Your consultant

In topic Consumer & Health:

Patrick Kirchner

Scientific Advisor

+49 761 38693-243

kirchner(at)cep.eu

Bastian Sattelberger

Policy Analyst

+49 761 38693-248

sattelberger(at)cep.eu

Consumer & Health

During the course of European integration, consumer protection and health protection have gradually developed into independent policy areas and goals of the EU, alongside and supplemental to the realisation of the Single Market. Under the European treaties, the EU is now not only under an express duty to ensure a high level of consumer and human health protection, but according to the EU Charter of Fundamental Rights everyone has also the right of access to preventive health care and the right to benefit from medical treatment. cep keeps track of EU legislative proposals which are of economic relevance in these fields.

“New Deal” for Consumers – Part 2: EU Consumer Law (Directive)

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In view of increasing EU-wide violations, the EU-Commission wants to strengthen the enforcement of, and thus improve compliance with, EU consumer protection law. In the context of its “New Deal for Consumers”, it has submitted a corresponding Directive.

Exemption from SPC Protection for Medicines (Regulation)

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By way of an exemption from protection certificates, the EU wants to permit the manufacture of generics and so-called biosimilars for export, even where the original medicine is still protected by a certificate in the EU. Using this exemption, it wants to remedy competitive disadvantages for EU manufacturers and strengthen its generics and biosimilars industry.

“New Deal” for Consumers – Part 1: Representative Actions (Directive)

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A new EU Directive on representative actions for the protection of the collective interests of consumers is to replace the existing Directive on injunctive relief. It is supposed to substantially expand the scope of representative actions in consumer law and thereby to promote the enforcement of consumer law whilst at the same time preventing abusive litigation.

Health Technology Assessment (Regulation)

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The EU Commission wants to create joint clinical assessments and harmonised assessment procedures at EU level for innovative health technology in order to remove barriers in the internal market. Thus, redundant duplication of work both in national HTA centres and for developers of health technology can be avoided and costs, currently incurred by developers due to differing national assessment concepts, can be reduced.

Guarantee Law for Sales of Goods (Directive)

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Due to reasons of cost, traders refrain from offering their goods across borders and consumers shy away from purchasing in other countries due to legal uncertainty. The Commission wants to change this by way of a Directive. It wants to remove barriers in cross-border trade with extensive full-harmonisation of guarantee law for sales of goods.

Antimicrobial Resistance (Communication)

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The EU Commission wants to increase efforts to combat the spread of antimicrobial resistance. With this aim, it has submitted a European Action Plan in line with the concept of “One Health”. In cep’s view, this is a sensible European initiative because resistant pathogens spread across borders thus making it necessary to take both EU-wide and global combating measures.

Data Transfers to Third Countries (Communication)

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The EU Commission wants to make the transmission of personal data to non-EU countries easier in order to promote mutual trade and effectively combat international crime.

Cooperation on Consumer Protection (Regulation)

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The Commission wants to improve cooperation between national consumer protection authorities in combating cross-border infringements of EU consumer protection laws. In cep's view, however, burdensome duties of cooperation should only apply to infringements which could noticeably damage the internal market.

Cross-border Parcel Delivery Services (Regulation)

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In order to improve cross-border parcel delivery, the EU Commission proposes uniform information obligations for delivery services. In addition, obligations for universal service providers to report tariffs and terminal rates, an "assessment of affordability" of these tariffs by the regulatory authorities and network access obligations applicable to universal service providers vis à vis third parties are proposed.

Contract law for the supply of digital content (Directive)

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In addition to online sales of goods, the EU Commission also wants to boost the market for digital content and ensure that it can also be offered and acquired across borders. With the proposed Directive, it wants to fully harmonise the guarantee rights and other consumer rights in contracts relating to the supply of digital content and thereby remove legal uncertainty and promote sales of digital content.

Guarantee law for online trade (Directive)

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Online traders avoid offering their goods across borders for reasons of cost; consumers are discouraged from online purchases abroad due to uncertainty about their rights. The EU Commission wants to change this by way of the proposed Directive. With full harmonisation of the law on legal guarantees for online sales of goods, it wants to remove legal uncertainty in crossborder online trade and thereby encourage such trade.

Alcohol Strategy 2016–2022

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The European Parliament has urged the EU Commission to “immediately” develop a new strategy to combat harmful alcohol consumption in the EU. In its resolution it already defines an array of concrete measures. The cep is assessing these measures in detail.

Experience with the ATMP Regulation (Report)

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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.

