Search results (723 cards)

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

Jan. 12, 2015

Breaking news

France Stratégie is the French public body that advises the French Government on economic and social policies.

In January 2015, one of its researchers, Medhi Nemri, published an analytical note: "Demain, l'Internet des objets (Tomorrow, the Internet of Things)".

The release sees the Internet as a "essential facility" whose development capabilities will allow interaction between objects: the "Internet of Things". This world of "connected devices" would be a "tipping".

Indeed, the objects are connected in the industrial system (smart manufacturing) and the municipal utilities are beginning to organize themselves in the same way. The note stresses the importance of fostering an open platform for all public services. Private space is organized in the same way, for example health, but individuals often see these connected objects as gadgets. Yet by the technology platforms, interconnection allows a general improvement of services. The more traditional companies may depend on Internet companies developing these platforms.

The issue of power of this economy are standardization and standard naming of objects. In this ecosystem, data are the creation of economic value.

The author of the paper proposes the idea of a "right to experiment" way to foster innovation. This would in mobility, health management, insurance. The note doesn't specify the consequences of such a "right to experiment": Does this mean a decline in sectoral regulations?

In any case, the note stresses the need to reaffirm the rights of persons and to protect privacy.

June 24, 2019

Breaking news

In what it presents as a set of guidelines designed by a risk-driven approach, the FATF published on 21 June 2019 recommendating to fight the use of crypto-assets and cryptocurrency platforms for launderind money and financing terrorism.

This fight against money laundering is (with the fight against corruption) often presented as the core of the Compliance Law. The FATF takes a large part of it. Even if this new branch of Law aims to crystallize other ambitions, such as the fight against tax fraud or climate change, or even the promotion of diversity or education and the preservation of democratie, the legislation of Compliance Law are mature in the matter of money laundering and the terrorism financing, as they are in the fight against corruption.

The news comes then not from the new legal mechanisms but rather from the new technological tools that could allow the realization of the behaviors against which these obligations of compliance have been inserted in the legal system. It is then to these technologies that the law must adapt. This is the case with crypto-assets and cryptocurrency platforms. Because these are rapidly evolving technologies, with the exercise of written guidelines in 2019 to inform the meaning of the provisions adopted in 2018, the FATF is taking the opportunity to change the definition it provides of crypto-assets and cryptocurrencies. So that a too narrow definition by the texts does not allow the operators to escape the supervision (phenomenon of "hole in the racket" - loophole)..  

 

___

 

In fact, in October 2018, the FATC (Financial Action Task Force) developed 15 principles applying to these platforms, to allow this intergovernmental organization to carry out its general mission to combat money laundering and the financing of terrorism. These June 2019 recommendations are to interpret them.

 

In this very important document, where it is expressly stated that it is a matter of fixing the obligations of those who propose crypto-assets and crypto-currencies, the notion of self-regulation is rejected. Il est writter : "Regarding VASP (virtual assets services providers) supervision, the Guidance makes clear that only competent authorities can act as VASP supervisory or monitoring bodies!footnote-119, and not self-regulatory bodies. They should conduct risk-based supervision or monitoring, with adequate powers, including the power to conduct inspections, compel the production of information and impose sanctions. There is a specific focus on the importance of international co-operation between supervisors, given the cross-border nature of VASPs’ activities and provision of services."

On the contrary, it is a matter of elaborating the control obligations that these service providers must exercise over products and their customers (Due Diligences), which must be supervised by public authorities. 

In order to exercise this supervision and monitoring, the national authorities themselves must ensure that they work together : "As the Virtual Assets Services Providers (VASP) sector evolves, countries should consider examining the relationship between AML/CF (Anti-Money Laundering and Counter Terrorist Financint) measures for covered VA activities and other regulatory and supervisory measures (e.g., consumer protection, prudential safety and soundness, network IT security, tax, etc.), as the measures taken in other fields may affect the ML/TF risks. In this regard, countries should consider undertaking short- and longer-term policy work to develop comprehensive regulatory and supervisory frameworks for covered VA activities and VASPs (as well as other obliged entities operating in the VA space) as widespread adoption of VAs continues".

