sábado, 12 de mayo de 2012

Crimen organizado: una lucha global

1. Prevenir y combatir la delincuencia organizada transnacional, con pleno respeto de los derechos humanos, tomando como marco de referencia la Convención de Palermo y sus tres protocolos. Ello se hará de acuerdo a los principios de igualdad soberana e integridad territorial de los Estados y de no intervención en los asuntos internos de otros Estados.
2. Profundizar la cooperación en materia de prevención, investigación, procesamiento y actuaciones judiciales relacionadas con actos de delincuencia organizada transnacional.
3. Alentar la coordinación entre los respectivos órganos de la OEA con competencia en los temas vinculados con el combate de la delincuencia organizada transnacional, así como la cooperación entre éstos y la Oficina de las Naciones Unidas Contra la Droga y el Delito (ONUDD).
4. Fortalecer las capacidades y habilidades nacionales, subregionales y regionales para enfrentar la delincuencia organizada transnacional.

El crimen organizado transnacional

¿Cómo se define crimen o delito, y si éste es organizado? Tal discusión, principalmente jurídica, señala la existencia de un tipo de delincuencia que se diferencia de lo que se denomina “delincuencia común” debido a los procesos de evolución o perfeccionamiento que caracterizan este antiguo fenómeno rejuvenecido con el advenimiento de la sociedad de la información. Varios elementos señalan esta diferencia: a) rebasa los controles gubernamentales, b) establece líneas especiales de operaciones basadas en un sistema complejo de tipo empresarial, bien estructurado para la comisión de hechos delictivos, c) persigue por medio de determinadas acciones violentas la búsqueda y obtención de poder económico y social, no tanto político d) la delincuencia está delante de lo que caracteriza a la delincuencia común tradicional y convencional. e) adicionalmente, se puede señalar que el delito organizado posee una marcada dimensión transnacional y una alta capacidad de adaptación al nuevo contexto, así como una fuerte especialización en los ámbitos específicos como lo son el tráfico ilegal de estupefacientes, armas, personas, así como el blanqueo de dinero asociado con los delitos anteriores.

La transnacionalización del crimen ha aumentado los problemas que de él se derivan. El crimen organizado cruza las fronteras y sus acciones se relacionan con los distintos tipos de amenazas de carácter global.

Para poder enfrentar esta nueva forma de criminalidad es necesario contar con una perspectiva y visión transnacional; esto significa coordinar políticas globales y locales, convirtiéndose esto en uno de los principales retos que poseen los Estados, las sociedades y todos los actores que buscan enfrentar este flagelo.

El crimen organizado tiene un objetivo esencialmente económico, sin embargo, para poder recibir esos recursos ocupa la extorsión y la violencia como instrumentos fundamentales. Esta característica es la que representa el mayor peligro para las sociedades latinoamericanas y caribeñas. El crimen organizado posee una fuerte coherencia interna, altos grados de especialización y sofisticación. No es ideológico, no busca el poder político como tal, lo que busca es la influencia y la capacidad de decisión sobre los agentes del Estado, con independencia de la ideología de éstos. Es una empresa ilegal, aunque normalmente penetran empresas legítimas.

Delitos transnacionales y cooperación internacional

La crisis del Estado se expresa fundamentalmente en tres aspectos: Un Estado de Derecho débil por la falta de imperio a la ley; la incapacidad del Estado para asegurar los bienes públicos básicos para el conjunto de la población y en una importante erosión de sus sistemas políticos, en especial en las jóvenes democracia. La debilidad institucional de las democracias refuerza cada uno de los elementos reseñados y posibilita una mayor erosión del Estado por parte del crimen organizado.

domingo, 29 de abril de 2012

Delitos que cruzan fronteras: Centroamerica

El robo y hurto de vehículos, la trata de personas y los delitos relacionados al narcotráfico son los principales problemas que enfrentan, en común, los países de Centroamérica.

Delitos transnacionales

Se hace necesario recordar la diferencia existente  entre Delito Interestatal, delito Internacional y Delitos Contra el derecho internacional.

  Por delito Interestatal  o Transnacional debe entenderse aquellos delitos  comunes que por sus características intrínsecas  afectan dos o más Estados por lo que entra en juego la cooperación Judicial Internacional; ejemplo de estos delitos es el narcotráfico, el tráficos de mujeres y niños
.
   El delito Internacional es aquel que surge cuando se quebrantan bienes jurídicos que son inherentes al género humano y en los cuales están interesados todos los estados del mundo porque afectan a la humanidad misma, conmueve sus cimientos.

  El delito contra el derecho internacional es aquel que surge por la violación de aquellos derechos establecidos por los propios Estados en sus relaciones entre si. Esta categoría de delitos se encuentran tipificados en nuestro código penal en los artículos  152 al 159 vigentes y abarca desde la piratería, las invasiones  hechas por particulares a otros Estados y los cometidos por ciudadanos contra el presidente de naciones extranjeras dentro del territorio venezolano.

es necesario aclarar que organismo es el encargado de establecer las responsabilidades y aplicar las penas que correspondan y así tenemos que:

  Si el sujeto activo que comete el delito contra los derechos humanos es un Estado, para los países o estados Partes que integran la Organización de Estado Americanos (OEA.) Tal organismo  es la CORTE INTERAMENRICANA DE LOS DERECHOS HUMANOS y así tenemos por ejemplo que Venezuela como estado parte integrante de la OEA. Fue sancionada por por el caso conocido como “El Amparo” a reparar el daño inflingido y a pagar unas sumas de dinero por vías de indemnización económicas.

  De manera que la Corte Interamericana de los derechos Humanos es competente para sancionar con reparación e indemnización económica, únicamente a los estados partes cuando estos resultan responsable de La violación de los derechos humanos.

  Ahora bien, si es uno o varios particulares organizados o no,  que cometen un delito contra los derechos humanos, la competencia para juzgar a esa o esas personas corresponde a la CORTE PENAL INTERNACIONAL que se rige por el Estatuto de Roma.

   También es bueno recordar que antes de la instauración de la Corte Penal Internacional fueron creados Tribunales Penales Interrnacionales ad- hoc, tribunales especiales para juzgar delitos cometidos contra el genero humano creados por el Consejo de Seguridad de la ONU .Estos Tribunales como los de Neuremberg, el de Tokio, después de la segunda Guerra Mundial , así cono los Tribunales de Ruanda y de la Ex Yugoslavia violaban y violan el principio de legalidad pues son creados  para juzgar delitos de lesa humanidad, de guerra y de genocidio, precisamente, después de cometido el delito; observándose que los procesados por delitos en estos tribunales han alegado la violación del principio de legalidad  se pudiera decir como afirmaron los jueces de Neuremberg “Los individuos, no los Estado son los que cometen delitos “  y para abandonar el principio de legalidad tambien se dijo que la impunidad de la conducta es más insopotrtable que la vulneración del principio peor que la violación del principio de legalidad es la impunidad de estos delitos atroces” Caso Milosevic

   Precisamente, para evitar la violación de este principio se consideró entre  otros, la creación de la Corte Penal Internacional para el juzgamiento  de personas que fueran señaladas como incursas en estos delitos. 

sábado, 28 de abril de 2012

La législation française anti-blanchiment http://www.minefi.gouv.fr/notes_bleues/nbb/nbb160/tracfin.htm

Elle repose sur les textes suivants.
La loi n° 90-614 du 12 juillet 1990, relative à la participation des organismes financiers à la lutte contre le blanchiment des capitaux provenant du trafic des stupéfiants, impose de nouvelles obligations aux établissements de crédit et professions financières, dont celle d'informer TRACFIN chaque fois qu'une transaction leur paraît suspecte : le principe de la "déclaration de soupçon", qui rompt le secret bancaire, est institué.
La loi n° 93-122 du 29 janvier 1993, relative à la prévention de la corruption et à la transparence de la vie économique et des procédures publiques, élargit le champ d'application de la loi précitée au produit de l'activité d'organisations criminelles.
La loi n° 96-392 du 13 mai 1996, relative à la lutte contre le blanchiment et le trafic des stupéfiants, et à la coopération internationale en matière de saisie et de confiscation des produits du crime, crée un délit général de blanchiment du produit de tous crimes et délits (article 324-1 du code pénal). Ce texte renforce également le contrôle exercé sur les changeurs manuels et soumet les courtiers d'assurance et de réassurance aux mêmes obligations anti-blanchiment que les entreprises d'assurances dans le cadre de la loi du 12 juillet 1990. Il conforte, par ailleurs, le rôle de TRACFIN au centre d'un système international puissant de lutte contre le blanchiment, en lui permettant d'exercer son droit de communication au profit d'organismes étrangers exerçant des compétences analogues et soumis à des obligations identiques de secret professionnel.
Enfin, la loi n° 98-546 du 2 juillet 1998, portant diverses dispositions d'ordre économique et financier, assujettit les professionnels de l'immobilier (notaires et agents immobiliers essentiellement) à l'obligation de vigilance et de déclaration de soupçon à TRACFIN.

