Ghislaine Issenhuth

Partner

Ghislaine Issenhuth is our key contact person for drug manufacturers, medical device manufacturers, medical laboratories, insurance companies and health institutions 

Acting both as legal advisor and litigation lawyer, her practice area covers all regulatory issues relating to health products (marketing authorisations, market access, promotion, compliance, anti-gifts law and disclosure requirements, clinical trials, CE marking, e-health), in matters of liability for defective products and in the conduct of unfair competition proceedings.

A few milestones of her distinguished career: Ghislaine has worked for international organisation such as UNESCO, WHO, as well as the French Health Authority. Apart from her activities as lawyer, she also is a member of the Regional Ethics Committee “CPP Ile de France V” and of CODEEM (Compliance and Ethics Committee of Pharmaceutical Companies).

Ghislaine holds a PhD in health law on the subject of biobanks and has taught at the Faculty of Law in Geneva and at the Faculty of Pharmacy in Angers.

Thanks to her combined hands-on experience and academic approach of the pharmaceutical regulations, she was invited to debate and give lectures in the context of seminars, and published several contributions on these topics.

Services

  • Education
  • CAPA bar examination, Paris (2013)
  • PhD in health law, Geneva University (2007)
  • DESS “Biotechnology law”, Saint-Quentin-en-Yvelines University (2002)
  • DEA in general private law, Paris II Panthéon-Assas University (2001)
  • Maîtrise in general private law, Paris II Panthéon-Assas University (2000)

Languages

  • French
  • English

Publications / Seminars

Seminars

  • Urocast on the subject of patients’ rights, May 2022
  • Update of professional ethics regulations, meeting « Ethique & Compliance », October 2021
  • Clinical research: the patient’s role – Annual Conference of the Association Europa Donna, November 2020
  • Combining the positions of executive officer and qualified person: what are the rules? Webcast organised by the French National College of Pharmacists, January 2019
  • GDPR and the “temperature” data, TIPS annual conference, November 2018
  • E-health: Legal framework and issues, SNITEM legal committee, 21 September 2018
  • E-health: a Europe-wide remedy, Macif, May 2018
  • Are class actions a threat to the health industry? Sciaci, June 2017

