Per uno Stato Laico e Democratico nella Palestina Storica, la Medicina per la Pace

La collaborazione tra personale sanitario israeliano e palestinese acquisisce  un significato simbolico e concreto, non solo nel campo medico, ma anche nello sforzo di ottenere pace e giustizia in quest'€™area di conflitto. Per la prima volta nella storia, nel 2013 un ministro palestinese ha visitato il complesso ospedaliero di Hadassah, eccellenza della sanità  a Gerusalemme, accompagnato da una delegazione di funzionari palestinesi. Nel 2012 oltre 210 mila palestinesi sono entrati in Israele per trattamenti sanitari e medici. Il dato è vistosamente cresciuto anche soltanto rispetto al 2008, quando i palestinesi del West Bank e della Striscia di Gaza che hanno beneficiato di cure mediche gratuite nello stato ebraico sono stati 172 mila

 Per uno Stato Laico e Democratico nella Palestina Storica, la Medicina per la Pace

 fotochighine_n

by Cinzia Chighine*

Regione Toscana, Attività  Internazionali  

 

Venti anni fa, esattamente il 13 settembre 1993, sono stati firmati gli accordi di Oslo all’interno dell’autorevole cornice della Casa Bianca:  una stretta di mano simbolica tra il Primo Ministro israeliano Yitzhak Rabin e il Presidente  dell’OLP, Yasser Arafat ha siglato lo straordinario momento, segnando  il processo di Pace in Medioriente.

Dopo un ventennio, il processo politico, così entusiasticamente lanciato – perchè di Pace si trattava – appare oggi nel corso della Storia recente solo un obiettivo intermedio in un percorso iniziato il 29 novembre 1947, con la Risoluzione delle Nazioni Unite che sancì la spartizione della Terra d’ Israele con la Palestina.

Molti fattori hanno contribuito al collasso del processo di Oslo, ma la radice del suo crollo e i semi della catastrofe, che seguì, furono piantati dai tre leader Arafat, Rabin e Peres. Tutti e tre ricordati nella storia “€œUomini di Pace”€ ma con forti responsabilità  fin dall’inizio del processo nel fallimento degli Accordi stessi [1].

Arafat non ha saputo o voluto agire come uomo della transizione palestinese, dimostrando limiti sia in termini di mentalità  che di leadership, non svolgendo a pieno il ruolo da Statista che l’era diplomatica gli richiedeva. L’esempio più evidente è l’immagine del suo arrivo alla cerimonia della Casa Bianca per la firma, indossando una divisa militare. La scelta di non cambiare l’uniforme in un vestito di affari, ha sancito per sempre nel ricordo storico di tutti il ruolo da combattente più che da grande statista.

Da parte israeliana, Peres e Rabin hanno fatto un grosso errore a non comunicare alle opinioni pubbliche israeliane e palestinesi, subito dopo la firma degli Accordi di Oslo, il fatto che questa nuova fase rappresentasse una profonda trasformazione della politica israeliana, che mirasse finalmente a conseguire un’inequivocabile soluzione di due Stati per due Popoli sulla base dei confini del 1967 – condizionati, naturalmente, al corretto rispetto delle misure di sicurezza per entrambi i territori.

Di conseguenza, gli apparati della burocrazia israeliana non hanno mai regolato un nuovo approccio “€œdi buon vicinato”€ con i palestinesi: i vari attori delle Forze di Difesa israeliane, la Polizia e Ministeri non hanno mai trasformato il loro atteggiamento psicologico e pratico per una nuova realtà  in evoluzione.

In pratica, Rabin e Peres hanno intenzionalmente lasciato vaga la visione dei negoziati, così facendo hanno generato una dissonanza tra  visione diplomatica internazionale e gravi conflittualità  interne.

La mancanza di una strategia israeliana chiara e condivisa ha creato un problema che ben presto è divenuto ancora più ruggente con l’accordo del 1995: quando la squadra negoziale israeliana scoprì che le istruzioni erano di raggiungere un esito nella trattativa che avrebbe lasciato aperte tutte le opzioni – “€œforse ci sarà  uno Stato palestinese, o forse no, forse Israele si ritirerà , o forse no, forse ai palestinesi si sarebbe accordata solo l’autonomia, o forse no”€ – l’assenza di qualsiasi strategia ha portato ad un accordo minimo con il solo esito concreto di imporre superficiali “successi” israeliani ai palestinesi con l’obiettivo generale di negare loro i necessari passi per la creazione di uno stato emergente in Palestina. Questa situazione ha contribuito sostanzialmente al fallimento della realizzazione degli accordi di Oslo.

Allo stesso tempo, Israele ha continuato – fino ad oggi-  la costruzione e l’espansione degli insediamenti, lanciando un messaggio interpretato da molti palestinesi, e non solo, come un segnale evidente che Israele non potrà  mai ritirarsi da queste zone. Inoltre, l’umiliante trattamento sul terreno di tutti i palestinesi come nemici potenziali continua in maniera e frequenza sempre più cruenta, anche se la maggior parte dell’opinione pubblica israeliana è convinta che “€œla popolazione vicina”€ ormai non costituisca  più una minaccia per Israele.

Le relazioni tra Israele e i palestinesi sono deteriorate a un ritmo sempre più veloce sotto la prima amministrazione Netanyahu (1996-1999) e con la sucessiva amministrazione 1999-2001 di Ehud Barak, che ha contribuito sostanzialmente al deterioramento della situazione. Lo stesso fallimento del vertice di Camp David, che  per alcuni opinionisti [1] è in gran parte attribuibile alla strategia sbagliata di Barak sui negoziati – ha scatenato l’ Intifada , che a sua volta ha portato alla violenza reciproca e la perdita di fiducia nella possibilità  di realizzare la Pace in Terra Santa.

Oggi, a vent’anni da Oslo, è giunto il tempo di fare tutto il possibile al fine di portare il conflitto israelo-palestinese a termine e di intraprendere un viaggio nuovo, scardinando e andando oltre l’attuale visione diplomatica internazionale, ponendo nuovi obiettivi alle società  israeliana e palestinese, affrontando le ingiustizie e la reale condizione dei cittadini arabi di Israele nel corso degli anni.

Una nuova strategia capace di affrontare, ad esempio, la definizione dello Stato non più solo come quella del popolo ebraico – una formulazione adeguata nel periodo post seconda guerra mondiale – ma di uno Stato laico e democratico nella Palestina storica [2], di tutti i suoi cittadini [3]. Una nuova strategia capace di essere dinamica e ricettiva al cambiamento.

Nel rinnovamento, la società  dovrà  necessariamente  formulare un nuovo denominatore comune il più ampio possibile tra le sue diverse componenti, al fine di facilitare l’integrazione di tutti, riconoscendo sostanzialmente l’effettiva natura della società  israeliana e nel contempo permettendo agli arabi di sentirsi cittadini a pieno titolo, con pari diritti e doveri.

Nella realtà  attuale sembra che Israele non abbia una politica di Pace. Le continue  dichiarazioni a sostegno della Pace e di due Stati non costituiscono una strategia, soprattutto quando si scontrano con la realtà  drammatica degli insediamenti in espansione, gli avamposti illegali che fioriscono settimanalmente, l’assoluto immobilismo dello sviluppo economico e sociale palestinese in Area C (il 60 per cento della Cisgiordania) bloccato a causa della costante minaccia di annessione israeliana,  l’€™aumento delle by pass roads, riservate agli israeliani, le zone militari chiuse, attorno alle città  e ai villaggi palestinesi, che hanno cancellato ogni possibilità  di uno stato contiguo, la conseguente cantonizzazione della Cisgiordania che ha prodotto delle enclave palestinesi, circondate da insediamenti israeliani, simili a bantustan del Sudafrica.

La sensazione generale per i palestinesi è quella di umiliazione, con nessun cambiamento all’orizzonte, nonostante che le recenti risoluzioni europee in materia di controllo israeliano sulla Cisgiordania sembrano aver aperto una campagna anti-israeliana che pone una minaccia economica per il Paese.

La mancanza di progressi politici indebolisce anche la parte palestinese moderata, la quale continua a sostenere l’ approccio di “€œDue Stati”€ sulla base dei confini del 1967 [4].

