Businesses need fast answers, a clear path forward, and guidance based on direct experience when tackling the complexities of EU regulatory concerns. We have a unique perspective and a first-hand knowledge of how legislative bodies and regulatory agencies work, both at EU and at the national level.
'Extremely experienced in all regulatory issues', the Crowell & Moring team is 'very pragmatic and very thorough', Legal 500 EMEA
Our EU Regulatory practice works together with local, national and multinational companies to identify and manage the legal requirements that affect their businesses. In particular, we:
- Advise on EU regulatory laws and standards to ensure compliance across all the EU member states.
- Help clients identify and manage risks as they develop strategies to maximize business growth.
- Monitor the latest legal developments that affect our clients.
- Assist our clients in lobbying at both national and EU level in relation to new legislative and policy proposals.
- Counsel our clients where necessary on litigation before national and EU courts.
The EU Regulatory practice is by its nature multidisciplinary. We are able to advise our clients on all aspects of marketing and brand protection within the EU by combining our broad regulatory capabilities with our individual lawyers’ up to date and in-depth knowledge both of the industry sectors concerned (such as information technology, life sciences, telecommunications and food) and of the complementary fields of law (including intellectual property, competition law and international trade).
Our lawyers deal directly with many EU authorities and work closely with a network of experts across Europe so as to guarantee high quality, quick assistance to our clients. Our international capabilities are assured by our collaboration with our Crowell & Moring colleagues in the U.S. and London, and our colleagues at Crowell & Moring International, LLC (our affiliated policy and regulatory affairs consultancy firm, which has extensive prior experience in trade negotiation), while our Brussels location gives us the advantage of proximity to key decision-makers in the European Institutions.
Our Services and Experience
Where legal regulatory requirements relate to products, we assist our clients throughout their product’s lifecycle – from manufacture to disposal. We have considerable experience working with consumer and industrial product manufacturers, component suppliers, and sellers and distributors; and we have particular experience with clients seeking to extend their valuable brand names into new product areas.
Product Risk Management
Product Design
We assist our clients in the identification of applicable EU and member state legislation and standards; the registration of product components (e.g. under REACH and Biocides Regulations or the General Product Safety Directive); the choice of favorable customs treatment and in considering end-of-life options.
Product Launch
Issues here include the registration of the product with the relevant authorities; the development of liability risk profiles prior to sale; the design of distribution chains and the drafting and negotiation of distribution contracts; negotiation concerning pricing and reimbursements; the protection of intellectual property rights; marketing, promotional campaigns and product labeling compliance; the obtaining of necessary authorizations; and compliance with consumer rights legislation.
Aftermarket Issues
This includes the resolution of regulatory and enforcement issues and the assessment of risk; product liability litigation and the coordination of corrective actions (recalls etc.); the minimizing of consumer risk while preserving brand integrity; and advice on consumer research.
Conflicts
Where litigation cannot be avoided, court actions may concern: the existence of competitors’ illegal products on the EU market; a defense against third-party claims (e.g., of failure to comply with regulatory obligations); counterfeit and the infringement of copyright-protected content; the wrongful use of advertising and unfair commercial practices; a complaint to the European Commission against member states for noncompliance with EU legislation.
International Trade
Export controls and sanctions regulations present significant challenges and potential compliance risks for global companies. We monitor, analyze and report on developments in this rapidly changing web of laws and policy, and we conduct internal reviews, investigations, respond to government inquiries and agency interventions, and coordinate closely with our White Collar and Regulatory enforcement colleagues to manage risk.
- Advice on export controls and sanctions.
- Addressing customs issues for global clients.
- Monitoring WTO-related issues.
- Providing strategic counseling and risk analysis.
Privacy, Data Protection, Cybersecurity
Privacy and data protection issues affect many of our clients, whether they provide products or services. We help them to achieve data protection compliance through counseling and global and EU-wide privacy audits. We facilitate a better understanding of data processing and information management and enable our clients to map the location and flow of data and identify potential threats and compliance issues.
- Privacy compliance programs and privacy policies for clients.
- Advice on data protection obligations (such as the retention and transferal of customer data) and on direct marketing issues.
- Advice on internet/email monitoring, the use of cameras, and on social media in the workplace.
Advertising
We advise our clients on the advertising of their products and services and on all regulatory aspects relating to the marketing of their products. We also help them to assess the legality of their competitors’ marketing practices.
- Advice on restrictions with regards to promotional offers.
- Internal audits and reviews of company guidelines.
- Representation in the event of misleading, aggressive and/or comparative advertising.
White Collar Crime
We advise both public institutions and local and multinational companies on a broad range of criminal matters. To raise awareness of potential criminal liability and increase our clients’ understanding of their professional responsibilities, we organize internal training programs and develop compliance programs and client codes of conduct. We assist in interactions with regulatory authorities and defend our clients in court when necessary. Typical areas in which we provide services include public and private bribery, breach of trust and misappropriation of funds, theft, concealment, forgery, fraud, infringement of labor law, and offenses related to IP rights (e.g., counterfeiting).
Public Policy
We monitor evolving EU legislation that affects our clients. By teaming up with Crowell & Moring International, LLC, and with trusted lobbyists, we are able to help our clients navigate the intricacies of the EU rule-making process. This allows our clients to influence developing legislation and potentially limit its impact on their businesses. Proactive monitoring also provides clients with advance warning of changes to legal regimes, affording them lead time to adapt product design, sourcing, or manufacturing, and thereby reduce cost.
Public Procurement
Our clients are increasingly being confronted with public procurement and competitive tendering procedures when contracting with public authorities or with private entities. We advise our clients both in relation to the generally applicable rules and with respect to their own particular tenders. We offer a full range of services to bidders and contracting authorities covering the procedures and requirements relating to the award of public contracts as well as EU and NATO procurement rules and assist our clients at every stage of the tendering process. Where necessary, we challenge public authority decisions on behalf of our clients, and we advise on Public Private Partnership projects.
Our Industry/Sector Focus
Our EU Regulatory Practice spans virtually every industry sector with a particular focus on automotive; betting and gambling; chemicals; energy; fast-moving consumer goods; food and feed; information technology; internet and e-commerce; life sciences/biotechnology; media and entertainment; telecommunications; and tobacco.
In particular, our clients have included a leading U.S. manufacturer of electric vehicles; large pharmaceutical companies, a plastics manufacturer, an online gambling vendor, major manufacturers of toys and sports equipment, the leading Belgian cable distributor, cosmetics manufacturers, a leading tobacco manufacturer, oil companies and manufacturers of medical devices.
“‘Excellent firm’ Crowell & Moring has ‘a highly specialised’ and ‘very accessible’ technology, media and entertainment team which has strength handling the full range of contentious and non-contentious, IP, regulatory, corporate and commercial matters in the space.” Legal 500 EMEA
“The team’s well-rounded offering is highlighted by sources: ‘They have an interesting mix of telecoms and media combined with a strong IP and regulatory practice.’” Chambers Europe
“Crowell & Moring’s regulatory expertise [for pharmaceuticals, medical devices and biotechnology] ranges from marketing authorisations and off-label use to parallel imports and pricing.” Legal 500 EMEA