EC seeks comment on unique medicine identifiers

The European Commission has published a concept paper on the unique identifier for medicinal products outlined in the EU's falsified medicines directive and due to be fleshed out via the delegated acts process in 2014.

The delegated acts procedure is designed to lay out in practical terms what the new legislation demands in principle, i.e. the introduction of obligatory safety features that allow verification of the authenticity of medicinal products, including the "characteristics and technical specifications of the unique identifier."

The directive also requires the Commission to carry out an impact assessment of the safety feature requirements, along with the procedures for verification and the information repositories used to manage the system, to ensure that it is cost effective and does not have any unwanted socioeconomic consequences.

In its concept paper - available here - the EC notes that "the only way to uniquely identify a pack [of medicine] is to give it a number 09'serialisation number')", held by a carrier such as a barcode.

It notes there are two options on the table - allowing the manufacturer to decide the technical specification or to achieve a harmonised system through legislation - and asks for comments on the benefits and disadvantages of each policy option. The tamper-evidence requirement of the directive can already be left up to the discretion of the manufacturer.

The document also asks for comment on the proposed composition of the serialisation number - which as a minimum should contain the manufacturer product code and pack number - and whether any additional information such as batch number or expiry date should be included.

Information is also sought about whether national reimbursement numbers for medicines are replaced by the serialisation number or contained within it, as well as the relative merits of linear barcodes, 2D barcodes and radiofrequency identification (RFID) tags in this setting, ideally including an assessment of cost-benefits.

The second part of the concept paper concerns the systems used to verify the unique identifiers, and as expected questions whether this should be carried out only at the point of dispensing - as favoured by the European Federation of Pharmaceutical Industries & Associations (EFPIA) - or at additional (either systematic or random) points in the supply chain, i.e. at wholesale distributors.

The document also considers the thorny issue of data ownership and the "establishment, management and accessibility" of the repositories against which verification data is checked, particularly where information of a commercially-sensitive nature is concerned.

Three policy options are laid out for consideration and comment: leaving it to the stakeholders (e.g. pharma companies, pharmacists and distributors) to develop systems; some form of centralised pan-EU repository; and the establishment of national governance systems.  

Questions are asked about issues of personal data and confidentiality, and the requirement for replacing safety features with 'equivalent' features - i.e. another unique identifier - in cases where a product is re-packaged.

Finally, the paper looks at the scope of the directive, for example the exclusion of certain categories such as non-prescription medicines from the requirements on the grounds of being at low risk of falsification (the 'white list' and 'black list' approach). It asks for comment on the best way to measure risk in order to categorise products into the two lists.

Stakeholders are invited to comment on the consultation paper until April 27, 2012.