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 Findings –Legislation –Seizures –Sharing information –Collaboration –MRAs and WHO initiatives –Free Trade Zones –Market Control Summary

The Questionnaire 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) There were 44 questions 1.Legislative aspects (5) 2.Anti-counterfeit actions (6) 3.Sharing information (5) 4.Collaboration with other departments (11) 5.NMRA and WHO initiatives (4) 6.Free trade zones (4) 7.Market control (9) Response received from 5 countries –Botswana, Mauritius, Seychelles, Tanzania and Uganda

Legislation 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 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 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 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 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) 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 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) 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) 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

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