International Medical Products Anti-CounterfeitingTaskforce.

International International

Medical Products Medical Products

Anti-Counterfeiting Anti-Counterfeiting

TaskforceTaskforce

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 questions1. 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 countriesAfghanistan, 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 3.300 to 8.972

• Number of medicines on the market ( 4answers )– Range between 1.700 to 5.800

• 9 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

شكرًا�شكرًا�Thank YouThank You

MerciMerciDankeDanke