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Development and Health: Some Thoughts on the Sustainable Development Goals

A full assessment of the SDGs, let alone of their implementation, will not be possible for some time. What is clear enough is that they differ from the MDGs and from most development efforts of the last decades in two important aspects: 1) They approach development as a global activity, involving all countries, as opposed to an area defined by deficiencies in low-income countries in the Global South; 2)They address numerous aspects where developmental improvements have been promised before but whose ongoing trends are uncertain or downright negative, such as climate change, global arms expenditures, deforestation, desertification, waste production or road traffic deaths

Iris-Borowy

by Iris Borowy

professor of History at Shanghai University, College of Liberal Arts

 

Development and Health: Some Thoughts on the Sustainable Development Goals

 

The beginning of 2016 has marked the official launch of the Sustainable Development Goals (SDGs), a list of seventeen goals, specified by a total of 169 targets, to be reached by 2030. They replace the Millennium Development Goals (MDGs), which were established between 2000 and 2005 and lasted until 2015. Admittedly, the SDGs are symbolic rather than legally binding and they cannot commit any government or any institution to do anything. But, symbols can have powerful effects, and following the precedent of the Millennium Development Goals, the SDGs come as part of a reasonably established system of international cooperation based on a set of recognized goals. The list covers a broad range of aspects:

  1. End poverty in all its forms everywhere
  2. End hunger, achieve food security and improved nutrition, and promote sustainable agriculture
  3. Ensure healthy lives and promote wellbeing for all at all ages
  4. Ensure inclusive and equitable quality education and promote lifelong learning opportunities for all
  5. Achieve gender equality and empower all women and girls
  6. Ensure availability and sustainable management of water and sanitation for all
  7. Ensure access to affordable, reliable, sustainable and modern energy for all
  8. Promote sustained, inclusive and sustainable economic growth, full and productive employment, and decent work for all
  9. Build resilient infrastructure, promote inclusive and sustainable industrialisation, and foster innovation
  10. Reduce inequality within and among countries
  11. Make cities and human settlements inclusive, safe, resilient and sustainable
  12. Ensure sustainable consumption and production patterns
  13. Take urgent action to combat climate change and its impacts
  14. Conserve and sustainably use the oceans, seas and marine resources for sustainable development
  15. Protect, restore and promote sustainable use of terrestrial ecosystems, sustainably manage forests, combat desertification and halt and reverse land degradation, and halt biodiversity loss
  16. Promote peaceful and inclusive societies for sustainable development, provide access to justice for all and build effective, accountable and inclusive institutions at all levels
  17. Strengthen the means of implementation and revitalise the global partnership for sustainable development

At first sight, this seem rather a disappointing loss of attention to health issues as compared to the MDGs, where four out of eight goals directly addressed health. This time, merely goals 2 (an end to hunger and malnutrition) and 3 (to ensure healthy lives), directly address health, and goals 6 (water and sanitation) and 5 (gender equality and empowerment women) only a little less directly, since the connection both between sanitation and the position of women and (especially infant and maternal) health is well established. Thus, by comparison, one might conclude that health had been downgraded to give way to other developmental priorities.

This paper argues that nothing could be further from the truth. Without doubt, the MDGs presented an agenda strong on health, and in 2010 WHO prided itself about contributing to them in twenty ways. But, tellingly, all were policies that were directly tied to medical or health management procedures. What the step from MDGs to SDGs brought was not so much a weakening of a commitment to health as a shift in perspective on health from a primarily local and direct to a primarily global and indirect approach. This change is hardly out of line with earlier policies of international health. WHO, other institutions and scholars have insisted for a long time that health care provides only part of what is required to maintain good health. It is the social determinants which play an important, and arguably a much larger role.

In this sense, most or, indeed, all of the SDGs can be read as being related to health. Reducing poverty, improving education, providing sufficient energy which causes neither pollution nor nuclear contamination nor climate change, improving living standards, providing lucrative and healthful employment, reducing inter- and intrastate inequality, providing safe and healthy urban living environments, promoting sustainable economies and lifestyles, mitigating climate change, conserving ocean resources, preventing desertification and biodiversity loss, preventing warfare and promoting global partnership all interact in one way or the other with people’s health around the world. Thus, the SDGs can be seen as a strongly social approach to health within the vacillations between bio-medical and social approaches which have characterized the approaches to international health policies throughout the twentieth century and beyond. Besides, it is difficult to conceive of developmental processes not having an impact on and being influenced by a country’s development. So, simply by being the paramount recent initiative in global development, the SDGs are of relevance to considerations of global health.

Development: the record

The SDGs use the expression of “development” as though its meaning was clear and universally accepted. However, the concept is not easy to define and has become a vehemently contested field. Left-wing activists or scholars frequently reject the concept as a thinly veiled euphemism for a process of rigging global structures and perceptions of reality to benefit the global rich at the expense of the global poor, a view taken by writers such as Arturo Escobar and Gilbert Rist since the early 1990s. Public debate between experts has centered on whether financial transfers from the North to the South through development aid is necessary to improve living conditions in the South (argued e.g. by Jeffrey Sachs) or whether such assistance is counterproductive and should be discontinued (e.g. argued by his former student Dambisa Moyo). Still others, especially on the political right, have simply tired of seemingly endless and fruitless efforts to turn Africa and the world in general into a place without poverty and misery.

Given this record of pessimism and rejection, the SDGs are remarkably untouched by doubt and modesty. On the contrary, some of these goals seem ambitious to the point of utter neglect of realism. Already the first goal is downright provocative. Will it really be possible to end poverty in all its forms everywhere in a mere fifteen years? In fairness, UN officials are not the only ones who think so. Hans Rosling does, too. The Swedish professor with a mission to acquaint people with statistics argues passionately, that eradicating poverty is possible and perfectly in line with enormous reductions of world poverty since 1970s. And poverty as simple lack of income is not the only field that is improving more rapidly than is generally realized. As the ignorance project of the gapminder foundation shows, many people dramatically underestimate the impressive ways in which recent development has been successful. (Those who would like to test their own ignorance, can read the nine questions and compare their answers to those of Swedes, Norwegians, Americans, Germans or South Africans.) Key criteria of wellbeing, notably health data such as life expectancy, infant mortality and hunger, have improved substantially during the last 200 years, along with literacy and income (See the interactive graphs supplied by gapminder.) As a long-term trend, improvements in income and life expectancy are also borne out by the data by late economic historian Angus Maddison and, for the twentieth century, by the UN Development Programme. In its 2015 Human Development Report, it shows that the UN development index, an index consisting of per capita gross national income, education and health, shows improvements in all regions of the world.

