Information & News
Background of this Conference
Counterfeit medicines represent an enormous public health challenge today.
WHO estimates that around 1% of sales in developed countries to over 10% in
developing countries are counterfeited and that counterfeit drugs are
increasingly present even in better controlled markets.
More recently the European Commission stated that "a recent analysis of the
present situation has revealed that counterfeit medicines have become an
increasing threat to public health over the past few years". The Commission
has observed the following worrying trends in particular:
- a sharp increase in seized counterfeit medicines
- a trend towards counterfeiting of life-saving drugs (not only
"lifestyle" medicines)
- a trend towards targeting the classical supply chain
- a blurred line between counterfeit and sub-standard active
substances in medicinal products
The FDA has just requested comments and information regarding standards and
technologies used for the identification, validation, tracking and tracing ,
and authentication of prescription drugs. Particularly, they were requesting
information and comments from drug manufacturers, distributors, pharmacies,
other supply chain stakeholder, foreign regulators, standard organizations
and other interested parties for the purpose of securing the drug supply
chain against counterfeit, diverted, subpotent, substandard, adulterated,
misbranded, or expired drugs.
Counterfeit Initiatives
EDQM
EDQM participates in an international meeting on heparins
The EDQM participated in a recent meeting organised by the United States
Food and Drug Administration (FDA) to state the European Pharmacopoeia's
position and to share its experience on the current issues concerning the
quality of heparins following adverse effects reported earlier this year.
http://www.edqm.eu/medias/fichiers/La_DEQM_participe_a_une_rencontre_internationale_sur_les_heparines_13_mai_2008.pdf
Combining forces to protect patients from counterfeit medicines and
pharmaceutical crime
A model for a network and single points of contact (SPOCs) across
disciplines and borders
http://www.edqm.eu/medias/fichiers/Model_for_a_Network_and_Single_Points_of_Contacts_SPOCs.pdf
INTERNATIONAL CONFERENCE - EUROPE AGAINST COUNTERFEIT MEDICINES, 23-24
October 2006
Moscow, Russian Federation
Conference documentation available for download
http://www.coe.int/t/e/social_cohesion/soc-sp/public_health/pharma_and_medicine/Speeches_Conference_Moscow_CountMed.asp#TopOfPage
FDA
Counterfeit Webpage
FDA informs about Task Force Reports, Alert Networks and recent initiatives
http://www.fda.gov/counterfeit/
Information on Heparin
http://www.fda.gov/cder/drug/infopage/heparin/
WHO
IMPACT
International Medical Products Anti Counterfeiting Taskforce - IMPACT
http://www.who.int/impact/en/
European Commisssion
Legal Proposal
Background information on the legal proposal to combat counterfeit medicines
for human use (Power Point presentation)
http://ec.europa.eu/enterprise/pharmaceuticals/counterf_par_trade/conterfeit_doc/2008_04_presentation-counterfeit.pdf
"Key ideas for better protection of patients against the risk of counterfeit
medicines"
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2008/2008_03/consult_counterfeit_20080307.pdf
Counterfeit medicines - Responses to public consultation (2008)
http://ec.europa.eu/enterprise/pharmaceuticals/counterf_par_trade/counterfeit_consult_2008.htm
Other Anti-Counterfeit Initiatives
The Global Pharma Health Fund e.V. (GPHF)
http://www.gphf.org/web/en/start/index.htm
EFPIA: Zero tolerance for counterfeit medicines
http://www.efpia.org/Content/Default.asp?PageID=537
