Covington opened its first European office in 1988 and now has more than 100 lawyers in London and Brussels. The European food and drug practice group includes more than twenty-five lawyers, who are qualified in various European Union (EU) Member States, and several research assistants with law or science degrees. Collectively, the lawyers and other staff speak the main languages of the European Union, and the offices maintain extensive collections of EU and national regulatory materials.
The group has advised hundreds of companies and trade associations, including many of the major multinational pharmaceutical manufacturers, biotechnology companies, and major producers of medical devices, cosmetics, foods, food additives, food packaging, food supplements, biocidal products, pesticides and specialty chemicals, and other consumer products. The group also has in-depth expertise in the EU chemical regime (REACH), which has a significant downstream impact on consumer and health products. The offices handle regulatory matters before the European Commission, the European Medicines Agency (EMA), and national regulatory agencies in the European Union, and they provide extensive regulatory advice to individual clients. The European offices also handle public policy, litigation, trademark, international tax, compliance, and corporate and commercial matters for food and drug industry clients. The European offices are closely integrated with the Washington and Beijing offices, so they can provide clients with coordinated advice on multinational matters and immediate access to all of the firm’s facilities and staff.
Representative Matters
- We have actively participated in the development of key pharmaceutical legislation in Europe, including the Orphan Medicines Regulation, the 2004 revision of the EC pharmaceutical legislation, the Paediatrics Regulation, the Pharmaceutical Penalties Regulation, the Advanced Therapy Medicinal Products Regulation, the Falsified Medicines Directive, and the revision of the pharmacovigilance principles. We also represent clients on the draft EU legislation on information to patients, a new Transparency Directive on pricing and reimbursement procedures, new Medical Devices Regulations, and a new Clinical Trials Regulation.
- We are counsel to Pharmaceutical Research and Manufacturers of America (PhRMA) in Europe on various legislative and policy issues, and we have advised the European Federation of Pharmaceutical Industries and Associations (EFPIA) and trade associations of the pharmaceutical industry in EU member states.
- We advise Cosmetics Europe and other personal care industry associations on major policy issues.
- We successfully defended a pre-market approval in Olivieri v. Commission (T-326/99), the first legal challenge of an EC approval for a medicine before the EC Court of First Instance.
- We represented Merck in MSD v. Commission (Case T 273/03). The EC Court annulled a decision of the Commission harmonizing the labeling for Renitec.
- We represented Shire and Janssen-Cilag before the English High Court and the European Court of Justice in Generics (UK) Ltd. v. Licensing Authority (2009), which held that a drug product approved in an EU candidate member state before its accession to the Union could not later be used as the reference product for a generic marketing authorization application in an EU member state. This is one of the few recent decisions of the European courts favoring the interests of innovative pharmaceutical manufacturers in the interpretation of the EU generic drug rules, and it remains highly relevant because of the numerous Eastern European countries that have entered the Union in recent years.
Accolades
- Law360, Life Sciences Group of the Year (2012)
- Chambers Global (2013)
- Firm
- Life Sciences, Global-wide
- Life Sciences, Europe-wide
- Individual
- Life Sciences, Regulatory/Compliance, Global-wide: Peter Bogaert, Grant Castle and Richard Kingham
- Chambers UK (2013)
- Firm
- Life Sciences, UK-wide
- Life Sciences, Regulatory, UK-wide
- Life Sciences, Transactional, UK-wide
- Life Sciences, Product Liability, UK-wide
- Product Liability, Food, UK-wide
- Individual
- Life Sciences, Regulatory, UK-wide: Grant Castle and Richard Kingham
- Life Sciences, Transactional, UK-wide: Paul Claydon, James Gubbins, and Daniel Pavin
- PLC Cross-border Super League
- Ranked 1st in the Life Sciences Regulatory Super League (2004-2011)
- Ranked 1st in the Life Sciences Industry Super League (2005-2010)
- PLC - Life Sciences, Which Law Firm? (2012)
- Leading: Life Sciences, England, EU, and USA
- Leading: Regulatory, Belgium, England, EU, and USA
- Highly Recommended: Life Sciences, Belgium
- Legal 500 UK (2012)
- Pharmaceuticals and Biotechnology
- Legal 500 EMEA (2013)
- EU Regulatory - Pharmaceuticals and Biotechnology
- EU Regulatory - Food
- LMG Life Sciences (2012)
- Lifecycle Firm
- Highly Recommended: Regulatory, FDA (Pharmaceutical)
- Recommended: Regulatory, FDA (Medical Devices)
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