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Engaging in Multi-stakeholder Diplomacy for Health 9 – 11 November 2016. Course Co-Directors: Stefan Germann, World Vision Internationaland Michaela Told, Global Health Centre 

Developing African academics to approach health challenges in Africa: 2017 doctoral research scholarship. HEARD, university of KwaZulu-Natal 

SpeakOut! 2016 – UNPO International Human Rights Training 9th-11th of November 2016, The Hague, the Netherlands 


Chagas Disease: A Reflection on the Lack of Access to Treatment

The response to Chagas disease still needs inclusive protocols, sustainable and adequate financing and does not have a robust portfolio of investigation of new treatments and diagnosis. Beyond that, production capacity and supply of Benznidazole (BZN) medication is far from being minimally sufficient. The price factor also strongly impacts access to medication. A point deserving attention in the analysis of BZN’s prices is the need, as in the response to other diseases in general, to maintain competition as a factor of market regulation

by Eloan Pinheiro *, Lucia Brum ***, Renata Reis **, Juan-Carlos Cubides ***

*Consultant in Public Health Policy; ***Brazilian Medical Unit (BRAMU), Médecins Sans Frontières–Brazil; **Advocacy and Interinstitutional Relationships, Médecins Sans Frontières-Brazil

Chagas Disease

A Reflection on the Lack of Access to Treatment



Chagas disease or American trypanosomiasis is a potentially fatal disease caused by the protozoan Trypanosoma cruzi and endemic in 21 countries in the Americas region, being mainly transmitted by Triatominae insects. The World Health Organization (WHO) recognizes Chagas as a neglected disease due to two elements: the fact that mainly affects people who are unaware of their rights to health and low investment in innovation and development, especially in access to diagnosis and treatment [1].

Over the past 30 years, there has been a significant reduction in the number of cases of the disease due to actions to combat the vector developed by national programs under the intergovernmental initiatives in the Americas. However, little progress has been made in relation to the component of care and treatment for people who were already infected. Currently the WHO estimates that there are approximately 6 million people infected by Chagas disease in the world, which generally face known limitations in access to diagnosis and treatment [2].

Benznidazole (BZD) and Nifurtimox are the only drugs available for the treatment of Chagas disease in the world. Launched in 1967 and 1972, respectively, these drugs quickly proved to be effective in the treatment of acute infections, but were largely ignored for the treatment of chronic infections due to the high frequency of undesirable side effects, low apparent cure rates and a lack of international consensus on the diagnostic criteria and parasitological cure.

Unfortunately, the portfolio of molecules currently investigated for this neglected disease is reduced, reducing as well the possibility of developing new treatments. Nifurtimox is manufactured by Bayer Health Care as Lampit® and Benznidazole was produced by Roche as Rochagan® or Radanil®. Originally, Roche had the registration for the drug in Argentina, Brazil, Bolivia, Uruguay, Peru, Nicaragua and Japan. After Roche stopped its BNZ production on April 2003, the Brazilian laboratory LAFEPE figured as the only global producer, providing the finished product directly to Bolivia, Paraguay, Ecuador, Colombia, Venezuela, Honduras, El Salvador, Chile, Switzerland, Mexico, Argentina and Brazil.

Brazilian production always had problems in both the normative aspect (especially in relation to greetings rules of health authorities) and in relation to production. The lack of supply on the active ingredient (API-BZD) led to the shortage of the drug in 2011. After years of monopoly drug production by LAFEPE, another BZD producer stepped in: the Argentine laboratory ELEA part of the international group Chemo. This new production is not enough to cover the necessities in countries with high burden of the disease and bring to the picture another variable to analyze on the private production of drugs: high costs.

Access to BZD: Needs vs. Production Capacity
The annual production capacity of the two producers is a ton (1,000 kg) per year each, and may double this quantity, in exceptional cases. Thus, the current annual production capacity of API varies between 2,000 kg and 4,000 kg/year and the latter quantity is a possibility.

For treating an average adult patient; tablets of 100 mg in 3 daily doses for 60 (sixty) days are required. It takes 180 (one hundred eighty) tablets for an adult to complete their treatment equivalent, to 0.018 kg of raw materials. Pediatric use also requires sixty 60) days to comply with the treatment, taking tablets of 12.5 mg, 6 times per day; this is equivalent to 0.0045 kg of raw material (Table 1).

Eloan FINALtable 1

Table 1. API-BZD quantitative estimation necessary for treatment of an adult and a child

The number of patients and API-BZD required in order to provide their treatments in four endemic countries in Latin America, namely Argentina, Bolivia, Brazil and Mexico is shown in Table number 2. Considering the amount noted for the treatment of adults and children only in the selected countries, 77.4 tons of API-BZD are required while the production mentioned above (4.4 tons of total maximum capacity of both producers) responds only to 5.7% of the actual need.

