A recommendation concerning professional “good practices” in pharmaceutical treatments issued by the Haute Autorité de la Santé (French Healthcare Regulator) was attacked before the Council of State by an association. It was invalidated by Council of State decision on April 27, 2011 for violation of the principal of impartiality, because members of the regulator’s working group had interests in the pharmaceutical industry.
ITALIAN
Relazione di settore (Salute): Una raccomandazione sulle “buone prassi” pubblicata dall’Autorità di regolazione in material di salute è stata annullata a ragione della sua parzialità
Una raccomandazione relativa alle “buone prassi” nei trattamenti farmaceutici resa dalla Haute Autorité de la Santé (l’autorità francese di regolazione in materia di salute) era stata contestata da un’associazione dinanzi al Consiglio di Stato. Il 27 aprile 2011, il Consiglio di Stato ha annullato tale raccomandazione in quanto resa in violazione del principio d’imparzialità, diversi membri del gruppo di lavoro nominati dall’autorità di regolazione avevano interessi personali nell’industria farmaceutica.
SPANISH
Informe Temático (Salud): Una recomendación concerniendo las “buenas prácticas” publicada en por el regulador francés de la salud fue invalidada por razones de parcialidad.
Una recomendación concerniendo las “buenas prácticas” en tratamientos farmacéuticos publicada por la Haute Autorité de la Santé (el Regulador francés de la salud) fue atacada frente al Consejo de Estado por una asociación. Fue invalidada por el Consejo de Estado en una decisión del 27 de abril del 2011 por violación del principio de la imparcialidad, porque miembros del grupo de trabajo del regulador tenían ciertos intereses en la industria farmacéutica.
PORTUGUESE
Informe setorial (Saúde): Uma recomendação relativa a “boas práticas” publicada pelo regulador francês de saúde foi anulada por motivos de parcialidade.
Uma recomendação relativa a “boas práticas” em tratamentos farmacêuticos adotada pela Haute Autorité de la Santé (Regulador francês de saúde) foi atacada perante o Conselho de Estado por uma associação. Ela foi invalidada pela decisão do Conselho de Estado de 27 de abril de 2011 por violação do princípio da imparcialidade, pois alguns membros do grupo de trabalho do regulador tinham interesses na indústria farmacêutica.
Revogação – Ônus da prova – Conflito de interesses – Deontologia – Ex post – Boas práticas – Guia – Hard Law – Haute Autorité de la Santé (Regulador Francês da Saúde) – Imparcialidade – Independência – Legislador – Responsabilidade – Programa de tratamento médico – Obrigação – Parcialidade – Indústria farmacêutica – Recomendação – Ciência – Autoridade científica – Dados científicos – Grupo de trabalho.*
* Em The Journal of Regulation, estas palavras-chave são fornecidas pelo Editor e não pelo Autor.
David J. Dickinson is an Attorney-Advisor for the Office of Transportation and Air Quality within the Office of Air and Radiation of the United States Environmental Protection Agency in Washington, DC.
He received his J.D from George Washington University, National Law Center in Washington, D.C., and his B.A. in History and Political Science from the University of California, San Diego.
As part of a procedure initiated for anti-competitive behaviors, the European Commission has three times requested, between the 13th of March and the 11th of November 2019, from Facebook the communication of information, reitarated in a decision in May 2020.
Facebook contests it alleging that the requested documents would contain sensitive personal information that a transmission to the Commission would make accessible to a too broad number of observers, while "the documents requested under the contested decision were identified on the basis of wideranging search terms, (...) there is strong likelihood that many of those documents will not be necessary for the purposes of the Commission’s investigation".
The contestation therefore evokes the violation of the principles of necessity and proportionality but also of due process because these probatory elements are collected without any protection and used afterwards. Moreover, Facebook invokes what would be the violation of a right to the respect of personal data of its employees whose the emails are transferred.
The court reminds that the office of the judge is here constraint by the condition of emergency to adopt a temporary measure, acceptable by the way only if there is an imminent and irreversible damage. It underlines that public authorities benefit of a presumption of legality when they act and can obtain and use personal data since this is necessary to their function of public interest. Many allegations of Facebook are rejected as being hypothetical.
But the Court analyzes the integrality of the evoked principles with regards with the very concrete case. But, crossing these principles and rights in question, the Court estimates that the European Commission did not respect the principle of necessity and proportionality concerning employees' very sensitive data, these demands broadening the circle of information without necessity and in a disproportionate way, since the information is very sensitive (like employees' health, political opinions of third parties, etc.).
It is therefore appropriate to distinguish among the mass of required documents, for which the same guarantee must be given in a technique of communication than in a technic of inspection, those which are transferable without additional precaution and those which must be subject to an "alternative procedure" because of their nature of very sensitive personal data.
This "alternative procedure" will take the shape of an examination of documents considered by Facebook as very sensitive and that it will communicate on a separate electronic support, by European Commission's agents, that we cannot a priori suspect to hijack law. This examination will take place in a "virtual data room" with Facebook's attorneys. In case of disagreement between Facebook and the investigators, the dispute could be solved by the director of information, communication and medias of the Directorate-General for Competition of the European Commission.
