Life Sciences: Europe


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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 28 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, London and Geneva experienced in the representation of pharmaceutical, biotechnology, medical device, food, cosmetics and other life sciences clients in a wide range of regulatory, antitrust and trade law issues.

Our EU 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 devices 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; pricing and reimbursement; 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 novel foods, general EU food law and food safety, the Food Supplements Directive, food for special medicinal purposes, rules on genetically modified organisms (GMOs), legislation on irradiated food, and generally the application in the EU of the precautionary principle.

For cosmetics clients, 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.

For all sectors, we advise on all aspects of the distribution chain, including stock allocation systems.

Drawing from previous regulatory and legal experience at the European Commission, 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 SANTE), the Internal Market, Industry, Entrepreneurship and SMEs Directorate-General (DG GROW) and the European Commission’s Legal Service. We also work with other official EU bodies such as the EMA, 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 life sciences 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 (for example, the European Commission’s 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 in Geneva provides assistance to clients on a wide range of complex topics before the WTO and other international organizations, including the World Health Organization (WHO), which increasingly touch upon trade and investment law and policy. Our practitioners have direct experience with these organizations, and have handled high-level policy advocacy projects for clients.

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 and Maarten Meulenbelt, who focuses his practice on EU regulatory affairs, litigation and competition law issues affecting the life sciences sector in Europe.

Accolades

  • Sidley’s leading practice in the European life sciences sector is recognized in the 2014 edition of LMG Life Sciences Europe, where Sidley is also featured as one of ten Pan-European firms, nine Sidley lawyers are featured as “Life Science Stars” and nine practice areas are ranked including: Regulatory, Corporate & Commercial, Competition & Antitrust, and Parallel Import. One competitor says “We aspire to create a practice like they do, and their global platform is among the broadest in the industry,” and one client adds “There is no firm like Sidley in terms of a global platform. They have helped us in the U.S. and multiple European jurisdictions as well.”
  • In the 2014 edition of Chambers Europe, Sidley received a number one ranking in Regulatory: Life Sciences/Pharma. One client commented that “The attention to detail was excellent as the lawyers dug into the facts and took the time to investigate our matter, to explain the law and regulations.”Sidley’s EU Life Sciences practice is ranked as “leading” (the highest tier) by PLC Cross-Border Life Sciences Handbook 2011/12 in the regulatory category, and as “highly recommended” in the competition category. Worldwide, 21 Sidley lawyers are individually recognized in their jurisdictions, including Maurits Lugard for EU Regulatory, Kristina Nordlander for EU Competition/Antitrust and Maarten Meulenbelt for both EU Regulatory and EU Competition/Antitrust.
  • Sidley is ranked in the highest tier of EU Regulatory practices by The Legal 500 EMEA 2015, with particular mention of the firm’s strength in the areas of food, environment (“Clients comment that Sidley Austin LLP delivers ‘very good value, and understands the issues and the wider implications’. It boasts an impressive client base.”), and pharmaceuticals and biotechnology.
  • Sidley’s EU competition team is highly ranked in all the leading guides such as Chambers Global (“This international group is warmly praised for its collaborative culture: business-oriented and flexible, the team offers a truly personalized service to its clients, working closely with them to achieve the best results.”) as well as The Legal 500 EMEA (“Sidley Austin LLP’s lawyers are ‘specialists you want to have on your side in a difficult case’; the firm ‘builds on the synergies involved where regulation, trade and competition issues are all intertwined’.”).
  • Sidley’s EU trade practice and our team leaders receive consistently high rankings and clients praise in Chambers Global (“[Sidley] has an international reputation for excellence in this field, as well as a valuable familiarity with EU trade regulations.”) and The Legal 500 EMEA (“Sidley Austin LLP continues to deliver ‘a first-rate service and perfect industry knowledge’. Clients value the team’s ‘resourcefulness in identifying and coming up with creative original ideas and strategies’. With a ‘a great network in Brussels and an excellent reputation with the EU authorities’, the practice advises complainants, respondents, users, governments or other stakeholders.”).
  • Sidley is the 2014 “Global Trade & Customs Law Firm of the Year” according to Who’s Who Legal and has had that honor every year since the award’s inception in 2005.

