EU: new Delegated Act on Shipments of Medicinal Products through EU

The Directorate-General for Health and Consumers (DG SANCO) of the European Commission has published a draft Delegated Act concerning a new requirement of the Falsified Medicines Directive under which medicinal products are being shipped through the EU. The somewhat cumbersome title of the concept paper is "Delegated Act on the Criteria to be considered and the Verifications to be made when assessing the potential falsified Character of Medicinal Products introduced in the Union but not intended to be placed on the Market".

Public consultation ends on 10 December 2012 and responses should be sent preferably by e-mail to: SANCO-INTRODUCTION-FALSIFIED@ec.europa.eu. The adoption of the delegated act is tentatively scheduled for 2013.

Background:

Directive 2011/62/EU, the so called "EU Falsified Medicines Directive" requires Member States to prevent medicinal products that are introduced into the EU, but are not intended to be placed on the EU market, "from entering into circulation if there are sufficient grounds to suspect that those products are falsified". Member states have to implement this requirement from 2 January 2013.

Proposal:

Medicinal Products should be checked for their identity, their source or their history. When checking, analytical testing as well as verifications of the packaging and of the labelling could be considered. The concept paper takes into account the respective challenges like for example a possible lack of reference samples or unknown original packaging but does not give special guidance on how to deal with that. The same counts for the principle of proportionality to avoid unjustified disruptions of trade flows.

The checking or "verifications" as said in the text, "may be carried out by different authorities in different Member States" (and not by a company involved in the supply chain process).

By the way, what is a Delegated Act?

"The Treaty of Lisbon creates a new category of legal act: delegated acts. The legislator delegates the power to adopt acts amending non essential elements of a legislative act to the Commission.

For example, delegated acts may specify certain technical details or they may consist of a subsequent amendment to certain elements of a legislative act. The legislator can therefore concentrate on policy direction and objectives without entering into overly technical debates.

However, this delegation of power has strict limits. In effect, only the Commission can be authorised to adopt delegated acts. Furthermore, the legislator sets the conditions under which this delegation may be implemented. Article 290 of the Treaty on the Functioning of the EU specifies that the Council and the Parliament may revoke a delegation or limit its duration." (Source: Website of the European Union)

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)