Geographical indication protection for non-agricultural products (Green Paper)

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The Commission discusses whether and how geographical indications for non-agricultural products can be protected EU wide. A protected geographical indication consists of a product denomination which contains the geographical origin of a product. A protected geographical indication may be used by all producers provided their products originate from the specified geographical place of origin and the products possess the established product characteristics – e.g. quality features, production methods or "reputation" – attributable to that place of origin. The Commission discusses in particular whether protected geographical indications could be entered into a central register which would be administered e.g. by the Commission. 

Exceptions to copyright

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The European Commission has announced a reform of the copyright rules in the EU before the end of this year. It intends to reduce the differences between national copyright rules by way of harmonised exceptions. The cep assesses the benefits and problems of mandatory exceptions to copyright.

Safety of Tourist Accommodation (Green Paper)

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The Commission wants to get an insight into national safety regulations for tourist accommodation. By way of this Green Paper, it wants to present its ideas and thoughts on how the confidence of providers and consumers can be increased, including, where necessary, by way of follow-up measures at EU level. In addition, the Commission wants to collect additional information on the safety of tourist accommodation by holding a public consultation.

Parcel Delivery in European Online Retailing (Communication)

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

Package Travel and Assisted Travel Arrangements (Directive)

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The Commission wants to harmonise consumer protection for travellers. For this purpose, bookings in travel agents and online will be placed on an equal footing.

Collective Redress: Representative and Class Actions (Recommendation)

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The Commission recommends that the Member States introduce collective actions. Collective actions refers to actions brought by two or more affected parties or by an authority or entity on their behalf. Collective actions should facilitate the enforcement of legal rights, particularly where individual actions are too costly for affected parties.

Market Surveillance (Regulation)

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The European Commission has proposed a "Product Safety and Market Surveillance Package" containing, in particular, a proposal for a Regulation on consumer product safety and a proposal for a Regulation on the regulatory market surveillance of products. With its proposal for a Regulation on market surveillance, the Commission wants to prevent, by way of effective and EU-wide market surveillance, the distribution of products which represent a risk to any aspect of public interest protection, such as health, safety, consumer protection and the environment.

Product Safety (Regulation)

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The European Commission has proposed a "Product Safety and Market Surveillance Package" containing, in particular, a proposal for a Regulation on consumer product safety and a proposal for a Regulation on the regulatory market surveillance of products. The proposal for a Regulation on product safety aims to simplify the different rules on consumer product safety as well as ensuring that consumer products are safe.

Basic account for everyone (Directive)

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The Commission wants to grant all EU citizens the right to have a payment account with basic features (basic account), make it easier to switch banks, particularly across borders, and improve the transparency and comparability of fees.

Single market for green products (Communication)

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The European Commission intends to promote the dissemination of green products and green commercial practices by ways of transparency and consistency with the labelling of environmental performances of products and practices. Within a three-year test phase, the Commission recommends to apply its developed methods of the “Product Environmental Footprint“ and that of the “Organisation Environmental Footprint“.

Parcel delivery (Green Paper)

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The Commission wants to stimulate cross-border e-commerce and, for this purpose, is considering regulating the parcel delivery market.

Investment Products for Retail Investors (PRIPS) (Regulation)

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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.

Tobacco products (Directive)

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The Commission wants to combat tobacco consumption, particularly among young people, and for this purpose re-harmonise the rules on tobacco products.

European Consumer Agenda (Communication)

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The Commission outlines its medium-term strategy for EU consumer policy by 2014 under the European Consumer Agenda.

Data Protection (Regulation)

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The Commission wishes to reform the EU data protection law fundamentally with the General Data Protection Regulation. It is mainly aimed at an EU-wide full harmonisation of the data protection standard while taking account of the latest technical challenges of the internet age. It is to replace the existing Data Protection Directive (95/46/EC).

Amendments to the Pharmacovigilance System (Directive)

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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.

Amendments to the Pharmacovigilance System (Regulation/Directive)

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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.

Anti-counterfeiting of medicinal products (Directive)

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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.

Data Retention (Report)

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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. 

Passenger Name Record Data (Directive)

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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.

Tourism Policy (Communication)

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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”.

Pharmacovigilance (Directive)

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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.

Second Consumer Markets Scoreboard (Communication)

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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.

Information on Medicinal Products (Directive)

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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.

Mechanisms for Consumer Collective Redress (Green Paper)

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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.

Consumer Contractual Rights (Directive)

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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 Consumer Markets Scoreboard (Communication)

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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.

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