Dr. Valerio Reggi
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المزورةة فحة المواد الطبيلدولية لمكا الرابطة اa WHO initiative to combat counterfeit medical products Dr V. Reggi - World Health Organization
Transcript of Dr. Valerio Reggi
الرابطة الدولية لمكافحة المواد الطبّية المزورة
a WHO initiative to combat counterfeit
medical products
Dr V. Reggi - World Health Organization
الرابطة الدولية لمكافحة المواد الطبّية المزورة
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”
الرابطة الدولية لمكافحة المواد الطبّية المزورة
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
الرابطة الدولية لمكافحة المواد الطبّية المزورة
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
الرابطة الدولية لمكافحة المواد الطبّية المزورة
… jeopardizes the credibility of health care delivery systems, pharmaceutical supply systems,
… and governments!
A counterfeit medical product ….
الرابطة الدولية لمكافحة المواد الطبّية المزورة
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 ?
الرابطة الدولية لمكافحة المواد الطبّية المزورة
“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 PRODUCTS
الرابطة الدولية لمكافحة المواد الطبّية المزورة
IMPACT AFTER 1 YEAR
Secretariat: WHO
5 working groups:legislative and regulatory infrastructure regulatory implementation enforcementtechnologycommunication
الرابطة الدولية لمكافحة المواد الطبّية المزورة
LEGISLATIVE & REGULATORY INFRASTRUCTURE
http://www.who.int/entity/impact/events/FinalPrinciplesforLegislation.pdf
الرابطة الدولية لمكافحة المواد الطبّية المزورة
ENFORCEMENT
• Coordination of operations among participating countries
• Internet monitoring and purchases• Training materials and manuals to improve
skills of enforcement officers• Improve information exchange
الرابطة الدولية لمكافحة المواد الطبّية المزورة
INTERPOL and WHO are strengthening their collaboration to support countries to combat counterfeit medical products
الرابطة الدولية لمكافحة المواد الطبّية المزورة
ENFORCEMENT
“ASEAN+China” Conference - November 2007, Jakarta10 ASEAN Member Countries + China
Drug 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)
الرابطة الدولية لمكافحة المواد الطبّية المزورة
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.
الرابطة الدولية لمكافحة المواد الطبّية المزورة
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.
الرابطة الدولية لمكافحة المواد الطبّية المزورة
Thank
you
www.who.int/impact
