Farmaci equivalenti: la qualità accessibile a tutti (Italian Edition)

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In order to carry out this analysis, the length of the networks and tracks in the 12 countries have been verified by combining data available from Eurostat, the EU Commission and the UIC and verifying it with that of individual network operators where discrepancies or uncertainties were present.

The following graphs show these relationships for each of the 12 countries considered and for the 11 countries together with the exclusion of Italy. In relation to the extension of the network, the average annual state aid for the past four years has amounted to thousand euros per km of line in Italy compared to an average value for all of the other countries of thousand euros Graph 7.

Other major countries in the EU other than Italy UK, FR, DE recorded significantly lower values than outs between and thousand euros per year per km of line; finally, greatly reduced, are the values of Sweden, thousand euros, and Spain, 71 thousand.

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Since this data for Italy may be influenced in an anomalous way by the cost of the completion of high-speed lines even if the assumption of 13 million euros of debt until for the AV were not included , we redid the exercise for the entire period, which shows that the average annual aid per km of network over the 11 years was thousand euros in Italy compared to an average value for the other 11 countries of thousand euros Table 3.

All of the other countries total values are significantly less than ours: France and the UK around , Germany , Sweden and Finland and Spain thousand. The EU data excludes Italy. A refinement of the previous analysis is relating the annual subsidies to the railway sector not in terms of network km, but in terms of track km, a relationship that can be considered more accurate than previous years given the apparent correlation between management and construction costs and track lengths and one that is able to avoid distortions in favour of countries that have a number of single-track lines that is lower than average e.

Sweden and Finland and to the detriment of countries that have a number that is above-average e. Belgium and the Netherlands. In relation to km of track, the average yearly subsidy in the last four years in Italy was thousand euros compared to an average total of thousand for the other 11 countries Graph 8. Even in this case all of the other major EU countries have significantly lower values than that of Italy: France around , the UK , Germany and Sweden The final analysis, in not having enough statistical data in relation to annual train km circulating on the networks, we will examine subsidies in relation to the total traffic of passengers and goods measured by the units of traffic conventionally given by passenger km plus tonne km of goods transported.

Over the four-year period considered, the average annual subsidy per unit of traffic in Italy was In essence, compared to the average behaviour of the other states concerned, around three-fifths of the subsidies granted in Italy were equally distributed, while the remaining two-fifths would remain in public coffers.

This proportion, derived from the experience of the four most recent years, can be reasonably extended to the whole period taken into consideration. The effects of excess subsidies on public finance Since Italian public finance granted the rail sector, according to the results of the EU Commission, The public sector would have not only saved this 35 billion euros in state aid, but it would also have spent less in interest on the public debt as a result of borrowing a lower sum to finance railway expenditure.

The costs accumulated by Italian public finance deriving from excess state aid, compared to the European average, given to the Italian railway sector between and are shown in Graph This leads to a total estimated cost of just under 50 billion for Italian public finance. However, this amount is considered underestimated, as it does not include transfers to the rail sector in the three years between , since it was not notified according in accordance with the periodic statistics on state aid published by the EU Commission. Considering a rough estimate of the latter, the magnitude of the excess rail expenditure in Italy would increase to around 60 billion in total for the period.

Concluding Observations This study represents a first attempt at analysing state aid to the railway sector in the Western countries of the European Union, carried out with the aim of assessing the dimensions of aid in relation to the main size variables of the sector, such as the lengths of the networks and tracks and total passenger and freight traffic transported. Although this is a very simple and preliminary exercise compared to a more complex analysis, it would seem that it has never been done before, probably due to the absence, on a Community level, of comprehensive and reliable data on the length and other features of national rail networks the information and data on the Eurostat database are incomplete and inconsistent.

From the analysis, a highly differentiated situation in Europe emerges: i a group of countries with permanently lower subsidies the Iberians, the Scandinavians and Austria ; ii a group of countries with a medium level of subsidies all of the major countries: Germany, France and the UK ; iii a group of countries with permanently high subsidies Italy, Denmark, Belgium and the Netherlands. These differences cannot be explained by analysing the relevant differences in network characteristics or levels of transport and therefore require important in-depth study in the future.

A consequence of the limited attention paid to state aid to the rail sector is that it is stationary over time in relation to EU GDP, contrasting with the tendency to lower it, which has instead occurred in all of the other remaining sectors and led to its reduction by half and reduced to a quarter in Italy in relation to GDP since the Commission began its systematic monitoring at the start of the 90s.

The idea that emerges from the reading of the specific rules and guidelines for the assessment of state aid to the rail sector, together with the severity demonstrated for other sectors and for different types of transport, for example aviation, is that rail transport has so far benefited from weakened forms of application that appear to be motivated: i partly by the need for modal rebalance recognised by national transport policies; ii partly by the natural monopolistic character of the network whose duplication is not economically feasible and thus does not adversely affect competition, at least intermodal, public financial support for construction, maintenance and exercise of the network; iii finally, by the non-competitive traditional structure, from a legal point of view, of even the transport service.