L’ attuale iniziativa guidata dal Segretario di Stato americano John Kerry sembra offrire  l’opportunità  di avanzare nel processo sempre più complesso e intricato. Ma la realtà  ci offre attualmente una combinazione particolarmente sfavorevole: un governo israeliano che non è disposto a portare avanti l’agenda di Pace, un’opinione pubblica israeliana apatica e scettica, gli sconvolgimenti nel mondo arabo, che molti in Israele percepiscono come una minaccia, la debolezza politica della leadership palestinese, che soffre di una grave divisione sostanziale tra Fatah e Hamas, così come tra la Cisgiordania e Gaza, limitando ulteriormente la manovrabilità  politica palestinese.

Negli ultimi tre decenni  i progetti negoziali falliti hanno disseminato di carcasse la diplomazia mediorientale. Per più di 30 anni, esperti e politici hanno avvertito un “punto di non ritorno”. Il Segretario di Stato John Kerry è solo l’ultimo di una lunga serie di diplomatici americani sposati ad un’idea il cui tempo è ormai passato.

Entrambi le parti hanno motivi per aggrapparsi all’ illusione della “€œTwo States Solution“€. L’Autorità  palestinese ha bisogno che la sua gente continui a credere che si stiano compiendo progressi verso una soluzione a due Stati in modo che possa continuare a ottenere gli aiuti economici e sostegno diplomatico utili a sovvenzionare gli stili di vita dei suoi leader, i posti di lavoro di decine di migliaia di soldati, spie, agenti di polizia e funzionari pubblici e la prominenza del potere in una società  palestinese che lo vede come corrotto e incompetente.

Il Governo israeliano si aggrappa alla nozione dei due Stati , perchè sembra riflettere i sentimenti della maggioranza ebraica israeliana e mimetizza sforzi incessanti per espandere il territorio di Israele nella West Bank.

I politici americani hanno bisogno dello slogan “€œdue Stati”€ per mostrare che stanno lavorando per una soluzione diplomatica, per mantenere la lobby pro-Israele e per mascherare la loro incapacità  umiliante di una strategia diplomatica alternativa.

Infine, l’industria del “€œProcesso di Pace”€ – con le sue legioni di consulenti, esperti, accademici e giornalisti ha bisogno di un rifornimento costante di lettori, ascoltatori e finanziatori. Il tutto produce un terribile congelamento [5].

Di fronte l’esigenza ruggente di quotidianità  e sopravvivenza delle due popolazioni.

La situazione è similare alla Spagna del 1975, quando il dittatore Francisco Franco è entrato in coma: i mezzi di informazione hanno iniziato una lunga veglia di morte, annunciando ogni notte che il Generalissimo Franco non era ancora morto. Questa disperata fedeltà  accomuna  le speranze nel viatico della soluzione dei due stati oggi.

E’ˆ vero che alcuni coma miracolosamente finiscono e grandi sorprese a volte capitano. Il vero problema è che i cambiamenti necessari per realizzare la visione della realizzazione dei due robusti Stati, israeliano e palestinese, richiederebbero oggi più che mai un alto livello di attenzione diplomatica, che ad oggi è carente e scadente.

Notizia di questi giorni è che in cambio di un accordo fra le parti, Bruxelles offre buoni affari in Europa. La proposta “Partnership Privilegiata Speciale”, giunta nel dicembre 2013 da Bruxelles – che con una mano ferma critica le colonie israeliane, ma con l’altra torna a proporre una pace economica tra le parti – si basa su un pacchetto senza precedenti da parte dell’Unione Europea di supporto politico, economico, cooperazione sanitaria e sicurezza ad entrambe le parti, israeliana e palestinese, se saranno in grado di finalizzare la Pace [6]. La proposta dei 28 è cristallina: la UE offrirà  a Israele e al futuro Stato di Palestina l’ingresso facilitato nel mercato europeo, rapporti di natura culturale e scientifica, sostegno nell’investimento e nel commercio con partner europei. Precondizione al super-pacchetto europeo (oltre, ovviamente, ad un accordo di Pace definitivo) è il congelamento dell’espansione coloniale israeliana nei Territori Occupati.

Il piano europeo rientra perfettamente in quella “pace economica” che l’amministrazione di Washington tenta da tempo di far passare come il miglior strumento per un accordo che ponga fine a sei decenni di conflitto. Un’opzione che lo stesso premier Netanyahu ha più volte ribadito e che ha trovato la sua massima espressione, il maggio scorso, nell’iniziativa “Breaking the Impasse” di 200 businessman israeliani e palestinesi: parlare di affari e fare affari per risolvere le questioni politiche [7].

Dal punto di vista oggettivo, l’attuale prospettiva è che l’opzione dei due Stati è svanita, e ciò che rimane è quello di agire attraverso mezzi non violenti per stabilire uno “€œStato Unico”€ indipendente e democratico tra il fiume Giordano e il Mar Mediterraneo. Al di là  della trappola della normalizzazione e oltre le politiche israeliane di destra, tra cui l’estremismo religioso, che si basano su una promessa divina e una equazione che pone la Terra al di sopra del Popolo e dello Stato, sempre più esponenti della politica isreliana e palestinese [8] recentemente propongono formule su uno Stato Unico come soluzione al conflitto, sostenendo un singolo  stato egualitario [9].

Ghada Karmi – medico, scrittrice e docente universitaria di origine palestinese [10] – nel suo recente libro dal titolo “€œSposata a un altro uomo. Israele e la questione palestinese”€, ripercorre le tappe più importanti del conflitto mediorientale da quando l’€™idea di costituire uno Stato ebraico in Palestina fu per la prima volta discussa, e porta avanti la tesi del “€œOne-state solution“€: quella di uno Stato unico, laico e democratico, nel territorio della Palestina storica, che assicuri a tutti i cittadini, arabi, ebrei e di altre culture e religioni, uguali diritti di cittadinanza.

La sua analisi nasce dal tentativo di offrire nella complessità  del conflitto un contributo alla sua soluzione, proponendo, con approfondite analisi storiche e psicologiche, una tesi ritenuta impopolare: “€œUno Stato laico e democratico”€ dove i diritti non derivano dall’€™appartenenza a un gruppo etnico o religioso, ma dalla legge che ne stabilisce l’€™uguaglianza e che riflette la situazione attuale di multiculturalità  della popolazione in quell’€™area a causa anche delle migrazioni di persone ebree da tutto il mondo, che Israele ha favorito.

D’€™altra parte, le società  arabe hanno avuto storicamente una connotazione di pluralismo e tolleranza religiosa e l’analisi mostra come quelle terre siano state rifugio degli stessi ebrei dalle persecuzioni nei secoli.

Un percorso lungo, un futuro lontano, attivando e ricostruendo un’identità  che inizi il suo cammino verso un senso reciproco di appartenenza e coesione sociale. Soluzione in prospettiva migliore di quella attuale, in cui il senso di supremazia, di discriminazione, di proprietà  esclusiva comincia, anche se molto gradualmente, a modificarsi attraverso lotte difficili, democratiche, un lento processo dello sviluppo della consapevolezza. Una sfida formidabile che col tempo soprattutto le nuove generazioni si sentiranno di costruire per la Pace e la convivenza, orientate verso la creazione comune di una nuova società .

La speranza è supportata dall’€™esempio del Sud Africa anche nelle forme del pentimento e della riconciliazione con i riconoscimenti delle ingiustizie commesse e le pratiche di riparazione verso le vittime. Una lotta che, oltre a rendere desiderabile la soluzione di uno stato unico e democratico, è ora solo quella concretamente fattibile e preferibile in assoluto, salvaguardando le necessità  di sicurezza d’€™Israele, le sue umane paure e i bisogni di giustizia dei palestinesi.

Proprio come un palloncino riempito gradualmente con raffiche d’aria, quando è passato il limite della sua resistenza alla trazione, scoppia, così ci sono soglie di radicali squarci in determinati momenti storici a cui far fronte con un cambiamento dirompente in politica [11]. Quando più inclinature si incrociano, l’impossibile diventa improvvisamente probabile, con implicazioni rivoluzionarie per i governi e le nazioni. Come si vede vividamente in tutto il Medio Oriente, quando le forze di cambiamento e di nuove idee sono soffocate da tutto e per troppo tempo come la popolazione palestinese è stata ed è nel conflitto israelo-palestinese, il cambiamento improvviso, inaspettato nelle strategie diplomatiche,  diventa sempre più probabile [12].