After particularly interesting comparative law information on Italy, the Scandinavian countries and the United States, the report concludes: "International Co-operation is Key", because of the global nature of this activity.

 

Since the issue is not the global Regulation of these platforms and types of products, but only the possible modes of money laundering and terrorist financing to which they may give rise, the FATF recalls that neither crypto-products nor product suppliers are not referred to as such. As the guidance's title recalls, common to the 2018 document adopting the 15 principles and this interpretive document, these are "risk-based" rules. Thus, it is according to the situations that these - products and suppliers - that they may or may not present risks of laundering and financing of terrorism: depending on the type of transaction, the type of client, the type of country, etc. For example, from the moment that the transaction is anonymous, that is impossible to know the "beneficiary", or that it is transnational and instantaneous, which makes it difficult to supervise because of the heterogeneity of national supervisions little articulated between them.

In reports that public supervisors must have with crypto-product suppliers, they must adjust according to the level of risk presented by them, higher or lower: "Adjusting the type of AML/CFT supervision or monitoring: supervisors should employ both offsite and onsite access to all relevant risk and compliance information.However, to the extent permitted by their regime, supervisors can determine the correct mix of offsite and onsite supervision or monitoring of Virtual Assets Services Providers (VASPs). Offsite supervision alone may not be appropriate in higher risk situations. However, where supervisory findings in previous examinations (either offsite or onsite) suggest a low risk for ML/TF, resources can be allocated to focus on higher risk VASPs. In that case, lower risk VASPs could be supervised offsite, for example through transaction analysis and questionnaires".

This "adjustment" required does not prevent a very broad conception of the power of supervision. So, for nothing escapes the recommendations (and in particular the obligations that ensue for the suppliers of these products), the definition of the crypo-assets and crypo-currencies is this one: “Virtual asset” as a digital representation of value that can be digitally traded or transferred and can be used for payment or investment purposes. Virtual assets do not include digital representations of fiat currencies, securities, and other financial assets that are already covered elsewhere in the FATF Recommendations."

And for the same reason of effectiveness is posited the principle of technological neutrality: "Whether a natural or legal person engaged in Virtual Assets (VA) activities is a Virtual Asset Services Provider (VASP) depends on how the person uses the VA and for whose benefit. As emphasized above, ...  then they are a VASP, regardless of what technology they use to conduct the covered VA activities. Moreover, they are a VASP, whether they use a decentralized or centralized platform, smart contract, or some other mechanism.".

The interpretative guidelines then formulate the obligations that these platforms have with regard to the supervisors they obey(question of the "jurisdiction", ratione loci ; ratione materiae): " The Guidance explains how these obligations should be fulfilled in a VA context and provides clarifications regarding the specific requirements applicable regarding the USD/EUR 1 000 threshold for virtual assets occasional transactions, above which VASPs must conduct customer due diligence (Recommendation 10); and the obligation to obtain, hold, and transmit required originator and beneficiary information, immediately and securely, when conducting VA transfers (Recommendation 16). As the guidance makes clear, relevant authorities should co-ordinate to ensure this can be done in a way that is compatible with national data protection and privacy rules. ".

These platforms are not uniformly defined due to the diversity of their activities. Because it is their activity that makes them responsible for this or that regulator. For example from the Central Bank or the Financial Regulator: "For example, a number of online platforms that provide a mechanism for trading assets, including VAs offered and sold in ICOs, may meet the definition of an exchange and/or a security-related entity dealing in VAs that are “securities” under various jurisdictions’ national legal frameworks. Other jurisdictions may have a different approach which may include payment tokens. The relevant competent authorities in jurisdictions should therefore strive to apply a functional approach that takes into account the relevant facts and circumstances of the platform, assets, and activity involved, among other factors, in determining whether the entity meets the definition of an “exchange”!footnote-121 or other obliged entity (such as a securities-related entity) under their national legal framework and whether an entity falls within a particular definition. In reaching a determination, countries and competent authorities should consider the activities and functions that the entity in question performs, regardless of the technology associated with the activity or used by the entity".

