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Updated: Dec. 16, 2010 (Initial publication: Dec. 16, 2010)

Sectorial Analysis

Main information

In an amicus curiae brief of October 29, 2010, in the Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. case, before the Court of Appeal for the Federal Circuit, the US Department of Justice reversed a longstanding policy by declaring human genes ineligible for patents, because they are part of nature. This new position could have an enormous impact on the medical and biotech industries.

France

39/43 quai André Citroën 75015 Paris FRANCE Phone : +33 (0)1 40 58 38 00

France

Haute Autorité de Santé Tél : 01 55 93 70 00 Fax : 01 55 93 74 00 2, avenue du Stade de France 93218 Saint-Denis La Plaine Cedex FRANCE Contact by e-mail

Updated: May 5, 2010 (Initial publication: Feb. 23, 2010)

Contributions

Updated: Dec. 15, 2010 (Initial publication: Dec. 15, 2010)

Sectorial Analysis

ENGLISH

In an amicus curiae brief of October 29, 2010, in the Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. case, before the Court of Appeal for the Federal Circuit, the US Department of Justice reversed a longstanding policy by declaring isolated human genes ineligible for patents, because they are part of nature. This new position could have an enormous impact on the medical and biotech industries.
 
FRENCH

Fiche thématique (Innovation, Santé): le Ministère de la Justice américain se déclare opposé à la brevetabilité du génome humain isolé.
 
Dans une lettre d'amicus curiae datée du 29 octobre 2010, dans le cas Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al, porté devant la Cour d'appel du circuit fédéral, le Département de la Justice américain renverse sa précédente politique en déclarant les gènes humains isolés non brevetables parce qu'ils font partie de la nature. Cette nouvelle position pourrait avoir un impact très important pour les industries médicales et biotechnologiques.
 
GERMAN
 
Thematischer Bericht (Innovation, Gesundheit): das amerikanische Justizministerium hat sich gegen die Patentierbarkeit des isolierten Humangenoms geäussert.
 
In einem amicus curiae Brief vom 29. Oktober 2010, im Fall Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al, 
vor dem Bundesberufungsgericht, hat das amerikanische Justizministerium seine ehemalige Politik aufgehoben, indem sie sich gegen die Patentierbarkeit des isolierten Humangenoms stellt, da sie Teil der Natur sind. Diese neue Politik könnte sehr wichtige Konsequenzen für die Heil- und Biotechbranchen mit sich tragen.
 
 
 
SPANISH

 

Informe Temático (Innovación, Salud): El Ministerio de Justicia americano se declara en contra de la patentabilidad del genoma humano aislado.

En un informe amicus curiae  del 29 de octubre del 2010, en el caso de Association for Molecular Pathology, et at. v. United States Patent and Trademark Office, et al., ante la Corte de apelación del circuito federal, el Departamento de Justicia reversó una antigua política al declarar que el genoma humano aislado es inelegible para los patentes, ya que forman parte de la naturaleza. Esta nueva posición podría tener un impacto enrome en las industrias medicales y de biotecnología.

 
ITALIAN
 
Relazione tematica (Innovazione, Salute): Il US Department of Justice (il Dipartimento di giustizia degli Stati Uniti d’America) si esprime contro la brevettabilità del genoma umano isolato

In una comparsa in quanto amicus curiae datata del 29 ottobre2010, nel caso Association for Molecular Pathology, e al. v. United States Patent and Trademark Office  (l’Ufficio marchi e brevetti degli Stati Uniti), dinanzi alla Corte d’appello federale, il US Department of Justice (il Dipartimento di Giustizia degli Stati Uniti) ha dichiarato, contrariamente alla pratica consolidata, che i geni umani non possono essere brevettati in quanto parte della natura. Questa nuova posizione può avere un impatto considerevole sulle industrie mediche e biotech.

CHINESE
 
主题性报告(医疗改革): 美国司法部宣称反对基因专利权
 
2010年10月29日,美国司法部通过amicus curiae摘要中涉及的一起由美国联邦巡回上诉法院审理并与Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al相关的案件,以人类基因为自然地组成部分并无资格取得专利权为由,宣称推翻之前基因专利权的相关政策。这项新政策将对生物与制药企业产生巨大影响。

 

 

Other translations forthcoming.

Updated: Sept. 19, 2012 (Initial publication: March 23, 2011)

Sectorial Analysis

ENGLISH

The Autorité de la Concurrence (French Competition Authority) issued a recommendation (n° 11-A-05) on March 8, 2011 in which it recommends that the Autorité de régulation des communications électroniques et des postes (ARCEP — French Telecommunications and Postal Regulatory Authority) proceed with studies envisaging the possible breakup of France Telecom into two separate functional entities, one managing monopoly activities (the network), and the other managing competitive activities (services).
 
SPANISH 

Informe temático (Telecomunicaciones): La Autoridad francesa de la competencia recomienda que el Regulador francés de telecomunicaciones considere una separación funcional de las actividades de France Telecom.