These reports are in stark contrast to a persistent narrative regarding the uselessness of development. When Rist cites increasing global income inequality during the last forty years as proof of “undeniable failures in improving the condition of millions of the poor” he overlooks the very real improvements of health of millions of poor people, notably with regard to sanitation, nutrition or life expectancy. Clearly, recent global development has neither been limited to helping the rich, nor has it been fruitless, and whoever argues that falling infant mortality rates do not represent improvement lacks the experience or the empathy to imagine the pain of parents who lose a child. However, Rist is also right in pointing out that improvements have been very uneven and that they have been accompanied by marked deteriorations in other fields.

Part of the challenge is inequality within societies, which has clearly increased in many countries during the last decades. In part, this development is related to the systemically differing growth rates of capital and of the economies at large, as recently described by Thomas Piketty. But in a short-term perspective, this effect is amplified by political influence through legal donation and bribery, legal and illegal tax avoidance, and through an inflated financial sector which now accounts for one in five billionaires and which allows huge gains for some while reducing the bargaining position of labour. This goes hand in hand with a larger potentially destabilizing effect of a financial sector which is increasingly disconnected from the real economy.  The danger showed during the recent financial crisis, which turned into debt crisis and then into an austerity crisis. Despite initial measures to reform the banking system, many of these are quietly being weakened or removed again. Besides, key structural risk factors such as multifunction banks, the separation of high-risk investment from accountability and generally a culture of too-big-to-fail remain in place. At the same time, economic inequality itself bears the risk of destabilizing financial systems, since the very poor are tempted to borrow money to achieve a living standard they cannot afford and the very rich have a lot of money which they wish to profit from by lending it out. Besides, inequality within wealthy nations is measurably and positively correlated to health impairment such as shortened life expectancy, higher rates of infant mortality, drug abuse, teenage pregnancies, obesity, homicides and mental illness.

Inequality between countries is more complicated. The issue came, once again, to the forefront of public attention when a recent Oxfam report declared that in 2015, a mere 62 individuals owned the same amount of wealth as the bottom half of the global population, 3.6 billion people.  This forms a dramatic concentration of wealth even since 2010 when 388 of the richest people were needed to match the wealth of the bottom half. During those five years, the richest 62 people saw their wealth increase by 44 per cent, matched by a drop of wealth among the poorest half of the global population by 41 per cent.

However, this focus on the richest of the rich obscures the larger picture of the overall distribution of global wealth. True, the Gini coefficient (a measure of inequality with 0 expressing perfect equality and 1 perfect inequality or 1 person owning everything) of the world at large remains scandalously high, higher than any individual country. But according to calculations by Christoph Lakner and Branko Milanovic, the impressive economic developments in India and, particularly, in China have moved several millions of people from utter poverty to levels of modest comfort and thereby closer to a living standard enjoyed in high-income countries. As a result, global inequality has been falling since the late 1980s in the sense that wealth differences between a majority of global population are diminishing. However, not everyone participates equally in this move: large parts of people in Africa and the lower income sectors of traditionally high-income countries in Europe and North America have seen only modest increases, at best. As a result, most people in Africa tend to be even more on the losing end of development, relative to the rest of the world, while (lower) middle class people in North America and Europe barely hang on to their absolute wealth status which is still above that enjoyed by the average Indian or Chinese, but they are losing ground, relatively, both to these Indians and Chinese and to those with high incomes in their own countries. In crude terms, the growing number of refugees of recent times tend to be those whom global development has failed, and when coming to the traditionally rich countries in Europe and North America, they are meeting a growing percentage of people, whom global development seems to failing today. Clearly, it is an explosive – and clearly unhealthy – combination.

The picture becomes even bleaker when considering the reasons for the perceived positive development in Southern and Southeastern Asia, defined mainly as rapidly growing income. China provides a particularly revealing example. Approximately 600 million people have been raised from poverty, an immense achievement, whose beneficial effects for people’s health and overall wellbeing should not be minimized. But the Chinese people have been paying a heavy price in terms of environmental destruction, pollution, increasing domestic inequality, growing risks to food security due to farmland degradation and widespread corruption. The development has privileged the urban over the rural population, involving some extreme concentration of wealth with five percent of the population owing an estimated 95 percent of the country’s wealth. The environmental burden has been similarly dramatic. Accounts different as to whether seven or only two of the ten most polluted cities of the world are in China, but there is general agreement that the pollution level in Chinese cities is high. The massive demand of resources had increased the risk of widespread resources depletion. China has had to import dramatically increasing amounts of coal to sustain its economic growth, and 60 percent of Chinese cities with a population of over 100,000 people are experiencing water shortages. In the interest of rapid industrialization and GDP growth, huge amounts of concentrated organic waste water and hazardous wastes have been released into the environment. Two thirds of Chinese rivers are seriously polluted and over 80 percent of urban rivers are seriously degraded. People living in the vicinity of clusters of polluting enterprises are especially at risk, both from industrial accidents, releasing large amounts of toxic substances, and from ongoing high levels of emissions. A growing number of villages (“death villages”) show significantly elevated numbers in cancer and overall mortality. Unlike in the European countries or in the US, it is not ethnic minorities or the poor who bear the highest environmental burdens but, on the contrary, it seems to be that those who have profited most from economic development also suffer most from its environmental repercussions.

Otherwise, China merely appears to show a concentrated form of the global development. Less polluted living conditions in wealthier countries notwithstanding, the world at large has gained economic wealth at the expense of future life support systems.  Humanity probably began living beyond its ecological means in the early 1970s. Today, the world is using the resources and waste absorption capacities of approximately 1.5 planets per time unit. 15 out of 24 crucial ecosystem services, evaluated by the Millennium Ecosystem Assessment in 2005, were degraded or being used unsustainably, including fresh water, air and water purification, climate regulation and pest control. And the world may be heading towards a four degree temperature rise promising inundated coastal cities, increased food insecurity, frequent high-intensity tropical storms and further irreversible loss of biodiversity by the end of this century. Adding environmental to social challenges, the damages of climate change will be unevenly distributed, affecting primarily those already poor and vulnerable. If wellbeing has been improving worldwide during the last decades, there is reason to be skeptical about whether it will continue to do so in the future.

