Gaza Strip: the Press of War on People’s Health

The last war in the Gaza Strip has left many people in bad conditions. Their health, food, home security and living conditions as a whole got worse in the last year. The situation is unbearable and cannot improve without Israel pressure relief combined with not hypocrite help by the international system

Pietro_picture-150x150

by Pietro Dionisio

Degree in Political Science, International Relations

Cesare Alfieri School, University of Florence, Italy

 Gaza Strip: the Press of War on People’s Health

 

The last Gaza war had a huge impact on Palestinian people. There were 2,251 Palestinian deaths against 73 Israeli and 11,231 Palestinian injuries against 1,600 Israeli. But, the shadow of the war does not stop at this! In fact, the economic consequences are enormous. The slow pace of recovery in Gaza has been insufficient to make up for the 2014 recession and conflict. Timid signals of growth in the first quarter of 2015, driven by the reconstruction process, came to a halt in the third quarter. According to the International Monetary Fund, the Gaza economy is not expected to reach its 2013 annual level until the end of 2017.

Additionally, one and half year after the 2014 hostilities, more than 7,000 explosive remnants of war (ERW) are estimated to remain in the Gaza Strip. Only 30 per cent of ERW have been identified and removed. The remaining 70 per cent pose a threat to the population of Gaza, especially children and adults who work on agricultural land littered with ERW.

What’s more, victims are not only caused by war, but by low quality healthcare as well. In fact,  nearly 50 per cent of Gaza medical equipment is outdated and the average wait for spare parts is approximately 6 months. In 2014, the MoH Central Drug Store in Gaza reported that an average of 26 per cent of medicines on the essential drug list (124 of 481 items) and 47 per cent of medical disposables (424 of 902 items) were at or near zero stock for MoH facilities. The main reason was an insufficient budget rather than security restrictions imposed by Israel. Furthermore, increasing poverty is the most pervasive barrier to specialized health services access.

Limited opportunity for health professionals in Gaza to attend training courses abroad and access restrictions to get familiar with new medical techniques are also slowing down improvements in developing health care services in Gaza. Political disagreements between the concerned parties remain a challenge in spite of the April 2014 reconciliation between Ismail Hanijeh, the prime minister of Hamas, and a senior PLO delegation dispatched by the Palestinian President Mahmoud Abbas.

Moreover, as stated by the Office for the Coordination of Humanitarian Affairs (OCHA), the Gaza blockade is responsible for a chronic energy crisis in the coastal enclave, impairing service delivery, students’ educational outcomes, the functioning of hospitals and medical equipment and the working of more than 280 water and waste water facilities. Over recent weeks, these circumstances have further worsened and brought increased hardship to Gaza people, with daily electricity supply being only 4-8 hours on (12 hours off) schedule.

Gaza hospitals not only lack electricity but, as reported, the entire health care system is in ruins due to Israeli restrictions on the import of medical equipment from outside Gaza. Israel allows patients to receive medical care abroad only in life-and-death cases, involving a lengthy bureaucratic process. This leaves many Palestinians in Gaza suffering from severe orthopedic problems, visual and hearing impairments or other serious illnesses without access to the required medical care and treatments.

The poor living conditions are made even worse by food insecurity. As such, many Palestinian farmers, fishers and herders face many challenges. Relevantly, since the Separation Barrier and Israeli settlements expand, farmers have increasingly less land and water resources for their crops and animals.

Adding to access constraints, families face disproportionate economic hurdles. For example, many must rely on water brought by tankers, which costs four-times more than the networked water supply. The high costs of livelihood inputs – such as fertilizers and animal feed – reduce farmers’ profits and inflate market prices. These conditions lock communities in poverty, leaving one in five Palestinians food insecure. In particular, 47 per cent of Palestinian households in the Gaza Strip were food insecure in 2014, with a 2 per cent increase in 2015.

