In the GMP News from 17 December 2008, we reported about the European Commission's package of measures intended to ensure the supply of safe, innovative and accessible medicines to European citizens. In the following you will be given more information on the legislative proposals meant to stem the increasing number of counterfeit medicines.
The proposals by the European Commission to prevent the counterfeiting of medicinal products are amendments or supplements to Directive 2001/83/EC, concerning mainly Articles 46 and 54. Even though the wording of the requirements is still quite vague, the implementation into legally binding regulations will have far-reaching consequences for the pharmaceutical industry.
Article 46 is amended to include the requirements on the use and distribution of active pharmaceutical ingredients (APIs). Among other things, the text lays down that only such APIs can be used as have been produced in compliance with the rules of Good Manufacturing Practice. The task of monitoring the fulfillment of these requirements by the manufacturers of the used APIs lies with the marketing authorisation holder or with a person authorised by the marketing authorisation holder and accredited for this purpose by the competent authorities (Art. 46 (f)). In addition, Article 46b defines that APIs used as starting material for the manufacture of medicinal products can only be imported if they have been produced in compliance either with the EU GMP rules or with comparable regulations, and this fact is confirmed in writing by the exporting country. The latter requirement can be omitted if the exporting country is listed and classified as sufficiently safe by the EU with regard to its domestic GMP rules, frequency of inspection and information exchange (Art. 111b).
Article 54 deals with the introduction of features meant to prevent counterfeiting through identification, authentication and traceability of prescription medicinal products. These features are intended to enable distributors and pharmacists to verify authenticity, to identify each package and to determine whether unauthorised opening of the packaging has been attempted (Art. 54a (1)). In individual cases, removal or covering of the safety features will be permitted: the marketing authorisation holder must have ascertained authenticity beforehand, an at least comparably safe feature has to be applied, and the replacement must be subject to supervision by the competent national authorities (Art. 52a (2)).
The most interesting article is 54a (4), which defines when the application of safety features is mandatory and which represents a compromise solution. The article does not list specific requirements, it rather describes a risk-based approach. Solely for especially risk-prone and prescription medicinal products, safety features are meant to be mandatory. This risk analysis includes items like price and sales volume of the product, number of hitherto occurred counterfeits of this product in the EU as well as therapeutic characteristics. This article, too, provides for exemptions. It is not yet clear what these risk analyses will look like or who will perform them in the Community before the Directive can be put into national legislation. This will possibly be done by the EMEA; in any case a harmonised procedure for all of the EU is desirable, since this is the only way to make such a system work effectively.
The proposals must be passed by the European Parliament and the member states before they can come into force, which is not to be expected before the elections in June 2009. What is certain is that there is still a great need for discussing the topic of safety features and that the contents of future regulations can still be influenced by the industry and associations. The international ECA Conference Tracking & Tracing is dedicated to this subject and demonstrates how the falsification of medicinal products can be sensibly avoided by means of mass serialisation. Among the speakers, there is a representative from EFPIA who will give an update on the current situation.
Dr. Robert Eicher
On behalf of the European Compliance Academy (ECA)