This situation, however, is set to change drastically with the opening up of services to competition, which has already been done in the European Union for the freight sector and in some countries, although only on a voluntary basis, even for the passenger sector. Today, aid consequently risks being distortive in those countries that have chosen to spontaneously bring forward liberalisation of the national passenger transport sector, however, like Italy, they have failed to remove the high levels of subsidies or at least make their allocation means non-distortive.

Now that, at least in some states, the possibility of competition has been legally introduced, does state aid continue to not be detrimental as there is no competition at all? Or is there no competition because state aid given impedes its manifestation and it is therefore the aid that is detrimental?

In monetary terms, this illustrates an excess of 35 billion euros in public transfers in the period, which highlighted an overall cost for public finance of around 50 billion euros if we add the interest charges accrued as a result of financing the aid with public debt. The elevated state aid to the rail sector consequently results in both a major public finance problem and a potential factor of competition distortion in markets such as Italy that have already been legally opened.

La disciplina degli aiuti di stato in Europa risulta complessa Friederiszick, et al. L'Articolo afferma che la Commissione esamina con gli Stati membri i regimi di aiuti esistenti negli Stati stessi. Il Regolamento CE n. Di seguito sono esposti i criteri indicati per la valutazione di ogni tipologia. Sostegno e finanziamento delle infrastrutture Il paragrafo 2.

I finanziamenti pubblici per lo sviluppo delle infrastrutture possono costituire un aiuto di Stato. Secondo la Corte di giustizia occorre valutare se il provvedimento a favore delle infrastrutture sia in grado di generare un alleggerimento degli oneri ordinari che gravano sul bilancio delle imprese ferroviarie. Pertanto, nel rispetto di alcune condizioni le spese per l'acquisto del materiale rotabile si considerano sovvenzionabili.

Cancellazione di debiti Questa tipologia si basa sulla considerazione storica che le imprese ferroviarie hanno spesso conosciuto fasi di pesante indebitamento a causa degli investimenti, fenomeno che ancora interessa diversi gestori di rete. A seguito della direttiva suddetta, la ristrutturazione dei debiti avviene con strumenti differenti. Infatti, in un mercato liberalizzato ed efficiente, il coordinamento avviene ad opera degli operatori.

Nonostante questo, in molti casi gli investimenti per lo sviluppo delle infrastrutture continuano ad essere realizzati dal settore pubblico e, anche dopo la liberalizzazione, possono sussistere fallimenti che giustificano un intervento dello Stato. Garanzie concesse dallo Stato La comunicazione della Commissione sull'applicazione degli articoli 87 e 88 del trattato agli aiuti di Stato concessi sotto forma di garanzie definisce le regole applicabili alle garanzie di Stato anche nel settore del trasporto ferroviario.

La comunicazione della Commissione GU C 71 dell' In linea generale, le garanzie concesse in settori relativamente concorrenziali sono incompatibili con il trattato CE. Per queste ragioni essi sono tradizionalmente contabilizzati e pubblicati dalla stessa Commissione in forma separata. Il totale degli aiuti al settore ferroviario ammonterebbe in conseguenza ad oltre 47 miliardi e il totale generale degli aiuti di stato europei ad oltre miliardi. Come illustrato nel Graf. Il Graf.

La Commissione U. EU- Represents all Member States which the calculation includes as of the year when data were available. Nella tabella precedente la Commissione U. I dati su sfondo grigio sono stati stimati in base a dati dei regolatori o delle imprese nazionali beneficiate.

I dati utilizzati sono riportati nella Tab. In essa quattro valori non comunicati dagli Stati sono stati stimati sulla base delle informazioni disponibili dai regolatori nazionali o dai bilanci degli enti interessati. Si tratta in conseguenza di un dato sottostimato in quanto non include gli aiuti di Stato alle imprese ferroviarie minori ed eventuali trasferimenti al gruppo FS effettuati nel ma di competenza di esercizi diversi e in conseguenza non riportati nel bilancio.

Come riportato nella Tab. Risultano invece molto distanziati nella classifica totale degli aiuti di Stato i paesi con reti rilevanti che hanno realizzato importanti processi di liberalizzazione del mercato: la Gran Bretagna con 58 miliardi di euro e la Svezia con soli 13 miliardi di euro. Spagna e Svezia, infine, hanno beneficiato di aiuti ridotti in valore assoluto pur essendo dotate di reti relativamente estese: 14 mila km la Spagna e 11 mila la Svezia. Tutti gli altri principali paesi registrano valori sensibilmente inferiori al nostro: Francia e Regno Unito circa , Germania , Svezia , Finlandia e Spagna mila.