Food access decline in Gaza is a result of growing unemployment, high food prices, and extreme volatility of the economy. But, fortunately, something is moving on. On 3 April 2016, Israel just expanded the Palestinian fishing zone off the southern portion of Gaza’s coast to nine nautical miles from six, allowing fishing in areas that had been off limits for a decade. The expansion of the fishing zone is expected to add 400.000 shekels, nearly $ 106.000, to the 6 million shekels in annual revenue generated by Gaza’s fishing industry.

However, aside from the good news above, there’s nothing to be happy for since the situation as a whole is unbearable for almost all the population and many concerns are renewed every day. The fragile political context, the disastrous humanitarian conditions, as well as the lack of adequate water supplies and electricity services are just a few examples of the many issues on the table.

The resources received from international organizations may have limited impact without  Israel pressure relief. Furthermore, the international political fora should stop blathering nice words suitable for the occasion and leave the veil of hypocrisy. That’s nothing new, but the only way of guaranteeing a better future to Gaza population.

 

L’ Impegno dei BRICS per la Salute Globale

Il gruppo BRICS (Brasile, Russia, India, Cina e Sudafrica) sta contribuendo alla salute globale in un’ottica di multilateralismo fondato su stanziamenti economici, “capacity building”, facilitato accesso a terapie e assistenza, e sviluppo di nuove strategie e strumenti. Il crescente investimento in innovazione sanitaria, produzione di medicine, diagnostici e vaccini da parte dei BRICS prevedibilmente continuerà a rappresentare un beneficio per i Paesi poveri 

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by Daniele Dionisio

Membro, European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases

Progetto Policies for Equitable Access to Health – PEAH

  L’ Impegno dei BRICS per la Salute Globale

 

Brasile, Russia, India, Cina e Sudafrica, gruppo espresso dall’acronimo BRICS, sono note economie emergenti e globalmente rappresentano circa il 25% del prodotto interno lordo mondiale.

Se la crescita dei BRICS sembra ora rallentare, questi Paesi hanno mostrato migliori capacità di recupero dalla recente crisi finanziaria globale rispetto a USA ed Europa. Non stupisce, perciò, che il capitolo di spesa dei BRICS per cooperazione internazionale sia in ascesa. Complessivamente, i BRICS enfatizzano la cooperazione Sud-Sud e stanno contribuendo alla salute globale in un’ottica di multilateralismo  fondato su stanziamenti economici, “capacity building”, facilitato accesso a terapie e assistenza, e sviluppo di nuove strategie e strumenti.

Dopo il loro primo meeting a Pechino nel 2011, i ministri della Salute dei BRICS decisero nel 2012 di incontrarsi annualmente in occasione delle assemblee mondiali OMS. Ma già nel loro primo meeting quattro priorità furono condivise: rafforzamento dei sistemi sanitari nazionali BRICS (garantendo l’accesso alle tecnologie per la salute), investire nella lotta alle patologie infettive e a quelle non trasmissibili, sostegno a organizzazioni internazionali di riferimento e a partenariati per la salute globale, e trasferimento di tecnologie ai Paesi in via di sviluppo anche al fine della produzione autonoma di farmaci generici di qualità.

Le Sfide

Con l’eccezione del Sudafrica, le patologie non trasmissibili rappresentano il maggior problema per i BRICS. E l’incidenza è in crescita: la Russia ha uno dei più alti tassi mondiali di malattie cardiovascolari; mentre il carico di diabete è elevatissimo per Cina e India.

In aggiunta, i Paesi BRICS (Russia esclusa) sono endemici per almeno una delle più comuni patologie tropicali neglette (NTDs). Ed è dell’ ottobre 2015 l’impegno dei ministri BRICS della Salute “to strive for achieving the Global 2020 NTD control and elimination goals, for universal coverage of everyone in need by 2030.”

