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Pharmaceuticals: EU – Japan Agreement on Information Exchange Concerning Medicines
After lengthy discussions, the European Union and Japan have reached an agreement on the exchange of confidential information about the authorisation and safety of medicines. The new confidentiality arrangements will allow the transfer of advance drafts of legislation, scientific advice on product development and, most importantly, transfer of detailed assessments of applications for marketing authorisations. As a result, producers of pharmaceuticals filing for marketing authorisations either in Europe or Japan should be aware that the information they provide will be transferred to the relevant authority in the other country. Pharmaceutical companies should therefore take into consideration rules concerning marketing authorisation in both jurisdictions, as the release of certain information to one authority may affect their application in the other jurisdiction.
Environment: EU Strategy to Reduce CO2 Emissions From Motor Vehicles
Contact Philip Bentley
The European Commission has proposed a comprehensive strategy to reduce carbon dioxide (CO2) emissions from new cars and vans sold in the European Union. Average emissions from new cars sold in the EU-27 must be reduced to 120g CO2/km by 2012 – a reduction of 25 per cent from current levels. Improvements in vehicle technology would have to reduce average emissions to no more than 130g/km, while complementary measures would contribute a further emissions cut of up to 10g/km, thus reducing overall emissions to 120g/km. For vans, the fleet average emission targets would be 175g by 2012 and 160g by 2015, compared with 201g in 2002. Commission President Barroso welcomed the new measures and called upon the car industry to preserve their long term competitiveness by taking an innovative lead in the interest of consumers. The legislative framework to implement the strategy will be proposed by the Commission by the end of 2007.
Environment: Harmonisation of Environmental Offences and Penalties
In order to tackle the cross-border implications of environmental crime, the European Commission proposes to harmonise such crimes and their penalties across the European Union. A draft paper calls for sanctions for environmentally harmful activities, which typically cause substantial damage to the air, soil, water, animals or plants. Nine sets of offences are listed, such as unlawful treatment of waste or unlawful possession of protected wild plants and animals. According to the Commission, these offences must be considered criminal throughout Europe, with a harmonised punishment ranging from one to ten years' imprisonment. Companies held liable for these environmental offences would be penalised with fines between EUR 300,000 and EUR 1.5 million.
State Aid: Commission Investigation into Reduced Interest Rates for Intra-Group Financing
The European Commission has decided to open a formal investigation procedure into planned reductions of Dutch tax rates for net interest received on intra-group loans. Currently in Holland, when a company injects capital into another company, the dividend it receives is tax exempt, whereas when it lends money, the interest received is taxed at the general corporate rate of 25.5 per cent. The Netherlands notified a proposal for a tax break scheme called “Groepsrentebox” aimed at lowering the tax rate on interest received in the context of intra-group financing from the general corporate tax rate of 25.5 per cent to 5 per cent. Although it appears to be open to all companies, the Commission considers that the scheme would de facto benefit groups of companies and not individual companies. The Commission has therefore decided to open a formal investigation procedure.
Mergers: German Merger Cooled Down
The European Commission has referred certain aspects of the proposed acquisition of scrap metal company TSR to the German Competition Authority for examination under German competition law. The transaction involves German companies Cronimet and Remondis, and the Italian company Alfa Acciai. The acquisition of TSR allegedly threatens to significantly affect competition on the regional markets for the collection of carbon steel scrap in the Ruhr area and for the collection of alloyed steel scrap around Stuttgart where there are considerable overlaps between the parties. Moreover, due to joint ventures with other leading market players, considerable structural links would be created on these markets. Furthermore, TSR's current existing participation in the Recool joint venture, along with Abfallentsorgungsgesellschaft Ruhrgebiet mbH (AGR), would further strengthen Remondis' position on the German market for the recycling of cooling systems. The notified operation does not give rise to any competition concerns in other parts of the European Economic Area, and the Commission has therefore approved the rest of the deal under the EU Merger Regulation.