Svezia e Finlandia e a danno dei paesi che hanno invece una quota superiore alla media es. Belgio e Olanda. Anche in questo caso tutti gli altri maggiori paesi registrano valori sensibilmente inferiori a quello italiano: Francia circa , Regno Unito , Germania , Svezia Gli altri tre principali paesi UK, FR, DE hanno registrato valori compresi tra 5,9 e 8,6 centesimi per km, la Svezia solo 4,3 centesimi. In sostanza, seguendo i comportamenti medi degli altri Stati considerati, circa tre quinti dei sussidi che sono stati erogati in Italia sarebbero stati egualmente erogati mentre i residui due quinti sarebbero rimasti nella casse pubbliche.

Il settore pubblico avrebbe risparmiato non solo questi 35 miliardi come minori aiuti di Stato ma avrebbe anche sostenuto una minor spesa per interessi sul debito pubblico derivante dal minor ricorso al debito per finanziare la spesa ferroviaria. I costi cumulati per la finanza pubblica italiana derivanti dagli eccessivi aiuti di Stato, rispetto alla media europea, concessi al settore ferroviario italiano dal al sono rappresentati nel Graf.

Si perviene in questo modo a stimare un onere complessivo per la finanza pubblica italiana di poco inferiore a 50 miliardi.


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Queste differenze non appaiono inoltre spiegabili attraverso rilevanti differenze nelle caratteristiche delle reti o nei livelli di trasporto e richiedono pertanto importanti approfondimenti causali per il futuro. In termini monetari essa identifica un eccesso di trasferimenti pubblici al settore pari a 35 miliardi di euro nel periodo i quali evidenziano un costo complessivo per le casse pubbliche di circa 50 miliardi se si includono anche gli oneri in termini di interessi generati attraverso il loro finanziamento con debito pubblico. English to Italian: Tutela diplomatica e consolare dei cittadini europei in Paesi terzi.

General field: Social Sciences Detailed field: Law general. Translation - Italian This research paper looks at the diplomatic and consular tutelage of European citizens in third countries. The student that has addressed this issue, questioned herself on the topic after having conducted preliminary research based on the evolution of this matter in Europe; the results of which immediately identified that the current regulatory framework remains unclear. Diplomatic tutelage has its own precise legal provision set out in Article 23 of the Treaty on the Functioning of the European Union.

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Go to Lot Quotidianamente, la stampa riporta notizia di sperimentazioni, di sviluppi terapeutici e di nuovi orientamenti normativi che rincorrono, a fatica, i progressi evocati. Affrontando la questione della sperimentazione umana in questa prospettiva, si nota come il riconoscimento a livello internazionale del diritto alla salute, a partire dalla Dichiarazione dei Diritti Umani del e a seguire tutte le Convenzioni e Carte che hanno confermato questa impostazione, abbia influito sugli esperimenti condotti su esseri umani e in quale misura oggi viene tollerato questo fenomeno.

Nel ' il progresso medico ha determinato un drammatico cambiamento del concetto di deontologia correlato alle discipline scientifiche e conseguentemente anche del trattamento riservato ai soggetti di ricerca. Altro famoso caso fu il Tuskegee study finanziato dal servizio per la salute pubblica degli Stati Uniti per cui dal al quasi quattrocento afroamericani affetti da sifilide vennero lasciati morire senza alcuna cura, anche quando questa era stata trovata, per studiare il decorso naturale della malattia.

Durante la seconda guerra mondiale numerosi furono gli esperimenti nazisti compiuti su esseri umani, utilizzati come cavie, nei campi di concentramento. Molti sono gli esempi di studi effettuati su nuovi farmaci o terapie poi smentiti da ulteriori ricerche. Si tratta di una pratica che implica la consultazione delle migliori fonti scientifiche per individuare prove utili e fondate ai fini della risoluzione di un quesito clinico. Come si svolge la RCT Quando si studia un nuovo trattamento farmaco, terapia occorre valutarne la sicurezza e dimostrare che questo sia fonte di effetti benefici per la persona.

Un clinical trial presuppone l'interruzione della normale pratica e la somministrazione del trattamento oggetto di studio. In tal caso lo studio viene definito cieco. Al termine della sperimentazione, o qualora ci fossero complicazioni, si va a vedere cosa effettivamente i partecipanti allo studio stavano assumendo e si fa una comparazione degli effetti tra i diversi gruppi di persone. Attraverso un confronto randomizzato, il trattamento studiato viene somministrato ad un rilevante gruppo di persone per capirne meglio l'efficacia, gli effetti e confrontarlo con le terapie usate tradizionalmente.

In questa fase, infatti, vengono comparati gruppi di persone che assumono trattamenti diversi al fine di valutare gli effetti benefici e quelli collaterali derivanti da ciascuno. Secondo quanto previsto dall'art. In particolare un piccola parte di queste ricerche viene portata avanti da medici di medicina generale MMG e da pediatri di libera scelta PDL i quali grazie al rapporto continuo con le persone e le loro storie, possono da un lato cogliere quali esigenze non sono state ancora affrontate e risolte e dall'altro seguire la sperimentazione nella vita di tutti i giorni.

Una ricerca clinica infatti ha motivo di esistere solo quando vi sia incertezza, per medico e paziente, circa il trattamento da somministrare tra quelli disponibili; questo implica l'attribuzione randomizzata delle terapie per confrontarne gli effetti e tacitarne le incertezze.

