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Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive litigation experience before the EU Court of Justice in dozens of cases.

Over the past seven years, Mr. Van Vooren has developed a niche practice on compliance with the Biodiversity Convention and the Nagoya Protocol, a set of rules to combat bio-piracy worldwide. He has accumulated unique, practical experience in dozens of jurisdictions around the world, and has handled everything from benefit-sharing negotiations, over compliance programs, to inspections by authorities.

  • T-613/19 European Network for Independent Living and Validity vs European Commission - re. UN Disability Convention.
  • T-549/18 Hexal v European Medicines Agency - re. New Active Substance status.
  • Case C-311/18, Data Protection Commissioner v. Facebook Ireland and Maximillian Schrems, representing the Software Alliance.   
  • Drafting multiple guidelines and SOPs on compliance with the Nagoya Protocol for pharmaceutical, food and cosmetics companies.
  • Advice on organizing complex supply chains for gene therapy and other advanced therapies in light of e.g. EU rules on cells and tissues, and the ATMP Regulation.
  • Advice to pharmaceutical companies on EU regulatory matters, e.g. orphan exclusivity, regulatory exclusivity, SPCs, referral procedures, paediatrics, variations, GMP.
  • Assistance to trade associations and companies in the pharmaceutical, and agri-food sectors on EU GMO rules.
  • Multiple regulatory due diligences to support mergers and acquisitions in the food industry.
  • Assistance on national ABS laws under the Nagoya Protocol in more than 21 jurisdictions, including e.g. Australia, Canada, China, Falkland Islands, France, French Polynesia, India, Indonesia, La Réunion, Madagascar, Mexico, South Africa, Spain, and Switzerland.  
  • T-329/16 Bristol Myers Squibb vs. Commission & European Medicines Agency, seeking annulment of withdrawal of orphan designation prior to marketing authorization.
  • Drafting and advice on Chinese access and benefit-sharing legislation implementing the Nagoya Protocol.
  • Advice on a pathogen marked as a Public Health Emergency of International Concern (PHEIC) under Regulation 511/2014 on compliance with the Nagoya Protocol.
  • Three annulment procedures before the EU General Court concerning the remission of paid excess tariffs (Cases T-603/13, T-171/14 and T-125/16).
  • Preliminary reference to the EU Court of Justice on the direct effect of a WTO bound tariff in the EU (Case C-306/13).
  • Two direct actions before the EU General Court, concerning Regulation 511/2014 on access and benefit sharing to genetic resources implementing the Nagoya Protocol for the EU (Cases T-559/14 and T-560/14).
  • Representing the Belgian government in more than a dozen procedures before the EU General Court, the EU Court of Justice, and the EFTA Court. Including case C-16/16P Belgium v. Commission, seeking annulment of a Commission act that harmonizes consumer protection rules.
  • Counsel for two trade associations intervening before the EU General Court in procedures challenging Commission bans on agrochemicals and treated seeds (Cases T-429/13, T-584/13 and T-451/13).
  • Multi-year EU regulatory and public policy support for a sectoral harmonizing Directive. Recent engagements have included the adoption of delegated and implementing acts (comitology), standardization, and follow-up of national implementing laws throughout the 28 EU Member States.
  • Counsel for the applicant in Case T-655/11, resulting in a 25% reduction of the fine imposed for a banana cartel. Currently on appeal (Case C-469/15P), focusing on procedural irregularities.
  • Wide-ranging EU regulatory support for a large European trade association in the gaming sector. Issues covered included the fourth anti-money laundering Directive, the general data protection Regulation, the audio-visual services Directive, CEN standardization processes, and the Council of Europe Convention on match-fixing.

Pro Bono

  • Mr. Van Vooren assists multiple associations advocating for the human rights and social inclusion of persons with disabilities before the EU institutions.

Memberships and Affiliations

  • Chairman of the taskforce on EU-US trade negotiations (TTIP), AmCham Belgium (2013-2017)
  • Honorary associate professor of EU law, University of Copenhagen, Denmark (2013-present)
  • Member of the Centre for the Law of EU External Relations, Asser Institute, the Netherlands (2010-present)
  • Associate Fellow, Centre for Global Governance Studies, Leuven University, Belgium (2010-present)

Previous Experience

  • Associate at a law firm in Brussels, Belgium (2013-2016)
  • Assistant professor of EU Law, University of Copenhagen, Denmark (2010-2013)
  • Research Fellow in the law Department of the European University Institute, Florence, Italy (2006-2010)
  • Adviser, Belgian permanent representation of Belgium to the United Nations, New York (2006)