzania Food & Drugs Authority. Quick Overview of National Situations on Counterfeit Medicines. The Questionnaire

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IMPACT - Regional Meeting on Combating Counterfeit Medical Products9-10 November 2009, Kempton Park South Africa

WHO Survey on situation of counterfeit medicines in SADC

Tanzania Food & Drugs Authority


Quick overview of national situations on counterfeit medicines
Quick Overview of National Situations on Counterfeit Medicines

  • The Questionnaire

  • Findings

    • Legislation

    • Seizures

    • Sharing information

    • Collaboration

    • MRAs and WHO initiatives

    • Free Trade Zones

    • Market Control

  • Summary


The questionnaire
The Questionnaire Medicines

  • Developed from the data collection tool for review of national situations concerning counterfeit medicines

  • Objective - get a quick overview of the situation concerning counterfeit medicines in a country.

  • Pretested in Tanzania in August 2008

  • Tested in 8 African countries in 2008 (Results presented during Abuja IMPACT Regional meeting, October 2008)


The questionnaire 2
The Questionnaire (2) Medicines

  • There were 44 questions

    • Legislative aspects (5)

    • Anti-counterfeit actions (6)

    • Sharing information (5)

    • Collaboration with other departments (11)

    • NMRA and WHO initiatives (4)

    • Free trade zones (4)

    • Market control (9)

  • Response received from 5 countries

    • Botswana, Mauritius, Seychelles, Tanzania and Uganda


Legislation
Legislation Medicines

  • 3/5 countries use pharmaceutical legislation

  • 4/5 countries would welcome specific legislation on CM* addressing:

    • definition- 4 Countries

    • empowering NMRA - 5

    • criminalization of counterfeiting- 3

    • appropriate sanctions - 5

    • mechanisms for international, regional and national cooperation - 5

*CM=counterfeit medicines


Seizures
Seizures Medicines

  • 4/5 countries report having seized CM

  • Origin of seizures

    • NMRA 2

    • Police & customs 2

    • Pharmacists and other concerned persons 4

  • Gap identified

    • different answers from countries

  • 3 countries report having applied sanctions

    ( 2 applied civil and penal sanctions)


Sharing information
Sharing information Medicines

  • Only 3 replies received

  • No information sent outside country (Except 1 country to IMPACT)

  • 3/5 countries are aware of RAS*

  • No information to NMRA of country of origin of CM (one country : sometimes)

    RAS*: Rapid Alert System


Collaboration
Collaboration Medicines

  • 4 countries reported coordination with police and/or customs

    • joint actions carried

  • Reasons for poor collaboration

    • no tradition of cooperation (3)

  • In 4 countries

    • NMRA authorization required for clearing medicines at Customs

    • Only 2 countries provided number of permits issued


Nmras and who initiatives
NMRAs and WHO initiatives Medicines

  • Single Points of Contact (SPOC)

    • 4/5 countries aware of SPOC

    • 2 countries have designated SPOCs

  • 2 countries participated in at least 1 meeting


Free trade zones ftz
Free Trade Zones (FTZ) Medicines

  • 2 countries declared having FTZ

  • 2 countries - FTZ oriented to export and local market

  • In 2 countries - FTZ is inspected by NMRA (difficult to conduct such inspections)

  • In 1 country - FTZ is subject to pharmaceutical legislation


Market control
Market Control Medicines

  • Number of medicines authorized (3 countries)

    • Range between 3,232 to 7,053

  • Number of medicines on the market

    • Range between 2,791 to 6,200

  • 4 countries declared market survey

  • Existence of informal market

    • 2 countries declared having informal market

  • Raids conducted in the informal sector

    • 1 country conducted raids


Summary 1
Summary (1) Medicines

  • Need of specific legislation on CM

    • Unanimity specifically for empowering NMRA and promoting cooperation

  • Weak or irregular cooperation with police and customs

  • Information not shared with other NMRAs and other law enforcers within the country

  • Few SPOC-based network


Summary 2
Summary (2) Medicines

  • No systematic declaration of cases to WHO

  • Weak cooperation at different levels

  • Difficult pharmaceutical control in free trade zones

  • Market survey conducted in 4 of the 5 countries

  • Inadequate feedback from member states

    • Only 5/13 countries reported


Thank you
Thank you Medicines


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