Lavoro Facile 12222 n.08

Emanuel, D. Wendler e G. Rispetto della persona: implica il rispetto dell'autonomia del singolo e la protezione dei soggetti vulnerabili; 5. Principio di beneficenza: massimizzare i benefici e minimizzare i rischi; 6. Principio di giustizia : equa distribuzione degli effetti positivi e negativi fra tutti i soggetti che partecipano ad uno studio sperimentale.

Da citare anche sono le Guidelines for Good Clinical GCP-ICH adottate dalla International Conference of Harmonizzation che illustrano le procedure da seguire per ottenere il consenso informato dei pazienti e garantire allo stesso tempo la riservatezza dei dati. Questi documenti saranno poi ripresi parlando dei comitati etici. Il medico che si ammala prova innanzitutto cosa vuol dire la cieca fiducia nei confronti di chi lo cura, quasi uno stato di sudditanza e di sottomissione. Queste informazioni riguardano sia i benefici che i rischi derivanti dalla sperimentazione. In ogni caso ai partecipanti viene offerto un costante monitoraggio e cure gratuite.

Il consenso informato Secondo quanto previsto dall'art. Anche l'art.

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Questa persona riceve innanzitutto una informazione adeguata sullo scopo e sulla natura dell'intervento e sulle sue conseguenze e i suoi rischi. E continua all'art. Il consenso, dove appropriato, deve essere espresso e poter essere ritirato dalla persona interessata in qualsiasi momento e per qualsiasi motivo, senza conseguenti svantaggi e pregiudizi. Queste raccomandazioni sono raccolte anche nella Dichiarazioni di Helsinki che, nell'ultima versione, all'art.

Diritto di sapere e di non sapere Art. Ogni persona ha il diritto di conoscere ogni informazione raccolta sulla propria salute. D'altra parte, infatti, non sarebbe giusto caricare di eccessivi pesi persone esterne al problema. I comitati etici Nati originariamente come organo di consulenza e supporto a casi caratterizzati da complesse implicazioni etiche, i comitati si sono nel tempo diversificati per le molteplici funzioni svolte: nel hanno iniziato ad assumere un ruolo significativo, soprattutto negli USA.

Oggi si parla dei comitati etici come di organismi che riflettono il rapporto tra assistenza e ricerca, globale e locale. Caratteristica dei C. Proprio questa configurazione rispecchia la scommessa dei C. Fanno parte del quadro di riferimento: la Dichiarazione di Helsinki, in particolare gli artt. In Italia un po' ovunque sono stati costituiti C. L'ultimo decreto in materia, D. Il parere del C. Concludendo, in ragione delle funzioni di cui sono titolari, i C.

Tali istituti verificano la sussistenza dei requisiti soggettivi ed oggettivi necessari per iniziare la ricerca e la sperimentazione di medicinali, adottano pareri non vincolanti ed operano in un regime di notifica dell'avvio degli studi clinici. Questo modello, diverso dalla normativa italiana che richiede una previa autorizzazione esplicita, ha ispirato la disciplina introdotta dalla direttiva n.

Incaricati di elaborare principi deontologici professionali e di garantirne l'osservanza, a tali comitati va principalmente riconosciuto il merito di aver promosso il dibattito sui limiti etici della ricerca e della sperimentazione clinica e di aver conseguentemente influenzato in tal senso l'emanazione della legge 20 dicembre n. Tale legge ha consentito l'istituzione su base regionale dei comitati etici per la ricerca che, a partire dal , vengono designati come Comitati consultivi per la protezione delle persone nella ricerca biomedica CCPPRB e ha fissato i requisiti minimi per il funzionamento di tali organismi.

Come scritto sopra, la sperimentazione di nuovi farmaci per uso umano, che verranno poi messi in commercio, deve essere autorizzata dalle Ethik-Kommissionen secondo quanto previsto dalla legge federale sui prodotti farmaceutici Arzneimittelgesetz. Tra questi assumono rilevanza i Local Research Ethics Committees, istituiti a partire dagli anni Sessanta presso strutture ospedaliere e di ricerca medica sulla base delle Guidelines on Responsability in Investigations on Human Subject.

La riforma del sistema sanitario del Regno Unito, attuata nel , ha determinato la distribuzione territoriale dei Local Committees sulla base del modello tradizionale britannico delle District Health Authorities, che sostiene sotto il profilo amministrativo i comitati. I compiti attribuiti ai Local Research Ethics Committees sono prevalentemente di tipo consultivo sia con riferimento a temi generali sia guardando ad aspetti specifici della politica sanitaria; tuttavia, la citata riforma ha conferito ai Committees anche funzioni di garante della riservatezza dei dati relativi ai soggetti partecipanti alle sperimentazioni.