A livello pratico, giorno per giorno, un singolo Stato appare oggi più che mai un concetto che sembra oggettivamente possibile da attuare e sostenere nella pratica quotidiana, parlando di affari economici, di occupazione giovanile ma soprattutto di salute e gestione delle cure mediche, dove la priorità  della vita scavalca i rigidi confini e allaccia legami. Le differenze e le divisioni tra Israele e Palestina sono immense: due culture, due religioni, due nazionalità , due racconti, due identità . Tutto è diverso ma di fronte all’emergenza della salute per se stessi o un proprio caro compare  un denominatore comune per colmare l’enorme divario. In quell’istante, in quel luogo, in quello spazio entrambe le parti raggiungono il punto in cui si è in grado di condividere e superare i propri simboli, ricordi e paure.

Nella West Bank, a causa dell’€™aggravarsi della situazione socio-politica e umanitaria, degli effetti di più di 40 anni di occupazione israeliana e dell’€™aumentata dipendenza dagli aiuti esterni, l’€™accesso a servizi medici sostenibili per i residenti palestinesi è stato fortemente compromesso e le possibilità  di sviluppo di un sistema sanitario palestinese indipendente sono, allo stato attuale, difficilmente realizzabili.

Le restrizioni alla libertà  di movimento imposte dalle forze di occupazione israeliane alla popolazione palestinese creano gravi problemi sia per quanto riguarda l’€™accesso dei pazienti ai servizi sanitari sia per quanto concerne la formazione e l’€™aggiornamento di personale medico e la costruzione di un efficace sistema sanitario. Gli indicatori di salute evidenziano la critica situazione in cui si trova il sistema sanitario palestinese: la mortalità  infantile è sei volte superiore a quella di Israele mentre la mortalità  materna è addirittura 20 volte più alta [13].

Per la prima volta nella storia, nel maggio 2013 un ministro palestinese ha visitato il complesso ospedaliero di Hadassah, eccellenza della sanità  a Gerusalemme, accompagnato da una delegazione di funzionari palestinesi. L’incontro con i vertici dell’ospedale israeliano era finalizzato ad accrescere il numero di medici palestinesi che prestano servizio presso la struttura sanitaria (attualmente non meno di 60) eccellenza nell’area mediorientale, e a favorire la cooperazione fra l’Hadassah Medical Center e l’ANP. La visita dei vertici della sanità  palestinese rientra nel quadro di una quotidiana collaborazione in ambito di cooperazione sanitaria intercorrente.

Nel 2012 oltre 210 mila palestinesi sono entrati in Israele per trattamenti sanitari e medici. Il dato è vistosamente cresciuto anche soltanto rispetto al 2008, quando i palestinesi del West Bank e della Striscia di Gaza che hanno beneficiato di cure mediche gratuite nello stato ebraico sono stati 172 mila [14].

L’€™obiettivo generale degli interventi di cooperazione sanitaria tra Israele e Palestina, spesso sostenuti in un quadro di accordo trilaterale con un partner europeo, è quello di promuovere e tutelare il diritto alla salute della popolazione palestinese che risiede nei Territori occupati, nonchè di favorire un processo di collaborazione e dialogo fra operatori sanitari israeliani e palestinesi.

Attraverso il sistema sanitario palestinese e, nel contempo, la riduzione delle barriere tra popolazione israeliana e palestinese, si esprime la solidarietà concreta, la denuncia delle politiche che limitano il corretto funzionamento del sistema sanitario e l’€™accesso alle cure, coinvolgendo i cittadini israeliani ad agire per il cambiamento.

In questo senso la collaborazione tra personale sanitario israeliano e palestinese acquisisce  un significato simbolico e concreto, non solo nel campo medico, ma anche nello sforzo di ottenere pace e giustizia in quest’€™area di conflitto. La sostenibilità  dell’azione è quindi anche intesa nel rendere possibile il proseguimento del dialogo e della collaborazione israelo-palestinese.

Il problema non sta nella divisione fisica della terra ma  piuttosto nella volontà  e il coraggio politico di farlo.

Dialogare è difficile e complicato e richiede pazienza e tempo, ma è sicuramente un investimento. Bisogna mantenere aperti tutti gli spiragli e non spegnere il lucignolo che fumiga. Nel dialogo professionale del sistema sanitario palestinese ed israeliano in termini di capacity building e di formazione professionale ad esempio sembra che ciò sia già  possibile.

RIFERIMENTI

1-    Ron Pundak, “€œ20 years on, Oslo architect has plan B”€ (articolo pubblicato il 21 Settembre 2013 in Haaretz).

2-   Ghada Karmi, “€œSposata a un altro uomo. Per uno Stato laico e democratico nella Palestina storica”€, DeriveApprodi, Roma 2010. 

3-   E’ giusto ricordare che circa il 20% dei cittadini dello Stato d’Israele sono arabi e almeno  altri 200.000 sono cristiani immigrati in Israele da Stati dell’ex Unione Sovietica nel  quadro della “€œLegge del Ritorno”€.

4-   Ron Pundak , “Secret Channel -€“ Oslo”€ pubblicato da Fondazione Konrad Adenauer  2013.

5-    Yossi Beilin, “€œBeware the extremists: lesson from Oslo, twenty years on”€,  pubblicato in Haartez  il 9 settembre 2013. 

6-   Comunicato emesso il 16 dicembre 2013 dai Ministeri degli Esteri europei. 

7-   Ian S. Lustick, “€œIllusione di due Stati”€ pubblicato in Haartez  il 14 settembre 2013.

8- Heinrich Boll Stiftung, “20 Years since Oslo: Palestinian Perspectives in Perspectives. Political Analyses and Commentary from the Middle East & North Africa”, Issue n. 5 pubblicato in Dicembre 2013.

9-  Danny Danon, “Israel’s Deputy Defense Minister calls for the annulment of Oslo Accords”,  pubblicato in Haartez  il 21 settembre 2013. 

10-  Ghada Karmi, docente all’€™università  di Exter è una donna palestinese, vissuta in Inghilterra, diventata la sua patria di adozione. Situazione condivisa da milioni di profughi dopo il 1948, anno del riconoscimento della creazione dello stato di Israele, che diede origine alla più vasta diaspora di un popolo nel Medio Oriente. 

11-  Yossi Sarid, “€œConfessions of an Oslo Criminal“€  pubblicato in Haartez  il 19 luglio 2013. 

12- La storia offre molte di queste lezioni. In Gran Bretagna, ad esempio, l’intera classe politica britannica considerava l’incorporazione permanente dell’Irlanda come un fatto politico inequivocabile fino al diciannovesimo secolo. Dal 1880, la questione irlandese ha rappresentato per la politica britannica la questione più importante, comportando l’ammutinamento nell’esercito e una guerra civile. Una volta finita la guerra, ci sono voluti un paio di anni per la nascita di un’Irlanda indipendente. Cosa era inconcepibile  prima è diventato un dato di fatto poi. 

13-  Fonte  “€œWHO monthly reports on Gaza and WestBank“€ reperibili in Local Development forum (www.lacs.ps). 

14-  Adiv Sterman, “PA health minister in first visit to Hadassah hospital” €pubblicato in The Times of Israel, 6 maggio 2012.

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 *Cinzia Chighine, nata a Viareggio nel 1974 e cooperante di professione per dieci anni in Africa e Medioriente, oggi vive  a Firenze dove lavora nel Settore Attività  Internazionali della Regione Toscana.

News Link n. 75

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.

 

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The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.

 

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IFPMA and Global Fund Collaborate to Help Protect Patients from Fake Medicines 

OMS e diritto alla salute: quale futuro 

Experts At WHO Select Eight Projects To Boost Medical R&D For Developing Countries 

IP-Watch Works To Open TPP Text; USTR Misses Response Deadline

First as Tragedy, Then as Farce 

EU to consider policy change on tying aid to land rights

World AIDS Day 2013: Moving Closer to Zero

To Win the Fight Against AIDS, We Must First Defeat TB

Community-based intervention to enhance provision of integrated TB-HIV and PMTCT services in South Africa

Is Aid a Waste of Money? 

How to cut the multilateral aid budget 

Why Are Cancer Drugs Commonly The Target Of Schemes To Extend Patent Exclusivity? 

Trade: the real cost of red tape 

Is India breaking new ground by requiring corporates to spend 2% of company profits on CSR? 