Global Context of International Crime http://www.fas.org/irp/threat/pub45270chap1.html

Implications of a Changing World

Law enforcement officials around the world have reported a significant increase in the range and scope of international criminal activity since the early 1990s. The level and severity of this activity and the accompanying growth in the power and influence of international criminal organizations have raised concerns among governments all over the world--particularly in Western democracies--about the threat criminals pose to governability and stability in many countries and to the global economy. International criminal networks have been quick to take advantage of the opportunities resulting from the revolutionary changes in world politics, business, technology, and communications that have strengthened democracy and free markets, brought the world's nations closer together, and given the United States unprecedented security and prosperity:
  • Post-Cold War landscape. The end of the Cold War resulted in the breakdown of political and economic barriers not only in Europe but also around the world. This change opened the way for substantially increased trade, movement of people, and capital flows between democracies and free market countries and the formerly closed societies and markets that had been controlled by Soviet power. The end of the Cold War also brought with it an end to superpower rivalry in other regions of the world, encouraging movement toward peace and more open borders. These developments have allowed international criminals to expand their networks and increase their cooperation in illicit activities and financial transactions.
  • Economic and trade liberalization. Increasing economic interdependence has both promoted and benefited from reforms in many countries opening or liberalizing state-controlled economies with the intention of boosting trade and becoming more competitive in the global marketplace. Criminals have taken advantage of transitioning and more open economies to establish front companies and quasi-legitimate businesses that facilitate smuggling, money laundering, financial frauds, intellectual property piracy, and other illicit ventures. Multilateral economic agreements reducing trade barriers in North America, Europe, Asia, and other regions of the world have substantially increased the volume of international trade. In the United States, the volume of trade has doubled since 1994, according to the US Customs Service, and will double again by 2005. Criminal groups have taken advantage of the high volume of legitimate trade to smuggle drugs, arms, and other contraband across national boundaries.

Crímenes transnacionales en un mundo globalizado

Crímenes transnacionales en un mundo globalizado.
 http://www.estudiodurrieu.com.ar/articulo_2007_05_31.html

Los delitos transnacionales, tales como el de financiamiento del terrorismo, lavado de dinero, narcotráfico, piratería, evasión fiscal, delitos de lesa humanidad, genocidio, corrupción y fraude corporativo, entre otros, contienen un carácter económico, social y de perspectiva supranacional. Por este motivo, la comunidad internacional resolvió diseñar un régimen global con miras a detener su acentuado avance.
El interés universal en combatir los crímenes en cuestión mediante el diseño de políticas de prevención y represión globales se ha visto manifestado en la suscripción de tratados internacionales impulsados principalmente por organismos multilaterales tales como el Banco Mundial (BM), la Organización de Estados Americanos (OEA) y la Organización de Naciones Unidas (ONU).
La necesidad de recurrir a la cooperación internacional en materia penal radica básicamente en que nos encontramos inmersos en una era globalizada donde la comisión de los crímenes trasciende ampliamente los márgenes territoriales de los Estados, fenómeno que comienza a observarse como una de las amenazas más trascendentes para el régimen democrático y republicano de gobierno.
En este sentido, Pedro R. David nos dice que “el delito, especialmente el delito transnacional, ejecutado por organizaciones delictivas de alcance global, de enorme poderío económico y técnico, generador de corrupción y destrucción de formas legítimas de convivencia, constituye sin duda la amenaza más grave a la paz mundial en el presente, sin excluir, desde luego, los flagelos de la marginalidad en la que casi tres cuartas partes de la humanidad está inserta” [3].
El hecho de que las organizaciones criminales dedicadas a estos crímenes ya no cuenten con nacionalidad o límites territoriales, ha llevado a muchas naciones a incorporar principios acordes con la aplicación extraterritorial de la ley penal, con miras a reconocer, en última instancia, una justicia supranacional o universal que pueda tener competencia para tratar asuntos que por su gravedad y magnitud amenazan la estabilidad social y económica de las naciones.
Pareciera que ya no basta con el reconocimiento de la jurisdicción territorial [4], real o de defensa [5], o por la nacionalidad del autor o la víctima [6], si lo que se quiere es combatir en forma efectiva el crimen organizado y transnacional en el mundo entero. Con este último objetivo, los Estados se van aproximando cada día más a un Derecho penal supranacional [7]. El fenómeno del mundo globalizado en el que nos encontramos así lo exige.
Pedro David nos vuelve a decir que la globalización “... más que un modelo de características universales, es un nuevo paradigma de características internacionales y en beneficio principalmente de los sectores dominantes” [8].
Esta competencia universal o cosmopolita tiene su lógica si reconocemos la progresiva y avanzada transnacionalidad de las actividades empresarias y tecnológicas en las que el mundo se ve envuelto.
El circuito económico, operado generalmente a través de entidades bancarias con conexiones en el exterior, podrá significar que el giro de capitales vaya perdiéndose poco a poco, hasta arribar finalmente a un paraíso fiscal donde el secreto bancario y las sociedades “off shore” sean costumbre; y a través de estos medios originar un reciclaje del dinero originariamente “sucio” en el sistema financiero lícito de un país y/o del otro; produciéndose finalmente un fuerte impacto negativo en el Producto Bruto Interno (PBI) de los respectivos países que fueron víctimas de las maniobras delictivas [9].
Por otro lado, el impacto que el uso de internet, la tecnología y los medios de comunicación tienen en el tema , no puede ser dejado de lado en el análisis de las instituciones jurídicas que combaten y nos previenen de los flagelos que nos acechan.
Los acontecimientos de la era contemporánea enumerados anteriormente, han forzado a varios Estados a acercarse cada día más a lo que se ha denominado como el “principio universal, mundial o cosmopolita de la aplicación espacial del Derecho penal” [10]. Concretamente, como lo venimos anunciando, no caben dudas de que los Estados, sin perder su soberanía y los principios jurídicos esenciales propios de su idiosincrasia y cultura, tienden a construir un Derecho penal internacional, mediante la armonización de sus sistemas internos a la luz de principios universales.
El establecimiento de las Cortes Penales Internacionales ad hoc para la ex Yugoslavia y Ruanda, en conjunto con la suscripción del tratado de Roma en 1998 que da origen a la Corte Penal Internacional, son suficiente prueba de la realidad que describimos [11].
Además de los tribunales penales internacionales con competencia universal, existen Estados que invocan la existencia de una jurisdicción universal que los habilita para juzgar crímenes cometidos en otro Estado. Dos de los países más representativos de esta posición son, por un lado, el Reino de España mediante la incorporación de los artículos 3.4° de la LO 6/1985 y 301.4° de su Código Penal Español y, por el otro, los Estados Unidos de Norteamérica, a través del fallo “Pasquantino et al. vs. United States” . A continuación nos referiremos a ambos antecedentes.

viernes, 6 de abril de 2012

Protection de la santé publique, maîtrise des dépenses de santé, droit général de la concurrence et régulation sectorielle

Marie-Anne Frison-Roche,
http://www.thejournalofregulation.com/Protection-de-la-sante-publique.html

La Commission européenne a publié un rapport le 8 juillet 2009 sur le secteur pharmaceutique en estimant que celui-ci n’est pas suffisamment ouvert à la concurrence notamment concernant les médicaments génériques.
Elle en mesure les effets néfastes au regard du poids des systèmes de protection sociale, qui pèsent sur les États membres. Elle en regrette les retards sur l’innovation, qu’elle relie à une utilisation des brevets, maniée d’une façon « stratégique » par les laboratoires de médicaments princeps, ainsi qu’à une régulation trop lâche menée par les offices des brevets auxquelless’ajoute un usage systématique des droit d’agir en justice. L’article conteste non pas tant la logique interne du raisonnement mais la primauté ainsi donnée au droit de la concurrence. En effet, l’organisation du secteur du médicament est avant tout régulée par le biais de l’administration, par des mécanismes
En outre, on ne peut dissocier l’organisation de ce secteur de la notion de « droit à la santé », droit fondamental que la concurrence ne peut prétendre avoir l’ambition de concrétiser, alors que le droit de la régulation peut le poser comme objectif et le politique y mettre le prix. Par son rapport, l’autorité de concurrence s’est comportée en autorité de régulation, ce qui est politiquement et institutionnellement illégitime.

