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EU draft regulation to prevent fake medicine sales

The European Commission has proposed that all prescription medicines in the EU have a unique identifier and an anti-tampering device to prevent "falsified" medicines reaching consumers. 04 Sep 2015

The Commission has published draft regulations setting out ways to prevent these medicines entering the supply chain in the UK.

Falsified medicines are medicines with false sources such as names or ingredients; histories, such as batch numbers, or false source information, the Commission said. 

These medicines may contain low quality ingredients, or the wrong dosage of ingredients, and can be a major health threat, the regulations said. Contaminated heparin, a blood thinner, has been connected to dozens of deaths worldwide in 2008, it said.

Falsified medicines have been found in all areas of the supply chain, legal and illegal, prescription and over-the-counters, and in both branded and generic medicine, the Commission said.

The safety features are therefore proposed as a way to identify genuine medicines. The structure and content of the unique identifier would need to be agreed and harmonised across the EU, and an "end to end" system set up to check the safety features, the draft regulation said.

An impact assessment run by the Commission looked at the benefits, costs and cost-effectiveness of the proposal, at the technical options for the identifier, at how authenticity would be verified, and at how the repository system would be managed, it said.

It was decided that the unique identifier should be the same across the EU, and placed in a 2D barcode containing the product code, serial number, batch number and expiry date.

Medicines should be systematically verified by pharmacies before being supplied to the public, and those at higher risk should also be checked by wholesalers.

A repository system for the unique identifiers should be set up. Steps should also be taken to make sure that personal data is protected, although the initial proposal would not involve any personal data being stored in repositories, the Commission said.

The Commission has carried out consultations, and worked closely with manufacturers, wholesale distributors, hospitals and pharmacies, plus the European Medicines Agency, followed by a public consultation in 2012, it said.

"All respondents expressed full support for the Commission’s initiative, on the grounds that the unique identifier would create better protection for European patients against falsified medicines. Most respondents supported harmonising the technical specifications of the unique identifier across the Union to ensure interoperability among different manufacturers and different EU member states. Most stakeholders also supported the checking of the unique identifier at the end of the supply chain, namely at the pharmacy or hospital level," the Commission said.

"Most industry supported a repository system set up and managed by the stakeholders. However, two national medicines agencies out of seven who replied favoured the EU or national governance of the repository system while one authority called for national governance only," it said.

The Commission is now seeking comments on the draft regulations, until 11 October. Once finalised, the regulation will take effect three years from its publication in the EU official journal.