Transcript Dr. Valerio Reggi

a WHO initiative
to combat
counterfeit
medical products
Dr V. Reggi - World Health Organization
‫الرابطة الدولية لمكافحة المواد الطبيّة 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 الطبيّة 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 الطبيّة المزورة‬
A counterfeit medical product ….
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!
2005: 3 women killed in Argentina by a
counterfeit iron preparation
2006: 300+ people killed in Panama by
mislabelled glycerine
‫الرابطة الدولية لمكافحة المواد الطبيّة المزورة‬
A counterfeit medical product ….
… jeopardizes the credibility of
health care delivery systems,
pharmaceutical supply systems,
… and governments!
‫الرابطة الدولية لمكافحة المواد الطبيّة المزورة‬
What is IMPACT ?
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.
‫الرابطة الدولية لمكافحة المواد الطبيّة المزورة‬
“IMPACT approach”:
collaboration among all those concerned is essential
BORDER CONTROL
AUTHORITIES
PERIPHERAL
PUBLIC SECTOR
INSTITUTIONS
OTHER PUBLIC
SECTOR
INSTITUTIONS
JUDICIARY
POLICE & OTHER
ENFORCEMENT AUTHORITIES
FAKE
MEDICAL
PRODUCTS
MEDIA
DRUG REGULATORY
AUTHORITIES
PATIENTS
HEALTH
PROFESSIONALS
MANUFACTURERS
DISTRIBUTION
SYSTEM
‫الرابطة الدولية لمكافحة المواد الطبيّة المزورة‬
IMPACT AFTER 1 YEAR
Secretariat: WHO
5 working groups:
legislative and regulatory infrastructure
regulatory implementation
enforcement
technology
communication
‫الرابطة الدولية لمكافحة المواد الطبيّة المزورة‬
LEGISLATIVE & REGULATORY
INFRASTRUCTURE
http://www.who.int/entity/impact/events/FinalPrinciplesforLegislation.pdf
‫الرابطة الدولية لمكافحة المواد الطبيّة 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 الطبيّة المزورة‬
INTERPOL and WHO are
strengthening their collaboration
to support countries to combat
counterfeit medical products
‫الرابطة الدولية لمكافحة المواد الطبيّة المزورة‬
ENFORCEMENT
“ASEAN+China” Conference - November 2007, Jakarta
10 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 الطبيّة 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 الطبيّة 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 الطبيّة المزورة‬
‫‪www.who.int/impact‬‬
‫الرابطة الدولية لمكافحة المواد الطبيّة المزورة‬