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Peter Bogaert 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 EU 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 key legislation, including the orphan medicines regime, the 2004 revision of the EU pharmaceutical legislation, and the EU Regulations on paediatrics, financial penalties, advanced therapies, medical devices and veterinary medicines.
  • Counsel to several industry associations on strategic regulatory and policy dossiers.
  • Numerous cases before the EU courts, including Olivieri v. Commission, the first legal challenge of an EU approval for a medicine, and various cases on regulatory exclusivities.
  • 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 and orphan exclusivity.
  • Life cycle management planning for various pharmaceutical companies.
  • Defence of the orphan medicine 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)
  • 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)