The European Commission (http://europe.eu.int/index_en.htm) 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[1].
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.
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. ViagraR[2], CialisR[3]) and viral infections (e.g. TamifluR[4]) 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 analysing 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.
[1] Developed by Sanofi Aventis
[2] market authorisation holder: Pfizer
[3] market authorisation holder: Lilly ICOS
[4] market authorisation holder: Hoffmann La Roche
Source:
http://europe.eu.int/rapid/pressReleasesAction