Negli ultimi anni si sono aggiunti altri organismi con funzioni consultive, istituiti con provvedimenti ad hoc relativi a settori specifici: Advisory Committee on Genetic Testing e la Human Genetics Advisory Commission. I CEIC sono tenuti anche a vigilare sull'esecuzione dello studio clinico. Direttiva n. Per quanto riguarda gli aspetti sostanziali della direttiva, l'art. I controlli consistono in accertamenti presso i siti di sperimentazione e, se necessario, presso la sede dello sponsor; i risultati sono riconosciuti da tutti i Paesi membri e sono contenuti nella relazione messa a disposizione dello sponsor.

Introduction: an overview of experimentation In recent years, ethical and legal issues stemming from the progress of science and technology in the field of biomedicine have become a popular topic of discussion of an increasingly wider audience. Every day, the press reports news of experimentation, developments of treatments and new regulatory guidelines that chase, with difficulty, the evoked progress.

Said developments have initiated an articulated, and not always clear, dialogue between science and civil society, thus helping to bring the debate regarding the public utility of modern science, outside of the confines of the scientific community. Bioethics has become a testimony to these fundamental principles - dignity of human beings and individual freedom — and has not neglected, but rather included the right to life, the protection against inhumane treatment, inviolability and non-commodification of the human body and the freedom of scientific creation related to freedom of thought.

The principle of responsibility is added to these, as stated by H. Jonas , as a model necessary for the survival and development of humanity in a society dominated by technological and industrial progress. These themes, derived from bioethics, have been interpreted by international law, particularly in the European community, in order to convert these messages into a legal form.

By addressing the issue of human experimentation from this perspective, one can notice how the international recognition of the right to health, since the Declaration of Human Rights in and following the Conventions and Charters regarding this issue, has influenced experiments conducted on human beings and the extent to which the phenomenon is tolerated today. Human experimentation has ancient origins, according to reports by Celso, Herophilius of Chalcedon carried out vivisection on prisoners sent by the Ptolemaic King, that over centuries has marked very different stages.

It is sufficient to consider the experiment of Walter Reed. An American doctor that, in order to develop the inoculation against yellow fever, subjected individuals to experimentation without informed consent, and in some cases even under duress. Another famous case was that of the Tuskegee study funded by the U. S public health service from to in which almost four hundred African Americans with syphilis were left to die without a cure, even after it was found, in order to study the natural course of the disease.

So many scandals were reported that, Henry Beecher , a well-known professor at the Faculty of Medicine at Harvard University, published an article in which he exposed dozens of examples of researchers who included people in hazardous research without informing them. During the Second World War, numerous Nazi experiments were carried out on humans used as guinea pigs in concentration camps.

Following the process that saw the leaders of the operation involved, the Nuremberg Code, the guidelines of which will be examined later, was adopted. The main purpose of this essay is to show how the ethical issues raised by experimenting on humans have today become major topics of discussion, and to illustrate the limits imposed by the international community to this phenomenon, so vast that, given its importance, would require an even vaster discussion. Clinical trials Medicine: an experimental discipline Medicine has always had considerable and unavoidable power in society, bestowed by the fact that it marks the stages of life, from birth to death, provoking strong emotions, great expectations and irrational fears in people that have to use them.

While on one hand this bestowed power allows medical science to assume a key role in society, on the other hand it must be clarified that this role is not undertaken in an abstract manner, but in close contact with humanity and, it is for this reason that medicine is deeply influenced by values, the economy and the political systems to which it belongs. In this context, one questions whether it is really possible for patients to become ill and thus favour the development of public health policies free from market logic, since the main interest of the community, particularly the most vulnerable, is not the protection of rights, but the affirmation of private interests; medicine reflects this state of affairs.

Medical science is spoken about as an experimental discipline in which knowledge must be continually improved and placed under review, as there are few certainties and many different avenues that can be taken. There are many examples of studies regarding new medicines or therapies later contradicted by further research.

Experimentation does not constitute a particular phase of medical practice, but occurs in the presence of areas of uncertainty regarding medicines used to treat, prevent, or reduce the side effects of a certain illness. It is therefore the practice, that is dealing with patients, that indicates the most urgent aspects that need to be researched, in which time and ideas need to be invested. It is from this that the need for all doctors involved in the research to know how to utilise the results obtained from the production of knew knowledge and tailor it to individual cases is derived.

The relationship between medicine and research can be summarised as follows: health is a right and the right to health requires research, as it is one of the best ways to help and participate when answers are missing. In , Johannes Fibiger carried out a study for the first time using a new, rigorous method as whilst administering a serum against diphtheria to numerous patients on alternate days, he identified methodological criteria to follow when carrying out research: a larger sample of patients, a long period of study and alternation.

It were then that Archibald Cochrane, an English epidemiologist, who, in order to protect health rights and avoid that it be left to the disposition of doctors, in , stressed the importance of implementing RCT systematic methods in all pharmacological research. It is a practice that requires the consultation of the best scientific sources to identify relevant and well-grounded evidence with the purpose of resolving a clinical problem.

