WHO Survey on situation of counterfeit medicines in SADC Tanzania Food & Drugs Authority

1. 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

2. 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

3. 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)

4. The Questionnaire (2) • 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

5. 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

6. 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)

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

15. Thank you