Eloan FINALtable 2

Table 2. API-BZD quantitative estimation necessary to meet the demand of BZD medicines in countries with larger epidemiological indices [3]

Right to Health and Access to Essential Medicines
The right to enjoyment of the highest attainable standard of physical and mental health even though it is crystallized in various international legal instruments today is far from assured for a substantial part of the population. This right was first proclaimed in the Constitution of the World Health Organization (WHO) in 1946, whose preamble defines health as “a state of complete physical well-being, mental and social and not merely the absence of disease”. The Universal Declaration of Human Rights of 1948 also brings health as part of the right to an adequate standard of living (Art. 25)[4]. The right to health was also recognized as a human right in the International Covenant on Economic, Social, 1966, and is reinforced in numerous international treaties and documents.

In recent years, it has been given greater attention to the right to the highest attainable standard of health. Thus, the organs that monitor the implementation of human rights treaties, the WHO and the UN Human Rights Council has sought to observe and report misrepresentation of a wider range of rights, among them the right to access essential medicines. Over time, it became increasingly apparent the direct link between access to essential medicines and the progressive realization of the right to health. This broad global recognition imposed the translation of this recognition in public policy enforcement of this right.

Chagas disease is an emblematic case of disrespect to the right of access to treatment according to the statements mentioned. Considered one of the most widely distributed diseases in the Americas, Chagas disease completed in 2009 a hundred years of its discovery and even today lacks inclusive protocols, is not sustainable and adequate funding, capacity and supply BZD medicine is far to be minimally sufficient.

The information exposed before (Table 1) brought illustrative data on the deficit of the world production capacity of BZD taking into account the four Latin American countries with high prevalence making urgent to discuss the issue. Currently the existing amount of BZD in the world allows only treat about 111,000 patients (taking into account the real world production of 2 tons of raw material per year) or about 222,222 patients (if produce 2 tons more per year); this equates to only 3.22% of treatments currently needed in the referred countries.

In summary, many lobbying efforts and medical advocacy can be undertaken by social organizations, affected groups of people, but a pressure to governments and producers must accompany those actions, so that the productive capacity of BZD be expanded and the current monopolized production of BZD be stopped. Over the years, given the experience on treatment of Chagas disease in multiple countries it is important to acknowledge the socio-cultural and political-economic aspects involving inequity issues, which are often not considered. The disease affects the most vulnerable and deprived populations in countries were the problem remains under a huge invisibility. Unfortunately, the perception of many public managers is that Chagas is the disease of backwardness and poverty, so it is better to hide it than to face it; when the real solution lies on breaking the cycle of neglection by offering appropriate diagnosis and treatment to all in need.

[1]. Lee, B.Y., Bacon, K.M., Bottazzi, M.E., Hotez, P.J., 2013. Global economic burden of Chagas disease: a computational simulation model. Lancet Infect. Dis. 13 (4), 342–348.
[2]. Available, Source: WHO, 2010.
[3]. Institute for One World Health. Estimative on BZD for T. cruzi infected people in the Americas. 2007
[4]. Available

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UNCTAD : Mappa Povertà 2016

Come la schiavitù e la discriminazione razziale, la povertà non è naturale. Essa è  prodotta dall’uomo e può essere vinta ed eradicata dalle azioni degli esseri umani
Nelson Mandela (2005)


by Daniele Dionisio*

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

UNCTAD 2016: Mappa della Povertà


Quante povertà?

Il rapporto UNCTAD 2016 suddivide la povertà in ‘relative’, ‘consistent’, ed ‘extreme-absolute’, dove l’ultima definizione chiaramente attiene alla condizione di quanti impossibilitati al godimento di sufficienti livelli di nutrizione e di buona salute. Per queste fasce di popolazione la Banca Mondiale ha introdotto nel 1991 la soglia di 1.25 dollari di introito giornaliero (poi elevata a 1,90 dollari nel 2015, ma tuttora presente nel target 1.1 dei recenti Sustainable Development Goals-SDGs delle Nazioni Unite) quale standard di povertà assoluta nei Paesi più poveri.

Nel 1990 circa 1.9 miliardi di persone (più di un terzo della popolazione mondiale) sopravvivevano con meno della soglia giornaliera predetta. Entro il 2015 la percentuale era però scemata al 12% significando che più di un miliardo di persone erano state sottratte alla più pesante miseria. Indiscutibilmente un grande successo, anche se circa 836 milioni di persone versano tuttora in povertà assoluta.