These developmental challenges have everything to do with other acute political problems we are facing today. Unequal development and economic instability provide conditions in which some will not find jobs and recognition and will be tempted to look for social respect in extremist ideologies. Unequal development produces the refugees who are fleeing from environmental degradation and poverty or from living conditions which, though not absolute poverty, they know to be immeasurably worse than those considered normal in high-income countries. Even those situations of repression and warfare, like in Syria, which are seemingly unrelated to development in a narrow sense often turn out to have been influenced by developmental factors. Thus, there is good evidence that unusual droughts in Syria between 2006 and 2009 reflected climate change and contributed to the social stress which led to the uprising against the government of Bashar al-Assad. It does not require a lot of imagination to realize that further environmental degradation, caused by climate change or otherwise, will further increase the numbers of disillusioned people, who will seek redress for their disadvantages – perceived or real enough – by seeking to move to other countries as refugees or terrorists.

Development: conclusions from the record

Clearly, global development is both going well and going terribly wrong, and the big – and urgent – challenge is to find a mode of development that safeguards much of what is going well (the increasing income, increasing life expectancy, decreasing infant mortality…) while avoiding what is going wrong (climate change, environmental degradation, social fragmentation). The SDGs are the most serious and comprehensive international attempt, as yet, to galvanize a critical mass of organizations and institutions into taking serious steps towards such a form of development. While “sustainable development” has been derided by many, by those who see it as a front for business as usual as well as by those who believe in the long-term benefits of business as usual and see little need to change it. Indeed, the SDGs also entail inherent contradictions, particularly with regard to health, as, indeed, I have argued elsewhere. Thus, it is at present difficult to see how the calls for “per capita economic growth in accordance with national circumstances, and in particular at least 7% per annum GDP growth in the least-developed countries” (goal 8)  and plans to “promote inclusive and sustainable industrialization, and by 2030 raise significantly industry’s share of employment and GDP … and double its share in LDCs” (goal 9) can in practice be reconciled with the tasks to “integrate climate change measures into national policies, strategies and planning” (goal 13) and to “substantially reduce waste generation through prevention, reduction, recycling and reuse” (goal 12). Thomas Pogge and Mitus Sengupta have criticized the SDGs for perceived crucial weaknesses: no clear responsibility and accountability for implementation, insufficient demand of structural reforms of the global institutional order, insufficient attention to human rights, an absence of suitable measurements of progress, insufficient clarity on necessary measures to combat climate change and a misguided focus on only the illegal portion of frequently destructive practices like arms trade and high-risk financial investments.

All this may be true. But the perfect is enemy of the good. And, compared to earlier plans, notably the MDGs, progress seems substantial.  The MDGs, for all their – welcome – focus on health, took a largely end-of-pipe approach to development and health, assuming that (health) problems in parts of the world should be addressed by specific health policies directed at that part of the world. In other words, if children were dying in low-income countries, the remedy had to be found in health interventions directed at children in low-income countries, such as vaccinations. Vaccinations are important, and giving all children worldwide access to them is also an important goal. But children’s health is affected by a lot of other factors as well, only some of which lie in their immediate surroundings.

But the MDGs set an important precedent by turning development into a global action, in which an unprecedented number of organizations cooperated on what was endorsed as a common responsibility towards the development of the world. By placing reports online, the MDG administrators also established an unprecedented impression of accountability regarding the record of global efforts towards these goals. In 2015, the final report was positive in a celebratory (partly self-congratulatory) way. Several goals had been met and even for those that were not met, many had seen substantial improvements. The proportion of people in “the developing world” living on less than $ 1.25 per day had dropped from half in 1990 to 14 per cent in 2015. During the same period, the global under-five mortality dropped from 90 to 43 deaths per 1,000 live births and maternal mortality ratio declined by 45 per cent worldwide. Even more impressing, the report claimed that over 6.2 million malaria deaths were averted between 2000 and 2015 and 37 million tuberculosis deaths prevented between 2000 and 2013. Worldwide, 2.1 billion people gained access to improved sanitation, the proportion of external debt service to export revenue in developing countries fell from 12 per cent in 2000 to 3 per cent in 2013. In fairness, the report also pointed out remaining serious shortcomings: global emissions of carbon dioxide had increased by over 50 per cent, and by the end of 2014 conflicts had turned 60 million people into refugees, the highest recorded level since the Second World War.

The numbers are doubtlessly impressive, though they must be seen in context. In some instances it seems unclear to what extent the improvements were indeed a result of MDG-related policies or simply a continuation of prior developments. Child mortality rates, for instances, had been falling since the 1960s. Similarly, according to UNCTAD, development assistance of OECD countries did increase in absolute terms, but as a percentage of Gross National Income it barely recovered the level of 1990, before attention to former Eastern Block countries had reduced assistance to the global South. However, UNCTAD does credit the MDGs with having increased aid to Sub-Saharan Africa. Generally, the mere generation and presentation of data must be considered progress in international development, since it enabled experts and public alike to identify problems and monitor pertinent progress (or lack thereof) in a broader range of fields than usually easily available.

The significance of data becomes particularly clear when noting some gaps in the final report. The text remains silent on five out of a total of sixty indicators on the official list. They include a conspicuous cluster of indicators regarding economic inequality: 1.2 (poverty ratio gap), 1.3 (share of poorest quintile in national consumption) and 1.4 (growth rate of GDP per person employed). While the exact history behind these absences still needs to be discovered, it is striking that they refer to one area of blatant developmental failure: the persistent global inequality, especially its apparent increase within numerous countries.

But in the long run, the true significance of the MDGs may not be their immediate outcome but their effect on an international infrastructure and public expectations regarding developmental policies. Most important, perhaps, was their implicit assumption that these goals would be achievable, and that those that were not achieved by 2015, could and should be met in the future.  Thus, though originally used as a way to deflect more far-reaching, albeit diffuse, demands expressed in various international conferences during the early 1990s, by 2010 the MDGs had evolved into publicly visible moral obligations to continue and increase international developmental efforts. They also provided a blueprint for subsequent strategies, based on a list of clearly defined and quantified goals. Its result was a joint Colombian/Guatemalan proposal to replace the MDGs with “Sustainable Development Goals” (SDGs) after their termination.

