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Eveline Van Keymeulen

Partner
Paris | Brussels
  • 45, rue Saint-Dominique
  • Paris 75007
  • France
Profile Experience

Eveline Van Keymeulen is a partner in Latham & Watkins' Brussels and Paris offices and a member of the firm's Healthcare & Life Sciences Practice.

She advises multinational companies and start-ups in the pharmaceutical, biotech, medical devices, cosmetics, and food and beverage sectors on a broad variety of complex European, domestic and cross-border regulatory matters, including clinical trials, product approvals, regulatory incentives, market access, promotion and advertising, post-market obligations, and general compliance matters. 

In addition, Eveline has extensive experience advising on cannabis and hemp based product regulations. She successfully challenged the legality of French hemp regulations in the first landmark case related to cannabidiol (CBD) products before the Court of Justice of the European Union (Case C-663/18, Kanavape).

Eveline is ranked in Chambers for Life Sciences Regulatory (2020) and has been recognized as a Legal 500 Rising Star / Next Generation Lawyer in Healthcare and Life Sciences (2018-2020), and as a National and Global Leader by Who's Who Legal Life Sciences (2016-2020). She has recently been awarded the European Advisory Lawyer of the Year and Impact Case of the Year awards by LMG Life Sciences (2021).

Eveline has authored numerous articles and has been a featured speaker on EU regulatory matters at prominent conferences such as the Pharmaceutical Law Academy in Cambridge. She also serves on the editorial board of the European Pharmaceutical Law Review.

 In addition, Eveline has been quoted in BBC Business Daily, Bloomberg, The Times, Les Echos, and other leading international business journals on life sciences regulatory and policy matters. 

Recognitions

Ms. Van Keymeulen is recognized as one of the leading life sciences practitioners in France by Legal Media Group 2021, Best Lawyers 2021, and Euromoney’s Women in Business Law Expert Guide 2021

"Advisory Lawyer of the Year" and winner of "Impact Case of the Year" LMG Life Sciences 2021 

"Ms. Van Keymeulen enters the rankings on the back of strong market recognition. She advises clients from the life sciences industries on regulatory mandates. Clients value her "high level of energy" with one source also appreciating her for being "extremely flexible and genuinely engaged" as well as having "a can-do attitude." Chambers, Pharma/Life sciences: Regulatory – France 2020 

“Receives effusive praise from peers this year for her adeptness on matters such as marketing authorizations and product life cycle management.” Who’s Who Legal, Life Sciences 2020

“Brilliant and sharp. She can navigate hard legal issues but she can also make our industry and its challenges simple to understand when addressing a lay audience.”
The Legal 500, Healthcare and Life Sciences – Belgium 2020

Thought Leadership

  • “France”, The Pharma Law Handbook (January 2021)
  • “Pharmaceutical incentives: A Practice Note”, Lexis PSL (January 2021)
  • “Pharmacovigilance: A Practice Note”, Lexis PSL (July 2019)
  • “Has the Orphan Regulation Met its Aims? A Critical Examination of the European Union’s Regime Incentivising Research and Development of Medicines for Patients with Rare Diseases”, European Pharmaceutical Law Review (December 2018)
  • “The EU Clinical Trials Regulation: A Practice Note”, Lexis PSL (August 2018)
  • “Rewarding Innovation: Pharmaceutical incentives as a crucial instrument to foster public health”, European Pharmaceutical Law Review (July 2018)
  • “The CJEU’s first ruling on the classification of software as a medical device: A predictable scenario with a possible cliff-hanger?”, European Pharmaceutical Law Review (February 2018)
  • “Sunshine” in Belgium: New statutory transparency requirements for life sciences companies”, European Pharmaceutical Law Review (October 2017)
  • “The revised French transparency regime: additional disclosure obligations for life sciences companies”, Practical Law Company (PLC) (October 2017)
  • “Court of Justice of the EU anchors market exclusivity for orphan medicinal products (annotation of Cases T-140/12 and C/138/15P)”, Jurisprudentie Geneesmiddelenrecht (July 2016)
  • “Digital Health in the EU: Moving “Beyond the Pill”, mHealthNews (January 2015)
  • “France’s biosimilar law may set trend inside the EU”, Law360 (February 2014)
  • “Specific provisions for medicines”, The Belgian Competition Act (2013) 
  • “The proposed EU device regulation: a look on the - possibly - bright side”, SCRIP Regulatory Affairs (June 2013)
  • “The new import regime for APIs in the EU: too much too soon?”, SCRIP Regulatory Affairs (March 2013)
  • “How do patent rights affect regulatory approvals and data exclusivity rights for pharmaceuticals in the EU?”, Pharmaceutical Patent Analyst (September 2012)
  • “Belgium”, Life Sciences Handbook (2009-2012) 
Presentations