Progresso disomogeneo                           

I successi più eclatanti sono documentati in Asia orientale e Pacifico dove la proporzione di quanti in povertà estrema (soprattutto in Cina e India) è crollata da più dell’80% negli anni ottanta del secolo scorso a meno dell’8% oggi. Meno drammatico, ma significativo, in Asia meridionale nello stesso periodo la percentuale si è ridotta dal 59% al 19%, mentre in Africa sub-sahariana il dato ha visto una flessione dal 57% degli anni novanta  al 43% odierno.

Al di là dei progressi, povertà estrema sfortunatamente permane in aree asiatiche, caraibiche e, soprattutto, sub-sahariane. In Madagascar versa in povertà assoluta l’82% della popolazione, il 78% in Burundi, il 77% nella Repubblica Democratica del Congo (RDC), il 71% in Malawi.

Almeno in 15 Paesi sub-sahariani il 50% delle rispettive popolazioni è in povertà estrema. E il problema non interessa solo l’Africa se è vero che Haiti e molta parte dell’arcipelago della Micronesia mostrano livelli di povertà estrema coinvolgenti più del 50% degli abitanti.

Questi dati indicano che, nonostante il declino globale, la riduzione della povertà è tuttora disomogenea nelle diverse aree geografiche.

Al riguardo, povertà estrema permane concentrata in Africa sub-sahariana e Asia meridionale, con l’80% della popolazione legata ad un introito giornaliero inferiore a 1.25 dollari. Nel 2011 le Nazioni Unite riferivano che, mentre il 60% delle fasce più povere era confinato in 5 precisi Paesi (Bangladesh, Cina, RDC, India e Nigeria), i progressi delle regioni caraibiche nella riduzione della povertà tra gli anni novanta e il 2011 avevano sofferto di eccessiva lentezza.

In questo contesto, la povertà delle fasce giovani di popolazione è destinata a configurarsi nei prossimi decenni quale sfida maggiore per i Paesi a crescita demografica rapida.

Un approccio allargato

Con l’obiettivo primario di eradicare la povertà estrema, il Goal 1 dei Sustainable Development Goals-SDGs è imperniato su una visione ampia della povertà quale fenomeno poliedrico e multidimensionale in un mix complesso di cause economiche, sociali e ambientali. Coerentemente, i targets del Goal 1 chiamano alla eradicazione della povertà estrema in generale, ma pure alla riduzione di quella propria delle fasce più giovani o di quella correlata alla discriminazione sessuale; esortano alla introduzione di ridistribuzione sociale per proteggere poveri e vulnerabili; alla adozione di uguali diritti e uguale accesso alle risorse economiche e ai servizi; al contenimento dell’impatto di shock climatici, economici e sociali; all’implementazione da parte dei  Paesi di politiche e dinamiche atte a ridurre ed eliminare la povertà.

La mina delle disuguaglianze

L’impegno internazionale ad eradicare la povertà dovunque e in ogni suo aspetto è racchiuso dunque nel Goal 1 degli SDGs quale naturale prosecuzione del Goal 1 dei precedenti Millennium Development Goals. 

Purtroppo, la mina vagante delle disuguaglianze rende arduo scommettere sul conseguimento di povertà zero entro il 2030. Quale fondato ottimismo, infatti, se ad oggi circa 830 milioni di persone ancora sopravvivono con meno di 1,90 dollari di introito giornaliero, se 1.8 miliardi di persone guadagnano meno di 2,50 dollari al dì, se, infine, un guadagno medio giornaliero di 250 dollari finisce nelle tasche di solo l’1% della popolazione mondiale mentre il 50% non supera i 7 dollari?


Mandela calls for action on ‘unnatural’ poverty

UNCTAD: Goal 1 No Poverty

UN: Sustainable Development Goals – SDGs

UN: The Millennium Development Goals Report 2015

UN: World population prospects, the 2015 revision

UN: Transforming Our World: The 2030 Agenda for Sustainable Development

World Bank (2005). Poverty lines. In: Introduction to Poverty Analysis. Chapter 3. Washington, D.C.

Ferreira F, Jolliffe D M and Prydz E B (2015). The international poverty line has just been raised to $1.90 a day, but global poverty is basically unchanged. How is that even possible? Let’s Talk Development – A blog hosted by the World Bank’s Chief Economist

United Nations Economic Commission for Africa (2015). Economic Report on Africa: Industrializing through trade. UNECA. Addis Ababa

Woodward D and Abdallah S (2010). Redefining Poverty: A Rights-based Approach. New Economics Foundation London



*Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. Dionisio is former director of the Infectious Disease Division at the Pistoia City Hospital (Italy), and Head of the research project PEAH – Policies for Equitable Access to Health.









