Our Practice

Life Sciences: Europe


European Union regulatory and policy decisions affect the way Sidley’s Life Sciences clients conduct business throughout the world. The scope of the EU’s influence – based on a single set of rules and procedures for 27 European countries - continues to grow, both within Europe and globally.

Sidley’s EU law practice is a leader in helping companies, industry associations and governments navigate and shape EU rules. Our lawyers apply innovative strategies to help pharmaceutical, food and medical devices clients achieve their competitive business objectives. Sidley’s strength in the three cornerstones of EU law critical to global business –regulatory, competition and trade law – allows us to craft solutions tailored to our clients’ legal and policy concerns.

Our EU law group includes lawyers in Brussels and London experienced in the representation of pharmaceutical, biotechnology, medical device, food, cosmetics and other life sciences clients in a wide range of matters.

Our regulatory, competition and trade lawyers offer a rare combination of private- and public-sector experience and have a sophisticated understanding of EU institutions and policies. We represent clients on a wide variety of matters before the European Commission, the European Parliament, the Council of Ministers, EU Member State authorities and the European Courts.

Regulatory Law

Pharmaceutical, food and medical device companies that market their products and services in Europe face an intricate web of rules and regulations. EU regulation is continually evolving: it is adopted in Brussels, applied by European and national administrations and interpreted by the European and national courts. In order to ensure compliance, companies need up-to-date, practical advice on how the EU rules affect their industry.

Our EU life sciences lawyers regularly advise pharmaceutical companies on: good clinical practice (GCP); marketing authorizations; the importation and manufacture of medicinal products and ingredients and good manufacturing practice (GMP); pharmacovigilance (drug safety); marketing and advertising of medicinal products; labeling; environmental issues; counterfeit products; and compassionate use.

Our EU lawyers advise medical device manufacturers on rules for placing medical devices on the market, importing and manufacturing devices, post-market surveillance and device safety. We also work with medical device companies on market access and customs issues.

Areas of advice for food companies include general EU food law and food safety, the Food Supplements Directive, rules on genetically modified organisms (GMOs), legislation on irradiated food, and generally the application in the EU of the precautionary principle.

For cosmetics/beauty companies, our EU practice includes matters related to market access, product formulation, labeling, permissible claims, borderline determinations (between cosmetic products, medicinal products and medical devices) and safety issues.

Drawing from previous regulatory and legal experience at the European Commission and in national governments, as well as decades of private-sector experience, our EU life sciences lawyers have built and continue to maintain close contacts with the relevant EU authorities such as the European Commission's Health and Consumer Protection Directorate-General (DG Sanco), the Enterprise Directorate-General (DG Enterprise) and the European Commission's Legal Service. We also work with other official EU bodies such as the European Medicines Agency, the European Food Safety Authority (EFSA) and the Scientific Committee on Consumer Products.

Competition Law

Our EU competition lawyers have decades of experience representing corporations, trade associations, government entities and regulatory bodies in the full spectrum of competition law matters, including merger clearances, public authority investigations, state aid, litigation, antitrust counseling and policy projects. Our group leaders are among the highest-ranked practitioners in the European Union and have acted in many of the leading competition cases in recent years.

Our lawyers have handled competition law issues for applicants, complainants and defendants in a wide range of industries and business sectors, including biotechnology, food, pharmaceuticals and medical devices.
Complementing and working closely with our strong EU regulatory practice, our EU competition lawyers have particular experience advising pharmaceutical clients on the antitrust aspects of complex commercial agreements such as licensing, research and development and marketing agreements. We advise on EU and global merger control issues and assist clients in public authority investigations (including the on-going pharma sector inquiry) and litigation.

Trade Law

The influence of the European Union in the global market is constantly evolving with significant impact on investment and trade. Our EU law team comprises a leading trade law group experienced in advising clients on the full spectrum of EU and international trade matters that affect our global life sciences clients. We provide companies with effective ways to open markets, address trade barriers and protect their investments around the world. When working to obtain market access for clients, our lawyers have successfully leveraged the WTO Agreement on the application of sanitary and phytosanitary measures (SPS Agreement) and the WTO Agreement on technical barriers to trade (TBT Agreement), as well as other international agreements.

Our Team

Our EU Life Sciences team is led by Maurits Lugard, a former legal counsel in the European Commission (Legal Service and DG Enterprise) with extensive experience in a broad range of EU life sciences regulatory issues. Our team also includes Kristina Nordlander, an EU competition and regulatory practitioner with experience in antitrust, regulatory and contractual issues relevant to the pharmaceutical sector, including parallel trade and REACH compliance, Laurent Ruessmann, a highly-ranked trade lawyer with experience advising life sciences client on regulatory, privacy, data security and international trade issues, and Stephen Spinks, a highly-ranked antitrust lawyer with experience in the pharmaceutical and medical device sector.

Accolades

  • Sidley's EU Life Sciences practice leader Maurits Lugard is recognized as one of the leading regulatory lawyers by PLC Cross-Border Life Sciences Handbook.
  • Sidley is ranked in the highest tier of EU Regulatory practices by Legal 500 EMEA, with particular mention of the firm’s strength in the areas of environment (”EU regulatory law is a strong component of Sidley Austin LLP’s overall Brussels practice. Clients laud the firm’s ‘pragmatic legal advice based on sound legal analysis’.”), food and drugs (“Sidley Austin LLP are recommended for ‘finding workable solutions in complex situations and being very available’.”), and pharmaceuticals and biotechnology (“Sidley Austin LLP possesses an enviable record in this area. . . . [T]he ‘team have technical and factual competence’.”).
  • Sidley’s EU competition team is highly ranked in all the leading guides such as Chambers Global (“Since opening its doors in Brussels in 2003 this firm has made a good impression on the competition market, winning praise as a ‘great practice that really knows its stuff, with a strong team spirit that makes it a pleasure to work with’.”).
  • Sidley’s EU trade team consistently tops all the trade law rankings such as Chambers Global (“A global giant for trade work, this firm has a ‘first-class office’ in Brussels which advises on all areas of the field, from policy to remedies to WTO law.”).

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