 

 

 

 

Poor-quality Anti-tuberculosis Drugs Threaten the Global Disease Control Strategy

The importance of poor-quality anti-tuberculosis drugs cannot be underestimated, as they may disrupt all major complex interventions to ensure treatment efficacy. Not only treatment failure may ensue, but, more importantly, rapid emergence of acquired drug resistances can also be favoured

Poor-quality Anti-tuberculosis Drugs Threaten the Global Disease Control Strategy

                                                                            

by Giorgia Sulis*and Alberto Matteelli**

University Division of Infectious and Tropical Diseases, University of Brescia

Tuberculosis (TB) represents a major public health problem worldwide, with over 8.6 million estimated cases and 1.3 million deaths in 2012. TB remains a global threat in low- and middle-income countries where it represents the paradigm of poverty-related diseases [1]. Undoubtedly, important progresses have been achieved since the first global TB strategy was launched in 1994 and subsequently updated in 2006 in order to better address the needs [2-5], leading to declining trends in incidence and mortality during the recent decades [1]. However, several challenges continue to undermine the way towards control and eventually elimination of the disease.

Quality-assured drug supply is certainly among the most relevant issues under debate, with counterfeits and sub-standards appallingly on the rise [6, 7]. By definition, counterfeit drugs are deliberately and fraudulently mislabelled medicines with respect to identity and/or source [8]. For instance, quantitative and/or qualitative alterations of ingredients and fake packaging all belong to this category. Furthermore, substandard medicines include those lacking quality control requirements, and might probably be even more common than counterfeits [9].

WHO estimates that counterfeits account for about 10% of the global drug trade, reaching a peak of at least 25% in developing countries, where regulatory and enforcement systems for medicines are weak. However, the real burden of poor-quality medical products on the global market is not exactly known. The very few studies that have been conducted to assess the dimension of the problem of under qualified medicines are limited by the small sample size and are mainly related to a specific drug class in selected geographic areas [10]. Antimicrobials are by far the most frequently involved class of medicines and, coincidentally, they are also the most needed in resource-limited settings which are disproportionately affected by infectious diseases as compared to industrialized countries [11, 12]. Fake pharmaceuticals can be purchased at lower prices thus widening access possibilities especially for the poors. Since most drug stocks do not routinely undergo a proper quality control procedure before usage in several TB high burden countries, the product characteristics vary considerably depending on its final destination. Though usually found on illegal circuits, authorized companies may also be involved in their market [13].

The mainstay of TB control programs is early diagnosis and proper treatment of patients, principally the contagious ones. Standard short course chemotherapy has been at the centre of any TB control strategy. It is composed of a two-month induction phase with four drugs followed by a four-month continuation phase with two drugs [14]. Treatment adherence is essential for a successful outcome and TB programs devote huge efforts and resources to ensure patient support throughout the entire treatment period. Fixed dose combinations were developed and widely adopted, in order to reduce the number of pills and treatment complexity.

The importance of poor-quality drugs cannot be underestimated, as they may disrupt all major complex interventions to ensure treatment efficacy [15]. Not only treatment failure may ensue, but, more importantly, rapid emergence of acquired drug resistances can also be favoured [16].

Multidrug resistance tuberculosis (MDR-TB) is currently recognized as one of the most serious challenge to TB control and eventual elimination. Diagnosis is a real challenge for the weak health systems in resource constrained settings: it is estimated that only approximately 10% of the MDR-TB cases estimated to occur in 2012 were enrolled in care [1]. Moreover, in settings where MDR-TB diagnosis is actively promoted, rapidly increasing the number of identified MDR-TB cases, patients start queuing for treatment for the limited availability of second line TB drugs. While treating a TB patient with a short-course standard regimen has an average cost of 19 US dollars, the economic costs of treatment for one single MDR-TB case can reach 10.000 US dollars. 

Solutions for the challenge posed by counterfeit medicines are strongly needed, but they are not at reach. In 2001 a targeted strategy to fight this scourge (the Global Drug Facility, GDF) was developed, with the purpose of providing assistance and support to needing countries in terms of affordable supplying of medicines and their management [17]. This is among the most important initiatives within the global TB control program aimed to directly provide drugs to both governments and non-governmental organizations (NGOs) through a well-established and strictly controlled process assuring absolute adherence to quality criteria from the sourcing of raw materials to the final distribution and proper stocking of the packaged product. Today, uncertainty about the quality profile is particularly significant for products coming from outside the GDF channel, which miss the prequalification process and unfortunately still constitute a large proportion of the global drug stock. The consolidation of public funds- €”and the GDF source – €”for the purchase of TB drugs has a twofold rationale: it maximises leverage for reduced prices on quality-assured first-line drugs and second-line drugs, thus enabling wider access to them, while also minimising the use of public funds for procurement of drugs of uncertain, potentially substandard, quality.

A relevant proportion of underqualified medicines could be detected through relatively inexpensive and simple assays at destination countries, based on chromatographic techniques, like HPLC and TLC [18]. Such tests are able to identify the type and concentrations of the various components but their execution is not compulsory and then only rarely pursued. In a vicious mechanism, whenever local regulatory authorities fail implementing their controller role not requiring to operate in accordance with basic standards, fraudulent manufacturers are encouraged to enter the market.

The way to fight counterfeit medicines with global efforts is not straight forward and sometimes crosses with political problems. The Indian and Brazilian Governments and some non-governmental organisations, have opposed the work of IMPACT – the International Medical Products Anti-Counterfeiting Taskforce -€“ created by WHO in 2006 [19]. The principal reason is they believe it would confuse quality and intellectual property rights issues and thus undermine access to legitimate and much lower-cost generic medicines consumed mostly in poor areas.

So, once again, the poorest are also the most vulnerable, widely lacking access to adequate healthcare facilities and medications that results in worsening conditions. Putting aside financial responsibilities, our major and definitely unacceptable defeat remains the loss of human lives.

 

*Giorgia Sulis (Resident in Infectious Diseases since August 2013), was born in Italy in 1986. After graduating from the University of Pavia as a medical doctor in July 2011, she earned a postgraduate research fellowship on HIV/AIDS infection among migrants at the University of Brescia. During the first semester of 2013 she attended a TropEd Course in Tropical Medicine and International Health held in Brescia.

**Alberto Matteelli was born in Italy in 1960. After graduating from the University of Pavia as a medical doctor he got his first job as WHO Junior Professional Officer in 1988 to work in Tanzania. He is employed by the Spedali Civili di Brescia since 1991. Currently he is the head of the Community Infections Unit, head of the Hospital STI centre, and co-Director of the WHO collaborating Center for TB/HIV co-infection.

 

References

[1]  World Health Organization (WHO). Global tuberculosis report 2013. Available  at: http://www.who.int/iris/bitstream/10665/91355/1/9789241564656_eng.pdf(last accessed 16 Nov 2013).

[2]  World Health Organization (WHO). Global Plan to Stop TB (2001-2005). A comprehensive plan to tackle TB, including opportunities, actions, and investments needed. October 2001. Available at:http://www.stoptb.org/assets/documents/global/plan/GLOBAL_PLAN_TO_STOP_TB_2001_2005.pdf (last accessed 16 Nov 2013). 

[3] Raviglione MC. The Global Plan to Stop TB, 2006-2015. Int J Tuberc Lung Dis. 2006 Mar;10(3):238-9. 

[4] World Health Organization (WHO). The Global Plan to Stop TB, 2006-2015. January 2006. Available at: http://www.stoptb.org/global/plan/main/ (last accessed 16 Nov 2013).7 

[5] World Health Organization (WHO). The Global Plan to Stop TB 2011-2015. October 2010. Available at:http://www.stoptb.org/assets/documents/global/plan/TB_GlobalPlanToStopTB2011-2015.pdf (last accessed 16 Nov 2013). 

[6] Seear M. The need for coordinated action against falsified and substandard medicines. Int J Tuberc Lung Dis. 2013 Mar;17(3):286. doi: 10.5588/ijtld.12.0988. 

[7] Gautam CS, Utreja A, Singal GL. Spurious and counterfeit drugs: a growing industry in the developing world. Postgrad Med J. 2009 May;85(1003):251-6. doi: 10.1136/pgmj.2008.073213. 

[8] World Health Organization (WHO). Counterfeit drugs. Guidelines for the development of measures to combat counterfeit drugs, 1999. Available at:http://whqlibdoc.who.int/hq/1999/WHO_EDM_QSM_99.1.pdf (last accessed 16 Nov 2013). 

[9] Ravinetto RM, Boelaert M, Jacobs J, Pouget C, Luyckx C. Poor-quality medical products: time to address substandards, not only counterfeits. Trop Med Int Health. 2012 Aug 22. doi: 10.1111/j.1365-3156.2012.03076.x. 