The modification of certified efficiency evidence, obtained in the short term, especially in areas that are not very univocal and are subject to change, indicates abuse by the scientific community and pharmaceutical industries. How RCT is carried out When a new treatment is studied medicine, treatment its safety should be evaluated and it should demonstrate that it is a source of beneficial effects for patients.

A clinical trial assumes the interruption of normal practice and the administration of the treatment the object of the study. When choosing the subjects to participate in the efficacy studies, only certain categories of patients suffering from an illness may be included, however those suffering from comorbid conditions are excluded. It is important that research is carried out on a substantial number of people, a representative sample that allows results to be transferable in other contexts.

According to the RCT model, patients are divided into groups similar in age, disease characteristics and other factors, not by a doctor but by a computer; this process is known as randomisation. One group generally receives the treatment, the object of the study, while the other group, the control group, receives a previously used therapy or a placebo , or both together. For this reason, usually the patient is not told upon entering the study whether they are taking the active drug or the placebo.

This is known as a blind study. On the contrary, when the patient is aware of the treatment that they will receive, it is known as an open study. Considering that the perception of the researcher is also affected, it is carried out in such a way that the doctors do not know which treatment is given to the participants. At the end of the trial, or in the case of any complications, the object administered to the study participants is revealed, and a comparison of the different effects of the two groups is made.

It is for this reason that receiving the best possible treatment, more than just a placebo for diseases for which there is no treatment , and being informed about taking a controlled or placebo medicine is one of the rights of the study participants. CLINICAL PHASE II: involves the inclusion of subjects with the specific illness for which the drug is intended, in order to evaluate to what extent the pharmacologically active doses are capable of producing effects that are attributable to treatment goals, and subsequently an initial safety profile is drawn up; 4.

By means of a randomised comparison, the studied treatment is administered to a relevant group of people in order to better understand its efficacy and effects, before being compared to the traditionally used therapies. In this phase, groups of people who are administered different treatments are compared in order to assess the benefits and side effects coming from each.

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At the end of this phase, the drug promoter, if the study is registrative, may request commercial authorisation. In rare cases, and for very serious diseases for which there is no valid treatment, the participants of the study may continue to receive the same treatment as if the trial were to continue. Clearly, the registration of these medicines is carried out based on the surrogate indicators of efficiency, which take into account, for example, the reduction of the cancer mass rather than the reduction of mortality.

This procedure, while on one hand it leads to quicker approvals, on the other hand it produces less reliable results. A famous case is that of Gefitinib, a drug placed on the U. S market in following a fast-track approval procedure before later being withdrawn as according to the National Cancer Institute, it was unable to improve the life expectancy of patients; in fact, subsequent investigations revealed that not only did the drug not help patients suffering from lung cancer, but it could actually be counterproductive.

Since this case, not an isolated incident, many questions have emerged regarding the risk posed to the patients during the first trial, whether it was successful or not. This is a complex issue as it involves drugs aimed at a limited category of sick people and the pharmaceutical industries believe that patients should not be deprived of any drug that may be able to benefit them, albeit minimally.

Where experimentations are carried out As a rule, research should be conducted where the people, to whom the results should be applied, are found, however, it is common practice that studies take place in hospitals or in specialist medical centres carried out by doctors. A small part of this research is carried out by general practitioners GPs and paediatricians, who, thanks to their on-going relationships with patients and their histories, can both understand the needs that have not yet been addressed and resolved, and follow the experimentation daily.

Experimentation ethical requirements The uncertainty principle is the basis for all experimentation projects as it is an ethical and scientific requirement that cannot be disregarded. Clinical research only exists when patients or physicians are uncertain of which treatment to administer amongst those available; this requires the random administration of treatments in order to compare the effects and reduce incertitude. In North America, clinical equipoise — that reflects collective incertitude — is the dominant ethical foundation […].

In the paper written by E. Wendler and G. Documents that, at an international level indicate the way in which experimentation should be carried out, also emphasise how it responds to health care needs whose goal is to transform medical incertitude into research in order to provide answers increasingly conforming to the needs of mankind.

The Oviedo Convention and the Declaration of Helsinki, adopted in by the World Medical Association WMA , thus a deontological document, is regularly updated in what is universally recognised as a reference point for biomedical research; originating from the need of medical science to answer important questions regarding its responsibilities, roles and duties. Later in this essay, we will look at how the ethics of experimentations in poor countries have different characteristics and how the standard of care is not always guaranteed.

It is a document that resuming the principles contained in the Convention regarding experimentation, focuses on human dignity and the protection of human rights so much so that article 28 obliges Member States and sponsors to follow the principles stated therein if the research is carried out in non-signatory countries.

Twenty-two guidelines are outlined in this document: the first trace the path to follow in order to achieve good quality, valid, clinical research. The others analyse the controversial aspects of informed consent, the sensitive issue of privacy, the liability of sponsors and doctors as well as the need to protect people involved in the study both during and after the experimentation, in cases where states cannot guarantee health care.