International Pressure on India’s Drug Industry: The Hide-and-Seek Game of Modi’s Administration

India’s pharmaceutical industry is among the biggest ones in the world and plays a major role in the market especially for less developed countries. Regulatory warnings and bans on Indian drug factories for failing manufacturing standards are hitting the sector since several years. The government is making a political move to accomplish with international blames but how much concrete the change will be still remains unclear


by Pietro Dionisio

Degree in Political Science, International Relations

Cesare Alfieri School, University of Florence, Italy

 International Pressure on India’s Drug Industry

The Hide-and-Seek Game of Modi’s Administration


The Indian pharmaceutical sector accounts for about 2.4 per cent and 10 per cent of the global pharmaceutical industry in value and volume terms respectively, and is expected to expand at a 15.92 per cent Compound Annual Growth Rate (CAGR) from US$ 20 billion in 2015 to US$ 55 billion by 2020.

Additionally, the government plans to set up a US$ 640 million venture capital fund to boost drug discovery and strengthen pharmaceutical infrastructure at a time when the market is dominated by generic drug industries accounting nearly 80 per cent of the whole Indian pharma production. The Pharma Vision 2020 by the government’s Department of Pharmaceuticals aims to make India a major hub for drug discovery.

What’s more, over the last 10 years, the export of India’s generic pharmaceuticals has reshaped the global drug business. Once known as exporters of bulk active pharmaceutical ingredients (APIs), Indian generic drug makers have moved upwards on the global value chain and managed to gain a foothold in regulated markets such as the US and Europe. Nowadays, India is the largest provider of generic drugs globally accounting for 20 per cent of global generic drugs exports. This makes India a lifeline for millions of people in developing countries, especially in Africa.

But things could unfortunately change since India faces pressure from the United States (US) and Big Pharma lobbies to roll-back its in force health patent rules that still put people first against corporate profits.

In May, a first alert was played by the Narendra Modi central administration by issuing a new policy document about intellectual property rights (IPRs) at large (not only health-related). The new direction is likely to be an effect of the India-US working group created a couple of years ago to review IPRs and loosen pressure on the Country. In the document, seemingly compliant with the WTO’s agreement on TRIPS (Trade Related Intellectual Property Rights), IPRs are meant to be an economic tool allowing India to provide economic growth while safeguarding the public interest. However, just at a careful reading, the words leave room for more than one interpretation making the legislation ambiguous.

And there is more.

In an effort to improve the economy, the government is trying to reform its drugs law to make it easier for companies to do business while ensuring the safety and efficacy of medicines. As such, the government is willing to open the country to foreign investors as regards all economic, including pharmaceutical, sectors. Relevantly, the administration will allow foreign investors to buy up to 74 per cent of Indian drug companies without prior government approval.

So conceived, the move is raising concerns about its effects on domestic pharmaceutical industry. Admittedly, due to  high sector fragmentation, a gradual takeover by foreign investors is likely to impair India’s role as a supplier of low-cost generic medicines to much of the world and create upheaval in the global generics market.

Not to mention that the new direction would also aim to improve regulatory standards and bring drug industry into line with global norms and enforcement of rules, including a fresh look at penalties and punishment for companies violating manufacturing and clinical trial guidelines.The move follows regulatory warnings and bans in recent years on Indian drug factories for failing manufacturing standards.

All things taken together, it is bad news for poor people that the Indian Ministry of Health and Family Welfare has been in touch with the US and EU regulators to get advices and suggestions and make the new law (likely to be ready soon) aligned with international standards. Perhaps, will there be some additional pressures on India? All people in need touch wood.

Otherwise, there is no doubt that the new bill could have the potential to solve significant issues affecting the pharma sector including relevant to the weak Indian drug control system.

Inherently, at a time when Indian drugmakers are defending themselves from poor manufacturing quality accusations from US and European regulators, or have been hauled up before the court for alleged data integrity and sanitary violations, the new bill, once enforced, could hopefully help solve the problem.

Like a coin, the political move embarked on by India shows two faces. It is not clear, indeed, if the government is really changing its position about pharmaceuticals. The words used in the official documents are ambiguous, though it is clear that the Indian administration is trying to slacken the international pressure on its drug sector. However, a real change shouldn’t preferably be made happen considering the role that Indian generic drug makers cover internationally for the sake of poor people living in less developed countries. On the flip-side, since more control on drugs quality is vital, the new law could serve as a much-needed tool.