WHO : MEDICAL DEVICE REGULATIONS Global overview and guiding principles

 http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf
http://enzo-umpierrez.blogspot.com.ar/


The regulation of medical devices is a vast and rapidly evolving field that is often
complicated by legal technicalities. For example, legal terms and their meanings are
sometimes non-uniform even within one regulatory system. In an attempt to make this
complex subject easier to grasp, this Guide presents a common framework that integrates
the regulatory systems of the five countries or regions with the most advanced medical
device regulations. Non-technical language, graphics, tables and memory anchors are
used to present an overview of medical device safety issues and regulatory philosophy.

domingo, 1 de abril de 2012

The European regulation that deals with the sanitary security of materials

http://www.contactalimentaire.com/index.php?id=163&L=1

The European regulation that deals with the sanitary security of materials and items that come into contact with foods comes under the DG-Sanco (General Directorate of consumers' health and protection) within the European Commission. The competences of this general directorate include the food safety.

The capacity to contact with food and materials is controlled by the Regulation CE n°1935/2004. Materials and items included are:
  • packaging and conditioning,
  • containers and cookwares,
  • materials, machines and materials used for production, storage or transport of foods,
  • nipples and lollipops.
 Foodstuffs included are foods and drinks which are:
  • either finished or intermediate products,
  • intended for human nutrition.
 Excluded products a.o. :
  • coating materials,
  • static drinking water distribution systems.
Specific regulations or directives describe the inertness criteria for some materials (Plastics, ceramics, regenerated cellulose film and partly regenerated for rubbers) and also the modalities to check the conformity.

Specific regulations or specific directives contain the inertness criteria which depend on the nature of materials. For some materials (plastics for instance), there is a list of authorised materials in Europe (positive lists) that are completed by lists of materials authorised on the national level (colorants for plastics in France, for instance). Those materials are the only one authorised in the manufacturing of materials. The authorisation of a material is delivered by the DG-Sanco with downstream aspects of the standing Committee of the food chain and animal health, once the favorable opinions of the scientific authorities such as the European Food Safety Authority (EFSA) and previously the Scientific Committee on Food end. Those opinions are distributed over the Internet. When there is no existing specific requirement for a material, the inertness principle quoted in the regulation still applies. Industrialists have to demonstrate that the principles have been met.

The regulation CE n°1935/2004, specific regulations and specific directives represent the European regulation of materials in contact. Some specific directives were transposed into national legislation in form of orders by material. Regulations were not transposed and apply as is In France.
When there is no specific regulation or directive for a material, the existing national provisions apply, which is the case in France for rubber, silicone, stainless steel, aluminium, for instance. Moreover, France extended the scope of this regulation to materials in contact with feedingstuffs.

To help indsutrials to demonstrate their product conformity, the DGCCRF (French Administration) published the general fact sheet relevant to the regulation of materials in contact with foods (see the Brochure n°1227 published to the OJ) that contains the responsibilities of different actors in the chain and explains the application of the inertness principle in fact sheets by material.

  Several resolutions of the Council of Europe concerning materials in contact with foodstuffs exist ( see the list of resolutions of the Council of Europe). If there is no statutory instrument, those resolutions may be used again as recommendations (see the resolution Framework Resolution ResAP (2004) 1 in the case of quahogs in France).

The provisions in respect of material hygiene and  packaging are included in the regulation of foodstuffs. The regulation 852/2004 of the Hygiene package determines the requirements in respect of foodstuff hygiene (as an alternative to the Directive 93/43/CE that has been repealed since January 1st 2006). This regulation contains specific provisions applicable to conditioning and packaging of foodstuffs.

viernes, 23 de marzo de 2012

Malaria vaccine

 Very interesting article from (CNN) -- A malaria vaccine has eluded scientists for decades, but preliminary results from a phase 3 clinical trial in Africa are providing hope.
The data suggest that the vaccine, known as RTS,S, cuts the number of malaria cases in half.
Overall 15,000 children in seven African countries are participating in the trial, which represents the furthest that any malaria vaccine candidate has ever progressed.
The preliminary results, which were announced at a malaria forum hosted by the Bill and Melinda Gates Foundation in Seattle, covered 6,000 of the participating children, all aged between 5 and 17 months.
The developers, GlaxoSmithKline and the PATH Malaria Vaccine Initiative, which receives funding from the Bill and Melinda Gates Foundation, said it showed roughly a 50% reduction in malaria cases in a 12 month period following vaccination.
Results from a group of infants between 6 and 12 weeks old will be announced late next year.
"Scientists have been working to develop a malaria vaccine for 40 years, and these findings show that we are on track in the development of a vaccine for African children, those who need it most," said Dr. Mary Hamel of the U.S. Centers for Disease Control and Prevention, who is one of the principal investigators on the study.
The vaccine is designed specifically for children because their immune systems are still developing, making them the easiest prey for the parasitic disease. Youngsters under the age of 5 account for the vast majority of the 800,000 people who die of the condition each year.
Philip Ouma and his mother, Rosemary
Philip Ouma and his mother, Rosemary
This year, Global Health Frontline News visited trial sites in Kenya, where 2-year old Philip Ouma was getting a booster shot. He buried his head in his mother's chest as a plunger with an inch-long needle glided into his arm and deposited its contents.
Unlike many of the babies and toddlers in this vaccine trial, Philip didn't burst into tears or even make a sound.
His mother, Rosemary, enrolled him in the trial because her three other children had repeatedly been sickened by malaria, putting an enormous strain on the family.
Indeed, the entire community felt the strain in their part of western Kenya, where malaria accounts for one-third of all deaths among children.
To administer the trials, the Kenyan government joined with the CDC and the Walter Reed Army Institute of Research.
Dr. Louis Macareo, who directs Walter Reed's clinical trial center in Kombewa, says this vaccine is different because instead of attacking the parasite, it seeks to boost the immune system. "When you get malaria, it spawns off a cascade of events in your body where your body produces antibodies that fight against the malaria," he said. "What we try to duplicate with the vaccine is to stimulate the body's immune system to produce similar antibodies."
The developers of RTS,S say preliminary results suggest that the incidence of adverse effects of the vaccine are comparable to those found in children receiving other vaccines in this blind trial.
The CDC's Mary Hamel says there was some increased incidence of fever and associated seizures in the older age group during the seven days following the RTS,S vaccination, but they were rare and all the children recovered.
GlaxoSmithKline and the PATH Malaria Vaccine Initiative say side effects will be monitored over the next three years to develop a safety profile.
If approved for widespread use, RTS,S would be given in tandem with other childhood vaccines, enabling overstretched health systems to introduce it with little difficulty.
And it's hoped that implementation could be just around the corner. The vaccine's developers say a 30-month analysis of the vaccine's effectiveness will be complete by the end of 2014.
If the results remain positive, the World Health Organization says it could recommend the vaccine as early as 2015.
Kayla Laserson, the director of a CDC partnership with Kenya's main research institute, known as KEMRI, says implementation talks are already under way. "Certainly, the preparations for it are there to go straight from discovery that this is in fact efficacious, to policy, to implementation; all those conversations are happening, so everyone is ready."
While a 50% cut in prevalence would not be a silver bullet against malaria, it would be a significant milestone with the potential to save hundreds of thousands, if not millions, of young lives.
But malaria control experts stress that if this vaccine ever does go to market, it would need to work in tandem with other interventions.
"Such a vaccine would not replace proven malaria control interventions such as insecticide-treated bed nets," the CDC's Hamel said, "but could be an important addition to those interventions."
Andrew Witty, the CEO of GlaxoSmithKline says that if approved, his company does not intend to make a profit from this venture. GlaxoSmithKline, which says that it has spent $300 million dollars on the development of RTS'S, will provide the vaccine at 5% above the cost of production, and that the excess amount will be reinvested for research into the next malaria vaccine.
David Lindsay is the managing editor of Global Health Frontline News.

