AREZZO, Italy, November 26, 2014 /PRNewswire/ --
The Falsified Medicine Directive imposes the alignment of the 28 Member States regulations to the new norms. Italy could become the model to follow.
Italy has a leading role in Europe in the Pharmaceutical Sector. Italy is, in fact, among the first nations in Europe to have introduced a unique serialised code for medicines (called 'Bollino' in Italy) in order to deliver a decisive aid to the fight against counterfeit medicines, and, more broadly, in support of an easy and reliable authentication solution for all pharmaceutical products.
The Italian Ministry of Health and all the main operators in the sector across Europe are collaborating for the creation of an anti-counterfeit system which is effective and safe for consumers. The Directive 2011/62/EU sanctions the need of a unique serialised code for the authentication of medicines at point of dispensing.
Italy has not only already participated in the design of this directive, but it is now ready to put it into action. Aegate, leader in medicine authentication across Europe and present in Italy for the last 7 years is working with public institutions to enable the real time, unique, code checking at point of dispensing.
The company has in fact deployed and developed a protection service capable of authenticating pharmaceutical products at the very moment they are scanned. It requires that the unique code is recognised within 250 milliseconds.
The Aegate service's main objective is the highest possible guarantee of patient safety, protecting him or her from consuming medicines which may be suspicious, recalled, expired and, at the same time, it represents a valid instrument for guarantees for pharmacists and pharmaceutical companies.
Thanks to an envisaged protocol agreement which the Ministry of Health and the European company are in the process of finalising, the Aegate system, which is already integrated in 90% of Italian pharmacies, would have access to the National database to control and execute a real-time authentication of medicines.
The Italian Federation of the Associations of Scientific Pharmaceutical Representatives (FEDAIISF) asserts that the global market for counterfeited and trafficked medicines produces in the black market from €50 Billion to €200 Billion; an enormous market which unfortunately has disastrous effects not only in the Economy but more importantly on the health of patients. It is estimated from this federation that about 200,000 deaths in the world are directly attributable to falsified medicines (in fact some estimations put the number of deaths to 1 million).
An agreement between the Ministry of Health of Italy and Aegate (TM) could represent the key step in the alignment of Italy to the directive and would contribute to putting Italy as a leading model for Europe in matters of pharmaco-vigilance and fight against falsified medicines.
In alignment with the European legislation, the Ministry together with Aegate could offer to all stakeholders of the value chain a system to identify and authenticate in a unique, serialised and tamper proof way all medicines.
The objective would be to extend the model across Europe.
Mark De Simone, CEO of Aegate™, has discussed the opportunity of such protocol and agreement with the representatives of the National Authorities during the 9th Health Care Risk Management Forum taking place in Arezzo. This is one of the most prestigious Italian events in the sector.
"For the last 10 Years Aegate™ has been operating leading services for the assurance of Patient Safety in medicines". "We have invested over €65 Millions in intellectual property to develop highly secure systems that verify today over 200,000 medicines per hour in real time. Thanks to this possible cooperation with the Ministry, we hope to open a broad communication channel for the safety of consumers linking both ends of the supply chain, from the manufacturer of medicines to pharmacists, doctors and hospitals across the world."
For more information on Aegate, please visit http://www.aegate.com
Commercial Director Aegate Ltd
Cambridge Technology Centre
Melbourn SG8 6DP UK