Respect for the person: implies respecting the personal autonomy of the individual and the protection of vulnerable subjects; 2. The principle of beneficence: maximise benefits and minimise risks; 3. The principle of justice: the equal distribution of positive and negative effects amongst all participants of the experimental study. The Guidelines for Good Clinical Practice GCP-ICH adopted by the International Conference of Harmonization should also be mentioned as they illustrate the procedure that should be followed in order to obtain informed consent from patients and at the same time guarantee the confidentiality of personal data.

These documents will later be reviewed when discussing the topic of ethics committees. One should consider, however, that while on one hand the trial allows the medicine to alter the natural course of the disease, providing innovative, and in some cases less invasive solutions, on the other hand, particularly in patients suffering from severe diseases, the research may create an asymmetric situation in which the sick individuals rely on research hypothesis, interpreting them as promises. Unfortunately, in many cases, these expectations are not met and it is therefore important that those who participate in clinical studies make conscious decisions and that the fragility of participants being in such extreme situations, is not more powerful than that of those who have to study these hypotheses.

Anyone, regardless of age or social status, suffering from a disease is vulnerable to healing hypotheses. A doctor who becomes ill discovers, first of all, what it means to trust in those who should cure him, almost in a state of subjection and submission. Informing the individual: benefits and risks No one can describe better the symptoms, effects and feelings of a treatment better than those who have experienced it first hand. From a sharing and cooperation point of view, people that participate in clinical studies make an important contribution to medical science: they allow the identification of unresolved problems, clarify the most important information to be evaluated and its relationships, and suggest developments for research procedures, how to collect data and how to interpret and communicate the results.

On this basis, it is important to keep in mind, however, that individuals are subjects and not objects of study: from this, the distinction between people and guinea pigs is derived. Over the years, human guinea pigs have been spoken about too often, from Nazi crimes to many other cases, and today, to prevent history from repeating itself, standard practice is to give the participant an informed consent module to fill out, composed of detailed, written information with the intention of facilitating their involvement in the study. This information concerns both the benefits and the risks of the experimentation to be carried out.

With regards to the benefits, they can be direct when the treatment being studied is found to be innovative and effective for the person involved, or indirect when the subject contributes to research without deriving any personal benefit. In any case, participants are offered constant monitoring and free medical care.

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The issue of risk, however, is more complex, as it should always be evaluated in relation to the problem and its severity: when faced with a serious and disabling illness, that offers little hope of life, side effects are considered more acceptable and tolerable; thus the risk is more easily accepted. The situation is clearly different if healing prospects are higher: here the risks may be too high. In any case the informative module is exhaustive and side effects are described in detail, explaining any possible event.

This complicates the patients understanding of the proposal and the actual degree of toxicity of the study. The main point is that in reality, experimentation is not so different from normal clinical practice: the paths are uncertain and lengths, obstacles and precise destinations are unknown. Informed consent is a result of personal choice, related to correct, complete and transparent information.

Since the creation of the International Covenant on Civil and Political Rights in , free and informed consent represents a fundamental guarantee of the protection of human dignity in science. The practice of obtaining informed consent results from a delicate and complex path that medicine has taken in order to change the traditional idea that people are not free to make decisions concerning their own health, as these decisions need to be made by people who are scientifically and technically capable of managing these specific problems.


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  5. Nowadays, it is no longer doctors that make decisions regarding our health, but everyone has the right, freedom and responsibility to choose how to be treated from a range of possible cures; patients are offered the possibility to understand what is happening. Beforehand, this person is given the appropriate information regarding the purpose and the nature of the intervention and its consequences and risks.

    However, this is not always a linear process and it is not always possible for people that living in contexts that do not facilitate it: an individual can only choose if they are able to understand the situation and if they are given the possibility to understand. In circumstances of vulnerability that may result from fear, loneliness or other factors, the autonomy of the individual may be exercised only if supported by a significant healthy and free declaration.

    A signature on a form is not sufficient to illustrate that all of the necessary information to make an informed and conscious choice has been understood: the declaration is the only way to avoid forcing or pressure of any kind. People have the right to know about any collected information regarding their health.

    In accordance with the foregoing, the right to information belongs to the sphere of private life: the first condition to be met in order to participate in a trial and to any normal health treatment is the knowledge of the diagnosis and prognosis in realistic terms. Articles of the Italian Code of Medical Deontology also define the commitments of doctors, in this case Italian doctors, concerning the information and acquisition of consent.

    However, the right to know and the right to not know are equally protected so that if a person chooses not to know the details of the treatment, this decision must be respected. Thus, the protocol added to the Oviedo Convention on Biomedical Research , taking into consideration the information outlined in the convention, article 13 states that: an individual that is asked to participate in a research project shall be given adequate information in a comprehensible form.

    This information will be documented. A person cannot be obliged to receive news of their health and it is therefore possible to delegate choices that do not involve great responsibility to others, by asking doctors to consult people that the patient trusts. On the other hand, it would be unfair to burden people external to the problem. Therefore, it can occur that participants in clinical trials may prefer not to know everything about the treatment that will be administered.

