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The European Medicine Agency (Agence européenne du Médicament - EMA) launched on May 31, 2012 a database, available on an Internet site, indicating "suspicious side effects" of drugs allowed on European Union markets. The information comes both of the different authorities of national regulation of drugs and pharmaceutical companies who spontaneously reported these side effects.

Translated summaries

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

ENGLISH

The European Commission’s initiatives towards a Single Market in energy, transport and electronic communications should aim to further regulatory transparency and not market homogenisation. The article provides a quantitative and qualitative assessment of indiscriminating homogenisation of the mobile telecommunications market. The potential impacts on market power and the loss of consumer welfare are by no means negligible and imply important policy considerations

FRENCH

Les initiatives de la Commission européenne en vue d’un marché unique des communications de l’énergie, de transport et électroniques devraient viser à une plus grande transparence réglementaire et non pas à l’homogénéisation du marché. Le présent article fournit une évaluation quantitative et qualitative de l’homogénéisation inconsidérée du marché des télécommunications mobiles. Les impacts potentiels sur le pouvoir de marché et la perte de bien-être des consommateurs ne sont nullement négligeables et impliquent des considérations politiques importantes.

Comparison of various models of risk regulation in order to understand how those systems shape the relationship between law and science and how they attempt to overcome the public’s distrust of science-based decision making in the EU.

Full reference: Frison-Roche, M.-A., The control by regulator of the essential infrastructure manager's investment plan: example of electric network and the notion of "doctrine", Newsletter MAFR - Law, Compliance, Regulation, 24th of August 2020

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

 

Summary of the news

On 31st of July 2020, the Commission de Régulation de l'Energie (CRE and French energy regulator) has examined the investment plan of the French electric network manager (RTE) as it does every year. This investment plan is an economic document but it also contains societal purposes, especially the adaptation of the electric network in order to integrate renewable energies. 

The control by the CRE is not a financial control. The crucial operator (RTE) is free to decide the way it wants to manage its budget. The CRE just advices on the financial side by recommending for exemple to be more flexible in its financial strategies. The true CRE's control is about the investment plan's general orientations, the methodology of needs analysis and crucial operator's investment choices which must be aligned with those of the regulator.

Such a control leads to the emergence of an "investment doctrine" from the side of the crucial operator, mixing its own choices and the regulator's guidelines. Beyond this, the elaboration of the investment plan is the result of a true co-writing between the regulator and the firm which discuss together, exchanges points of view and methods. Such a method, expressing a kind of coregulation, could be used in other sectors. 

Main information

The Basel Committee on Banking Supervision approved a package of new proposals to strengthen global capital and liquidity regulations for consultation, as part of its comprehensive response to the international financial crisis.

Full reference: Frison-Roche, M.-A., Judge between Platform and Regulator: current example of Uber case in U.K., Newsletter MAFR - Law, Compliance, Regulation, 29th of September 2020

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

 

Summary of the news:

On 22nd of September 2017, Transport of London (TFL), London Transport Regulator, refused to renew the licence, granted on 31st of May 2012 for 5 years, authorizing Uber to transport people because of criminal offenses committed by Uber's drivers. On 26th of June 2018, The Westminster Court prolonged Uber's licence for 15 months under the condition that the platform prevent the reproachable behaviors of its drivers. After these 15 months, the TFL refused once again to prolonge Uber's licence because of the persistence of aggressions against passengers. Uber, once again, contest this decision before the Westminster Court. 

In a decision of 28th of September 2020, the Court observes that during the 15 months, the platform implemented many measures to prevent aggressions, that the level of maturity of these measures has improved over time and that the number of offenses was reduced over the period (passing from 55 in 2018 to 4 in 2020). The Court estimated the the implementation of this actions is sufficient to grant a new licence to Uber. 

