From 1st  July online suppliers of medicines in the EU must be registered in the country they are operating.

They also need to display on every page of their website offering medicines for sale, the new European common logo.

These requirements stem from the Falsified Medicines Directive, introduced to protect patients from falsified medicines in both the legitimate and unauthorised supply chains. The patient/consumer can click on the Logo to check if the supplier is genuine. This should enable patients to buy their medicines from an authorised source.

To mark this occasion a debate took place in the EU Parliament to raise awareness of the issue of patient safety and buying medicine online.

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Debate at the European Parliament

MEP José Inácio Faria who hosted the meeting put the issue in to context with some startling facts. No less than 30,000 websites that look like legal sellers of medicines are targeting the population at any one time. Reports also show that 97% of online drug sellers worldwide are operating illegally, by failing to comply with applicable laws and standards put in place to protect patients.

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MEP Faria on the dangers of buying fake medicines online

MEP Faria stated “Shockingly these fake products might contain rogue ingredients such as brick dust, cement, floor polish, cartridge ink, talcum powder, leaded paint, and even a form of rat poison — strychnine — which all have been discovered in fake medicines sold online. The buyer also risks having their bank account details stolen as well."

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MEP José Inácio Faria, Mike Isles, ASOP EU and Lynda Scammell, MHRA

Mike Isles who is representing two patient safety organisations, namely The European Alliance for Access to Safe Medicines and The European Alliance for Safe Online Pharmacy in the EU highlighted two critical success factors: securing the common logo symbol from cybercrime copying and thus misleading the public into a false sense of security and the need to educate the public. Isles said “Very unfortunately the Commission’s Directive which obliges Member States to deliver awareness campaigns to the public about the dangers of fake medicines and the purpose of the Common Logo comes with no budget. So at best the success of this aspect will be variable across the 28 Member States which is of real concern.”

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Mike Isles, Executive Director of ASOP EU on the Common Logo

A number of Member State’s were present who elaborated on the stages of the logo implementation. In particular, the UK’s Lynda Scammell from MHRA Enforcement Group, Philippe De Buck, Belgium Medicines Agency and Domenico Di Giorgio, Italian Medicines Agency, gave their updates on the implementation. However not all Member States have signed up to this element of the Falsified Medicines Directive and MEP Faria said that “It is not good when there is a time lap between the most conscientious of Member States who adopt new directives efficiently compared to those that lag behind as patient safety is at stake here.”

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Lynda Scammell and Philippe De Buck giving their updates on the implementation of the Common Logo in the UK and Belgium

Many questions were raised by the floor and to the question, if it is important to make the logo as secure as possible from an IT perspective, the answer was a resounding yes. Erwin van Uffel from the Belgian Customs Office confirmed that each Member State should follow basic IT security rules“…for instance having a secure server which has good protection from potential hackers combined with an encrypted link to and from the websites are just two of the essentials but there are more and it would make absolute sense for Member States to share best practice and IT creativity to help beat the criminals who make it their life to invade other people’s cyber space.”

Mike Isles stated that Google who are very active Members of ASOP EU, had been collaborating on educational campaigns that can reach the public via Google search optimisation campaigns. Isles said "We are close to launching an educational campaign in Italy to inform patients and consumers about the risks of buying online and how to buy safely. We will be able to learn a great deal from this as it will enable us to understand what search words are being inputted and through an anonymous survey contained within the website we hope to get rich information back to better understand the motivations behind online buyers of medicines who will often be placing their health at risk – our vision is that this educational site in Italy can be the beginning of many across Europe.”

Isles’ concluding remarks were important as he quoted from a sworn written statement given to the Subcommittee on Courts, Intellectual Property and the Internet – a powerful US Government backed committee. The statement was given by the President of LegitScript, John Horton. This is a company that monitors the online sales of drugs. It maintains the world’s largest database of internet pharmacies and supports companies such as Google and Microsoft to ensure their services are not abused by criminals. Horton said that the Internet Corporation for Assigned Names and Numbers (ICANN) – a company that oversees many aspects of the world wide web - needs to make its compliance processes more transparent to prevent obvious failures such as “…giving a green light to certain registrars to provide domain names to criminal networks engaged in illegal online pharmacy crime”. Until this happens he said “ICANN will continue to lack the kind of accountability and trust that internet users as a whole deserve.”

 

 

For further information contact Mike Isles at mike.isles@eaasm.eu