  • First-Hand Perspectives – France’s Regulatory, Political, Medical, Business and Cultural Landscape, Global Cannabis Institute, London, 13-14 November 2019
  • European Regulations, Insights & Opportunities – Where are we now? The future of cannabis and CBD, CBD Expo, London, 12 July 2019
  • Harmonising the regulatory framework, European Cannabis Symposium, Copenhagen, 6 May 2019
  • Relative Therapeutic Value Rating System (VTR) in France - What has to be expected?, FORUM Institut: Drug Cost and Control Conference, Berlin, 15 March 2019
  • The ‘it’ drug: European CBD markets and the regulations shaping them, Cannabis Europa, Paris, 8 February 2019
  • A legal perspective about data protection and contract agreement in clinical research, French ePharma Day, Paris, 21 November 2018
  • Biologics, biosimilars, biobetters: Are they special?, European Pharma Law Academy, Cambridge, 11 September 2018
  • Issue spotting: Review of the most important cases and the latest trends affecting the future of life sciences law, Women Leaders in Life Sciences Law Conference,
  • Amsterdam, 20 June 2018Transparency of clinical trial data, Pharma.be PharmAcademy, Brussels, 23 February 2018
  • Editorial versus marketing content: The shadow line between advertising and information, International Marketing and Advertising Law Forum, Frankfurt, 4 December 2017
  • The EU Clinical Trial Regulation: how to prepare implementation?, French ePharma Day, Paris, 28 November 2017
  • Examining and complying with recent legislative and regulatory developments, Annual Pharma Anti-Counterfeiting & Serialisation Conference, London, 20 September 2017
  • Clinical Trials: Scope of the Regulation and preparing for implementation, European Pharma Law Academy, Cambridge, 12 September 2017
  • Legal and regulatory challenges related to patient-centricity in drug development: how far can companies go?, French ePharma Day, Paris, 30 November 2016
  • Transparency of clinical trial data: what’s in a name? The New Regulation and its interaction with the EMA Transparency Policies, French ePharma Day, Paris, 25 November 2015
  • Examining Unlicensed and Off-Label Use, EU Pharmaceutical Law Forum, Brussels, 20 May 2015
  • Un regard international sur les relations entre l’industrie pharmaceutique et les professionnels de santé, Matinale SEPHIRE, Tunis, 24 April 2015
  • Getting Ready for Sunshine in Russia: Lessons Learned from the French Sunshine Act, Pharmaceutical Regulatory and Legal Affairs Conference, Moscow, 12 February 2015
  • Early Access to Medicines: A Comparison between National Practices regarding Off-Label Use (Making the Patchwork More Transparent), Drug Information Association (DIA) EuroMeeting, Vienna, 26 March 2014
  • The Pharmaceutical Legislation - EU and Belgium, Belgian Regulatory Affairs Society (BRAS), Introduction to Regulatory Affairs Conference, Brussels, 4 May 2012
  • The European Union and its institutions & the Belgian medicines institutions, Belgian Regulatory Affairs Society (BRAS), Introduction to Regulatory Affairs Conference, Brussels, 4 May 2012

