The existing EU legislation regulating medical devices will be replaced by the Medical Devices Regulation. The new regulation changes the European legal framework for medical devices, broadens the scope of the products and operators covered under this legislation and provides for increased responsibilities and obligations for manufacturers and notified bodies. It entered into force in May 2017 and will fully apply from 26 May 2020.
The European Commission's report 'Competition policy for the digital era' is its most substantial step yet towards crystallising the dialogue on the question of how competition law could or should adapt to the rapidly changing technological landscape and the growing role of the digital economy. However, while the report touches on a wide range of ideas and proposals, it openly notes that not all of these are developed in detail or go beyond "very preliminary" conclusions.
The European Commission recently adopted new rules to help insurers invest in equity and private debt and provide long-term capital financing. As a result of the new rules, insurers will have to hold less capital for investments in equity and private debt, including in small and medium-sized enterprises. The newly adopted rules take the form of a delegated regulation, amend the EU Solvency II Directive and follow on from the mid-term review of the Capital Markets Union Action Plan.
The European Court of Justice recently ruled that EU member states must require employers to establish an objective, reliable and accessible system for measuring their employees' daily working times. Without such a system, the hours and overtime actually worked cannot be reliably measured and employees' ability to enforce their rights cannot be guaranteed.
Section 8 of the Alicante Provincial Court (acting as the EU Trademark Court) recently dismissed Equivalenza Retail, SL's appeal against the Alicante Commercial Court Number 2 judgment in which it had been sentenced for infringing various perfume trademarks owned by Hugo Boss, Gucci and Lacoste in the context of its smell-alike business. Equivalenza had used the trademarks both in comparison lists and orally in commercial speech.
In January 2019 EU member states issued statements with wide-ranging effects for intra-EU investment protection. All member states pledged, among other things, to terminate intra-EU bilateral investment treaties (BITs) by 6 December 2019 and instruct investors not to initiate any new intra-EU investment arbitration proceedings under BITs. This article sheds light on the background of this development and its potential impact on investment protection.
In December 2018 the EU Trademark Court of Appeal declared that the Ibiza Beach drink marketed by Productos Ibicencos, SL and Aromáticas de Ibiza, SL – whose bottle was highly similar to the well-known Malibu bottle – infringed The Absolut Company AB's (TAC's) 3D and graphic trademarks which protect the shape of such bottle. Among other things, the court held that the defendants had taken unfair advantage of TAC's trademarks, as their product was very similar in appearance.
Virtual currencies have been analysed and considered by numerous policymakers at the EU level. According to the European Central Bank, the legal definition of 'virtual currencies' tends to vary depending on the context, while the European Banking Authority defines them as a digital representation of value that is neither issued by a central bank or public authority nor necessarily attached to a fiat currency, but used as a means of exchange and transferred, stored or traded electronically.
The Federated European Patent Register provides information regarding the legal status of EU patents. Among other things, the register provides a direct link to national patent registers, which makes it easier to obtain up-to-date information on the status of patents. Although there is room for further improvement, the register provides quick and easy access to the basic post-grant legal status of EU patents.
A hard Brexit would increase liability risk for EU carriers and freight forwarders, and disputing parties would need to overcome a number of factual and legal hurdles. Before undertaking cross-border transports, carriers are well advised to make clear agreements with senders in order to clarify that customs clearance delays are expected for an unforeseeable duration and request instructions from senders in accordance with the Convention on the Contract for the International Carriage of Goods by Road.
The EU Prospectus Regulation's provisions concerning the format and content requirements for prospectuses will come into force on 1 July 2019. Ahead of the provisions, the European Securities and Markets Association intends to publish final draft guidelines on risk factors in early 2019. Issuers and their advisers will then need to ensure that they comply with the new regime in respect of any prospectuses to be published on or after 21 July 2019.
In October 2018 the EU Trademark Court Number 1 of Alicante granted the interim injunction application filed by Xiaomi Inc against Blablatel Mobile SL for trademark infringement due to the parallel import of technological products from outside the European Economic Area. This decision is notable, as it confirms that importing goods that were originally intended to be marketed outside the European Economic Area without the trademark owner's consent constitutes trademark infringement.
With respect to employers with a multi-jurisdictional presence in the European Union, where a dispute arises between them and an employee concerning the law applicable to cross-border employment contracts, it is first necessary to assess whether the objectively applicable law was deviated from by way of a choice-of-law clause. If so, it is then necessary to determine whether this affects the objectively applicable law's mandatory provisions and whether these are more favourable to the employee than the law chosen.
The EU Regulation on Ship Recycling obliges EU-flagged vessels to conduct dismantling operations in European Commission-approved ship-recycling facilities in accordance with the Ship-Specific Ship-Recycling Plan and the Inventory of Hazardous Materials. The regulation aims to mitigate and eventually eliminate the adverse effects of operating, maintaining and recycling EU-flagged ships on human health and the environment.
In employment contracts with a cross-border reach, it is always necessary to determine the objective law to which the contract is to be subject and to what extent this may be deviated from by way of a choice-of-law clause. While the primary deciding factor in this context is the place in which employees generally perform their work, a number of problems may be encountered when determining where this is.
Foreign companies planning to transfer local business units to a domestic company must first resolve a number of issues. Since the cross-border spin-off is currently not regarded as a feasible option, the transfer of assets and liabilities must be effected by way of an asset deal. In Europe, this generally triggers a business transfer under local law whereby the employment contracts of the staff within the unit in question are transferred to the domestic company.
Many international companies run their domestic operations via a branch of a foreign parent, rather than a locally established company. While cross-border spin-offs are theoretically permitted under European law, they do not represent a feasible option due to inadequate domestic regulations. Whether such reorganisations will affect workers' employment status and works councils' co-determination rights, particularly following a change in operations, must be assessed on a case-by-case basis.
The European Commission recently proposed to implement an internal and external whistleblowing reporting process which gives employees and external persons the opportunity to report breaches of EU law and ensures that such reports will be followed up. The scope of the proposal is broad, but such protection should be reasonable, taking into account the interests of not only the whistleblower, but also the companies in question and the public.
Companies should always clarify which social security laws apply to employees who are deployed in other countries. For such employees, it is often important to know whether they can remain in the social security system of their home country in order to avoid losing their existing social security accruals. Where the cross-border deployment of staff relates to non-EU countries, it is necessary to determine whether a social security treaty with the country in question has been concluded.
Sending employees on secondments to company sites in other countries is a major issue in cross-border employment law. It is often a popular way of deepening cross-border cooperation, particularly in terms of transferring know-how and securing closer contact with foreign branches. Employers increasingly wish to fall back on instruments of this kind, especially in preparation for Brexit. In legal terms, particular focus should be placed on drafting contracts.