martes, 13 de marzo de 2012

Qu'est-ce qu'un médicament générique? http://sante.lefigaro.fr/social/sante-publique/medicaments-generiques/quest-ce-quun-medicament-generique

Un médicament générique est un médicament similaire à un médicament autorisé (molécule princeps)

Un médicament générique est un médicament similaire à un médicament autorisé (molécule princeps) depuis au moins 10 ans dans l'Union européenne, et qui profite de la chute du brevet du princeps pour être commercialisé.
Le médicament générique doit contenir la même quantité en principe actif et être de même forme pharmaceutique que le médicament original. Il ne peut pas avoir de nouvelles indications que la molécule princeps qu'il copie.
De même, sa notice scientifique ne peut être transformée qu'après modification de la notice de la molécule princeps. Un générique est donc conforme à la spécialité de référence, et présente les mêmes effets, même fabrication, même forme pharmaceutique. En revanche, le goût, la couleur, les excipients utilisés peuvent être différents.

Regulatory policy

Regulatory Policy. http://enzo-umpierrez.blogspot...
Under the regulatory point of view, countries
do not develop new legislation to address convergence. Instead, they
modify existing regulations or institute new regulations to address new
technologies. For example, in the United States, the Federal
Communications Commission (FCC) introduced regulatory modifications to
allow new technologies, such as power line communications (PLC).

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1747603/pdf/v010p00329.pdf

Science in regulatory policy making: case studies
in the development of workplace smoking
restrictions
Lisa A Bero, Theresa Montini, Katherine Bryan-Jones, Christina Mangurian

Regulatory Policy Committee Annual Report 2011:

Regulatory Policy Committee Annual Report 2011: Departments achieve year on
year improvement but number of regulatory proposals deemed ‘Not fit for
purpose’ remains unsatisfactory
The independent Regulatory Policy Committee (RPC), charged by government with
assessing the quality of analysis and evidence supporting government departments’
proposals to regulate, today publishes its Annual Report 2011 ‘Improving Regulation’.
The report shows that 72% of just under 600 Impact Assessments (IAs) reviewed were
judged to be ‘Fit for Purpose’, a significant improvement from the 56% recorded in 2010.
However, this leaves more than a quarter of all proposals judged ‘Not fit for Purpose.’
IAs, produced to support regulatory proposals, are scrutinised by the RPC to assess the
quality of the case made and to validate the government’s One-In, One-out system. An
RPC Opinion is produced rating each IA as Red, Amber or Green (RAG). A Red rating
declares the IA ‘Not Fit for Purpose’. This draws Ministers’ attention, in real time, to
significant concerns with the quality of analysis and evidence provided to support the
proposal, and informs their decisions. ‘Improving Regulation’ presents departmental
RAG performance and lists the IAs that have been reviewed alongside the rating
assigned.
Chairman of the RPC Michael Gibbons said: “Across Whitehall, Departments have
worked hard to show a greater commitment to IAs and an improvement in their quality
with considerable year on year improvement in response to the independent challenge
presented by the RPC. This is a very significant step forward and provides evidence that
the scrutiny we provide is beginning to make a real difference. This would not of course
be possible without the highly visible and consistent commitment of Ministers to this
cause.
“But a quarter of IAs still fail to pass the RPC test and this is worryingly high.
Departments need to raise their game still further and we should all expect and work
towards 80%, ideally more, ‘Fit for Purpose’ RPC Opinions by the end of 2012.
Secondly, we are looking for a step change in the number of best practice ‘Green’
ratings, with only a third achieving this standard in 2011. Thirdly, renewed effort from
those Departments whose performance does not reflect the overall picture. We are also
looking for greater consideration of alternatives to regulation at consultation stage and
more robust cross-Whitehall evidence gathering.
“2011 has seen a significant rise in the quality of evidence and analysis supporting
regulatory proposals, essential to ensuring that the policymaking process delivers
effective outcomes. But there is room for more improvement and we will look for this in
2012 and beyond.”
The RPC also provides an independent review of the costs and benefits of measures
covered by the Government’s One-in, One-out rule, whereby departments must offset
any new regulatory cost on business with cuts to the cost of existing regulation.
Mr Gibbons continued: ”The Government’s One-in, One-out rule has undoubtedly put
pressure on Departments to strip away regulation. This challenge makes Departments review regulatory design and bring forward ‘Outs’ for the RPC to validate. The two most
common problems we find are 1) inaccurate forecasting of the cost and benefits to
business and 2) incorrect classification of what is an ‘In’ or an ‘Out’ and we will be
looking for improvements in these areas this year."
For further information please see http://regulatorypolicycommittee.independent.gov.uk
or contact Sue Youngman, Compass Rose & Co on 07768 283 162.
1. The RPC was set up in 2009 to provide independent scrutiny of the evidence
supporting proposed regulatory measures put forward by Government. In 2011 it
moved to commenting, for the first time in the UK, on evidence in real time,
before it was seen by ministers. It becomes an Advisory Non-Departmental
Public Body in April 2012.
2. The RPC does not comment on the Government’s policy objectives. It comments
on the analysis and evidence supporting new regulations.
3. The RPC is a group of independent experts, including businessmen, academics,
trade union and consumer representatives. The Committee is supported by a
secretariat of officials with a mixture of analytical, policymaking and economic
expertise. Further information on the Committee can be found on the RPC
website.
4. Departments submit IAs accompanying regulatory proposals to the RPC, and an
RPC Opinion must be given before Ministers on the Reducing Regulation
Committee, the Cabinet sub-Committee set up to vet all new regulatory
proposals, will consider the proposal. Under the RPC’s traffic light system, if it is
‘Fit for Purpose,’ it is classified as either ‘Amber’ or ‘Green’. ‘Amber’ is used to
denote an IA with areas of concern that should be corrected but which is still ‘Fit
for Purpose’. If an IA is classified ‘Red’ it is ‘Not Fit for Purpose’ – the RPC has
major concerns over the quality of evidence and analysis.
5. The RPC’s Opinions inform the decisions that are taken by Ministers as to
whether they proceed or not with the proposal. If the Government proceeds with
a proposal despite the RPC assigning a ‘Red flag’ the Opinion is published on
the RPC website.
6. Each IA is tested against well-established standards for Government appraisal
set out in the Better Regulation Executive’s toolkit[1] and guidance for impact
assessments along with HM Treasury’s Green Book[2].
The RPC has previously published its seven recommendations for how to improve the
quality of IAs:
· Don’t presume regulation is the answer
· Take time & effort to consider all options
· Make sure you have substantive evidence
· Produce reliable estimates of the costs and benefits
· Assess non-monetary impacts thoroughly
· Explain and present results clearly
· Understand the real cost to business of regulation 1. The RPC has also been asked by ministers to provide a quality check of the
figures for the government’s ‘One in, one out’ policy. Under this policy each new
regulation which imposes a cost to business must be balanced by the removal of
existing regulation with at least as great a cost.
2. The RPC has been tasked with ensuring that the claimed costs and benefits of
regulatory proposals are more than just ‘claims’, and that the costs and benefits
to business have been identified and are a realistic and credible estimate of their
potential impacts.
1. http://www.bis.gov.uk/assets/biscore/better-regulation/docs/i/10-1269-impactassessment-
guidance.pdf
2 http://www.hm-treasury.gov.uk/d/green_book_complete.pdf