Eveline's recent experience includes advising:

  • A leading European pharmaceutical industry association on various strategic legal and policy analyses of the EU framework regulating innovation in pharmaceutical product development, including in-depth assessments of personalized medicine, accelerated approval pathways, drug repurposing and unmet medical need, drug-device combination products, complex and virtual clinical trials, innovative manufacturing techniques, the SPC manufacturing waiver, and a variety of other cutting-edge issues that have inspired the EMA Regulatory Science Strategy and the European Commission’s Pharmaceutical Strategy 
  • A global pharmaceutical company on the development of a market access strategy for an innovative gene therapy treatment for children in the EU, including advice on early access programs in multiple member states, alternative pricing and reimbursement options for cross-border treatments in Europe and related data protection issues (informed and regulatory consent)*
  • Several international pharmaceutical companies on the interpretation of EU regulatory data protection (RDP) rules and strategic life cycle management issues, including advice on the chances of success and procedural pathways for a legal challenge of marketing authorizations granted to fixed dose combination products in the EU and various EU member states* 
  • Multiple pharmaceutical companies on the boundaries between commercially confidential information and the mandatory publication (“transparency”) of clinical trial data, including in legal proceedings before the European Courts, as well as on practical implementation questions triggered by the EU Clinical Trial Regulation and possible implications of such transparency requirements on intellectual property rights* 
  • Multiple pharmaceutical companies and trade associations on the interplay between regulatory and patent rights, including on enforcement strategies related to second medical use patents and the interpretation of the Bolar exemption in several EU member states, and advising such companies on regulatory strategies and legal arguments in the context of patent litigation and antitrust proceedings and investigations* 
  • Successfully defending several specialty pharmaceutical and medical device companies in regulatory, product liability and commercial litigation proceedings in Belgium and France* 
  • Successfully representing a pioneering European CBD e-liquid brand in the first referral to the Court of Justice of the European Union (CJEU) related to the marketing of cannabidiol (CBD) based products, the positive outcome of which will have a major impact on the European CBD industry* 
  • Various global banks, investment funds and European stock exchange companies on the legal and regulatory framework and risk assessment related to investments in medical and well-being cannabis companies in Europe and various EU member states, including advice on the legal and regulatory risks related to the suspension of a listed holding company because of the diversification of its activities in the cannabis industry 
  • The world’s leading medical cannabis producers and retailers on navigating the complex regulatory framework and legal pathways to the European market (e.g. advice on medical cannabis pilot programs in several member states, advice on novel food applications in the EU and UK, advice on enforcement practices in different member states), including in the context of acquisitions and initial public offerings 
  • A broad range of life sciences actors on health emergency procedures and the regulatory and legal risks and liabilities related to the rapid development and making available of Covid-19 diagnostic tests, including the emergency use of clinical and diagnostic labs, the self-assembly of diagnostic kits by employers, the qualification and validity of different types of testing (including self-tests), and the development of digital solutions to raise public awareness 
  • Several consumer electronics, pharmaceutical and insurance companies on the regulatory (medical device) and data protection aspects related to the implementation of digital health platforms and mobile health apps (e.g. symptom checkers, clinical calculators) and on the successful launch and roll-out of such technologies in several EU jurisdictions 
  • A leading global online retailer and e-commerce platform on numerous legal and enforcement risk assessments related to the online sale and advertising of an extensive variety of regulated products in key EU member states, including the online sale of medicinal products (and related online pharmacy establishment requirements), diagnostic tests, medical devices, cosmetic products, food and beverages as well as other regulated products 
  • A broad range of companies active in the life sciences sector as well as pharmaceutical trade associations on national regulations related to anti-bribery, anti-gift and transparency (“sunshine act”) obligations in various EU member states and related data protection and antitrust questions arising from such regulations 
  • A number of well-known cosmetic and food and beverage companies on complex product qualification and borderline questions related to innovative products and associated cosmetic or health claims

*Matter handled prior joining to Latham

Qualifications and Education

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