Viewpoint: The patchwork of European pharma serialization

Much of the discussion at the Pharmaceutical Serialization & Traceability 2015 conference - which ended last Wednesday in Geneva - was about upcoming European regulations.

The Falsified Medicines Directive (FMD) related delegated acts were adopted by the European Commission in early October and will be published sometime in the beginning of 2016. The regulation will affect, in practice, all of the EU as well as Iceland, Norway, and Switzerland.

Instead of a single market for pharmaceuticals, we will still however have a patchwork of differing regulations. Not only it is up to the national authorities to decide which pharmaceuticals are prescription-only and which can be sold over-the-counter (OTC) (1), but the national authorities will be able to blacklist OTC drugs to require the safety measures (2). As the fake drug manufacturers will probably move their business to the easier market of OTC drugs, the blacklists will probably grow longer very soon.

Then there are the countries, probably France, Germany, and Spain, requiring a national reimbursement code on the datamatrix (3). Even the formatting of the expiry date varies from country to country (4). As the use of safety measures is not allowed in OTC drugs not blacklisted, the pharmaceutical manufacturers need to ask for permission from the national authorities (5) to use even the anti-tampering device - which is widely used in e.g. food packaging. At least the Finnish authorities have given their unofficial promise to semi-automatically approve all requests to use the anti-tampering device in OTC drugs sold to the Finnish market.

Then, of course, there are the three countries (namely Belgium, Greece and Italy) which are allowed six extra years to move to the Europe-wide pharmaceutical ST&T-system as they already have their own systems in place (6).

1. Prescription-only or OTC
2. Nationally blacklisted OTC drugs
3. National reimbursement code, when applicable
4. Formatting of the expiry date
5. National permission to use anti-tampering device in OTC drugs
6. Pre-existing national serialization

Considering there is at least these six measures which make serialization different in the different European Union (and related) countries, and some of these will change without international synchronization, the pharmaceutical marketing authorization holders will have a hard time adhering to the regulations.