[10] Kelesidis T, Kelesidis I, Rafailidis PI, Falagas ME. Counterfeit or substandard antimicrobial drugs: a review of the scientific evidence. J Antimicrob Chemother. 2007 Aug;60(2):214-36. 

[11] Murray CJ, Lopez AD. Measuring the global burden of disease. N Engl J Med. 2013 Aug 1;369(5):448-57. doi: 10.1056/NEJMra1201534. 

[12] Almuzaini T, Choonara I, Sammons H. Substandard and counterfeit medicines: a systematic review of the literature. BMJ Open. 2013 Aug 17;3(8):e002923. doi: 10.1136/bmjopen-2013-002923. 

[13] Bate R, Jin GZ, Mathur A. Does price reveal poor-quality drugs? Evidence from 17 countries. J Health Econ. 2011 Dec;30(6):1150-63. doi: 10.1016/j.jhealeco.2011.08.006. 

[14] World Health Organization (WHO). Treatment of Tuberculosis: guidelines for national programmes, 4th Edition. Available at:http://whqlibdoc.who.int/publications/2010/9789241547833_eng.pdf (last accessed 16 Nov 2013). 

[15] Bate R, Jensen P, Hess K, Mooney L, Milligan J. Substandard and falsified anti-tuberculosis drugs: a preliminary field analysis. Int J Tuberc Lung Dis. 2013 Mar;17(3):308-11. doi: 10.5588/ijtld.12.0355. Epub 2013 Jan 14. 

[16] Barber SL, Smid M, Hennig C, Huang B, Arifaj D. Multidrug-resistant tuberculosis and quality-assured medicines. Lancet. 2009 Jul 25;374(9686):292. doi: 10.1016/S0140-6736(09)61366-0. 

[17] Arinaminpathy N, Cordier-Lassalle T, Vijay A, Dye CThe Global Drug Facility and its role in the market for tuberculosis drugs. Lancet. 2013 Oct 19;382(9901):1373-9. doi: 10.1016/S0140-6736(13)60896-X. 

[18] Laserson KF, Kenyon AS, Kenyon TA, Layloff T, Binkin NJ.Substandard tuberculosis drugs on the global market and their simple detection. Int J Tuberc Lung Dis. 2001 May;5(5):448-54. 

 [19] World Health Organization (WHO). IMPACT. The handbook, 2011. Available at: http://www.who.int/entity/impact/handbook_impact.pdf (last accessed 28 Nov 2013). 

Devil in the Detail: Health in Jeopardy at US-led Ministerial TPP Talks in Singapore

The ominous prospects on health bound up with TPP negotiations are alarming at a time when trade agreements and governments’€™ choices, largely by the US and the European Union, are turning IP agendas into policies which protect monopolistic interests at the expense of unbiased access to care and  lifesaving treatments in resource-limited settings

Devil in the Detail

Health in Jeopardy at US-led Ministerial TPP Talks in Singapore


By Daniele Dionisio
Member, European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases

 

 

 

The Trans-Pacific Partnership, or TPP, talks began in March 2010, promoted by the United States (US) to deepening free trade in the Pacific realm. Shrouded in unprecedented level of secrecy,  the talks aim to address global trade issues including piracy and counterfeiting, while raising standards by taking into account the implications for the multilateral trade system and the different economic levels and needs of participating countries. These currently include Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, US and Vietnam. 

 

A plan for medicines, known as Trade Enhancing Access to Medicines, or TEAM, was

introduced by US negotiators at the eighth round of TPP talks in Chicago on September 9-15, 2011.

While the US administration did not disclose the plan contents, a US white paper

released September 12 outlined its aims to accelerate access to medicines, get rid of tariffs on medicines and medical devices, and step up legal certainty for manufacturers of generic medicines. The paper also urged TPP parties to reaffirm their commitment to the Doha Declaration on the TRIPS Agreement and Public Health.

 

The TEAM plan incurred, however, harsh opposition by many public interest groups and non-governmental organizations, also in the light of a leaked draft which led Médecins Sans Frontières to allege that the TPP chapter on intellectual property (IP) would encompass TRIPS-plus measures including:

– Making it easier to patent new forms of old medicines that offer no added therapeutic efficacy for patients (“evergreening”). 

– Restricting “€œpre-grant opposition,”€ which allows a patent to be challenged before it is

being granted.

– Enforcing intellectual property beyond what TRIPS requires, allowing customs officials to impound shipments of drugs on mere suspicion of IP infringement, including “€œin transit”€ products that are legal in origin and destination countries.

– Expanding data exclusivity beyond World Trade Organization (WTO)’€™s request for data protection against unfair commercial use only.

– Extending patent lengths beyond 20-year TRIPS requirements.

– Preventing drug regulatory authorities from approving new drugs if they may infringe existing patents.

 

And India raised concerns that the TEAM approach would delay access to affordable generic medicines.

Regrettably,  while on 12 November 2011 TPP negotiators agreed to reinforce and develop existing WTO’€™s TRIPS rights and obligations, no shared solutions to the issues above were achieved over  the subsequent years of strictly “€œclosed doors”€ negotiations, in the face of growing controversy in many TPP nations about demanded trade-offs relevant to  medicine prices and the overall health impact of  IP chapter terms.

Relevantly, US Congress members have been severely limited in their access to treaty-related documents, while as reported, “…Content industries and pharmaceutical industries sit on the IP advisory committee…smaller innovators, generics companies, and public interest groups do not…”€

As such, it is good news that the whole draft of IP chapter  from the 26-30 August 2013 round of TPP negotiations in Brunei  was leaked and made available by Wikileaks on 13 November 2013.

While showing  that at least the August draft was hugely prone to big industry interests, the leak has confirmed that all concerns above were definitely to the point. As such, enforcement, which makes up the widest  section of IP chapter, not only re-presents but even exacerbates, mainly per US requests (including much blamed penalties relevant to third party accountability), the provisions from the shelved ACTA treaty.

As an effect of  mounting resonance bound up with the leaked draft, some lip-service has been flaunted as a corrective to the “€œriding roughshod”€ bullying policy over TPP negotiators the US still pursued throughout the 19-24 November 2013  TPP round in Salt Lake City.

 

Relevantly, an 27 November 2013 statement by the US Trade Representative  gave little openings limited to data protection length of biologic medicines and patent pre-grant opposition procedures.

However, as reported, “…Required patents for new uses, required granting of patents on medicines even in the absence of improved therapeutic effects, data/regulatory monopolies on clinical trial data (data exclusivity), mandatory patents on virtually all medical, surgical, and diagnostic procedures, enhanced damages for patent infringement, mandatory injunctions, and stronger border measures will all be mandatory the minute the TPP is signed. Even more ominously, IP will remain in the investment chapter, meaning that drug companies will immediately be able to sue TPP members if the companies’€™ expectations of IP-based profits are thwarted by fully lawful legislative, regulatory, or judicial decisions…”

Inherently, the  impending threat of an investor state system enforcement as regards access to medicines cannot be underestimated. In this regard, many forms of government regulations, including price cuts of medicines, could be argued not to conflict with the TRIPS agreement, yet to make pointless or erode the expectations of the patent owners.

Relevant risk sectors also include tariffs on medicines, as would be the case should a country that has agreed to reduce tariffs on an imported product later subsidize home manufacturing of the same medicine. A complaint against this country under an investor state system would be allowed to re-establish the conditions of competition in the original transaction.

Additionally, the sectors relevant to packaging and labelling requirements, and to IP protection enforcement measures, may also result as risk target areas, since they might affect the patent holders’€™ access to the market of medicines.

Under these circumstances, should an investor-state system be enforced in TPP, it would make it easier for a claim to be lodged against a member for nullifying or eroding benefits by applying IP protection rules or packaging and labelling models that, despite full alignment with TRIPS requirements, are deemed to be insufficiently stringent or fraudulent.

These prospects appear ominously alarming at a time when trade agreements and governments’€™ choices, largely by the US and the European Union, are turning IP agendas into policies which protect monopolistic interests at the expense of unbiased access to care and  lifesaving treatments in resource-limited settings. So, it was not by chance that on 27 November 2013, after inclusion in the just-concluded Canada-EU Trade Agreement, the European Union Trade Commissioner  defended the inclusion of an investor-state dispute settlement provision also in the Transatlantic Trade and Investment Partnership (TTIP).

Not to mention fear that terms including an “€œinvestor-state mechanism“€ could be approved inside an EU-India deal on track to conclusion.  This would mean a threat to India as a provider of lifeline medicines to the poor’€™s world.