In 2012, UN Secretary General Ban-Ki Moon launched the UN Sustainable Development Solutions Network (SDSN), designed to mobilize a broad range of global scientific and technological expertise. The SDSN information found expression in several reports, including (The Action Agenda, Indicators and a Monitoring Framework for the SDGs) and side events and fed into a three-year process of intergovernmental negotiations. Early on, it became obvious that the new list would be incomparably longer and broader than the MDGs. In August 2015, numerous high-ranking delegates agreed on a global framework for financing development post-2015, reaffirming their commitment to a comprehensive development agenda. In September, in a glamorous ceremony attended by many heads of governments as well as celebrity heroes of development, such as Malala and Bono, and accompanied by performances by singers Shakira and Angélique Kidjo, the UN General Assembly accepted the SDGs.

The glamour glossed over the fact that the process was – and is – not completed. Work on the indicators, the crucial measurement by which progress towards those goals is supposed to be assessed, is still going on and no date for a final agreement has been set. Thus, a full assessment of the SDGs, let alone of their implementation, will not be possible for some time. What is clear enough is that they differ from the MDGs and from most development efforts of the last decades in two important aspects:

  1. They approach development as a global activity, involving all countries, as opposed to an area defined by deficiencies in low-income countries in the Global South. This difference is crucial not only in academic conceptual terms but also in the way it translates into the choice of goals and the demands places on actors in all parts of the world. While some goals remain focused on developmental demands on countries in the South, such as hunger, education or sanitation, others are unequivocally addressed at high-income countries in the North, notably with regard to climate change, consumption patterns and global partnership. If (partially) implemented, the SDGs have the potential not only to transform the conventional understanding of development into one of as a shared global responsibility but also to increase the global awareness of the global entanglement of wellbeing, whereby the health of people in one country depends vitally on decisions and practices in many other countries;
  2. They address numerous aspects where developmental improvements have been promised before but whose ongoing trends are uncertain or downright negative, such as climate change, global arms expenditures, deforestation, desertification, waste production or road traffic deaths. Most – or, indeed, all – of the demands formulated in the 169 targets have been voiced before, spectacularly in the Millennium Declaration in 2000, but also earlier at the UN conferences of the 1990s, notably the UN Conference on Environment and Development, held in 1992 in Rio de Janeiro. In other words, the SDGs are addressing some of the essence of the challenge at hand: the fact that the benefits of development are being achieved at the price of serious damage, and that fundamental changes will be necessary, i.e. goals that are not satisfied easily (relatively speaking) by bringing the advantages of the well-off to the less well-off (vaccinations for children everywhere) but that will require finding a way to improve people’s health through better jobs, more income and better living standards without, at the same time, compromising their health through land degradation, inequality, pollution and climate change.

No successful outcome is guaranteed. Even the incomparably more modest MDGs were only partially successful. But even some success in only some SDGs would be a vast improvement. A world  in which everyone enjoys “access to affordable, reliable, sustainable and modern energy services,“  in which “inequality within and among countries“  is seriously addressed, in which “the regulation and monitoring of global financial markets and institutions” are improved and “the implementation of such regulations” strengthened, in which “per capita global food waste“ and “the number of deaths and illnesses from hazardous chemicals and air, water and soil pollution and contamination” are substantially reduced and in which “the development, transfer, dissemination and diffusion of environmentally sound technologies to developing countries on favourable terms” are actually promoted would be a much better place.  Even halfway progress would be extremely good news. Above all, it would save lives. Many lives.

There is good reason to criticize the SDGs. But from a health point of view, there is little reason not to support them.

 

 

Norme UE Anticontraffazione Farmaceutica

Le “cattive medicine” rappresentano una grave minaccia per la salute perché, oltre ad essere inutili, possono uccidere o facilitare la diffusione di microbi resistenti alle cure

MINOLTA DIGITAL CAMERA

by Daniele Dionisio

Policies for Equitable Access to Health –PEAH  

 Nuove Norme UE Anticontraffazione Farmaceutica

 

Il 9 febbraio 2016 la Gazzetta Ufficiale dell’Unione Europea  (UE) ha pubblicato il Regolamento delegato in concreta attuazione della Direttiva 2011/62 sui Medicinali Falsificati (Falsified Medicine Directive).

Secondo l’ EMA (Agenzia Europea dei Medicinali), il nuovo sistema sarà in grado di impedire l’ingresso dei farmaci contraffatti nella filiera legale, renderà più trasparente ed affidabile l’acquisto on line dai siti certificati (legale in Europa dal 1° luglio 2015), e migliorerà il controllo sui farmaci scaduti, revocati, ritirati e rubati.

Il sistema si basa sull’apposizione di caratteristiche di sicurezza (un dispositivo anti-manomissione  e un identificativo univoco rappresentato da un codice a barre bidimensionale) sull’imballaggio dei medicinali per uso umano. Le parti interessate sono tenute all’apposizione delle caratteristiche predette non oltre il 9 febbraio 2019.

All’interno del codice a barre bidimensionale saranno registrati: il codice AIC (autorizzazione immissione in commercio) del farmaco, l’identificativo unico di ogni confezione, il numero di lotto, la  data di scadenza e, eventualmente, il codice di rimborso nazionale.

Rientreranno nel sistema tutti i medicinali etici (esclusi i farmaci omeopatici, le soluzioni, i solventi, alcuni test allergologici e pochi altri) e alcuni farmaci senza obbligo di ricetta.

Ogni Paese sarà tuttavia libero di estendere  l’apposizione ad altre classi terapeutiche.

Il sistema opererà a monte (industria) e all’atto della dispensazione, e i vari archivi si confronteranno con la piattaforma europea  che annullerà, all’atto della dispensazione, l’identificativo unico (in pratica impedendo che un medesimo farmaco possa essere venduto due volte).

L’EMA ha formulato un Piano di implementazione  per la normativa; nel contempo, la Direzione Generale Salute della Commissione UE ha reso disponibile un documento  di “Domande e risposte”.