Papers and publications

  • La dispensation à l’unité : une mise en œuvre à l’épreuve de la pratique (Unit administration of drugs: implementation tested in practice), Hospitalia, February 2022
  • Responsabilité de plein droit et infection nosocomiale : extension de son application à travers la notion de service rattaché à un établissement (Automatic liability and nosocomial infection: extension of its application through the notion of a department belonging to an institution), Hospitalia, November 2021
  • Tabula rasa du régime de l’accès précoce des médicaments – Acte 2. Un objectif de simplification au cœur des modalités d’application de la réforme (Tabula rasa of the system for the early access to medicines – Step 2. A simplification objective at the heart of the reform’s implementation methods), Hospitalia, October 2021
  • Vente en ligne de médicaments : quand la Cour de justice de l’Union européenne oblige le Conseil d’Etat à revenir sur sa jurisprudence (Online sale of medicines: when the Court of Justice of the European Union forces the French “Conseil d’État” to reconsider its case law), Hospitalia, May 2021
  • LFSS 2021 : tabula rasa du régime de l’accès précoce des médicaments (2021 Social Security Financing Act: tabula rasa of the system for the early access to medicines), Hospitalia, February 2021
  • Recours pourr excès de pouvoir et doit souple : la décision GISTI constiue-t-elle une avancée pour les industries de santé (Ultra vires proceedings and soft law: is the GIST decision to be deemed as a progress for health companies?) Hors Série RGDM, January 2021
  • La déontologie au sein des entreprises du médicament: comprendre le rôle et les missions du Codeem (Ethics within pharmaceutical companies:understanding the role and missions of Codeem), Gazette de l'AFAR, December 2020
  • Le Health data hub au cœur d’une divergence de position entre le Conseil d’Etat et la CNIL ? (Health Data Hub: the crux of differences of opinion between the French “Conseil d’État” and CNIL - the French Data Protection Authority), Hospitalia, December 2020
  • Fin du renouvellement quinquennal de l’inscription des spécialités pharmaceutiques sur la liste des produits remboursables : parution du décret n°2020-1090 du 25 août 2020 (End of the five-year renewal of the registration of proprietary drugs on the list of reimbursable products: publication of decree n°2020-1090 of 25 August 2020), Hospitalia, September 2020
  • L’émergence d’un droit d’exception en réponse à une crise sanitaire sans precedent (The advent of emergency law in response to an unprecedented health crisis), Hospitalia, June 2020
  • Le difficile équilibre entre le devoir d’impartialité et la liberté d’expression (The difficulty of balancing the duty of impartiality and freedom of expression), Hospitalia, February 202
  • Décision de l’administration et cause exonératoire de responsabilité : une question non résolue (Administrative decision and cause for waiving liability: a pending issue), Hospitalia, January 2020
  • La loi "Ma Santé 2022" instaure l'interdiction d'accorder des hospitalités aux étudiants (The “Ma Santé 2022“ Act introduces a ban on benefits for students), Hospitalia, September 2019
  • Publicité et Médecins : vers la fin d’une interdiction absolue (Advertising and physicians: the end of an absolute ban seems to be in sight), Hospitalia, April 2019
  • La substitution au cœur de la LFSS 2019 (Generics: the big topic of the 2019 Social Security Financing Act), Hospitalia, January 2019
  • Perspective 2019 : la révision de la loi de bioéthique (Looking ahead to 2019: the review of the bioethics law), Hospitalia, December 2018
  • L’autonomie du patient confrontée au statut hybride de la personne de confiance (Patient autonomy vs the hybrid status of the trusted person), Ehpadia, October 2018
  • E-santé : la diversité des régimes juridiques applicables constitue-t-elle un frein à son développement ? (E-health: is the variety of applicable legal regimes an obstacle to its development?) Hospitalia, September 2018
  • Déploiement du Dossier Médical Partagé dans les EHPAD (Deployment of the Shared Medical File in EHPADs [longterm care & retirement home]), Ehpadia, July 2018
  • Intelligence artificielle: un cadre règlementaire adapté? (Artificial intelligence: is the regulatory framework adequate?) Hospitalia, May 2018
  • EHPAD à but non lucratif & Taxe d’habitation : le dégrèvement doit bénéficier aux residents (Non-profit EHPADs [longterm care & retirement home] & Council Tax: residents must benefit from the rebate), Ehpadia, April 2018
  • Les défis inhérents à la mise en application du RGPD (The challenges of implementing the GDPR), Hospitalia, February 2018
  • Les perspectives d'évolutions réglementaires des EHPAD en 2018 (The prospects for regulatory changes applicable to EHPADs [longterm care & retirement home] in 2018), Ehpadia, January 2018
  • Le statut juridique de la mélatonine enfin tranché par le Conseil d’Etat (The legal status of melatonin finally decided by the French “Conseil d’État”), PA, 11 June 2014 n°116
  • Les biobanques : la question de l’utilisation autologue des banques de sang de cordon ombilical (Biobanks: the issue of autologous use of umbilical cord blood banks) in Les Grands Avis du Comité consultatif national d’éthique (Key Opinions of the National Consultative Ethics Committee), LGDJ, 2013
  • Analyse critique de la nouvelle réglementation relative au commerce en ligne de medicaments (Critical review of the new regulations applicable to online trade in medicines), PA, 23 May 2013 n°103
  • Du renforcement de la fiabilité de la chaîne d’approvisionnement des médicaments (Strengthening the reliability of the drug supply chain), RDS, April 2013
  • La loi Bertrand : le nouveau statut des médicaments éphémères (« Bertrand » Act: the new status of short-lived medicines), RDS, November 2012
  • Échographies fœtales à visée médicale et non médicale : définitions et compatibilité - Rapport d'évaluation (Fetal ultrasound for medical and non-medical purposes: definitions and compatibility - Evaluation report), HAS, 2012
  • Les fondements de la responsabilité médicale en droit français interrogés par l’arrêt « Perruche » (The founding principles of medical liability under French law questioned by the « Perruche » ruling), in « Risques et information dans le suivi de la grossesse : droit, éthique, pratiques sociales » (Risks and information in pregnancy monitoring: law, ethics, social practices), Staempfli, 2010
  • Autonomie individuelle et Biobanques. Etude de droit comparé (droit européen, droit français et droit suisse) (Individual Autonomy and Biobanks. Comparative law study (European law, French law and Swiss law), Schulthess, 2009
  • L’information et la gestion des risques dans le suivi de la grossesse lors du 1er trimestre: quelques réflexions sur le défi éthique et le cadre légal en Suisse (Information and risk management in 1st trimester pregnancy care: some thoughts on the ethical challenge and Swiss law), Médecine & Droit, 2009
  • Quel rôle pour les commissions d’éthique de la recherche dans la réglementation des biobanques ? Perspective de droit suisse et européen (What role for research ethics committees in the regulation of biobanks? A Swiss and European legal perspective), in « Matériel biologique et informatisation : beaucoup de bruit pour rien ? » (Biological materials and computerisation: much ado about nothing?), 2006
  • Collaboration in the consultation process on the preliminary draft of a federal decree on a constitutional article concerning research on human beings and on the preliminary draft of the Federal Act on Research on Human Beings of 01.02.2006
  • Banques de données génétiques humaines et consentement (Human genetic databases and the issue of consent), 15th World Congress on Medical Law, 2005

Read on

The woman behind the lawyer

In her free time, Ghislaine oscillates between playing tennis, a sport she took up a few years ago, and giving in to her passion: the theater.