    Another important aspect to consider regarding informed consent is that often, it fails its purpose, namely to inform : the material given to the patient is too long and dispersive, written using technical language that is hard to understand for those external to the scientific field.

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    It is important to clarify that consent is only legitimate when it forms part of an information process aimed at allowing people to freely choose what they believe to be appropriate. In this regard, extensive literature has been formed, some key ideas are taken from several sources: for example, including ordinary people and patients in the preparation of informative modules improves its readability and comprehension.

    One of many studies in the field, that states that information modules should be short and readable, is symbolic; ethics committees, that are responsible for verifying the appropriateness of information practices and its involvement, but, continue to approve modules that patients cannot understand, should acknowledge the barriers that have failed to introduce common sense rules regarding readability.

    The documents that are given to patients are very similar both in terms of language and structure and do not take into account the culture, state of mind and habits of the people involved: the same standardised module is used for everyone and any further doubts will be clarified in an meeting with the physician. Due to transparency, however, it becomes important to highlight the essential information in both the documents that are given and in meetings with doctors.

    Using the logic of participatory research, informed consent may represent the starting point for establishing co-operational projects between networks of ethical committees in order to propose new communication methods. The purpose of the information is to ensure that individuals can actively participate and make autonomous decisions to the furthest extent possible, as in reality, no one is fully rational and independent, especially in cases such as these where the stakes are high. In fact, committees to examine research protocols and consent modules were established in hospitals and universities alongside other committees looking closely at issues relating to the abortion, sterilization and termination of treatment for people in a permanent vegetative state.

    Today, ethics committees are considered organisms that reflect the relationship between care and research, both globally and locally. It is true that the issues addressed by committees are never purely technical and behind every case there is a different story being debated and sensitive issues being addressed; issues closely related to life and death.

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    International literature governing ethics committees mostly considers their efficiency and ability to adapt to GCP and ICH: the context in which they operate is poorly illustrated. The Declaration of Helsinki, in particular articles 6 and 28, the Oviedo Convention chapter V and the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research articles 3,5,7,9, are all part of the reference framework. Ethics committees in Italy Italy, similarly to other countries, has set up a National Bioethics Committee NBC that, in this field, is the most authoritative reference point.

    The aim of the ethics committee is to inform public powers and the community about scientific and technical research progress and biological experimentation, as well as to guide, monitor and evaluate the results and the possible application of said progress to the protection of human rights and dignity.

    However, considering the plurality of interests that need to be protected within committees, these goals are not easily achieved. It is not easy to provide neutral information when issues that profoundly affect our culture and sensitivity are the subjects of discussions; creating a critical mass that is independent from political, market, and general influences is a long and winding road. One of the issues frequently at the center of discussion is the distinction between ethics committees set up for experimentation and those for clinical practice. Decentralisation was implemented not only to speed up the research protocol evaluation procedures, but also to promote the creation of a critical mass: diverse opinions within the committee rarely emerge, it is however important that people external to the scientific field law, sociology and ethics experts contribute to and influence the decisions that are adopted, i.

    The Ministerial Decree 12th May defines in detail the composition of an ethical committee for clinical drug trials. The assessment of ethical adequacy should refer to a range of skills and expertise that reflect, in an appropriate manner, professional and lay perspectives. Article 2. The opinion of the EC is vital for the development of a trial: in virtue of the plurality of internal points of view, the committee will examine the protocol, taking into consideration: the importance and relevance of the trial, whether the indicated parameters are respected, and if the trial is considered worthwhile it meets the researchers to clarify any doubts.

    The EC does not have the power to change protocol contents, but it is responsible in deciding whether to implement it or reject it and ensure its safety conditions. The autonomy of the EC is mostly expressed in the field of information, so much so that establishing cooperation networks, with the aim of developing new forms of communication and language between care and research, would be useful.

    The committee, however, is regularly updated on the progress of the trial and any possible side effects arising from the treatment being researched: it falls within the powers of the committee to suspend the study if it believes that the safety conditions previously outlined are inadequate or no longer exist. Regulation of ethics committees in some European countries Similarly to Italy, legal systems in other European countries have also witnessed the creation of institutions intended to evaluate, in different ways, the ethical, social and legal developments resulting from advances in the fields of biological research and clinical trials.

    This phenomenon dates back to the sixties in some countries and has led to the emergence of a variety of various institutions with different names but similar characteristics: independence, multidisciplinarity and a variety of views represented. Said institutions verify the existence of subjective and objective requirements necessary to begin research and experimentation of medicines, adopt non-binding opinions and notify people when clinical trials begin.

    This model, unlike Italian legislation that requires explicit authorisation, has encouraged the rules introduced by Directive n. In France, it was only at the end of the seventies that the spontaneous creation of ethics committees in public and private hospitals was witnessed, operating outside of any regulatory framework. Effettua l'acquisto del medicinale presso la nostra farmacia online e ti spediamo l'ordine a qualsiasi indirizzo d'Italia da te indicato.

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