martes, 21 de febrero de 2012

Politiques de Medicaments en France, Allemagne et Angleterre

Les dépenses publiques de médicaments, qui ont doublé au cours des dix dernières années, sont une préoccupation majeure en France comme dans la plupart des pays industrialisés. La France se distingue toutefois par une dépense deux fois plus élevée que l’Angleterre et une fois et demie plus élevée que l’Allemagne. Pour contrôler leurs dépenses, ces pays utilisent des listes définissant les médicaments pris en charge (liste positive) ou non pris en charge (liste négative) par les financements publics. Cette étude compare le processus de définition de ces listes et les règles de prise en charge des médicaments en France, Allemagne et Angleterre, et évalue leur impact sur la consommation de médicaments. Trois catégories de médicaments pour lesquels les pays ont adopté des stratégies différentes ont été étudiées : les benzodiazépines, les vasodilatateurs et les médicaments visant à améliorer la qualité de la vie (obésité, tabagisme). Il semble que la taille du panier pris en charge soit indépendante de la nature positive ou négative de la liste. De plus, ces exemples révèlent que ce sont les comportements de prescription et non le nombre de produits disponibles pris en charge qui expliquent les écarts de dépenses entre les pays. L’expérience de nos voisins suggère l’importance de dispositifs efficaces pour réguler la demande, notamment des incitations financières à une prescription et une consommation plus rationnelles.

Pharmaceutical Company Business Strategies

One of the constants of pharmaceutical company strategy over the past decade has been increasing scale. Only by growing larger are companies able to afford the considerable costs of drug development and distribution. This is well summarised in the PricewaterhouseCoopers report Analysis and Opinions on M&A Activity (1999).
Within this broad approach at least two business models are discernable:
(i) Blockbuster model involving the search for, and distribution of a small
number of drugs that achieve substantial global sales (say in excess of $1
billion p.a.). The success of this model depends on achieving large returns
from a small number of drugs in order to pay for the high cost of the drug
discovery and development process for a large number of candidates. Total
revenues are highly dependant on sales from a small number of drugs.
(ii) Diversification model in which a larger number of drugs are marketed to
smaller niche markets. The advantage of this model is that its success is not
dependant on sales of a small number of drugs. However without a
blockbuster to help pay for the high development costs, the model only works
for small markets where distribution costs are low.
(iii) Intermediate model which borrows some of each.
To date the blockbuster model has been recognised by industry analysts as the dominant model (see for instance Mercer Management Consulting 2001). However interest in alternative models is growing as consideration is being given to the marketing of biotech drugs with smaller markets and higher treatment costs and the expectation of more personalised medicine.

jueves, 9 de febrero de 2012

Food regulation in UK

Regulation and legislation

 http://www.food.gov.uk/foodindustry/regulation/

Food Regulations The production, processing, distribution, retail, packaging and labelling of food stuffs are governed by a mass of laws, regulations, codes of practice and guidance.

Find out more

General food law

Whether you work in a food business or you are a consumer interested in food law, there are general requirements, which are listed on this page.

The Food Standards Act 1999

The Act was introduced in the House of Commons on 10 June 1999 and received Royal Assent on 11 November 1999.

Incident report form for food and feed recalls and withdrawals

The Agency has produced an online form so food and feed businesses can notify us if they need to withdraw products from the market. The form can also be used by food authorities to report incidents.

Food Alerts, product withdrawals and recalls

The FSA issues a 'Product Withdrawal Information Notice' or a 'Product Recall Information Notice' to let local authorities and consumers know about problems associated with food. In some cases, a 'Food Alert for Action' is issued. This provides local authorities with details of specific action to be taken on behalf of consumers.

Regulatory approach

The Food Standards Agency has a statutory objective to protect public health and consumers' other interests in relation to food and drink. However, we are aware that excessive or unclear regulations can place a burden on business, the public sector and civil society groups (such voluntary groups, charities and not for profit organisations) and so hinder effective delivery of the intended benefits.

European legislation

Much of the detailed legislation on food standards originates in the European Union. This section includes details on how food hygiene legislation was consolidated and simplified as well as details of other European legislation.

Codex

The Codex Alimentarius is a series of food standards and related texts that aim to provide a high level of consumer protection and fair practice in the international trade of food and agricultural products.

Hygiene legislation

Food hygiene legislation affects all food businesses that regularly produce, handle, transport, process or supply food. This includes caterers, primary producers (such as farmers), manufacturers and retailers. How it affects you will depend on the nature of your business.

Whistleblowing

FSA policy on handling disclosures made under the Public Interest Disclosure Act 1998.

lunes, 23 de enero de 2012

Regulatory history

Throughout history, governments have regulated food and drug products. In general, the focus of this regulation has been on ensuring the quality and safety of food and drugs. Food and drug regulation as we know it today in the United States had its roots in the late nineteenth century when state and local governments began to enact food and drug regulations in earnest. Federal regulation of the industry began on a large scale in the early twentieth century when Congress enacted the Pure Food and Drugs Act of 1906. The regulatory agency spawned by this law – the U.S. Food and Drug Administration (FDA) – now directly regulates between one-fifth and one-quarter of U.S. gross domestic product (GDP) and possesses significant power over product entry, the ways in which food and drugs are marketed to consumers, and the manufacturing practices of food and drug firms. This article will focus on the evolution of food and drug regulation in the United States from the middle of the nineteenth century until the present day.
 http://www.suntimes.com/10187079-417/how-to-tell-if-youve-had-a-stroke.html

Canada Food and Drugs Act Liaison Office

About Health Canada

Food and Drugs Act Liaison Office

Who we are

The role of the Food and Drugs Act Liaison Office is to improve relations between external stakeholders and representatives of Health Canada, as well as to increase the openness and transparency in the regulatory process.
We are an impartial and confidential resource for individuals, business and organizations when they experience problems with how Health Canada administers the Food and Drugs Act.

What we do

We receive complaints, concerns or enquiries about alleged acts, omissions, improprieties and broader systemic problems on matters pertaining to the Food and Drugs Act.
We listen, offer options, facilitate communication, and examine issues impartially.
We act as an intermediary and help the parties arrive at a mutually agreed upon resolution.
We help prevent similar issues by making recommendations to the Department.

How we can help you

Our conflict resolution specialists offer a range of flexible services to help you with concerns about how Health Canada administers the Food and Drugs Act.
You might be
  • A business owner unhappy with the way a licensing decision was made
  • An individual concerned about the process for approving a drug or other product
  • A stakeholder frustrated by the communications between you and the department
  • Someone having trouble with the regulatory process or enforcement of the Food and Drugs Act
We can
  • Work with you to address the issue in a confidential and impartial manner;
  • Liaise between you and Health Canada;
  • Facilitate meetings between you and Health Canada; and
  • Provide mediation services to help you and Health Canada staff resolve issues quickly and efficiently.
Our past work provides examples of how we can help in various situations.

Related Resources

For questions about Health Canada's programs and services you can call (866) 225-0709, or contact General Inquiries.
For concerns or complaints about a food product, please Next link will take you to another Web site contact the Canadian Food Inspection Agency.
For information on Health Canada's enforcement and compliance activities or to place a trade or consumer complaint related to the products and devices covered under the Food and Drugs Act, please visit the Compliance and Enforcement section.
To report an adverse reaction or side effect from a drug or health product, go to the MedEffect Canada Web site (www.healthcanada.gc.ca/medeffect).

mental Acerca de las ENT Países Temas de salud Publicaciones Informe sobre la situación mundial de las enfermedades no transmisibles 2010

 http://www.who.int/nmh/publications/ncd_report2010/es/index.html

Enfermedades no transmisibles y salud mental

Informe sobre la situación mundial de las enfermedades no transmisibles 2010

Resumen de orientación

Compartir

Presentación

En este informe se presentan los datos estadísticos, la evidencia y las experiencias necesarias para poner en marcha una respuesta más contundente a la amenaza creciente que plantean las enfermedades no transmisibles. Los consejos y recomendaciones formuladas tienen interés universal, pero el informe presta especial atención a la situación de esas enfermedades en los países de ingresos bajos y medios, que soportan actualmente casi el 80% de la carga de morbilidad por dolencias como los trastornos cardiovasculares, la diabetes, el cáncer y las enfermedades respiratorias crónicas. Se abordan también las consecuencias sanitarias de la epidemia mundial de obesidad
El informe aplica un enfoque analítico, utilizando datos mundiales, regionales y específicos de los países para documentar la magnitud del problema, prever futuras tendencias y evaluar los factores que explican esas tendencias. Según se señala, la epidemia de estas enfermedades se ve avivada hoy por factores poderosos que afectan a todas las regiones del mundo: el envejecimiento demográfico, la urbanización rápida y no planificada, y la mundialización de modos de vida malsanos. Muchas enfermedades crónicas evolucionan lentamente, pero los modos de vida y los comportamientos están cambiando a una velocidad y con un alcance sorprendentes.

