Product Compliance, Risk Management and Advertising

Product Design

Before commencing production, businesses need to be sure that the production process and the product’s inherent characteristics will lead to optimal profitability. We help our clients identify the applicable EU and member state legislation and product safety standards; identify which countries offer the most favorable customs treatment and classify the product within the customs nomenclature; register product components, e.g., under the REACH and Biocides Regulations; and consider potential end-of-life obligations.

Product Launch

We coordinate all steps prior to the effective launch of a product on the EU market, or to its export to third countries. These include:

• Developing product liability risk profiles with reference to regulatory obligations and product liability litigation.
• Reviewing marketing materials and obtaining appropriate marketing authorizations.
• Drafting and negotiating distribution contracts.
• Protecting intellectual property rights.
• Negotiating pricing and reimbursement.
• Ensuring compliance with privacy regulation.

Aftermarket Issues

Once a product has been placed on the EU market, our team advises on regulatory and enforcement issues and potential product liability litigation. We help our clients assess risk and develop their postmarket strategies. We assist where a recall or corrective action is warranted, and work across different member state jurisdictions (we can rely on an extensive network of trusted local counsel where necessary). For example, we:

• Coordinate corrective actions, including recalls and the negotiating of alternative measures.
• Advise on the communication of price modifications relating to price-regulated products.
• Advise on consumer research.

Advertising

We advise our clients on the rules relating to the advertising of their products and services, and on all regulatory aspects relating to the marketing of their products, so as to ensure that their advertising materials are compliant with the relevant rules and codes of conduct. We also help clients assess the legality of their competitors’ marketing materials and represent our clients in litigation related to misleading, aggressive, and/or comparative advertising, and unfair commercial practices. For example, we:

• Advise on restrictions with regards to promotional offers.
• Perform internal audits for our clients and review company guidelines.
• Represent clients in the event of misleading, aggressive, and/or comparative advertising.

Public Policy

We monitor evolving EU legal and regulatory obligations that affect our clients’ products. We regularly work with our public policy group, Crowell Global Advisors, and with trusted lobbyists, to help our clients navigate the intricacies of EU legislation and the rule-making process. This enables clients to influence developing legislation and potentially limit its impact on their business and products.

• Challenging the validity of legal restrictions.
• Intervening in the EU legislative process (e.g., organizing events with key stakeholders).
• Assisting in drafting responses to public consultations organized by the European Commission.

Our Team

Our Brussels office lies in close proximity to the EU institutions and our multinational team gives us direct contact with local authorities in various jurisdictions. We work closely with our U.S. colleagues, enabling us to help our multinational clients develop a unified, global strategy. Our lawyers form an interdisciplinary team linking important experience from our corporate, commercial, antitrust, IP, and trade practices.