EU executive
warns about fake drugs on the internet
March 27, 2006
The European Commission has
issued a warning that fakes of the medicine
rimonabant are currently being sold via several
websites.
Rimonabant has been developed to treat obesity
and related risk factors and smoking cessation.
The medicine is still under evaluation by the
European Medicines Agency (EMEA).
"The product will only receive marketing
authorisation by the European Commission once
its quality, safety and efficacy have been satisfactorily
established by the EMEA scientific committee,
and this approval is still pending. Once approved,
the company intends to market rimonabant under
the name AcompliaTM. Patients who buy unlicensed
and counterfeit or illicit copies of rimonabant
may be putting their health at risk. This latest
example underlines European Commission concern
that criminals are taking advantage of the anonymity
of the internet to sell fake, adulterated and
unlicensed medicines to an unsuspecting public,
putting lives at risk as well as undermining
the pharmaceutical industry. "EC said in
a statement.
Commission Vice-President Günter Verheugen
responsible for enterprise and industry products
said: "I am alarmed at the ever increasing
number of counterfeit medicines sold via the
internet. This represents a real danger to the
health of patients. The Commission is working
with European and international partners to
do everything possible to ensure legal methods
for marketing of medicines are respected and
enforced."
Counterfeiters try to bypass the foreseen regulatory
pathways of licensing and supervision by competent
authorities.
According to a recent survey by the Member
States, 170 medicines were identified to be
counterfeit in the illegal distribution channels
over the past 5 years. Such illegal trade often
occurred through the internet. Among the cases
identified, lifestyle, growth hormones for bodybuilding
use and sleeping drugs played a particular role.
Unauthorised copies and fakes of licensed medicines
for the treatment of erectile dysfunction (e.g.
Viagra,
Cialis)
and viral infections (e.g. Tamiflu) have also
been on the sales lists of criminal counterfeiters.
Counterfeits may include fakes which do not
contain any of the medicine or the wrong medicine.
At the same time, they may damage the image
of a product and companies investing in the
research and application of these products,
while criminals try to make money without taking
any responsibilities and risks.
To be marketed in the EU, all medicines must
undergo a rigorous evaluation for authorisation
to demonstrate that they are effective, adequately
safe and of high quality. This is ensured by
a robust regulatory system for the authorisation
of new medicines. The EU also has a strong legal
framework for the licensing, manufacturing and
distribution of medicines. At the end of the
distribution chain, only licensed pharmacies
and approved retailers are allowed to offer
medicines for sale, including the legitimate
sale over the Internet.
Member States enforcement services closely
cooperate to combat fake medicines. To further
protect patients and industry from criminal
counterfeit activities, the Commission is currently
analyzing the situation and working together
with Member States, the European Medicines Agency
and international partners on what further actions
may be necessary to safeguard public health.
Source: http://www.dtt-net.com/en/index.php?page=view-article&article=1267&CMSSESSID=2b2c522d75d1af06f2ec599b9b4d80bc
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