FAO-EC project to promote climate-smart farming http://www.fao.org/news/story/en/item/119835/icode/


FAO-EC project to promote climate-smart farming


Malawi, Vietnam and Zambia will benefit from collaborative effort

Photo: ©FAO/Noah Seelam
Farmers participating in an FAO land and water management project in Guthi, India, check a new drip irrigation system.
16 January 2012, Rome - FAO and the European Commission announced today a new €5.3 million project aimed at helping Malawi, Vietnam and Zambia transition to a "climate-smart" approach to agriculture.

Agriculture — and the communities who depend on it for their livelihoods and food security — are highly vulnerable to climate change impacts. At the same time agriculture, as a significant producer of greenhouse gases, contributes to global warming.

"Climate-smart agriculture" is an approach that seeks to position the agricultural sector as a solution to these major challenges.

It involves making changes in farming systems that achieve multiple goals: improving their contribution to the fight against hunger and poverty; rendering them more resilient to climate change; reducing emissions; and increasing agriculture's potential to capture and sequester atmospheric carbon.

"We need to start putting climate-smart agriculture into practice, working closely with farmers and their communities," said FAO Assistant Director-General for the Economic and Social Development Department, Hafez Ghanem. "But there are no one-size-fits-all solutions — better climate-smart farming practices need to respond to different local conditions, to geography, weather and the natural resource base," he added.

"This project will look closely at three countries and identify challenges and opportunities for climate-smart agriculture and produce strategic plans tailored to each country's own reality," Ghanem said. "While not all solutions identified will be universally applicable, we can learn a lot about how countries could take similar steps and begin shifting to this approach to agriculture."

martes, 17 de enero de 2012

Germany - GM Food regulations

Germany - GM Food regulations

The German Minister for Agriculture Ilse Aigner has presented a standardised logo for food products ‘without gene technology’.Improvement of the poor acceptance of the ‘without gene technology’ label is expected, reports GMO Compass. To date, only a few manufacturers have made use of this tag.
Since May 2008, it has been possible in Germany to apply the label ‘without gene technology’ to food products. Its primary application is in the identification of foods, such as meat, derived from animals for which no GM plants such as maize or soy were used in the feed. However, in contrast to other foodstuffs, a declaration of being ‘without gene technology’ is also permitted for animal-based products even in the case that vitamins, enzymes or other additives manufactured with gene technology were present in feed.
The criteria are stricter for other foodstuffs: neither the application of additives obtained through genetic modification nor the accidental admixture of GM plants is allowed, reports continue. To date, however, products ‘without gene technology’ have not been broadly available. With the exception of a dairy commodity from the Campina, the products to which this declaration has been applied generally are made by small, regional manufacturers.
With the presentation of a standardised logo, Minister Aigner stated the goal of  "making it easier for consumers to choose food products without gene technology in an informed manner". The minister also indicated its provision of "more freedom of choice" and its "enhancement of transparency when shopping for groceries". The new logo is expected to be made available to interested manufacturers free of charge.

FDA Panelists Had Ties to Bayer

Food and Drug Administration advisers, in a recent vote, said the benefits of four popular Bayer AG birth-control pills outweigh the blood-clot risk. What the FDA didn't disclose is that three of the advisers have had ties to Bayer, serving as consultants, speakers or researchers.
The three doctors were members of a special safety committee convened last month to assess the safety of the products, called Yaz, Yasmin, Beyaz and Safyral. Bayer's own studies show no excess danger, but other research including an FDA-commissioned study suggests there is one.

National Policy on Traditional Medicine and Regulation of Herbal Medicines - Report of a WHO Global Survey

National Policy on Traditional Medicine and Regulation of Herbal Medicines - Report of a WHO Global Survey

Executive summary
Background
Traditional medicine (TM) has always maintained its popularity worldwide. In addition, over the last decade, we have seen an increasing use of complementary and alternative medicines (CAM) in many developed and developing countries. The safety and efficacy of traditional medicine and complementary and alternative medicines, as well as quality control, have become important concerns for both health authorities and the public.
Various traditional medicine practices have been developed in different cultures in different regions, but without a parallel development of international standards and appropriate methods for evaluating traditional medicine Therefore, sharing national experience and information is crucial.
Challenges
Countries face major challenges in the development and implementation of the regulation of traditional, complementary/alternative and herbal medicines. These challenges are related to regulatory status, assessment of safety and efficacy, quality control, safety monitoring and lack of knowledge about TM/CAM within national drug regulatory authorities.
Challenges related to the regulatory status of herbal medicines: Before manufactured drugs came into widespread use, herbal medicines played an important role in human health. There are great differences between Member States in the definition and categorization of herbal medicines A single medicinal plant may be defined as a food, a functional food, a dietary supplement or a herbal medicine in different countries, depending on the regulations applying to foods and medicines in each country. This makes it difficult to define the concept of herbal medicines for the purposes of national drug regulation, and also confuses patients and consumers.
Challenges related to the assessment of safety and efficacy: Requirements and methods for research and evaluation of the safety and efficacy of herbal medicines are more complex than those for conventional pharmaceuticals. A single medicinal plant may contain hundreds of natural constituents, and a mixed herbal medicinal product may contain several times that number. If every active ingredient were to be isolated from every herb, the time and resources required would be tremendous. Such an analysis may actually be impossible in practice, particularly in the case of mixed herbal medicines.
Challenges related to quality control of herbal medicines: The safety and efficacy of herbal medicines is closely correlated with the quality of the source materials used in their production. The quality of source materials is, in its turn, determined by intrinsic factors (genetic) and extrinsic factors (environmental conditions, cultivation and harvesting, field collection and post harvest/collection transport and storage). Therefore, it is very difficult to perform quality controls on the raw materials of herbal medicines.
Good Manufacturing Practice (GMP) specifies many requirements for quality control of starting materials, including correct identification of species of medicinal plants, special storage and special sanitation and cleaning methods for various materials. In the quality control of finished herbal medicinal products, particularly mixed herbal products, it is more difficult to determine whether all the plants or starting materials have been included.
Challenges related to safety monitoring of herbal medicines: Adverse events arising from consumption of herbal medicines may be due to any one of a number of factors. These include the use of the wrong species of plant by mistake, adulteration of herbal products with other, undeclared medicines, contamination with toxic or hazardous substances, overdosage, misuse of herbal medicines by either health care providers or consumers and use of herbal medicines concomitantly with other medicines. Therefore, analysis of adverse events related to the use of herbal medicines is more complicated than in the case of conventional pharmaceuticals. Furthermore, herbal medicines are often used for self care; thus, there is a great need to educate consumers and public in their proper use.
Lack of knowledge about herbal medicines within national drug authorities: The general lack of knowledge about herbal medicines within national drug authorities and the lack of appropriate evaluation methods are factors that delay the creation or updating of national policies, laws and regulations for traditional medicines, contemporary/alternative medicines and herbal medicines.
In order to meet these challenges, the WHO Traditional Medicine Strategy was developed, with its four primary objectives: framing policy; enhancing safety, efficacy and quality; ensuring access; and promoting rational use Resolution WHA56.31 on traditional medicine was adopted at the Fifty-sixth World Health Assembly in May 2003. The resolution requested WHO to support Member States by providing internationally acceptable guidelines and technical standards and also evidence based information to assist Member States in formulating policy and regulations to control the safety, efficacy and quality of traditional medicines.
Global Survey and Database
WHO decided to conduct a global survey on national policies on TM/CAM and regulation of herbal medicines and store the results in a global database. In 2001, WHO developed the Global Survey questionnaire, which focused on the main challenges listed above. The questionnaire was divided into three main parts:
• general review of policy and regulation of TM/CAM
• regulation of herbal medicines
• countries’ needs for future WHO support and technical guidance