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We can draw three lessons from this ordinance:
This decision shows that Procedural Law and Compliance Law are not opposed. Some often say that Compliance guarantees the efficacy and that Procedure guarantees fundamental rights, the protection of the one must result in the diminution of the guarantee of the other. It is false. As this decision shows it, through the key notion of sensitive personal data protection (heart of Compliance Law) and the care for procedure (equivalence between communication and inspection procedures; contradictory organization of the examination of sensitive personal data), we see once again that two branches of Law express the same care, have the same objective: protecting people.
The judge is able to immediately find an operational solution, proposing "an alternative procedure" axed around the principle of contradictory and conciliating Commision's and Facebook's interests has shown that it was able to bring alternative solutions to the one it suspends the execution, appropriate solution to the situation and which equilibrate the interest of both parties.
The best Ex Ante is the one which anticipate the Ex Post by the pre-constitution of evidence. Thus the firm must be able to prove later the concern that it had for human rights, here of employees, to not being exposed to sanctioning pubic authorities. This Ex Ante probatory culture is required not only from firms but also from public authorities which also have to give justification of their action.
Germany adopted a law modifying its investment legal framework in application of the UCITS IV Directive (Directive 2009/65/EC) on December 15th, 2010. This law introduces three main changes, in taxation, in the framework of micro finance funds and in the supervisory regime for investments.
FRENCH
Fiche thématique (Finance): l’Allemagne transpose la directive OPCVM IV
L’Allemagne a modifié le 15 décembre 2010 son cadre légal sur l’investissement en application de la directive OPCVM IV (Directive 2009/65/EC). La nouvelle loi introduit trois principaux changements dans le régime fiscal, le cadre légal des fonds de micro-finance et la supervision des investissements.
GERMAN
Thematischer Bericht (Finanz) : Deutschland überträgt die OGAW-IV-Richtlinie.
Deutschland hat das Investmentgesetz am 15. Dezember 2010 verändert, um es zur OGAW IV-Richtlinie (Richtlinie 2009/65/EC) gemäß zu machen. Eingeführt wurden drei Hauptveränderungen im folgenden Bereichen: Das Steuerregim und das Rechtssystem von Mikrofinanz, sowie die Investmentsaufsicht.
SPANISH
Informe temático (finanza): Alemania implementa el UCIT IV directive
Alemania adoptó una ley que modifica el marco legal de inversiones en aplicación del UCITS IV Directive (Directive 2009/65/EC) el 15 de diciembre del 2010. Esta ley introduce tres cambios substanciales, en el área de impuestos, en el marco de fondos de microfinanzas y en el régimen de supervisión de las inversiones.
PORTUGUESE
Informe temático (finanças): Alemanha dá aplicação à diretiva UCIT IV
A Alemanha adotou, em 15 de dezembro de 2010, uma lei que, ao dar aplicação à Diretiva UCITS IV (Diretiva 2009/65/EC), modifica seu marco legal de investimentos. Esta lei introduz três mudanças principais, na área de impostos, no marco legal de fundos de micro finanças e no regime de supervisão dos investimentos.
ITALIAN
Relazione tematica (Finanza): La Germania ha applicato la direttiva in material di OIVCM
Il 15 dicembre 2010, la Germania ha adottato una legge in materia di OICVM, applicando la quarta direttiva OICVM (la Direttiva 2009/65/CE). Questa legge introduce diversi cambiamenti, per quanto riguarda le imposte, in materia di fondi di micro finanza e nel controllo del regime degli investimenti.
Edouard de Lamaze, an Attorney at the Paris Bar, was successively a delegate to the Caisse Nationale des Barreaux français (CNBF), elected by the Paris Bar to be a member of the Union Nationale des Professions Libérales (...)
The translated summaries are done by the Editors and not by the Authors.
ENGLISH
“Global Financial Integration, Thirty Years on. From reform to crisis”
combines many academic contributions on international financial
governance, that each offer original and in-depth analysis of the
financial crisis’ causes. To safeguard the authors’ legal and economic
reasoning, the bibliographical report has been divided in three parts
and will be brought to The Journal of Regulation’s readers in three
successive issues . The following report analyses the third part of the
volume.
The new Autorité de Régulation des Activités ferroviaires (ARAF- Railway Activities Regulatory Authority) has been implemented.
GERMAN
Das Gesetz vom 8. Dezember 2009 führt die rechtlichen Rahmenvorschriften der Eisenbahnregulierung ein. Die neue „Autorité de Régulation des Activités Ferroviaires“ (ARAF – Einsenbahnregulierungsbehörde) ist eingesetzt worden.
SPANISH
La ley del 8 de diciembre del 2009 organiza la regulación del transporte ferroviario y establece la nueva Autoridad de regulación.
La nueva “Autorité de Régulation des Activités ferroviaires” (la Autoridad de regulación de las actividades ferroviarias) ha sido implementada.
