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The problem of fake drugs has been an increasing concern for European regulators over the years, especially with easy access to medicines via the Internet.

According to recent statistics, 62% of medicines purchased online are fake or substandard [1]. At the beginning of this year, the not-for-profit European Medicines Verification Organisation (EMVO) was launched to help implement EU Directive 2011/62/EU on falsified medicines and ensure patient safety across Europe. The organisation is working on the creation of a central hub that holds information about legitimate medicines sold in the EU – and the recent news that three software companies have signed up to the project has meant that the EMVO is closer than ever to making the database a reality.

EU Directive 2011/62/EU on falsified medicines

Falsified medicines are defined in Directive 2011/62/EU, which came into force in 2013 to tackle the issue. These fake drugs make false claims about the identity, source and history of a product. The drugs contain sub-standard or falsified ingredients or ingredients with active substances in the wrong dosage; they make false claims about where the drug is made and who made it; and they do not give accurate information about the records and documents relating to the distribution channels used. The Directive recognises that “The illegal sale of medicinal products to the public via the Internet is an important threat to public health as falsified medicinal products may reach the public in this way. It is necessary to address this threat.” The Directive therefore takes measures to prevent falsified medicines entering the legal supply chain and reaching patients

National compliance with the falsified medicines directive

In the UK, for example the Government’s Medicines and Healthcare products Regulatory Agency (MHRA) published a press release in June this year which outlined how from the 1st of July, anybody in the UK selling medicines online to the general public needs to be registered with the MHRA and to be on the MHRA’s list of registered online retail sellers. In addition, they also need to display on every page of their website offering medicines for sale, the new European common logo. The logo will contain a hyperlink to their entry in the MHRA’s list of registered online sellers and will allow anybody buying medicines online to be able to check if the website is legitimately registered. Patients and consumers are then able to identify online pharmacies and retailers who provide authorised medicines.

2015 and the growth of EMVO

Based in Luxembourg, EMVO was established as a key tool in the fight against the emergence of falsified medicines in the EU legitimate supply chain, with the ultimate goal of improving patient safety. Its founding members are EAEPC, the European Association of Euro-Pharmaceutical Companies, EFPIA, the European Federation of Pharmaceutical Industries and Associations, EGA, the European Generic and Biosimilar medicines Association, GIRP, the European Association of Pharmaceutical Full-line Wholesalers and PGEU, the Pharmaceutical Group of the European Union.

The monitoring system set up by EMVO will offer a modern technology solution for professionals to check product authenticity at the point of dispensing. This ‘European Hub’ will be connected to a series of national data repositories and can be used by pharmacies and other registered parties to check a product’s authenticity. EMVO’s aim is that the system is harmonised and interoperable between the various countries – in order to facilitate patient safety across Europe. Products that are traded between EU member states (known as parallel traded products) will be able to be verified – as well as products produced in more than one EU country.

EMVO now aims to help member states to get their drug lists up and running by creating a model of the drug database to minimise the burden of national stakeholder organisations (who will eventually will be responsible for the establishment and management of the systems). This blueprint model, known as the national Blueprint System Template, includes a support plan and implementation package. Three European software companies were signed up to assist in this project over the summer; Aegate Holdings Limited, Arvato Systems GmbH and Solidsoft Reply.

Germany takes the lead

Under the guidance of EMVO, Germany will be the first Member State to contribute fully to the improved Europe-wide verification system, through its securPharm system [2]. The creation of EMVO and the work carried out in Germany is a step in the right direction in the fight against falsified medicines. Hopefully, stakeholders in the other EU member states will be encouraged to join up to the project and register with a service provider to create their own databases of legitimate pharma products that can be used to identify fake drugs circulating in the country. According to Richard Bergström, Director General of EFPIA, the industry has lent its full support to tackling the problem of fake drugs: “All partners in the ESM believe that patient safety must come first and that counterfeiting must be dealt with in an efficient way by the whole supply chain. Patients need to be able to trust in the medicines they take and we are all proactively engaged in ensuring patients have access to medicines of the highest quality.”

[1] http://www.efpia.eu/uploads/Modules/Documents/european_stakeholder_model_esm_publication_june_2012-20120622-007-en-v1.pdf
[2] http://www.in-pharmatechnologist.com/Regulatory-Safety/First-part-of-European-fake-fighting-database-linked-to-securPharm

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The author

Ruth KnowlesRuth Knowles is a freelance science writer who has written articles and press releases on a range of life science and health topics. She received her MSc in Science Communication from the University of the West of England, Bristol.

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