المزورة ة الطبّي المواد لمكافحة الدولّية الرابطة

a WHO initiative to

combat counterfeit

medical products

Dr V. Reggi - World Health Organization

المزورة ة الطبّي المواد لمكافحة الدولّية الرابطة

WHO definition

“a medicine, which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients, with the wrong ingredients, without active ingredients, with the incorrect amount of active ingredients or with fake packaging”

المزورة ة الطبّي المواد لمكافحة الدولّية الرابطة

A counterfeit medical product is …. ……not a medical product!Arbitrary and unpredictable composition

Manufactured evading regulatory control

Manufactured and sold hiding its real origin

Meant to deceive, unsafe

المزورة ة الطبّي المواد لمكافحة الدولّية الرابطة

It is not primarily an IP issue! It is mainly a personal and public health problem!

Medical products are not bags, CDs, watches or T-shirts!

A counterfeit medical product ….

2005: 3 women killed in Argentina by a counterfeit iron preparation2006: 300+ people killed in Panama by mislabelled glycerine

المزورة ة الطبّي المواد لمكافحة الدولّية الرابطة

… jeopardizes the credibility of

health care delivery systems,

pharmaceutical supply systems,

… and governments!

A counterfeit medical product ….

المزورة ة الطبّي المواد لمكافحة الدولّية الرابطة

IMPACT is a taskforce launched by WHO to gather all the most important international actors in the fight against the counterfeiting of medical products

IMPACT aims at coordinating global action in order to promote and protect

public health.

What is IMPACT ?

المزورة ة الطبّي المواد لمكافحة الدولّية الرابطة

“IMPACT approach”: collaboration among all those concerned is

essential

OTHER PUBLIC SECTOR

INSTITUTIONS

MANUFACTURERS

DISTRIBUTION SYSTEM

PATIENTS

PERIPHERAL PUBLIC SECTOR

INSTITUTIONS

BORDER CONTROL AUTHORITIES

POLICE & OTHER ENFORCEMENT AUTHORITIES

HEALTH PROFESSIONALS

DRUG REGULATORY AUTHORITIES

JUDICIARY

MEDIA

FAKEMEDICAL PRODUCT

S

المزورة ة الطبّي المواد لمكافحة الدولّية الرابطة

IMPACT AFTER 1 YEAR

Secretariat: WHO

5 working groups:legislative and regulatory infrastructure regulatory implementation enforcementtechnologycommunication

المزورة ة الطبّي المواد لمكافحة الدولّية الرابطة

LEGISLATIVE & REGULATORY INFRASTRUCTURE

http://www.who.int/entity/impact/events/FinalPrinciplesforLegislation.pdf

المزورة ة الطبّي المواد لمكافحة الدولّية الرابطة

ENFORCEMENT

• Coordination of operations among participating countries

• Internet monitoring and purchases• Training materials and manuals to

improve skills of enforcement officers• Improve information exchange

المزورة ة الطبّي المواد لمكافحة الدولّية الرابطة

INTERPOL and WHO are strengthening their

collaboration to support countries to combat

counterfeit medical products

المزورة ة الطبّي المواد لمكافحة الدولّية الرابطة

ENFORCEMENT

“ASEAN+China” Conference - November 2007, Jakarta

10 ASEAN Member Countries + ChinaDrug regulatory authorities, police, customs, associations of health professionals, manufacturers, wholesalers, NGOs.

Result: - launched the establishment of a SPOC-based network;- preparatory work for new coordinated operation (in the wake of Jupiter South-East Asia operation that lead to identifying source of counterfeit antimalarials)

المزورة ة الطبّي المواد لمكافحة الدولّية الرابطة

IMPACT toolkit

•Experience from different countries;

•Model legislation & regulations;

•Training materials and methodologies;

•Tools and manuals to assist national authorities in implementing activities;

•Tools and methodologies for the assessment of national/regional situations.

المزورة ة الطبّي المواد لمكافحة الدولّية الرابطة

What can countries do?• Strengthen legislation ensuring a) counterfeiting medical

products is a crime and b) punishment is commensurate to the consequences that it has on personal health and on the credibility of national health systems.

• Strengthen regulatory oversight (including in so-called ‘free zones’) ensuring that all manufacturers, importers, exporters, distributors and retailers comply with the appropriate requirements that are necessary for a secure distribution chain.

• Improve collaboration among governmental entities (such as health, police, customs, local administrative units, judiciary), private sector and civil society in order to effectively combat counterfeiters.

• Develop a communication strategy to ensure that health professionals, the general public and the media are aware of the dangers associated with counterfeit medicines.

المزورة ة الطبّي المواد لمكافحة الدولّية الرابطة

Thank

you

www.who.int/impact