Publications Archive

The Commission indicates that it is generally satisfied with the application of the Regulation on advanced therapy medicinal products (ATMP Regulation) but considers that it could be improved by extending the certification procedure to include universities and other non-commercial institutions. In addition, it calls for restriction of the hospital exemption, which allows ATMPs to be used without a marketing authorisation in domestic hospitals.

The Commission wants to stimulate cross-border e-commerce in the EU by improving parcel delivery conditions.

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 EU-Commission proposes to revise the Directve as to doorstep selling, unfair contract terms, distant selling, as well as to the purchase of consumer goods and subsume it under a new directive. The main target of the Directive is the transition from minimum harmonisation of consumer contractual rights to a full harmonisation.

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.

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 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.

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.

The Commission intends to screen the performance of certain product and service markets by way of a "Consumer Markets Scoreboard". The Commission assumes that citizens expect markets to deliver best possible outcomes in the interest of consumers which, at the same time, should be socially acceptable. Where, according to the Consumer Markets Scoreboard, "market malfunctions" are detected regulations or measures in the field of competition law or consumer policy are to be introduced. Alongside its Communication the Commission presented a first Consumer Markets Scoreboard containing the results of various consumer surveys and price research, yet without drawing any concrete conclusions.

The Commission wishes to introduce uniform key information documents on investment products (PRIPS) in order to strengthen investor protection and to create a level playing field for investment product manufacturers. The key information documents must be provided to retail investors before the acquisition of an investment product (e.g. an investment fund) and must have a standardised structure.