Altra importante area di sfida e influenza dei BRICS è il loro contributo al dibattito sulle attuali mutazioni climatiche esiziali per la salute. Russia, Cina e India detengono, infatti, enormi riserve di carbone (circa un quarto del volume mondiale), e mentre la Cina sta investendo in energia pulita, ha tuttavia in programma l’apertura di circa 70 nuovi aeroporti.

Al riguardo è notizia positiva che quattro dei BRICS (Russia esclusa) abbiano fondato un gruppo di coordinamento, chiamato BASIC, per esprimere una posizione unitaria sul problema climatico.

Operatività

Brasile
Le iniziative correnti includono HIV/AIDS, nutrizione infantile, finanziamenti multilaterali e “tobacco control”. Il Brasile è stato autorevole nel negoziato “Framework Convention on Tobacco Control”  ed è attualmente Paese “smoke-free” leader su scala mondiale data la dura legislazione anti-fumo per gli spazi pubblici.

Sulla scia del successo interno per l’accesso universale alle terapie anti-HIV, il Paese è impegnato nel supporto internazionale, incluso  l’investimento di 21 milioni di dollari per la costruzione di un impianto per farmaci specifici in Mozambico. Il Brasile ha devoluto, nel periodo 2006-2009, 106,5 milioni di dollari a OMS e PAHO (Pan-American Health Organization), si è impegnato per 20 milioni di dollari in vent’anni a GAVI (Global Alliance for Vaccines and Immunisation), e ha contribuito alla fondazione di UNITAID, di cui è generoso finanziatore.

Il Paese è, inoltre, accreditato produttore di farmaci generici di qualità e basso costo.

Sul fronte NTDs il Brasile sta collaborando con il Venezuela per la lotta alla cecità fluviale (oncocercosi) e ha realizzato un programma nazionale di controllo ed eliminazione delle aree endemiche per NTDs.

Russia
La Russia spende annualmente centinaia di milioni di dollari in cooperazione internazionale, soprattutto per la salute. Il suo contributo comprende stanziamenti per polio, vaccini e NTDs, oltre al supporto ad iniziative e partenariati per la salute globale (la Russia è partner di Banca Mondiale, OMS e Fondo Globale per la Lotta ad AIDS, TB e Malaria).

In coerenza il governo ha investito oltre 4 miliardi di dollari nel potenziamento, innovazione e sviluppo dell’ industria farmaceutica nazionale nell’ambito del programma Pharma 2020.

La Federazione Russa ha inoltre ospitato nel 2011 la prima conferenza internazionale sulle malattie non trasmissibili alla cui risposta globale ha destinato 36 milioni di dollari.

India
Il budget complessivo per aiuti all’estero è in crescita costante. Ma se il governo è sensibile alla salute internazionale, le problematiche sanitarie interne restano prioritarie. Alla salute globale l’India contribuisce con la produzione di farmaci e vaccini di qualità e basso prezzo (80% dei farmaci acquistati da donatori per i paesi in via di sviluppo; 60-80% dei vaccini approvvigionati tramite le Nazioni Unite), con la campagna di eradicazione della polio, e pure con il network “Pan-African Telemedicine and Tele-Education” che collega ospedali e università dell’Africa occidentale con controparti indiane per la diffusione e condivisione di pratiche ottimali. Queste iniziative si sommano alla erogazione di servizi a basso costo, come esemplificato dall’Aravind Eye Hospital la più grande organizzazione oculistica mondiale con 2,4 milioni di persone curate ogni anno. Aravind eroga servizi gratuiti, o a prezzi minimi, al 65% dei pazienti e ha assicurato assistenza tecnica all’estero, Cina ed Egitto inclusi.

Recentemente l’India ha istituito il “National Deworming  Day” e conduce il maggior programma mondiale per la distribuzione di farmaci anti-filaria: quasi metà della popolazione mondiale a rischio di filariasi linfatica vive, infatti, in India.