The concern is even greater now that a 12 June 2013 EU custom regulation has incurred criticism of allowing illicit seizing of in-transit goods (including legal generic medicines) “€œover a simple suspicion of IP infringement without checking beforehand whether these goods are headed to the European territory or just in transit” and without “€œclear and convincing evidence of a substantial risk of diversion”€. These terms would hamper TRIPS flexibility grants and run against EU commitments regarding access to treatments without restrictions.

On these grounds, what expectations now that trade ministers are gathering from  7 to 10 December at  an TPP meeting in Singapore that the US eagerly wishes to be the “€œend game”€ of negotiations?  Claims that a “€œdeal”€ could finally be announced are hardly credible with the load of unresolved issues still on the table. And, unless there is an infusion of standing power by TPP participating countries against US  pressure,  the US will certainly force through its position to consolidate monopoly control by large companies, hence undermining access to  health and lifesaving medicines for millions of people in resource-constrained settings.

—————————————————————

Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is an advisor for “€œMedicines for the Developing Countries”€ for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy).  

 He may be reached at d.dionisio@tiscali.it

News Link n. 72

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.

 

News Link 72

Gilead attempt to secure patent on hepatitis C drug opposed in India

Fire in the Blood 

How innovations will pave the way to an AIDS-free generation

Stock-outs rock world’s biggest HIV treatment programme

Land, livelihoods and sustainable development

Poverty eradication & climate change: Friends or foes?

What Europeans think about development aid

INFOGRAPHIC: How transparent are aid donors?

Aid for trade, trade for aid : What’s the new deal?

Trade: time for a new vision 

EU Commissioner Defends Investor-State Provisions; NGOs Propose “Alternative Trade Mandate” 

European Commission: Fact sheet “Investment Protection and Investor-to-State Dispute Settlement in EU agreements”

European Commission Floats Proposal To Stop Theft Of Trade Secrets  

USTR Says Its TPP Proposal On IP And Public Health Shows Flexibility

WHO: Identification of Health R&D Demonstration Projects ( Summaries of the regional selection processes for experts and projects)  

WIPO GREEN: New Online Marketplace Seeks Environmentally Sustainable Solutions for Climate Change

WIPO GREEN database 

South-South Cooperation Rising; WIPO Pushed To Persevere In Its Efforts 

International Organisations Launch Campaign Against Fake Medicines

Make a Difference and Be a Part of #TheGiveEffect

Salute e mercato 

Less Neglect, More Openness: Two ‘Grand Experiments’ in Health Innovation 

Protecting Shared Traditional Knowledge: Issues, Challenges and Options 

 

 

 

 

News Link n. 71

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.

 

News Link 71

5 ways to fight resistance to sustainability, from Muhammad Yunus

Food security demands diversity  

Chi controlla l’industria di alimenti e bevande?

How a Toilet Makes Everyone Taller 

Grass-roots movements key to ending world’s toilet problem: UNICEF

ACCESSO ALL’ACQUA POTABILE  

Finding the urban crisis tipping point

The MPP: Working In Partnerships to Increase Access to Medicines

TPP Chief Negotiators’ Meeting Kicks Off as December Deadline Hastens  

Access to medicines in grave danger as Trans-Pacific Partnership talks continue 

TPP provisions on Injunctions, are the TRIPS exceptions in or out?

EU adopts seven-year environment strategy

European apathy spells end for corporate social responsibility rules

Parliament gives final approval to EU long-term budget

DAI: New kids on the EU bloc 

EUdevdays.eu  26-27 November 2013  

Development Asia Interviews Ban Ki-Moon on the Post-2015 Development Agenda 

Climate change crisis fund to assist poor countries almost empty

Countries with poor tax collection may lose international aid, says Justine Greening 

Intrigues et jeux de pouvoir au cœur d’une grande organisation internationale 

India Weathering Doubts About Its Approach To Intellectual Property  

Cipla plans bigger international presence

GSK to invest Rs 864 crore to set up pharma unit in India

A Question Of Balance In IP Rights In South Africa

Comments Received To South Africa’s Process For New IP Policy

La salute non si compra, si fa insieme  

Better Health for Latin Americans  in Europe 

The drug and vaccine landscape for neglected diseases (2000—11): a systematic assessment

Policy Cures new factsheets on R&D and funding of diagnostics for neglected diseases and diarrhoeal diseases   

 

 

 

 

 

News Link n. 70

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.

 

News Link 70

SIMET (Società Italiana di Medicina Tropicale) Congresso Nazionale 28-30 novembre 2013 Torino 

29th November 2013 Licensing of Climate Change related Technologies to Developing Countries: Options and Challenges

Wikileaks’ Release Of TPP Chapter On IP Blows Open Secret Trade Negotiation 

Inside Views: Capture, Sunlight, And The TPP Leak 

Celebrating Women and the Dignity of Family Planning

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WHO, UNICEF Launch Largest-Ever Polio Vaccination Campaign In Middle East  

mHealth Toolkit 

Late night deal seals 2014 EU budget 

ACTION PLAN ON DISABILITY , a process set up by the Dgcs in 2011

Immigrati, la loro “dote” ammonta a 1,5 miliardi di euro

As growth slows, developing countries face uncertainties over debt, UN conference told 

Event Brings Business Perspective To Creating, Leveraging IP In Developing Countries 

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Coca-Cola to check Cambodia land-grab claim

Four Global Trends to Watch for in African Resource-Rich and Soon-To-Be-Rich Countries 

Effective aid funding vital to fight malaria, says spending watchdog

WHO R&D ‘Demonstration Projects’: A Member State-driven step towards a sustainable global framework for neglected disease R&D

Poor countries left in the dark on climate finance: COP19

He who pays the piper… 

Is All Aid Good Aid? 

Bill Gates and President Bill Clinton on the NSA, Safe Sex, and American Exceptionalism 

Hey NGOs! Stop fighting with each other!

 

 

 

 

 

 

News Link n. 69

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.

 

News Link 69

EU 2013 Report on Policy Coherence for Development

EU Dev Days Brussels: Finishing and moving beyond the health MDGs Auditorium A Tuesday 26 November 2013 – 14:00 PM – 15:30 PM

‘Top-down’ approach needed for EU-Africa partnership — EU official

Commission pledges €5 billion aid for Sahel

Human resources for universal health coverage: from evidence to policy and action 

Cash Transfers and Deeper Causes of Poverty

La lezione del Sud del mondo sul finanziamento della sanità

Guerra alla droga ed epatite C

WHO Gathers R&D Projects For Developing Countries Ahead Of December Meeting 

Beyond philanthropy: What happens when a multinational creates its own development agency? 

Global Fund embarks on new procurement strategy

The risk with the Global Fund’s new TB strategy

Foreign Aid: Saving The World Or Forgetting England?

Why UN Climate Talks Must Deliver a Brighter Future for Us All

As climate changes, will we change with it?

Global peace impossible without fair deal for the poor, says IDB President 

UK warned that youth unemployment is ‘public health time bomb waiting to explode’ 

Call for FAO to shift focus 

How shipping unions  sunk food aid reform

A Question of Quality: Why Retention Matters for AIDS Treatment

 

 

 

 

 

 

 

 

European Commission’s Trade Agenda and Least Developed Countries

The EU’€™s blatant attempts to prevent the LDCs from getting the full extension they had a right to under the TRIPS Agreement and its use of underhand tactics on the world’€™s poorest nations…. is an indication that corporate profits now outweigh any global commitment the EU has to the international human rights

 

European Commission’€™s Trade Agenda and Least Developed Countries

Corporate Profits Trump Concerns of the World’€™s Poorest Countries

by Shiba Phurailatpam

Regional Coordinator and Director of Asia Pacific Network of People Living with HIV (APN+)

 

 

This decade has seen the unveiling of an aggressive trade agenda by the European Commission that threatens the right to health and access to medicines in the Global South. Questions on the health impact of Europe’€™s trade policies have been swirling since the EU-India Free Trade Agreement negotiations revealed multiple intellectual property demands of India that will hinder the manufacture and supply of generic medicines. Now the EU is making those same demands of Thailand, another crucial manufacturer of generic medicines.

In 2013, even the world’€™s poorest countries who are members of the WTO were not spared the EU’€™s trade pressures.

Who are the Least Developed Countries (LDCs)?