La Autorité de la Concurrence (la Autoridad francesa de la competencia) publicó una recomendación (n°11-A-05) el 8 de marzo del 2011 en la que recomienda que la Autorité de régulation des communications électroniques et des postes (ARCEP – la Autoridad regulatoria francesa de telecomunicaciones y servicios postales) proceda con sus estudios concibiendo la posible división del France Telecom en dos entidades funcionales separadas, uno que manejaría las actividades monopolísticos (la red), y el otro manejando las actividades competitivas (los servicios). 

 

 

 

 


 
 
 
 
 
Other Translations fortcoming.

France

http://www.conseil-constitutionnel.fr/

 

The Conseil constitutionnel (French Constitutional Council)  was established by the Constitution of the French Fifth Republic, dated 4 October 1958. It is a court with a variety of missions, including compliance control of the law to the Constitution.

It operates a priori control of French laws but also a post-control of laws since 2008.

The French Constitutional Council regularly makes important decisions on Regulation.

Oct. 19, 2020

Newsletter MAFR - Law, Compliance, Regulation

Full reference: Frison-Roche, M.-A., Conditions for the legality of a platform managed by an American company hosting European health data​: French Conseil d'Etat decisionNewsletter MAFR - Law, Compliance, Regulation, 19th of October 2020

Read by freely subscribing the other news of the Newsletter MAFR - Law, Compliance, Regulation

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News Summary: In its ordinance of 13th of October 2020, Conseil national du logiciel libre (called Health Data Hub), the Conseil d'Etat (French Administrative Supreme Court) has determined the legal rules governing the possibility to give the management of sensitive data on a platform to a non-europeans firm, through the specific case of the decree and of the contract by which the management of the platform centralizing health data to fight against Covid-19 has been given to the Irish subsidiary of an American firm, Microsoft. 

The Conseil d'Etat used firstly CJEU case law, especially the decision of 16th of July 2020, called Schrems 2, in the light of which it was interpreted and French Law and the contract linking GIP and

The Conseil d'Etat concluded that it was not possible to transfer this data to United-Sates, that the contract could be only interpreted like this and that decree and contract's modifications secured this. But it observed that the risk of obtention by American public authorities was remaining. 

Because public order requires the maintenance of this platform and that it does not exist for the moment other technical solution, the Conseil d'Etat maintained the principle of its management by Microsoft, until a European operator is found. During this, the control by the CNIL (French Data Regulator), whose the observations has been taken into consideration, will be operated. 

We can retain three lessons from this great decision:

  • There is a perfect continuum between Ex Ante and Ex Post, because by a referred, the Conseil d'Etat succeed in obtaining an update of the decree, a modification of the contractual clauses by Microsoft and of the words of the Minister in order to, as soon as possible, the platform is managed by an European operator. Thus, because it is Compliance Law, the relevant time of the judge is the future. 
  • The Conseil d'Etat put the protection of people at the heart of its reasoning, what is compliant to the definition of Compliance Law. It succeeded to solve the dilemma: either protecting people thanks to the person to fight against the virus, or protecting people by preventing the centralization of data and their captation by American public authorities. Through a "political" decision, that is an action for the future, the Conseil found a provisional solution to protect people against the disease and against the dispossession of their data, requiring that an European solution is found. 
  • The Conseil d'Etat emphasized the Court of Justice of The European Union as the alpha and omega of Compliance Law. By interpreting the contract between a GIP (Public interest Group) and an Irish subsidy of an American group only with regards to the case law of the Court of Justice of European Union, the Conseil d'Etat shows that sovereign Europe of Data can be built. And that courts are at the heart of this. 

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Read the interview given on this Ordinance Health Data Hub

 

To go further about the question of Compliance Law concerning health data protection, read the news of 25th of August 2020: The always in expansion "Right to be Forgotten"​: a legitimate Oxymore in Compliance Law built on Information. Example of​ Cancer Survivors Protection 

 

Updated: Jan. 30, 2012 (Initial publication: Jan. 30, 2012)

Publication of The Journal of Regulation

Translated summaries

The translated summaries are done by the Editors and not by the Authors.


ENGLISH

The main theme of the eighth issue of The Journal of Regulation is that of Neutrality in systems of economic regulation in accordance with the conference that the Journal organized around this issue. This question is essential for a number of reasons: on one hand, companies sometimes demand that regulation be ‘neutral’ in the impact it has on their economic activities. On the other hand, States have other reasons for believing that regulation palliates market failure by using price-fixing to restore neutrality in certain sectors of the economy that are incapable of producing a fair market price. Still others believe that Regulation is not neutral because it intervenes against the neutrality of the market by imposing access to common goods, social policy concerns, etc.


FRENCH

Le principal thème du 8° numéro du Journal of Regulation est la question de la neutralité dans les systèmes de régulation économique, telle qu’elle avait été examinée dans le colloque annuel du Journal. Cette question est essentielle pour un certains nombres de raisons. D’une part, les entreprises exigent parfois que les régulation soient "neutres" dans les activités économiques des entreprises. D’autre part, les Etats peuvent avoir d’autres raisons d’adopter des régulations que de palier des défaillances de marchés, lesquelles sont incapables de produire des prix. Les Etats restaurent alors par leurs interventions une neutralité que les marchés ne peuvent pas techniquement engendrer. D’autres croient encore que la Régulation n’est pas neutre parce qu’elle intervient précisément contre la neutralité du marché, en imposant l’accès pour tous à des biens communs, décisions politiques adoptées pour des considérations de politique sociale.