Related Practices

Follow us on Twitter:

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 28 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, London and Geneva experienced in the representation of pharmaceutical, biotechnology, medical device, food, cosmetics and other life sciences clients in a wide range of regulatory, antitrust and trade law issues.

Our EU 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 devices 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; pricing and reimbursement; 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 novel foods, general EU food law and food safety, the Food Supplements Directive, food for special medicinal purposes, rules on genetically modified organisms (GMOs), legislation on irradiated food, and generally the application in the EU of the precautionary principle.

For cosmetics clients, 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.

For all sectors, we advise on all aspects of the distribution chain, including stock allocation systems.

Drawing from previous regulatory and legal experience at the European Commission, 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 SANTE), the Internal Market, Industry, Entrepreneurship and SMEs Directorate-General (DG GROW) and the European Commission’s Legal Service. We also work with other official EU bodies such as the EMA, 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 life sciences 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 (for example, the European Commission’s 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 in Geneva provides assistance to clients on a wide range of complex topics before the WTO and other international organizations, including the World Health Organization (WHO), which increasingly touch upon trade and investment law and policy. Our practitioners have direct experience with these organizations, and have handled high-level policy advocacy projects for clients.

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 and Maarten Meulenbelt, who focuses his practice on EU regulatory affairs, litigation and competition law issues affecting the life sciences sector in Europe.

Accolades

  • Sidley’s leading practice in the European life sciences sector is recognized in the 2014 edition of LMG Life Sciences Europe, where Sidley is also featured as one of ten Pan-European firms, nine Sidley lawyers are featured as “Life Science Stars” and nine practice areas are ranked including: Regulatory, Corporate & Commercial, Competition & Antitrust, and Parallel Import. One competitor says “We aspire to create a practice like they do, and their global platform is among the broadest in the industry,” and one client adds “There is no firm like Sidley in terms of a global platform. They have helped us in the U.S. and multiple European jurisdictions as well.”
  • In the 2014 edition of Chambers Europe, Sidley received a number one ranking in Regulatory: Life Sciences/Pharma. One client commented that “The attention to detail was excellent as the lawyers dug into the facts and took the time to investigate our matter, to explain the law and regulations.”Sidley’s EU Life Sciences practice is ranked as “leading” (the highest tier) by PLC Cross-Border Life Sciences Handbook 2011/12 in the regulatory category, and as “highly recommended” in the competition category. Worldwide, 21 Sidley lawyers are individually recognized in their jurisdictions, including Maurits Lugard for EU Regulatory, Kristina Nordlander for EU Competition/Antitrust and Maarten Meulenbelt for both EU Regulatory and EU Competition/Antitrust.
  • Sidley is ranked in the highest tier of EU Regulatory practices by The Legal 500 EMEA 2015, with particular mention of the firm’s strength in the areas of food, environment (“Clients comment that Sidley Austin LLP delivers ‘very good value, and understands the issues and the wider implications’. It boasts an impressive client base.”), and pharmaceuticals and biotechnology.
  • Sidley’s EU competition team is highly ranked in all the leading guides such as Chambers Global (“This international group is warmly praised for its collaborative culture: business-oriented and flexible, the team offers a truly personalized service to its clients, working closely with them to achieve the best results.”) as well as The Legal 500 EMEA (“Sidley Austin LLP’s lawyers are ‘specialists you want to have on your side in a difficult case’; the firm ‘builds on the synergies involved where regulation, trade and competition issues are all intertwined’.”).
  • Sidley’s EU trade practice and our team leaders receive consistently high rankings and clients praise in Chambers Global (“[Sidley] has an international reputation for excellence in this field, as well as a valuable familiarity with EU trade regulations.”) and The Legal 500 EMEA (“Sidley Austin LLP continues to deliver ‘a first-rate service and perfect industry knowledge’. Clients value the team’s ‘resourcefulness in identifying and coming up with creative original ideas and strategies’. With a ‘a great network in Brussels and an excellent reputation with the EU authorities’, the practice advises complainants, respondents, users, governments or other stakeholders.”).
  • Sidley is the 2014 “Global Trade & Customs Law Firm of the Year” according to Who’s Who Legal and has had that honor every year since the award’s inception in 2005.

Related Practices

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