Cina
Il Paese ha sensibilmente aumentato le spese per cooperazione internazionale, Africa soprattutto, attraverso canali bilaterali di mutuo interesse e non ingerenza nelle politiche nazionali. La salute occupa uno spazio modesto nel complessivo stanziamento, ma il governo cinese ha investito considerevolmente in capitoli specifici, nel contempo potenziando l’industria farmaceutica nazionale e l’innovazione tecnologica interna (oltre 1 miliardo di dollari destinati a ricerca/sviluppo farmacologico e controllo/prevenzione delle infezioni).

Coerentemente, la Cina si è dotata di un nuovo piano nazionale contro la schistosomiasi la cui esperienza ha condiviso nel recente “Forum on China-Africa Cooperation” tenuto lo scorso dicembre in Sudafrica.

Alla salute globale la Cina provvede con team medici (migliaia di operatori cinesi sono attivi in oltre 60 Paesi per servizi e formazione), controllo della malaria, pianificazione familiare, ed investimento in innovazione sanitaria (nel 2011 il Ministero cinese per la Scienza e Tecnologia ha attivato un partenariato con la Bill & Melinda Gates Foundation inclusivo di sviluppo di nuove tecnologie sanitarie per i Paesi poveri).

Sudafrica
L’impegno internazionale è modesto rispetto agli altri BRICS poichè il governo ha soprattutto investito nelle problematiche sanitarie interne, non ultimo il capitolo HIV/AIDS. Ma il contributo del Sudafrica, comunque importante, comprende la diagnostica della tubercolosi, la fornitura di vaccini, e finanziamenti per Ricerca&Sviluppo attraverso la propria Technology Innovation Agency. Al riguardo, oltre ad una innovativa GeneXpert diagnostica molecolare per tubercolosi, il Paese produce tutti i vaccini previsti dal South Africa’s Expanded Programme on Immunisation, che inoltre fornisce a Namibia, Botswana e Swaziland.

Più luci che ombre

Motivazioni economiche e politiche possono aver determinato l’impegno dei BRICS al supporto internazionale per la salute globale e lo sviluppo, e non mancano preoccupazioni circa l’efficacia nel tempo dei loro programmi. Nondimeno, il crescente investimento in innovazione sanitaria, produzione di medicine, diagnostici e vaccini da parte dei BRICS prevedibilmente continuerà a rappresentare un beneficio per i Paesi poveri.

I BRICS si sono impegnati alla collaborazione reciproca, e stanno cominciando a lavorare insieme per migliorare l’impatto dei loro programmi assistenziali. Nel contempo sono già operative agenzie centrali dedicate, come nel caso di Russia e Brasile, che aiuteranno a massimizzare l’impatto degli investimenti. La Cina ha un dipartimento per lo sviluppo all’interno del Ministero per il Commercio, e nel 2011 ha prodotto un “white paper” quale formale, pubblica visione d’insieme del suo approccio allo sviluppo internazionale.

Per progredire ulteriormente nella direzione intrapresa, i BRICS dovrebbero espandere ai Paesi vicini i modelli di cooperazione  adottati e massimizzarne l’impatto mediante un approccio trasversale. Giusto ad esempio, la lotta alle NTDs dovrebbe essere compresa nelle  campagne per la malnutrizione e l’accesso all’acqua potabile e alle prioritarie misure igieniche, sistemi fognari e “no open defecation” inclusi. Il conseguimento di questi obiettivi proteggerebbe le comunità dal circuito di rischio delle parassitosi intestinali.

Al riguardo sarebbe strumentale la copertura finanziaria offerta dalla nuova BRICS Development Bank. Auspicabilmente, la BRICS Bank dovrebbe investire in complementarietà con le controparti (Banca Mondiale, Fondo Monetario Internazionale, Banca Asiatica per lo Sviluppo, Banca Africana per lo Sviluppo,  Banca Asiatica per le Infrastrutture) relativamente ai progetti di salute e sviluppo  per i Paesi a risorse limitate.

