title: [Legal value of the recomendations of good practice: example for breast cancer hormonotherapy].
abstract: On April 27th 2011, the French Supreme Administrative Court (Conseil d'État) granted the Recommendations for Good Practice set out by the French National Authority for Health (Haute Autorité de santé--[HAS]) a legal status, considering that they "must be regarded as (…) decisions which may be subject to an action for annulment". The judge came to this conclusion through a quasi-syllogistic reasoning. Firstly, the French Code of Medical Ethics requires physicians to care for their patients in accordance with established scientific knowledge. Secondly, the HAS recommendations recall in particular this established scientific knowledge. Treating patients according to established scientific knowledge requires then that physicians follow the HAS recommendations. While the case at bar does not directly involve liability for medical malpractice-since the applicant only sought to have an HAS recommendation declared void-it is nonetheless necessary to examine the impact of this ruling for health professionals. Indeed, this decision raises a number of concerns for everyday medical practice. Guidelines concerning the endocrine treatment of hormonodependant breast cancers are plentiful. In January 2010, the HAS and the French National Institute for Cancer (Institut national du cancer) issued a "Guide for long-term illnesses-Breast cancer" (Guide ALD - Cancer du sein). In addition to these nation-wide guidelines, the Regional Networks for Cancer (réseaux régionaux de cancérologie) issued their own recommendations. Other guidelines are also set out in the framework of consensus conferences, such as the Nice Saint-Paul-de-Vence (France) and St. Gallen (Switzerland) conferences. In the United States, the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO), and in Europe, the European Society of Medical Oncology (ESMO) make recommendations as well. Therefore, the HAS recommendations are hardly the sole source of information for physicians and these documents sometimes contradict each other. Besides, these can quickly become obsolete, what still limits their relevance. Nevertheless, in the judge's mind, there is no place for conflicting interpretations; scientific knowledge must be consistent, homogeneous and objective. However, the reality is quite the opposite. This simplistic vision shared by judges does not seem to grasp the complexity of everyday medical practice. After a critical reading of the Conseil d'État judgment, we shall consider the potential issues and concerns raised by this ruling in medical practice using the example of hormone therapy for breast cancer patients.
authors.affiliation: Université de Strasbourg, Hôpitaux universitaires de Strasbourg, Pôle de gynécologie-obstétrique, Unité de sénologie, avenue Molière, 67200 Strasbourg, France, Institut de génétique et de biologie moléculaire et cellulaire (IGBMC), Laboratoire de biologie moléculaire et cellulaire des cancers du sein, 1, rue Laurent-Friès, 67400 Illkirch, France.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Delpous
authors.affiliation: Université de Strasbourg, Institut de recherches Carré-de-Malberg, Faculté de droit de Strasbourg, 11, rue du Maréchal-Juin, 67045 Strasbourg, France.
authors.forename: Ghislain
authors.initials: G
authors.lastname: Benhessa
authors.affiliation: Université de Strasbourg, Institut de recherches Carré-de-Malberg, Faculté de droit de Strasbourg, 11, rue du Maréchal-Juin, 67045 Strasbourg, France.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Bilalis
authors.affiliation: Institut de génétique et de biologie moléculaire et cellulaire (IGBMC), Laboratoire de biologie moléculaire et cellulaire des cancers du sein, 1, rue Laurent-Friès, 67400 Illkirch, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Tomasetto
authors.affiliation: Université de Strasbourg, Hôpitaux universitaires de Strasbourg, Pôle de gynécologie-obstétrique, Unité de sénologie, avenue Molière, 67200 Strasbourg, France.
authors.forename: Carole
authors.initials: C
authors.lastname: Mathelin
mesh_terms: D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D004992:Ethics, Medical; D005260:Female; D005602:France; D006801:Humans; D007883:Legislation, Medical; D008495:Medical Oncology / Q000331:legislation & jurisprudence / Q000592:standards; D008593:Menopause; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy*; D017410:Practice Guidelines as Topic; D017697:Premenopause
chemical_list: D018931:Antineoplastic Agents, Hormonal
keywords: breast cancer; guidelines; hormonotherapy; legal value