 

____

Reading this very important document, it is possible to make 6 observations: 

1. Interpretative documents are often more important than rules interpretated themselves. En these guidances, first and foremost, these are major obligations that are stated, not only for platforms but also for national laws, and well beyond the issue of money laundering. So, it is laid: "Countries should designate one or more authorities that have responsibility for licensing and/or registering VASPs. ...  at a minimum, VASPs should be required to be licensed or registered in the jurisdiction(s) where they are created. ".This is a general prescription, involving a general regulation of these platform, which registered in a general way, will probably be supervised in a general way.

Secondly, it is a series of binding measures that is required of the National legal systems, for example the possibility of seizing crypto-values.

It shows that the soft Law illustrates the continuum of the texts, and allows their evolution. Here the evolution of the definition of the object itself: the definition of crypto-assets and crypto-currencies is widened, so that the techniques of money laundering and terrorist financing are always countered, without it being necessary to adopt new binding rules. We are beyond mere interpretation. And even more of the principle of restrictive interpretation, classically attached to the Repressive Law ...

2. Fort the effectiveness of the Compliance Law, definition become extremely broad. Thus, to follow the FATF, the definititon off a financial institution is as follows: "“Financial institution” as any natural or legal person who conducts as a business one or more of several specified activities or operations for or on behalf of a customer". This is more the definition of a company in Competition Law!footnote-120....Why ? Because otherwise, an operator finds a status allowing him to escape the category and obligations listed. The principle of efficiency implies it. The principle of "legality", derived from criminal law, has hardly any existence. But this also corresponds to the general evolution of the financial world, in which one no longer stars from the organ (for example to be a"bank") but of activity, but from an activity or a fonction whose metamorphoses are so rapid that it is almost impossible to define them ....

3. In the same way, the definition of crypto-assets or crypto-currencies: "“Virtual asset” as a digital representation of value that can be digitally traded or transferred and can be used for payment or investment purposes. Virtual assets do not include digital representations of fiat currencies, securities, and other financial assets that are already covered elsewhere in the FATF Recommendations". This definition is purely operational because nothing can escape the FATF: all that is financial or monetary, whatever its form or support, its traditional form or a form that will be invented tomorrow, is within its competence and, through a such definition, is under national supervisors. In Compliance Law, and since everything is based on risk analysis, the idea is simple: nothing must escape obligations and supervision.

4. Platform apprehension is done by the criterion of activity, according to the "functional" method. Thus, its supervision, or even its regulation, and its obligations of compliance, will apply, depending on what it does, to the Financial Regulator (if it does ICO) or to others if it only uses tokens as an instrument of exchange. If it makes several uses, then it would fall under several Regulators (criterion ratione materiae).

5. The principle of "technological neutrality" is a classic principle in Telecommunications Law. Here we measure the interference between the principles of Telecommunications Law and Financial Law, which is logical because crypto-financial objects are born of digital technology. This neutrality allows both technological innovation to develop and supervision to be unhindered for not having foreseen an innovative technology appearing after the adoption of the legal text. Here again, the effectiveness of Compliance and risk management are served, without the innovation being thwarted, which is often opposed.

6. What is expected of national public authorities is a very wide "interregulation". This is both "positive". Indeed, this includes financial matters but also the security of networks, or the protection of consumers. It can be called equilibrium interregulation in that all goals converge. But this is also an "interregulation" that can be described as balance. Indeed, the FATF is concerned about the protection of personal data. However, it emphasizes that the effectiveness of the Compliance system must stop. But the protection of personal data is also a part of Compliance Law.... This is one of the major challenges in the future: the balance between security and the fight against global evils(here the fight against money laundering and terrorism) and the protection of the privacy of individuals, as both fall under Compliance, but both have opposite legal effects: one the transmission of information, and the other the secret of the information. 

____

 

 

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

Contributions

Updated: May 1, 2010 (Initial publication: Jan. 26, 2010)

Symposiums

The President of the Autorité de régulation des communications électroniques et des postes (Arcep –French Electronic and Postal Communications Regulation Authority) presents his vision of Telecommunications Regulation in favour of Network Neutrality.

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.

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

___

 

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. 

___________

 

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 

 

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.