The Commission wishes to improve the pharmacovigilance rules of 2010 by amending the pharmacovigilance system. New transparency and information obligations for authorisation holders are to be introduced. The initiation of the urgent union procedure is to be automatised and the list of drugs for additional surveillance is to be extended.

The Data Retention Directive stipulates that providers of telecommunications, mobile and internet services are obliged to retain traffic and location data of users. The purpose of this is the investigation, detection and prosecution of “serious crime”. In its Report, the Commission evaluates the Member States’ application of the Data Retention Directive, its benefit and impact. 

According to the Commission’s proposals “PNR data” of passengers travelling from or to third countries are to be collected by air carriers during the passengers’ flight booking procedure and must be transferred to Member States’ authorities. The Directive regulates data processing (collection, retention and analysis) through national authorities, the data exchange between Member States and the data transfer to third countries.

With the Lisbon Treaty the EU acquired new competences in the field of tourism which are anchored in primary law. In its Communication the Commission describes the “challenges” and presents an “action framework for tourism in Europe”. The Commission wishes to make the cultural and natural wealth of Europe better known, for example by introducing a “European Cultural Heritage Seal”. Furthermore, a publicly funded “voluntary” exchange mechanism for tourists is to enable “key groups” such as young people (up to the age of 30) and the elderly (65+) to travel to tourist destinations in other Member States during the low season. Finally, the Commission plans to conduct “awareness-raising campaigns relating to the choice of destinations and the means of transport to promote “sustainable and responsible high-quality tourism”.

The EU-Commission has fundamentally revised the EU Codex for Medicinal Products in its Pharmaceutical Package presented in December 2008. The focus lies on informations for patients, the protection against falsified medical products and the monitoring of authorised medical products (pharmacovigilance). For the latter, essential improvements are the obligation for an implementation of a risk-management-system for all newly authorised medical products and the option for authorities to impose requirements even after authorisation.

The consumer markets scoreboard serves to monitor the “performance“ of the internal market from the consumers’ perspective and to identify parts of it that “are not functioning well“. Moreover, consumer options for cross-border shopping within the EU are to be assessed and the general conditions for effective consumer protection in the single Member States be benchmarked.

The analysed Proposal for a Directive is part of the Pharmaceutical Package to improve the safety of medicinal products. The Proposal focuses on the protection of distribution chains from manufacturers to pharmacies against the entry of falsified medicinal products. During debates held previous to the Proposal the Commission opted for maintaining parallel import trade. To this end, the measures proposed now are restricted to prescription medicines, which constitute the majority of medicinal products traded through parallel import.

The Commission's Proposal aims to establish a harmonised legislative framework for the provision of information to the general public on medicinal products for human use subject to medical prescription. In particular, clear boundaries are to be set between information provided by pharmaceutical companies and prohibited advertising.

Regarding mass claim cases the Commission wants to open up the possibilities of collective redress for damages claims or develop existing possibilities. To this end, in its Green Paper it presents different options to address the issue which have an effect on cross-border cases as well as purely national ones. It further considers to introduce standardised judicial procedures for collective redress.