Il ruolo dell’Italia 

Nella lotta alla contraffazione l’Italia è in linea con la Direttiva Europea 2011/62, di fatto recepita con il Decreto Legislativo n° 17/2014. Per certi versi l’Italia ha anzi normativamente giocato d’anticipo.

Infatti,  il DM 15 luglio 2004 già consentiva di monitorare, anche informaticamente, tutte le transazioni di farmaci nella filiera legale, attribuiva un codice identificativo a tutti i soggetti coinvolti nel ciclo di vita di un medicinale, e registrava le transazioni di tutte le confezioni trasmesse dagli attori della filiera in una banca dati centrale gestita dalla Direzione Generale del sistema informativo del Ministero del lavoro, della Salute e delle Politiche sociali.

Successivamente, in linea con i DL 219/2006, DL 248/2006, e DL 274/2007, tutti i soggetti coinvolti nel ciclo di vita di un medicinale divenivano noti in quanto oggetto di un provvedimento di autorizzazione o di notifica della loro attività.

Dal 2007 il sistema italiano anti contraffazione si implementava, inoltre, con la task-force IMPACT Italia costituita da Agenzia Italiana del Farmaco (AIFA), Ministero della Salute, Istituto Superiore di Sanità, Carabinieri NAS, Ministero dello Sviluppo Economico e Agenzia delle Dogane. Questa collaborazione ha sviluppato iniziative come la cooperazione internazionale, l’analisi di intelligence della vendita di farmaci attraverso internet,  il training e supporto agli investigatori, il monitoraggio delle reti illegali, la messa a punto di strumenti informatici da usare sul campo, l’informazione al pubblico, e la realizzazione di moduli online per la segnalazione di casi da parte degli utenti.

Per effetto della normativa descritta è improbabile in Italia la vendita in farmacia di medicinali non in regola poiché il sistema consente l’ingresso nella filiera legale solo a farmaci “autentici” provvisti di bollino ottico, identificando nel contempo i responsabili di eventuali attività illecite.

Un problema cruciale

L’urgenza della normativa anticontraffazione è indiscutibile solo pensando al forte trend di crescita del fenomeno, oggi non più circoscritto ai Paesi in via di sviluppo bensì esteso anche a quelli industrializzati.

La contraffazione ingloba farmaci di marca e farmaci generici, medicinali salvavita e “life style saving”. Un medicinale contraffatto può contenere le stesse sostanze di quello originale o sostanze/dosaggi diversi, può non contenere alcun principio attivo o addirittura può essere composto da ingredienti contaminati e pericolosi. Le diverse tipologie sono tuttavia accomunate dalla scarsa qualità in quanto la produzione, pur se con ingredienti non tossici, esula dalle norme di buona fabbricazione e distribuzione accettate a livello mondiale.

Sebbene la contraffazione interessi moltissimi farmaci, generici e di marca (antidolorifici, antipiretici, sedativi, antibiotici, cardiologici, antitumorali, antidiabetici, anti-AIDS, antimalarici, etc.), essa non configura reato in diversi Paesi poveri; e se alcuni governi africani lamentano import di medicinali contraffatti, non per questo controllano la qualità offerta dalle proprie fabbriche. Anche quando i colpevoli siano catturati, le pene restano lievi.

Peggio, la globalizzazione agevola la distribuzione via internet di medicine fuori regola ad un’infinità di networks mondiali dove più della metà dei prodotti in vendita è contraffatta.

Le “cattive medicine” rappresentano una grave minaccia per la salute perché, oltre ad essere inutili, possono uccidere o facilitare la diffusione di microbi resistenti alle cure.

Se cicli di antibiotici sotto dosati possono risultare inefficaci o a rischio vita, centomila morti per malaria sono state annualmente registrate nella sola Africa per medicine di cattiva qualità.

L’industria della contraffazione vanta un fatturato di centinaia di miliardi di dollari, e immensi  guadagni si realizzano con piccoli investimenti. In tal senso, l’India è tra le sedi più a rischio perché offre di base costi manifatturieri  del 40% in meno che altrove.

La maggioranza dei farmaci contraffatti origina infatti in Asia, principalmente Cina e India e, se  l’Africa è sotto tiro, il mondo occidentale non è risparmiato.

Le statistiche dell’Unione Europea indicano un incremento pari al 384% di falsi medicinali sequestrati nel 2006 rispetto a quanto avvenuto nel 2005. E secondo stime ritenute attendibili, la percentuale di medicinali contraffatti sul mercato globale si attesterebbe intorno al 7 %, con punte significative del 50% in alcuni Paesi di Africa e Asia.

Il 70% dei contraffatti oggetto di sequestro proviene dalla Cina. Nel 2011, 50 carichi dell’antinfluenzale ‘Tamiflu’, privi di principio attivo e di sospetta provenienza cinese, furono intercettati alle dogane in USA. Più o meno nello stesso periodo, circa il 68% del mercato del farmaco in Nigeria risultava dominato da medicine cinesi contraffatte, mentre l’Ufficio Investigativo Criminale di Taiwan rendeva noto il sequestro di farmaci contraffatti cinesi per un valore di 9 milioni di dollari.

Ancora nel 2012 in Cina 200.000-300.000 decessi erano imputabili a farmaci contraffatti.

PER APPROFONDIRE

Measures to help protect patients from falsified medicines http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/02/news_detail_002467.jsp&mid=WC0b01ac058004d5c1

COMMISSION DELEGATED REGULATION (EU) 2016/161 http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2016.032.01.0001.01.ENG

DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0074:0087:EN:PDF

Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/02/WC500201413.pdf

SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE: QUESTIONS AND ANSWERS http://ec.europa.eu/health/files/falsified_medicines/qa_safetyfeature.pdf

DECRETO LEGISLATIVO 19 febbraio 2014, n. 17 http://www.gazzettaufficiale.it/eli/id/2014/03/07/14G00027/sg%20

Lotta alla contraffazione farmaceutica http://www.agenziafarmaco.gov.it/it/content/lotta-alla-contraffazione-farmaceutica

IMPACT Italia http://www.impactitalia.gov.it/home.php

The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Perspectives. Am J Trop Med Hyg April 20, 2015 http://www.ajtmh.org/content/early/2015/04/16/ajtmh.15-0221.full.pdf+html

