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Peter Bogaert is a managing partner of the Brussels office, and has a broad European life sciences practice. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert's practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he represents numerous innovative life sciences companies, including start-ups, as well as several industry associations.

  • Active participation in the development of many pieces of legislation, including the Orphan Medicines Regulation, the 2004 revision of the EC pharmaceutical legislation, the Paediatrics Regulation, the Pharmaceutical Penalties Regulation and the Advanced Therapies Regulation.
  • Counsel to Pharmaceutical Research and Manufacturers of America (PhRMA) in Europe on various legislative and policy issues.
  • Successful defense of a pre-market approval in Olivieri v. Commission, the first legal challenge of an EC approval for a medicine.  The claim was brought by a former investigator for the product and was dismissed by the EC Court of First Instance.  
  • Advice on the interplay between regulatory procedures and patent rights and assistance in the management of the procedures.
  • Detailed advice on supplementary protection certificates and the EC paediatrics rules, including regulatory planning with regard to SPC extensions.
  • Life cycle management planning for various pharmaceutical companies.
  • Defence of the orphan drug status of various products in the EU.
  • Regulatory strategies for protecting core downstream use of functional ingredients in consumer products, with specific attention to the impact of a revised chemical classification for use in finished products.
  • Regulatory audits and gap analyses for life sciences companies, focusing among others on pharmacovigilance procedures and commercial practices.
  • Regulatory strategy throughout Europe for food ingredients that have significant health benefits.

Memberships and Affiliations

  • Brussels Pharma Law Group, founding member and program committee (1995-present)
  • Regulatory Affairs Journal, member of the editorial board
  • Chambers Global, Life Sciences (2013-2018)
  • Chambers Europe, Life Sciences (2009-2020) and Environment - EU Regulatory (2016-2017)
  • JUVE, Life Sciences and Brussels (2015-2016) 
  • Legal 500 EMEA, EU Regulatory - Food, Pharmaceuticals, Medical Devices & Biotech, Healthcare & Life Sciences (2010-2017), and Chemicals (REACH) (2017)
  • LMG Life Sciences Europe, Life Sciences Star - Regulatory (Belgium and European Union) (2014)
  • PLC Which Lawyer?, Life Sciences - Regulatory, Belgium and EU (2001-2012)
  • Best Lawyers in Belgium, Regulatory (Pharmaceutical) (2009-2015)
  • Best Lawyers in Belgium, Regulatory "Lawyer of the Year" (2012)
  • Who's Who Legal, Life Sciences (2011)   
  • Legal Experts EMEA (2010)    
  • Global Counsel, “One of the top ten life sciences lawyers in the world” (2001-2002)