We received responses from 141 countries, representing 74% of the 191 Member States of WHO at that time. The data were entered into the WHO Global Database developed for the survey. The information in the database is listed under 21 qualitative and quantitative structural indicators, which are intended to assess the situation of TM/CAM policies and herbal medicine regulation. Analysis of the survey results will provide the basis for further development of a comprehensive set of indicators, including background and process indicators for the monitoring of national TM/CAM policies and herbal medicine regulation.
Structure of report
This report is in four parts, covering national policy on traditional medicine and complementary/alternative medicine; regulation of herbal medicines; difficulties encountered by Member States and their needs for WHO support; summary of each country profile, classified by WHO region.
National policy on traditional medicine and complementary/alternative medicine: A national policy on TM/CAM may include some of the following key elements: a definition of TM/CAM, provision for the creation of laws and regulations, consideration of intellectual property issues. The policy may further describe the main strategies proposed by the government for achieving the objectives of the policy Forty five (32%) of the responding Member States reported having a policy on TM/CAM. Of those Member States which currently do not have a national policy, 51 (56%) indicate that such policies are currently being developed. Most Member States with a national policy established it recently, since only five States reported having a national policy before 1990. Forty Member States (28%) reported that they had issued a national programme on TM/CAM. Seventy five countries (53% of the responding Member States) reported having a national office in charge of TM/CAM. In most of these countries, the national office is located within the Ministry of Health Sixty one countries (43% of the responding Member States) reported that they have expert committees for TM/CAM. In all, 58 Member States indicated that they had at least one national institute on TM, CAM or herbal medicines.
Regulation of herbal medicines: This section is the central part of the Global Survey. It contains a great deal of detailed information related to regulation of herbal medicines, e.g. regulatory status of herbal medicines, regulation requirements, number of registered herbal medicine products and quality control requirements such as GMP, monographs, etc. Before 1988, there were only 14 Member States with regulations relating to herbal medicines, but the figure increased to 53 Member States (37%) having laws and regulations in 2003. Of those Member States without current laws or regulations, 42 (49%) declared that these regulations were in the process of being developed. Such results show that Member States are increasingly involved in developing the regulation of herbal medicines.
The questions about the regulatory status of herbal medicines also show, interestingly, that in most Member States (97 out of 142 respondents) herbal medicines are sold as over the counter medicines, in contrast to 50 Member States where herbal medicines are also sold as prescription medicines. Medical claims, health claims and nutrients contents claims are the most common types of claims with which herbal medicines may legally be sold (90 Member States allow medical claims, 62 allow health claims and 49 allow nutrient content claims).
The collected information about herbal medicines also shows that 86 Member States (61%) have a registration system for herbal medicines and 17 have 1 000 or more registered herbal medicines. Judging from these data, many Member States are giving the regulation of herbal medicines careful consideration.
Difficulties encountered by Member States and needs for WHO support: This survey demonstrates that Member States have made progress over recent years. However, there are still difficulties in the regulation and harmonization of TM/CAM worldwide. The survey also identifies the main difficulties regarding regulatory issues for herbal medicines - lack of research data, lack of appropriate control mechanisms, lack of education and training and lack of expertise. In this regard, Member States requested WHO to continue providing support for those countries endeavouring to develop a national policy and regulations on TM/CAM.
Summary of each country profile classified by WHO region: The country summaries follow a generalized template, including the status and year of establishment of the following: policy on TM/CAM (national policy, law/regulation, national programme, national office, and national institutes) and the regulation of herbal medicine (law/regulation, regulatory status types, claim types, pharmacopoeia and monographs used, manufacturing requirements and control mechanisms, safety requirements and control mechanisms, registration system, essential drug list, post marketing surveillance, marketing site and annual sales). These summaries are available for all 141 countries that responded to the survey.
Table 1. Survey return on selected topics, with regional breakdown
 
Survey response
Survey
%
(141)
Global
%
(191)
AFRO1
AMRO
EMRO
EURO
SEARO
WPRO
National policy on TM/CAM
135
96%
71%
35
18
16
36
10
20
Law or regulation on TM/CAM
138
98%
72%
36
18
16
36
10
22
National programme on TM/CAM
133
94%
70%
35
18
16
35
9
20
National office for TM/CAM
136
96%
71%
35
18
16
36
10
21
Expert committee on TM/CAM
133
94%
70%
35
18
15
35
9
21
National research institute on TM, CAM or herbal medicines
135
96%
71%
34
18
16
35
10
22
Law or regulation on herbal medicines
140
99%
73%
36
18
16
38
10
22
Registration of herbal medicines
139
99%
73%
36
18
16
38
10
21

1 AFRO: WHO Regional Office for Africa; AMRO: Regional Office for the Americas; EMRO: Regional Office for the Eastern Mediterranean; EURO: Regional Office for Europe; SEARO: Regional Office for South-East Asia; WPRO: Regional Office for the Western Pacific.

Table 2. Regional breakdown of responding countries
African Region
Region of the Americas
Eastern Mediterranean Region
European Region
South-East Asia Region
Western Pacific Region
Angola Antigua & Barbuda Afghanistan Armenia Bangladesh Australia
Benin Argentina Bahrain Austria Bhutan Cambodia
Botswana Bolivia Djibouti Azerbaijan Dem. People’s Rep of Korea China
Burkina Faso Brazil Egypt Belarus India Cook Islands
Burundi Canada Iran (Islamic Rep of) Belgium Indonesia Fiji
Cameroon Chile Jordan Bulgaria Maldives Japan
Central African Rep Colombia Kuwait Czech Republic Myanmar Kiribati
Chad Costa Rica Libyan Arab Denmark Nepal Lao People’s Democratic Rep
    Jamahiriya      
Comoros Dominica Oman Estonia Sri Lanka Malaysia
Congo Dominican Republic Pakistan France Thailand Micronesia (Federated States of)
Côte d’Ivoire Ecuador Qatar Georgia   Mongolia
Democratic Rep. of the Congo El Salvador Saudi Arabia Germany   Nauru
Equatorial Guinea Guatemala Sudan Hungary   New Zealand
Ethiopia Jamaica Syrian Arab Republic Iceland   Niue
Gabon Mexico United Arab Emirates Ireland   Papua New Guinea
Gambia Nicaragua Yemen Israel   Philippines
Ghana Peru   Kazakhstan   Rep of Korea
Guinea Suriname   Kyrgyzstan   Singapore
Guinea Bissau     Latvia   Solomon Islands
Kenya     Lithuania   Tuvalu
Madagascar     Netherlands   Vanuatu
Malawi     Norway   Viet Nam
Mali     Portugal    
Mauritania     Rep of Moldova    
Mozambique     Romania    
Niger     Russian Fed    
Nigeria     Serbia & Montenegro    
Rwanda     Slovakia    
Sao Tome & Principe     Slovenia    
Senegal     Spain    
Seychelles     Sweden    
Sierra Leone     Switzerland    
South Africa     Tajikistan    
Togo     The former Yugoslav Rep of    
      Macedonia    
United Rep of Tanzania     Turkey    
Uganda     Ukraine    
Zambia     United Kingdom of Great Britain & Northern Ireland    
      Uzbekistan    
37
Member States
(80% of 46)
18
Member States
(51% of 35)
16
Member States
(76% of 21)
38
Member States
(73% of 52)
10
Member States
(100% of 10)
22
Member States
(81% of 27)
Total respondents: 141
 http://apps.who.int/medicinedocs/en/d/Js7916e/2.html