PER APPROFONDIRE

The BRICS countries: a new force in global health? http://www.who.int/bulletin/volumes/92/6/14-030614/en/

BRICS champion the fight to end neglected tropical diseases https://www.devex.com/news/brics-champion-the-fight-to-end-neglected-tropical-diseases-87523

BRICS Renew Commitment to NTD Elimination Goals in Moscow Declaration http://www.globalnetwork.org/brics-renew-commitment-ntd-elimination-goals-moscow-declaration

Shifting Paradigm: How the BRICS Are Reshaping Global Health and Development http://www.g20civil.com/documents/brics/ghsi_brics_report.pdf

New Development Bank BRICS http://ndbbrics.org/za.html

3 Reasons the BRICS’ New Development Bank Matters http://thediplomat.com/2014/07/3-reasons-the-brics-new-development-bank-matters/

The BRICS Post http://thebricspost.com/

The latest news and comment on the Brics group of emerging national economies – Brazil, Russia, India, China and South Africa http://www.theguardian.com/business/brics

BRICS health ministers commit to put the BRICS countries on the Fast-Track to end the AIDS epidemic http://www.unaids.org/en/resources/presscentre/featurestories/2015/october/20151030_BRICS

Preliminary observations on social security and health care systems of the BRICS http://www.ipc-undp.org/pub/eng/OP294_Preliminary_Observations_on_Social_Security_and_Health_Care_Systems_of_the_BRICS.pdf

 

 

 

 

 

 

 

 

 

 

 

 

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Maximalist Machinations in the TPP: an Illustration with Biologics

Biologics is the future of medicines, and PhRMA is preparing for the next wave of IP to suit the changing medicines landscape. 

....that it is based on the idea that maximalist IP is needed to drive innovation of new medicines. 

Unfortunately, most of the public health exceptions interred in today’s trade agreements are... difficult for governments to employ in protection of their public health policies. This is because these exceptions require that the public health measures in question be ‘not more trade restrictive than necessary’ or that they are not disguised barriers to trade. 

The assertion that trade as is does not trump public health is disingenuous and the new biologics market exclusivity provisions indicate a new and perilous trend... to delay entry of biosimilars into the market

Fifa Rahman

by Fifa Rahman*

Policy Consultant at Malaysian AIDS Council

 Maximalist Machinations in the TPP: an Illustration with Biologics

 

On Wednesday, the 6th of March of 2013, the Grand Copthorne Waterfront Hotel in Singapore was bustling with the movements and voices of TPP negotiators from 11 countries, as well as representatives of multinational corporations and civil society. The 16th round of TPP negotiations was underway, and on this day was a break for negotiators to attend lecture style presentations from stakeholders, and later for chief negotiators to sit on a stage in alphabetical order, and provide superficial updates to enquiring stakeholders.

Stakeholders were given rectangular tables in two rooms to set up propaganda materials, with corporations like Google, Visa, and several big seed companies habituating the larger room, and civil society stakeholders working on environmental protection, internet freedoms, and access to medicines occupying the smaller one.

Rumours had just begun of a 12-year biologics provision in the IP text to match. The IP text leaked at that point had no mention yet of biologics. The next leaked text as we now know contained a placeholder for biologics, and the final IP leak contained the ambiguous 5 or 8 years of market exclusivity for biologics.

A fellow activist from the Kuala Lumpur-based Breast Cancer Welfare Association had been particularly concerned, and approached a number of negotiators to emphasise the impact on access to cancer medication. After the chief negotiator briefing, a tick-the-stakeholder-consultation-box fallacy during which non-answers were frequent and spewed without hesitation, this activist approached the US Chief Negotiator Barbara Weisel, with pleas on behalf of breast cancer patients. In response to this, Weisel took his hand in hers, and told him that her mother was a cancer survivor, and that she understood. Later during the Kota Kinabalu negotiation round, Barbara Weisel would, in response to my query, state that there was a need to find the ‘golden balance’ in IP.