A Flawed “Bad Medicine” Campaign. Health Affairs Blog  October 18, 2011  http://healthaffairs.org/blog/2011/10/18/a-flawed-bad-medicine-campaign/

Farmaci contraffatti. Una minaccia globale  http://www.saluteinternazionale.info/2012/04/farmaci-contraffatti-una-minaccia-globale/

 

 

 

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Household air pollution and the sustainable development goals 

Popular Media, Outbreaks, and Parallels with Key Themes in ‘Contagion’

This thematic review analyzes four key areas of public health and preventive medicine practice portrayed by the film 'Contagion': infectious disease transmission dynamics, the role of public health physicians, the interface between clinical practice and public health, and the role of social media in health promotion. The findings presented here promote an understanding of how the film represents these topics and illustrates the potential benefits to public health as a discipline arising from popular media depictions

Jin_Hee_Kim-15-150x150

Jin Hee Kim

Dalla Lana School of Public Health, University of Toronto

michaelschwandt

Michael Schwandt

College of Medicine, University of Saskatchewan

Lawrence Loh

Lawrence C. Loh

Dalla Lana School of Public Health, University of Toronto, and Director of Programs at The 53rd Week Ltd

 Popular Media, Outbreaks, and Parallels with Key Themes in Contagion

 

INTRODUCTION

The film Contagion, which depicts fictional events surrounding the emergence of a novel virus and its rapid worldwide spread,[1] opened on September 9, 2011 to great fanfare, widespread advertising, and media frenzy. On opening weekend, a broad viewership in North America contributed $22.4 million in revenue to propel the movie to the number one spot at the box office.[2]

Numerous television interviews with moviegoers demonstrated that the movie had achieved some traction in guiding people through the work of public health in outbreak and emergency situations.[3] Other disciplines portrayed in film and television have resulted in altered public perception and expectations of real-life professionals working in those areas, such as the “CSI effect” on forensic scientists.[4],[5] A broad-reaching release such as Contagion similarly provided and opportunity for increased public knowledge and awareness of public health and preventive medicine practice, while also stereotyping and distorting nascent impressions of the discipline and its activities. It is thus worthwhile for public health physicians to reflect on this depiction of their specialty to identify potential changes in public perception.

This thematic review analyzes four key areas of public health and preventive medicine practice portrayed by Contagion: infectious disease transmission dynamics, the role of public health physicians, the interface between clinical practice and public health, and the role of social media in health promotion. The findings presented here promote an understanding of how the film represents these topics and illustrates the potential benefits to public health as a discipline arising from popular media depictions.

THEME 1: INFECTIOUS DISEASE DYNAMICS

“On day one, there were two people, and then four, and then 16…In three months, it’s a billion – that’s where we’re headed.”

– Jude Law (as health blogger Alan Krumwiede)

“Stop touching your face!”

– Kate Winslet (as CDC Epidemic Intelligence Service Officer Dr. Erin Mears)

While principles of infectious disease epidemiology by necessity underlie the story of any real or fictional epidemic, cinematic portrayals of outbreaks rarely mention the technical details.[6],[7] Characters in Contagion, however, make explicit reference to terms and concepts used in the public health practice of communicable disease control. These filmmaking decisions drive the plot and characterize the epidemic, while also providing information on infectious diseases and their control.

The basic reproductive number “R0” is prominently referenced in the film’s dialogue, which correctly identifies it as the number of new infections transmitted by a single infected individual. Early in the MEV-1 epidemic, Dr. Mears (Kate Winslet) explains to local health officials that ascertaining the R0 for the infection is critical to predicting its potential spread. Less overtly, Mears highlights the components of the R0 for any infection: frequency of personal contacts within a population, probability of transmission during contacts, and the duration of the infectious period.

By describing these concepts, the film lays the groundwork for viewers to connect these themes to the mitigation measures later introduced, including: quarantine (lowering contact rate) and vaccine development (lowering the probability of transmission). While reviews drew parallels to other films addressing communicable disease control such as Blindness and Outbreak, which also employed quarantine and other measures as plot devices, Contagion was unique in that it further explored why these strategies work (or fail).

Contagion also focuses on the most universal and evidence-based approach to reducing transmission: hand hygiene. The emphasis of this control measure occurs alongside the perhaps more glamorous strategies of vaccine experimentation and novel cures. This is entirely realistic and educational; in the event of a novel respiratory outbreak, hand hygiene would be the chief infection control strategy messaged to the public. When Dr. Mears scolds her support staff in the film (“Stop touching your face!”) and various Centers for Disease Control (CDC) staff are seen fastidiously applying alcohol gels to their hands, they are communicating a valuable public health message to audiences, a message as memorable as the dramatic symptoms of MEV-1.

Popular media assessment of the potential impact of these realistic portrayal of disease transmission was mixed, with some outlets pointing out that existing hand hygiene messages are already largely ignored and that the message that “other loved ones” are actually potential disease carriers would not be well-received. [8] However, other outlets were more optimistic, highlighting the newfound awareness of celebrities from the movie, and suggesting that Contagion was “a 105-minute public service announcement with a simple message: Wash your hands. Often.” [9]

THEME 2: ROLE OF THE PUBLIC HEALTH PHYSICIANS

“I’d rather the news story be that we overreacted than have people dying

because we didn’t do enough.”

– Laurence Fishburne (as Dr. Ellis Cheever)

The film addresses the role of the public health physician early on, as Dr. Ellis Cheever (Laurence Fishburne) passes one of the service staff in the CDC parking lot. The staff member wonders if his son may have attention deficit disorder, and requests Dr. Cheever’s advice. Cheever responds “I’m not that kind of doctor,” and promises to refer the child on to a colleague.

As the outbreak investigation ramps up, two physician epidemiologists lead field investigations, demonstrating the role of public health physicians as experts in data analysis, risk communication, and knowledge transfer. One scene also captures the highly political nature of the job, with resistant local officials voicing economic concerns and referencing public outcry over the perceived pandemic influenza H1N1 overreaction.

Contagion also illustrates the critical balance between population health protection and personal privacy. Dr. Mears takes an exposure history from the husband of the index case, and during the interview, inadvertently divulges that the index case had an extramarital dalliance prior to her untimely death.

