Medicines sold across Europe will have to carry barcodes and other improved security mechanisms, under proposals unveiled by the European Commission to crack down on counterfeit drugs.
The Commission says it aims to use technology to enable “total traceability" of all medicines bought in pharmacies or online.
Even with the new measures, some repackaging will continue to allow the parallel trade in pharmaceutical products to continue.
Gunter Verheugen, the EU industry commissioner responsible for the ‘pharmaceutical package’ said the measures were needed to address the growing problem of counterfeit drugs. He said over 2.5m drug packages were seized at the EU’s external borders last year, five times the number in 2005.
Under the new proposals, products will have to employ mandatory safety measures such as seals and barcodes that only certified manufacturers will be able to use.
The move was announced as part of a package of measures that would also allow drug manufacturers to promote information about their prescription-only products directly to EU citizens – direct to consumer (DTC) – for the first time.
As part of the package of measures the Commission says it wants to give patients access to centralised EU information on the side effects of drugs.
Moreover, to ensure clarity of information, the EU executive calls for advertising of prescription medicines to be scrapped. It also wants to introduce stricter rules regarding the content of pharmaceutical adverts, including those on the internet, in the form of an EU code of conduct.
According to a report in the Financial Times newspaper, the new laws would also allow manufacturers to directly communicate summaries of product characteristics and certain other details, but only through “health-related publications”, internet websites on medicinal products and in written answers to public queries.
While a national newspaper would not qualify as a “health-related publication”, its health supplement would. Consumer groups remain wary about any relaxation of DTC rules
“Without a clear distinction between information and advertising, allowing direct-to-consumer information is like letting advertising in through the back door,” warned Which?, the UK consumer association.
European consumer group BEUC said the guidelines were "advertising in disguise," claiming that the pharmaceutical industry would be "allowed to choose on which particular disease or specific medicine and to what extent the ‘information’ will be provided, and how much money to spend on it."
European Commission: The Pharmaceutical Forum
European Commission: Final Conclusions and Recommendations of the High Level Pharmaceutical Forum