 The UN lists 49 countries as least developed, i.e. they meet three criterion: 

– a low-income criterion, based on a three-year average estimate of the gross national income (GNI) per capita under $750;

– a human resource weakness criterion, involving a composite Human Assets Index (HAI) based on indicators of: (a) nutrition; (b) health; (c) education; and (d) adult literacy; and

– an economic vulnerability criterion, involving a composite Economic Vulnerability Index (EVI) based on indicators of: (a) the instability of agricultural production; (b) the instability of exports of goods and services; (c) the economic importance of non-traditional activities (share of manufacturing and modern services in Gross Domestic Product (GDP); (d) merchandise export concentration; and (e) the handicap of economic smallness (as measured through the population in logarithm); and the percentage of population displaced by natural disasters.

LDCs comprise more than 880 million people or about 12% of the world’€™s population but account for less than 2% of the world GDP and about 1% of the global trade in goods (2013 UNDP/UNAIDS Policy Brief). Adult literacy rate in LDCs is on average at 60.7%, with gross enrolment in tertiary education at about 6.6% while primary school dropout rate at 40.9 % of the population; only 1.7 per 100 people have personal computers, while about 5 out of 100 have access to the worldwide network; more than half of the LDC population do not have access to electricity, water or sanitation facilities (LDC Watch and OWINFS Open Letter).

LDCs and the WTO’€™s intellectual property rules 

Of the UN recognised LDCs, 34 are members of the World Trade Organisation (WTO) and had to sign the WTO’€™s Agreement on Trade Related Aspects of Intellectual Property Rights or TRIPS. TRIPS requires all WTO members to implement an intellectual property legal regime which includes the granting of trademarks and patents on pharmaceutical products.

At the time TRIPS was negotiated, a key safeguard enshrined in the agreement in Article 66 for LDCs was that they would have a ten year transition period to apply the TRIPS Agreement “€œin view of the special needs and requirements of least-developed country Members, their economic, financial and administrative constraints, and their need for flexibility to create a viable technological base”€.

Developed country members of the WTO were also obligated under this Article to set up conditions to encourage the transfer of technology to LDCs.

Crucially Article 66 also recognises the right of LDCs to get further extensions of the transition period on a duly motivate request. The operative part of Article 66.1 reads: “€œThe Council for TRIPS shall, upon duly motivated request by a least-developed country Member, accord extensions of this period” (emphasis added).

The ten year transition period for LDCs was due to expire in 2005. In 2002, LDCs received a waiver for the grant or enforcement of patents and test data protection on pharmaceuticals till 2016 which was agreed as part of the Doha Declaration on TRIPS and Public Health.  In 2005 the transition period to comply with TRIPS for LDCs was extended by 7.5 years to June 2013.

LDC€™’s 2012 TRIPS extention request

Last year, on 5 November 2012 Haiti on behalf of the LDC group submitted a request to the TRIPS Council for the transition period for LDCs to apply the TRIPS Agreement to be extended from the 2013 deadline to the time that they graduate from LDC status. The LDC request stated the obvious:

“€œThe least developed country Members of the WTO represent the poorest and weakest segment of the international community. The economies of least developed country Members are extremely vulnerable, with large segments of their population living in poverty. They also face numerous challenges such as high burdens of infectious and non-infectious disease, low literacy, inadequate access to clean water and sanitation, low agricultural productivity, environmental and climate-related challenges”€.

The resolution highlighted the extremely vulnerable situation that the LDCs find themselves in with little development of productive capacity and had been unable to move beyond “€œout-dated technologies”€ (as noted above, under TRIPS, developed countries are obligated to facilitate such technology transfer.)

The request accordingly notes:

“€œDeveloping a viable technological base is a long-term process. Given the increasing complexity of modern industrial practices, least developed country Members need a continuing waiver from TRIPS in order to be able to grow economically viable industrial and technological sectors, to consolidate capacity, and to work their way up the technological value chain. Moreover, because of their extreme poverty, least developed country Members need the policy space to access various technologies, educational resources, and other tools necessary for development. Most IP protected commodities are simply priced beyond the purchasing power of least developed country Members and their nationals”€.

UNAIDS and UNDP support LDC Proposal

In February of 2013, UNAIDS and the United Nations Development Programme (UNDP) voiced their strong support for the proposal and issued a policy brief on the importance of the extension of the transition period. The policy brief highlights the serious challenges faced by LDCs in confronting disease and illness. Heavy health burdens in LDCs include the estimated 9.7 million people living with HIV. The disease burden co-exists with poverty and the inability to provide prevention, treatment and care “€œparticularly where respective interventions call for high-cost medicines, diagnostics, and other health products”€ often made expensive by patents. “€œCancer incidence is expected to rise 82% from 2008 to 2030 in low-income countries (compared to 58% in upper-middle and 40% in high-income countries).”€

UNAIDS and UNDP note that:

“…without the requirement of providing intellectual property protections, LDCs are free to follow the historic path of copying and adaptation to develop their technological capacities, at the same time strengthening their human, administrative, financial and other capacities…”€

The LDC proposal garnered wide support from civil society, academics and experts (NGO letter; Global Commission on HIV and the Law).  Developing countries also extended their full support to the LDC proposal, some even noting that the 2005 extension contained some unwarranted conditions which should not feature in the new extension (Government of India intervention).

EU leads developed countries demand for “€œinformal consultations”€

The extension sought by the LDC’€™s “€œduly motivated request”€ should have been immediately granted as per the clear language of TRIPS. But developed countries including the EU that are strident in their demands that the developing world comply with other provisions of the TRIPS Agreement appear to not take their own commitments under that same agreement quite so seriously.

The hopes of the LDCs that the request would be granted in accordance with their rights under the TRIPS Agreement were dashed at the March 2013 TRIPS Council meeting where the matter was taken up. Instead the LDC proposal was put through months of closed door negotiations with developed countries preventing them from realising one of the few rights they have under the TRIPS Agreement.

Nepal, on behalf of the LDC groups gave a detailed explanation for the proposal:

“€œLDCs need the continuation of flexibility as their situation has not changed significantly over the years. Their marginalization continues. They have not been able to develop their productive capacities which limit their meaningful integration into the world economy. LDCs’ economic indicators have not changed since 2005… 

…All LDCs are net payers of royalties. These countries have not been able to spend even a small fraction of their national budget to research and development as they have to concentrate more on basics like health and education. The developmental schemes for transfer of technology provided in TRIPS Article 66.2 have not effectively and adequately materialized. The level of technological development in the LDCs has remained low. In UNDP’€™s Technological Achievement Index LDCs are at the bottom. So are they in UNIDO’€™s Competitive Industrial Performance Index and UNCTAD’€™s Innovation Capability Index. Numbers from WIPO reports indicate that LDCs have not been able to enter the race of technology and innovation.

Unless LDCs have flexibilities to adopt policies to stimulate technological catch-up with the rest of the world, they will continue to fall behind other countries and face deepening marginalization…

…LDCs’€™ request has been motivated by the need of policy space to (to quote UNDP’€™s latest issue brief) ‘€˜conserve the autonomy to determine appropriate development, innovation, and technological promotion polices, according to local circumstances and priorities’€™. They need such space to ensure access to various technologies, educational resources, medicines and tools necessary for development. Most IP-protected goods and services are simply beyond the purchasing power of least developed countries and their people”.

This appeared to have little impact on the EU and the rest of the developed world that persisted with attempts to impose conditionalities on the LDCs. The EU in its intervention at the March TRIPS Council meeting stated that it was “€œwilling to consider”€ the proposal but was unhappy with the lack of a time frame or the consideration of efforts by the EU and the World Intellectual Property Organization (WIPO) in some LDCs to develop IP systems already.

The EU’€™s statement as well as those of other developed countries were remarkable as they were speaking in fact of an obligation of the TRIPS Council and not something that was negotiable! If a developing country were to ever state that they would only “€œconsider”€ and demand negotiations on one of their obligations under the TRIPS Agreement, it would surely be met swiftly with a trade dispute and unilateral trade sanctions. But LDCs have little muscle to flex at the WTO and at the March 2013 meeting this became painfully obvious as the EU called on the TRIPS Council Chair to facilitate “€œinformal consultations”€ and bulldozed the LDC group into negotiations.

By May, it became clear that these consultations were meant only to create pressure on the LDCs to back down from their request. As an outraged open letter to Alfredo Suescum, Ambassador of Panama to the WTO who was the chair of these informal consultations noted the “€œunfair and prejudicial”€ process was limited to developed countries that were opposing the request instead of also involving the developing countries that were supporting the request. The letter noted that this was an attempt to “€œoverwhelm the negotiating capacity of the poorest members of the WTO by placing them in an unfair position where they have to face the united might of the developed countries.”