Media relations also figure prominently in the movie. One scene involves Dr. Cheever at a press conference, providing an overview of the outbreak and discussing control measures such as hand hygiene. He also responds to insinuations that the MEV-1 outbreak is “another H1N1 overreaction.” A later television interview has a different outcome; Dr. Cheever’s reluctance to provide the number of deaths results in a media catastrophe when the conspiracy theorist Alan Krumwiede (Jude Law) correctly accuses him of preferentially informing loved ones on the severity of the outbreak prior to the public announcement.

Contagion generally portrays the physicians as selfless and caring, but with human failings. In one dramatic field hospital scene, a dying Dr. Mears offers her jacket to a neighbouring patient suffering from rigors. In contrast, Dr. Cheever’s decision to divulge confidential information reveals his fallibility. When confronted, he states: “I did it because I have loved ones, and I would do it again in a heartbeat.” A later scene shows him immunizing his service staff’s son in lieu of taking the immunization himself.  Portraying such intensely personal conflicts allows the audience to find common ground with public health physicians, who often do not share a similar connection to individuals as those in traditional clinical practice.

THEME 3: INTERFACE BETWEEN CLINICAL PRACTICE AND PUBLIC HEALTH

Public health is often challenged to demonstrate its relevance to the people it serves. Some of the most common opportunities for public health to market its relevance arise through specific educational and clinical occurrences. Contagion provides no shortage of memorable scenes exploring such avenues.

As one of the top ten greatest public health achievements, identified by the CDCvaccines represent a significant point of linkage between individual patients and public health. The movie follows the chain of vaccine development from bench research to administration to individual patients, demonstrating to viewers the role of public health in research and policy. Similarly, popular scepticism and the anti-vaccine movement are other clinical considerations with significant connections to public health practice that are heavily explored by the movie.

Another interface between public health and clinical practice is the role of government agencies in disasters and emergencies. Patients do not often consider who administers a health care system until it begins to fail. Contagion cinematically reinforces this link through scenes involving overcrowded waiting rooms and field hospitals, mass graves, and immunization centres.

Communicable diseases – both the common and the rare – represent another intersection of public health priorities and individual patient care. The film strengthens this point with references to a wide spectrum of diseases which require public health action. The fear of an unknown disease weighs heavily throughout the film, thrusting public health officials into action, but some scenes focus on the medical care of MEV-1 patients and reference societal perceptions about the common cold.  As much as public health needs to be informed by medical care of the ill, the control of communicable diseases provide tangible opportunities for the field to connect with the minds of individual patients.

Public health generally fares poorly at promoting its work. Contagion reminds us to be aware of the linkages between certain everyday clinical interventions and public health. At the same time, scenes from the movie depicting these linkages will also draw public attention to the public health basis of these activities. Overall effects on audience perception remain to be seen, and public health physicians should consider how to take advantage of potential changes in the population’s interest and understanding.

THEME 4: SOCIAL MEDIA AND PUBLIC HEALTH

“If I could throw your computer into jail I would.”

– Enrico Colantoni (as U.S. government agent Dennis French)

Another theme front and centre in Contagion is social media as a platform for magnifying and hastening the spread of sensational messages.  Rejected by mainstream print media, blogger Krumwiede amasses an online following to whom he promotes an alternative treatment (Forsythia) while spreading dire warnings about the vaccine.  The viewer inevitably links his activities with a riot in a community pharmacy over Forsythia rationing. In another example of online information spread, Facebook is identified as having propagated Dr. Cheever’s breach of confidence, resulting in widespread revelation and legal consequences.

Contagion illustrates the internet’s ubiquity and the rise of social media, while linking these phenomena to the personal contexts in which they exist – Krumwiede is depicted as exploiting his newfound influence to acquire investor interest in his activities, while news arising from Cheever’s breach spreads out of control online. Both examples demonstrate the power of social media to reach the masses and potentiate action or behaviour change; both also show the unpredictable and uncontrollable nature of such communications.

While the movie depicted the reliance of public health officials on traditional media outlets, a rapidly changing event of such magnitude is precisely the kind that requires the instantaneous information transfer that social media facilitates.  Many public health organizations function on outdated information technology systems, with social media websites frequently excluded from communications plans and even blocked to employee access.[10] In many ways, it reflects a denial that such technologies are increasingly integral to today’s society, with this shift in mass communications reflecting possible changes in the populations they serve.

As social media and information technology continues to evolve, public health institutions will need to find ways to engage their communities through these new modalities and remain attentive to emerging research on online behaviours.  In Contagion, a government official’s retort to Krumwiede, “If I could throw your computer into jail I would,” is especially telling – attempts to control the technology rather than trying to understand the technology’s users are probably misguided and likely to fail.

CONCLUSIONS

Overall, Contagion explores key public health concepts, achievements and messages in the midst of a novel outbreak, and portrays dilemmas faced by public health physicians who straddle the worlds of population and clinical medicine. Contagion promotes an understanding of modern public health practice in a world of dense connectivity and rapid advances in telecommunications. More than tools for modern living, these developments are changing the way we interact in our social environments.

Many of the themes identified in Contagion have been observed in recent outbreaks of notable scale, including the 2015 Ebola outbreak in West Africa and the 2016 Zika virus outbreak in Latin America, current as of this publication. During Ebola in particular, themes around social media information and misinformation was demonstrated by YouTube videos that ranged from comedy to detailing conspiracy theories; health behaviour messaging and the role of public health physicians was observed in press releases and communications (e.g. to encourage changes to burial practices in West Africa); and linkages between front line services and public health were made real in preparations and responses to suspect Ebola cases both in West Africa and in high income settings.

During novel outbreaks, public health physicians would thus do well to recall Contagion, and use elements of the movie’s themes together with evidence-based strategies to consider potential responses, inform public health efforts, and engage the public.

REFERENCES

[1]. Soderbergh, S. (Director). (2011). Contagion [Motion picture]. United States: Warner Bros. Pictures.

[2]. Barnes, B. (2011, September 11). Contagion’ Is No. 1 at Weekend Box Office. The New York Times, Arts Beat. http://artsbeat.blogs.nytimes.com/2011/09/11/contagion-is-no-1-at-weekend-box-office (accessed on October 11, 2011).

