International Medical Products Anti-CounterfeitingTaskforce

Quick Overview of National Situations on Counterfeit Medicines in the Eastern Mediterranean Region (EMR) Countries Essential Medicines & Pharmaceutical policies (EMP) WHO/EMRO

East Mediterranean Region (EMR)

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

The Questionnaire Developed from the draft data collection tool for review of national situations concerning counterfeit medicines Objective - get a quick overview of the situation concerning counterfeit medicines in EMR countries. Pretested in 9 African countries in 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 13 countries Afghanistan, Djibouti, Egypt, Iraq, Jordan, Lebanon, Oman, Pakistan, Somalia, Sudan, Syria, Tunisia and Yemen

Legislation 10 countries use pharmaceutical legislation and 3 have specific legislation on counterfeit medicines 6 countries use specific definition on counterfeit medicines 10 countries would welcome specific legislation on Counterfeit Medicines addressing: –Definition (5) –empowering MRA (8) –criminalization of counterfeiting (7) –appropriate sanctions (5) –mechanisms for international, regional and national cooperation (11)

Seizures 9 countries report having seized CM Origin of seizures –MRA ( 9 always) –police & customs ( 3 often and 5 occasionally ) –private sector (3) Gap identified – In few cases irregular cooperation between MRA, Police and Customs 7 countries report having applied sanctions 3 of them applied penal sanctions

Sharing information 4 countries identified the counterfeit medicines as international origin Only 6 countries aware of RAS* 2 countries "sometimes" shared information with MRA of country of origin RAS*: Rapid Alert System

Collaboration 10 countries reported coordination with police and customs and 8 carried joint actions Reasons for poor collaboration –limited resources (2) –no legal framework (5) In 11/13 countries – MRA authorization required for clearing medicines at Customs but only 4 countries provide number of permits issued 6 countries reported the number of cases submitted to the court and in the six cases the court asked for a special report from the NRA

MRAs and WHO initiatives Single Points of Contact (SPOC) –7 countries aware of SPOC –6 countries unaware of SPOC –Only 3 countries have designated SPOCs 2 countries participated in at least 1 meeting

Free Trade Zones 9 countries declared having FTZ 5 countries - FTZ oriented to export and local market In 5 country - FTZ is inspected by MRA In 6 country - FTZ is subject to pharmaceutical legislation

Market Control Number of medicines authorized ( 8 answers ) –Range between to Number of medicines on the market ( 4answers ) –Range between to countries declared making market survey Existence of informal market –6 countries declared having an informal market, most of them are limited to rural areas Raids conducted in the informal sector –5 countries

Summary (1) Need of specific legislation on CM –In majority to strength cooperation at different levels –But also for empowering MRA and criminalization of CM Irregular cooperation with police and customs Information not shared Not systematic cooperation with customs and police

Summary (2) No SPOC-based network and only 3 designated SPOCS Very weak declaration of cases to WHO ( only 1/13) Insufficient regional cooperation Pharmaceutical control in free trade zones only in 5 countries Good knowledge medicines market in 8 countries but controlled by NRA only in 4 countries

See you again شكراً Thank You Merci Danke