ITALIAN

Il tema principale di questo ottavo numero de The Journal of Regulation è la Neutralità nei sistemi di regolazione economica in linea con la conferenza organizzata dalla rivista relativamente a tale tema. Tale tema riveste un’importanza fondamentale per diverse ragioni: da un lato, le società talvolta richiesto che tale regolazione sia neutrale rispetto all’impatto provocato sulle loro attività economiche. Inoltre, gli Stati hanno diverse ragioni per considerare che la regolazione riduca il rischio di disfunzioni del mercato usando il potere di fissazione del prezzo garantendo così la neutralità che certi settori sono incapaci di raggiungere in quanto incapaci di stabilire un prezzo equo di mercato. Infine, altri ritengono che la Regolazione non sia neutrale in quanto interviene sulla neutralità del mercato ed impone l’accesso ai beni comuni, obiettivi di politica sociale, ecc.



ESPAGNOL

El tema principal del 8º volumen del Journal of Regulation es a cuestión de la neutralidad en los sistemas de regulación económica, tal como ha sido examinada en coloquio anual del Journal. Esta cuestión es esencial por varias razones. De una parte, las empresas a veces exigen que las regulaciones sean “neutras” en las actividades económicas de las empresas. Por otra parte, los Estados pueden tener otras razones para adoptar regulaciones , a parte de lidiar con los fallos de los mercados, los cuales son incapaces de producir precios. Los Estados restauran, a través de sus intervenciones, una neutralidad que los mercados no pueden engendrar. Algunos siguen pensando que la Regulación no es neutra porque interviene precisamente en contra de la neutralidad del mercado, al imponer el acceso universal a bienes comunes, decisiones políticas adoptadas por consideraciones de política social.



ARABIC

الموضوع الرّئيسي للطبعة الثامنة لمجلة التنظيم هو الحياد في النّواضم الاقتصادية وفقا للمؤتمر أللذي انتظم حول هذه القضية. هذا السّؤال ضروري لأسباب متعدّدة : أوّلا، الشّركات تطلب في بعض الأحيان "محايدة" اللّوائح في تأثير على أنشطتها الاقتصادية. من ناحية أخرى، فإن الدول الأخرى يعتقدون أن التّنظيم يخفّف من فشل السوق بمساعدة استخدام التسعير من أجل استعادة الحياد في القطاعات الاقتصاد غير القادرة على إنتاج سعر السوق العادل. لا يزال البعض يعتقد أن التنظيم ليس محايدا لأنّه يأتي ضدّ الحياد السوق عن طريق اشتراط الحصول على الملكية المشتركة، والمخاوف من السياسة الاجتماعية، الخ


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Other translations forthcoming.

Sept. 7, 2020

Newsletter MAFR - Law, Compliance, Regulation

Full reference: Frison-Roche, M.-A., Conflict of interests & "revolving doors"​: what the European Ombudsman said in May 2020, the European Banking Authority agreed in August.Three lessonsNewsletter MAFR - Law, Compliance, Regulation, 7th of September 2020

Read by freely subscribing other news of the Newsletter MAFR - Law, Compliance, Regulation

 

Summary of the news: 

Supervision and regulation authorities' impartiality and independence are conditioned to the fact that their members do not have any conflict of interest with the sector that they supervise or regulate. Such an absence of conflict of interest is necessary to guarantee a climate of trust between the authority and operators. This supposes that regulation and supervision authority members do not cumulate functions of operator and of regulator/supervision during but also after their mandate in the regulation/supervision authority because the anticipation of a future hiring can influence present decisions. 

On 2nd of August 2019, the executive director of the European Banking Authority (EBA) informed the authority of its willingness to become PDG of the Association des marchés financiers en Europe, lobby of the financial sector. EBA approved this perspective. However, "Change Finance", a civil coalition, sized the European Mediator explaining that such a professional reorientation created an inevitable conflict of interest. The European Mediator reacted on 7th of May 2020 through a recommendation saying that although EBA took preventive measures, theses measures are not sufficient with regard to the risks. In this recommendation, the European Mediator also made some general propositions to manage future conflicts of interest:

  • The interdiction for senior managers to have positions able to create a conflict of interest for two years.
  • The information of senior managers and candidates to senior managers positions of the actual rules.
  • The implementation of internal procedures blocking access to confidential information to the member who notified its willingness to occupy later a position able to constitute a conflict of interest with its current position. 

In a letter of 28th of August 2020, the president of EBA told to the European Mediator that he accepts these remarks and propositions. 

In this particular case, we can draw three lessons:

  1. The difficult articulation between independence/impartiality (necessary for trust) and regulator/supervisor expertise. The European Mediator and the ABE are agree that the interdiction to get some positions must be limited in time.
  2. The necessity that everyone can anticipate rules correctly.
  3. The necessity to preserve legal security.