Why are safety measures forbidden in European OTC drugs?


The EU Falsified Medicines Directive and the following Delegated Act on Safety Features are mostly well-written and take into account many of the issues found out when developing similar legislation in other countries or in some EU member states with their pre-existing pharmaceutical serialisation systems.

What keeps puzzling me, as well as many other people working on the field of pharmaceutical manufacturing, information systems and logistics, is that what is compulsory for prescription drugs seems to be forbidden for over-the-counter (OTC) drugs. Thus, the safety features, comprising of the unique product serial code, the EU-wide data repository for tracking and validating the product codes, and the anti-tampering device, must not be used for normal OTC pharmaceuticals.

“In accordance with Article 54a(1) of Directive 2001/83/EC, medicinal products subject to prescription are to bear the safety features while medicinal products not subject to prescription are not allowed to. However, whether a medicinal product is subject to EN 12 EN prescription is most often decided nationally and may vary across Member States. … . As a result, the same medicinal product may be required to bear the safety features in one Member State but not in another.” Delegated Act pp. 11-12 (40).

There may be a few reasons for this, such as:

  1. The OTC drug manufacturers have lobbied hard to prevent the possibility of one manufacturer competing against the others with a safer, safety-included, medicine. In my opinion, this is the most plausible reason.
  2. The EU Commission does not want the OTC drugs to have the look-and-feel of a prescription drug.
  3. Just plain sticking to the letter of the directive, for which the different language versions have also been modified lately to contain more strict wording (e.g. the German “müssen nicht” -> “dürfen nicht“).

OTC pharmaceuticals need exactly the same protection against counterfeiting as do the prescription-only ones. In many cases the same medicine is prescription-only in some EU countries and OTC in others. When a citizen purchases medicine from a legal pharmacy, he/she should be able to be sure the medicine is genuine and does not thus contain unwanted and harmful substances. Due to a recent case of counterfeit omeprazole, this medicine has been added to the otherwise empty list of OTC drugs that are required to have the safety measures.

What is just odd here, is that other types of goods can use similar safety features. For example, most of the packed food has a package with tamper-evidence (e.g. perforated boxes). So do, e.g., the patch packages sold in pharmacies – side-by-side with OTC pharmaceuticals. One must remember, that cosmetics is also commonly sold in pharmacies, and can use similar safety measures, including an online database for checking the authenticity – if the brand owner wants so. To mix up things a bit more, there are also OTC pharmaceutical ointments which in some cases are quite similar to the cosmetics sold in the same pharmacies.

There is still time to amend the legislation. I am not a lawyer, but to me it seems that just clarifying the wording or even just the interpretation might suffice.

Servicepoint Ltd in Finland provides serialization and other types of automation to pharmaceutical industry as well as other industries in North-Eastern Europe.

Iiro Jantunen
CTO, Chief Technology Officer
Servicepoint Kuopio Oy
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