[3]. CNS News.com. Uh-oh: Scientists say film ‘Contagion’ is for real. http://www.cnsnews.com/news/article/uh-oh-scientists-say-film-contagion-real (accessed on March 1, 2016).

[4]. Scott R, Skellern C. DNA evidence in jury trials: the “CSI effect”. J Law Med. 2010 Dec;18(2):239-62. Retraction in: J Law Med. 2011 Mar;18(3):preceding page 421.

[5]. Holmgren JA, Fordham J. The CSI effect and the Canadian and the Australian Jury. J Forensic Sci. 2011 Jan;56 Suppl 1:S63-71.

[6]. Petersen, W. (Director). (1995). Outbreak [Motion picture]. United States: Warner Bros. Pictures.

[7]. Meirelles, F. (Director). (2008). Blindness [Motion picture]. United States: Rhombus Media.

[8]. The Guardian (2011) “Contagion won’t spread disease prevention” Retrieved July 21, 2014, from http://www.theguardian.com/film/filmblog/2011/oct/24/contagion-spread-disease-prevention

[9]. Access Hollywood (2011). “Steven Soderbergh Acknowledges Washing Hands More After Making ‘Contagion’.” Retrieved July 21, 2014, from http://www.accesshollywood.com/steven-soderbergh-acknowledges-washing-hands-more-since-making-contagion_article_53009

[10]. Acceptable Use Policy. Policy No: 1002. Version 2.1. February 6, 2009. Information and Technology Division, IT Strategic Planning & Architecture. City of Toronto.

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Illegal Migrant Status and the Littleness of the European Health System

Values such as respect for human rights, human dignity and equality are at the heart of European Union (EU) mission. Yet, even a patchy survey shows that the healthcare system built to assist illegal immigrants does not couple with these concepts since each country gets its own system. Owing to the lack of a shared agenda, across the board improvement perspectives still lie beyond the EU grasp

Pietro_picture-150x150

by Pietro Dionisio

Degree in Political Science, International Relations

Cesare Alfieri School, University of Florence, Italy

Illegal Migrant Status and the Littleness of the European Health System

 

Illegal immigration is hot topic today. Indeed, the future of  Shengen Agreement is in the politicians’ hands now that a flow of exhausted immigrants requiring health assistance crosses the EU borders every day. Is the European healthcare system able to cope with such an unprecedented emergency?

Illegal migrants are at most risk of health problems since, as a result of their financial fragility and illegal status, their rights and privileges are far below those enjoyed by the regular citizens. Under these circumstances, they are denied access to countries’ health assistance system because they are not entitled to the rights granted by national laws. Social benefits for them are usually limited to basic medical assistance in emergency situations, whereas poverty and hardship prevent them from accessing private healthcare.

The current dynamics of external migration to EU incorporate many health risks including epidemic diseases, difficulties related to pregnancy, vulnerability to HIV and AIDS, as well as children’s illnesses and psychological problems.

Some countries in the EU including France, Belgium, Italy and Spain have put systems in place to cope with these issues.

For instance, the Italian government has set up a scheme whereby foreign citizens who are illegally present in Italy are given an “STP” (Temporarily Present Foreigner) six month-valid, though renewable, identification code entailing some benefits. Illegal migrants who cannot afford to fork full ticket expenses out of pocket will only pay a fraction. Otherwise, by signing a “declaration of indigence”, which is valid for six months, they can be exempted from the entire amount duty. The “declaration” entitles them to services such as first level health, emergency and pregnancy services, as well as services for exempted diseases and aging or disabling conditions.

“Aide Médicale de l’État” is the scheme provided by France: one year validity and renewable, it allows undocumented migrants to access health care free of charge.

In the face of this, other countries that do not provide the same health care protection, such as Sweden or Denmark, presently are among the main final destinations of immigrants.

In Sweden, the entitlement of undocumented migrants to health care is highly restricted. However, since July 2013, undocumented adults have the right to subsidized care for conditions requiring urgent medical attention, whereas undocumented children are given the same rights as Swedish residents: a step forward since illegal migrants were previously entitled to unsubsidized emergency care only, except for former asylum seeking children, who had the same rights as Swedish residents.

In Denmark the situation is even worse. In fact, asylum seekers and foreign nationals without legal residence are not covered by the national health insurance system. Only children benefit from the health care service on equal footing with regular residents. Actually, while the “Danish Immigration Service” is tasked with caring for illegal migrants, it only covers pain relief treatments or interventions that cannot be postponed.

The reported country cases above shed some light on the main EU problem, namely the lack of any relevant shared agenda and common operational strategy. Article 35 of the Charter of Fundamental Rights of the European Union leaves the establishment of rules for access to health care to national legislators by stating that “everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices. A high level of human health protection shall be ensured in the definition and implementation of all the Union’s policies and activities”.

What’s more, at country level marked  differences exist in the way regions and municipalities implement existing national legislation with the effect that irregular migrants are not granted equal enjoyment from health care services throughout the country.

In this regard, the local authorities of Stockholm city in Sweden and of Bremen, Cologne, and Frankfurt cities in Germany have chosen a more friendly health policy towards irregular migrants as compared to the rest of either countries. For example, the municipal administrations of Bremen, Cologne and Frankfurt have set up dispensaries for medical consultations to illegal immigrants and basic services as outpatient centers providing free medical examinations without restrictions. The patients are only charged the service cost in proportion to their income if they have one. In case of serious illness, the medical officers may opt for the patient admission to specialist hospitals involved in the project, and/or check whether it would be the case for an asylum grant on health reasons. The structures in question are also collaborating with local NGOs that seek to offer complementary services to health care assistance.

Overall, the fragmented system highlighted here is inconsistent with the main values flaunted by the EU institutions. Expressions such as respect for human dignity and human rights, including the rights of persons belonging to minorities, or equality and human dignity, represent the core values supporting the EU legitimacy. Unfortunately, these concepts risk to lose their integrity when they collide with political and financial interests and a narrow-minded mindset.

All the European member states must find a common solution to the illegal migration issue. Meanwhile, the EU leadership should firmly bear in mind that if Europe lacks the structural strength to host overflowing masses of people, the respect for human rights and equality should never be forgotten.

 

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