“It is sheer hypocrisy that these countries themselves blatantly copied, imitated and borrowed each other’€™s intellectual property for their technological advancement in the pre-IP era and now they are imposing the false notion that IP is essential for development, which basically guides their current opposition to LDCs’€™ request.”    –Arjun Karki, LDC Watch on the opposition by developed countries to the unlimited time frame  

 

That same month the EC recommended to the European Council that the EU position in the TRIPS Council should be that the LDC extention should not be more than what was granted in 2005 (i.e. 7.5 years) and that LDCs should not decrease any existing levels of IP protection below that of TRIPS. Regrettably this position was then adopted by the European Council.

The latter conditionality is also referred to as a “€œno rollback clause”€ which is similar to one that was imposed in the 2005 LDC extention decision. India in its intervention at the March meeting noted that “…the no roll back provision has no place in the TRIPS Agreement and had in fact reduced the policy space for the LDCs in utilising the TRIPS flexibilities during the transition period to engage in technological development and ensuring access to affordable goods to its citizens.”

The EC’€™s continued efforts to water down the LDC proposal did not go unnoticed and in June health groups in Uganda (part of the LDC group) organised a protest to hand over a letter to the Head of the Delegation of the European Union Mission to Uganda registering their opposition to the EU’€™s position on the LDC extention.

The 2013 LDC extention decision

On 11 June 2013, the final extention details were finally announced and as opposed to the full enjoyment of their right under the TRIPS Agreement, the world’€™s poorest countries under pressure from the EU and the US had to settle for an 8 year extention till 2021.

Crucially, however, the LDC objection to the “€œno roll-back”€ clause from the 2005 decision succeeded. Instead of any mandatory or obligatory condition to freeze their national IP systems, LDCs merely expressed a determination to preserve these developments.

The decision re-iterates that this extention does not preclude any future requests for further extentions and is without prejudice to the 2016 extention for the grant or enforcement of patents on pharmaceutical products.

Without the obligation, LDCs can now review the impact of their early compliance with TRIPS most of which has taken place under technical assistance from the developed world or the WIPO. WIPO’€™s technical assistance has not been without criticism and an evaluation in 2011, the report of an External Review of WIPO Technical Assistance in the Area of Cooperation for Development, was released.

The WIPO Review found that in relation to WIPO’€™s technical assistance and advice in relation to development matters,

“…respondents overwhelmingly poorly rated WIPO’€™s efforts to adapt its legislative advice to reflect national development priorities in areas such as public health and access to education. Similarly, WIPO’€™s assistance to put into practice the IP flexibilities that are included in their national laws (e.g., through patentability guidelines, advice on issuing a compulsory license; guidelines on differences between their national patent laws and those of countries which may assist their country in patent search and examination) was predominantly ranked by respondents in the poor range….Further, with regard to WIPO advice to tailor the implementation of national treaties to reflect national development needs and priorities, 11 of 14 respondents that provided a ranking, rated WIPO’€™s assistance in this area as in the poor range or only satisfactory. Interviews with stakeholders during the country visits conducted by the Review Team also affirmed that while WIPO’€™s legislative assistance is appreciated, particularly by IP offices, WIPO is not proactive in providing advice on flexibilities and officials do not perceive that they can rely on WIPO for tailored or pro-development advice. Several country visits by the Review Team also highlighted that countries sometimes perceive that a request for advice on the use of flexibilities would not be an appropriate request to make of WIPO and/or that it would likely be refused”€.

EU’€™s shocking press release

As aggressive as the EU was throughout the negotiations with the LDCs, few could have expected the EC’€™s next move once the final decision was announced.

On 11 June 2013, the day the final LDC extension decision was announced, the EC issued a press release purportedly welcoming the LDC extention decision. In it, the EC claimed it had always been supportive of LDCs enjoying every flexibility under TRIPS despite their actions in the previous month of blatantly violating WTO rules by forcing negotiations and compromise on a crucial right of LDCs under TRIPS.

Completely disregarding the actual text of the final decision, the EU press release also stated

“€œThe decision does not affect the transition period for patents for pharmaceutical products, which was agreed in 2002; LDCs will not have to protect these patents until 2016.  Where least-developed countries voluntarily provide some kinds of intellectual property protection even though they are not required to do so under the TRIPS Agreement, they have committed themselves not to reduce or withdraw the current protection that they give”€.

These statements were grossly misleading and a misrepresentation of the final decision. The language of the “€œno roll back”€ clause included in the 2005 decision was removed from the 2013 decision and civil society and health groups immediately condemned the EU press release.

In a strongly worded letter, civil society groups and academics immediately clarified the misrepresentations of the EC stating that “€œthe EU’s interpretation of the new extension decision is fundamentally flawed and purposefully misleading, and is just another attempt to undermine rights of the poorest nations granted under Article 66.1 of TRIPS”€.

It was also pointed out that the EC’€™s statement on the 2016 deadline was designed to mislead LDCs as not only can that deadline also be extended, the latest extention applied to the whole of the TRIPS Agreement (except Articles 3, 4 and 5 of TRIPS that LDCs are required to comply with). The EC’€™s interpretation would lead to an absurd situation where LDCs do not have to apply the TRIPS Agreement till 2021 but have to start granting or enforcing pharmaceutical patents after 2016.

The importance of the transition period 

The importance of the transition period for the development of LDCs and in the context of medicines for the development of local manufacturing and technology has been underscored in several statements of support for the LDC proposal.

Brazil in its support (intervention, TRIPS Council, Agenda item 11, 5 March 2013) noted that, “€œthe incorporation of developing countries, in particular the least developed ones, into the so-called knowledge economy has proved to be a daunting challenge, the complexity of which could barely be assessed almost twenty years ago, when the Uruguay Round was completed”€.

Indeed several developing countries, after complying with TRIPS are now reviewing their laws to ensure the full incorporation of TRPS flexibilities as their ability to access affordable generic medicines becomes more and more difficult. The Philippines amended its law in 2008, nearly 10 years after TRIPS compliance to include TRIPS flexibilities. In 2012, Argentina issued strict patent examination guidelines for pharmaceutical products. Brazil and South Africa are currently undertaking their own review and the reform proposals on the table all entail the inclusion of key health safeguards such as those similar to the Indian prohibition on evergreening.

The Indian experience with patent law perhaps has the most to offer as experience for the LDCs. India’€™s patent system was inherited from the British and resulted in the highest prices of medicines anywhere in the world. In 1970 the Indian government abolished product patents on food and medicine aiming to be self-reliant in these areas and to be able to access affordable medicines. During this time, India also set up scientific research centres and adopted an industrialisation policy that supported local pharmaceutical production. India’€™s minuscule pharmaceutical industry grew to become one of the largest centers of generic production in the developing world. The safety, quality and affordability of Indian generic medicines soon resulted in India supplying most developing countries with medicines. Unlike the majority of developing countries, India also waited till the very end of its transition period (2005) to amend its patent law to comply with TRIPS. As a result not only was India able to incorporate every single TRIPS flexibility that had evolved over time, it was also able to preserve the maximum space for generic production. The result of delayed compliance with TRIPS is clear. Take Thailand on example, also a local manufacturer of generic medicines, Thailand complied with TRIPS by 1999. Thus, although the first generic AIDS medicines was synthesised in Thailand, by 2007 the country had to issue compulsory licences on patented first and second line AIDS medicines. By contrast first line and to a large extent second line AIDS medicines remain off patent in India.

As successful as India’€™s health safeguards in its patent law have been, patents are now being granted in India and cancer and hepatitis C patients are facing treatment costs in thousands of dollars. India has already had to issue a compulsory licence on a cancer medicine whose cost was too high. India is also being sued incessantly by multinational companies like Novartis and Bayer for the safeguards in the Indian law while the EU is pressuring the Indian government in the FTA negotiations to adopt TRIPS-plus patent protection.

LDCs can use the transition period to the full extent to set up local manufacturing of medicines and other pharmaceutical products. The lack of intellectual property protection in all areas of technology would allow LDCs to access knowledge and medicines at affordable prices.

To do this, LDCs must retain the ability to fix mistakes they may have made in early or over compliance with the TRIPS Agreement.

The EU’€™s blatant attempts to prevent the LDCs from getting the full extension they had a right to under the TRIPS Agreement and its use of underhand tactics on the world’€™s poorest nations like the misleading press release is an indication that corporate profits now outweigh any global commitment the EU has to the international human rights.