Jan. 18, 2016

Compliance and Regulation Law Glossary

March 27, 2015

Sectorial Analysis

The cost issue of regulation is a recurring issue.

One can complain specifically, when companies are protesting about the "cost of regulation" or when the topic is taken as an object of study, through the cost / benefit calculation.

A practical question of importance is whether there is a "legal question" or not.

The "juridicity" of a question is defined by the fact that discussing about this question has an effect on the outcome of a case before a judge. This concrete definition, leaving the judge's power, binding nature of the rule (here the balance between cost and benefit) the effectiveness of its decision before the judge, its consideration by him in the decision he makes, has been proposed in France by Carbonnier. It is opposed to a definition of Law by the source, the author of the rule, which identifies law for example through Parliament Acts, because the text is adopted by the legislator, listed source of law.

The first definition, more sociological, more flexible, giving the spotlight on judge better corresponds to a legal system which gives more room for ex post and for the judge. It is logical that we find more demonstrations of this conception in the common law systems.

However, the issue of cost / benefit is being debated before the Supreme Court of the United States, about the latest environmental regulations, adopted by the Environment Protection Agency (EPA). It is a question of law. It is under the empire of the judge.

For it is in this light that President Barack Obama in November 2014 asked a very costly regulation, and it was under his leadership that the Environmental Protection Agency has developed texts. Indeed, pollution of certain plants are the cause of asthma and laid in public health imperative to fight a regulation that results in a direct cost on firms. Indeed, some plants pollution is the cause of asthma and President Obama has asked public health imperative to combat by a regulation that results in a direct cost on the industry. The regulations adopted in 2012 they cost a $ 9 million, some claiming that future ones could result in billions of costs directly related to business The President emphasized by stating that the health of children was priceless.

By challenging those of 2012 before the Supreme Court, in the case Michigan v. EPA, this is the other texts that conservative states and companies have in mind because it is the principle that is posed: : does A regulator have the right to take regulations very "expensive" when the advantage, however legitimate it is, is small-scale in terms of costs? The Supreme Court, having chosen to handle the case, listened to March 25, 2015, the arguments of each other and discussed the case.

The question is the integration or not into the constitutional notion of "necessity of the law" of the "cost / benefit" calculation. This is a crucial point because the concept of "necessity of the law" is a common notion to the constitutions of many countries.

However, not only the so-called judges "conservatives" as Justice Antonio Scalia, took position felt it was crazy not "consider" the cost of new regulations from the expected health benefits, but also Justice Stephen Breyer called "progressive," said "irrational" the environmental regulator has not taken in consideration such an imbalance between cost and benefit.

It is true that Justice Breyer was formerly professor of competition law at Harvard.

Judgment will be given in June.

Updated: June 8, 2012 (Initial publication: June 6, 2012)

Thesaurus : Doctrine

International Handbook on Regulating Nanotechnologies

Updated: April 13, 2012 (Initial publication: April 13, 2012)

Thesaurus : Doctrine

The Politics of precaution: Regulating Health, Safety and Environmental Risks in Europe and the United States.

Updated: Jan. 13, 2012 (Initial publication: Jan. 11, 2012)

Sectorial Analysis

Main information

On December 20, 2011, the European Commission adopted a decision based on the Almark ruling that expounds upon the four conditions necessary so that compensation paid by a State to any state-owned or private company entrusted with the operation of a public service not require prior notification of the European Commission, despite the general prohibition on State Aids. Each state has a wide margin of discretion in the definition of services that could be classified as being services of general economic interest. A communication and de minimis regulation will complete this decision.

Updated: Jan. 8, 2012 (Initial publication: Jan. 8, 2012)

Thesaurus : Doctrine

La régulation des secteurs de la santé

Updated: Dec. 21, 2011 (Initial publication: Dec. 21, 2011)

Thesaurus : Doctrine

Protection of public health, control of healthcare expenditure, general competition law and the sector's regulatory framework

Updated: Dec. 19, 2011 (Initial publication: July 5, 2011)

Sectorial Analysis

Translated Summaries


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.


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.


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.



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.



Other translations forthcoming.

Updated: Dec. 5, 2011 (Initial publication: Dec. 5, 2011)

Thesaurus : Doctrine

Régulation et Tarification des Hôpitaux

Updated: Sept. 19, 2011 (Initial publication: Sept. 19, 2011)

Sectorial Analysis

Main information

An advertisement broadcast in Burkina Faso for an insecticide did not reveal its health risks. The national media regulator published a decision on September 6, 2011 ordering that it be taken off the air and “requested” that the media refrain from broadcasting advertisements dangerous for human health and dignity.

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.

Updated: May 20, 2010 (Initial publication: May 6, 2010)

Sectorial Analysis

Main information

On April 27, 2010, the European Parliament’s Committee for Health voted to introduce an amendment to the European Commission’s ‘Pharmacovigilance and Prescription Medicine Package’, which would introduce a strict regime for online prescription medicine sellers.

Updated: May 5, 2010 (Initial publication: May 5, 2010)

Sectorial Analysis

Main information

The European Court of Justice upheld German regulations on Bovine Spongiform Encephalitis (BSE, or ‘mad cow disease’) testing, which were more stringent than those required by the European Union, on the grounds that Member States are alone legitimate to determine the level of public health protection they guarantee their citizens.

Updated: April 12, 2010 (Initial publication: April 6, 2010)

Sectorial Analysis

Main information

The U.S. District Court in Newark, New Jersey, dismissed a class action suit brought against drug manufacturer, Schering Plough, alleging that payments it made to two generic drug manufacturers in order to delay the introduction of generic forms of one of its products, violated antitrust law.