We can learn three lessons from this decision: 

1. The Compliance obligation is not a result obligation but a mean obligation, which means that it is not reasonable to expect from a crucial operator (Uber, for instance) that it prevent every cases of agression but that it is salient to judge it on the effort it deploys to try to be closer to this ideal situation. Moreover, the crucial operator must be proactive, that is going away from the figure of passive subject of Law who apply measures enacted by the regulator in terms of fighting against aggressions to be an actor of the research of the best way to fight abusive behaviors, internalizing this "monumental goal. 
2. The judge appreciates the violation committed by those whose the firm is responsible "in context", that is evaluates the concrete situation in a reasonable way. 
3. It is the judge who decides in last resort and like the crucial operator, it must be reasonable. 

 

Read to go further:

• Frison-Roche, M.-A., Firm, Regulator and Judge: thinking Compliance through these three characters, 2018
• The report of the Assemblée nationale (French Parliament chamber) on the question 

On June 19, 2012, the European Parliament adopted an extensively modified version of the draft text prepared by the European Commission on credit rating agencies. It does not address the issue of the concentration of the rating market, believing that this is a matter of competition and not of regulation. It reduces the scope of the rotation rule in three years and only for structured products. It requires agencies to issue a schedule of two or three dates in the year where they can change their sovereign debt notes. Next to these devices of ex ante regulation, Parliament adopts an ex post system, civil liability of agencies, in which it will be for them to demonstrate to investors that they have complied with the rules in force.

In Belgium, in December 2008, the Flemish Region issued a decree tariffing the injection into the electricity in the distribution network. The Belgian Energy regulator, the "Commission de Regulation de l’Electricité et du Gaz" (CREG – Belgian Regulatory Commission for Electricity and Gas), which has federal jurisdiction, challenged this Decree in the Constitutional Court; the regulator considered that the Region has no jurisdiction to establish such a tariff. By the decision of July 12, 2012, the Court gives reason to the regulator and cancels the order adopted by the Region, stating the need for a federal jurisdiction to adopt such tariff, in this case the jurisdiction of the regulator.

 

On November 15, 2010, the Autorité de la Concurrence (the French Competition Authority) hosted a meeting on the theme of online gambling and the opening of the market to competition. The first debate concerned sports federations and betting rights.

 

FRENCH

Rapport bibliographique (Symposium): Symposium de l'Autorité de la Concurrence sur la régulation des jeux en ligne.

Le 15 novembre 2010, l'Autorité de la Concurrence a organisé un colloque sur le thème de la régulation des jeux en lignes et l'ouverture du marché à la concurrence. Le premier débat concernait les fédérations sportives et le droit au pari.

GERMAN

Bibliographischer Bericht (Symposium): Symposium der französischen Wettbewerbsbehörde über die Regulierung von Online-Wetten.

Am 15. November 2010 hat die Autorité de Concurrence (die französische Wettberwerbsbehörde) ein Symposium über die Regulierung von Online-Wetten und die Wettbewerseröffnung dieses Marktes veranstaltert. Im ersten Gespräch wurde das Thema Sportverbände und Wetterecht behandelt.

ITALIAN

 

The book "Concurrence, santé publique, innovation et médicament" (Competition, public health, innovation, and medicine), published by French publisher L.G.D.J., provides an analysis of the pharmaceutical sector’s oscillation between competition and regulation. The first part of the study is consecrated to "Médicament dans la regulation des dépenses de santé" (The role of medicine in the regulation of healthcare costs), which exposes health-related questions in their most government-controlled aspect. The second part conceives health through its social function, with "Innovation et incitation à la recherche" (Innovation and incentive to perform research), while the last part explains "Les difficultés des prises en compte par le droit de la concurrence des spécificités du secteur pharmaceutique" (Competition Law’s difficult apprehension of the pharmaceutical sector’s specificities). The three parts of this study offer an exhaustive presentation of the stakes involved in healthcare law, economy, and policy, and clearly shows that the hybrid nature of this sector makes it more a matter for regulation rather than for competition law.