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NEWS
- IMPACT's Legislative and Technology Work
Groups held the 1st annual GLOBAL FORUM on February 13-15 in
Singapore.
- IMPACT's Regulatory Implementation Work Group met
April 25-26
in Washington D.C.
- IMPACT's Technology Work Group met March 13
in Prague
- The first Anuual Meeting of IMPACT
was held November 15-16, 2006 in Bonn, Germany.
- IFPW and member participants attend Bonn
meeting
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Background Information
In February 2006, the World Health Organization
(WHO) held a conference in Rome entitled "Combating Counterfeit Drugs:
Building Effective International Collaboration" addressing the dangers that
counterfeit drugs pose to patient health and the integrity of the healthcare
industry. The 160 conference participants determined that international
communication and collaboration, between all stakeholders in the healthcare
industry, would be required to combat the growing problem of counterfeit drugs
and therefore issued the
Rome Declaration - which included a recommendation to
form an International Medical Products Anti-Counterfeiting Taskforce (IMPACT).
In July 2006, organizations in support of the
IMPACT program attended another meeting in Rome to finalize the taskforce's
Terms of Reference and thus make IMPACT operational. Included in the Terms
of Reference was the establishment of five Working Groups to focus on the
counterfeiting issue from various perspectives and specific areas. The initial
Working Groups, and their preliminary mandates, are:
LEGISLATIVE & REGULATORY
INFRASTRUCTURE
- survey existing national and
international legislation & requirements;
- assess gaps in existing national and
international legislation & requirements on
manufacturing, distribution, exportation, and importation;
- develop model legislation;
- develop initiatives aimed at law-makers
in order to promote adoption of new
legislation requirements for the distribution system
- assess existing national best practices
and develop model best practices
REGULATORY IMPLEMENTATION
- promote implementation of Good
Manufacturing, Good Distribution and Good
Pharmacy Practice guidelines and quality assurance systems to ensure
supply chain
integrity;
- develop model training materials aimed
at improving quality assurance within and
supervision of distribution chain;
- develop guidance on the role of quality
control laboratories in combating counterfeit
drugs;
- develop data collection tools and
methodologies to assess national regulatory and
enforcement systems in order to identify gaps and measures needed;
- at the request of national authorities
develop ad hoc projects to improve capacity to
combat counterfeit medicines;
- promote secure exchange of information
and alerts among regulatory and/or
enforcement officials as appropriate
- promote networking and collaboration
among national drug regulatory authorities
- develop guidance for pharmacovigilance
systems to include reporting and
investigating suspected cases of counterfeit medicines
ENFORCEMENT
- develop advocacy materials to increase
resources available for enforcement
- promote multi-country initiatives to
improve coordination and information exchange
among enforcement institutions and officers;
- Develop projects aimed at improving
communication and collaboration between
regulatory and enforcement officers
- develop training materials and manuals
to improve skills of enforcement officers
- Identify gaps in existing legislation,
need for resources and propose solutions
TECHNOLOGY
- assess (including piloting when feasible
and necessary) technologies to prevent, deter,
or help to detect counterfeit products taking into account: a) cost, b)
scalability, c)
specific country needs and situations, d) feasibility, e) regulatory
implications;
- facilitate exchange of information on
technologies and their implementation
- disseminate information and
recommendations on the merits and limitations of
technologies
COMMUNICATION
- develop agreed messages and ensure
IMPACT presence, as appropriate, at important
national and international events;
- develop advocacy, risk communication and
education strategies and materials taking
into account the need to address specific target groups such as patients
and health
professionals;
- develop more effective collection and
analysis of information on suspected and
confirmed cases of counterfeit medical products and dissemination of
confirmed cases
as appropriate;
- develop initiatives to communicate risks
of purchasing medicines from unknown
sources (e.g. Internet);
- assist national authorities to develop
risk communication and advocacy materials
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IFPW Involvement
The International Federation of Pharmaceutical
Wholesalers (IFPW), along with the European association of wholesalers - GIRP,
has been named as a Participant in IMPACT to represent the pharmaceutical
distribution sector, specifically full-line pharmaceutical wholesalers.
In order to properly represent the sector, IFPW
invites pharmaceutical wholesale and/or wholesalers' association organizations to
participate in committees that mirror 4 of the 5 IMPACT Working Groups
(excluding Enforcement). These committees will share information on
combating drug counterfeiting and will represent IFPW on the various IMPACT
Working Groups.
It is intended that IFPW's committees will
communicate electronically and will physically meet only if necessary. There
is no cost to participate in the committees. However, individuals
volunteering to represent IFPW at IMPACT events and on IMPACT Working Groups
will be responsible for their own travel expenses.
If your are interested in participating on one or
more IFPW - IMPACT Committees, please complete the following form:
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For more information, please
contact
IFPW.
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