lunes, 16 de enero de 2012

STATE RETAIL RATE REGULATION OF LOCAL EXCHANGE PROVIDERS AS OF SEPTEMBER 2004

EXECUTIVE SUMMARY
Following the trend of previous years, local exchange carriers are still transitioning from traditional forms of rate
regulation−i.e. rate-of-return regulation (ROR)−towards alternative forms of regulation, including rate freeze, price caps,
flexible regulation and deregulation. Among these regulatory regimes, price cap regulation is the most commonly adopted
by states to regulate the rates of their incumbent local exchange carriers, particularly of larger incumbents.
The enclosed tables and figures show the status of retail rate regulation of local exchange carriers in the United
States as of September 2004. The information included in this report was obtained from the Supplemental White Papers
on Retail Rate Regulation of Local Exchange Providers, published each year by State Telephone Regulation Report. Staff
members from 32 states and the District of Columbia reviewed this information and provided revisions, improving the
accuracy of the report.
A total of 37 states use some form of price cap regulation (see Table 1 and Figure 1). Of them, only six states (AL,
DE, DC, LA, RI and TX) apply it to all their ILECs, including Regional Bell Operating Companies (RBOCs) and other
competitors. The most common trend is for the states to regulate the rates of their large incumbents under a price cap
plan while maintaining their smaller incumbents under ROR regulation (18 states); other states have granted smaller
incumbents flexible regulation or rate deregulation, either partial or complete, while regulating large ILECs under price
caps (7 states). As it is explained in Table 4, many small incumbents can opt to change to price caps or some other form
of alternative regulation, but many have decided to remain under traditional forms of regulation. Finally, the remaining six
states (AR, KY, MN, NY, ND, and OR) use a mix of regimes, including price caps, to regulate both their large and small
incumbents.
Despite the prevalence of price caps, traditional rate of return regulation (ROR) is still in use in 36 states, mostly to
regulate smaller incumbents, as illustrated in Figure 2. The number of states that use ROR for all their ILECs has
decreased over time; as of September 2004, only Alaska, Hawaii, Montana, New Hampshire and Washington did so.
Arizona and Idaho are special cases; both states use ROR for all their ILECs, but Qwest is under hybrid plans that
combine ROR with price caps in Arizona and with deregulation in Idaho.

 An increasing tendency among states is to apply different regulatory regimes to each of their incumbent local
exchange carriers, combining price caps with ROR, price flexibility and deregulation, as shown in Tables 1 and 2, and in
greater detail in Table 4. As of September of 2004 eleven states were using a combination of regimes to regulate the
ILECs providing service in their territories.
Classifying carriers under a specific type of rate regulatory regime has become more difficult in recent years, as
more states implement alternative regulation plans. These plans combine features of different regulatory regimes, such as
rate freeze, price cap regulation or even rate-of-return regulation with pricing flexibility or deregulation, so as to adequately
respond to the increasing level of competition faced by a particular carrier in its different baskets of services.
Massachusetts, New York, Ohio, Pennsylvania and Wyoming are cases in point. As a result of these combinations, a
single label such as price cap plan or deregulation becomes inadequate to appropriately define the characteristics of
these hybrid alternative regulation plans. Finally, complete rate deregulation has been implemented only in Nebraska and
more recently in South Dakota, states where Qwest is the largest ILEC.
With respect to the competitive local exchange carriers (CLECs), the prevalent regulatory trend is rate flexibility (27
states), closely followed by rate deregulation (21 states), as illustrated in Table 1 and Figure 3. This trend is based on the
assumption in most states that the retail rates of CLECs are competitive. Only three states (DE, NJ and VA) impose some
regulations over CLEC rates, either by capping the rates for some services at the incumbent’s level or by stetting costbased
floors. Regardless of the type of rate regulation they operate under, CLECs are required in most states to obtain
state certification by demonstrating technical, financial and managerial competence before beginning operations in the
state. Only Kentucky, Massachusetts, Montana and Washington allow CLECs to operate by simply registering with the
public commission or another appropriate authority; North Dakota requires certification only to facilities-based CLECs. As
for the requirements to file tariffs and notify rate and service changes, Montana, Nevada, North Carolina and Oregon
provide their CLECs the greatest flexibility, even when compared to states that do not review CLECs’ rates. Competitive
carriers in these four states are not required to file tariffs or provide notification of changes and the rate changes are not
normally reviewed by their respective state commission. Table 5 provides greater detail on the state commission
requirements on CLECs regarding certification, rate filings, rate changes, reviews and notifications.
Table 3 presents the major changes in retail rate regulation that occurred since April of 2003. During the 2003-
2004 period, the rate plans of major ILECs in 14 states (AZ, CA, CO, DE, IL, KY, LA, MN, MS, NC, OK, SC, WV and WI)
and the District of Columbia went under review and the majority of these plans were extended with some changes. New
plans were established for major ILECs in Indiana (SBC, VZ, and Sprint), Kentucky (Alltel KY) and Massachusetts (VZ),
while state commissions in Maryland, Vermont, Virginia and North Carolina opened dockets to evaluate existing plans for Verizon (MD, VT) and Sprint (NC) or, as in the case of Virginia, new price cap plans for Verizon VA and Verizon South. In
fact, Verizon’s rate plans and proposals were reviewed or are currently been reviewed in 21 of the 42 states reporting
changes since April of 2003, the highest number among Regional Bell Operating Companies (RBOCs).
Nevertheless, among the RBOCs, Qwest had the most radical changes in its rate regulation during the 2003-2004
period, changes justified by the increased presence of competition in its area of service. This carrier filed proposals for
deregulation or greater price flexibility in eight of its fourteen regional states (AZ, CO, ID, MN, SD, UT, WA and WY).
Although Qwest’s application for full rate deregulation in the seven largest exchanges in Idaho was unsuccessful, it won
statewide retail rate deregulation from the South Dakota PUC in October of 2003, making it the only RBOC having
obtained full retail rate deregulation in two of its regional states (NE and now, SD). Qwest is also requesting full price
flexibility for all retail services in competitive zones in Arizona, and for all but basic services in Colorado; it was granted
deregulation for business rates in three major metropolitan areas in Minnesota and of all analog business telecom
services in all markets in Washington; it increased the number of rate deregulated local residential lines in the most
populated areas of Utah, and moved from a price cap plan to a cost-based pricing flexibility regime in Wyoming, all since
April 2003.
SBC and Verizon are also following this trend, proposing full deregulation of retail rates in Missouri and Maryland,
respectively. In Massachusetts, Verizon’s new alternative regulation plan provides it greater flexibility for pricing nonbasic
residential and all business services, while a plan proposed by the company in Vermont would grant it rate
deregulation for all but basic residential services, if approved. BellSouth has also made inroads towards retail rate
deregulation in North and South Carolina during this period. In North Carolina it proposed a reclassification of services for
its price cap plan that would move most services into the full pricing flexibility category; meanwhile, in South Carolina, the
Legislature enacted rate deregulation for all retail service bundles from price-regulated incumbents (BS, VZ and Sprint),
and the state government has until the end of 2004 to act on the measure.
Among the states reporting changes during this period, Alabama is conducting the most comprehensive review of
regulation. The Public Service Commission opened a comprehensive regulatory review (Case 28950) of all local
exchange providers to determine if the technological, structural and policy changes that occurred since the 1996 Telecom
Act require a corresponding regulatory change. In the proposed plan, carriers would be regulated according to level of
competition they are facing. In sum, the trend among states is towards providing greater price flexibility to incumbent carriers as the level of
competition in local exchange services increases in their regional areas. This flexibility is expressed either by deregulating
certain services, such as non-basic and competitive services, or certain carriers based on their size, such as telephone
cooperatives and other smaller incumbents. Some larger incumbents are also making inroads in achieving full retail rate
deregulation in competitive zones. As for CLECs, rate flexibility is the prevailing trend.
The tables included in this report provide different levels of detail. Table 1 presents a distribution of the states by
type of rate regulation regime applied to their ILECs and CLECs. Figures 1 and 3 illustrate this information. Table 2
provides basic information on the specific type of plan applied to large incumbents, other incumbents and CLECs. Table
3 summarizes major changes in rate regulation that occurred since April 2003. Tables 4 and 5 provide more detailed
information on the specifics of the retail rate regulation plans of ILECs and CLECs, respectively, including earnings
regulation, notice periods, as well as requirements on infrastructure investment and quality of service.