The problem with the quest to find the ‘golden balance’ is that it is based on the idea that maximalist IP is needed to drive innovation of new medicines. In addition, this claim that negotiators were looking to find the golden balance, was uttered on the cusp of US negotiators tabling 12 years of market exclusivity for biologics medications – which include several blockbuster cancer drugs like Herceptin for breast cancer, insulin, and several vaccines, and other provisions that would delay entry of generics into markets and reduce transparency on pharmaceutical R&D costs. The disingenuous statements continued right to the signing of the TPP on 4 February 2016, where a number of Malaysian politicians, including the Minister of Health and the Minister of International Trade and Industry, claimed that as far as IP is concerned, it was status quo for Malaysia. This claim was centred on the fact that Malaysia already has 5 years data exclusivity, and the 5 years exclusivity for biologics in the TPP mirrored that. Naughty, given that the Malaysian law provided for data exclusivity and the TPP provided for market exclusivity, which in reality could run consecutively, delaying access to generics even further.

A tool that IP maximalists claim will contribute to the golden balance is the public health exception within these trade agreements. Most recently, at the Global Dialogue for the UN Secretary-General’s High Level Panel on Access to Medicines in Johannesburg on 17th March 2016, Roger Kampf, Counsellor in the Intellectual Property division of the World Trade Organisation (WTO) referred to the public health exception and stated that these prove that trade does not trump health. Unfortunately, most of the public health exceptions interred in today’s trade agreements are a variation of the GATT XX exception, which is notoriously difficult for governments to employ in protection of their public health policies. This is because these exceptions require that the public health measure in question be ‘not more trade restrictive than necessary’ or that they are not disguised barriers to trade. (Shaffer et al. 2005)

The assertion that trade as is does not trump public health is disingenuous and the new biologics market exclusivity provisions indicate a new and perilous trend. While some academics disagree strenuously with me, the introduction of IP provisions specific to biologics does not merely represent a change from HIV activism to cancer activism, although this in itself, in my view, is significant. Biologics is the future of medicines, and PhRMA is preparing for the next wave of IP to suit the changing medicines landscape.

Because market exclusivity is so new, there isn’t yet a lot of research on it. A recent study on market exclusivity in the U.S., however, found that ‘a uniform increase in the minimum period of regulatory exclusivity would disproportionately benefit drugs that are likely to be of less clinical importance’. (Wang et al. 2015) It should also be noted that data exclusivity and market exclusivity are different – and that they have run at different times for the same medicine. (Teva v European Medicines Agency) This means that they can be used as a tool to delay entry of biosimilars into the market.

Some have claimed that biosimilars take 13-16 years to come to market anyway, so a 12-year exclusivity shouldn’t get activists’ panties into a knot. But as technology transfer happens and biosimilar companies get better and better, this time will get shorter. So while the provision may seem rather docile now, biologics market exclusivity has the potential to grow into a much more menacing monster. All should care about this because the TPP is the model for future trade agreements, and that monster will eventually manifest itself in the form of a negotiator, ready to take a patient’s hand in hers, telling him he understands.

 

A deadline-oriented public health policy professional and strategic advocate with 7+ years of experience in HIV and HCV, with a focus on drug policy reform, access to affordable medication and intellectual property, anti-discrimination policy, and qualitative research on women who use drugs, and 2+ years of experience in tobacco control. Co-editor of the 2013 book Drug Law Reform in East and Southeast Asia. Alumnus of the U.S. Department of State International Visitor Leadership Program (IVLP) (individualised) on HIV, Pharmaceuticals, and Global Governance. https://www.linkedin.com/in/fifa-rahman-6ba2ab2a

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Related link: TPP: Up with Corporate Profits Outweighing Equity in Health! http://www.peah.it/2015/11/tpp-up-with-corporate-profits-outweighing-equity-in-health/

 

 

 

 

 

 

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Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

PEAH5

Breaking News: Link 183

 

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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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