Air Transport: Another Round of EU-US Open Skies Talks
Yet another round of aviation negotiations has been opened between the European Union and the United States. The negotiations originally started in 2003 after the European Court of Justice declared that bilateral 'open skies' deals between the US and individual EU Member States were illegal. Despite the negotiation in 2005 of an EU-US text designed to replace the bilaterals, the two blocks have been forced back to the negotiation table following a US announcement that part of the 2005 deal could not be implemented. The European Commission has declared that it cannot continue to refrain from requiring termination of the illegal bilateral deals, thereby emphasising the urgency for a EU-US agreement to be reached.
The European Court of Justice (ECJ) was asked by a French Court to interpret Community legislation concerning transition to the Euro currency. The proceedings before the French Court related to an action brought by a company for the repayment of a tax on sales of flour, meal and wheat. Upon transition to the Euro, French legislation fixed a tax of EUR 16 per tonne, while the company argued that the application of Community regulations on the conversion of French Francs into Euro would lead to a lesser amount. The ECJ found that even though Member States are free to increase taxes, the legislative text effecting the increase must distinguish clearly the decision of the authorities to increase the tax from the operation of conversion of that amount into Euro.
Internal Market: National Debt Management Platforms Come Under the Competition Microscope
The European Commission has asked national governments to respond to a questionnaire about the ways in which they place the management of their national debt, with a view to determining whether it is now time for alternative platforms to be made available. At present, national debt management offices generally deal with specified groups of bankers (primary dealers) who are then obliged to trade the debt over a designated platform. The concern appears to be whether there is still a need for national debt management offices to concentrate liquidity on one platform – for example in Rome the designated platform is MTS – as opposed to alternative platforms.
Consumer Protection: Consultation on Eight Consumer Protection Directives
The new European Commissioner for Consumer Protection, Meglena Kuneva, has presented a Green Paper reviewing EU consumer protection rules. It covers existing EU directives on unfair contract terms, sale of consumer goods and guarantees, distance and doorstep selling, package travel, timeshare, injunctions and pricing rules. The objective is to update these rules and include consideration of cross-border online transactions. The paper suggests action on 28 issues, including the notion of a cross-border purchase, harmonised rules on product returns, consumer choice of remedies for late, partial or non-delivery, and rules covering “cooling off periods” during which consumers can return the purchased product. Interested parties are invited to comment by 8 May 2007.
Monday 12 February – Friday 16 February 2007
General Affairs and External Relations Council (12 – 13 February 2007)
Transport, Telecommunications and Energy Council (15 February 2007)
Justice and Home Affairs Council (15 – 16 February 2007)
Education, Youth and Culture Council (16 February 2007)
COURT OF JUSTICE
C-239/05 BVBA Management, Training en Consultancy
Convention on jurisdiction
C-292/05 Lechouritou and Others
C-34/04 Commission v Netherlands
Freedom of movement for persons
C-270/05 Athinaïki Chartopoïïa
Freedom to provide services
C-345/04 Centro Equestro da Leziria Grande
Free movement of goods
Area of Freedom, Security and Justice
C-386/05 Color Drack
C-237/05 Commission v Greece
Environment and consumers
C-259/05 Omni Metal Service
Freedom of establishment
C-112/05 Commission v Germany
Free movement of capital
C-464/05 Geurts and Vogten
Free movement of goods
C-426/05 Tele2 UTA Telecommunication
C-411/05 Palacios de la Villa
C-178/05 Commission v Greece
C-335/05 Rizeni Letoveho Provozu
COURT OF FIRST INSTANCE
T-256/04 Mundipharma v OHMI - Altana Pharma
T-353/04 Ontex v OHMI - Curon Medical
T-501/04 Bodegas Franco-Españolas v OHMI - Companhia Geral da Agricultura das Vinhas do Alto Douro
T-204/04 Indorata-Serviços e Gestão v OHMI